cyrilzakka/clinical-trials huggingface dataset:
A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Tolerant Users Undergoing Surgery to Reduce Post-operative Opioid Use

Tto learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients following surgery.

Primary Objective:

To assess the efficacy of SpellBound's AR-enabled scavenger hunt to reduce the rate of additional inpatient opioid use in pediatric cancer patients who are chronic/tolerant opioid users undergoing surgery compared to a control non-AR game in a randomized controlled trial.

Secondary Objectives:

To assess the impact of AR versus non-AR control technology in pediatric oncology patients, including:

* Inpatient opioid use
* Average daily inpatient pain score
* Number of opioid requests during hospital stay
* Inpatient PedsQL (quality of life) questionnaire score
* Ambulation/"out of bed" movement
* Number days to discharge-ready status
* Patient experience assessed by satisfaction scores on questionnaire designed by MD Anderson Cancer Center Child Life team
* Outpatient opioid use reported at 30, 60, 90 days.
* Outpatient pain scores reported at 30, 60, 90 days
* Outpatient PedsQL scores reported at 30, 60, and 90 days
* Potential adverse events related to the use of AR (i.e., falls).

Eligibility Criteria:
Inclusion Criteria:

1. Ages 5-15
2. English and Spanish-speaking parents/legal guardians and patients
3. Undergoing surgery requiring postoperative hospitalization is defined as ≥2 hours of duration of surgery and requiring postoperative hospital admission of at least one night
4. Expected to be prescribed postoperative inpatient opioids
5. Prescribed daily opioids for pain for a period equal to or longer than 30 days before surgery.
6. Sufficient cognitive capacity to comprehend and interact with the game. This is defined as the ability to utilize mobile technology (use iPad with or without assistance) and activate and respond to AR experiences within the app as determined by the clinician.
7. Both the child and a legal guardian are willing and able to provide informed consent.

The range from 5-to 15 is based on a recent pilot RCT in which the PI found that older adolescents (\>15 years of age) were disinterested in the interactive game.

Exclusion Criteria:

1. Have never taken opioids or have had no daily opioid use within the last 30 days before surgery
2. Inability to demonstrate an understanding of the game from English instructions
3. Any additional concerns based on the study physicians' assessments b. Setting: Academic tertiary cancer center: University of Texas - MD Anderson Cancer Center and Baylor College of Medicine - Texas Children's Hospital
Tranexamic Acid vs. Combination With Fractional Carbon Dioxide Laser in Melasma

The objective of this study is to assess and compare the efficacy of tranexamic acid intradermal microinjection alone versus its combination with low power fractional CO2 laser in a sequential pattern.

In all participants one half of the face will be randomly assigned to low power fractional CO2 laser while other side to Tranexamic acid intradermal microinjections on the 1st session. This split face session will be repeated every six weeks for 3 sessions.

In addition, Tranexamic acid intradermal microinjections will be applied for full face at the 2nd and 4th week of each split face session.

The response will be evaluated by the Melanin and erythema Indices which will be measured using reflectance spectrophotometer, Dermoscopy and photography before starting the study, two and four weeks after the last session. The sessions will take 4 months for each patient and another one month free of sessions for follow up.


Eligibility Criteria:
Inclusion Criteria:

* Patients with bilateral symmetrical facial melasma

Exclusion Criteria:

* Pregnancy and lactation.
* Patients taking oral contraceptive pills or hormonal replacement therapy at the time of the study or during the past 12 months.
* Concomitant use of anticoagulants.
* Bleeding disorders.
* Personal or family history of deep venous thrombosis or thromboembolic events.
* Scarring and keloid tendency.
* Active skin infection, active Herpes simplex virus.
* History of Post-inflammatory hyperpigmentation.
* History of photosensitivity or photosensitizing medication as sulfonamides tetracycline,retinoids, bleaching creams, peeling and laser two months before the study.
* Occupational sun exposure.
Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population

Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated topically with P-3058 nail solution according to the appropriate treatment schedule.


Eligibility Criteria:
Inclusion Criteria:

* Age between 2 to 17 years
* Males and females
* Clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis without spikes/dermatophytoma and without lunula involvement or white superficial onychomycosis.
* Positive mycroscopy examination from the target nail at screening.
* Positive culture for dermatophyte from the target nail at screening.

Exclusion Criteria:

* Patients with onychomycosis caused by yeasts or non-dermatophytes mould.
* Patients with nail psoriasis.
* Patients with nail changes due to eczema, lichen planus or alopecia areata.
* Patients with one-hand two-foot syndrome.
* Patients with immunodeficiency disorder or use of immune suppressive therapy 3 months prior to screening visit or need for it.
* Use of systemic antifungal drugs in the 6 months prior to screening visit.
* Use of topical nail antifungal drugs in the four weeks prior to screening visit.
Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan

The purpose of this study was to evaluate the dose-response relationships of alogliptin, once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal clinical dose for type 2 diabetic patients.

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

To evaluate the long-term safety and efficacy of alogliptin, participants in the present study could enter a long-term extension study SYR-322/OCT-001 (NCT01263496) that was planned separately.

Eligibility Criteria:
Inclusion Criteria:

* A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(Week -4).
* A HbA1c differences within 10.0%\* (\*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.
* Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).

Exclusion Criteria:

* Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.
Cognitive Hyper-performance - Effects of Stimulating Substances in Chess-players

Effects of caffeine, methylphenidate, modafinil and placebo on cognitive performance of chess players in chess games and neuropsychiatric standardized tests. We hypothesize that substances will change cognitive performance in chess players leading to changed results in chess games and neuropsychiatric tests.


Eligibility Criteria:
Inclusion Criteria:

* male
* 18-60 years old
* existence of ELO-number

Exclusion Criteria:

* physical diseases (e.g. diabetes mellitus, etc.) with necessity of using prescription drugs
* psychiatric diseases (e.g. psychosis, bipolar disorders, etc.) with necessity of using prescription drugs
* addiction of psychoactive substances
* smoker or quitter (\< 5 years)
* use of more than 5 cups of coffee per day
* irregular day-night-rhythm (e.g. shift workers)
TPVB, PECSB, ESPB for Postmastectmy Pain

Aim of the work The aim of the study is to compare between the effects of ultrasound guided thoracic paravertebral block, pectoral nerve block II, and erector spinae block in management of pain during cancer breast surgeries. The hypothesis of the study is that the three groups will give comparative results.


Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status classification class I or II
2. Age group 18 - 60 years of the female gender
3. Patients undergoing breast cancer surgeries

Exclusion Criteria:

1. Patient refusal
2. History of hypersensitivity to local anesthetics
3. Bleeding disorders or patients receiving anticoagulants
4. Spine or chest wall deformities
5. Pregnancy
6. Local infection at the site of injection.
The Impact of an Antimicrobial Utilization Program on Antimicrobial Use

Multidisciplinary antimicrobial utilization teams (AUT) have been proposed as an effective mechanism for improving antimicrobial use, but data on their efficacy remain limited. The researchers postulated that a multi-disciplinary AUT would improve antimicrobial use in a teaching hospital when compared to the standard of care (no AUT intervention).

Design: Randomized-controlled intervention trial. Setting: A 953-bed urban teaching hospital.

Patients: Patients admitted to internal medicine ward teams who were prescribed selected antimicrobial agents (piperacillin-tazobactam, levofloxacin, or vancomycin) during the 10month study period.

Intervention: Eight internal medicine ward teams were randomized monthly to academic detailing by the AUT while 8 internal medicine ward teams were randomized indication-based prescription of broad spectrum antimicrobials.

Measurements: Proportion of appropriate empiric, definitive, and end antimicrobial usage (antimicrobial use from the initiation of therapy until definitive therapy is prescribed).

This study was conducted when Bernard C Camins, MD (BCC), one of the investigators, was still employed at Emory University. The principal investigator is no longer at Emory University. This trial is being registered by one of the investigators, BCC, so we can submit the manuscript for publication. BCC is now at Washington University and this study was conducted while he was at Emory University.

Eligibility Criteria:
Inclusion Criteria:

* All patients prescribed vancomycin, piperacillin-tazobactam, or levofloxacin during the time period of the study.
Stroke Process in FEmoral Versus Radial Access

In patients with suspected acute stroke due to large vessel occlusion with indication for endovascular treatment, radial access is just as safe, fast, and effective as femoral access, and it improves the entire stroke treatment process.

Investigators will compare the procedure times, angiographic results as well as the clinical evolution and the patient's experience during their hospital stay and after discharge, depending on the arterial access practiced for mechanical thrombectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with high suspicion of ischemic stroke due to large cerebral vessel occlusion defined by NIHSS\> 10.
* Immediate availability of the entire team responsible for endovascular treatment (Neurologist, Neurointerventional physician, Anesthetist, Nursing, Technicians ...)
* Radial artery diameter ≥2.5 mm
* Presence of femoral pulse or patency by ultrasonography in its defect.
* Previous functional independence (mRS 0-2).

Exclusion Criteria:

* Life expectancy of less than 6 months.
* Intracranial hemorrhage
* Patients with pre-existing neurological or psychiatric pathology that may confuse future evaluations.
* No availability for follow-up after 90 days.
Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy is more effective with or without rituximab in treating mantle cell lymphoma.

PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine and cyclophosphamide combined with rituximab to that of fludarabine and cyclophosphamide alone in treating patients who have mantle cell lymphoma.

OBJECTIVES:

* Compare the response rates in patients with previously untreated mantle cell lymphoma treated with fludarabine and cyclophosphamide with or without rituximab.
* Compare the time to disease progression in patients treated with these regimens.
* Compare the toxicity of these regimens, in terms of adverse event profile, in these patients.
* Compare the overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms:

* Arm I: Patients receive fludarabine IV\* and cyclophosphamide IV\* on days 1-3.
* Arm II: Patients receive rituximab IV on day 1 and fludarabine IV\* and cyclophosphamide IV\* on days 2-4.

NOTE: \*In both arms, fludarabine and cyclophosphamide may be administered orally instead of IV.

Treatment repeats every 28 days for 2-8 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 56-82 patients (28-41 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed previously untreated mantle cell lymphoma requiring therapy

  * Any stage

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Not specified

Life expectancy

* At least 3 months

Hematopoietic

* Not specified

Hepatic

* Bilirubin no greater than 2.5 times upper limit of normal (ULN)\^\*
* Alkaline phosphatase no greater than 2.5 times ULN\^\*
* Hepatitis B and hepatitis C negative NOTE: \*Unless related to lymphoma

Renal

* Creatinine no greater than 2.5 times ULN\^\* NOTE: \*Unless related to lymphoma

Other

* No other malignancy within the past 5 years except non-melanoma skin cancer or curatively resected carcinoma in situ of the cervix
* No prior psychological illness or condition that would preclude study compliance
* No known hypersensitivity to murine proteins
* No concurrent uncontrolled medical conditions
* No other illness that would severely limit life expectancy
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation

The AHF-CODE preserved study is a prospective, non-randomized, monocenter study performed in patients with heart failure with preserved ejection fraction admitted for worsening heart failure.

The main objective of the AHF-CODE preserved study is to identify congestion markers (clinical, biological and ultrasound) at the end of hospitalization for acute heart failure that are associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalised for acute heart failure.
* Patient with preserved ejection fraction (FE ≥ 50%).
* Patients considered clinically discharging from hospitalisation for acute heart failure.
* Age ≥18 years
* Patients having received complete information regarding the study design and having signed their informed consent form.
* Patient affiliated to or beneficiary of a social security scheme.

Exclusion Criteria:

* Comorbidity for which the life expectancy is ≤ 3 months
* Dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate \<15 ml/min/m² at inclusion.
* History of lobectomy or pneumonectomy lung surgery
* Severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc.
* Pregnant woman, parturient or nursing mother
* Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
* Adult person who is unable to give consent
* Person deprived of liberty by a judicial or administrative decision,
* Person subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Effectiveness of Chilipad in Enhancing Sleep Quality &amp;amp; Wellbeing

This study tests the Chilipad Dock Pro Bed Cooling System and Sleep Tracker, focusing on how temperature affects sleep quality and well-being. Over a 35-day period, metrics captured by our Sleep Tracker and participant feedback will be used to evaluate sleep quality and assess well-being. Participation requires minimal time and effort - set-up, sleep, and check-in periodically to provide feedback.

Sleep quality is a cornerstone of well-being, yet many struggle to achieve restful nights. Emerging research suggests that temperature regulation can play a vital role in sleep quality. The Chilipad Dock Pro Bed Cooling System promises to optimize sleep by maintaining an ideal temperature. Social media buzz and user testimonials have lauded its effectiveness, but scientific validation is limited.

The Chilipad Dock Pro is an advanced sleep system designed to optimize sleep by dynamically adjusting the bed\&amp;#39;s surface temperature. It consists of a mesh mattress pad and a Dock Pro control unit that circulates water through the pad, allowing users to customize the temperature between 55°F and 115°F. The system offers both single and dual control, making it ideal for individual or shared use. Equipped with AI-driven features, the Dock Pro can monitor sleep patterns and environmental factors to make real-time adjustments, ensuring optimal sleep conditions throughout the night. This intelligent temperature management system is enhanced when paired with the optional Sleepme Tracker, creating a personalized sleep experience.

This single-arm trial evaluates the impact of the ChiliPad Dock Pro Bed Cooling System on sleep quality and well-being. Participants act as their control, as placebos are impractical. Participants will be asked to sequentially add Chilipad functionality throughout the trial. The study will use validated scales like the PROMIS Sleep Disturbance Scale, Well-being Survey, and SF-36 to quantify the system\&#39;s effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* in the United States
* recent purchaser or customer of Sleep.me

Exclusion Criteria:

* Individuals with severe insomnia
* Individuals with severe allergies or skin conditions
* Individuals with pacemakers or implanted medical devices
* Individuals with severe anxiety or stress disorders
* Pregnant individuals
* Individuals who travel across timezones frequently and/or sleep in their own bed less than 21 days in a month.
* Individuals with incontinence issues
* Individuals with severe mobility issues.
Medium Chain Fatty Acids and Ketones

16 participants were randomized to complete two seven-day intervention periods with twice-daily consumption of Medium-chain fatty acids (MCT) or long-chain fatty acids (LCT) oil. Before and after each intervention, participants completed a five-hour experimental day evaluating the response to a first intake of the MCT or LCT oils (pre MCT or LCT), which was repeated after the intervention period of daily intake (post MCT or LCT) (Fig. The intervention periods were separated by a 2-4-week washout period.

Prior to the experimental days, the participants abstained from alcohol and vigorous physical activity and consumed a controlled, eucaloric diet comprising 30 energy % (E%) fat, 52 E% carbohydrate, and 18E% protein to ensure similar conditions before each experimental day.

On the experimental days, participants arrived by passive transport in the overnight fasted state (12 h) at 8 a.m at the institute. At arrival, participants were weighed, and body composition was determined using dual-energy x-ray absorptiometry (DXA). Then a catheter was inserted into an antecubital vein. Following 30 min of supine rest, whole-body oxygen uptake and substrate oxidation were determined, whereafter a basal venous blood sample was obtained. Subsequently, participants ingested a test drink containing 35g of MCT or LCT oil diluted in 100g of a low-fat, low-carbohydrate cocoa milk within five min. 100 ml water was provided together with the test drink. Participants were blinded to the type of oil intake on the experimental days. The participants were then followed for five hours. Venous blood samples and indirect calorimetry measurements were performed frequently during the five hours. Participants rested in a bed throughout the test day.

Following the first test day, a seven-day intervention period (chronic intake) with twice-daily consumption of MCT or LCT oil was conducted. During the seven days of daily oil intake, the participants ingested 2x10g oil in 15g cocoa milk on day 1-2, 2x20g oil in 30g cocoa milk on day 3-5, and 2x30g oil in 40g cocoa milk on day 6-7. This corresponded to 812kJ on day 1-2, 1625kJ on day 3-5, and 2413kJ on day 6-7. The participants were instructed to maintain their habitual dietary patterns and physical activity level during the intervention. The participants were instructed to consume the oil together with breakfast and dinner and were supervised to ensure compliance.

After the chronic intake period, a second experimental day (post), mirroring the one of the pre day, was conducted.

After a wash-out period the intervention was repeated in a cross-over design.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 20 and 35
* Moderate physical activity level, defined as 1 to 3 weekly sessions of exercise.
* Non-smokers
* No use of medicine
* No known prediabetes or diabetes

Exclusion Criteria:

High habitual intake of MCFA (e.g., coconut milk, coconut oil, or dairy products), A ketogenic diet, known diabetes or pre-diabetes, use of medications, daily use of nicotine products
Study of the Efficacy of Local Analgesia as an Adjunct to General Anesthesia in Thyroidectomy and Parathyroidectomy

We aim to study the effect of local anesthetic when used in conjunction with general anesthesia during thyroidectomy or parathyroidectomy. We hypothesize there is equivalent pain control between bilateral superficial cervical plexus block and local wound infiltration when used in conjunction with a general anesthetic.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* Surgical indication for parathyroidectomy or thyroidectomy

Exclusion Criteria:

* Patients \< 18 years old
* Patient with history of chronic opioid use
* Patient with chronic pain syndromes
* Patient with allergy to marcaine