cyrilzakka/clinical-trials huggingface dataset:
Auditory Function in Patients With and Without Multiple Sclerosis

We propose to evaluate auditory function and neuropsychologic function in 150 Multiple Sclerosis (MS) patients and in 150 patients who do not have MS. Experimental subjects will be recruited by selecting patients with a verified diagnosis of MS from the registry of patients established by the Oregon Health Sciences University, Multiple Sclerosis Research Center. Control subjects will be matched with respect to age, to gender and to audiometric configuration.

This study will compare the prevalence and nature of hearing dysfunction in patients with MS and in a group of control subjects without MS. The work will address three main goals:

1. Evaluating the possibility that MS is a risk factor for hearing impairment, tinnitus and central auditory dysfunction.
2. Determining the nature and the extent of auditory dysfunction in individuals with MS compared to those without MS; and determining neuropsychological function in each group.
3. Evaluating the extent to which disability in individuals with MS may be amplified by the presence of auditory dysfunction.

Measurements of auditory function and psychometric performance will be compared between MS patients and control subjects without MS. These subjects will come to the Portland VAMC for four sessions of comprehensive auditory and psychometric testing. Additional information on disease history and status, hearing history, and current-disability status will be obtained.

Subjects The patient group (Group 1) will consist of 150 patients with diagnosed MS, recruited at the MS Center of Oregon. For this group, inclusion criteria for each patient will include: (1) a clinical or laboratory supported diagnosis of "definite MS" (Poser, et al., 1983); (2) a diagnosis of relapsing, remitting or secondary progressive MS; (3) A Kurtzke Expanded Disability Status Score (EDSS) of 0 to 7.0, inclusive; (4) no history of a clinical relapse or change in EDSS for three months preceding entry into the study; and (5) a brain MRI scan (within the preceding year) that shows at least three white-matter lesions on T2-weighted images consistent with MS.

The control group (Group 2) will consist of 150 subjects without MS who are matched to the patient group with respect to age (± 5 years), to gender and to audiometric configuration (within ±10 dB Hearing Level for the octave test frequencies from 500 through 8000 Hz). Subjects in Group 2 will be recruited from the VA audiology clinic and from a cohort of more than 360 subjects and patients who have been used as controls in five other studies. Both males and non-pregnant females will be recruited in equal numbers. Minority individuals will be recruited in accordance with recommendations for proportional minority representation established by the Office of Human Research Accountability and the Minority Affairs Program. The protocols will be explained verbally by the investigators, and restated in consent forms approved by the VA IRB, and signed by the subject, by the investigator and by a witness.

Eligibility Criteria:
Multiple Sclerosis
Resectability of Pancreatic Head Cancer by Contrast-enhanced MDCT:a Multi-center Study

The purpose of this multicenter and double-blind clinical trial is to prospectively assess the sensitivity, specificity, negative predictive value, positive predictive value, and accuracy in respectability of pancreatic head cancer with contrasted-enhanced MDCT and its various post processing techniques, taking operational and pathological records as the gold standard.


Eligibility Criteria:
Inclusion Criteria:

* Patients with (or suspected) pancreatic head cancer
* Being examined by contrasted-enhanced MDCT
* Receiving surgical treatment (including palliative surgery) in all research centers

Exclusion Criteria:

* Patients having (or suspected) pregnancy or breast-feeding
* Patients having allergic reactions to iodinated contrast agents or Hypersensitivity reactions to allergens(including drugs)
* Patients receiving ERCP before contrasted-enhanced MDCT examination
* Patients without surgery because of a high degree of surgical risk
Older Veterans EmpoweRed To Use Regular Exercise (OVERTURE) II

The purpose of this study is to investigate the practicality of a short-term (8-weeks), home-based digital versatile disc (DVD) chair exercise program among 40 sedentary older Black/African American and White/Caucasian veterans with three or more chronic health conditions, such as type 2 diabetes, hypertension, and osteoarthritis.

This study will determine the feasibility of a home-based DVD chair exercise program, "Sit and Be Fit." Participants will be asked to complete a chair-exercise program Monday through Friday. Each chair exercise session lasts approximately 30 minutes. Participants will receive a new DVD player, the exercise DVD, and the necessary exercise equipment to complete each session. The equipment includes a set of 1 pound hand weights, a 10" exercise ball, a small handball, a resistance band, an exercise log, and a satisfaction survey. Upon initial enrollment, both groups will receive a baseline health assessment that will include health-related quality of life, subjective well-being, body mass index (BMI), comorbidity, blood pressure, lower body extremity fitness, physical activity, and hand grip strength. Excluding health status, all other measures will be completed at post-assessment (the end of week 8 for Group A and Group B). The intervention group (Group A) will receive the equipment after completing eligibility screening, an informed consent, and health assessments. The waitlist control group (Group B) will receive the equipment at week 9 after the post-assessment. Group B will complete the program through week 16. The waitlist control group(Group B) will not receive an additional post assessment at the end of week 16.

Eligibility Criteria:
Inclusion Criteria:

* Be a veteran, which will be verified through documentation, such as discharge papers, military identification card, or military photographs
* Identify as Black/African American or White/Caucasian; demonstrate proof of age 65+; self-report of three or more chronic health conditions
* Pass a cognitive screening related to thinking/reasoning/decision making; report less than 30 minutes of daily physical activity
* Systolic blood pressure lower than 180
* Diastolic blood pressure lower than 100
* Resting heart rate 90 or lower
* Three or more chronic health conditions
* Permission from primary care physician (PCP)
* Own a sturdy stand-alone chair without arms
* Own an operable television
* Willing to be randomized to the intervention or the waitlist control group

Exclusion Criteria:

* Non-veteran
* Non-Black or African American/White or Caucasian
* Younger than 65 years of age
* Systolic blood pressure 180 or higher
* Diastolic blood pressure is 100 or higher
* Resting heart rate higher than 90
* Less than three chronic health conditions
* Failure to pass a cognitive screening
* Report more than 30 minutes of daily physical activity
* No approval from PCP
* No sturdy stand-alone chair without arms
* No operable television
* Unwilling to be assigned to the intervention or the waitlist control group
Pulsed Field Ablation Versus Radiofrequency Ablation for Persistent Atrial Fibrillation

This clinical trial aims to compare the efficacy and safety of pulsed field ablation and radiofrequency ablation to treat persistent atrial fibrillation in adults.

Participants will:

Undergo pulsed field ablation or radiofrequency ablation. Keep follow-up for at least 12 months.

Traditional treatment options for persistent atrial fibrillation (PeAF) include pharmacological management, electrical cardioversion, and catheter ablation. Pulmonary vein isolation (PVI) has become the cornerstone of ablation therapy and has been shown to be effective in clinical practice. However, its efficacy is relatively limited in patients with persistent AF compared with those with paroxysmal AF, and many patients still experience recurrence after treatment.

In recent years, linear ablation strategies based on alcohol ablation have been shown to improve the one-year maintenance of sinus rhythm in patients with PeAF. Traditional radiofrequency ablation (RF) has demonstrated good outcomes but still has certain limitations when dealing with PeAF. In several clinical studies, pulsed field ablation (PFA), an emerging and innovative technique, has shown non-inferiority in treating paroxysmal AF. Furthermore, PFA has also demonstrated significant efficacy in linear ablation sites such as the mitral isthmus line, posterior left atrial wall, and tricuspid isthmus line, highlighting its potential in treating PeAF. This study aims to compare the safety and efficacy of PFA and radiofrequency ablation (RF) in the treatment of PeAF through a multi-center, prospective, randomized, open-label, non-inferiority clinical trial, to provide a safer and more effective treatment option for clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years
* Patients with non-valvular persistent atrial fibrillation undergoing their first catheter ablation (AF duration: 3 months to 3 years)
* Left atrial diameter on parasternal long-axis view of echocardiogram \< 50 mm
* Agree to be randomly assigned to the ablation strategy and able to follow up

Exclusion Criteria:

* Atrial fibrillation due to reversible causes
* LVEF \< 30%
* Severe congenital heart disease
* Severe liver or kidney dysfunction (eGFR \< 15, Child-Pugh grade 3), or history of dialysis
* History of cardiac surgery, such as coronary artery bypass grafting, mechanical valve or prosthetic valve replacement
* History of pacemaker implantation, left atrial appendage closure, or patent foramen ovale closure
* Contraindications to oral anticoagulation
* Contraindications to right or left heart catheterization
* Pregnancy
* Life expectancy \< 1 year (e.g., advanced malignancy, end-stage renal disease)
* Currently enrolled in another trial evaluating medical devices or drugs
* Other situations where the investigator determines the subject is unsuitable for the study
Calibration of a New Reflectance Oximeter.

This study is about the development of a new medical device for the monitoring of of sleep disordered breathing. This device is developed by the CEA-LETI-LE2S and will be composed of an oximeter, an actimeter in order to measure the activity level of the subject, his state of sleeplessness/sleep, and a CO2 partial pressure transcutaneous sensor (PtcCO2).

Developing this device is realized in several steps : a study (ALMOST) is already in progress and its goal is to acquire a database of polysomnography to create automatic algorithms in order to detect respiratory disorders with this device under development.

The main goal of the study is to calibrate the oxymeter under development.


Eligibility Criteria:
Inclusion Criteria:

* Subjects (both gender) aged between 18 to 50 years affiliated to a certain social security, that has given their free consent to participate to the study
* Subjets without any pathology known and not under medical treatment likely to suffer from controlled hypoxia at levels demanded in the protocol.
* Subjets having a regular practice of sport

Exclusion Criteria:

* Subjet non affiliated to a certain social security
* Smoker or person exposed to passive smoking
* History of acute mountain sickness or known sensitivity to hypoxia
* Any chronic pathology known, in particular pathologies behind high rates of methaemoglobin
* Pregnant, parturient or breastfeeding women, person deprived of liberty by judicial or administrative decision, person under a legally protected order and could'nt be included in clinical trials (persons mentioned in L1121-5 to L1121-8 of CSP).
* Subjets likely to not be cooperative or respectful of the inherent constraints to study participation.
Utilization of a Knee Brace With Extension Swing

The purpose of this research is to help determine if use of the Guardian brace during prehab and post-op rehab after TKA can help improve functional outcomes and reduce the incidence of post-operative flexion contractures which reduce knee range of motion after surgery.

This will be a prospective study with consecutive TKA patients with pre-operative flexion contractures of 5 degrees or greater. Patients will be randomized to one of two groups: 1) use of the Guardian knee brace peri-operatively, and 2) no Guardian brace use.

Pre-operative range of motion (ROM) and leg strength will be tested (4 to 6 weeks pre-operatively and the week before surgery) as well as during the recovery period at 6 weeks and 3 months post-operatively. The study will attempt to quantify quadriceps and hamstring strength using a Medical Engineering TKR2000, which can digitally measure quadriceps and hamstring strength with accuracy equivalent to a Biodex Dynanometer. The TKR2000 also accurately measures terminal flexion and extension of the lower extremity. Pre- and post-operative patient reported outcome measures (KOOS JR. score) will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age
* Surgical candidates undergoing primary TKA
* Surgical candidates with pre-operative flexion contracture of 10 degrees or greater
* Patient is willing to cooperate and follow study protocol and visit schedule

Exclusion Criteria:

* Patient is pregnant
* Patient is unable to provide written consent
* Patient has psychiatric disorder that precludes safe study participation
* Patients with a prior history of surgery in the affected knee
* Vulnerable patient populations
Effects of Kinesio Taping Application in Women With Overactive Bladder

The aim of this study is to compare the effects of kinesio tape application on bladder symptoms and quality of life in women with overactive bladder (OAB).


Eligibility Criteria:
Inclusion Criteria:

* 20 to 65 years of age,
* having overactive bladder
* being volunteer

Exclusion Criteria:

* pregnancy,
* only stress incontinence,
* the presence of a malignant condition with a history of acute infection,
* having a mental problem to prevent co-morbidity, evaluation and cooperative
A Longitudinal Study of the Trajectory of Financial Toxicity and Its Relationship With Symptom Burden in Breast Cancer Patients

Breast cancer has become the leading cause of global cancer incidence. With the improvement of treatment methods, some breast cancer patients have experienced different degrees of financial toxicity, which seriously affected the quality of life, treatment compliance and treatment outcomes of patients. Currently, there are some related studies on financial toxicity in breast cancer patients, but they are mainly cross-sectional studies, lacking the use of validated financial toxicity tools to measure the longitudinal change trajectory of financial toxicity. The financial toxicity of breast cancer patients may change dynamically with the treatment stage, expenditure and time, so it is necessary to conduct a rigorously designed prospective study to explore the trajectory of financial toxicity. In addition, previous studies have showed that financial toxicity may be associated with anxiety, distress, pain and overall symptom burden. However, the relevant evidence is currently limited. This study is designed as a prospective longitudinal study to explore the trajectory of financial toxicity and its influencing factors in breast cancer patients in China, and to focus on the relationship between symptom burden and financial toxicity, which will help clinicians identify potential high-risk populations, and provide a new perspective for future intervention programs.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with breast cancer and underwent surgery
* Be going to receive one or more of chemotherapy, radiotherapy, targeted therapy, endocrine therapy, and immunotherapy
* With the ability to understand and communicate in Chinese
* Provided informed consent

Exclusion Criteria:

* Illness was considered too severe for participation
* With cognitive or psychiatric disorders
Performance of a Hearing Aid Platform Including Different Styles of Hearing Aids

The reason for this study is to evaluate a new hearing aid product generation replacing the one on the market. The goal is to evaluate the audiological performance, usability as well as features and functions.

This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa. The focus is to compare a new hearing aid product generation with the one on the market as well as with competitor devices regarding the audiological performance, usability as well as features and functions with the aid of 382 mild to profound hearing impaired subjects (18-90 yrs). The subjects, all of them native (Swiss) German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during nine weeks including weekly appointments of 2 hours.

Eligibility Criteria:
Inclusion Criteria:

* all kinds of hearing loss (sensorineural, conductive, combined)
* all kinds of hearing loss (flat, sloping) which are in the fitting range of the hearing aids
* mother tongue (swiss) german

Exclusion Criteria:

Subjects

* with a reduced mobility unable to attend weekly study appointments
* without access to a number of different hearing situations
* with strongly reduced ability to describe auditory impressions and the usage of the hearing aids
* which are uncooperative so that it is not possible to record a valid pure tone audiogram
* with a strongly reduced dexterity
* with psychological problems
* central hearing disorders
Safety and Adequacy of Trans-jugular Liver Biopsy in Patients With Liver Disease: SAFE-TJLB Study

Liver biopsy is considered the gold standard for the evaluation of acute and chronic liver disorders. Liver biopsy provides information regarding diagnosis, disease progression, and response to therapy in patients with chronic liver diseases. Trans-jugular liver biopsy (TJLB) consists of obtaining liver tissue through a rigid cannula introduced into one of the hepatic veins typically using jugular venous access. This approach reduces the risk of hemorrhage after biopsy because the bleeding resulting from the biopsy needle will drain into the hepatic veins. In the past, the specimens obtained by a transjugular approach were considered suboptimal compared with the samples obtained with percutaneous needles because they were smaller and more fragmented. TJLB was initially indicated for patients who had a contraindication to percutaneous biopsy such as those with a coagulopathy or congenital clotting disorders, ascites, acute liver failure, large amount of adipose tissue, and patients after liver transplantation. The clinical role of TJLB has expanded due to the possibility of performing hemodynamic evaluation of the hepatic and portal venous systems, which provides useful information and may guide therapy in patients with portal hypertension.

Lacuna in literature:

There is no prospective study in India evaluating the safety and efficacy of trans-jugular liver biopsy in patients with liver disease.

Hypothesis:

Trans-jugular liver biopsy is safe, gives adequate sample for pathological examination in patients with liver disease.

Aim of study:

To evaluate safety and adequacy of trans-jugular liver biopsy in patient with liver disease.

Primary objective:

1. Adequacy of trans-jugular liver biopsy
2. Safety of trans-jugular liver biopsy

Secondary objective:

1. Indications of liver biopsy
2. Procedural time (in and out of catheter)
3. Number of passes
4. Failure rate
5. Day care time
6. VAS: pain (Abdomen and Neck, pre and post procedure)
7. Complications- arrythmia, hematoma
8. Time of Fluro exposure

Patients and methods Study Design A prospective, observational cohort study will be conducted in patients with suspected or known liver disease between November 2023 to May 2024 at the Institute of Liver and Biliary Sciences (ILBS), New Delhi.

Clinical protocol An informed consent was taken from patients with liver disease undergoing liver biopsy as per clinical indication. The following demographic data was recorded at inclusion: Age, gender, co-morbidities, type, and etiology of liver disease. Laboratory parameters include complete blood count, liver function tests, kidney function tests, INR. Severity of liver disease (MELD score, CTP score, AARC score).

Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years age.
2. Patient with suspected or known liver disease undergoing trans-jugular liver biopsy as per clinical indication.

Exclusion Criteria:

- None
The Effects of Heart Rate Variability Biofeedback Training on Hematopoietic Cell Transplantation Patients

Patients undergoing hematopoietic stem cell transplantation (HCT) often continue to experience anxiety, depression, isolation, and other psychosocial distress due to the severe nature of the transplant experience. Storytelling interventions that provide an opportunity for emotional disclosure have shown preliminary efficacy to alleviate psychosocial distress and improve emotion regulation during health challenges. Not only are these changes observed in response to such interventions, but they can also be directly strengthened with HRV biofeedback (HRVB) training, a device-driven breath pacing practice that uses colored light signals to provide feedback to increase vagal tone and improve emotional responses and sleep quality by regulating negative affect and stress. This randomized controlled trial will explore the effects of HRV biofeedback (HRVB) training combined with a digital storytelling intervention and changes in psychosocial distress with a modified waitlist control in a population of Hematopoietic cell transplantation (HCT) patients.

This randomized controlled trial will explore the effects of an HRV biofeedback (HRVB) training session with a modified waitlist control in a population of Hematopoietic cell transplantation (HCT) patients. We will secondarily explore effects of a brief storytelling intervention, with or without the prior HRVB training. Two group of 10 HCT patients over the age of 18 will be recruited and enrolled into the study. The time of participating in this study will be 2-week proposed activities from the time of enrollment to completion. Specific participation will include baseline data collection (about 30 minutes), HRVB training session (30 minutes), watching and discussing stories (15 min for each week= 30 minutes) and one final data collection (about 30 minutes) at the end. For HRVB group, participants will be instructed to practice their HRV biofeedback skills at home for 10 minutes each day for a two-week period (about 140 minutes). Lab visit is required only twice for baseline data collection and final data collection. Other works will be via internet.

Eligibility Criteria:
Patient Inclusion Criteria:

* age 18 or older
* recently underwent Hematopoietic cell transplantation (HCT) (within 3 months after hospital discharge)
* must be able to speak, read, and write in English
* access to a working phone and e-mail account
* have a smart phone

Patient Exclusion Criteria:

* cognitive impairment that prohibits completion of study assessment visual or hearing impairment
* other (e.g., provider non-approval or logistical constraints such as patient moving out of town)