cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Efficacy of Quercetin Versus Its Encapsulated Nanoparticle on Tongue Squamous Cell Carcinoma Cell Line

Squamous cell carcinoma (SCC) is the most common oral cavity carcinoma. Conventional therapeutic modalities for oral malignancy include surgery, radiotherapy and chemotherapy alone or in combinations.The major obstacle of using current anticancer drugs is; first the non-specific tissue distribution, as these drugs are unable to distinguish between normal and cancer cells.Quercetin is a bioactive flavonoid having strong antioxidant properties. .Among all the nanomaterials, polymeric nanoparticles are of significant interest for drug delivery applications due to many unique features of nanoparticle polymers.This is the first study to investigate the anticancer effects of (Quercetin) either free or encapsulated by PLGA-PEG NPs in tongue squamous cell carcinoma (TSCC) cell line.

Squamous cell carcinoma (SCC) is the most common oral cavity carcinoma. Conventional therapeutic modalities for oral malignancy include surgery, radiotherapy and chemotherapy alone or in combinations. The major obstacle of using current anticancer drugs is; first the non-specific tissue distribution, as these drugs are unable to distinguish between normal and cancer cells. Quercetin is a bioactive flavonoid having strong antioxidant properties. It is naturally present in a wide variety of fruits and vegetables. Among all the nanomaterials, polymeric nanoparticles are of significant interest for drug delivery applications due to many unique features of nanoparticle polymers. Polymeric nanocarriers have been fabricated from natural and synthetic polymers. Poly ethylene glycol-poly lactide-co-glycolic acid (PEG-PLGA) amphiphilic copolymer is an emergent system because it can be easily synthesized and possesses a lot of good qualities. Several previous in vitro and in vivo studies have evaluated the cytotoxic effects of quercetin and have revealed that it decreases cell viability and increases cell apoptotic rate in OSCC. However, the anti-cancer property of quercetin in tongue squamous cell carcinoma (TSCC) has not been studied yet. This is the first study to investigate the anticancer effects of (Quercetin) either free or encapsulated by PLGA-PEG NPs in tongue squamous cell carcinoma (TSCC) cell line.

Eligibility Criteria:
Inclusion Criteria:

* Tongue Squamous cell carcinoma cell lines
* Quercetin drug.
* Quercetin-encapsulated PLGA-PEG nanoparticles (Nano-QUT)
* Application of a Quercetin drug as chemotherapeutic drug.
* Detection of Quercetin activity in apoptosis or cytotoxicity/cell viability.

Exclusion Criteria:

* Any cancer cell line other than tongue Squamous cell carcinoma cell lines
* Any use of Quercetin other than chemotherapy.
* Detection of Quercetin activities other than apoptosis or cytotoxicity/cell viability
Treatment With Botulinum Toxin Type A (BOTOX®) in Chinese Patients With Moderate to Severe Frown Lines

A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated with facial laser resurfacing.


Eligibility Criteria:
Inclusion Criteria:

* moderate or severe frown lines
* facial laser treatment between 4 to 8 weeks prior to Day 1

Exclusion Criteria:

* previous use of botulinum toxin for any indication
* diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
* microdermabrasion or superficial peels, permanent make-up to the brow and forehead area within the last 3 months
* facial cosmetic procedures within the last 6 Months
* treatment to forehead, brow, nose or midface areas with any filler within the last 12 months
* use of a new topical skin care product within 1 month of the screening
* any prior forehead or periorbital surgery or brow lift
* deep dermal scarring, excessively thick sebaceous skin, and/ or loss of skin elasticity
* any facial skin infection or unhealed skin lesion
* pregnant or breast-feeding
Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj.

The purpose of this study is to assess the ease of use, preference, and safety after 8 weeks subcutaneous administration of EutropinPen Inj. in patients pretreated with recombinant human growth hormone by reusable device.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who has been using reusable device growth hormone injection in recent 3 months at least for 6 weeks
* Subjects who meets the indication of EutropinPen inj.

Exclusion Criteria:

* Subjects who has diseases below on screening visit

  * Diabetes
  * Malignant tumor
  * Epiphyseal closure
  * Chronic kidney disease (recieved kidney transplantation)
  * Acute respitory failure
Health Effects of Increasing Muscle Activation While Sitting in Office Workers

Previous research suggests that prolonged sitting increases risk for cardiometabolic diseases and the risk factors associated with cardiometabolic diseases. However, no study to date has examined if a chronic intervention that breaks up prolonged sitting in a real-world environment results in a reduction in the metabolic risk factors associated with cardiometabolic diseases. Thus, the objective of this study is to examine the potential health benefits of breaking up sitting bouts throughout the workday using a small cycling device (DeskCycle) in office workers involved with jobs that require prolonged bouts of sitting. The investigators hypothesize that breaking up sitting will be associated with improvements in cardiometabolic disease risk factors. More specifically, the investigators hypothesize that breaking up sitting will decrease blood glucose during an oral glucose tolerance test (OGTT), increase cardiorespiratory fitness (VO2max), decrease blood pressure, decrease body fat, increase HDL cholesterol, and decrease LDL cholesterol, total cholesterol, and triglycerides.


Eligibility Criteria:
Inclusion Criteria:

* Both males and females
* Subjects will need to be 18-55 years old
* Subjects will need to be sitting at least 6 hours/day on 5 days/week
* Subjects will need to be exercising less than 5 hour/week

Exclusion Criteria:

* Females that are pregnant or breast-feeding.
* Subjects must be free from any acute or chronic physical condition that would influence the outcome measures of the protocol. Examples include, but are not limited to advanced chronic disease states (chronic kidney, liver, heart, or lung disease), morbid obesity, emphysema, and an inability to use the legs for normal locomotion. Normality will be established on the basis of clinical history, physical exam, and vital signs. Any subject with a history of an uncontrolled metabolic disorder/disease or symptoms of active illness will be excluded from study. Any subject with a history of an uncontrolled metabolic disorder/disease such as diabetes (Type I or Type II) or symptoms of active illness will be excluded from study.

  * Subjects will be excluded if they have a fasted blood glucose level \>126 mg/dl or a systolic blood pressure \>140 mmHg.
* Medical/psychiatric/sleep disorders history: any clinically significant unstable medical or psychological condition within the last year (treated or untreated).
* Drug use:

  * Use of any medications, including over-the-counter and herbal products, that may affect metabolic function within 1 month prior to the study or need to use any of these medications at any time during the study (self-report by interview). Examples of potential medications that will exclude a subject include: beta-adrenergic blockers, sulfonylureas, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, meglitinides, and dipeptidyl peptidase IV inhibitors. Note, subjects may be tested at a later date.
  * Use of any investigational drug within 1 month before the study
Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder

Childhood ADHD and comorbid oppositional defiant disorder (ODD) and conduct disorder (CD) are considered risk factors for subsequent substance abuse, and youth with both ADHD and ODD/CD are at greatest risk.

However, the effects of treatment of ADHD with stimulant medications such as methylphenidate (MPH) and mixed amphetamine salts (MAS) on risk for substance abuse are poorly understood. The study team propose to use fMRI to study the effects of extended release mixed amphetamine salts (MAS-XR) in drug-naïve youth 7-12 years at low risk (i.e., ADHD only) and high risk (i.e., ADHD + ODD/CD) for substance abuse on the brain reward system, to better understand the potential impact of these medications on an aspect of brain functioning which is thought to underlie vulnerability to substance abuse.


Eligibility Criteria:
Inclusion Criteria:

* General: pre-pubertal (e.g. Tanner stage 1 or 2)
* age 7-12 inclusive
* signed consent/assent
* parent communicates sufficiently in English
* Has ADHD as determined by parent interview
* ADHD-Rating Scale-5 total score (interview with parent) of 1.5 SD \> age/sex norms
* Youth with CD or severe ODD: CD or ODD + 2 symptoms of CD

Exclusion Criteria:

* major neurological/medical illness
* history of head injury
* fetal exposure to alcohol/drugs;
* diagnosis of major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, generalized anxiety, social phobia, Tourette's Disorder, PTSD, autism spectrum disorder) current suicidal ideation or past history of suicide attempt
* Wechsler Abbreviated Scale of Intelligence (WASI) score \<75; 7)
* current treatment with stimulants (prior or current treatment with non-stimulants is permitted, but participants must be off medication for 2 weeks at baseline; youth who had a past, brief stimulant medication exposure of no more than about a month, and not within the past 6 months may be included .)
* current or past alcohol/drug use (interview; urine toxicology)
* psychological or medical condition which precludes being in the scanner (e.g., claustrophobia, morbid obesity)
* metal in the body that cannot be removed
* visual disturbances that may impair task performance
* precocious puberty (e.g. Tanner stage \>2).
Evaluation of the LipiFlow System With a New Activator

Minimum 50 eyes and up to 100 eyes will be treated in this prospective, open-label clinical study. The investigator or designee will perform LipiFlow treatment with the Activators LFD-2100 on both eyes of a subject. The data from the treatment reports generated by the LipiFlow console and from the questionnaire will be used to assess the clinical utilization of the Activator LFD-2100. This study will be conducted in up to four sites in the USA.


Eligibility Criteria:
Inclusion Criteria:

To be able to participate in this study, subjects must:

* Be at least 22 years old.
* Has been diagnosed as bilateral MGD prior to the study visit, or has evidence of MGD in both eyes. NOTE: MGD diagnosis can be based on prior medical records, investigator opinion or based on assessment of meibomian glands of the lower eyelid.
* Availability, willingness, ability and sufficient cognitive awareness to comply with study protocol, examination procedures and visit.
* Be willing to provide informed consent and authorization to disclose protected health information or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical procedures.
* Ability to understand and respond in English.

Exclusion Criteria:

Subject will not be able to be in the study, if the subject:

* Has a history of certain medical conditions that have been identified as contraindications and precautions of the LipiFlow System
* Has a history of prior eye surgery or trauma, active eye disease, or other eye abnormality in the study eye(s), which in the opinion of the investigator would confound the study results.
* Is pregnant, or is breast feeding.
* Concurrent participation or expected participation in an interventional (i.e., surgical or pharmaceutical interventional) clinical trial within 14 days prior to study screening.
A Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a sleep phase advance.


Eligibility Criteria:
Inclusion Criteria:

* Aged \>/= 18 years
* Females of child-bearing potential using medically-acceptable method of birth control \>/= 1 month prior to screening

Exclusion Criteria:

* Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
* Recreational drug use within past 30 days
Safety & Accuracy of the ActiSight Needle Guidance System in Percutaneous Chest Aspiration and Biopsy

This study is intended to provide clinical data regarding safety and accuracy of the ActiSight™ Needle Guidance System in assisting Chest CT guided biopsies.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 18 years of age or older at the time of enrollment
* Subjects meeting all medical conditions for percutaneous chest aspiration/biopsy with safe path to lesion between ribs, however, not in the breast area in women or men with gynecomastia
* Single target pulmonary lesion greater than 10 mm in size (diameter) and depth of lesion greater than 40 mm from the skin
* INR \<1.3
* Written informed consent to participate in the study
* Ability to comply with the requirements of the study procedures

Exclusion Criteria:

* Fibrous tissue or cyst in access path (not including target lesion)
* Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
* Central lesion is located in radius of less than 2 cm from lobar blood vessels and the heart.
* The selected needle path has a safety margin of less than 2 cm from major blood vessels and the heart
* Use of ticlopidine or similar antithrombotic medication
* For subjects taking warfarin or other anticoagulant medication, INR \>1.3
* Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
* Subjects who cannot tolerate mild sedation
* Subjects with FEV1 \< 800 mL unless approved by principal investigator following consultation with multidisciplinary team
* Subjects with the following laboratory values, unless approved by hematologist:

  * Platelet count \<100,000/mL
  * APTT \>39 sec or PT \>15 sec
* Pregnancy or lactation
* Patient is unable to comply with requirements of the procedure, i.e. holding breath
* Participation in an investigational trial within 30 days of enrollment
* Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder, or any chronic condition that could, in the opinion of the investigator, of interfering with the conduct of the study.
* Subjects who are uncooperative or cannot follow instructions
Effects of Heat-suit Training on Biological and Performance Characteristics in Elite Cyclists

The overall objective of the study is to investigate the effects of five weeks of heat-suit training on training-associated changes in hemoglobin mass, skeletal muscle characteristics and endurance exercise performance in elite cyclists

Endurance exercise performance depends on a range of determinants, including hemoglobin mass in blood and content of respiratory mitochondria in skeletal muscle. Low-intensity training (LIT) with heat exposure may be beneficial for development of these variables. The purpose of this study is to investigate the effects of five weeks of LIT-training with heat suit (five times a week; 50 min per session) on hemoglobin mass and other blood characteristics in elite cyclists (males and females) compared to a non-heat-suit training control group, including subsequent investigation of the retrograde effects of \~one month of training without heat suit. The study will also investigate the effects of heat-suit training on endurance exercise performance/performance determinants and other muscle biological charateristics, and will investigate the basic characteristics of mitochondrial function and abundances in these highly trained athletes. Training sessions with heat suit (or lack thereof) will complement the habitual training routines of the participants.

Eligibility Criteria:
Inclusion Criteria:

* VO2max \> 65 ml/kg/min (male participants)
* VO2max \> 50 ml/kg/min (female participants)
* \>7 hours of endurance training per week for the 6 months leading up to the study
Observational Study on Pregnant Women With Chronic Hepatitis B and Their Infants

The study was conducted to observe the clinical features during pregnancy in women with chronic hepatitis B virus infection and mother-to-child transmission of hepatitis B virus.


Eligibility Criteria:
Inclusion Criteria:

1. Gestation of 4-32 weeks
2. HBsAg+ \> 6 months, HBeAg+/-
3. Informed consent signed voluntarily
4. Good compliance and able to be followed up as planned

Exclusion Criteria:

1. Coinfection with hepatitis C virus or human immunodeficiency virus;
2. Comorbidities of other severe conditions that hinder compliance with follow ups and because of that, the subjects are anticipated to be unable to complete the project.;
3. Unable or unwilling to use mobile health tools.
Pre-exposure Prophylaxis: A Miracle Drug or a Moral Hazard

The investigators study the behavioral consequences of Pre-exposure Prophylaxis or PrEP on sexual health behaviors, sexual health outcomes, and partner selection preferences. The study collects observational, self-reported data on PrEP status, PrEP taking-history, PrEP adherence over the last 30 days, STD diagnosis history dating back to January 2015 up to December 2019, sexual health behaviors (e.g., positioning, number of lifetime/recent partners, condom adherence etc.), and various demographic characteristics. The survey finishes with a conjoint experiment which asks respondents to select between two potential partners, and follow-up question about each profiles. Potential partners' characteristics include recreational drug use and condom adherence. Recruitment is conducted via running an ad on Facebook in New York, London, Toronto and Sydney for comparative purposes, as these metro areas have varying levels of PrEP use and accessibility.

See statistical analysis plan.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or above
* living in the London, New York, Toronto or Sydney metro area
* self-reported sex at birth is male
* reported ever having sex with a male

Exclusion Criteria:

* not meeting the inclusion criteria
Pain Processing and Pain Reporting in Patients With Alzheimer's Disease

The study investigates pain processing and pain reporting in patients with Alzheimers disease compared to healthy participants.

Employing a within-subject design, the study includes patients with Alzheimers disease and healthy participants that are exposed to thermal stimuli. During the test session the facial expressions of the participant are video recorded.

By repeating this on separate test days, the involvement of pain relief and pain increase is investigated.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate patients with Alzheimers disease (group 1)
* Healthy participants ( group 2)

Exclusion Criteria:

* Chronic pain conditions
* Other medical, psychiatric or neurological disorders
* Use of pain-reliving medication 24 hours prior to testing
Improving Childhood Obesity-Related Behavior Change Through Better Risk Communication

One-third of American children are overweight or obese, leading to an increased risk for cardiovascular disease (CVD), early mortality, and other risks throughout their lifespan relative to normal weight children. In our pilot work, we found that 67-83% of parents underestimate a child's long-term risk of developing cardiovascular disease in adulthood and that parents thought their own child's risks were 13-15% lower than those of a typical child in their community, even controlling for family health and demographic characteristics. Parents were 40 times less likely to predict that their child, rather than a typical child in their community, would be overweight or obese in adulthood. These findings suggest that parents suffer from optimism bias, the tendency to overestimate one's chances of experiencing unlikely positive events. Belief that a child is at increased risk for adverse health outcomes in adulthood could be an important motivator for a family to initiate behavior changes and vice versa.

The overall goal of this research is to develop provider-based risk communication approaches to motivate parents of obese children to engage in behavior change to protect their children from CVD and other obesity-related co-morbidities later in life. Specifically, the investigators will:

1. Develop risk communication methods that providers can use to better convey accurate information about a child's health behaviors, obesity status, and future health risks to parents.
2. Using an online experiment, we will evaluate the impact of new risk communication methods on parental engagement in behavior change.
3. Pilot test the feasibility, acceptability, and impact of new risk communication approaches in pediatric primary care clinics.

This work will give pediatricians novel tools to effectively discuss the long-term consequences of childhood obesity with parents. The findings from this work will inform an interventional trial that will assess the impact of improved risk communication techniques on child behavior change and health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* must be a parent of a 5-12 year old child
* child must be a patient at University of Washington Medical Center
* child must have BMI at or above 95th percentile for age and sex
* parent must have home or mobile internet access

Exclusion Criteria:

* None
Performance Evaluation by the User of BGM Contour Care According to ISO 15197:2015

Performance Evaluation by the User of the Blood Glucose Monitoring SystemContour Care in accordance with DIN EN ISO 15197:2015


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with clinical indication for blood glucose measurements (i.e. Diabetes mellitus)
* Male or female patients with hypo-, eu- or hyperglycemia
* The written informed consent had to be signed
* The volunteers must be older than 18 years
* The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion Criteria:

* Pregnancy or lactation
* Acute or chronic diseases that

  * pose a risk of aggravation by the measure
  * pose a health hazard to the personnel
* A current constitution that does not allow participating in the study
* Participation in another study or activity with the blood glucose measuring system evaluated in the present study
* Application of substances listed in Appendix A of DIN EN ISO 15197:2015