cyrilzakka/clinical-trials huggingface dataset:
Development of a Battery of Audiological Tests for the Precision Diagnosis of Age-related Hearing Loss

Age-related hearing loss, or presbycusis, is caused by many genetic and environmental factors. Its prevalence poses a public health challenge of early identification and effective hearing aid treatment. However, the lack of screening and of a validated audiological test battery to diagnose an individual's needs and to guide hearing aid adjustments is a major obstacle.

Furthermore, monogenic forms of hearing loss affect only one functional module of hearing. The audiological test(s) dependent on the function of this module are affected, in a progressive manner, but not the others. A previous study showed that in early onset presbycusis patients, a quarter of the subjects tested were affected by monogenic presbycusis.

The collection of audiological and vestibular tests, carried out on proven monogenic presbycusis patients and compared to that of normal hearing patients, would constitute a battery of tests allowing a precision diagnosis, then developed to all forms of presbycusis in order to study if the identification of abnormal functional modules can usefully guide the diagnosis and the early fitting.

The AUDIOGENAGE project is a multi-center, non-invasive case-control study conducted by CERIAH (CEntre de Recherche et d'Innovation en Human Audiology) and LCA (Laboratory de correction auditive) in 700 volunteer participants identified in two groups:

* 500 Patients with age-related hearing loss of anticipated onset,
* 200 Control subjects, considered as normal hearing for their age at inclusion.

All participants will undergo 6h audiological and vestibular tests, and also neurocognitive test (self-questionnaire). These tests will be conducted over 2 to 4 visits. A 10 mL-blood sample will be collected for a genetic analysis.

Eligibility Criteria:
Inclusion Criteria:

For all participants:

* Be over the age of 18,
* Be affiliated to a social security system,
* Have a good command of the French language (oral and written).

For the group of participants with anticipated presbycusis:

* Over the age of 40, having a hearing aid recipient or coming for a first hearing aid recipient
* Between 18 and 40, having a hearing aid recipient, coming for a first hearing aid recipient or declare a progressive genetic birth defect

For healthy volunteers:

- Have no known hearing loss.

Exclusion Criteria:

* Report having been chronically exposed to loud sounds.
* Have a history of ototoxic substances,
* To have sequelae of ear infections and/or a history of ENT disease that permanently affects hearing or balance,
* Have an ethnic origin for which the Pasteur Institute does not have information on the frequency of variants of the genes studied.
* Have type II diabetes,
* Have a neurological or psychiatric condition that interferes with comprehension or ability to move,
* Be under guardianship,
* Be deprived of liberty by judicial or administrative decision, or be subject to legal protection,
* Not being subject to a social security system,
* Taking narcotic substances, alcohol or medication that diminishes cognitive abilities.
Host RNA Signature in Children With Cancer and Infection

The aim is to investigate if RNA expression signature can discriminate bacterial from viral infection or non-infectious inflammation in children with cancer.

Earlier studies in immunocompetent children have shown promising results, but studies in immunocompromised children are lacking.

We aim to include 300 febrile episodes in children with cancer. The samples will be analysed by RNA sequencing. If succesfull, this method can help prevent unnecessary antibiotic treatment, reduce hospital admissions, side effects and antimicrobial resistance and improve quality of life for children during cancer treatment.

Children with cancer are at high risk of invasive bacterial infections particularly during neutropenia. Febrile neutropenia is an early sign of a potentially fatal infection requiring broad-spectrum empiric antibiotics. However, the majority of children do not have a bacterial infection, but still receive antibiotics, since current tests cannot distinguish causes of fever. A number of transcriptomic studies of immunocompetent patients show that host leukocyte patterns of activated RNA can discriminate bacterial infection from non-infectious inflammation with high accuracy, but studies in immunocomprised patients are few.

Methods

A prospective non-interventional observational multicentre study including febrile childhood cancer patients during 24 months at all Danish Pediatric Oncology Departments (Rigshospitalet, Aarhus, Odense and Aalborg University Hospitals). Leukocyte RNA expression will be analysed in whole blood samples by RNA sequencing adjusted for low RNA input. 300 febrile episodes will be included, and predictive host RNA signatures will be identified in a discovery cohort and assessed in a validation cohort. Further, to explore the transcriptome in non-febrile children with neutropenia, we include a control group of 15 children with cancer and no fever.

Time frame Inclusion of children: 1st of June 2019 to 31st of May 2021 Analysis of samples (RNA sequencing): 1st of June 2021 - 1st of December 2021

Perspective

The study will create a base for a randomised trial regarding implementation of RNA signature versus normal procedure in handling febrile children with cancer. This can lead to the development of a targeted RNA-expression analytical platform that can prevent unnecessary antibiotic treatment in the majority of children with febrile neutropenia. This will reduce hospital admissions, side effects, antimicrobial resistance and improve quality of life during cancer treatment. The results can be extrapolated to the adult patients with cancer, who are often treated with prophylactic antibiotics, which complicate finding the infectious agent. Additionally, the test may be applied in other immunosuppressed children with infections.

Eligibility Criteria:
Inclusion Criteria:

Children with cancer and fever. Fever defined as temperature above 38.5 °C measured once, or 38.0-38.5 °C for ≥ 1 hour.

Exclusion Criteria:

The children can be excluded if they turn out to have a different diagnosis than expected or if it is not possible to draw the blood tests.
The Effect of EFT on Psychological States in a Veterans Population

A need exists to find fast yet effective treatment protocols for the large number of US military service personnel coming back from Iraq with post traumatic stress disorder (PTSD), and a variety of co-occurring psychological problems. EFT (Emotional Freedom Techniques) has demonstrated promise as a PTSD treatment in pilot studies. This study examines the effects of six sessions of EFT coaching on veterans who score at or above the military cutoff point for PSTD. Subjects are also assessed for conditions that often accompany PTSD, such as depression and anxiety. Changes pain, cravings, and physical symptoms are also measured. Assessments are made after six sessions are complete, and again after three and six months.

A need exists to find fast yet effective treatment protocols for the large number of US military service personnel coming back from Iraq with post traumatic stress disorder (PTSD), and a variety of co-occurring psychological problems. This study examines the effects of six sessions of EFT coaching on a veterans population. The sample will recruited from clients of practitioners who are coaching veterans. Participants will be assessed for PTSD and other psychological conditions such as anxiety and depression. Evaluations will be made using well-validated instruments, the SA-45 (Symptom Assessment 45) and the PCL-M (Posttraumatic Stress Disorder Checklist - Military). Those meeting the military's criterion for a PTSD-positive assessment on the PCL-M will be randomized into two groups. A wait list control group continues to receive Standard of Care (SOC) from their current healthcare provider. The experimental group receives SOC plus EFT coaching. A baseline measurement is obtained approximately thirty days in advance of coaching, when subjects apply to participate in the study, and again immediately before coaching begins. Participants are assessed after three sessions and six sessions, to determine symptom changes at these milestones. Followup assessments occur three months and six months post-coaching. Pain levels, alcohol use, recreational drug use, and prescription drug dosages are also tracked, in order to determine any correlation between participant characteristics and psychological symptom change. Data will also be analyzed to determine if there are outcome differences between participants receiving EFT from life coaches, and those whose EFT coaching is delivered by licensed psychologists or social workers.

Eligibility Criteria:
Inclusion Criteria:

* Military Service
* Score of 50 or more on the PCL-M (PTSD Checklist-Military)
* The ability to follow instructions and complete written forms
* Under the care of a primary care provider

Exclusion Criteria:

* A score of 3 or more on questions 34 and 35 of the SA-45
Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined in the body.

To test this new drug, participants will receive an intravenous injection of Ga-68-PSMA and then have a PET/CT scan. The scan results will be made available to study participants and treating physicians.

This study evaluates Gallium-68 labelled PSMA-11 (also called Gallium-68 labelled PSMA-HBED-CC, or Gallium-68 labelled PSMA N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid), abbreviated here as 68Ga-PSMA. This molecule (or radiotracer) binds to receptors that are often present on prostate cancer cells. Using 68Ga-PSMA together with a positron emission tomography (PET) scanner (with computed tomography, called PET/CT), it is therefore possible to find prostate cancer lesions in the body. The study will test whether 68Ga-PSMA will identify prostate cancer more precisely than normal imaging methods (for example CT, MRI, or bone scan). A more precise identification of the location of the disease is important. Knowing where the disease is located will help to decide on the best course of action to treat the disease.

Men who have elevated tumor markers of prostate cancer are eligible for this study. Participants undergo a 68Ga-PSMA PET/CT scan before further treatment. Based on clinical information, including any prior imaging and biopsy/surgery information and follow-up information, we will determine whether 68Ga-PSMA PET/CT imaging was more accurate than the standard imaging. The study team will collect this information for up to 1 year after the 68Ga-PSMA PET/CT scan.

The results of the 68Ga-PSMA PET/CT scan will be shared with the participating patients. Also, results will be entered into the participant's medical record and shared with the treating physicians.

Eligibility Criteria:
Inclusion Criteria:

1. Histopathological proven prostate adenocarcinoma.
2. Rising prostate specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

   1. Post radical prostatectomy (RP) - according to American Urological Association (AUA) recommendation criteria: PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL.
   2. Post-radiation therapy - according to ASTRO-Phoenix consensus definition: Nadir + greater than or equal to 2 ng/mL rise in PSA.
3. Karnofsky performance status of ≥ 50.
4. Age ≥ 18.
5. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. Current investigational therapy for prostate cancer.
2. Unable to lie flat, still or tolerate a PET/CT scan.
3. Prior history of a malignancy within the last 2 years, except skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized, and except superficial bladder cancer.
4. Prisoner.
Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia

The investigators are doing this research study to explore whether the bacillus Calmette-Guérin (BCG) vaccine can be an effective treatment for fibromyalgia. The researchers believe that the BCG vaccine can benefit people with fibromyalgia by increasing immune signaling molecules, called cytokines. The Faustman Immunobiology Laboratory has previously studied BCG in long term type 1 diabetics, and found that BCG vaccinations showed a short and small pancreas effect of restored insulin secretion.

Eligible volunteers will be vaccinated with BCG in repeat fashion over a period of three years or receive placebo treatment. The investigators hypothesize that these repeat injections of BCG will reduce symptom severity by increasing immune signaling cytokines.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibromyalgia
* HIV antibody negative
* Normal complete blood count (CBC), LFT, metabolic panel
* Meets the requirements for pain measured by the widespread pain index and symptom severity scale
* Negative pregnancy test within 7 days before initiation of study drug (Female only)

Exclusion Criteria:

* History of HIV or hepatitis
* History of tuberculosis, mycobacterium exposure, TB risk factors, positive interferon-gamma release assay (IGRA, also known as T-SPOT.TB test) or BCG vaccination
* Current treatment with glucocorticoids or disease likely to require steroid therapy
* Conditions or treatments associated with risk of infections such as patients with a previous history of severe burns, or treatment with immunosuppressive medications of any type
* Daily use of aspirin \> 160 mg, or chronic, daily NSAIDs
* Current treatment with antibiotics
* History of keloid formation
* Severe pain due to other conditions
* Current treatment with any Type II diabetes medication (such as metformin, farxiga, etc.)
* Pregnant or not using acceptable birth control
* Living with someone who is immunosuppressed and/or at high risk for infectious diseases
Evaluating CBT Delivered by Community Health Workers on Maternal Mental Health and Infant Cognitive Development in Insecure Environments

This study evaluates a cognitive behavioral therapy intervention for mothers with symptoms of anxiety and depression living in insecure environments using a randomized controlled methodology. Key outcomes of interest include maternal mental health and infant cognitive development. The intervention will be delivered by community mental health workers who will be trained to administer 8 to 12 cognitive behavioral therapy sessions.


Eligibility Criteria:
Inclusion Criteria:

* Women in their third trimester of pregnancy
* Who exhibited symptoms of anxiety and depression

Exclusion Criteria:

* Women who express suicidality
The Effect of Music Therapy on Delirium

The purpose of this study is to test the effect of a twice daily, 30-minute, interdisciplinary, music therapist developed, nurse initiated, music listening intervention on acutely ill older patients as compared to patients who receive care as usual. Half of the participants will receive music therapy and the other half will receive care as usual.

Delirium is a complex, preventable, neuropsychiatric syndrome that is associated with higher mortality rates post discharge, increased hospital stays, increased mortality and an increased risk for developing dementia. Early, nonpharmacological treatment of delirium is preferable and supported by the literature to preserve patient safety. Music therapy is an evidence based, goal directed treatment process in which the music therapist and the patient maintain a state of well-being to achieve individualized patient goals. Music interventions are therapist developed and nurse initiated, in accordance to individual patient needs to maintain well-being, and show promise for improving attention and engagement. Understanding the effect of an individualized music intervention on the incidence, duration and severity of delirium has the potential to facilitate the use of cost-effective methods to modify individual environments to deliver appropriate care for acutely ill older adults. Purpose: The purpose of this study is to test the effect of an interdisciplinary music intervention on the incidence, severity and duration of delirium in older acutely ill adults. Methods: A randomized control pilot study will be used to test the effect of a music therapist-developed, music listening intervention on delirium. Acutely ill patients will be randomized into a usual care control group or an experimental group receiving the music intervention twice daily for 30 minutes. Data analysis: Descriptive statistics will be used to describe the sample. Independent t-tests will be used to examine group differences in delirium severity and duration. Chi-square analysis will be used to assess group differences in delirium incidence. Implications: For patients exposed to the stress of hospitalization, a music intervention may enhance delirium care and promote care that is safe and efficient.

Eligibility Criteria:
Inclusion Criteria:

Age 65 or older Admitted to the Progressive Care Unit (PCU), must be able to speak English Must be able to hear music through headphones. Must not have a documented history of dementia Must not have a documented history of permanent cognitive impairment, Must not be delirious at the beginning of the study (CAM negative) Must be able to sign a consent form.

Exclusion Criteria:

Age less than 65, Not admitted to the Progressive Care Unit, Positive for delirium (CAM positive) Does not speak English, Has a hearing impairment, Documented history of dementia Documented history of permanent cognitive decline Expected death within 24 hours of enrollment, Transferred off the floor Unable to sign consent.

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Balloon REmodeling Antrostomy THErapy Study

This study is designed to evaluate safety and effectiveness of a less invasive procedure to treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis. Additionally, this study will assess the feasibility of performing the procedure under local anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Subjects age 18 or older with chronic rhinosinusitis of the maxillary or maxillary and anterior ethmoid sinuses
* A CT scan taken after maximal medical therapy (e.g., local or systemic antibiotics, topical steroids, etc.) must show one of the following:

  1. Narrowing of the outflow tract of the maxillary sinus ostium or infundibulum with mucosal thickening of 2 mm or greater of the maxillary sinus antrum.
  2. Evidence of maxillary sinus air/liquid level.

Exclusion Criteria:

* Evidence of chronic posterior ethmoid, sphenoid or frontal sinusitis
* Inability to understand the study or a history of non-compliance with medical advice
* Unwilling or unable to sign Informed Consent Form (ICF)
* Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies)
* History of any cognitive or mental health status that would interfere with study participation
* Previous sinus surgery or intervention including sinuplasty
* Pregnant women
* Severe septal deviation causing obstruction of the ostiomeatal unit
* History of primary ciliary dysfunction
* Hemophilia
* Currently undergoing or in the past 6 months had undergone chemotherapy for cancer or radiation therapy in the head or neck region
* History of cystic fibrosis
* Known Sampter's Triad (aspirin sensitivity, asthma, sinonasal polyposis)
* Known sinonasal tumors or obstructive lesions
* History of mid facial fractures or orthognathic surgery (does not include nasal fracture)
* History of insulin dependent diabetes
* Not able to stop anti-coagulant (e.g., warfarin) until the International Normalized Ratio(INR) is below 1.5
* Not able to stop anti-platelet (e.g., clopidogrel, aspirin, etc.) for at least 14 days prior to study procedure
* Not able to stop any non-steroidal anti-inflammatory medications and homeopathic medications for at least 14 days prior to the study procedure
* Presence of nasal polyps that may interfere with the treatment procedure
* Presence of features consistent with sinus fungal disease on CT or physical examination
Impact of Maternal BMI on Plasma Levels of Oxytocin During Labor Augmentation

The aim of this study is to examine the associations between maternal BMI and levels of oxytocin in maternal plasma during augmentation with oxytocin during first stage of labor in term pregnancy.

A translational prospective experimental study in the delivery ward in Linköping. The study population will include women in two BMI groups (underweight/normal weight and overweight/obese) during first stage of labor with singleton full term pregnancy and cephalic presentation.The BMI is calculated from weight and height registered at the first antenatal visit around week 8-12. At the delivery ward, if the women are in need of labor augmentation with oxytocin infusion, a peripheral venous catheter will be placed in the contralateral arm from the arm where oxytocin will be administrated. The oxytocin infusion will be prepared to a concentration of 10 mU/ml and will be given according to a standardized protocol or to an infusion level giving maximum of 5 uterine contractions per 10 minutes. Blood samples for measuring plasma levels of oxytocin will be taken prior to start and before every increase in the rate of oxytocin infusion. The blood samples will be collected through the first stage of labor.

Eligibility Criteria:
Inclusion Criteria:

Full-term pregnancy (from gestational week 37+0), singel pregnancy, vertex presentation, knowledge in the Swedish language, 18 years and older, known BMI, need of labor augmentation with oxytocin infusion during opening stage.

Exclusion Criteria:

Not participating in other studies at the delivery ward
A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)

The purpose of this study is to determine whether the refrigerator-stable formulation of an investigational vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile to that of the freezer-stable formulation of the vaccine.

The duration of treatment is 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who are at least 50 years of age or older with a history of varicella (chicken pox)

Exclusion Criteria:

* Prior history of herpes zoster (shingles)
* Prior receipt of varicella or zoster vaccine
* Immunosuppressed
Study To Evaluate The Efficacy And Long-Term Adherence Of Spondyloarthropathies(SpA) Patients On Enbrel

This study is to evaluate local data in Iraqi patients with Spondyloarthropathies on Enbrel treatment with regards to efficacy and adherence using data from the Baghdad Teaching Hospital (Rheumatology Center)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed SpA patients
* 18 years of age and older.
* Did not receive previous other biological treatments.
* Patients have at least 1 year on Enbrel.

Exclusion Criteria:

* Had previously used another biological treatments.
* Use of etanercept for less than 1 year duration.