cyrilzakka/clinical-trials huggingface dataset:
Mobile Technology Monitoring System to Assess a Web-based Intervention for Teen Risky Driving

This research study examines the feasibility of using an in-vehicle mobile technology monitoring system to measure teen secondary task engagement during on-road driving as the outcome measure for a web-based intervention to prevent risky driving in novice teen drivers.

This research study examines the feasibility of using an in-vehicle mobile technology monitoring system to measure teen secondary task engagement during on-road driving as the outcome measure for a web-based intervention to prevent risky driving in novice teen drivers. Approximately 20 teens who have been licensed for less than 90 days will be enrolled and evaluated at baseline, \~1 week and \~4 weeks. Participants will complete an intervention after the \~1 week assessment. This study will provide information on the feasibility of the web-based intervention to prevent risky driving and estimation of effect size of the intervention on cell phone use while driving.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females age 16-17 years at time of enrollment (i.e. can turn 18 while enrolled in research and still be eligible).
2. Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan
3. PA driver's license for 90 days or less at time of teen assent
4. Personal email address and computer and internet access
5. Ability to read and write English
6. Primarily drives one vehicle with the ability to accommodate the DriveID device
7. Parental consent and teen assent

Exclusion Criteria:

1. Participation in a Center for Injury Research and Prevention at CHOP teen driving study within the past 6 months
2. Unable to follow study procedures
Palliative and End-of-life Care in Advanced Dementia: Evaluation of a Program of Organization of Care in Long-term Care

Rationale: In Canada, as in most industrialized countries, Alzheimer's disease and other related dementia are increasingly prevalent in older people. At an advanced stage, institutionalization in a long-term care (LTC) setting will be the fate of a majority of patients. A structured palliative care approach is increasingly used for cancer patients, but is still rarely accessible in LTC institutions for older people with advanced or terminal dementia. This approach should include a more systematic detection and treatment of pain and other physical and psychological symptoms during the last weeks of life, as well as better communications between patients, families and care staff, particularly relating to advanced care directives. Objectives: The general objective of this study is to implement and evaluate a multidisciplinary and multidimensional program of palliative and end-of-life care for older persons with terminal dementia in LTC facilities. Methodology: The intervention program will include five components:

1. daily involvement of a nurse from the regular staff in the LTC facility as a change agent;
2. awareness sessions with administrators and staff on the importance of high quality palliative care in dementia;
3. a training program for physicians and all the staff involved in direct care of patients;
4. systematic discussions with families and distribution to families of a document on different aspects of palliative care in dementia;
5. systematic clinical care by regular staff for the control of pain, respiratory symptoms and mouth care. The program will be implemented in two LTC settings (one in Quebec City and one in Sherbrooke, Quebec, Canada), and results will be compared with the LTC control settings where usual care will be applied without implementation of the program.


Eligibility Criteria:
Inclusion Criteria:

Residents with advanced dementia with a score of 7 on the Reisberg scale
Pioglitazone Hydrochloride in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia

This phase II trial studies how well pioglitazone hydrochloride works in preventing head and neck cancer in patients who have oral leukoplakia. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of pioglitazone hydrochloride may be effective in preventing head and neck cancer.

PRIMARY OBJECTIVES:

I. Determine whether pioglitazone (pioglitazone hydrochloride) reverses leukoplakia in patients with hyperplastic or dysplastic oral cavity or oropharyngeal leukoplakia.

SECONDARY OBJECTIVES:

I. Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive pioglitazone hydrochloride orally (PO) once daily (QD) for 12 weeks in the absence of disease progression, unacceptable toxicity, or the development of carcinoma.

Patients are followed up at 4, 8, 12, and 16 weeks.

Eligibility Criteria:
Criteria:

* ECOG 0-2
* Diagnosis of oral cavity or oropharyngeal leukoplakia meeting 1 of the following criteria:
* Biopsy-proven hyperplasia in high-risk anatomic areas (e.g., floor of the mouth, mobile tongue, oropharynx, or in any erythroplakia lesion)
* Mild, moderate, or severe dysplasia at any site of the oral cavity or oropharynx within the lesion
* Measurable lesion that is clinically characterized by leukoplakia, erythroplakia, or erythroleukoplakia
* Able to be assessed by bi-directional measurements
* Life expectancy: More than 3 months
* Hemoglobin \>= lower limit of normal for males and post-menopausal females OR
* Hemoglobin \>= 11 g/dL for premenopausal females
* WBC \> 3,000/mm\^3
* Hepatic: Bilirubin \< 1.5 times upper limit of normal (ULN); AST and ALT \< 1.5 times ULN
* Renal: BUN \< 1.5 times ULN; Creatinine \< 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* No contraindication to thiazolidinediones
* No allergy to pioglitazone or other thiazolidinediones
* No serious oral infection
* No invasive carcinoma within the past 60 months except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No concurrent malignancy
* More than 3 months since prior biologic or immunologic therapy
* No concurrent insulin for diabetes
* No prior radiotherapy to the oral cavity
* More than 3 months since prior chemopreventative agents
* More than 3 months since prior experimental therapy
* More than 3 months since prior megadose vitamins or alternative therapy
* No prior thiazolidinediones
* No prior participation in this study
* No concurrent pharmacologic treatment for diabetes
* Concurrent chronic use of non-steroidal anti-inflammatory drugs allowed
* Platelet count \> 125,000/mm\^3
* Index lesion must be located in an anatomic site accessible by punch biopsy
A Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department

Pilot study to compare the efficacy and safety of 3-day, twice-daily regimens of nitrofurantoin and ciprofloxacin in emergency department (ED) patients presenting with UBC.


Eligibility Criteria:
Inclusion Criteria:

* pre-menopausal females
* ages 18-45 years old
* symptoms of a UTI (dysuria, frequency, urgency)

Exclusion Criteria:

* Onset of symptoms \>7 days prior to the ED visit
* Non-English speaking
* Symptoms of pyelonephritis
* Diabetic
* Indications of sepsis
* Immunocompromised
* Currently using prophylactic antimicrobials
* Medications that could interfere with study drug
* Pregnant
* Lactating
* History of kidney or liver disease
* Vaginal symptoms
* Presence of a urinary catheter
* Treatment for UBC \<2 weeks prior to ED visit
* Known allergy to study drug
* Unavailable for follow-up
Cardiac REgistry of Celution Device for the Processing of Adipose-derived Regenerative Cells

This cardiac registry study will collect information from patients with ischemic or non-ischemic heart failure that have been treated with adipose-derived regenerative cells (ADRCs) delivered via intramyocardial injection.


Eligibility Criteria:
Inclusion Criteria:

* Males or females \> 20 and \< 80 years of age
* Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization OR idiopathic dilated cardiomyopathy
* Symptoms of heart failure (e.g. NYHA Stages of Heart Failure Class II or III)
* On maximal medical therapy for heart failure and if present, anginal symptoms
* Hemodynamic stability (SBP ≥ 90 mm/Hg, HR \<110 beats/min)
* Ejection fraction ≤ 45%
* Left ventricular wall thickness \> 5 mm at the target site(s) for cell injection, confirmed by Contrast Echo within 4 weeks prior to enrollment, and free of thrombus

Exclusion Criteria:

* Vascular anatomy and/or peripheral artery disease that prevents or impedes cardiac catheterization
* Aortic or mitral valve disease where valve replacement is indicated
* Presence of mechanical aortic or mitral valves
* Presence of aortic dissection
* Planned staged treatment of CAD or other therapeutic intervention on the heart within the subsequent 3 months
* TIA or stroke within 30 days prior to the procedure
* ICD placement or ablation therapy within 30 days prior to the procedure
* Acute coronary syndrome (ACS) or a myocardial infarction in the 30 days prior to the procedure
* Revascularization within 30 days prior to intramyocardial injection of ADRCs
* Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline.
Expediting Access to Services for Equity

The goal of this clinical trial is to assess whether telehealth-based Family Navigation (FN) expedites enrollment (e.g., reduces time in days) in community-based autism intervention for Black toddlers under the age of 4 after their initial diagnosis of autism.

The main questions it aims to answer are:

Does Family Navigation decrease the time to initiation of intervention for Black toddlers with autism?

Does Family Navigation improve developmental outcomes at 18 months post-diagnosis of autism?

Does Family Navigation improve caregiver well-being?

Caregivers in the Family Navigation condition will receive 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom.

Researchers will compare participants who receive family navigation to participants who receive the standard of care (educational materials) to see if family navigation outperforms the standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Children up to 48 months who have a new diagnosis of autism, or who are waiting for a diagnosis of autism AND their caregiver.
* Live in Georgia or North Carolina
* Caregiver must be over the age of 18
* Their child with autism must identify as Black/African-American
* Speak conversationally fluent English.

Exclusion Criteria:

* No access to a telephone or internet connection for phone calls or video conferencing.
* Diagnosis of autism spectrum disorder is ruled out in the child.
Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children

The study assesses the effect of a new vibration system on pain reduction during the injection of local anesthesia. Children undergoing dental treatment are allocated to two groups; one receiving the Buzz, a vibration system and another group receiving nothing. Pain during injection of local anesthetic is assessed using a validated tool in addition to assessment of child cooperation during treatment.

Eligibility of children for inclusion into the study will be assessed followed by random sequence generation and randomization into one of the two study group and allocation concealment. Topical anaesthesia will be administered to the two groups followed by implementation of the vibration system in the test group. . Behavior and pain will assessed at the time of injection.

Eligibility Criteria:
Inclusion Criteria:

1. Children 5-12 years of age.
2. Positive or definitely positive behavior on Frankl scale.6
3. Children receiving treatment on the dental chair.
4. Free from allergies to topical anesthetic used in the study.
5. Parental consent for child participation in the study.

Exclusion Criteria:

1. Those in need of treatment under general anesthesia will be excluded from the study.
2. Children with allergies from topical anesthesia
Venting Effects on Speech Performance

This study aims to gather behavioral data on the effect of earmold venting on speech performance in noise with a new noise reduction feature.


Eligibility Criteria:
Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:

* 18-85 years of age
* Experienced hearing aid users
* N3-N4 hearing loss
* Fluent in English; ability to read and write in English
* Able to complete complex tasks
* Willing and able to provide informed consent
* Available for the data collection period

The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:

* Self-reported active ear-related pathology (otorrhea, dizziness, sudden hearing loss or worsening of hearing, otalgia)
* Visible deformity of the ear
* Chronic, severe tinnitus
* Unilateral hearing loss
* Cognitive impairment
Effect of Glycerol-Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest

The objective of this study is to determine the effect of consumption of drinks with varying amounts of glycerol and electrolytes on fluid balance at rest.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female
* If female, subject is not pregnant
* Subject is 18-50 years of age, inclusive
* You are at least recreationally active (engaged in light to moderate-intensity, intermittent, or steady-state exercise at least 3 days per week for at least 30 min at a time)
* Subject does not smoke (or has quit for at least 6 months)
* Subject is not taking medication that may interfere with the study (e.g., diuretics)
* Subject has no health conditions that would interfere with the study as indicated on the general health questionnaire (GHQ), e.g. cardiovascular, renal, or metabolic diseases
* Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
* Subject is willing to fast overnight (\~8-12 hours)
* Subject is willing to refrain from vigorous exercise for 24 hours
* Subject is willing to eat the exact same food the day prior to each visit to the laboratory
* Able to speak, write, and read English
* Provision of written consent to participate

Exclusion Criteria:

* Subject has participated in a clinical trial within the past 30 days
* Subject has participated in any PepsiCo trial within past 6 months
* Subject has a condition or is taking medication that the investigator believes would interfere with his/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
* Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If subject is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.
Effect of Aldosterone Blockade on Arterial Compliance

The present study investigated the long-term (12 months) effect of spironolactone treatment on glucose homeostasis, metabolic parameters and vascular properties.


Eligibility Criteria:
Inclusion Criteria:

1. patients with type 2 diabetes mellitus

Exclusion Criteria:

1. history of unstable angina, myocardial infarction (MI), cerebrovascular accident (CVA)
2. major surgery within the six months preceding entrance to the study
3. unbalanced endocrine disease
4. any disease that might affect absorption of medications
5. plasma creatinine \>2.5 mg/dl
6. elevation of liver enzymes to more that twice the upper normal limit
7. plasma potassium levels \>5.5 mg/dl
Efficacy of Pulse Radiofrequency Durations in Lumbosacral Pain

Brief Summary:

This study aims to compare the efficacy of short-duration (240 sec) and long-duration (480 sec) pulsed radiofrequency (PRF) applications on pain, functionality, patient satisfaction, and side effect profiles in patients with lumbosacral radicular pain. The PRF procedure will be applied to the dorsal root ganglion (DRG) under fluoroscopic guidance.

In this study, all procedures will be performed in the prone position under sterile conditions and guided by fluoroscopy. After identifying anatomical landmarks, the cannula will be positioned close to the dorsal root ganglion. The tip of the cannula will be placed in the dorsal-cranial quadrant of the intervertebral foramen in the lateral view, and between one-third and halfway along the pedicle column in the anteroposterior view. Once the RF cannula is properly positioned, an RF electrode will be inserted through the cannula and connected to the RF generator. The final position of the RF cannula will be confirmed by sensory stimulation (paresthesia) at less than 0.5 V and motor stimulation perceived at a level at least 1.5 times greater than the sensory stimulation threshold.

In the short-duration PRF group, a PRF cycle will be applied at 42°C for 240 seconds, while in the long-duration group, it will be applied at 42°C for 480 seconds. Following the PRF application, epidural spread will be confirmed using contrast dye, after which 4 mL of a solution containing 8 mg dexamethasone and 5 mg bupivacaine will be injected at each level.

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years

* Pain severity NRS ≥ 4
* Pain duration \> 12 weeks Refractory to conservative treatments (physical therapy, medical treatments) Exclusion Criteria Malignancy-related pain Diagnosis of diabetes mellitus or polyneuropathy Back pain more severe than leg pain Conditions that impair follow-up (e.g., psychiatric disorders, dementia) Patients refusing the procedure
Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage--Small Hemorrhage Evacuation (MIRACLE-S)

The objective of this study is to determine whether minimally invasive soft channel brain hemorrhage evacuation (scMIS), compared to usual care, leads to superior functional recovery as measured by utility-weighted modified Rankin Scale (UW-mRS) scores at 6 months in patients with basal ganglia intracerebral hemorrhage (ICH) of 20 ≤ volume ≤ 30 ml.


Eligibility Criteria:
* Inclusion Criteria:

  1. Adults (18 - 80 years) ;
  2. The clinical diagnosis is acute intracerebral hemorrhage, confirmed by imaging;
  3. Onset within 48 hours, and surgery can be initiated within 48 hours;
  4. Basal ganglia hemorrhage, with a bleeding volume of 20 ≤ volume ≤ 30 ml;
  5. Reduced level of consciousness (GCS 9-14);
  6. Pre-stroke mRS score≤1 points;
  7. Systolic blood pressure \<140 mmHg before randomisation;
  8. Informed consent obtain accordingly to local regulations.
* Exclusion Criteria:

  1. Definite evidence the ICH is secondary to a structural abnormality in the brain (eg arteriovenous malformation, intracranial aneurysm, tumour, trauma, cerebral venous thrombosis) or previous thrombolysis or neurointerventional surgery.
  2. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
  3. Platelet count \< 100,000, INR \> 1.4.
Surgery in Addition to the Medical Treatment of Lymphedema

Lymphedema is a chronic pathology with a real impact on the quality of life of patients. Despite optimal medical management of patients, some patients still have no pitting edema on which the medical treatment has no effect.

It is adipose tissue secondary to the evolution of lymphedema. It is often painful and important in terms of volume with the resulting functional consequences. The investigators propose to these patients a surgical management complementary to the optimal medical treatment by microlipoaspiration associated or not with a dermolipectomy. This surgical management began in 2014 in our service. The investigators want to evaluate the impact on quality of life of patients in this surgical management in addition to medical care.

Detailed Description:

This is a monocentric, observational cohort study.

Main judgment criteria:

Evolution of the quality of life score of the LYMQOL self-questionnaire between preoperative and postoperative (at 3.6 and 12 months) The investigators used a French translation of Keeley's LYMQOL (Quality Of Life Measure for Limb Lymphoedema) self-administered questionnaire in 2010 (2) to assess the quality of life of patients. This is a lymphedema specific questionnaire for which there is one version for the upper limb and one for the lower limb. Limb function, lymphedema symptoms, body image and mood are assessed independently. It allows to obtain a score between 1 and 4 which corresponds to the discomfort felt. The higher the score, the better the quality of life. It also includes, in the last question, a numerical scale allowing the patient to note her quality of life between 0 and 10.

Since 2016, patients have systematically completed quality of life questionnaires. Perimeter measurements are also done systematically at each visit, these data are available in the patient's computerized medical records (Dx Care).

Secondary judgment criterion:

Difference in the volume of the limb operated between preoperative and postoperative (3, 6 and 12 months)

The volume is calculated on the basis of stepped circumferential measurements (every 10 cm starting from the patella for the lower limb and every 5 cm starting from the bend of the elbow for the upper limb). These measures are taken at each consultation by our physiotherapists, specialized nurses or vascular doctors.

It is therefore a question of retrospectively analyzing the data collected.

The data will then be anonymised by a two-letter code and a number and will be entered on a Excel file available on a secure directory of the CHU for analysis.

A dedicated support protocol is already implemented in the Cf Appendix service. There are no special modalities for patients not included in the study.

Eligibility Criteria:
Inclusion Criteria:

* no pitting edema
* good therapeutic compliance
* weight stability

Exclusion Criteria:

- under 18 years old