Kornimate/medical-research-clean huggingface dataset:
optimisation of hearing aid fitting

Conditions: Hearing Loss; Hearing Abnormality

Summary: this study aims to explore if objective brain responses to speech stimuli (words and running speech) can be used to evaluate hearing aid fitting in adults. objective brain responses would be beneficial, as they could be used to evaluate hearing with people who are incapable or unwilling to provide subjective responses. the study aims to determine if eeg responses to speech sounds are sensitive to the effects of hearing aids for hearing aid users. secondary, the study will look into the need for using speech stimuli in order to obtain more robust responses compared to current clinical standards.

the research questions addressed are as follows 1. are speech-evoked objective brain responses sensitive to hearing aid amplification? 2. are speech-evoked brain responses sensitive to distortions in speech and can hearing aid amplification resolve issues with brain responses to distorted speech? 3. which tests are optimal for detection of objective brain responses to speech? 4. are realistic speech stimuli (words or running speech) able to robustly detect brain responses compared to current clinical standards (clicks and tones)? the study will be carried out on a group of mildly to moderately hearing impaired subjects between the age of 18 and 70. subjects will be recruited from the royal berkshire nhs foundation trust, where the research will be conducted. participants will have their hearing function and hearing aid fitting checked as described in the design and methodology section of this proposal. during the experiment, participants will be asked to listen to speech sounds presented from a loudspeaker at comfortable listening levels. the responses will be measured with the participant wearing and not wearing hearing aids. additionally, participants will perform a behavioural task for perception of speech. participants will be asked to attend 2 sessions of 2 hours. data collection will run over 1 year.

Eligibility criteria:
inclusion criteria: * subjects are between 18 and 70 years old * native english speakers * have mild to moderate hearing loss in their better ear measured using current clinical standards * routine hearing aid users exclusion criteria: * clinical observation indicates the presence of ear infections or an occluded ear canal on the day of testing * subjects with recent ear surgery (within a month before the day of testing) * subjects who are taking substances that could affect brain responses (e.g. medication for the treatment of depression)

Keywords: hearing loss hearing abnormality
measuring auto-fluorescence of white corpuscles for the early diagnosis and the monitoring of pneumonia in icu

Conditions: Pneumonia

Summary: the diagnosis of pneumonia is challenging in intensive care unit. the auto-fluorescence of white corpuscles is altered during pneumonia. in presence of bacterial growth on lung samples, the measure of autofluorescence of white corpuscles could help the clinicians to discriminate bacterial colonization from acute infection.


Eligibility criteria:
inclusion criteria: * hospitalization in intensive care units * mechanical ventilation * age \> 18 years * collection of a lung sample for bacteriological analysis for the suspicion of a first episode of lung infection. exclusion criteria: * refuse to participate

Keywords: pneumonia diagnosis prognosis tracheal aspirate bronchoalveolar lavage
a frequency-modulated music intervention to enhance cognitive processing therapy (cpt) for ptsd

Conditions: PTSD - Post Traumatic Stress Disorder

Summary: the goal of this clinical trial is to learn if the addition of frequency filtered music (safe and sound protocol) to daily cognitive processing therapy improves effectiveness for reducing ptsd symptoms. the main questions it aims to answer are: * does the addition of frequency filtered music reduce ptsd symptoms for patients receiving cognitive processing therapy for ptsd? * does the addition of frequency filtered music to cognitive processing therapy improve stress physiology (arousal)? * does improvement in physiological stress regulation help explain improvements in hyperarousal and ptsd symptoms? researchers will compare the effects of a frequency filtered classical music playlist to an identical playlist without added filtering. participants will be randomized to a music playlist. participants will: * receive 10 daily sessions of cognitive processing therapy * listen to 15 minutes of music before their therapy sessions (2.5 hours music listening total). * complete clinical interviews and questionnaires before, during, and up to 6 months after therapy. * have their physiological arousal monitored during listening and therapy sessions * wear a fitbit device and complete smartphone surveys for 4 weeks


Eligibility criteria:
inclusion criteria: * at least 18 years of age * meets diagnostic criteria for a) ptsd or b) subthreshold ptsd with hyperarousal (i.e., meets diagnostic threshold for 3 of 4 symptoms, one of which is hyperarousal) * ability to move between sitting to standing without assistance * ability to attend two weeks of daily in-person therapy sessions at either the ohio state university or at the wright-patterson air force base (wpafb) medical center exclusion criteria: * heart condition (such as cardiac arrhythmia) or pacemaker * an allergy that would prevent wearing adhesive for durations of 2 hours or less * insufficient english fluency to fully engage in psychotherapy * use of hearing aids * current or prior tinnitus (persistent ringing or other noises in ears not caused by an external sound) * severe traumatic brain injury * an ongoing stressor or condition deemed by the investigators to place the participant at risk for injury or a poor outcome (e.g., undergoing disability evaluation, undergoing a medical board evaluation to be medically discharged from the military, pending negative administrative or legal actions). * inability to complete the informed consent process due to the acute effects of a medical or psychiatric condition (e.g., intoxication, mania, psychosis)

Keywords: music hyperarousal cognitive processing therapy
melatonin and radiation therapy in treating patients with brain metastases

Conditions: Metastatic Cancer; Radiation Toxicity; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. drugs such as melatonin may make tumor cells more sensitive to radiation therapy and may protect normal cells from the side effects of radiation therapy. purpose: randomized phase ii trial to determine the effectiveness of combining melatonin with radiation therapy in treating patients who have brain metastases.

objectives: * determine the effect of melatonin, used as radiosensitization/radioprotection, on overall survival and clinical deterioration in patients with brain metastases who are undergoing radiotherapy. outline: this is a randomized, multicenter study. patients are stratified according to planned chemotherapy after whole brain irradiation (yes vs no). patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo whole brain irradiation once daily 5 days a week for 2 weeks. patients receive oral melatonin once daily every morning. * arm ii: patients undergo whole brain irradiation as in arm i. patients receive oral melatonin once daily every evening. all patients continue on melatonin for 6 months in the absence of disease progression or unacceptable toxicity. patients are followed at months 6 and 12 from start of radiotherapy and then every 6 months thereafter. projected accrual: a total of 128 patients (64 per treatment arm) will be accrued for this study within 5 months.

Eligibility criteria:
disease characteristics: * histologically confirmed solid tumor with brain metastasis * no germ cell tumors * rpa class ii with any of the following: * at least 65 years of age * extracranial metastases * uncontrolled primary malignancy * ineligible for or unwilling to participate in alternative rtog stereotactic radiosurgery studies patient characteristics: age: * see disease characteristics performance status: * zubrod 0-1 life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * able to swallow pills * not pregnant * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * more than 30 days since prior chemotherapy * concurrent chemotherapy after whole brain irradiation allowed endocrine therapy: * not specified radiotherapy: * see disease characteristics * no prior radiotherapy to the brain surgery: * not specified

Keywords: unspecified adult solid tumor, protocol specific tumors metastatic to brain radiation toxicity
sarc021c: a continuation study of th-cr-406/sarc021

Conditions: Soft Tissue Sarcoma

Summary: sarc021c is a nonrandomized, open-label, multicenter, continuation study designed to provide access to th-302 for patients currently receiving and benefiting from single agent th-302 therapy as part of the phase iii th-cr-406/sarc021 study.

the goal of this study is to provide continuation therapy with th-302 to patients with soft tissue sarcomas who obtained response or stabilization of disease with prior treatment on th-cr-406/sarc021 protocol. after written informed consent has been obtained and eligibility has been established, patients will receive the study drug as part of the continuation study. patients will receive treatment on study as long as they have clinical benefit and do not experience unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's irb/ethics committee. * previously enrolled on the th-cr-406/sarc021 protocol and benefiting from treatment. * study investigator deems continued participation is appropriate based on overall health of the patient. exclusion criteria: * any of the criteria for study discontinuation are met. * concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. * unwillingness or inability to comply with the study protocol for any reason.
low-dose radiation therapy in treating patients with follicular or marginal zone non-hodgkin's lymphoma

Conditions: Lymphoma

Summary: rationale: radiation therapy uses high-energy x-rays to kill cancer cells. it is not yet known which regimen of low-dose radiation therapy is more effective in treating follicular non-hodgkin's lymphoma. purpose: this randomized phase iii trial is studying two different regimens of low-dose radiation therapy (24gy versus 4gy) to compare how well they work in treating patients with follicular or marginal zone non-hodgkin's lymphoma.

objectives: primary * compare the local progression-free interval in patients with follicular non-hodgkin's lymphoma (nhl) treated with 2 different regimens of low-dose radiotherapy. secondary * compare acute toxicity at 4 weeks in patients treated with these regimens. * compare late toxicity in patients treated with these regimens. * compare tumor response at 12 weeks in patients treated with these regimens. * compare overall survival in patients treated with these regimens. * assess the health economics of these regimens in these patients. outline: this is a multicenter, randomized study. patients are randomized to one of two treatment arms. * arm i 4gy: patients undergo low-dose radiotherapy once daily on days 1 and 2. * arm ii 24gy: patients undergo low-dose radiotherapy once daily on days 1-5, 8-12, 15, and 16. in both arms, treatment continues in the absence of disease progression or unacceptable toxicity. after completion of study therapy, patients are followed up for 5 years. peer reviewed and funded or endorsed by cancer research uk projected accrual: a total of 650 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed follicular or mmarginal zone non-hodgkin's lymphoma (nhl) * any stage * radiotherapy is indicated for curative treatment of stage ia or iia disease or palliation due to tumor bulk or anatomical position patient characteristics: * life expectancy \> 3 months prior concurrent therapy: * more than 4 weeks since prior chemotherapy

Keywords: stage i grade 1 follicular lymphoma stage i grade 2 follicular lymphoma stage i grade 3 follicular lymphoma contiguous stage ii grade 1 follicular lymphoma noncontiguous stage ii grade 1 follicular lymphoma contiguous stage ii grade 2 follicular lymphoma noncontiguous stage ii grade 2 follicular lymphoma contiguous stage ii grade 3 follicular lymphoma noncontiguous stage ii grade 3 follicular lymphoma stage iii grade 1 follicular lymphoma stage iii grade 2 follicular lymphoma stage iii grade 3 follicular lymphoma stage iv grade 1 follicular lymphoma stage iv grade 2 follicular lymphoma stage iv grade 3 follicular lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma marginal zone lymphoma
ketoacidosis in individuals with type i diabetes mellitus (t1dm)

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to investigate individuals with type 1 diabetes who were disconnected from their insulin pump and insulin therapy was started again after positive ketones (u) in the urine or blood β-hydroxybutyrate.

individuals with type 1 diabetes were disconnected from their insulin pump and insulin therapy was started again after positive ketones (u) in the urine or blood β-hydroxybutyrate with different therapy regimens after positive blood ketones.

Eligibility criteria:
inclusion criteria: * type 1 diabetes exclusion criteria: * severe hypo- or hyperglycemia during last 6 months * acute illness

Keywords: therapy after positive ketone bodies in the blood timepoint of diagnosis timepoint of metabolic normalisation
risk factors for major complications after liver resection

Conditions: Liver Diseases

Summary: the aim of this study is to determine the risk factors for major complications following liver resection in the setting of a general surgery-teaching department in morocco, north africa

over the past 20 years, the refinement of liver surgery techniques, anesthesiology and perioperative management has dramatically improved the safety of liver resection patients. it has also led to a concomitant extension of indications for a growing number of patients with complex benign or malignant hepatobiliary diseases and/or high risk surgeries. published complication rates and risk prediction models and recommendations for patients undergoing liver resection primarily stem from far east or western high-volume specialized centers. in developing countries, including those in north africa, specific constraints (e.g., endemic indications, such as liver cystic hydatidosis, blood shortage, and the scarcity of liver surgeons and intensive care providers) may impact liver resection outcomes but they are rarely addressed in the literature. the aim of this study was to determine the risk factors for major complications following liver resection in the setting of a general surgery-teaching department in morocco, north africa

Eligibility criteria:
inclusion criteria: * all patients who underwent an hepatectomy * between january 2010 and december 2015 exclusion criteria: * all patient who only underwent liver biopsy with no resection * patients non operated

Keywords: audit liver resection surgical complications non-eastern/non-western quality improvement
effects of a long-term grapefruit juice consumption on vascular protection and bone metabolism

Conditions: Post-menopausal Status

Summary: epidemiological studies definitively show that fruit and vegetable consumption is an important factor for the prevention of age-related diseases such as cardiovascular diseases (cvd) and osteoporosis. citrus fruits are among the fruits which are the most frequently consumed worldwide, essentially as juices. citrus fruits are the exclusive sources of a particular class of dietary flavonoids, namely flavanones. grapefruit consumed as whole fruit or juice corresponds to a quantitatively significant source of a specific flavanone called naringin.

epidemiological studies definitively show that fruit and vegetable consumption is an important factor for the prevention of age-related diseases such as cardiovascular diseases (cvd) and osteoporosis. citrus fruits are among the fruits which are the most frequently consumed worldwide, essentially as juices. citrus fruits are the exclusive sources of a particular class of dietary flavonoids, namely flavanones. grapefruit consumed as whole fruit or juice corresponds to a quantitatively significant source of a specific flavanone called naringin. some scientific data obtained from animal studies or in vitro experiments suggested that flavanones could exert positive effects on several biomarkers of the cardiovascular or osteoporosis risks. however, until now, the clinical proof of the efficacy of these compounds is far to be obtained and more clinical trials are needed. the main goals of this project are (1) to characterize the effect of a long-term grapefruit juice consumption on both vascular and bone protections and (2) to assess the specific role of naringin, in these potential protective effects. to reach these goals, a randomized, cross-over clinical trial will be performed on 52 healthy post-menopausal women (50 to 65 years old, 3 to 10 years since menopause, waist \> 88 cm). such a population shares an increased risk of cvd and osteoporosis. they will consume for two periods of 6 months either 340 ml of grapefruit juice or a control isoenergetic beverage. major outcomes will be measured at baseline and at the end of each experimental period.

Eligibility criteria:
inclusion criteria: * caucasian healthy post-menopausal women * 19≤ bmi ≤29 and waist measurement \> 88 cm exclusion criteria: * metabolic diseases * hypertension * taking cyp3a4-metabolized drugs * taking blood lipids lowering drugs or antihypertensive drugs * hypercholesterolemia with hdl \< 1.30 mmol/l (i.e. \< 0.5 g/l) * osteoporosis (defined by t-score of -2.5 sd at hip and/or lumbar spine) * taking hormone replacement therapy (hrt) * smokers * taking dietary supplements

Keywords: post-menopausal women grapefruit juice naringin vascular protection bone metabolism
genetics in non-response to anti-vegf treatment in exudative amd

Conditions: Macular Degeneration

Summary: to assess genetic features and intraocular cytokine profiles of non-responders to anti-vegf treatment of exudative age-related macular degeneration. also to assess necessity and frequency of pro re nate medical re-treatment.


Eligibility criteria:
inclusion criteria: * active subfoveal cnv related to exudative age-related macular degeneration (all subforms) * age \> 60 years * visual acuity \> 20/400 * no previous treatment for amd exclusion criteria: * any previous amd therapy * other cnv types (myopic, parapapillary) * contraindication for ranibizumab treatment * prior study participation for amd * pregnancy / premenopausal women
post market clinical follow-up study protocol for dynasty® biofoam® acetabular components

Conditions: Joint Disease

Summary: sponsor is conducting this post market clinical follow-up (pmcf) study to evaluate the safety and efficacy of its total hip arthroplasty (tha) components marketed in the european union (eu) . these types of studies are required by regulatory authorities for all tha devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the eu. this study has been designed in accordance with meddev 2.12/2 rev 2.

total hip arthroplasty (tha) has been performed since the early 1920s and is generally considered to be one of the most successful orthopedic surgeries performed. the 8th annual report from the national joint registry of england and wales reported 95.3% component survivorship at 7 years for over 300,000 tha implantations. microport orthopedics, inc. (mpo) currently markets several tha components throughout the world, including the european union (eu). as part of the process for gaining approval to market in the eu, mpo is conducting this post market clinical follow-up (pmcf) study to evaluate the safety and efficacy of these tha components. the objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.

Eligibility criteria:
inclusion criteria: * has undergone primary tha for any of the following: * non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia * inflammatory degenerative joint disease such as rheumatoid arthritis * correction of functional deformity * subject is implanted with the specified combination of components * subject is willing and able to complete required study visits or assessments exclusion criteria: * skeletally immature (less than 21 years of age at time of surgery) * subjects implanted with non-mpo components (femoral stem, femoral head, acetabular liners) in the enrolled tha * subjects currently enrolled in another clinical study which could affect the endpoints of this protocol * subjects unwilling to sign the informed consent document * subjects with substance abuse issues * subjects who are incarcerated or have pending incarceration

Keywords: osteoarthritis avascular necrosis ankylosis protrusio acetabuli painful hip dysplasia rheumatoid arthritis correction of functional deformity revision procedures
masticatory muscle activity in patients with pain-related temporomandibular disorders

Conditions: TMD

Summary: the aim of this study was to evaluate masticatory muscle electrical activity in patients with pain-related and pain-free temporomandibular disorders (tmd) as well as in subjects with no tmd. ninety children with mixed dentition were recruited to the study. of this total, 30 subjects were diagnosed with pain-related tmd, 30 with pain-free tmd, and 30 without tmd. we used axis i of the research diagnostic criteria for tmd (rdc/tmd) to assess the presence of tmd in the examined children. the electromyographical (emg) potentials of the temporalis and masseter muscles were measured with a dab-bluetooth instrument (zebris medical gmbh, germany) at rest and during maximum voluntary clenching (mvc).


Eligibility criteria:
inclusion criteria: * mixed dentition (the subjects should be aged between 7 and 12 years) * consent to participate voluntarily in the study exclusion criteria: * subjects who had undergone orthodontic or masticatory motor system dysfunction treatment, had systemic or rheumatologic diseases, a history of mouth breathing, surgery, traumas or malformations in the head and neck region

Keywords: masticatory muscles surface electromyography muscle activity