cyrilzakka/clinical-trials huggingface dataset:
Impact of Chip Thickness and Size on Eating Responses

To analyze prototypes developed with the base and seasonings of products that exhibit variations in chip thickness and size. The information obtained from this analysis will serve as the basis for subsequent research to explore different prototype options with increased satiation properties.

There are two study components, a sensory study and an ad libitum study. Eighty-eight participants will test tortilla chips and eighty-eight will test extruded chips in the sensory study. On a first-come first-served basis, forty-four of the eighty-eight chip participants from the sensory testing phase will test tortilla chips, and forty-four of the eighty-eight extruded chip participants will test extruded chips in the ad libitum study.

Eligibility Criteria:
Inclusion Criteria:

* Report eating tortilla and/or extruded chips regularly, non-rejector of cheese flavor chips
* Provide informed consent
* Speak and understand English without difficulty
* Willing to eat similar food the day prior and on the day of each visit to the testing facility for ad libitum sessions
* Describe yourself as generally healthy

Exclusion Criteria:

* Those who are on restricted diet due to a weight loss or maintenance purpose
* Participants with class III occlusions for ad libitum sessions
* Have abnormal taste, chewing and smell ability
* Smoke or vape
* Being pregnant or breastfeeding
* Allergic or intolerance to any of the product ingredients (section 6), especially milk and wheat
* Participation in a sensory clinical trial within past 7 days (we do not expect carryover issue from the taste testing)
* Participation in any PepsiCo trial within past 6 months
Delgocitinib Cream for the Treatment of Moderate to Severe Atopic Dermatitis During 8 Weeks in Adults, Adolescents, and Children

This is a multi-center, open-label trial to evaluate safety and pharmacokinetics of topical delgocitinib cream applied to pediatric subjects (2-17 years) and adult subjects (18 years and above) with atopic dermatitis.

A phase 1 open-label, multi-centre, single-arm trial to evaluate the safety and pharmacokinetics (including MUsT) of twice daily topical application of delgocitinib cream for 8 weeks in adults, adolescents, and children with moderate to severe atopic dermatitis

Eligibility Criteria:
Key Inclusion criteria (Part 1: adults and adolescents; 12 years and above)

* Diagnosis of atopic dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria for AD
* Age 12 years and above at baseline
* AD involvement of 25-50% treatable body surface area (BSA) at screening and at baseline
* Moderate to severe AD (Validated Investigator Global Assessment scale for Atopic Dermatitis \[vIGA-AD\] score of at least 3) at screening and at baseline

Key Inclusion criteria (Part 2: children; 2-11 years)

* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD
* Age 2-11 years at baseline
* History of AD for at least 3 months (children aged 2-5 years), and at least 12 months (children aged 6-11 years)
* AD involvement of ≥35% treatable BSA at screening and at baseline
* Moderate to severe AD (vIGA-AD score of at least 3) at screening and at baseline

Key Exclusion criteria (Part 1 and 2: subjects aged 2 years and above)

* Active dermatologic conditions that may interfere with the diagnosis of AD
* Use of tanning beds or phototherapy within 4 weeks prior to baseline
* Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4 weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to baseline
* Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCIs), topical phosphodiesterase-4, or oral antibiotics within 1 week prior to baseline
* Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline
* Any disorder, which is not stable, and in the investigator's opinion could affect the safety of the subject, influence the results of the trial or impede the subject's ability to complete the trial
Caring for Caregivers: Supporting Caregivers of Youth With Spinal Cord Injury

The current study will implement and evaluate a multi-component, psychoeducational intervention for caregivers of children with spinal cord injury (SCI) ages 7-12. Two hypotheses will be tested. First, caregivers who participate in the intervention group will demonstrate better outcomes than caregivers in the control group. Second, children with SCI whose caregivers participate in the intervention group will demonstrate better outcomes than children with SCI whose caregivers participate in the control group.

The primary objective of this study is to implement and evaluate an intervention for caregivers of children with spinal cord injury (SCI) ages 7-12. A further objective of this pilot study is to identify which outcomes are being affected by the intervention. Past research has highlighted psychoeducational intervention (i.e., interventions including both educational/skills-building components and psychological support) as most effective in terms of impacting caregiver functioning. The current study will recruit 44 caregivers and their children with SCI. All caregivers will participate in a 2-day Parent Forum, an in-person educational session. Caregivers will then be randomly assigned to receive monthly phone calls from a mental health professional ("intervention group") or no additional targeted support ("control group"). We expect that caregivers who participate in the intervention group and their children will demonstrate better outcomes than caregivers in the control group and their children.

Eligibility Criteria:
Inclusion Criteria:

* Primary caregivers of youth with SCI ages 7-12 years.
* Youth sustained their SCI at least one year ago.
* Both the caregiver and child are able to speak English.
* Both the caregiver and child are able and willing to sign informed consent/assent and Health Insurance Portability and Accountability Act (HIPAA) compliant research authorization.

Exclusion Criteria:

* Caregiver or child has significant cognitive limitations and/or psychiatric comorbidities. These conditions will be identified by a clinical psychologist or physician.
Tolerability of Bimatoprost 0.01% vs Latanoprost Eye Drops

This study examines patient perceptions regarding the tolerability of two classes of glaucoma medication: bimatoprost and latanoprost.

Patients enrolled in this study completed a validated survey instrument (COMTOL) examining tolerability of topically applied ophthalmic medications that they are already taking in their regular course of care for glaucoma. The purpose of the study is to determine whether side effects and symptoms of the drugs already being taken cause problems with activities of daily living.

Eligibility Criteria:
Inclusion Criteria:

* Patients with glaucoma taking either bimatoprost or latanoprost

Exclusion Criteria:

* patients taking other medication or with other causes for ocular surface symptoms
Investigate Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose in Healthy Females

This study was to determine the ADME and metabolites of Proellex following a single oral dose of 25 mg.

The purpose of this study is to determine the absorption, metabolism, and excretion kinetics of Proellex and to determine and characterize metabolites present in plasma and urine following a single oral dose of 25 mg. The 25 mg dose selected for this study has been included in all previous clinical trials. This dose was well tolerated and demonstrated efficacy against uterine fibroids and endometriosis.

Eligibility Criteria:
Inclusion Criteria:

* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
* Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator
* 1 to 2 bowel movements per day.

Exclusion Criteria:

* Significant history or significant clinical manifestation (as determined by the Investigator) of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
* Participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to check-in
* Exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to check-in
* Donation of blood from 30 days prior to Screening through Clinic Discharge, inclusive, or of plasma from 2 weeks prior to Screening through clinic discharge, inclusive
* Receipt of blood products within 2 months prior to check-in
Joint Position Sense, Plantar Sensation, Balance and Dual Task Performance in Individuals With Type 2 Diabetes

Diabetes is a chronic disease characterized by hyperglycemia, which occurs when insulin is inadequate or the body's produced insulin cannot be used effectively, but according to the World Health Organization 2016 Global Report on Diabetes, it is an important public health problem that is one of the four priority non-infectious diseases. In addition to high mortality rates caused by diabetes-related complications, it is known that it can cause low quality of life and many additional problems in individuals. These complications and damage, which may be caused by diabetes, may result in reduced blood flow combined with neuropathy; As a result, foot ulcers, infections and consequently the need for amputation may increase. In addition to the additional complications caused by diabetic neuropathy, protective plantar sensory loss and decreased joint position have been reported in the literature. In particular, investigators did not find any comprehensive studies examining the relationship between these sensory changes and the dual task performance in diabetic subjects. In this study, investigators aimed to investigate the relationship between joint position sense, plantar sensation, balance and dual task performance in individuals with type 2 diabetes and to contribute to the literature with evidence-based, objective results.

The aim of this study is to investigate that the relationships between joint position sensation, plantar sensation, balance and dual task performance in type 2 diabetic patients.

First of all, a general evaluation form including demographic information and physical characteristics of the individuals who voluntarily agree to participate in the study and approve the informed consent form, will be filled. Then, with the first findings to be obtained, determination of sample size was planned. Bilateral ankle joint position sensation with goniometer, bilateral knee joint position sensation with an analog inclinometer (BASELINE® Bubble inclinometer-USA), plantar sensation with Semmens-Wenstein monofilaments, equilibrium with Prokin Isokinetic Balance System, dual task performance will be evaluated with adding motor and cognitive secondary tasks to the Time Up and Go Test and single leg balance tests.

Eligibility Criteria:
Inclusion Criteria:

* to accept to participate in the study voluntarily,
* to being diagnosed with type 2 diabetes,
* to being 30-65 age range.

Exclusion Criteria:

* refuse to participate in the study,
* Not cooperating,
* Being orthopedic, neurological and any other systemic disease,
* Being pregnant,
* Loss of vision,
* Loss of hearing,
* To be a standing diabetic ulcer,
* A Mini Mental Test score of 23 or less.
Contrast-enhanced Magnetic Resonance Angiography Investigation of Intracranial Aneurysms and Prospective Study of Risk Factors

This is a prospective observational registry with intent to detect the prevalence of intracranial aneurysms with contrast-enhanced MR angiography (CE-MRA) at 1.5T, and to determine the risk factors such as high blood pressure and cigarette smoking relating to intracranial aneurysms.

Intracranial aneurysms are common and have been reported increased incidence rate because of the widespread use of high-resolution imaging techniques. They are clinically important because of the life-threatening rupture and hemorrhage. Early detection and diagnosis is the key of treatment. Contrast-enhanced MR angiography (CE-MRA), as a simple, sensitivity and noninvasive method, is playing an important role in Vascular Imaging. CE-MRA has been an accuracy modality for intracranial aneurysm at most centers and proved the high sensitivity and accuracy comparing with DSA. Therefore, we use CE-MRA at 1.5T as a tool of epidemiological investigation of intracranial aneurysms.

In retrospective analysis, conventional risk factors for intracranial aneurysms include hypertension, hyperlipidemia, diabetes mellitus (DM), smoking history, and family history, etc. However, retrospective analysis probably gives an underestimation or overestimation of the actual results. Prospective analysis will get accurate data on the risk factors relating to intracranial aneurysms

Eligibility Criteria:
Inclusion Criteria:

* Aged 20 to 80 years
* Willing to undergo study procedures
* Who are fully informed about the study and have signed the informed consent form

Exclusion Criteria:

* History of intracranial aneurysm
* History of intracranial tumor
* History of cerebral infarction
* Acute stroke
* Require emergency treatment
* Contraindication for MRI examination
* Severely impaired renal functions
* Known anaphylactic reaction to MR contrast media
* Pregnancy or nursing
Classroom Break, Cognition, and Fitness in Elementary School Children

The goal of this randomized controlled trial is to learn about the effect of a 12-week school-based intervention combining mindfulness with high-intensity interval training (MF-HIIT), MF-only intervention, and HIIT-only intervention in relative to sedentary activities on executive function (EF) in 8-12 years old children. The main question it aims to answer is whether a 12-week school-based MF-HIIT intervention has larger beneficial effect on EF performance than that following a 12-week school-based MF-only and HIIT-only in relative to the sedentary activities.

Multiple cohorts of participants will be recruited to participate this one-semester study, including the pretest, intervention, and posttest phases.

During the pretest phase, participants an their parents will complete the following

1. Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient
2. Fitnessgram test to assess aerobic capacity, muscle endurance, flexibility, and body mass index
3. Child and Adolescent Mindfulness Measure (CAMM) questionnaire to assess dispositional mindfulness
4. Computerized tasks to assess EF
5. Parent-reported demographic and health information

Following the pretest phase, participants will receive the 12-week classroom-based intervention, with the classroom as the intervention unit.

Following the intervention and during the posttest phase, participants will complete the fitness, measures, EF measures, and dispositional mindfulness measure again.

Researcher will compare the EFn outcome measures following the MF-HIIT, MF-only, and HIIT-only interventions with the sedentary activity intervention to see if MF and HIIT has beneficial effects on children's EF.

Further, researcher will compare the EF measures following the MF-HIIT compared with MF-only and HIIT-only interventions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone.


Eligibility Criteria:
Inclusion Criteria:

* Age between 8-12 years old
* Intelligence Quotient ≥ 70
* Capable of performing exercise based on pre-participation health screening
* No formal diagnosis of neurological diseases (e.g., epilepsy)

Exclusion Criteria:

* Age outside of the range of 8-12 years old
* Intelligence Quotient \< 70
* No capable of performing exercise based on pre-participation health screening
* Has formal diagnosis of neurological diseases (e.g., epilepsy)
Τhe Effect of Lumbar Spine Mobilization and Manipulation on Pressure Pain Threshold in Patients with NSLBP

Manual therapy, including mobilizations and manipulations, appears to be as effective as other types of therapy for chronic low back pain.

The aim of this cross-sectional study is to compare the effects of lumbar spine mobilization and manipulation on the pressure pain threshold in patients with non-specific chronic low back pain.

Background: Manual therapy, including mobilizations and manipulations, appears to be equally effective as other types of therapy for chronic low back pain. According to the Orthopaedic Section of the American Physical Therapy Association (APTA), there is evidence indicating that these techniques can reduce pain, improve spinal and hip mobility, and decrease disability in patients with low back pain. The aim of this study is to compare the effects of lumbar spine mobilization and manipulation on the pressure pain threshold in patients with non-specific chronic low back pain.

Methods: The present study will be a cross-sectional study in which participants will be men and women aged 18 to 60 years. The sample size was estimated by effect size, with a minimum of 27 participants required to provide statistically or clinically significant results. Each subject will receive two interventions-mobilization or manipulation-on two different days, in a random order. The primary outcomes will be pain perception, including subjective pain intensity and pressure pain threshold. Secondary outcomes will include the range of motion (ROM) of lumbar spine flexion, extension, and lateral flexion. Data will be collected before and after each intervention. Assessors will use a digital algometer, an electronic inclinometer, and a numerical rating scale (NRS). ANOVA and t-test calculations will be performed on data processed by SPSS Version 25 to analyze results for all outcomes. The level of significance will be set at 5% (p = 0.05) with a confidence interval of 95% (CI = 95%).

Eligibility Criteria:
Inclusion Criteria:

* 18 to 60 years old
* diagniosed with non specific low back pain
* symptoms lasting for more than 12 weeks

Exclusion Criteria:

* spinal fractures,
* neurological impairment due to herniated spinal disc,
* spondylolisthesis,
* joint degenerative diseases,
* osteoporosis,
* spinal infections,
* cauda equina syndrome,
* spinal tumors or bone marrow malignancies,
* spinal surgeries
* history of cancer,
* use of steroids
Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of DME

The objective of this study is to evaluate if combination of intravitreal ranibizumab with micropulse laser shows non inferiority compared to intravitreal ranibizumab only in diabetic macular edema.

To investigate the efficacy of intravitreal ranibizumab injections compared to combination with Micropulse Laser in Chinese patients with visual impairment in DME.

The result of the study will be used to support new therapy in DME patients in China.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent form must be signed before any tests or procedures are done
* Male or female of 30 to 80 years of age (inclusive) at the first screening visit
* Diagnosis of type 2 diabetes, with fasting blood glucose≤10mmol/L, HbA1C≤10.0%
* Diabetic medication must be stable for at least 3 months before first screening visit and remain stable during study
* Diagnosis of non-proliferative diabetic retinopathy with diabetic macular edema resulting in visual acuity reduction
* Study eye's BCVA between 24 to 78 ETDRS letters at screening and baseline of the study
* Macular edema of the study eye and central retinal thickness ≥300 µm determined by SD-OCT
* Study eye had not had grid pattern photocoagulation, intraocular surgery, intravitreal corticosteroid injections and intravitreal anti-VEGF injections for at least 3 months before baseline
* Non-study eye's BCVA ≥ 24 ETDRS letters at screening and baseline of the study
* Non-study eye had not had intravitreal anti-VEGF injections for at least 3 months before baseline
* If both eyes qualify, then investigators will choose an eye with worse BCVA as study eye. Only study eye will receive intravitreal ranibizumab and/or Micropulse Laser treatment

Exclusion Criteria:

* Failure to follow study or follow-up procedures
* Pregnant or breast-feeding woman and woman without adequate method of contraception
* History of stroke or myocardial infarction within 3 months before screening
* Renal failure or creatinine \> 2.0 mg/dl
* Uncontrolled systemic diseases or systemic treatment that may affect results of the study
* Active ocular or intraocular infections of either eye
* Neovascularization of the iris or neovascular glaucoma of either eye
* A history of uveitis or vitreous macular traction in study eye
* Glaucoma or IOP≥24 mmHg of study eye
Impact of a Novel Patient Educational Booklet on Colonoscopy Quality

Background: Achievement of colonoscopy outcomes depends on high-quality bowel preparation by patients; yet inadequate preparation is common.

Objective: To develop and test an educational booklet to improve bowel preparation quality.

Design: "Before-and-after" study followed by randomized controlled trial.

Setting: Veteran Affairs medical center.

Patients: Patients undergoing outpatient colonoscopy

Measurements: The investigators first performed cognitive interviews to identify knowledge and belief barriers to high-quality colonoscopy preparation. The investigators then created a patient educational booklet addressing patient barriers to improve preparatory behaviors. The investigators tested the booklet in 2 sequential studies: (1) controlled "before-and-after" study in patients undergoing colonoscopy during 2 consecutive months: 1 without and 1 with the booklet; (2) randomized controlled trial. The outcome in both studies was bowel preparation quality measured on a 6-point Likert scale (\>5="good"). In each study the investigators compared the proportion achieving a "good" preparation between groups and performed logistic regression to measure the effect of the booklet on preparation quality while adjusting for the purgative received.

Limitations: Unknown impact on polyp yield and cancer reduction.


Eligibility Criteria:
Inclusion Criteria:

* Any patient scheduled to undergo outpatient colonoscopic CRC screening or surveillance in VAGLA

Exclusion Criteria:

* In patient admissions
Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery

The purpose of this prospective, blinded, randomized clinical trial is to investigate whether a ventilator-piloted PRM at the end of laparoscopic bariatric surgery could reduce overall postoperative pain and nausea.


Eligibility Criteria:
Inclusion Criteria:

* elective laparoscopic bariatric surgery (LBS)
* American Society of Anaesthesiologists (ASA) physical status classification I-II (with the exception of body mass index over 35 kg/m2)
* written consent

Exclusion Criteria:

* conversion to open surgery
* complication, Clavien-Dindo grade ≥ II