cyrilzakka/clinical-trials huggingface dataset:
Care Coordination/Home Telehealth to Safeguard Care in CKD

Home telehealth monitoring of veterans with chronic kidney disease, with a disease management protocol and safety-specific decision support, will increase the detection of adverse safety events, and in turn, reduce the need for urgent health resource utilization and associated poor outcomes.

Pre-dialysis chronic kidney disease (CKD) is associated with a high risk of harm related to medical care (adverse safety events). These events may occur outside the purview of the medical system, and hence, are under-recognized. Health information technology (IT) can enhance the detection of such events, and coordinated care can prevent their adverse consequences. Study design: 6-month randomized trial of coordinated care/home telehealth (CCHT) vs usual care in CKD patients. Intervention: Veterans Administration (VA) CCHT with a guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC). Study population: Veterans with Stage III-V CKD (no expected dialysis within 6 months), age ≥ 60 years old, and diabetes (n = 65 per arm). Study Site: Baltimore VA Medical Center (BVAMC), VA Geriatrics Research, Education and Clinical Center (GRECC), and RISC. Specific Aim 1: Compare detection of adverse safety events in CKD patients assigned to CCHT vs usual care. Specific Aim 2: Compare the frequency of urgent health service use and participant satisfaction with CCHT vs usual care group. Study Measurements: Vital sign and clinical measurements (daily BP, weight, and finger stick glucose), laboratory values, and patient- reported safety events obtained per CCHT protocol vs patient-reported safety events, laboratory values, and assessment at a mid-study safety clinic visit in usual care protocol. Emergency department (ED) visits, hospitalization, renal progression, incidence of ESRD, and death will be measured in both groups along with patient satisfaction. Outcomes: Aim 1: Counts of a diverse set of adverse safety events including hypoglycemia, hypotension, volume loss (by weight change), hyperkalemia, acute kidney injury (AKI), and patient-reported safety incidents. Aim 2: ED visits, hospitalization, and other adverse outcomes including renal function loss, ESRD, and death. Analytic plans: Adjusted rates of events tracked in Aim 1 and 2 and expressed as counts per month will be compared in CCHT vs usual care group with multivariate models as indicated. Expected findings: CCHT will increase the detection of adverse safety events but reduce urgent health resource utilization and adverse outcomes. Public Health Relevance: Home telemonitoring of CKD patients in conjunction with coordinated care and decision support can increase the detection of adverse safety events that occur outside the traditional health care system and offer new opportunities to reduce their associated poor outcomes on a platform that allows ready dissemination across a national health network.

Eligibility Criteria:
Inclusion Criteria:

* Veterans with Stage III-V CKD
* Diabetes

Exclusion Criteria:

* Expectation of dialysis or death within 6 months
Impact of Attention Deficit/Hyperactivity Disorder and Substance Use Disorder on Motorcycle Traffic Accidents

The purpose of this study is to determine whether motorcycle drivers with ADHD are at a greater risk for motorcycle accidents, and whether this risk can be mitigated by treatment with methylphenidate. We will evaluate the effectiveness of Methylphenidate on driving performance, among motorcycle drivers, and investigate the correlation between improvement of ADHD symptoms (inattention and impulsivity) and driving performance.

Traffic accidents (car and motorcycle) are the second leading cause of death in 15-34 year-old males. Within this group, the prevalence of motorcycle accidents is currently increasing at a significantly higher rate than the prevalence of car accidents, and studies in the international literature suggest that motorcycle drivers comprise a distinct driver profile to car drivers. Motorcycles are, by design, more difficult to control, and lend themselves more to performing dangerous stunts. Mistakes and lapses in judgment are likely to have more severe consequences when motorcycles are involved, especially when one considers the exposed nature of the driver. This is of special concern in Brazil, where a large population of so called "motoboys" delivers almost everything upon request, from food to work documents.

It is well known that individuals with ADHD have more traffic problems, such as: a higher risk of a car accident; more violent crashes; more traffic violations and a greater chance of losing the driver's license. On a driving simulator, subjects with ADHD usually present with more errors and crashes, in comparison to normal controls. Treatment with Methylphenidate (MPH), however, has been shown to improve driving performance on the simulator (For example, subjects significantly reduce their speed when necessary as compared to a placebo group), and this in turn is a good indicator of better real-life driving performance.

At present, there are no studies on the effect of ADHD treatment with MPH specifically on motorcycle drivers. This is relevant, since the increasing prevalence of traffic accidents can attributed to increased incidence of motorcycle accidents. If the treatment proves effective, this study will contribute to a reduction in a major social and health concern.

Eligibility Criteria:
Inclusion Criteria:

* Professional Motorcycle Driver
* Current diagnosis of ADHD

Exclusion Criteria:

* Mental retardation
* ADHD treatment in the last month
* Psychosis
Post-Approval Study of MelaFind

The purpose of this study is to collect data to describe the real-world use and safety and effectiveness of MelaFind® in a post-approval clinical setting.

The primary objective of this study to test the hypothesis that, among eligible and evaluable lesions with central histological reference standard status melanoma or high-grade lesion, the relative sensitivity ρ comparing enrolling dermatologists after MelaFind use with enrolling dermatologists if MelaFind were not available is greater than 110%. This represents a clinically meaningful increase in sensitivity.

The secondary objectives of this study are to evaluate real-world use and safety and effectiveness of MelaFind in a clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* The lesion is pigmented (i.e., melanin, keratin, blood)
* Clinical management of the lesion by the examining dermatologist is either biopsy of the lesion in toto, or 3-month follow-up of the lesion
* The diameter of the pigmented area is between 2 and 22 millimeters
* The lesion is accessible to the MelaFind hand-held imaging device
* The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form

Exclusion Criteria:

* The patient has a known allergy to isopropyl alcohol
* The lesion has been previously biopsied, excised, or traumatized
* The skin is not intact (e.g., open sores, ulcers, bleeding)
* The lesion is within 1 cm of the eye
* The lesion is on mucosal surfaces (e.g., lips, genitals)
* The lesion is on palmar hands
* The lesion is on plantar feet
* The lesion is on or under nails
* The lesion is located on or in an area of visible scarring
* The lesion contains foreign matter (e.g., tattoo, splinter, marker)
Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions

The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fed conditions


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to montelukast or any comparable or similar product.
MicroRNAs as Biomarkers of Pain Intensity in Patients With Chronic Fatigue Syndrome (CFS)

MicroRNAs were shown to play an important role in regulating pain-processing in a wide range of experimental models and clinical pain disorders. Thus, the aim of the present study is to evaluate a set of Micro-RNAs as diagnostic biomarkers of pain intensity in adolescents with chronic fatigue syndrome (CFS) and to correlate with inflammatory markers and pain related comorbidities.

The present study was performed to evaluate a set of Micro-RNAs as diagnostic biomarkers of pain intensity in adolescents with chronic fatigue syndrome (CFS) and to correlate with inflammatory markers and pain related comorbidities. Thus, a total of 150 adolescents aged (12-18 years) were invited to participate in this study. They are classified into two groups; adolescents with CFS (n=100) and healthy control (n=50). RT-PCR and immunoassay analysis were used to estimate miRNAs (miR-558, miR-146a, miR-150, miR-124, and miR-143) and immune-inflammatory markers (IL-6, TNF-α, COX-2) respectively.

Eligibility Criteria:
Inclusion Criteria:

* Participants with CFS who had constant or persisting fatigue lasting 3 months with the severe functional disability to such extent that prevents normal school attendance and also had no drug prescriptions (including hormone contraceptives), any medical or psychiatric disorder that might explain the fatigue were included in this study.

Exclusion Criteria:

* Participants who had drug prescriptions (including hormone contraceptives), any medical or psychiatric disorder that might explain the fatigue were excluded from this study.
Can Mobility Technicians Provide Value to Hospitalized Patients?

The specific aim of this study is to determine the impact of the addition of a dedicated mobility technician to the care team on specialty specific outcomes for patients recovering from surgical treatment for a hip or lower extremity long bone fracture or a lung transplant.

The practice of post-operative early ambulation has been shown to improve outcomes by promoting enhanced recovery after surgery in a variety of patients. To that end, VUMC is establishing a "Culture of Mobility". To do so, additional personnel are being hired to help ambulate patients with traumatic hip and femur fractures, other fractures of the lower extremity long bones, as well as those post-lung transplant or readmitted post-lung transplant based upon the best available evidence supporting mobility programs. The added personnel are needed as the currently available resources have insufficient bandwidth to ensure complete early ambulation for all patients. The relative effectiveness of adding a dedicated resource is assumed. Although the literature suggests adding person-hours increases the amount of mobility achieved, there is an opportunity to evaluate whether this is really the case.

The goal of this study is to evaluate the impact of adding the mobility technician to the existing care team. The mobility technician will be assisting patients who could benefit from early ambulation after surgery. We hypothesize that by adding this staffing resource, more patients will get the appropriate level of usual care. Specifically, we expect that adding the resource increases the proportion of those patients who are receiving the prescribed amount of early ambulation post-surgery, with subsequent improvements in functional independence at discharge, and decreases length of stay since patients achieve readiness for discharge sooner.


Eligibility Criteria:
Inclusion Criteria:

* All traumatic fractures of the hip or a lower extremity long bone
* Post-lung transplant patient
* Patient readmitted following a lung transplant

Exclusion Criteria:

* Non-traumatic joint replacements
* Patients with ankle fractures
* Pre-lung transplant patients
* Patients readmitted to the orthopedics unit following a traumatic injury
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm

Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline. Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period.


Eligibility Criteria:
Main Inclusion Criteria:

* Male or female pretreated outpatients between ages 18 and 80 years (inclusive)
* A clinical diagnosis of bilateral blepharospasm (BEB) characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of the orbicular oculi muscles
* A need for injection of Botulinum toxin (defined by a Jankovic Rating Scale (JRS) severity subscore \>= 2)
* On a stable dose of other medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to and expected throughout the Main Period
* Source documentation of the last two consecutive injection sessions with BOTOX® and a stable satisfactory therapeutic response directly prior to trial entry
* At least 10 weeks must have been passed between the last injection with BOTOX® for BEB and Baseline

Main Exclusion Criteria:

* Atypical variant of BEB caused by inhibition of levator palpebrae muscle
* Myotomy or denervation surgery in the affected muscles (e.g. peripheral denervation and/or spinal cord stimulation)
* The previous two injections with BOTOX® with more than 50 Units per eye
* Hypersensitivity to human serum albumin, sucrose, or Botulinum toxin A
* Neuroleptic induced blepharospasm
* Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial
* Treatment with Botulinum toxins for any indication other than BEB within 4 months prior to Baseline and during the trial
Measurement of Energy Metabolism in Infants

The purpose of this study is to measure energy expenditure during the first 3 months of life in infants.

This study intends to establish the feasibility of undertaking comprehensive metabolic phenotyping in infants. The overarching aim is to complete a prospective assessment of energy expenditure in the new infant metabolic chamber approximately one week apart to determine the accuracy and precision of infant protocols related to energy metabolism (sleeping metabolic rate, resting metabolic rate, diet-induced thermogenesis) and physical activity. This cross-sectional study will answer the following questions:

1. What is the test re-test reliability of measuring energy expenditure (sleeping metabolic rate, resting metabolic rate, diet-induced thermogenesis) in an infant under the same conditions, 5-7 days apart?
2. What is the reliability of 24h energy expenditure estimated by the infant metabolic chamber in comparison to a 7-day doubly labeled water study?
3. How do energy expenditure measurements in infants need to be adjusted to account for variability in infant size and body composition?

Eligibility Criteria:
Inclusion Criteria:

* Healthy, full-term infant
* Aged 1 month (28 days) to 3 months (12 weeks, 6 days) at the first visit
* Exclusively fed breast milk and/or infant formula
* Willing to accept doubly-labeled water

Exclusion Criteria:

* Unable to complete 3 clinic visits within about 14 days at Pennington Biomedical Research Center
* Born preterm (\< 37 weeks gestation)
* Congenital abnormality or disability
* Gastric reflux
* Acute illness within 7 days of the study (fever, diarrhea)
* Use of medications to treat a chronic condition (does not include use of vitamin supplements or PRN medication for flatulence or reflux such as Pepcid)
A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.

The purpose of this study is to determine whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma.

Oral squamous cell carcinoma is the most common malignant tumor of oral and maxillofacial region, and prone to early cervical lymph node metastases. Lymphatic spread is associated with increased risk of loco-regional recurrence, therefore, the identification of lymph node metastases preoperatively is very important for the optimal surgical therapy. Recently, cervical lymph node dissection(CLND) is performed in the presence of oral squamous cell carcinoma. However, whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma is still controversial. CLND will represent over-treatment in some case of early-stage oral squamous cell carcinoma. Therefore, How to accurately predict whether a patient should be performed CLND is important. Our previous study show that tumor budding is closely related to lymphatic spread in the oral squamous cell carcinoma. The purpose of this study is to find that whether the tumor budding guide the individualized surgical planning of early-stage oral squamous cell carcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. Han race;
2. Oral squamous cell carcinoma is confirmed by pathology;
3. The section of oral squamous cell carcinoma including primary two-thirds prior to the tongue, buccal mucosa， gingiva， mouth floor， hard palate mucosa;
4. The primary lesion is no more than 4cm;
5. Do not find cervical lymph node metastases and distant metastasis in the clinical examination including physical examination and MRI;
6. Patients and families agree to participate in the study;
7. Patients do not have cognitive disorders.

Exclusion Criteria:

1. Do not meet the inclusion criteria;
2. The primary lesion is more than 4cm or invade adjacent tissues;
3. Do not review on schedule;
4. Patients receive not only surgical procedures, but other antineoplastic treatment;
5. There are serious adverse events after operation;
6. Patients quit the study voluntarily;
7. Patients quit the study because of physical condition.
Prevention of Relapses in Proteinase 3 (PR3)-Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis

Treatment of patients with PR3-ANCA-associated vasculitis consists of two phases: remission induction with highly effective, but also relatively toxic, drugs and, secondly, after remission is achieved, maintenance therapy with less toxic drugs. Currently, remission-maintenance therapy with azathioprine is stopped after approximately 18 months. However, the optimal duration of azathioprine maintenance therapy is unknown.

The investigators have found that patients with PR3-ANCA-associated vasculitis who remain cytoplasmic anti-neutrophil cytoplasmic autoantibody (C-ANCA) positive after induction of remission have an increased risk to experience relapse of disease. Therefore they will test whether relapse risk in these patients can be reduced by extending maintenance therapy at the cost of acceptable therapy related toxicity. After induction of stable remission, ANCA will be measured by immunofluorescence (IIF). C-ANCA positive patients will be randomized for either standard therapy with azathioprine (until 18 months after diagnosis), or longterm azathioprine maintenance therapy (until 48 months after diagnosis).

Treatment of patients with PR3-ANCA-associated vasculitis consists of two phases: remission induction with highly effective, but also relatively toxic, drugs and, secondly, after remission is achieved, maintenance therapy with less toxic drugs. Currently, remission-maintenance therapy with azathioprine is stopped after approximately 18 months. However, the optimal duration of azathioprine maintenance therapy is unknown.

The investigators have found that patients with PR3-ANCA-associated vasculitis who remain C-ANCA positive after induction of remission have an increased risk to experience relapse of disease (MC Slot et al. Arthritis Rheum. 2004 15;51(2):269-73). Therefore they will test whether relapse risk in these patients can be reduced by extending maintenance therapy at the cost of acceptable therapy related toxicity. After induction of stable remission, ANCA will be measured by IIF. C-ANCA positive patients will be randomized for either standard therapy with azathioprine (until 18 months after diagnosis), or longterm azathioprine maintenance therapy (until 48 months after diagnosis).

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed ANCA-associated vasculitis
* PR3-ANCA antibodies present
* Indication for treatment with cyclophosphamide and prednisolone

Exclusion Criteria:

* Intolerance or allergy to azathioprine
Effects of 12-week Exercises on Alexithymia, Depression and Quality of Life in Geriatric Individuals

The aim of this study is to investigate the effects of aerobic and resistance exercises on depression, alexithymia levels and quality of life of elderly individuals.

In this study, investigators hypothesized that aerobic and resistance exercises can increase the quality of life of elderly individuals by reducing their depression and alexithymia levels. The aim of this study is to investigate the effects of aerobic and resistance exercises on depression, alexithymia levels and quality of life of elderly individuals.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 65 and over who volunteered to participate in the study,
* Conscious and without communication problems,
* No orthopedic injury that prevents walking
* Those who are physically inactive according to the International Physical Activity Assessment Questionnaire
* Those who have sufficient motivation to participate in the exercise program (will be evaluated by a one-on-one interview by the researchers)
* Being eligible to participate in an exercise program after a cardiac examination (resting ECG and questioning of cardiac symptoms, advanced tests such as exercise ECG test if necessary) performed by the physician.

Exclusion Criteria:

* Having a history of neuromuscular disease
* Serious medical condition (eg advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) that would prevent the person from participating in exercise training.
* Less than 1 year life expectancy
* Having an orthopedic injury that prevents walking
* Presence of advanced sensory deficit
* Having visual and hearing problems
* Not having sufficient communication skills (Mini Mental Test score below 24 points)
* Not having agreed to participate in the study
* Uncontrolled hypertension
* Not being found suitable for exercise in the examination performed by physicians and physiotherapists
Evaluating Quality and Cost of (Partial) Oncological Home-Hospitalization

Oncological home-hospitalization might be a patient-centred, cost-effective approach to deal wiht the current challenges in cancer healthcare.

The primary aim of this clinical trial is to evaluate patient-reported quality of life of patients receiving (partial) oncological home-hospitalization and to compare this outcome with patients receiving standard ambulatory hospital care.

Secondary endpoints that will be evaluated and compared between both randomized groups are: Quality of life related endpoints (i.e. distress, depression \& anxiety and general health-related quality of life); Costs; Safety; patients' reported Satisfaction \& Preferences and Efficiency for the hospital day care unit.


Eligibility Criteria:
Inclusion Criteria:

* Starting new oncological treatment at the outpatient hospital
* ECOG ≤ 2
* Living within 30 minutes of drive from the hospital

Exclusion Criteria:

* Important comorbidity (ECOG \> 2)
* Life expectancy \< 6 months
* Simultaneous treatment with radiotherapy
* Taking part in clinical trial with any Investigational Medicinal Product
* Language barriers or communication difficulties
* Problematic venous access