cyrilzakka/clinical-trials huggingface dataset:
Early Age-Related Hearing Loss Investigation (EARHLI)

Early Age-Related Hearing Loss Investigation (EARHLI) is a single site study that will randomize late middle age adults to either a hearing intervention (including hearing aids) or a health education intervention. Participants will be followed for 1 year. This study will provide information on reducing cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD).

EARHLI will be a phase II 1:1 randomized controlled trial of a hearing intervention (including prescription hearing aids) versus a health education program. Participants must be 55-75 years old and have early-stage age-related hearing loss and amnestic mild cognitive impairment. The trial will last 1 year and occur at a single site (Columbia University Irving Medical Center). Outcome measurements will include cognition, social engagement, and change in brain organization/connectivity. Assessments will occur at study start, 6 months, and 12 months. A total of 150 participants will be enrolled (75 per intervention group). Participants will also have a hearing test and a blood test. Approximately half of participants will have two MRI scans. As part of participating, all participants will get prescription hearing aids, either at study start or end.

Eligibility Criteria:
Inclusion Criteria:

* Age 55-75 years of age
* Adult-onset hearing loss of approximately mild to moderate in severity (4-frequency 0.5, 1, 2, 4 kHz pure tone average 20 dB to 55 dB HL in better hearing ear)
* Aidable hearing loss, defined by word recognition score in quiet ≥ 60% in better hearing ear
* Amnestic mild cognitive impairment (MCI) defined by Mini-Mental State Exam (MMSE2) score \>23, Clinical Dementia Rating (CDR) global score equivalent = 0.5, and ADNI3 criteria of Logical Memory II score of ≤6 if 0-7 years of education, ≤9 if 8-15 years, and ≤11 if ≥16 years
* Availability of a study partner (informant) for the administration of the cognitive screen and the ADCS-Activities of Daily Living-Prevention Instrument (ADCS-ADL-PI)
* Community-dwelling
* Fluent in English or Spanish
* Availability of participant in area for study duration

Exclusion Criteria:

* Self-reported congenital hearing loss, known genetic mutation-related hearing loss, or hearing loss onset before middle age (\<45 years old)
* Prior dementia diagnosis
* Reported disability in ≥ 2 activities of daily living (ADLs)
* Current or previous consistent hearing aid user (such as utilization of hearing aids within the past 6 months beyond brief trials)
* Unwillingness to wear hearing aids regularly (≥8 hours/day)
* Medical contraindications to the use of hearing aids (e.g., actively draining ear)
* Corrected vision impairment (worse than 20/63 on MNRead Acuity Chart in worse eye)
* Untreatable conductive hearing loss with air-bone gap \> 15 dB in two or more contiguous octave frequencies in both ears
The Effects of Noninvasive Neuromodulation on Mental Wellness, Behavior, and Electrophysiology

The purpose of the study is to test the effects of brief, low-intensity transcranial focused ultrasound (TUS) on electrophysiological, behavioral, and cognitive markers related to anxiety disorders.

We will test the effects of TUS on self-reported and clinical anxiety states in healthy participants and in those with diagnosed anxiety disorders. Participants in these studies will receive pulsed TUS to the brain regions of interest. We will test whether multiple doses of TUS lead to larger reductions in mental states related to anxiety in comparison to a single dose of TUS.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age, as verified via photo identification with date of birth.
* Should be an English speaker, as indicated by being able to read and comprehend the consent form.
* Experiment 2 : Participants will be included for a past diagnosis of anxiety within the past year.

Exclusion Criteria:

* Smokes or uses tobacco products or any form of nicotine excessively
* History of head injury with loss of consciousness for more than 5 min
* Uncorrected hearing or vision impairment, including color blindness
* Currently have or history of brain or mental illness judged likely to interfere with testing, including drug and/or alcohol dependence
* History of epilepsy
* Brain tumors
* Takes medications or drugs judged likely to change brain activity, including psychoactive drugs, stimulants, benzodiazepines, and/or others
* Factors that may lead to poor EEG or fNIRS recordings (e.g., hairstyle)
* Inadequate sleep
* Drug, alcohol or prescription drug intoxication, dependence or addiction
* Pregnancy, or becoming pregnant during the course of the study
* Mild cognitive impairment or impaired decision making
* History of migraines
* Experience with neurostimulation (which might unbind or alter the results)
* Metal implants in their head or face
Development Of A Blood Test To Improve The Performance Of Breast Cancer Screening

The purpose of this study is to collect blood and tissue to help develop tests that might be able to detect cancer earlier. The investigator will be collecting these samples and reviewing test results from participants who have had an area of concern found on breast imaging, as well as from participants who are scheduled to have a routine breast cancer screening mammogram.


Eligibility Criteria:
Inclusion Criteria:

* Females with one or more BI-RADS 4 radiographic lesions who are undergoing ultrasound, stereotactic or MRI-guided breast biopsy at MSKCC or at an MSK Alliance Member Site. If multiple imaging modalities were employed (mammogram, ultrasound, MRI) and no integrated score is provided, then the highest BI-RADS score will be used.
* Age ≥ 18 years at the time of breast biopsy
* Willing to provide blood samples for research purposes before biopsy.
* Able to provide written informed consent

Exclusion Criteria:

* Women with a BI-RADS 4 lesion who had the lesion previously biopsied
* Females with a current active malignancy other than non-melanoma skin cancers. Females are considered not to have a "current active" malignancy if they have completed therapy and have no evidence of systemic disease for at least three years from the initial diagnosis
* Currently pregnant women
* History of bilateral mastectomy.
* Participant has or is currently participating in another GRAIL-sponsored protocol
Deflazacort Expanded Access Program for Children, Adolescents and Adults With Duchenne Muscular Dystrophy

The expanded access program will provide access to treatment with deflazacort in children, adolescent, and adult patients with DMD in the U.S. who are ineligible, unable, or otherwise unwilling to enroll in a clinical study examining the efficacy of deflazacort while a new drug application is under preparation and review. Enrollment is open to all eligible patients.

Deflazacort will be supplied free of charge and shipped directly to patients or caregivers, as appropriate. Treating physicians will continue to follow their standard of care activities and procedures for management of DMD. Treating physicians participating in the expanded access program are required to collect/document any patient or caregiver reported safety events and report to the sponsor..

Eligibility Criteria:
Main Inclusion Criteria:

* Confirmed diagnosis of Duchenne muscular dystrophy
* The patient is ≥ 5 years old
* Current on all childhood vaccinations including the chicken pox vaccine

Main Exclusion Criteria:

* History or current medication condition that could affect safety or poses an additional risk
* Hypersensitivity or allergic reaction to steroids or their formulations
An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST)

This study will examine the effect of BIIB021 on GIST growth and metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
* Age greater than or equal to 18 years at the time of informed consent.
* Pathologically confirmed GIST refractory to, intolerant of, or not a candidate for imatinib and sunitinib therapy.
* FDG PET standard uptake value (SUVmax; averaged over a maximum of 5 lesions) greater than or equal to 2 at screening.
* ECOG performance status of less than or equal to 2.
* Lab values consistent with adequate renal hepatic and bone marrow function.
* Must utilize effective contraception.

Exclusion Criteria:

* Prior treatment with imatinib, sunitinib, or sorafenib with in 14 days of day 1.
* Prior treatment with Hsp90 inhibitors at any time.
* Prior antitumor therapies including prior experimental agents, approved antitumor small molecules (excluding imatinib, sunitinib, or sorafenib) and biologics, or radiotherapy with in 28 days or \<3 half lives (whichever is longer) before start of BIIB021treatment.
* Diabetes treated with insulin and/ or concurrent severe or uncontrolled other medical disease (i.e, systemic infection, hypertension, coronary artery disease, congestive heart failure).
* History of/ or predisposition to seizures.
The Effect of Different Molecular Weight of HA for Carpal Tunnel Syndrome

Recently, nerve hydrodissection is utilized to assist ultrasound-guided nerve injection and studies recommend its clinical benefit for peripheral entrapment neuropathy. Hyaluronic acid (HA) can decrease the post-surgery adhesion of soft tissue and nerve but its clinical application in clinical practice is very rare.

We just proved that single HA injection have short-term effectiveness in mild-to-moderate carpal tunnel (CTS) cases and this finding may hint the therapeutic effectiveness of nerve hydrodissection for CTS depend on absorption time of solution. In addition, no study compare different weight of HA for nerve injection so far. Hence, the purpose of this study aim to compare different weight of HA for CTS and whether hydrodissection effect depend on the absorption time of solution or not.

Participants established with diagnosis of mild-to-moderate CTS will been randomly assigned to high molecular weight HA (Aragan Plus, 20 mg/2 ml, 3000kDa) or low molecular weight HA (ARTZDispo, 25 mg/2.5 ml, 600-1200kDa) groups. With ultrasound guidance, total two-sessions of high or low molecular weight HA with one week interval will been injected into intra-carpal region. The Boston Carpal Tunnel Syndrome Questionnaire is assigned as primary outcome. The secondary outcomes encompass visual analog scale, electrophysiological studies, cross-sectional area of the median nerve, mobility of median nerve and absorption time of HA. The assessment is performed prior injection and at 2 week, 1, 2, 3 and 6 months post-injection.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-80 year-old.
* Diagnosis was confirmed using an electrophysiological study

Exclusion Criteria:

* Cancer
* Coagulopathy
* Pregnancy
* Inflammation status
* Cervical radiculopathy
* Polyneuropathy, brachial plexopathy
* Thoracic outlet syndrome
* Previously undergone wrist surgery or steroid injection for CTS
EUS-GBD vs Antibiotics for Patients at High Risk for Cholecystectomy

Objectives Acute cholecystitis commonly occurs in elderly patients who are at high-risk for surgery. Whether upfront Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is advantageous over antibiotics first for mild acute cholecystitis is uncertain.

Hypothesis to be tested The aim is to compare EUS-GBD versus standard protocol (antibiotics first) as a definitive treatment, in very high-risk patients suffering from mild to moderate acute cholecystitis. We hypothesize that EUS-GBD can reduce the 1-year risk of recurrent acute cholecystitis.

Design and subjects This is an international randomised controlled study including consecutive patients suffering from acute cholecystitis that are very high-risk for cholecystectomy. The patients would be randomized to receive EUS-GBD or antibiotics first.

Interventions: EUS-GBD versus antibiotics

Main outcome measures:

The primary outcome is the rate of recurrent acute cholecystitis in 1 year. Other outcomes include technical and clinical success, post-procedural pain scores, analgesic requirements, adverse events, re-admissions, re-interventions, quality of life and cost analysis.

Data analysis All outcomes would be analysed according to the intention-to-treat principle. Kaplan-Meier method with the log-rank test will be used to compare differences in recurrent acute cholecystitis in 1 year. A health economic analysis will also be performed. Assuming a 17.1% difference in recurrent acute cholecystitis rates, a 2-sided P value of 0.05, a power of 80%, and a 10% dropout rate, 110 patients is required.

Expected results The findings of this study can help establish the role of EUS-GBD in management of high-risk patients suffering from acute cholecystitis over antibiotics alone and Percutaneous transhepatic gallbladder drainage.


Eligibility Criteria:
Inclusion Criteria:

1. Consecutive patients aged ≥ 18 years old
2. Suffering from grade 1 or 2 acute calculous cholecystitis\*
3. At very high-risk for early laparoscopic cholecystectomy due to poor premorbid conditions\*\* or elderly patients suffering from acute cholecystitis but refused operations

Exclusion Criteria:

Patients with the following conditions are excluded from the study:

* Pregnancy
* Patients unwilling to undergo follow-up assessments
* Patients with suspected gangrene or perforation of the gallbladder
* Grade III acute cholecystitis33
* Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal)
* Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
* Patients with liver cirrhosis, portal hypertension and/or gastric varices
* Abnormal coagulation: International normalized ratio (INR) \> 1.5 and/or platelets \< 50.000/mm3
* Previous drainage of the gallbladder
* Patients suffering acute cholecystitis due to malignant cystic duct obstruction
* Patients with life expectancy of less than 3 years
Gastric Ultrasound in Tube Fed Intubated Patients

This study will use point of care (POC) gastric ultrasound to confirm that nasojejunal tube (NJ) feeds result in minimal to no gastric content and therefore are low risk for aspiration and should be allowed at the very least to decrease the time that enteral feeds need to be held prior to a procedure or if they need to be held at all. This would allow critically ill children to receive the nutrition that they need to heal for longer periods of time. Using ultrasound would also potentially eliminate the need for exposure to x-rays to confirm tube placement. Most ICUs have a POC ultrasound machine so this would be any easy tool to access to improve patient care.


Eligibility Criteria:
Inclusion Criteria:

* all PICU patients intubated \< 7 days that are receiving NJ or NG feeds

Exclusion Criteria:

* patients that cannot be moved
* patients with significant GI conditions affecting motility
* patients intubated for more than seven days
Study to Determine How Exercise and Calcium Affect Pubertal Bone

To determine if increasing the amount of calcium that girls eat or the degree of exercise in which they participate will increase their bone strength.


Eligibility Criteria:
Inclusion Criteria:

* 9-10 years of age
* Premenarcheal
* Female

Exclusion Criteria:

* corticosteroid or anticonvulsant therapy
* lactose intolerance or milk allergy
* family history of hypercholesterolemia
* mental or physical handicaps
* chronic disease
* body mass index ³ 85th percentile for age and gender
* baseline calcium intake of \> 1100 mg/day
* participation in team sports \> 3 times per week
Cartography of Allodynic and Hypoasthetic Territories Following TKA

The purpose of this study is to realize a cartography of the allodynic and hypoasthetic territories associated with a neuropathic pain appearing in patients who underwent a Total Knee Arthroplasty (TKA)

The occurrence of Post-surgical Pain depends on the surgical procedure performed, the surgical site and patients-dependents characteristics. Post surgical pain became chronic when it persist beyond two month.

Chronic post-surgical pain (CPSP) is one of the most common complications after surgery. Nerve injury during surgery has been implicated in the development of CPSP. Some patients with CPSP have neuropathic pain (NP). NP is pain cause by damage or disease affecting the somatosensory nervous system. It may be associated with abnormal cutaneous sensation such as hypoesthesia (partial loss of sensitivity to sensory stimuli) or allodynia (pain from normally non-painful stimuli)

Total Knee Arthroplasty (TKA) present a high risk of injury of the infrapatellar branch of the saphenous nerve, thus can cause the appearance of neuropathic post-surgical pain. Only few data are available concerning the skin areas affected after this surgery.

The goal of this study is to analyse the localization of allodynic or hypoasthetic territories that may appear after TKA. The investigators will include 200 patients undergoing TKA surgery at the CHU-Amiens-Picardie. Patient will be seen the day before their surgery, and at follow-up visits at 6 weeks, 6 months and one year postoperatively. A DN diagnostic test (DN4 test) will be performed at each visits. The cartography will be performed on each DN4-positive patients. In addition, patients will also complete questionnaires to assess the intensity of pain, quality of life and level of anxiety.

Thus, the knowledge of the localization of allodynic or hypoasthetic territories will allow a most efficient an faster detection and relief of post-surgical neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* major patient benefit from a first setting operation of TKA (total knee arthroplasty) by standard medial arthrotomy
* Patient signed an informed consent
* Patients receiving social coverage

Exclusion Criteria:

* Patient not wishing to be part of the study, or unable to consent,
* Patient under guardianship or deprived of his liberty
* Patients with neuropathic pain in the territory concerned preoperatively
* Patient who underwent TKA laying by a technique other than standard medial arthrotomy
Telesupport: Evaluation of Professionally Led Support Groups for Caregivers

This study is a collaborative effort between a community-based service organization, Supportive Older Women's Network (SOWN), and an academic research division at Thomas Jefferson University (TJU). We plan to use a randomized controlled two-group design to: 1) test the effectiveness of the intervention at 6 months to enhance social support and perceived efficacy in comparison to a control group; 2) test if gains are sustained over 12 months (within experimental group comparison); and 3) evaluate the cost and cost effectiveness of the intervention. Three secondary study aims are to describe the process and content of tele-support groups (dose/intensity, support group topics); evaluate the relative benefits for African American and White females; and determine if control group subjects benefit from receiving a peer's telephone number for mutual support (within group comparison between 6 and 12 months).


Eligibility Criteria:
Inclusion Criteria:

* Caregivers will be recruited for study participation who fit the following criteria: 1) female, 2) 55 or older, 3) has been a caregiver for a minimum of 6 months, 3) provides care to a person with a physician's diagnosis of ADRD, 4) has weekly access to a telephone for one hour without interruption during working hours, or if unable to have uninterrupted time, willing to have home-maker service. Homemaker service during the tele-group meetings will be arranged by the recruitment source. For this study, we plan to recruit only females since they represent the majority of those providing care to persons with ADRD and have been shown to demonstrate significantly more stress and negative health outcomes than male caregivers.

Exclusion Criteria:

* Male
* under age of 55
* not a caregiver of person with ADRD
Pilot Study of Minocycline in Huntington's Disease

This study is being conducted to assess the impact of minocycline on the progression of symptoms of HD. The study will also assess whether it is reasonable to continue with further study of minocycline in HD. We will measure the effect of minocycline on HD by measuring the change in Huntington's disease symptoms.

The DOMINO study is a randomized, double-blind, multi-center, futility study of minocycline in patients with HD. Subjects will be randomized (3:1) to one of the two study arms: (1) the group that receives active minocycline (100 mg po b.i.d.), and (2) the group that receives placebo. Subjects will be enrolled over an approximate six-month period and remain on blinded study drug for 18 months. The primary analysis will involve a comparison of the change over time in TFC between the minocycline group and a fixed value determined from historical control data. A placebo group will also be included to facilitate blinding and to permit a descriptive assessment of the validity of the assumed change over time in historical controls.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Clinical features of HD and a confirmatory family history of HD; and/or genetically confirmed HD
* Independently walking and fully self-sufficient in activities of daily living (eating, dressing, bathing)
* Able to take medication (capsules) by mouth

Exclusion Criteria:

* History of known hypersensitivity or intolerability to minocycline or known allergy to any tetracycline
* History of vestibular disease
* Subjects with underlying hematologic, hepatic or renal disease
* History of systemic lupus erythematosus (SLE)