cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Long-term Effects of Microfocused Ultrasound on Facial Tightening Using Quantitative Instruments

A non-randomized, evaluator-blinded study was conducted to observe the changes in the face before and after facial rejuvenation using microfocused ultrasound. The efficacy of microfocused ultrasound in facial rejuvenation was evaluated using standardized photographs in conjunction with a dermatological testing system and to explore the effects of microfocused ultrasound on the function of the skin.

Primary efficacy endpoints:Utilizing the 3D Life Viz mini system for standardized photo modeling enables the comparison and identification of enhancements in treatment outcomes. This research utilized standardized photo modeling to record the facial and mandibular conditions of patients, capturing images both before and after treatment (immediately post-operation and at 7, 30, 90, 180，270 and 360 days). The detection of improvements in treatment effects was then achieved through pairwise comparisons of the modeled data derived from these photographs;Secondary efficacy endpoints: Global Aesthetic Improvement Scale, patient satisfaction scores, Digital Visual Analog Scale

Eligibility Criteria:
Inclusion Criteria:

1. Ages between 25 and 60 years old.
2. Clear manifested skin issues such as sagging and wrinkles: Merz Facial Aesthetics Score of 2 or above.
3. Absence of significant systemic diseases, cardiovascular disorders, impaired liver or kidney function, malignant tumors, etc.
4. Willing to participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Individuals with a scar-prone constitution, allergic or abnormally healing skin.
3. Treatment areas with damaged skin, acute inflammation, active infection, rosacea, vitiligo in the progressive stage, or severe acne.
4. Patients with skin conditions such as urticaria, itching, or other dermatological diseases.
5. Those with psychological disorders or drug allergies.
6. Individuals harboring unrealistic expectations about treatment outcomes.
7. Treatment areas containing metal foreign bodies or fillers deemed unsuitable for treatment by the physician.
8. Recent facial laser treatments or injections within the past month, including but not limited to filler treatments such as hyaluronic acid, botulinum toxin, and PRP injection therapy.
9. Any skin-tightening cosmetic treatments on the face or neck within the last three months.
10. Any minimally invasive cosmetic treatments on the face within the last three months.
11. Thread embedding treatments on the face within the last year, excluding thread blepharoplasty.
12. Patients with severe insomnia or those requiring intense sun exposure within the next three months.
13. Patients deemed unsuitable for participation by the investigator.
14. Those unable to cooperate with the treatment and complete all required visits.
Vaginal Microbiome and IVF Pregnancy Outcome

The aim of this prospective, observational study is to investigate the prevalence of vaginal dysbiosis among women undergoing IVF procedures in the US. And to investigate the associations between the vaginal microbiome and the pregnancy outcome following IVF.

The present study will evaluate differences in vaginal microbiome composition in pregnant and non pregnant women who have undergone IVF treatment with frozen embryo transfer. Concurrently we aim to identify whether menstrual tissue and Cervicovaginal secretion possess complimentary biomarker information reflecting the immune/inflammatory status of the reproductive tract to determine its impact on pregnancy success following frozen embryo transfer IVF procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-44 years
* Patients whose written informed consent approved by the Institutional Review Board (IRB) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
* Women undergoing a planned frozen embryo transfer
* BMI between 18.5-35 kg/m2 (both included)
* Must be able to understand and read the informed consent form in English.

Exclusion Criteria:

* Current diagnosis of pathologies or malformations that affect the uterine cavity such as polyps, intramural myoma, adhesions, fibroids or hydrosalpinx.
* Any illness or medical condition that is unstable or which, according to medical criteria and Investigator's discretion may put at risk the patient's safety and her compliance in the study.
* Participants currently taking antibiotics or with any known condition requiring regular use of antibiotics, that would suggest the participant is likely to need antibiotic treatment during the observational period of this study.
* Systemic and/or vaginally applied antibiotic use within the last month prior to screening (except for prophylactic antibiotics related to egg retrieval).
* Patients utilizing oral contraceptive pills in the past month
* Latex or silicone allergy (Diva Cup and Vaginal Disc)
The Impact of Daily Carbohydrate Intake on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-loop System

Lifestyle factors, including diet, play an important role in the achievement of glycemic targets in patients with diabetes, even with the use of automated insulin delivery (AID) systems. Advanced hybrid closed-loop systems (AHCL), by implementing innovative and powerful control algorithms, have been shown to improve the post-meal glycemic control in their users through the delivery of automatic correction boluses. However, data about the influence of the daily amount of carbohydrate intake on glycemic outcomes in youth with type 1 diabetes using AHCL are missing. Therefore, this study will evaluate the association between daily carbohydrate intakes and meal patterns on glycemic control of young people living with type 1 diabetes using an AHCL system (Medtronic MiniMed 780G; Medtronic, Northridge, California) under real-life conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes
* Patients aged 7-18 years
* Patients using Medtronic MiniMed 780G with SmartGuard activated
* Patients whose informed consent has been obtained
* \>70% CGM data during observational period

Exclusion Criteria:

* Patients with partial clinical remission according to the Hvidovre Study Group definition
* Concomitant treatment with steroids or other drugs known to interfere with blood glucose levels
* Previous diagnosis of psychological or eating disorders
Study of Yili "Changqing" Pro-ABB Yoghurt in the Improvement of Human Gastrointestinal Tract System

The purpose of this study is to determine whether Yili "Chang Qing" Pro-ABB yoghurt is effective in improving mild constipation and the intestinal micro-ecology environment \& alimentation.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, 25-45 yrs;
2. Non-specific and/or moderate constipation;
3. Irregular or occasional gastrointestinal disorders (flatulence, gurgling, feeling heavy after eating, abdominal pain);
4. Slow transit or irregular bowels movements (abnormal feces solidity, bowel movements decreased, e.g. every 2-3 days or less than 3 times per week).

Exclusion Criteria:

1. Diagnosed as chronic constipation;
2. Treated gastrointestinal symptoms;
3. Lactose Intolerance;
4. Treatment by analgesic such as aspirin and paracetamol;
5. Had laxatives or other remedies to promote digestion 2 weeks prior to the study start;
6. Consuming dairy products or supplements containing pro/pre-biotic 10 days prior to the study start;
7. Currently suffering from diarrhea.
A Patient-Centered Asthma Management Communication Intervention for Rural Latino Children

The purpose of this research is to develop and evaluate an mHealth communication intervention designed to improve asthma medication adherence amongst rural Latino children in South Carolina.

The overall prevalence of asthma is highest in the US south, which has one of the fastest growing Latino populations in the country. In South Carolina, asthma is the leading cause of children's hospitalization and emergency department (ED) visits, with significant direct and indirect costs. Although rates of childhood asthma are lower in Latinos (with the exception of children of Puerto Rican origin) than in whites, Latinos are more likely to have a higher incidence of uncontrolled asthma symptoms, ED visits, repeat hospitalizations, and poorer health in general. Current interventions addressing asthma control include outpatient clinic based and home visitation programs. Rural Latino families have difficulty participating with these types of programs due to work, family, and transportation constraints.

The adaptability of mobile apps holds the potential to target the unique challenges to management experienced by rural Latino children with asthma experience. The goal of this study is to develop and evaluate a patient-centered collaborative intervention between rural Latino children with asthma and their families, school-based nursing, and primary care providers, facilitated by the use of a smart phone based bilingual mobile app. The specific aims are to:

1. Produce and validate a Spanish translation of an existing asthma management app and evaluate its usability with Latino parents of children with asthma; and
2. Develop and evaluate a triadic, patient-centered asthma intervention preliminary protocol, facilitated by the bilingual mobile app validated in aim 1.

Eligibility Criteria:
Inclusion Criteria:

1) children self/family-identified as Hispanic/Latino or African American, 2) school-aged (5-18 years) and attends school within the Lancaster County School District, 3) has received a diagnosis of asthma from a health care provider and is taking a controller medication, and 4) parents/primary caregiver (e.g., grandparents, extended family) language of preference is Spanish or English.
A Family Centered Intervention to Promote Optimal Child Development

This is a randomized controlled trial aimed at assessing the effectiveness of a patient decision aid (PDA) and text message reminder in promoting early intervention referral completion when infants and toddlers are identified with a developmental concern in the pediatric medical home. Subjects will be randomized to one of two study arms- (1) intervention (2) control condition. Subjects in the intervention arm will watch a video PDA and will receive a text message reminder approximately 7 to 14 business days after enrollment if they agree to the early intervention referral.


Eligibility Criteria:
Inclusion Criteria:

* Parent-child dyads in which the child is age 0 to 36 months screening positive for developmental concern and receiving care at a practice within Children's Hospital of Philadelphia Pediatric Research Consortium (PeRC).
* Caregivers able to give permission (informed consent).

Exclusion Criteria:

* Primary language other than English
* Children already enrolled in early intervention
The Effects of Dietary Palmitic Acid Triacylglyceride Position on Bone Strength Parameters in Infants

The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on bone strength parameters.

InFatTM is an advanced basic-fat ingredient, which mimics the fat composition and properties of human milk fat and enabling optimal intake of the essential calcium and energy (in the form of fatty acids) and easy digestion. These benefits are the results of a unique fatty acid composition on the glycerol backbone, which ensure high level of palmitic acid at the middle (sn-2) position.

The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on bone strength parameters, anthropometric parameters, wellbeing and stool characteristics in term and preterm infants.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age above 32 weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination.
2. Birth weight appropriate for gestational age (AGA) using current CDC growth charts, and above 1750gr.
3. The mother had unequivocally decided not to breast-feed (in formula groups) or the mother had decided to breast feed (in human breast milk group).
4. The infant is apparently healthy.
5. Parental/ legal guardian written inform consent
6. Apgar after 5 minutes \>7
7. Enrolled within their first 14 days of life for term infants and first month of life for preterm infants
8. At enrollment: clinical stability and acceptable weight gain

Exclusion Criteria:

1. The infant suffer from a congenital or chromosomal disorder (Cystic fibrosis, Tracheomalacia, Tracheoesophageal fistula, major congenital heart disease, down-syndrome)
2. The infant suffer from neonatal morbidities:

   * Bronchopulmonary dysplasia (BPD)
   * Intraventricular Hemorrhage3-4 (IVH)
   * Necrotizing Enterocolitis (NEC)
3. Laboratory or clinical sings of Osteopenia
4. The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula)
5. The mother suffers from any disease or disability that may interfere with her ability to take care of her infant
6. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study
Efficacy and Safety of S18986 in the Treatment of Mild Cognitive Impairment Patients

The purpose of this study is to demonstrate a long term efficacy of S18986 versus placebo on episodic memory performance in patients with MCI


Eligibility Criteria:
Inclusion Criteria:

* Memory complaint
* Acetylcholinesterase inhibitors stopped at least 3 months before selection

Exclusion Criteria:

* Dementia
* Parkinson's disease
* Vascular disorder
* Depression
* Epilepsy
Comparison of Outreach Approaches to Increase Enrollment in a Healthy Cholesterol Study

This study aims to determine the effectiveness of 4 different recruitment techniques for enrollment into a cholesterol study. 2,000 people that meet initial eligibility criteria for the study will be randomized into one of 4 groups and will all receive the same recruitment letter inviting them to participate in the study by enrolling on an online platform. Group 1 will receive the recruitment letter in a normal sized envelope, Group 2 will receive the recruitment letter in an 8.5 x 11 inch envelope, Group 3 will receive a recruitment letter shipped via USPS priority mail and a Group 4 will receive a recruitment letter with the image of an Amazon gift card and told they will receive a $25 gift card if they enroll in the study. All other groups are told that they will receive a $25 check upon enrollment in the study.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes and or history of CVD
* LDL \> or = 130 mg/dl - measured during screening
* A prescription filled for statin medication within the last 12 months
* Medication Possession Ratio (MPR) \<80%
* CVS Caremark Beneficiary

Exclusion Criteria:

* Less than 18 years old
* Contraindication to further statin use or have suffered side effects from statins, such as myopathy
* Will not or cannot give consent
* History of active or progressive liver disease or abnormal liver function tests on baseline screening
* Currently participating in another clinical trial with related aims
* Co-morbidities likely to lead to death within a short-period
Management and Treatment of Patients With Severe Malnutrition in Intensive Care Unit: a Registry

Severe malnutrition can be seen as a low BMI, great weight loss, and even low levels of micronutrients. Current studies on severe malnutrition are mainly in patient with anorexia nervosa. The refeeding phase of these high-risk patients bears a further threat to health and potentially fatal complications (such as refeeding syndrome, infection and severe arrhythmia). The objective of this study is to investigate complications due to refeeding of patients with severe malnutrition, as well as their mortality rate, establish and modify the guideline for management of severe malnutrition in Peking University Third Hospital.

Severe malnutrition can be seen as a low BMI, great weight loss, and even low levels of micronutrients. Current studies on severe malnutrition are mainly in patient with anorexia nervosa. The refeeding phase of these high-risk patients bears a further threat to health and potentially fatal complications (such as refeeding syndrome, infection and severe arrhythmia).

Intensive care unit of Peking University Third Hospital (PUTH) has treated several patients with severe malnutrition successfully since 2008. Most of these patients had a BMI \< 10 (kg/m2) at admission. After admission, a multidisciplinary team, consisting of specialists in the field of intensive care, pharmacy, psychology, and physical therapy assessed all patients. Most of the treatment has been regarded successful with a significant BMI gain and little in-hospital mortality. Based on long-term clinical experience, as well as on evidence-based literature, PUTH nutrition group developed a guideline version 1.0 for the treatment of severe malnutrition in August, 2015.

The objective of this study is to investigate complications due to refeeding of patients with severe malnutrition, as well as their mortality rate, establish and modify the guideline for management of severe malnutrition in PUTH.

This is a single-center, ambispective cohort study. Patients who meet the inclusion and exclusion criteria will be included in our registry. As a non-intervention study, these information as below will be collected: reason for admission, relevant medical history, basic demographic characteristics,anthropometric and clinical data, specific nutrition support regimen and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe malnutrition, admitted to PUTH from JAN 2008. (Severe malnutrition is defined as a body mass index (ratio of weight in kg divided by height in m2) \< 13)
* Management and treatment are in accordance with guideline version 1.0 for the treatment of severe malnutrition in PUTH.
* Patients requiring intensive care unit management who developed life-threatening complications (such as severe fluid/electrolyte disorders, severe arrhythmia) or had single-organ/multiorgan dysfunction.

Exclusion Criteria:

* Presence of malignancy.
* Life expectancy of less than 24 hours
* Presence of advanced Acquired Immunodeficiency Syndrome (AIDS)
* Aged \< 16 years
Graded Exposure (GEXP) in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I)

Background:

Research on the treatment of CRPS-I, as described in the Dutch evidence based treatment guidelines (Richtlijn Complex Regional Pain Syndrome type I, 2006), mainly showed improvement at the level of pain and coping with pain. Only little improvement in functional restoration was found. Research in other pain populations such al neck- and back-pain patients has shown that pain related fear contributes to the development of functional disability. GEXP in vivo which aims on systematically reducing fear of movement, shows promising results in CRPS-I patients (de Jong et al., 2005).

Objective:

The objective of the proposed project is to compare the effectivity of GEXP in vivo with that of standardized physiotherapy in CRPS-I patients with pain related fear.

Design:

The study concerns a single blinded, single center, randomized clinical trial. The treatment will be preceded by two pre-measures. After treatment there will be one post-measurement and 3, 6 and 12 month follow-up measurements.

Population:

The study population will consist of chronic CRPS-I patients between 18 and 65, with pain related fear (PHODA-LE-score ≥ 35 and PHODA-UE-score ≥ 32).

Intervention:

The two interventions that will be compared are GEXP in vivo (de Jong et al., 2005) and standardized physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo en Goris (1999). The GEXP in vivo comprises 17 sessions of one hour, the physiotherapy treatment of 34 sessions of 30 minutes. Both treatments will be given over a period of 17 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis CRPS-I according to IASP criteria.
2. Pain related (PHODA-LE-score ≥ 35 and PHODA-UE-score ≥ 32)
3. Age between 18 and 65.
4. Rehabilitation treatment has been indicated.

Exclusion Criteria:

1. Pregnancy.
2. Insufficient fluency in Dutch.
3. Generalized pain syndrome.
4. Dystonia.
5. Sympathectomy of the affected extremity.
6. Psychopathology
7. Involvement in a claim regarding the disease.
8. Substance abuse.
9. Symptoms on both upper or both lower extremities.
Financial Incentives to Promote Stimulant Abstinence in a Community-Based Syringe Exchange Program

The goal of this randomized control pilot study is to learn about a financial incentives intervention among individuals who use stimulants and take part in a community-based syringe exchange program. The main question it aims to answer is how financial incentives for not using stimulants will impact stimulant use. Participants in the experimental group will have the opportunity to earn financial incentives for providing a negative urine sample for stimulants using a point-of-care test, which indicates abstinence from stimulant use, along with health education on the health risks of stimulant use and substance injection. Researchers will compare the experimental group to the control group who will receive health education on the health risks of stimulants use and injection.

The investigators are proposing a two condition, parallel groups, randomized control pilot study to evaluate the efficacy of a financial incentives intervention among individuals who use stimulants and take part in a community-based syringe exchange program. The study design will include recruiting service recipients who already participate in programs offered by a syringe exchange program.The experimental group will have the opportunity to earn financial incentives contingent on providing a negative urine sample for stimulants using a point-of-care test, which indicates abstinence from stimulant use, in addition to health education on the health risks of stimulant use and substance injection. The control group will receive health education on the health risks of stimulants use and injection. All participants will participate in their syringe exchange services as usual. The investigators chose the health education as the control because participants across both conditions already receive the services provided by the syringe exchange program. Moreover, this control condition will help control for a potential type of between-groups variability.

Eligibility Criteria:
Inclusion Criteria:

* be 18 years or older
* report using stimulants in the past 30 days
* meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis for stimulant use disorder at a moderate or severe level (i.e., 6 or more of the 11 criteria)
* participation in services at syringe exchange program

Exclusion Criteria:

* failure to meet one or more inclusionary criteria
* individuals who are cognitively impaired by their drug use or psychiatric conditions that could preclude informed consent