Kornimate/medical-research-clean huggingface dataset:
a comparison of hearing aid noise programs on speech intelligibility

Conditions: Hearing Loss, Bilateral or Unilateral

Summary: hearing impaired participants will be fit with study devices which will have three different hearing aid programs. speech intelligibility will be measured using validated tests for each of the three hearing aid programs. the order of the hearing aid programs will be randomized across participants and each participant will be blinded as to the programs being tested.

program 1 is the current default in the commercially available devices. programs 2 and 3 are being tested against the current default.

Eligibility criteria:
inclusion criteria: * bilateral moderate to severe hearing loss (n3-n4) * experienced hearing aid user * fluent in english * cognitively able to complete complex listening tasks exclusion criteria: * unilateral hearing loss * new hearing aid user * unable or unwilling to complete complex listening tasks

Keywords: hearing loss
genetics of appendix cancer study

Conditions: Appendix Cancer; Appendiceal Cancer; Appendiceal Neoplasms; Appendiceal Mucinous Neoplasm; Appendiceal Adenocarcinoma; Appendiceal Carcinoid Tumor; Appendiceal Neoplasm Malignant Secondary; Appendix Adenocarcinoma; Appendix Mucinous Neoplasm; Appendix Tumor; Appendix Cancer Metastatic; Appendix NET; Low-Grade Appendix Mucinous Neoplasm; High Grade Appendix Mucinous Neoplasm; High Grade Appendix Mucinous Adenocarcinoma

Summary: the gap study is a prospective cohort study designed to comprehensively investigate genetic variations that may contribute to cancer development among individuals diagnosed with appendix/appendiceal cancer who are ages 18+ years.

the genetics of appendix cancer (gap) study aims to analyze hereditary factors, tumor characteristics and clinical features/outcomes among adults diagnosed with appendix cancer and their biological parents. patients are recruited at any time after a diagnosis of appendix cancer and followed for up to 6 years after study enrollment. this cohort is enriched by robust biospecimens and data collections.

Eligibility criteria:
inclusion criteria: gap social * known diagnosis of appendix cancer in the united states * mentally and physically able to consent and participate in the study gap vanderbilt * known diagnosis of appendix cancer * diagnosed by and/or consulting with a physician/clinical provider participating in the gap study * mentally and physically able to consent and participate in the study gap parent * biological parents (mother and/or father) of individuals actively participating in the gap study * residing in the united states * mentally and physically able to consent and participate in the study exclusion criteria: * women pregnant at the time of consent * prisoners * unable to provide informed consent * unable to read, write, or complete questionnaires in english

Keywords: genetics
an observational study of peginterferon (e.g. pegasys)-based direct acting antiviral triple therapy in patients with chronic hepatitis c genotype 1

Conditions: Hepatitis C, Chronic

Summary: this prospective observational study will evaluate the efficacy and safety of two approved pegylated interferon-based direct acting antiviral triple therapies in patients with chronic hepatitis c genotype 1. patients receiving pegylated interferon (e.g. pegasys) and ribavirin plus either telaprevir or boceprivir in accordance with local standard of care and us labeling will be followed for the duration of their treatment and for up to 24 weeks post-treatment.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * chronic hepatitis c, genotype 1 * receiving pegylated interferon-based direct acting antiviral therapy (pegylated interferon and ribavirin plus either telaprevir or boceprivir) in accordance with local standard of care and us labeling exclusion criteria: * contraindications per us labels
a phase ib study of rc148 as monotherapy or combination for locally advanced or metastatic nsclc

Conditions: Non-Small Cell Lung Cancer

Summary: this study will evaluate the efficacy, safety, pharmacokinetics and immunogenicity of rc148 injection as a single agent or in combination for the treatment of locally advanced or metastatic non-small cell lung cancer

primary objective: to evaluate the efficacy of rc148 injection as monotherapy or combination therapy in patients locally advanced or metastatic non-small cell lung cancer;

Eligibility criteria:
inclusion criteria: 1. voluntarily participate in the study and signed the icf; 2. be willing to and able to act on the trial and the follow up procedures; 3. male or female, aged 18-80 years; 4. expected survival ≥ 3 months; 5. ecog ps score 0 or 1; 6. all participants to be enrolled in cohorts 1-5 must be diagnosed with histopathologically or cytologically confirmed, unresectable locally advanced or metastatic nsclc (stage iiib//iiic/iv according to the 8th edition of uicc/ajcc) and not amendable to curative surgery or radiation as assessed by investigator. exclusion criteria: 1. histopathologically or cytologically confirmed small cell lung cancer; 2. received major surgeries and still in recovery within 28 days before the first dose; 3. received any live vaccine within 28 days prior to the first dose or plan to be vaccinated during the study (except for covid-19 vaccine); 4. received immune checkpoint inhibitor (anti-pd-1/pd-l1/ctla-4 antibody) or other immune checkpoint inhibitor treatment within 28 days prior to the first dose, or experienced prior permanent immunotherapy discontinuation due to immunotoxicity; 5. participated in other clinical trials and received other investigational anti-tumor therapy within 28 days prior to the first dose; 6. poor compliance and unable to complete the study procedures as assessed by investigator; 7. have any other medical conditions, abnormal physical examinations or laboratory examinations that would be suspected interfere with participation or evaluation of the trial or increase the risk to the participant, in view of the investigator.
feasibility study of hematology parameters in covid-19 disease

Conditions: Covid19; Sepsis; Adults; Emergency Department

Summary: the purpose of this study is to evaluate the potential for mdw and other cpd parameters (measured with cbc-diff) to identify covid-19 diseased adult individuals presenting to the hospital with symptoms suggestive of covid-19 or respiratory infection and whose standard of care includes cbc-diff and microbial testing.

the objective of this study is to evaluate mdw and/or combination(s) of hematology parameters that best identify patients with covid-19 disease who tested sar-cov-2 positive by standard of care (soc) covid-19 testing. a feasibility study of consecutive adult patients who presented to the hospital with symptoms suggestive of covid-19 or respiratory infection and whose standard of care testing involves a cbc-diff and microbial testing including rt-pcr testing for sars-cov-2 will be enrolled. this study will evaluate mdw and other cpd parameters performance in covid-19 patients and the ability of mdw to identify rt-pcr positive covid-19 patients as well as potential added value to rt-pcr tests of mdw. a minimum of 50 covid-19 positive and 150 covid-19 negative patients meeting inclusion criteria will be evaluated. patients with symptoms suggestive of covid-19 and who have rt-pcr test samples drawn will be retested on the dxh900 hematology analyzer to capture baseline mdw results. in addition, a retrospective data extraction will be performed for those patient samples tested during the post market study during the covid-19 pandemic that meet the revised study population.

Eligibility criteria:
inclusion criteria: * adult patients \[18-89 years of age\] * present to the emergency department * with symptoms suggestive of covid-19 or respiratory infection * whose assessment includes cbc-diff and rt-pcr testing exclusion criteria: * pregnancy * prisoners * \<18 years of age * \>89 years of age * previously evaluated in this study * no rt-pcr testing * sample age \>2 hours from time of draw * instrument flags, including vote outs and review flags for the mdw parameter * samples stored in refrigerated temperatures
buprenorphine/naloxone treatment for opioid dependence-experiment ii-2 - 5

Conditions: Heroin Dependence; Opioid-Related Disorders

Summary: the purpose of this study is to assess the abuse liability and reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in heroin-dependent volunteers

not available at this time

Eligibility criteria:
inclusion criteria: individuals must be at least 18 yrs of age, currently opioid dependent and must not be seeking treatment. co-morbid substance abuse or dependence disorders may also be present. individuals must be healthy despite drug dependency and have a history of iv opioid use. exclusion criteria: individuals with evidence of an active diagnostic and statistical manual of mental disorders (dsm-iv) axis i psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Keywords: heroin dependence
a prospective evaluation of the strattice-lift to treat anal fistula

Conditions: Anal Fistula; Rectal Fistula; Fistula in Ano; Transsphincteric Fistula

Summary: this clinical trial will evaluate the safety and efficacy of the strattice-lift procedure to treat anal fistulas.

the treatment of anal fistulas remains a challenging clinical problem. fistulotomy is highly effective, but carries a significant risk of postoperative incontinence. a variety of surgical procedures that do not divide the sphincter muscle may be offered to patients, however none of them are as effective as fistulotomy. the lift (ligation of intersphincteric fistula tract) procedure is a newer option for the treatment of transsphincteric fistulas. initial results have been promising. however, some fistulas recur after the lift procedure because the divided ends of the fistula tract recanalize. insertion of a barrier into the intersphincteric space may prevent this process. strattice is acellular porcine dermis, will be used for this purpose. this prospective trial will evaluate the safety and efficacy of the strattice-lift procedure for the treatment of transsphincteric anal fistulas.

Eligibility criteria:
inclusion criteria: 1. subject is 22 years of age or older 2. subject is willing to comply with study related procedures 3. subject is not pregnant 4. subject has a transsphincteric fistula 5. subject is medically fit to undergo lift 6. subject has a draining seton for a minimum of 6 weeks exclusion criteria: 1. crohn's disease 2. pelvic radiation treatment 3. known or suspected hiv/aids 4. known sensitivity to pork products 5. abscess or fistula etiology other than cryptoglandular 6. abdominal malignancies 7. patients with \<1 year life expectancy 8. history of smoking 9. known anorectal dysfunction (fecal incontinence) 10. chronic use of steroids or other agents which may affect wound healing 11. asa ≥ 2 12. unable to consent to study 13. unable to complete 1 year follow up
aria (atacand renoprotection in nephropathy pt.)

Conditions: Non-diabetic Nephropathy With Hypertension

Summary: to determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to the end of 28-week treatment


Eligibility criteria:
inclusion criteria: * hypertension; a)135mmhg \< systolic blood pressure \<180mmhg and/or 85 mmhg \< diastolic blood pressure \<100 mmhg. or b) the subject has been treated with antihypertensive medication * proteinuria (urinary protein/creatinine ratio between 500 mg/g and 5000 mg/g) exclusion criteria: * current serum-creatinine \> 265 mmol/l (\>3 mg/dl). * current serum-potassium \> 5.5 mmol/l * known hypersensitivity to angiotensin (at)1-receptor blocker

Keywords: candesartan cilexetil non-diabetic nephropathy hypertension urine protein creatinine ratio
covid-19 booster readiness survey

Conditions: Vaccination Refusal

Summary: the purpose of this administrative survey is to inform health system logistics by assessing the attitudes towards towards the bivalent covid-19 boosters held by healthcare workers (hcws) at a large, rural health system. it will also test, prospectively, the effect on interest in the bivalent covid-19 booster of different framing approaches in a survey question sent to employees of a large, rural health system.

the food and drug administration has authorized two bivalent covid-19 boosters with the expectation that the centers for disease control will soon recommend them. the researchers plan to survey the hcws at a large, rural health system on their attitudes on the bivalent booster. this survey will gather data on hcws' interest in a bivalent booster, reasons for hesitancy, risk perception about covid-19 infection and its complications, and prior covid-19 infection and vaccination. respondents will also be randomly assigned to see different versions of the question asking if they are interested in a bivalent booster with different framing approaches, such as protection of the self or protection of patients (for patient-facing employees). information on prior vaccination and perceptions of risk will also be gathered and used as covariates in the analysis.

Eligibility criteria:
inclusion criteria: * employee at the health system

Keywords: communication surveys and questionnaires vaccination economics, behavioral
attention to retinoblastoma diagnosed in the trauma setting

Conditions: Retinoblastoma; Wounds and Injury

Summary: to study the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma.

retrospective study of the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma and to alert ophthalmologists to the possibility of rb in children presenting with or without trauma-related symptoms and signs.

Eligibility criteria:
inclusion criteria: * the consecutive patients with rb managed at the ocular oncology service of zhongshan ophthalmic center, sun yat-sen university, between january 2013 and august 2018. exclusion criteria: * the patients who didn't have undergone trauma before diagnosis of rb.
the goodnews lifestyle enhancement program

Conditions: Cardiovascular Disease; Hypertension; Diabetes; Obesity

Summary: this study will train lay health promoters (lhps) from african-american churches to administer healthy living lessons and activities to their congregations in order to improve overall health and address cardiovascular disease. the primary hypothesis is that lhp training combined with a well supported maintenance strategy will be more effective than lhp training alone in reducing risk factors for cardiovascular disease.

the goodnews trial is an 18-month effectiveness trial with an 18-month extended maintenance study, among 20 african-american and low-income congregations participating in the goodnews faith-based lay health promotion program. after training, congregations will be randomized to either goodnews with a health maintenance intervention (goodnews-i) or goodnews program alone (goodnews-pa). the maintenance intervention combines elements of the medical care model and features of community-based support. primary data collection will occur at baseline, 18, and 36 months with the two primary outcomes being levels of physical activity as measured by 7- day physical activity recall (par) and dietary change as measured by the diet history questionnaire (dhq). the primary hypothesis is that the maintenance group will significantly increase physical activity and healthy eating behavior compared to the program only group. we also hypothesize that lipoprotein and glucose levels, and blood pressure will be significantly improved over baseline in the goodnews-i group and that these changes will be significantly greater than in the goodnews-pa group. at the end of the trial, both groups will continue in an 18-month extended maintenance study.

Eligibility criteria:
inclusion criteria: * member of selected church congregations in the predominantly african-american geographical area of dallas, texas, known as south dallas or the southern sector. * between the ages of 18 -70 years exclusion criteria: * anyone under the age of 18 * anyone who is not an active member of one of the participating churches

Keywords: community-based participatory research (cbpr) vulnerable population high-risk population african-americans health disparities clinical trial
maitland thoracic mobilization versus mulligan thoracic mobilization in kyphotic patients with shoulder impingement syndrome

Conditions: Shoulder Impingement Syndrome; Kyphosis Thoracic

Summary: in recent years the management of shoulder impingement syndrome (sis) included the thoracic spine as it was proved that it's highly correlated to pathologies in shoulder joint. sis is proved to be associated with kyphotic posture. also, it was proved that changing sitting posture affects the measured rom of shoulder joint and this implicates the influence of changing thoracic position on shoulder mechanics. explanations were made regarding the role of thoracic spine in affecting the shoulder joint through two ways. firstly, through affecting the mechanics of scapular movements and secondly through altering the length tension relationship of shoulder musculature. this study would aim at studying the most effective thoracic mobilization in the treatment of sis.


Eligibility criteria:
inclusion criteria: * shoulder impingement syndrome sis clinically diagnosed by using hawkins-kennedy test, the painful arc test, and the infraspinatus muscle strength test; and for a rotator cuff tear, the infraspinatus and the drop-arm test and supraspinatus muscle strength tests. * subjects will be diagnosed of having postural kyphosis proved by a physician referral or modified cobb's angle of more than 40 degrees (x-ray). exclusion criteria: * the participants with any musculoskeletal abnormalities eg. glenohumeral instability. * neurological abnormalities. * surgical operation of the last 4 months will be excluded from the study. * shoulder corticosteroid injection at any time in the past. * engaging in any athletic physical activities.
effect of melatonin on palatal wound healing (randomized controlled clinical trial)

Conditions: Wound Heal

Summary: the aim of the study is to assess the effect of topical melatonin loaded gelatin sponge on donor palatal site healing, after palatal graft harvesting.

autogenous soft tissue grafts can be considered the gold standard treatment for many muco-gingival problems. the most common site for harvesting soft tissue grafts is the palate. many harvesting techniques have emerged, but the epithelialized graft harvesting technique is one of the most reliable and effective techniques as it imparts the superficial section of the connective tissue which contains the highest amount of lamina propria. unfortunately, it leaves an open palatal wound healed by secondary intention, increasing pain and post-operative morbidity. in order to overcome these inadequacies investigators will cover the donor site with melatonin loaded gelatin sponge and evaluate its effect on the healing process.

Eligibility criteria:
inclusion criteria 1. patients who have at least one site of natural dentition or dental implants that need to be treated by free palatal graft surgery for indications including progressive recession, planned prosthodontics, presence of a mucogingival deformity, or a lack of keratinized gingiva. 2. patients who have at least 4 mm thickness of palatal mucosa (at donor site) exclusion criteria: 1. history of smoking. 2. patients who have any known disease that interfere with periodontal surgery. 3. patients who have any dermal or autoimmune diseases. 4. patients who have any previous adverse reactions to the products (or similar products) used in this study. 5. pregnant and lactating women. 6. patients who have a palatal infection.

Keywords: gelatin sponge melatonin
cognitive training and exercise for women with breast cancer and cognitive impairment

Conditions: Breast Cancer

Summary: chemotherapy-related cognitive impairment is a prevalent and distressing condition among breast cancer survivors, adversely affecting memory, attention, and overall cognitive function, thereby diminishing quality of life. emerging evidence suggests that multimodal interventions combining cognitive training and adapted physical exercise may mitigate these cognitive deficits and associated symptoms. this study aims to evaluate the efficacy of a 12-week structured intervention integrating cognitive training and supervised physical exercise in improving cognitive function, fatigue, sleep quality, psychological distress, and overall well-being in women with breast cancer. furthermore, it seeks to determine the optimal timing for such interventions to maximize their effectiveness. a randomized controlled trial involving 220 participants will assess subjective and objective cognitive outcomes, brain activity, and physical performance. the findings from this research may contribute to the development of evidence-based rehabilitation strategies, enhancing cognitive health and quality of life in breast cancer patients.


Eligibility criteria:
inclusion criteria: * women aged 18 years or older who were diagnosed with stage 0 to iv breast cancer. * women undergoing chemotherapy (at least two cycles) or having completed it at least six months earlier. * cognitive impairment must be reported, with scores below 54 on the fact-cog scale exclusion criteria: * women with significant neurological conditions. * women with psychiatric conditions. * women with contraindications for physical exercise.

Keywords: breast cancer chemotherapy-related cognitive impairment cognitive training exercise oncology nursing
combination therapy of anthracyclines for children with nephroblastoma

Conditions: 0.5-14 Year Old Children With Nephroblastoma

Summary: this study aims to estimate the efficacy and side effects of study drugs in children with nephroblastoma who are treated with combination therapy.


Eligibility criteria:
inclusion criteria: 1. age 6 months old to 14 years old. 2. no smoking history. 3. pathologically confirmed nephroblastoma. 4. informed consent and assent has been obtained before any study assessment is performed. 5. good compliance. 6. need to be applied to anthracycline chemotherapy according to the diagnosis and treatment recommendations for chinese children with nephroblastoma (current version cccg-wt-2016). 7. need to be applied to doxorubicin according to the diagnosis and treatment recommendations for children with nephroblastoma (cccg-wt-2016). exclusion criteria: 1. patients with cardiovascular disease in addition to nephroblastoma. 2. patients with digestive, neurological, circulatory, renal or liver disease, blood disorders or growth abnormalities unrelated to the tumor. 3. patients have been treated with chemotherapy or cardiotoxic nephrotoxic drugs in the past 4 weeks. 4. patients have participated in other clinical trials in the past 4 weeks. 5. patients with mediastinal disease. 6. patients who have undergone mediastinal radiotherapy due to other tumors or received other treatments that may cause heart damage.

Keywords: nephroblastoma anthracycline liposome doxorubicin doxorubicin pharmorubicin pirarubicin