Kornimate/medical-research-clean huggingface dataset:
patient reported outcomes (pros) in anal cancer patient treated by intensity modulated radiotherapy (imrt).

Conditions: Anal Cancer Patients

Summary: radiochemotherapy is the standard treatment for neoplasms of the anal canal with excellent rates of local control and preservation of the anal sphincter. however, patients may experience a deterioration of quality of life related to sequelae of the treatment particularly at intestinal, anal sphincter and sexual level. few studies to date have documented patient-reported outcomes (pros) in this area. the aim of this observational study is to verify the quality of life (qol) of the patients by means of self-completed questionnaires.

in recent times, the focus on collecting patient-reported outcomes (pros) has increased in healthcare. the food and drug administration defines pros as a -measurement of any aspect of a health status of the patient that comes directly from the patient-. these includes disease symptoms, functional aspects and quality of life (qol). the collection of pros, combined with physician-assessed toxicity, is constantly being incorporated into clinical practice and studies to provide a more holistic picture of the impact of treatment on patients and prove useful for planning future interventions. although the use of pros has now become the standard for measuring quality of life of patients there are still few studies on the self-reported long-term qol of anal cancer patients and on disease or therapy related symptoms that affect qol. therefore, the eortc (european organisation for research and treatment of cancer) has recently developed the specific quality of life questionnaire for anal cancer (qlq-an27) module to explore typical symptoms of anal cancer and its therapy. in this study, the qlq-an27 questionnaire will be administered together with the eortc quality of life 30 (qlq 30) in patients with anal cancer who have undergone radio-chemotherapy. the questionnaire may be administered before treatment, after treatment and during follow-ups until completion of the fifth year. this is an observational study both retrospective and prospective.

Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) 0-3 * minimum 18 years old * squamous cell carcinoma of the anal canal * low burden of metastatic disease at diagnosis * indication for radiochemotherapy treatment * informed consent exclusion criteria: * age under 18 years * eastern cooperative oncology group (ecog) higher than 3 * metastatic disease at diagnosis not amenable to radiochemotherapy treatment

Keywords: pros qol eortc anal cancer radiotherapy radiation therapy follow up
necessity for repetitive education of behavioral modification

Conditions: Patients Who Had the Urine Volume at Nighttime More Than One Third of Total Daily Urine Volume (NPU) and Voided More Than Two Times at Nighttime (Nocturia)

Summary: few studies have reported the efficacy of repetitive education for behavioral modification as the first-line therapy for patients with nocturnal polyuria (npu). the aim of this study is to investigate the efficacy of repetitive education for behavioral modification as the first-line therapy in the patients with npu and to show whether a single education for behavioral modification is sufficient for the patients.

even though behavioral modification therapy seems to be effective, it is not usually recommended for patients with nocturia because much patience and understanding is required for the patients to follow the therapy. few studies have reported the efficacy of repetitive education for behavioral modification as the first-line therapy for patients with nocturia and nocturnal polyuria (npu). furthermore, no report demonstrated the evidence about how many times or how long the education for behavioral therapy should be performed and how long will the education effect would continue. the aim of this study is to investigate the efficacy of repetitive education for behavioral modification as the first-line therapy in the patients with npu and to show whether a single education for behavioral modification is sufficient for the patients.

Eligibility criteria:
inclusion criteria: * the urine volume at nighttime more than one third of total daily urine volume * voided more than two times at nighttime exclusion criteria: * postvoid urine volume more than 100 ml * sleep disturbance including sleep apnea * diabetes mellitus * diabetes insipidus * neurogenic bladder * congestive heart failure * indwelling catheters * urinary tract infection or urinary stones

Keywords: behavior modification, behavior therapy, nocturia, polyuria, quality of life
analgesic efficacy and safety study of t-62 in subjects with postherpetic neuralgia

Conditions: Postherpetic Neuralgia

Summary: the purpose of this study is to evaluate the safety and efficacy of t-62 in subjects with postherpetic neuralgia.

study k862-08-2002 is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of t-62 in subjects with postherpetic neuralgia (phn) and its associated pain. up to 20 centers in the united states will participate in the trial. two doses of t-62 and placebo will be evaluated in parallel design. approximately 130 subjects will be enrolled to complete approximately 100 subjects. each subject will complete a 7-day screening period , a 28-day treatment period, and a 14-day post-treatment period. each subject will complete 8 clinic visits over the course of the study during which procedures and assessments of safety, efficacy, and protocol compliance will be performed.

Eligibility criteria:
inclusion criteria (additional criteria apply): 1. diagnosis of phn made by primary treating physician and is experiencing pain for at least 3 months after the healing of a herpes zoster rash. 2. subject is in general good health. 3. females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control or be surgically sterile or post-menopausal. double barrier methods and abstinence are the only acceptable birth control methods for this study. exclusion criteria (additional criteria apply): 1. subject has a current acute disease or unstable chronic disease other than post herpetic neuralgia. 2. subject has a clinically important history of a medical disorder (particularly cardiovascular, neurological \[e.g., diabetic neuropathy\], respiratory, or hepato-biliary systems \[e.g., gilbert syndrome\]) that would confound and/or interfere with the safety and efficacy evaluations defined in the protocol. 3. subject is being treated for a medical condition that affects cardiac conduction. 4. subject's plasma alanine aminotransferase (alt) aspartate aminotransferase (ast), total bilirubin, and alkaline phosphatase (ap) values are not within the normal reference ranges. 5. subject has a history of asthma requiring management for reactive airway disease in the last year. 6. subject uses and is unwilling/unable to discontinue use of (a) lyrica® (pregabalin), cymbalta® (duloxetine), neurontin® (gabapentin), topical lidocaine, topical capsaicin, or other medication specifically indicated (i.e., labeled) for the treatment of neuropathic pain, or (b) anticonvulsant medications to control post herpetic neuralgia. 7. subject currently requires anticonvulsant medications to control seizures.

Keywords: postherpetic neuralgia varicella zoster shingles neuropathic pain analgesia pain
surgical management of knee septic arthritis

Conditions: Septic Arthritis

Summary: surgical excisional debridement is the mainstay of management in septic arthritis with necessary decompression, lavage, debridement, and partial synovectomy. however, there has been considerable debate over the optimal modality. most surgeons perform an open arthrotomy or arthroscopic debridement, although serial aspiration can be considered as an option in very limited circumstances with patients who cannot tolerate surgery. while open arthrotomy has been often utilized, there has been an increasing number of proponents for arthroscopic treatment citing lower re-infection rates and better functional outcomes. however, there has been a lack of well-designed prospective studies comparing surgical treatment modalities for native knee septic arthritis. the goals of this present study are to determine if arthroscopic management of septic arthritis in the native knee resulted in a lower number of surgeries and a shorter length of stay compared to open arthrotomy. secondary outcomes included differences in postoperative pain and improvements in lysholm knee scores.


Eligibility criteria:
inclusion criteria: * adults (\>18 years old) * have a diagnosis of septic arthritis of the native knee (synovial wbc \>50k or acrystalline elevated synovial wbc \>25,000 with high clinical suspicion) * willingness to participate in the study exclusion criteria: * unwilling to participate in the study * acrystalline elevated synovial wbc \< 25,000 * crystalline arthropathy with elevated synovial wbc but \< 50,000 * have a history of a prior knee prosthesis (hemiarthroplasty, total knee arthroplasty)

Keywords: orthopedic septic arthritis synovectomy
evaluation of self-management education in first time hearing aid users

Conditions: Hearing Loss

Summary: the study will assess the impact of a hearing aid self-management intervention in first time hearing aid users compared to standard hearing aid self-management. namely, the c2hear multimedia videos, or reusable learning objects (rlos) will be used as the self-management intervention. a departmental hearing aid booklet (standard clinical care) will be used as the control intervention. the study will determine the role of these rlos in self-efficacy for hearing aid(s), hearing aid knowledge and readiness for action compared with standard hearing aid self-management education (hearing aid booklet) in groups of first time hearing aid users. both groups will receive the education at the earliest audiology appointment (hearing assessment), helping to distinguish any impact of earlier education delivery.

research question: to assess the role of interactive hearing aid self-management education on self-efficacy for hearing aid(s), readiness for action and hearing aid knowledge in first time hearing aid users. objectives: primary research question: - does the early delivery of interactive hearing aid self-management education improve self-efficacy for hearing aid(s) compared with standard care in first-time hearing aid users? secondary research questions: i. does the early delivery of interactive hearing aid self-management education improve readiness for hearing aids (their chosen intervention) compared with standard care in first-time hearing aid users? ii. does the early delivery of interactive hearing aid education improve hearing aid knowledge compared with standard care in first-time hearing aid users? study design: a single centre, prospective study with two randomised arms; intervention group (access to rlos in dvd/ or online format, patients' preference) and control (standard hearing aid education booklet). prospective first-time hearing aid users will be invited to take part in the study at hearing assessment, where they will be randomised to either the control or intervention group. following 6-8 weeks of independent use prior to receiving hearing aids, study investigators will assess the impact of each education type on individuals self-efficacy for hearing aids, readiness for action and hearing aid knowledge. comparisons will be made to previous evaluation of the rlos to allow exploration of the impact of earlier hearing aid self-management education on self-report measures.

Eligibility criteria:
inclusion criteria: * adults aged \> 18 years * prospective first-time hearing aid users (defined as no hearing aid use in the last 2 years) * english as their spoken language or good understanding of english exclusion criteria: * those unable to complete study questionnaires due to age-related problems (e.g. cognitive decline)

Keywords: first time hearing aid user
phat life: peer versus adult-led hiv prevention for juvenile offenders

Conditions: HIV/AIDS

Summary: this application proposes a 2-arm randomized controlled trial comparing the impact of phat life on 350 13-17 year-old offenders' risky sex, sti, substance use, and theoretical mediators when delivered by youth representatives (yr) vs. probation staff (ps). 100 facilitators will be recruited to deliver the intervention and participate in the research.

the main objectives of the proposed study are to compare the effectiveness, cost-effectiveness, and sustainability of youth representative-led vs. probation staff-led phat life in a real-world juvenile probation setting. the specific aims of this study are: 1. to conduct a methodologically-rigorous 2-arm trial comparing the impact of phat life on 350 13-17 year-old offenders' risky sex, sti, substance use, and theoretical mediators when delivered by youth representatives (yr) vs. probation staff (ps). 2. to compare the costs and cost-effectiveness of 100 yr-led vs. ps-led phat life with respect to the acquisition of incident sti. we hypothesize: (a) compared to teens in ps-led groups, we expect teens in yr-led groups to report less risky sex and substance use at 6-month follow-up, to demonstrate greater improvement on theoretical mediators of risk, and to have fewer incident sti infections; (b) we expect yr-led phat life to cost less and be more cost-effective than ps-led phat life.

Eligibility criteria:
inclusion criteria: a) male or female gender; b) remanded to a probation program; c) 13-17 years old; d) adolescent is fluent in english; e) are not wards of the department of child and family services (dcfs); and f) they have not already received the phat life intervention. exclusion criteria: a) are unable to understand the consent/assent process; b) do not speak english, because instruments are normed for english speakers; c) do not assent; d) legal guardians do not consent to teens' participation; e) are not 13 -17 years old; f) are not on probation or remanded to a probation program; g) are wards of the department of child and family services (dcfs); and h) they have already received the phat life intervention.

Keywords: hiv prevention juvenile justice sexual health evidence based intervention
nurse-led follow-up care for head and neck cancer patients

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to conduct an early evaluation of a nurse-led follow up intervention added to the usual medically oriented follow up care. besides evaluating the feasibility and acceptability to patients, the effect on psychosocial adjustment and quality of life of patients is determined.

background: after treatment for cancer, follow-up surveillance is regarded important. in head and neck cancer patients however, increasing research evidence shows that at least the goal of detecting recurrence of cancer during routine control visits in an asymptomatic stage is not achieved. other goals of follow-up such as management of treatment complications and helping patients and families cope and adjust remain important and ask for an accurate, effective but tailored and sensitive approach. increasingly, nurses are mentioned as care providers best suited to perform this task. aim: the purpose of this study is to conduct an early evaluation of a nurse-led follow up intervention added to the usual medically oriented follow up care. besides evaluating the feasibility and acceptability to patients, the effect on psychosocial adjustment and quality of life of patients is determined. methods and design: a quasi-experimental prospective design is used. two groups of patients are enrolled consecutively (n=160) and patient data are collected at baseline (t0), at 6(t1) and at 12(t2) months respectively. the duration of the intervention is defined to the first year of follow up. participating nurses are trained prior to the recruitment of the intervention group and receive supervision and individual coaching during the entire duration of the intervention phase. outcome measures: primary outcome, psychosocial adjustment to illness. secondary outcomes, health related quality of life, psychosocial problems, and usage of care.

Eligibility criteria:
inclusion criteria: * diagnosed with a primary head and neck tumour * absence of other cancers diagnosed * treatment with curative intent, all treatment modalities * treatment and 12 month follow-up planned in radboud university nijmegen medical centre * able to speak, write and understand dutch * cognitively able to give informed consent exclusion criteria: * actual psychiatric disease * actual alcohol addiction * known life expectancy of \< 6 months

Keywords: head and neck cancer nurse-led care follow-up care professional-patient relations psychosocial adjustment quasi-experimental prospective quality of life
treatment of patients colonized with methicillin-resistant staphylococcus aureus prior to bone and joint surgery

Conditions: Orthopedic Procedures; Methicillin-resistant Staphylococcus Aureus

Summary: the investigators anticipate that utilization of retapamulin preoperatively will eliminate mrsa colonization among patients who are colonized in their nares.

enhanced characterization of mrsa strains carried by patients and their eradication prior to surgery will significantly reduce healthcare costs to the va by reducing the number of mrsa positive patients who need to be isolated and or closely monitored, and allow healthcare providers to better predict the patient's requirements. in addition, the application of molecular methods will facilitate faster tracking of mrsa postoperative infections.

Eligibility criteria:
inclusion criteria: * patients who are admitted for an orthopedic surgical procedure * all patients will be screened and admitted to the study prior to surgery regardless of eventual culture results for mrsa exclusion criteria: * pregnancy * serious systemic illness due to renal, cardiac or hepatic disease * inability to complete follow-up assessments * allergy or intolerance to retapamulin * bmi \> 30 * uncontrolled diabetes, severe anemia, thrombocytopenia or an underlying hematopoietic disorder or malignancy * patients with serious life-threatening illnesses and those with terminal illness not expected to survive for two years or more will not be enrolled * antibiotics administered during the course of the study will be recorded (name, dose and dates)

Keywords: mrsa colonization orthopedic surgery altabax placebo
the effect of transcutaneous electrical nerve stimulation on quadriceps central activation and gait

Conditions: Tibial Femoral Knee Osteoarthritis; Osteoarthritis

Summary: participants diagnosed with tibial femoral knee osteoarthritis will be assigned to one of three treatment groups including: active transcutaneous electrical nerve stimulation (tens), placebo tens, and a control group. assignment of conditions will be concealed. all participants in each of the three groups will receive physical therapy for all 4 weeks of the intervention. main outcome measures will include quadriceps central activation ratio, quadriceps torque production, womac scores, visual analog pain scores during gait as well as knee joint kinetics and kinematics during gait. the purpose of this study is to to determine if the continuous use of tens therapy for activities of daily living and rehabilitation will positively impact all outcome measures.


Eligibility criteria:
inclusion criteria: * patients who have been diagnosed with a kellgren and lawrence grade of 1- 4 for tibial femoral knee oa in at least one leg or have been diagnosed with oa by a physician using evidence confirmed from imaging studies, arthroscopy, or visualization during an past surgical procedures, or have medical reports confirming oa using imaging studies, arthroscopy, or visualization during an past surgical procedures. * patients between the ages of 18 and 80 years of age. * patients will have a car less than 90%. exclusion criteria: * patients who are pregnant. * patients who have sought medical attention for a trauma to the knee injury within the past 6 months. * patients who have had any orthopaedic lower extremity surgery in the past 6 months, or any surgery that would inhibition proper functioning of the study methodology. * patients with a diagnosis of rheumatoid arthritis. * patients with a known hypersensitivity to electrical stimulation. * patients with any types of neuropathy. * patients with known muscular abnormalities. * patients with a history of a heart condition that precludes them from exercise. * the technique can not be performed on the leg that has had a total knee replacement, but if the other leg meets the inclusion criteria the subject can perform the study on the non- reconstructed leg. * patients diagnosed with malignancy over the stimulating electrode site (thigh and knee). * patients with serious infection near the stimulating electrode sites (thigh and knee) * patients have not had a knee injection in the past 2 weeks. * patients who are unable to walk a series of 30 meters without a walking assistance device.

Keywords: tibial femoral knee osteoarthritis osteoarthritis
erbium laser for treatment of vaginal looseness and sexual dysfunction.

Conditions: Sexual Dysfunction

Summary: patients with a primary complaint of vaginal looseness and sexual dysfunction, visiting a sexual dysfunction clinic at a tertiary medical center will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.

patients suffering from vaginal looseness and sexual dysfunction, as a primary sexual dysfunction complaint will be recruited, sign an informed consent and will receive a thorough explanation regarding the side effects and possible beneficial affects the laser treatments may bestow. patients will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination. follow up after treatment cessation will be for 12 months post-treatment.

Eligibility criteria:
inclusion criteria: * premenopausal women. * women with vaginal looseness and sexual dysfunction as a primary complaint. exclusion criteria: * vaginal bleeding of unknown source. * repeated vaginal infections. * known or suspected cervical pre-malignant neoplasia. * previous treatment with vaginal laser or other forms of energy-based treatment modalities. * pregnancy. * current pelvic inflammatory disease or urinary tract infection. * vaginal surgery during the year preceding study participation. * treatment with systemic or vaginal hormone replacement therapy. * current pelvic floor physiotherapy.