cyrilzakka/clinical-trials huggingface dataset:
Increasing Childhood Sleep Duration in the Primary Care Setting

Investigators seek to determine if a mobile health based intervention can be developed to target increases in childhood sleep duration.

Investigators seek to determine if an online based intervention can be developed to target increases in childhood sleep. The primary objectives of this study are to determine if different messaging strategies lead to the longer sleep duration.Children aged 9-12 who sleep about 6-8.5 hours per night will wear a Fitbit for 11 weeks in order to measure sleep patterns. Participants will have a sleep goal to meet each night. Participants will be randomized to one of thirty-two study conditions and receive text and/or email messaging. Some study arms receive additional messaging with different content and frequency of delivery. The study involves one visit to the Children's Hospital of Philadelphia (CHOP).

Eligibility Criteria:
Inclusion Criteria:

1. Males or females age 9 to 12 years.
2. Speak, read and write in English.
3. Parental/guardian permission (informed consent) and child assent.
4. Have a computer or a tablet computer with access to the Internet, or own a smartphone with a data and text plan.
5. Parent reported time in bed on school nights between 6.0-8.5 hours in bed at night (e.g. 7-hour time in bed: go to bed at 11pm \& get out of bed at 6am).

Exclusion Criteria:

1. Any clinically diagnosed sleep disorder (e.g. sleep apnea).
2. Diagnosed with a psychiatric disorder \[e.g. attention deficit hyperactivity disorder (ADHD), depression, anxiety\].
3. Diagnosed with an eating disorder.
4. Musculoskeletal or neurological disorder that limits physical movement and activity.
5. Use of medications (prescription or otherwise) known to affect body weight and/or sleep.
Tear Collection in Adult Volunteers

This exploratory study will collect tear samples from adult volunteers for determining and quantifying tear composition profiles. No investigational drug will be administered in this study.


Eligibility Criteria:
Inclusion Criteria:

-Adult volunteers without ocular disease.

Exclusion Criteria:

* Systemic medications that could affect eye health taken within 1 month of enrollment
* Eye infection or inflammation in either eye 3 months prior to screening
* History of herpes in either eye
* Diagnosis of dry eye or meibomian gland dysfunction
* Diagnosis of glaucoma
* Allergic conjunctivitis
* Use of rigid contact lenses within 1 year of screening
* Use of soft contact lenses within 1 week of enrollment.
Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain

Transrectal prostate biopsy is a commonly performed ambulatory procedure for diagnosing prostate cancer. Prostate biopsy are associated with pain or anxiety. Nitrous oxide (or laughing gas) is a well-known inhaled anesthetic which is frequently used in dental offices and for pediatric procedures to alleviate a patient's anxiety and pain. This study seeks to determine whether administration of nitrous oxide at the time of prostate biopsy will improve a patient's experience of care.

Nitrous oxide is a well-tolerated inhaled anesthetic that has been used for decades in pediatric and adult populations and is largely viewed as effective and safe. In addition to analgesic effect, nitrous oxide also produces a dissociative euphoria and amnesia that could potentially improve patients' anxiety and experience of cancer care. When used as a single agent at concentrations ≤50%, the American Society of Anesthesiologists (ASA) classifies nitrous oxide as Minimal Sedation, producing a state in which a patient responds normally to verbal commands, maintains airway reflexes, and spontaneous ventilation. Over the past several decades nitrous oxide has become less common due to concerns of nitrous oxide environmental exposure to the care team. There are now Federal Drug Administration (FDA)-approved systems that allow patient self-administered nitrous oxide (SANO), and importantly, include a scavenger system to eliminate exhaled environmental nitrous oxide. These systems are rapidly being adopted throughout the United States in Urology practices, but to date, there have been no studies evaluating patient outcomes and possible risks with the adjunct use of SANO. This study is a prospective, randomized, controlled trial to assess patient perceived pain and anxiety related to prostate needle biopsy with or without SANO, and the frequency of complications associated with SANO. A secondary aim will be to demonstrate that the SANO at the time of prostate biopsy does not significantly increase burden on Urologist productivity, nor increase the difficulty of operator ease in performing the prostate needle biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Biological male
* Aged 18 to 85 years
* Scheduled for clinically-indicated prostate needle biopsy
* Suitable for nitrous oxide/oxygen with willingness to be randomized to inhaled SANO or inhaled oxygen during the procedure
* Access to an email and computer

Exclusion Criteria:

* Perioral facial hair impeding good mask seal
* Learning disabilities and/or inability to cognitively complete survey questions
* Taken a pre-procedure benzodiazepine or narcotic.
* Has any of the following medical conditions:

  1. Inner ear, bariatric or eye surgery within the last 2 weeks,
  2. Current emphysematous blebs,
  3. Severe B-12 deficiency.
  4. Bleomycin chemotherapy within the past year.
  5. Class III or higher heart failure.
  6. Undergoing novel therapy for prostate cancer
WHNRC (Western Human Nutrition Research Center) Honey Study

The purpose of this research is to compare two snacks, one with honey and nuts and the other with sugar and nuts, on glucose levels before and after eating these snacks.

The investigators hypothesize that honey and nuts will have an additive effect on the reduction of postprandial glucose response. The investigators further hypothesize that consumption of honey paired with nuts will retain the benefit of sugar consumption in satiety and reduction of metabolic stress.

Consuming sugar creates a feeling of satiation, and may buffer metabolic stress. However, prolonged postprandial hyperglycemia has been identified as a potential risk factor in type 2 diabetes and cardiovascular disease. Nuts, which are recommended to be consumed as part of a Mediterranean diet, up to 2 servings per day, have been shown to dramatically reduce postprandial glucose response to carbohydrates. Additionally, honey, which is typically used as an added sugar within a Mediterranean diet pattern, has a lower glycemic index than table sugar and may result in a reduced postprandial glucose response relative to other nutritive sweeteners. However, it is not yet known whether honey can work additively with nuts to further reduce postprandial glucose response over the reduction caused by nuts alone.

Honey has been shown to produce equivalent or greater satiety to regular table sugar and there is some indication that honey can improve immediate/working memory. Therefore, combined consumption of honey and nuts may offer a way to maximize the benefits of carbohydrate consumption on satiety and metabolic stress reduction while minimizing its negative effects on metabolism. However, it is not yet known whether sugars contained in the more complex food matrix of honey, consumed together with a food like nuts can impact satiety and metabolic stress in the way that has been observed for sugar.

Eligibility Criteria:
Inclusion Criteria:

* Women must be pre-menopausal
* Willing to consume snacks that contain honey, table sugar, and tree nuts

Exclusion Criteria:

* Body Mass Index (BMI) \<18.5 or \>40
* Allergies to tree nuts
* Current medical diagnoses of chronic diseases including cardiovascular or pulmonary diseases, renal diseases, cancer, type 1 or type 2 diabetes, thyroid disease requiring medication, inflammatory or irritable bowel diseases, or those with recent major surgeries
* No individuals who fall in to the vulnerable categories of adults including those unable to consent, pregnant women, children, or prisoners will be eligible for this study
* Routinely taking medications known to affect glucose response.
* Caffeine and alcohol use will not be excluded, but should be carefully reported by each subject.

Regarding female candidates:

* Post-menopausal
* Women who have been pregnant or nursing within the last 6 months or plan to become pregnant during the trial will be ineligible
Use of Indocyanine Green During Pelvic Lymph Node Dissection in Prostate Cancer.

Standard treatment of local or locally advanced prostate cancer is radical prostatectomy (RRP) surgery. During RRP in certain patients extended lymph node dissection (ELND) is recommended. to detect eligible patients for ELND some nomograms based on clinical factors of them is used. The Briganti nomogram is one of them. If the patient has 7% or more probability on Briganti nomogram, then ELND is recommended. But ELND is complicated surgical procedure and may cause labor lost and cost.

It is aimed here to show whether the ICG based fluorescence imaging during laparoscopy may yield higher accuracy to detect metastatic LNs than the conventional ELND?

50 patients with diagnosis of local or locally advance prostate cancer and having LN invasion probability between 7-50% on 2018 Briganti Nomogram will be included to this study.

Before Laparoscopic radical prostatectomy (LRRP), ICG is injected left and right lobe of the propagate during cystoscopy.

Extended LND is performed in all patients. But before it, fluorescence imaging will be done, and ICG positive lymph nodes (LN) are dissected and sent pathology separately.

Positive LN yield pf ICG guided LND and conventional LND is compared.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally limited prostate cancer;
* Intermediate or high risk tumor
* Recommended and planned prostatectomy;
* Completed and signed written consent;
* Voluntarily agreement to participate in this study
* Age of the study participants ≥ 18 years.

Exclusion Criteria:

* Allergic reaction to active ingredient (indocyanine green);
* Iodine allergy;
* Hyperthyroidism;
* High-grade renal impairment;
* High-grade hepatic insufficiency;
* Unwillingness to the storage and disclosure of pseudonymous disease and personal data
* psychiatric pre-existing conditions or other circumstances that make a cooperation by the patient in question
Bystander Helping Behaviour for Myocardial Infarction Following First Aid Training

The objective of this study is to measure the effect of an innovative training programme on the help seeking behaviour and helping rates of bystanders in medical emergencies.

A systematic review on the effects of first aid training concluded that training must also include ways to overcome obstacles to bystander intervention. This could lead to better help and higher helping rates in medical emergencies.

The objective of this paper is to measure the effect of an innovative training programme on the help seeking behaviour and helping rates of bystanders in medical emergencies. We chose to test the helping behaviour for acute myocardial infarction because it is an important cause of mortality and invalidity. While the victim is urgently in need of help, delay in seeking professional help is an important problem.

Eligibility Criteria:
Inclusion Criteria:

* Course participants that are 18 years or older

Exclusion Criteria:

* Course participants that are younger than 18 years
* Health care students
* Health care professionals
Endothelial Dysfunction in Post-infection Fatigue Syndromes

Post-infection chronic fatigue syndromes, such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-COVID-19 condition (Long Covid), are conditions primarily characterized by debilitating fatigue. This fatigue can range from mild, where patients are still able to participate in some social activities (e.g., school, work), to moderate and severe, where sufferers are predominantly homebound and bedridden. As a result, ME/CFS and Long Covid not only negatively impact the quality of life of affected individuals and their caregivers but also represent a substantial and often silent burden on healthcare systems worldwide, including Austria. This is primarily because most cases remain undiagnosed due to the lack of standardized clinical assessments and diagnostic markers. Endothelial dysfunction, which is well known to affect blood flow, oxygen and nutrient delivery, and waste removal in the body, has been described as one of the key factors behind the symptoms experienced by ME/CFS and Long Covid patients. However, the mechanisms that might explain the development of endothelial dysfunction remain largely unexplored. Therefore, this project aims to evaluate key biological aspects related to the function of endothelial cells - a layer of cells lining blood vessels - using plasma samples from an Austrian cohort of ME/CFS and Long Covid patients. We expect that the findings from our study will provide new insights to better understand endothelial dysfunction in post-infection chronic fatigue syndromes, leading to improved patient stratification and tailored treatment alternatives.


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria for ME/CFS patients not infected with SARS-CoV-2 (n=17; females: 70.59%; age (years): 40.10 ± 10.80) and Long-Covid patients (n=30; females: 73.4%; age (years): 37.70 ± 9.96) include profound fatigue and at least one of the following symptoms: PEM, autonomic dysfunction, and/or orthostatic intolerance. All participants were included only if they were at least 12 weeks past an acute EBV infection and/or 10 weeks past an acute SARS-CoV-2 infection, respectively. SARS-CoV-2 specific IgA (A) and IgG (B) antibody titers were measured using commercial test kits (Anti-SARS-CoV-2-ELISA (IgA) and Anti-SARS-CoV-2-QuantiVac-ELISA (IgG); Euroimmun, Germany) in plasma samples.

Exclusion Criteria:

Participants' exclusion criteria included evidence of acute malignant diseases, diabetes mellitus, acute sepsis, chronic inflammatory gastrointestinal diseases, and frequent intake of analgesics, antacids, or antibiotics. Furthermore, no previously hospitalized SARS-CoV-2 patients were included, eliminating false-positive fatigue due to intensive care treatment, such as artificial respiration.
Multiple Ascending Dose (MAD) Combination in Subjects With Multiple Myeloma

To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-833923 administered alone, in combination with lenalidomide plus dexamethasone, or in combination with bortezomib in subjects with relapsed or refractory multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Multiple Myeloma
* Men and Women at least 18 years old
* ECOG status 0-2
* Last therapeutic or diagnostic treatment at least 21 days prior
* Bone marrow transplants must have been completed at least 3 months prior
* Any toxicity from prior therapies must have resolved to Grade ≤1

Exclusion Criteria:

* Women pregnant or breastfeeding
* WOCBP unwilling/unable to use acceptable method to avoid pregnancy
* Uncontrolled medical disorder or active infection
* Current or recent (w/in 3 months) gastrointestinal disorder
* Inability to swallow oral medication
* Inability to be venipunctured
* Uncontrolled or significant cardiovascular disease
* Uncontrolled hyperlipidemia
* Intolerance of lenalidomide or bortezomib if participating in Arms B and C
* Concurrent therapy with any other investigational product
* Subjects involuntary incarcerated
* Subjects detained for treatment of psychiatric or physical illness
Guided Self-help for Families With an Overweight Child

The purpose of this study is to evaluate whether a home based program can teach parents and moderately overweight kids who are of 8-12 years old with a BMI% between 85-97%, how to manage their child's weight. The study uses manuals and involves a short visit to the clinic every other week.

An estimated 4-5 million children between the ages of 6-17 in the United States are obese. Children who are obese are at an increased risk for many negative health consequences in childhood and in adulthood. In addition, these children are at an increased risk for psychosocial consequences in childhood and adolescence, including poor self-esteem, teasing, verbal abuse and social isolation. Guided self-help offers an opportunity to provide empirically based programs to a larger amount of the target population. Once such treatment methods are available, it is possible that the guided self-help treatment for childhood obesity can be disseminated to primary care practitioners, psychologists, nurses, and health educators. Ultimately, the goal of this application is to develop a treatment protocol that can be used by clinics and lay health professionals to intervene with children who are overweight and their parents.

Eligibility Criteria:
Inclusion Criteria:

* child between the ages of 8 \& 12
* an moderately overweight child with a BMI% between 85-97%
* child has a parent willing to participate
* child has a parent who can read English at a minimum of a 6th grade level
* family who is willing to commit to treatment attendance and attendance at all assessments.

Exclusion Criteria:

* Child psychiatric disorder diagnoses (based on parent report)
* Child diagnoses of a serious current physical disease (such as diabetes)
* Child who is taking medications that may impact their weight
* Child with physical difficulties that limit the ability to exercise
* Child with an active eating disorder
* Child and parent will be moving out of the San Diego County before study completion
* Child and/or parent has a modified diet due to religious or socially conscious reasons (such as Vegan, vegetarian)
Qigong Exercise and Sleep Quality

The purpose of this study was to investigate whether 12 weeks of practicing Mawangdui Guiding Technique has an improvement effect on subjective sleep quality, objective sleep quality, and daytime fatigue in older adults in a healthcare hospital.


Eligibility Criteria:
Inclusion Criteria:

* Aged sixty years and above; continuous residence in the participating healthcare hospitals for more than six months
* Conscious, with basic visual and auditory perception, communication, and cognitive functioning
* Voluntary enrollment in this study and signing of the informed consent form.

Exclusion Criteria:

* Individuals who have suffered a sudden accident, emergency surgery, or a rapid deterioration of a long-term medical condition
* Individuals who have recently been involved in other rehabilitation activities and who play sports on a regular basis
* Individuals who are unable to participate in physical activity (e.g., patients suffering from major diseases of the liver, kidneys, heart, brain, or blood system)
* Individuals suffering from deep venous thrombosis; individuals with musculoskeletal problems with signs of limitation of movement (e.g., unsettled broken bones, pelvic fractures)
* Individuals with preexisting psychiatric conditions (such as personality disorders, psychosis, and so on); and individuals with symptoms of severe depression.
POCUS for Difficult Peripheral Access in the Emergency Department - a RCT

Peripheral intravenous line insertion is the most commonly performed invasive procedure in the emergency department (ED). The research hypothesis is that a biplane sonographic approach (i.e., an out-of-plane and in-plane view) might be superior to a mono-plane approach (i.e., an out-of-plane or in-plane view) obtaining a peripheral vascular access among difficult patients admitted to the ED

Peripheral intravenous line insertion is the most commonly performed invasive procedure in the emergency department (ED). In some studies, difficult vascular access population was about 33% of evaluated patients and for most of them the "blind" method (i.e., palpation) fails in the line insertion. Ultrasound guidance often increase the success rate among these patients.

Two basic techniques were proposed for sonographic guidance, a transversal or a longitudinal approach to the chosen vessel (i.e., out-of-plane or in-plane view, respectively, "mono-plane" approach).

The availability of hand-held sonographic devices is increasing the number of emergency department were this guidance is used in a difficult vascular access population.

The Butterly iQ+ device is now able to show out-of-plane and in-plane views, simultaneously, the so called bi-plane view.

Aim of this randomized controlled trial is to test if a bi-plane sonographic vision might be able to increase the performance of trained operators in obtaining a peripheral vascular access among difficult patients admitted to the ED.

The present study will be a randomized controlled, 2-arm, nonblinded trial held at the Città della Salute e della Scienza di Torino, University hospital, Turin, Italy.

All healthcare workers already trained in ultrasound-guided vascular access will be considered eligible for the study (i.e., emergency physicians, residents, nurses) after an ad hoc brief (2 hours) training on the study.

This will be a "real world" study, each provider will be free of choosing the device he/she thought appropriate for each patient (in terms of length, gauge, type - peripheral midline will be included in the Italian center).

Using a computerized permuted blocks of random sizes, enrolled patients will be randomized in a 1:1 ratio to be evaluated using either the "standard" ultrasound-guided approach (out-of-place or in-plane view) or the bi-plane view (i.e. out-of-place and in-plane view, simultaneously).

Eligibility Criteria:
Inclusion Criteria: at least one of the following criteria have to be present along with the need for a peripheral access

* chronic renal disease/ongoing dialysis;
* sickle cell anemia;
* prolonged and/or frequent use of i.v. drugs;
* difficult vascular access (after a first attempt or self-reported);
* previously need for more than one attempts / ultrasound guidance for getting a peripheral vascular access.

Exclusion Criteria:

* no consent to participate in the study.
Mobile Service Robot for Task-Oriented Stroke Therapy: User Evaluations

By developing an affordable mobile service robot for therapeutic activities in a health center environment, this project addresses the issue of both the high cost and man-power required to provide rehabilitation for stroke survivors and other patients. Our goal is to measure users - clinician and patient - responses to a telepresence robot, VGo, that has been modified with a humanoid torso robot, NAO, to facilitate remote communication between the patient and clinician, and to complete supervisory exercise coaching.

This is a short demonstration and survey study. Clinical staff and patients will be gathered together and our idea for the mobile service robot will discussed. A demonstration of the telepresence feature of the robots and the NAO robot greeting and helping them with simple exercises will follow (e.g., pick up and object that is handy and lift their hands over their heads). The approximately 30-minute demonstration part of the study will start with an introduction and explanation about the project and a short speech about the Rehabilitation and Robotics Lab. After the demonstration the oral consent will be read and surveys will be handed out to those study participants who agree to complete them; if necessary, the research team will assist the study participant with the survey. Surveys will then be collected, and the group will be thanked by the research team.

Eligibility Criteria:
Inclusion Criteria:

* Certified rehabilitation healthcare professionals
* Participants with upper extremity disabilities
* Participant must be older than 18 years

Exclusion Criteria:

-Less than 18 years of age