cyrilzakka/clinical-trials huggingface dataset:
Impact of Hearing Aid Technology on Self-reported Outcomes

The study aims to investigate if the level of hearing aid (HA) technology has an impact on self-reported outcomes in patients with presbycusis in terms of overall IOI-HA scores, Factor 1, Factor 2 scores, SSQ scores, and the SSQ domains. The study explores if presbycusis patients report better outcomes with premium level HA technology compared to basic level HA technology. Further, the study investigates if premium level HAs provide more high-frequency gain than basic HAs using Real Ear Measurements.

In hearing rehabilitation clinics today, the choice of hearing aid (HA) technology level is primarily based on the individual hearing care providers´ preferences. There is a lack of knowledge in which level of HA technology should be chosen for patients with presbycusis and if these patients will report higher benefit from more technologically advanced hearing aids. Therefore, this study aims to investigate if level of hearing aid technology has an impact on self-reported outcomes measures as the IOI-HA, SSQ, and 15-D questionnaire in patients with presbycusis.

The study was designed as a two-arm parallel randomized controlled trial. A subgroup of patients diagnosed with presbycusis and participating in the Danish National Better hEAring Rehabilitation (BEAR) project was invited to participate in the study.

Data was collected from the Department of Audiology at Odense University Hospital (OUH), Region of Southern Denmark.

All patients underwent a hearing examination which consisted of a pure-tone audiometry, bone-conduction thresholds at 250 Hz to 4 kHz, and a measure of word recognition scores (WRS) and speech reception thresholds (SRT) detecting the threshold at the 50% correct response level.

The questionnaires were sent to all patients two weeks prior to the first visit in clinic and included; a non-standardized health-related questionnaire containing questions on demographic details such as sex, age, HA experience, motivation and the SSQ questionnaire. The IOI-HA questionnaire was sent if patients were experienced HA users at the time of inclusion. All questionnaires were compiled and managed using Research Electronic Data Capture (REDCap) tools developed by Vanderbilt University, Nashville, Tennessee, United States (Harris et al. 2009, 2019) and is hosted by Odense Patient Explorative Network (OPEN) in the Region of Southern Denmark. Patients received the questionnaires through an online link generated by REDCap, but a paper-and-pencil version was also available if necessary when they entered the clinic.

Patients were randomized into two groups based on age, sex and WRS, and fitted with either a high-end or a basic level hearing aid.

Approximately two months after hearing aid fitting, a follow-up visit was scheduled where a Real Ear Measurement (REM) was carried out. The IOI-HA and SSQ questionnaires were re-sent to all patients two weeks prior the follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with presbycusis

Exclusion Criteria:

* Not being able to fill out questionnaires
Effects of Web-Based Adolescent Health Promotion Program in Hearing Impaired Adolescents

Our research is to evaluate the effect and applicability of the adolescent health promotion program, which includes multiple behavioral interventions, on physical activity, nutrition and mental health of hearing impaired adolescents living in the community.

Purpose of the research; To evaluate the effect and applicability of the Web-Based Adolescent Health Promotion program, which includes multiple health behavior initiatives, on physical activity, nutrition, and stress management of hearing impaired adolescents in making healthy choices, assuming their own health responsibilities and acquiring healthy lifestyle behaviors.

Materials and methods; The research is a full experimental study with pretest-posttest control group, repeated measurement design, random groups.

Research sample; A total of 70 hearing-impaired adolescents aged 12-18, studying at Abdurrahman Gazi Sağlar Primary School, Van Special Education Vocational High School and Duyus Special Education and Rehabilitation Center affiliated to the Ministry of National Education in the city center of Van.

The data of the research; "Sociodemographic Characteristics Information Form", "Body Mass Index (BMI)", "Adolescent Nutrition Information Scale", "Adolescent Physical Activity Information Scale", "Adolescent Lifestyle Scale", "Adolescent Healthy Lifestyle Choices Scale", "Renewed Child" Anxiety and Depression Scale", "Daily Food Consumption Form", "Beverage Consumption Form", "Pedometer" were collected.

In the study; descriptive statistics will be evaluated with mean, standard deviation, percentage and frequency analysis. Comparisons between groups will be analyzed using Pearson's chi-square, Student's t-test, Mann Whitney-U test, Kruskal Wallis test, analysis of variance and Cohen's d effect size.

The results of this study;

* Physical Variables: Body Mass Index (BMI) and Weight
* Behavioral Variables: Weekly average number of steps and change, fruit and vegetable consumption amount, amount of water consumed, amount of sugary and acidic beverages consumed, "Adolescent Lifestyle" scale score average, "Adolescent" Lifestyle Choices scale score average,
* Cognitive Variables: "Adolescent Nutrition Knowledge" scale mean score, "Adolescent Physical Activity Knowledge" scale mean score, "Regenerated Child Anxiety and Depression" scale mean score will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Hearing impairment,
* In the 12-18 age group,
* Ability to access communication tools such as computers, tablets and smartphones and use the internet with these tools,
* Able to communicate in visual, sign language and written,
* Does not have a physical condition or disease that may prevent exercise,
* Volunteer to participate in the research,
* Permitted to participate in the research by their parents.

Exclusion Criteria:

* who want to withdraw from the research
Use of Multiparametric MRI in the Management of Head and Neck Cancer: a Retrospective Analysis

The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.

Background:The locoregional control rates in patients with advanced head and neck cancer remain suboptimal. Accurate diagnosis of metastatic cervical lymph nodes remains challenging. Technological advances in magnetic resonance imaging (MRI) enable to quantify diffusion and perfusion of the tumour and its surrounding tissues, which could improve diagnostic performance.

Objectives: The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.

Study design: a retrospective study will be set up to explore the diagnostic performance of the selected MRI parameters to differentiate between tumoural and non-tumoural cervical lymph nodes in patients with a histologically confirmed head and neck tumour ('affected group') or histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation ('control group').

Patients will be screened for inclusion in the analysis if they had a routine preoperative multiparametric MRI, according to a standardised protocol, between the 1st of December 2016 and the 30th of September 2018. All MR images will be screened by the resident to select those patients with one or multiple clearly distinguishable metastatic cervical lymph node(s), which can be clearly correlated with the final pathology report. Other strict inclusion criteria are described in detail in the protocol.

Eligibility Criteria:
Inclusion Criteria:

* patients that received a pretreatment multiparametric MRI according to a standardized protocol between December 2016 and December 2018
* histophatologically proven SCC in the head and neck region
* one or multiple clearly distinguishable cervical lymph node(s), that can be unambiguously correlated with the pathology report

Exclusion Criteria:

* patients not fulfilling abovementioned criteria
* patients with thyroid or skin cancer
* considerable artefact on MRI
* previous surgery, irradiation or chemotherapy in the HN region
BRAIN (Biomarker Rapid Assessment of Ischemic iNjury)

This project is designed to evaluate the clinical utility of a novel blood test, the Triage Stroke Panel, as an aid in the diagnosis and assessment of stroke. The Triage Stroke Panel test device, used with the Triage MeterPlus, is a rapid, point-of-care immunoassay. The test measures the concentration of various analytes present in EDTA-anticoagulated whole blood or plasma, specifically B-type natriuretic peptide (BNP), fibrin degradation products containing D-Dimer, matrix metalloproteiase-9 (MMP-9), and S-100B. The test utilizes a proprietary algorithm for the automatic calculation of a single Multimarker Index (MMX) result from the individual biomarker values. The MMX result is being evaluated for use as an aid in the assessment and diagnosis of stroke.

To date, there is no commercially available blood test approved in the United States for use as an aid in the assessment and diagnosis of stroke. There have been various reports in the scientific literature describing the ability of various biomarkers to predict or identify stroke, with varied success. A biomarker panel approach, similar to that used for the evaluation of chest pain patients (troponin I, CK-MB, and myoglobin) enhances diagnostic accuracy, particularly when the panel includes protein markers associated with various components of the disease pathophysiology. This study involves a retrospective analysis of data collected from patients that present with an acute focal neurological deficit, suspected cerebral ischemia, or suspected intracranial hemorrhage within 24 hours of symptom onset or last known well time will be enrolled into the study. Blood samples will be collected at enrollment and serially up to 72 hrs. from the time of onset or last known well time. The study population will also include a subset of patients with subarachnoid hemorrhage, who will have additional samples collected daily from day 3 through day 14 (at clinical sites participating in the vasospasm substudy) for the evaluation of cerebral vasospasm. The patient's participation in the study is complete when all samples have been collected or when they are discharged from the hospital, whichever occurs first. All blood sample will be analyzed using the Triage Stroke Panel test. Measurements will be performed at each clinical site and at Biosite (subject to test device availability). In order to minimize bias and eliminate significant risk to the patient, physicians will be blinded to all Triage Stroke Panel results during the course of the study. Completed case report forms (CRFs) and frozen plasma samples will be transferred to Biosite.

Eligibility Criteria:
Inclusion Criteria:

Age 18 and above Cerebral ischemia or intracranial hemorrhage suspected Enrollment within 24 hrs from symptom onset or last well-known time

Exclusion Criteria:

None
Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules

The purpose of this study is to evaluate the absorption of apixaban (BMS-562247) into the bloodstream of healthy volunteers, when administered as sprinkle capsules compared to tablets. Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will receive a single oral dose of apixaban twice during the course of the study.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form.
* Healthy male and female participants determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs (electrocardiograms), vital signs and clinical laboratory determinations.
* Women of childbearing potential (WOCBP) must have negative serum pregnancy tests (performed at screening and Day 1), must not be breastfeeding, and must agree to follow instructions for method(s) of contraception for duration of treatment with study drug apixaban, and for a total of 33 days after last dose of apixaban.
* Males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with study drug apixaban, and for a total of 93 days after the last dose of apixaban; and must be willing to refrain from sperm donation during this time.
* Body mass index (BMI) of 18.0 to 30.0 kg/m², inclusive. Body mass index = weight (kg)/\[height(m)\]².

Exclusion Criteria:

* History of chronic headaches (occurring 15 days or more a month) over the previous 3 months.
* History of gastroesophageal reflux disease, dyspepsia, protracted nausea, or chronic diarrhea.
* History or evidence of abnormal bleeding or coagulation disorders, hypermenorrhea, intracranial hemorrhage, or abnormal bleeding or coagulation disorders.
* Inability to comply with restrictions and prohibited treatments (e.g. women currently taking hormonal contraception).
* Use of tobacco- or nicotine-containing products (e.g. cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, nicotine gum) within 6 months prior to study drug administration.
* Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).

Other protocol defined inclusion/exclusion criteria could apply.
Free Cloxacillin Concentrations During Continuous Infusion: a Prospective Study in Hospitalized Adults

Cloxacillin is the first-line choice for the treatment of severe infections caused by the bacterium Staphylococcus aureus in Sweden. Over the past year, cloxacillin is increasingly administred through continuous infusion. In this study, the free (unbound) concentration of cloxacillin when administered as a continuous infusion will be measured to ensure that the free concentration is neither too high nor too low. A PK/PD model will be developed to predict which dosage of cloxacillin is appropriate for an individual based on age, gender, kidney function, and serum-protein level.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Treating physician has decided to start continuous infusion of cloxacillin

Exclusion Criteria:

* Unwilling or unable to provide written informed consent
LIAISON NES Influenza (FLU) A/B & Coronavirus Disease 2019 (COVID-19) Clinical Agreement in Australia

The DiaSorin Molecular LIAISON® NES FLU A/B \& COVID-19 real-time polymerase chain reaction (RT-PCR) assay is intended for use on the DiaSorin LIAISON® NES instrument for the in-vitro qualitative detection and differentiation of nucleic acid from influenza A, influenza B and SARS-CoV-2 virus from dry nasal swabs (NS) from human patients with signs and symptoms during the acute phase of respiratory tract infection in conjunction with clinical and epidemiological risk factors.

The LIAISON® NES FLU A/B \& COVID-19 assay is intended for use as an aid in the differential diagnosis of influenza A, influenza B and SARS-CoV-2 infection in a professional laboratory setting.

Negative results do not preclude influenza A, influenza B, or SARS-CoV-2, infection and should not be used as the sole basis for patient management decisions. The assay is not intended to detect the presence of the influenza C virus.


Eligibility Criteria:
Inclusion Criteria:

* Human patients with active signs and symptoms of respiratory tract infection at time of collection
* Specimens collected within 7 days of symptom onset for the initial collection
* Availability of age, gender, race, ethnicity, collection dates, collection time, routine respiratory testing method, routine respiratory result, signs and symptoms (e.g., fever), date of symptom onset for each symptom, vaccination status (Flu and COVID-19, as applicable), pre-existing medical conditions (as applicable), medications (e.g., COVID-19 antivirals), etc. for each subject

Exclusion Criteria:

* Incorrect swab type
* Incorrect transport media
* Incorrect specimen handling (specimens not stored at recommended temperature)
* Samples collected \>7 days from symptom onset
* Subjects not consented
Efgartigimod in Acute Neuromyelitis Optica Spectrum Disorders

This study aims to retrospective investigate the safety and effectiveness of Efgartigimod in the acute phase of neuromyelitis optica spectrum disorders (NMOSD) patients.

This is a multicentre, controlled, retrospective, real-world study which aims to compare the safety and effectiveness of Intravenous methylprednisolone (IVMP) with Efgartigimod injection add-on treatment with IVMP treatment in acute NMOSD patients. Twenty-four patients from 6 centres in China will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis).
* 2. Patients in the acute phase of NMOSD (definition of acute phase: new neurological symptoms or aggravation of existing symptoms within 30 days before received treatment, lasting at least 24 hours without fever), who had poor response to IVMP and without having received second-line therapies such as plasma exchange or intravenous immunoglobulin consequencely (Poor response is defined as a reduction in EDSS score of: I. \<1.0 from the baseline EDSS score when the baseline score was \<=5.5 II. \< 0.5 when the baseline EDSS score \> 5.5).
* 3. Patients who were approved for Efgartigimod treatment would be enrolled in the exposed group.
* 4. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 before treatment.
* 5. Patients have given their written informed consent.

Exclusion Criteria:

* 1. Lactating and pregnant females before treatment.
* 2. Participated in other interventional studies within 30 days before treatment.
* 3. Received plasma exchange, immunoadsorption, or intravenous immunoglobulin (IVIG） therapy within 1 month before treatment.
* 4. History of malignancies.
* 5. Combined with severe mental disorders and other conditions that unable to cooperate with follow-up.
* 6. After being evaluated by experts, patients with active hepatitis, active tuberculosis, or other special conditions which were ineligible to participate in this study.
Intralesional Injection of Mitomycin C Following Visual Internal Urethrotomy for Recurrent Urethral Stricture

To evaluate the effectiveness of administering mitomycin C through intralesional injection after performing visual internal urethrotomy (VIU) for the treatment of recurring urethral stricture.

Numerous studies have investigated the impact of intralesional administration of antifibrotic drugs on urethral strictures following visual internal urethrotomy (VIU). These drugs include mitomycin C, botulinum toxin A, somatostatin analog, and glucocorticoids. Mitomycin C (MMC) is known for its potent chemotherapeutic and antibiotic properties. It effectively hinders mitosis and fibroblast proliferation, playing a crucial role in tissue healing and scar formation by reducing the release of matrix proteins through the inhibition of proliferative fibroblasts. With its anti-proliferative and anti-scarring characteristics, MMC proves to be a suitable option for treating recurrent urethral strictures.

thus we conduct a randomized controlled trial to evaluate the safety and efficacy of Mitomycin in decrease urethral stricture recurrence.

Eligibility Criteria:
Inclusion Criteria:

* All adult male patients aged above 18 years with a single bulbar urethral stricture measuring less than ( 1.5 cm), and had failed at least one prior intervention for urethral stricture(urethral dilation \&amp; VIU) were included in our study

Exclusion Criteria:

* Patients with urethral strictures more than (1.5 cm), multiple urethral strictures, complex stricture, complicated by a fistula or abscess, completely occluded urethral strictures and previous urethroplasty were excluded
Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance

The study evaluate the effect of adaptative servoventilation (ASV) initiation combined with 14 days Zopiclone vs Placebo treatment in patients with central sleep apnea (CSA) syndrome.

ASV remain the optimal treatment for CSA in Heart Failure patients with preserved left ventricular ejection fraction (LVEF).

Yet, the adaptation to the ventilation is extremely challenging and the resulting difficulties encountered to sleep induction might be a reason for dropping out.

Zopiclone is indicated for the short-term treatment of insomnia where sleep initiation or sleep maintenance are prominent symptoms. In this study, Zopiclone, as sedative and hypnotic agent, is used during the ASV initiation period.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged between 18 and 90 years at the initial visit
* Central Sleep Apnea with an AHI ≥ 15/h and at least 50% of central events indicating an ASV therapy, as determined by a ventilatory polygraphy (PG) or a polysomnography (PSG)
* Cardiac Dysfunction with Left Ventricular Ejection fraction(LVEF)\> 45% determined by a transthoracic echocardiography (TTE), known for more than 12 weeks and stable for at least 4 weeks;
* Compliance less than 3 hours after 7 days of the setting up of ASV;
* Patient affiliated to a social security scheme or being beneficiary of such scheme;
* Patient voluntarily participating in the research, with written informed consent

Exclusion Criteria:

* Current use of continuous positive airway pressure (cPAP) for treatment of sleep apnea during the last 12 months
* Presence of chronic symptomatic heart failure with reduced left ventricular ejection fraction (LVEF ≤ 45%), and a CSA moderate to severe (AHI ≥15 / h)
* Presence of severe pulmonary bullous disease
* Presence of Pneumothorax or pneumomediastinum
* Hypotension, especially if associated with depletion of intravascular volume
* Dehydration
* Leaking of cerebrospinal fluid, cranial surgery or trauma recently.
* Episode of acute respiratory failure or heart failure in the previous month
Evaluation of the Effect of Output on Newly Developed Adhesives

The study investigates the impact real output has on the adhesion of the adhesives.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had a stoma for more than one year
4. Have intact skin on the area used in the evaluation
5. Has a stoma with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tab-let/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Actively participating in other interventional clinical investigations or have previously participated in this investigation.
Is Multifactorial Nutritional Treatment for Undernutrition in Older Adults in Primary Care Cost-effective?

The hypothesis is that there is a profit potential by implementing a multifactorial nutritional intervention among frail elderly since this will result in an improved nutritional status, functional capacity and improved quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Screening for nutritional risk

Exclusion Criteria:

* terminal condition or do not wish to participate