Kornimate/medical-research-clean huggingface dataset:
metastatic prostate cancer men's attitudes towards treatment of the local tumour and metastasis evaluative research

Conditions: Prostate Cancer Metastatic; Radiotherapy Side Effect; Surgery; Urologic Cancer; Quality of Life; Patient Satisfaction; Health Care Utilization

Summary: systemic therapy (i.e androgen deprivation therapy with docetaxel, enzalutamide, apalutamide or abiraterone acetate) has increased overall survival in men with hormone-sensitive metastatic prostate cancer. novel local cytoreductive treatments and metastasis directed therapy are being evaluated, these can confer additional harm, but might improve survival. we aim to elicit men's preferences for and willingness to accept trade-offs between potential improved survival and cytoreductive treatment risks using a 'discrete choice experiment'.

objectives: to determine the attributes associated with treatment that are most important to men with hormone-sensitive metastatic prostate cancer (mpca). to determine men's preferences for, and trade-offs between, the attributes (survival and side-effects) of different treatment options in metastatic prostate cancer including systemic therapy, local and metastases-directed physical therapies. phase: prospective multi-centre observational cohort design: discrete choice experiment, single-visit, electronic questionnaire design sample size: multi-centre stage (stage 3) n = 300 patients population: men with newly-diagnosed metastatic prostate cancer who have not consented to a form of local cytoreductive or metastasis directed therapy.

Eligibility criteria:
inclusion criteria: 1. diagnosed with prostate cancer within 4 months of screening visit 2. performance status 0-2 exclusion criteria: 1. castrate-resistant metastatic prostate cancer 2. patient has consented to a form of local cytoreductive treatment to prostate 3. patient has consented to a form of metastasis directed therapy
perioperative testosterone replacement therapy for the improvement of post-operative outcomes in patients with low testosterone

Conditions: Hypogonadism; Malignant Urinary System Neoplasm; Urinary System Disorder; Urinary System Neoplasm

Summary: this phase i trial investigates the safety of testosterone replacement therapy around the time of major urologic surgery (perioperative) in order to improve quality of life and post-operative outcomes such as decreased length of hospital stay, complications, and mortality in patients with low testosterone levels. studies have demonstrated that patients undergoing testosterone replacement therapy have increased lean body mass, decreased fat mass and have improved physical function. testosterone replacement therapy can also stimulate bone formation and may decrease the risk of fracture. information from this trial may be used to support the incorporation of testosterone level testing and testosterone replacement into the perioperative treatment decision-making process.

primary objective: i. to examine the safety and feasibility of perioperative testosterone replacement (tr) therapy in hypogonadal male patients undergoing major operations. outline: patients are assigned to 1 of 2 arms. arm i: patients with low testosterone levels receive testosterone cypionate intramuscularly (im) once a week (qw) for 3 months in the absence of disease progression or unacceptable toxicity. arm ii: patients with normal testosterone levels receive standard peri-operative care.

Eligibility criteria:
inclusion criteria: * patients already scheduled for major surgery requiring an overnight hospital stay * patients must be able to give informed consent * patients must be willing to do study's preoperative and post-operative assessment tools exclusion criteria: * patient with history of prostatectomy with detectable prostate specific antigen (psa) * patient with history of prostate radiation/chemotherapy treatment and has experienced bounce or rise in psa * patients with history of/undergoing orchiectomy * patients undergoing hormone replacement therapy currently or history of testosterone use within last year * patients who use anabolic steroids * patients with history of solitary or undescended testis * patients with history of pituitary disorders * patients with history of thromboembolic events in last year * patients with hematocrit \> 55% * patients with uncontrolled congestive heart failure * special populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women and prisoners
lllt to reduce low back pain

Conditions: Low Back Pain

Summary: the purpose of this research study is to gather information on the effectiveness of the trident low-level laser therapy (lllt) in combination with clinical patient education manuals to reduce lower back pain.

patients will be administered one of 4 treatment options using the trident lllt. the treatment options include 2 treatments, 4 treatments, 6 treatments or 8 treatments. all patients will receive two self-help patient education manuals. low back pain will be compared among all 4 options at the end of week 6.

Eligibility criteria:
inclusion criteria: * reporting a primary pain point in lower back. * pain intensity reported at baseline must be 4 and above on the visual analogue scale (promis numeric rating scale). * individual able to participate fully in all aspects of the study and have understood and signed study informed consent. exclusion criteria: * have used pain medications or participated in a pain treatment within three days of study enrollment. * have an implanted device (including lap band) in the targeted area of low level laser treatment. * have used an investigational drug within 30 days of study enrollment. * reports being currently pregnant, lactating, or are of child-bearing potential or are likely to become pregnant during the low level laser treatment phase and are unwilling to use a reliable form of contraception. acceptable forms of contraception include: hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants; barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm); intrauterine device (iud); total hysterectomy or tubal ligation; abstinence (no sex). * have a history of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease. * have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, metabolic disease (such as uncontrolled diabetes type 2), active cancer, actively receiving l treatment for cancer or within 1 year of cancer remission. * surgical intervention for pain within 1 month prior to enrollment. * active infection, wound or other external trauma to the areas to be treated with the laser * known photosensitivity disorder. * have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.

Keywords: laser lllt back pain pain low back pain
percutaneous aponeurotomy in the treatment of dupuytren's disease

Conditions: Dupuytren Disease

Summary: the efficiency of percutaneous aponeurotomy in the treatment of dupuytrens disease is well known. however, the duration of the clinical improvement after aponeurotomy is not well known. this study aims primarily at measuring the incidence rate of local relapse of dupuytrens-induced finger flessum, within two years following treatment by percutaneous aponeurotomy in dupuytrens.


Eligibility criteria:
inclusion criteria: * patient suffers from dupuytren disease * patient has at least one finger with at least 20° flessum on the metacarpophalangeal joint and/or on the proximal interphalangeal joint * patient has chosen to benefit from local treatment exclusion criteria: * pregnancy * breastfeeding * no social insurance
clinical evaluation of osna breast cancer system in breast cancer patients receiving neoadjuvant therapy

Conditions: Breast Neoplasms; Breast Diseases

Summary: the study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the osna breast cancer system for patients receiving sentinel lymph node biopsies after receiving neoadjuvant hormonal/chemotherapy as compared to permanent section hematoxylin and eosin (h\&e) and immuno-histochemistry (ihc) staining.


Eligibility criteria:
inclusion criteria: * male or female * 18 years of age or older * diagnosed pre-surgically with t1-t3 or t4 non-inflammatory breast cancer, clinically node positive or node negative upon clinical examination * scheduled for sln biopsy after receiving neoadjuvant hormonal or chemotherapy * subjects (or the subjects' legal representatives) who have read, understood (to the best of their ability) and signed the informed consent form. exclusion criteria: * pregnant subjects, confirmed by interview with either subject or treating physician * subjects previously diagnosed with other invasive cancer. subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma * participation in other neoadjuvant protocols specifically requiring sln biopsy prior to administration of neoadjuvant chemotherapy or hormonal therapy * subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).

Keywords: metastasis molecular pathology
tissue plasminogen activator & plasminogen activator inhibitor type-1 in gingival tissues of chronic periodontitis

Conditions: Chronic Periodontitis

Summary: tissue plasminogen activator and plasminogen activator inhibitor type-1 gene expression will be evaluated clinically and histopathologically through hematoxylin and eosin as well as by quantitative reverse transcription polymerase chain reaction in the gingival tissues of chronic periodontitis in an attempt to investigate whether the expression of these proteins could be involved in the disease pathogenesis or not, and to assess as well if their expression will be affected by the applied surgical periodontal treatment.

30 subjects were enrolled in this study and divided into: group i (control group): 10 periodontally healthy volunteers, group ii (chronic periodontitis group): 20 patients suffering severe cp and group iii (treated group): 20 patients who were scheduled for ofd. gingival samples were collected from all subjects at baseline and at 3 months after ofd from the cp patients. then, hematoxylin and eosin (h\&e) stained slides were examined and gene expression levels of t-pa and pai-1 were measured in the gingiva through quantitative reverse transcription polymerase chain reaction (rt-pcr).

Eligibility criteria:
inclusion criteria: * patients with severe chronic periodontitis * pocket depth (pd) of ≥5 mm * clinical attachment level (cal) ≥5 mm exclusion criteria: * pregnant women * subjects taking any type of medication and/or antibiotic therapy during the 3 months before the study * subjects who received periodontal treatment within the past 6 months * smokers
hepatic encephalopathy: lactulose or polyethylene glycol (h.e.l.p.)

Conditions: Hepatic Encephalopathy; HE; Cirrhosis; Altered Mental Status; AMS

Summary: the purpose of this study is to evaluate whether the use of polyethylene glycol is superior and more safe in treating hepatic encephalopathy compared to lactulose and also to determine if treatment with polyethylene glycol will reduce the duration of hospital stay.

hepatic encephalopathy is the occurrence altered level of consciousness as a result of cirrhosis and liver failure. main treatment goal for hepatic encephalopathy is to eliminate the precipitating factor and to decrease circulating ammonia level. current standard for treating he is treatment with lactulose. lactulose are metabolized by colonic bacteria to byproducts which cause catharsis and reduces ph, thereby inhibiting ammonia absorption. however, there is limited evidence available to demonstrate the efficacy. studies on animal model have suggested that polyethylene glycol 3350-electrolyte solution (golytely) is effective in clearing gut bacteria and reducing the ammoniagenesis in colon. recently published study by robert rahimi, university of texas southwestern medical center found that polyethylene glycol is more effective in improving he over the first 24 hours compared to lactulose and also may reduce duration of hospital stay.

Eligibility criteria:
inclusion criteria: * age 18 - 80 * male and female of all races and ethnicities * cirrhosis of any cause * any grade of hepatic encephalopathy (1-4) * representatives have to be willing to comply with all protocol procedures and to understand, sign and date an informed consent document and authorize access to protected health information on the subject's behalf exclusion criteria: * acute liver failure * prisoners * structural brain lesions (as indicated by ct and confirmed by neurological exam) * other causes of altered mental status * previous use of rifaximin or neomycin within last 7 days * pregnancy * serum na \<125 meq/liter * receiving more than 1 dose (30 cc) of lactulose prior to enrollment * uncontrolled infection with hemodynamic instability requiring vasopressors.

Keywords: hepatic encephalopathy hepatic coma he pse lactulose golytely cirrhosis hepatic insufficiency liver cirrhosis fibrosis brain damage, chronic delirium encephalitis neurotoxicity syndromes liver failure liver diseases digestive system diseases brain diseases, metabolic brain diseases central nervous system diseases nervous system diseases metabolic diseases pathologic processes confusion neurobehavioral manifestations neurologic manifestations signs and symptoms delirium, dementia, amnestic, cognitive disorders mental disorders central nervous system viral diseases virus diseases central nervous system infections poisoning substance-related disorders citric acid
coenzyme q10 and vitamin a, c, e in relation to the oxidative stress, antioxidant enzyme activity and inflammation in subjects with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: metabolic syndrome (ms) is a significant risk factor of cardiovascular disease. however, the relationships between coenzyme q10, antioxidant vitamins (vitamin a, c, e) and the prevention of the risk of ms are still inconsistent. the purposes of this study are going to investigate the relation of coenzyme q10, antioxidant vitamins concentration with the blood lipid levels, the markers of lipid peroxidation (tbars), antioxidant enzymes activities (catalase, glutathione peroxidase and superoxide dismutase), and the inflammatory markers (hs-crp,il-6 and adiponectin). the investigators will recruit ms patients (case group, n = 100) and age-gender matched healthy subjects from previous study(n = 105) as a control group . the inclusion criteria of ms are according to the bureau of health promotion, department of health in taiwan (2007).hopefully, the results of this study could provide the information to what has been know in ms subjects. the investigators expect coenzyme q10 or antioxidant vitamins could be a preventive supplement to reduce the risk of ms.


Eligibility criteria:
inclusion criteria: * metabolic syndrome * healthy individuals with normal blood biochemical values. exclusion criteria: * age \< 18y * antioxidant vitamins supplements use * pregnant women
elemental formula hypoallergenicity

Conditions: Food Hypersensitivity

Summary: the primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the american academy of pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (cma) with 95% confidence as compared to a commercially available hypoallergenic formula.


Eligibility criteria:
inclusion criteria: * born at term (\>36 weeks gestation) * 2 months to ≤12 years of age at enrollment * documented cma within 6 months prior to enrollment * otherwise healthy * asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable * expected daily intake of at least 8 oz (240ml) of the study formula during the open challenge phase * having obtained his/her legal representative's informed consent exclusion: * children consuming mother's milk at the time of inclusion and during the trial * any chromosomal or major congenital anomalies * any major gastrointestinal disease or abnormalities other than cma * chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay) * immunodeficiency * anti-histamine use in 7 days prior to the first food challenge (eyedrops are permitted) * oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroid use are permitted) * unstable asthma * severe uncontrolled eczema * severe anaphylactic reaction to milk within the last 2 years * severe anaphylactic reaction to breastmilk within the last 2 years * subject who in the investigator's assessment cannot be expected to adhere to the study protocol * currently participating in another clinical trial.

Keywords: cow milk allergy cma
monitoring treatment response with on-board dwi during neo-adjuvant chemo-radiation for rectal cancer using magnetic resonance-guided-radiotherapy systems

Conditions: Rectal Adenocarcinoma

Summary: feasibility of using a diffusion sequence of a mrgrt system as an early marker of treatment response during nrct of rectal adenocarcinoma.

feasibility of using a diffusion sequence of a mrgrt system as an early marker of treatment response during nrct of rectal adenocarcinoma.

Eligibility criteria:
inclusion criteria: 1. patient over 18 years old. 2. diagnosis of histologically confirmed rectal adenocarcinoma for which nrct has been indicated. 3. karnofsky index (kps) ≥ 70 or ecog = 0 or 1 4. signed consent to participation. 5. for women of childbearing age, effective contraception must also be agreed for the duration of treatment. 6. affiliation to a social security regimen, or beneficiary of such a regimen. exclusion criteria: 1. predominant mucinous component on initial mri, biopsy and / or definitive pathology. mucin may lead to overestimation of adc values on dwis. 2. contraindications to the mri procedure (non compatible pacemaker or other metallic foreign body, severe claustrophobia). 3. exclusive radiation therapy. 4. other associated neo-adjuvant treatment. 5. delayed completion of the surgery (more than approximately 10 weeks after the end of the nrct) or cancellation of the surgical procedure. 6. contraindications to capecitabine: severe hepatic impairment, severe renal impairment (creatinine clearance \<30 ml / min), 7. known deficiency of dihydropyrimidine dehydrogenase (dpd), known hypersensitivity to 5-fu / capecitabine and / or its excipients. 8. participation in a protocol with concurrent treatment. 9. pregnant or likely to be pregnant (without effective contraception) or breastfeeding 10. person in emergency situation, person of legal age subject to a legal protection measure, or unable to express his / her consent. 11. impossibility of attending the medical examination of the test for geographical, social or psychological reasons.

Keywords: diffusion weighted imaging radiation therapy
prophylaxis vaccine antibodies ebola

Conditions: Ebola Virus Disease

Summary: * three measures are currently being implemented to control ebola outbreaks: * monitoring of contacts * isolation and treatment of sick people * vaccination of the population in high-risk areas. * in contacts with high viral exposure and therefore a high risk of incubation and rapid expression of infection, the r-vsv-zebov vaccine does not provide adequate protection because vaccine antibody production is effective 6 to 10 days after administration. * specific monoclonal antibodies (mab) from the regeneron and mab114 research specialties have been shown to be effective in reducing mortality in patients with ebola virus disease (evd). * their use in a single parenteral administration and good tolerability make them candidates for use in post-exposure prophylaxis (pep) in individuals at high risk of viral exposure. * a comprehensive strategy for the protection of high-risk contacts must therefore be implemented, including the vaccine and the mabs, to ensure both immediate and prolonged protection. indeed, the efficacy of the vaccine is likely to be diminished when co-administered with mabs, as both strategies share the same viral target (the gp envelope glycoprotein) and the vaccine is replicative (and therefore may be inhibited by mabs). provae aim to evaluate the effectiveness of a comprehensive strategy to prevent transmission of mve in contacts at high risk of infection, including (i) post-exposure prophylaxis with mabs and (ii) vaccination with r-vsv-zebov.


Eligibility criteria:
the inclusion criteria for the efficacy trial are: * have had, within the previous 72 hours, a high-risk contact with an ebola patient confirmed by rt-pcr; * be 18 years of age or older at the time of inclusion; * have no symptoms of evd; * give consent to participate in the efficacy trial; * agree not to participate in any other therapeutic or vaccine study until the end of the trial follow-up. the criteria for non-inclusion in the efficacy trial are: * have a history of evd (self-report); * have been vaccinated with ervebo prior to the start of the study; * have participated in another therapeutic or vaccine study within 15 days prior to inclusion. inclusion criteria for the immunology ancillary study are: high risk arm: * be included in the efficacy trial; * be available for extended follow-up as specified in the protocol; * specifically consent to the immunology ancillary study. control arm: * be 18 years of age or older at the time of inclusion; * have no symptoms of evd; * eligible for ervebo vaccination according to national program criteria; * be available for extended follow-up as specified in the protocol; * consent specifically for the ancillary immunology study. the criteria for non-inclusion in the immunologic ancillary study are: * all efficacy trial non-inclusion criteria; * hiv positive; * pregnant women.
npc staged n2-3m0:adjuvant chemotherapy or just observation after concurrent chemoradiation

Conditions: Nasopharyngeal Carcinoma

Summary: by this clinical trial, the investigators are trying to give an answer to such a question. whether npc patients staged n2-3m0 need adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation?

recent research (lancet oncology 2012)shows that no survival benefits were achieved by adding adjuvant chemotherapy after concurrent chemoradiation in patients with locoregionally advanced npc. but in patients with even high risk of distant metastasis(staged n2-3m0),is adjuvant chemotherapy necessary?

Eligibility criteria:
inclusion criteria: 1. pathologically confirmed untreated npc patients staged n2-3m0 2. age: 18y - 65y 3. with mri examinations 4. ecog≤2 5. with written consent exclusion criteria: 1. without a second cancer 2. pregnancy 3. with other severe diseases(blood,liver ,kidney or heart diseases) 4. could not staged properly 5. without written consent

Keywords: nasopharyngeal carcinoma staged n2-3m0 adjuvant chemotherapy