cyrilzakka/clinical-trials huggingface dataset:
Wheelchair Skills Training for People with ARSACS and DM1

Wheelchairs (WC) are often provided to people with ARSACS and MD1 when they are not able to walk anymore. However, giving someone a MWC alone does not guarantee they will use it safely or properly. Many people who use WC need help from others to get around and they can not always do the things they like to do. This can lead to isolation, stress, and reduced quality of life. In addition, poor use of a MWC could lead to accidents and injuries. Our team recently showed that people with ARSACS have lower MWC skills than other adults who use MWC, and that teaching MWC skills to people with ARSACS seems to work. Now we are ready to test the program with more people with ARSACS and MD1 to see how it can improve MWC mobility and confidence. We also want to hear about people's expectations and experiences with MWC training. People who take part in research will answer questions before and after WC training, and we will follow up with them 3 months later to ask again about their WC use.

This projects directly adresses the mobility needs of people with ARSACS and MD1 who use MWC. Our results may improve how therapists provide training for MWC use, which may improve mobility, participation, and quality of life for people with ARSACS and MD1. Learning just one MWC skill could be life-changing. It could mean the difference between leaving the house or not, which could impact the ability to shop for groceries, see friends, or to have a job.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age, have a diagnosis of ARSACS or DM1, and use a manual WC for mobility (≥3 times/week for ≥8 hours/week).

Exclusion Criteria:

* anticipate a health condition or procedure that contraindicates training (e.g., surgery); or concurrently or planning to receive WC training during the study.
PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs )

This is a Pharmacokinetic and Pharmacodynamic study evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF. Individuals will be randomised to receive Azithromycin alone, IDA or combination therapy. Clinical and biochemical monitoring for safety will be undertaken. Drug levels will be measured in each of the three arms to assess whether combination therapy significantly alters drug levels.


Eligibility Criteria:
Inclusion Criteria:

* Adult aged 18-65
* Able to give informed consent

Exclusion Criteria:

* Known chronic illness
* Hb \<7 at baseline
* Liver function or Creatinine \* 1.5 Upper Limit of Normal
* Urinary tract infection at baseline
* Pregnancy (female participants only)
* Routine medications which interact with study drugs
* Lactose/Gluten intolerance
* Permanent disability impeding study participation
Sport as Therapy: a 6-months Lifestyle-Intervention for Patients With Coronary Artery Disease and/or Diabetes

Regular exercise training has shown to improve exercise capacity in patients with cardiovascular disease. The feasibility and transferability of exercise training in a community based cardiovascular rehabilitation setting is currently less well investigated. The objective of this study is to translate regular exercise training into a community based setting. A 6 months training intervention program with lifestyle counseling is performed, with both supervised training in rehabilitation centres as well as home based training. The aim of the project is to implement this program for a wider patient population and to improve exercise capacity, diastolic function as well as cardiometabolic parameters.

From 2011, patients insured at "Techniker" health insurance company with diagnosed coronary heart disease, heart failure and/or diabetes mellitus are being included in a 6-months training program. Training is performed 3 times weekly for 6 weeks, then twice weekly for another 6 weeks, while patients are asked to do home based training. The last phase of 12 weeks, supervised training is only once/week. Patients are asked to perform exercise training 3-5 times weekly. At the beginning as well as after 3 and 6 months, patients present for medical check-up with cardiorespiratory exercise testing from which training instructions are drawn. Training-intensity begins with moderate continuous training and switches to higher intensity interval training after 6 weeks. Resistance training starts after 6 weeks and is performed within the supervised training. All patients were offered an individual nutritional counseling.

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease and/or diabetes mellitus
* Heart failure

Exclusion Criteria:

* all conditions which are not compatible with exercise training:
* severe orthopedic disorders
* severe psychiatric disease
* severe valve insufficiency
* presence of myocardial ischemia (decision made by cardiologist)
Bone to Skin Thickness Study: Obese Versus Normal Population

The purpose of this study is to determine the bone to skin depth for groups of lean, obese and morbidly obese patients. This information will be potentially helpful with implant design for obese and lean patients.

This study will examine pelvic CT scans of injured patients to determine skin thickness in several distinct regions important in orthopedic surgery. All patients admitted to the University of Mississippi Medical Center with a pelvic ring injury or acetabular fracture obtain a pelvic CT scan as a standard part of patient evaluation. The CT scans attempt to encompass the entire soft tissue sleeve from the skin edge to the pelvic bones. Several landmarks described below have been described to measure important surgical sites where obesity is problematical. Therefore this study is an attempt to quantify the size of the soft tissue envelope in patients

However, patients who are markedly obese may be too large for the entire soft tissue sleeve to be imaged with the CT scan. The second part of the study then is to validate the CT scan measurements obtained using clinical measurements. The clinical measurements will be obtained during operative management of displaced pelvic ring injuries and/or acetabular fractures. During surgical exposure, a measuring tape will be used to measure the soft tissue thickness in those areas corresponding to the CT scan measurements. These measures will be compared to validate the effectiveness of CT scan measurements to accurately document the soft tissue dimensions.

Eligibility Criteria:
Inclusion Criteria:

* Anyone admitted to the University of Mississippi Medical Center with a pelvic ring or acetabular injury

Exclusion Criteria:

* Those not fitting the inclusion criteria
Observational Study of Canadian Patients (6 Years or Older) Receiving Dupixent® for Moderate to Severe Atopic Dermatitis

This is a prospective, 18-month observational study of adult, adolescent and pediatric Canadian participants with Atopic Dermatitis (AD) commonly known as Eczema, who receive treatment with Dupixent for moderate-to-severe AD (msAD) according to the Canadian-specific prescribing information (in accordance with the Canadian Dupixent Product Monograph). The study will be conducted in approximately 30 centers in Canada to assess participants of all ethnicities and races. At each participating site, all AD participants who receive an initial prescription for Dupixent will be invited to participate in this study, until the Canadian enrollment goal is achieved.

The duration of the study for each participant will be of 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 6 years or older at baseline visit (Canada has received the country's regulatory approval for use of Dupixent treating msAD for these ages).
* Participant is initiating dupilumab as part of routine clinical care through the Dupixent Patient Support Program (PSP) for the treatment of msAD, as per reimbursement criteria. Decision to treat with dupilumab must have been reached prior to and independently of recruitment in the study.
* Have a physician's diagnosis of msAD.
* Provided signed informed consent or parental/legally acceptable representative consent and/or participant assent. During the study, subjects will continue to receive maintenance therapies for their AD as clinically indicated and as per usual medical practice.
* Participant or Parental representative able to understand English and/or Canadian French to complete study-related questionnaires.

Exclusion Criteria:

* Participants who have a contraindication to the drug according to the Canadian-specific prescribing information label.
* Any condition that, in the opinion of the Investigator, may interfere with participant's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the participant from adequately completing the schedule of visits and assessments.
* Participants currently participating in any interventional clinical trial which modifies participant care.
* Prior use of Dupixent within 6 months of the baseline visit.
* Participants not willing to sign the Informed Consent Form.
Newborn Screening for Severe Combined Immunodeficiency (SCID) in a High-Risk Population

The goal of the proposed research is to establish the validity of a newborn screening method for severe combined immunodeficiency (SCID). The assay to be used is developed on the basis of PCR quantification of T-cell receptor excision circles (TRECs) that is absent in SCID patients, thus correlating with the disease

To show that early diagnosis of SCID with a TREC screening assay can warrant timely treatment of the disease and avoid life-threatening infections on patients. Babies with SCID are unable to fight infections. They become severely ill in their first months of life and do not survive unless their immune systems can be restored. SCID can be treated by bone marrow transplant if recognized early. The newborn screening test to be employed in this study is designed to diagnose SCID before infections occur. By conducting a pilot testing program in a high-risk population on the Navajo Indian Reservation, where one in 2,000 infants is born with SCID, we hope to confirm the benefits of newborn screening for early diagnosis of SCID

Eligibility Criteria:
Inclusion Criteria:

* Birth in a study hospital on the Navajo Reservation

Exclusion Criteria:

* None
Combined Use of Coronary MDCTA, Coronary Doppler Ultrasonography and PET Perfusion in Diagnosing Coronary Artery Disease

Multislice CT angiography is a novel but already established and widely used in diagnosing coronary artery disease (CAD). It is very reliable in ruling out hemodynamically significant narrowings in coronary arteries (Negative predictive value). However, it may overestimate the severity of the stenoses in up to 30% of the coronary artery lesions (positive predictive value 70%). However, when coupled with a functional or flow-sensitive diagnostic test, such as PET perfusion or coronary doppler ultrasonography, one can assume that even the PPV may be as high as 95 %. Despite this assumption, there's no scientific evidence to support use of such hybrid multi-modality tests at present.

The investigators hypothesis is that improving the diagnostic accuracy of non-invasive diagnosis of coronary artery disease will decrease the proportion of patients that need catheter angiographies. The avoidance of these unnecessary invasive procedures will improve patients´ quality of life and may even redirect health care resources in a more efficient way.

Coronary MDCTA (multi-detector CT angiography) is a novel but already established and widespread diagnostic method to diagnose coronary artery disease. When performed with a 64-detector (slice) CT, its strength is an excellent negative predictive value, NPV (98%). Specificity (86%) is good but the positive predictive value (PPV) is only moderate (70%). This is due to the ability of MDCTA to detect even minor vessel wall changes before they are functionally significant, and the tendency of CT to overestimate the volume of dense calcifications. However, when coupled with a functional or flow-sensitive diagnostic test, such as PET perfusion or coronary doppler ultrasonography, one can assume that even the PPV may be as high as 95 %. Despite this assumption, there's no scientific evidence to support use of such hybrid multi-modality tests at present.

Our hypothesis is that improving the diagnostic accuracy of non-invasive diagnosis of coronary artery disease will decrease the proportion of patients that need catheter angiographies. The avoidance of these unnecessary invasive procedures will improve patients´ quality of life and may even redirect health care resources in a more efficient way.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* age 40 - 80 years
* stable chest pain
* likelihood of obstructive coronary artery disease more than 25% based on gender, age, symptoms and exercise test

Exclusion Criteria:

* irregular rhythm
* hypersensitivity to contrast agents
* unstable chest pain
* decompensated congestive heart failure
* abnormal kidney function
* 2nd or 3rd degree AV block
* severe bronchial asthma
* pregnancy
* age over 80 years
* previously diagnosed coronary artery disease
Next Generation Chest X-Ray Tomosynthesis for Screening of Lung Cancer

The goal of this observational clinical trial is to learn if chest tomosynthesis is a potential alternative to computed tomography for the detection of lung cancer. It will also develop artificial intelligence tools to aid in the diagnosis of lung cancer on chest tomosynthesis images. The main questions it aims to answer are:

* What is the accuracy of chest X-ray tomosynthesis in diagnosing lung cancer in a population of individuals undergoing lung cancer screening or evaluation of a suspicious lung nodule?
* Can artificial intelligence help us detect lung cancer on chest tomosynthesis images?

Researchers will compare chest tomosynthesis images to computed tomography scans for each participant to see how they compare in diagnosing lung cancer.

Participants will a chest tomosynthesis scan in addition to their routine clinical computed tomography scan.

Lung cancer remains the most common cause of cancer death in the United States for which low-dose CT has proven benefit for early detection and survival from lung cancer. However, adoption remains low. Furthermore, \>95% of nodules detected on low-dose CT, especially those smaller than 6 mm, do not represent cancer. We have partnered to develop a novel chest x-ray tomosynthesis (CXRT) device with the hypothesis that this device might be an alternative to CT for detection of lung cancer. We seek to recruit a cohort of patients to undergo CXRT, composed of patients concurrently undergoing lung cancer screening CT and diagnostic CT for new lung cancer. We will determine the effectiveness of CXRT for detecting lung cancer in this population, evaluating its sensitivity and specificity for detecting cancer and lung nodules at multiple size thresholds in a multireader study. We will additionally develop artificial intelligence algorithms and evaluate their efficacy to further enhance cancer detection.

Eligibility Criteria:
Inclusion Criteria:

* undergoing lung cancer screening
* undergoing evaluation of suspicious pulmonary nodule
* newly diagnosed lung cancer

Exclusion Criteria:

* prior history of lung cancer treatment
Lavender Oil Aromatherapy for The Treatment of Acute Anxiety During Bone Marrow Biopsy Procedures

The purpose of this study is to assess the effectiveness of lavender oil as compared to standard of care (SOC) to relieve anxiety in participants undergoing a bone marrow aspirate and biopsy procedure

Bone marrow aspiration and biopsy (BMAB) is a primarily outpatient procedure that is used to aid the diagnosis of hematological diseases. During the BMAB, local anesthesia is used however, many recipients still commonly report pain. Poorly-controlled pain has been shown to have adverse, long-lasting psychological effects and those receiving BMAB are generally significantly anxious and concerned about pain when undergoing this procedure. Previous clinical studies suggest that lavender oil aromatherapy is effective in lowering anxiety experienced by participants. It will be hypothesized that lavender oil aromatherapy will demonstrate benefit to participants suffering from anxiety during the BMAB procedure.

Participants who are undergoing BMAB and meet the inclusion criteria will be randomized to either receive aromatherapy via lavender oil before and during the duration of the BMAB, or to a SOC arm.

The primary objective of this study is to assess the efficacy of lavender oil aromatherapy as compared to placebo aromatherapy to relieve acute anxiety in participants undergoing a BMAB procedure

Secondary objectives of this study are:

To assess the efficacy of lavender oil aromatherapy as compared to placebo aromatherapy to relieve acute anxiety in participants undergoing a BMAB procedure

To determine the feasibility of utilizing lavender oil aromatherapy during BMAB in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have the ability to understand and sign a written informed consent document, and be willing to follow protocol requirements
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
* Willingness to comply with all study interventions of lavender oil aromatherapy
* Anxiety \>3 on a 0-10 visual analog scale regarding the bone marrow biopsy/aspirate procedure

Exclusion Criteria:

* Allergy to lavender oil
* Mental incapacitation (ex. stroke, brain metastasis etc.) that would cause inability to follow directions, in the opinion of the investigators
* Ongoing uncontrolled active psychiatric condition that would interfere in the conduct of the study (e.g., mood disorders, anxiety, psychosis disorders, or substance use), as determined by the patient's primary cancer team.
* If a patient has a history of a psychiatric disorder, we will contact their primary cancer team to determine if their condition is controlled or uncontrolled, and if it will interfere with the study.
* Currently pregnant
* Recent changes in the past 2 weeks to medications prescribed for pain or anxiety
Total Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF Therapy

This is a prospective, randomized, open-label clinical trial to evaluate the efficacy and safety of total glucosides paeony capsules in maintaining clinical remission in patients with ankylosing spondylitis which achieved clinical remission after anti-TNF therapy. Patients will be divided into two groups randomly, one group receive non-steroid anti-inflammatory drugs(NSAID) mono-therapy and the other group receive total glucosides paeony capsules plus NSAID therapy for 24 weeks. The primary clinical endpoint is the proportion of patients which disease activity reaches relapse criteria. The investigator's hypothesis the proportion of relapse in total glucosides paeony capsules plus NSAID group would be lower than the NSAID mono-therapy group.


Eligibility Criteria:
Inclusion Criteria:

* Aged from 16-65 years, sign the Informed Consent
* Fulfill 1984 modified NewYork classification criteria for AS
* Achieved clinical remission after at least 12 weeks' therapy of anti-TNF therapy
* Hb≥9g/dl, ALT/AST≤ 2 folds of upper level normal range, creatine≤120mol/L(≤1.4mg/dl)
* Commitment to contraceptive for woman

Exclusion Criteria:

* History of psoriasis and/or inflammatory bowel diseases
* Receive intra-articular injection of cortisone within 3 months before enrollment
* History of the listed diseases: heart failure, Multiple sclerosis, severe chronic obstructive pulmonary disease, frequent infections, lymphoma or other cancers, tuberculosis
* Pregnant and lactating women
* Mentally ill, Alcoholics and drug addicts
Reliability of the Samsung Galaxy for the Detection of Moderate to Severe Obstructive Sleep Apnea

The study will test the reliability of the Samsung Galaxy for the Detection of Moderate to Severe Obstructive Sleep Apnea (OSA)

A prospective cohort of 150 individuals 22 years or older with a prior diagnosis or with a high likelihood of having moderate to severe OSA, screened using STOP-Bang and Epworth Sleepiness Scale questionnaires will be recruited and will utilize the Samsung Galaxy Watch technology to monitor sleep patterns, oxygen saturation, PPG, and heart rate variability amongst other physiologic parameters. All data will be collected over the course of two intervention nights in the sleep lab and at home for three nights.

Eligibility Criteria:
Inclusion Criteria:

* 22 years of age or older
* High pre-test likelihood of moderate to severe obstructive sleep apnea (OSA) based on screening questionnaires (STOP-Bang and Epworth Sleepiness Scale); or prior diagnosis of moderate-severe OSA.
* Able to provide informed consent confirmation

Exclusion Criteria:

* Severe and/or other acute medical illnesses as determined by the Investigator, in particular: Cardiac conditions such as Congestive Heart Failure (CHF), atrial fibrillation, Hx of Movement disorders: Parkinson's, Tremor, Lung conditions: Chronic Obstructive Pulmonary Disease (COPD), chronic bronchitis, emphysema, pulmonary fibrosis, acute episode of flu, allergies, asthma.
* Active comorbid sleep disorders, such as severe insomnia, restless legs syndrome, Periodic Leg Movement During Sleep (PLMS), narcolepsy, idiopathic hypersomnia
* Severe and/or unstable psychiatric disorders such as mood, anxiety, or psychotic disorders
* Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
* Inability to use a Samsung Galaxy device for sleep tracking
* Inability to have two nights in the Stanford sleep lab.
* Participants who are pregnant
* Tattoos or scars covering the forearm area of both hands
Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a digital intervention for co-occurring cannabis use and depression. Participants will be randomized to complete Amplification of Positivity - Cannabis Use (AMP-C) or symptom tracking. The main outcomes will include participant acceptability and usability ratings, completion rates and compliance, positive affect, substance use, and depression severity.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Resides in the United States
* Able to read and understand English and willing to provide informed consent/comply with the study protocol
* Moderate depressive symptom severity, as indicated by the Patient Health Questionnaire-9 (PHQ-9)
* Problematic cannabis use, as indicated by the Cannabis Use Disorder Identification Test - Revised (CUDIT-R)
* Current elevated anhedonia, as indicated by the PHQ-9
* Interest in receiving treatment for their cannabis use and/or depression
* Meet criteria for current MDD and CUD per the DSM-5

Exclusion Criteria:

* History of a psychotic disorder or bipolar disorder type I/II
* Active suicidal ideation or intent based on the Columbia-Suicide Severity Rating Scale
* Current psychotherapy engagement
* Changes in psychotropic medication within six weeks of the start of study