cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of LATISSE® in the Augmentation of Eyelashes of Korean Subjects

This study will evaluate the safety and efficacy of LATISSE® (bimatoprost 0.03%) in the augmentation of eyelashes in Korean women.


Eligibility Criteria:
Inclusion Criteria:

* Eyelash prominence assessment of minimal or moderate
* Of Korean ethnicity

Exclusion Criteria:

* Any eye disease or abnormality
* Any ocular surgery or use of any eyelash extension or eyelash growth products within 3 months
* Any permanent eyeliner within 5 years
* Eyelash implants of any kind
* Eyelash tint or dye application within 2 months
* Use of any treatment that may affect hair growth within 6 months
The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants

Music has been consistently shown magic power in brain plasticity. Several study proved music can influence electronic activity of preterm infants' brain, while none study covered region oxygen metabolic. The investigators aim to discover the effects of music therapy on near-infrared spectroscopy and electroencephalogram in premature infants.

Previous studies of music therapy have made some achievements for adult Parkinson's disease, schizophrenia, depression, anxiety, post-traumatic stress and pediatric autism spectrum disorders. For newborns, studies mainly focused on the effects of basic vital signs, feeding and pain score decreasing. So far, no studies evaluating the effect of music therapy on brain oxygen metabolic and electronic activity.

Eligibility Criteria:
Inclusion Criteria:

* Postmenstrual age of 32-36+6 weeks.
* Appropriate weight for gestational age.
* To have signed an informed consent to participate in the study.
* Have reached clinical stability.

Exclusion Criteria:

* Have nervous system diseases or obvious nervous system symptoms.
* Severe congenital diseases.
* The maintenance of sedative or analgesic drugs.
* Support with mechanical ventilation.
Lyske Trial (Danish) Groin Trial

To examine the effect of a specific training programme towards groin injuries in male footbal players. To evaluate the effect on other football related injuries as well. To examine any possible relations between various possible predictors such as experience, age, hypermobility and others, and the risk of sustaining inujries during football.


Eligibility Criteria:
Inclusion Criteria:

male adult football players playing in the participating clubs in the study period

-

Exclusion Criteria:

* under 18 years groin injury at the start of the study
Adolescent and Young Adult Survivor Transition

The purpose of this study is to help adolescents and young adult cancer survivors address their psycho-social needs during the transitional period. The transitional period begins at completion of cancer treatment and continues throughout that first year. Patients often report this period can be difficult and distressing in many areas of life. This study will use a simple tool to measure, on a regular basis, the level of distress a young adult may be feeling. Based on this assessment additional mental health support and intervention can be recommended to help cancer survivors cope and enhance their feelings of well-being.

Study Objective:

To establish a successful distress based intervention program for adolescent and young adult survivors in the transition period.

Study Design and Methods:

The type of design for this study is a feasibility pilot study with repeated measure, within group quantitative design. There is no randomization for this study. The patient will be assessed; at baseline, upon completion of therapy, and at regular three month intervals for the first year, for a total of five assessments. After receiving a referral a member of the AYAST team will contact the patient and set up the initial visit.

Eligibility Criteria:
Inclusion Criteria:

* Completed cancer treatment within the past three months of all cancer types and stages
* Signed, written consent

Exclusion Criteria:

* Have not completed cancer treatment within the past three months
Primary Intervention With Mucosal Insulin

A dose with proven drug bioavailability to the immune system for use in a phase II/III primary T1DM (type 1 diabetes) vaccination trial (POINT study) in genetically at risk subjects.

Study Design Randomized, placebo-controlled, double-blind/double-masked, multi-center, dose escalation primary intervention pilot study.

Accrual Objective 25 (3:2 randomization to active and control arms)

The objective of this study is to determine the feasibility, safety and bioavailability of oral insulin in children with high genetic risk for T1DM in a dose escalation primary intervention pilot study.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 2 years to 7 years who:

   * Have a multiplex first degree family history of T1DM (both parents, parent and sib, or two sibs);
   * Type 1 diabetes susceptible HLA DR4-DQB1\*0302 or DR4-DQB1\*0304 haplotype and

   None of the following HLA DR or DQB1 alleles:
   * DR 11
   * DR 12
   * DQB1\*0602
   * DR7-DQB1\*0303
   * DR14-DQB1\*0503 or
   * Have a sibling with T1DM;
   * Identical by descent for the HLA DR3/DR4-DQ8 genotype with their diabetic sibling;
2. Islet autoantibody negative at time of recruitment.

Exclusion Criteria:

1. Children with any kind of congenital or acquired chronic disease that potentially interfere with the study objectives.
2. Prior or current participation in another intervention trial.
3. Chronic oral steroid use and/or other chronic oral immunosuppressant
Treatment Interruption of Natalizumab

This is a randomized, rater blinded trial in patients who interrupt treatment with natalizumab with or without being treated with other immunomodulatory drugs, or continue treatment with natalizumab.

The main purpose of this study is to find out the following, when participants stop taking natalizumab for 24 weeks:

* when MS symptoms return, and
* if other drugs for MS may help control MS symptoms during the natalizumab-interruption period.

This study will also explore how quickly the effects of natalizumab return after resuming natalizumab dosing.


Eligibility Criteria:
Major criteria include:

* A diagnosis of a relapsing form of MS
* Treatment with natalizumab according to locally approved prescribing information
* Other protocol defined inclusion/exclusion criteria may apply
A Study to Compare Two Formulations of LY3209590 in Healthy Participants

The main purpose of this study is to compare the two formulations of LY3209590 in healthy participants. Study participants will be administered each formulation at separate study visits. Blood samples will be taken to compare how the body handles study drugs. The information about any adverse effects experienced will be collected and the tolerability of LY3209590 will also be evaluated.

Screening is required within 28 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 184 days including screening.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants who are overtly healthy as determined by medical evaluation
* Have a body weight of 45 kilograms or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive
* Contraceptive use by participants should be consistent with local regulations

Exclusion Criteria:

* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Have known allergies to LY3209590, related compounds, or any components of the formulation
* Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction
* Have an abnormality in the 12-lead electrocardiogram (ECG)
* Are lactating or pregnant
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma

This trial is conducted in the United States of America (USA). The purpose of this study is to evaluate the treatment of Recombinant Faction VIIa in Patients with Severe Bleeding Due to Trauma

Please note that this trial and trial F7TRAUMA-1711 (NCT00184548) have been merged.


Eligibility Criteria:
Inclusion Criteria:

* Trauma injury (blunt and/or penetrating) with evidence of active torso hemorrhage refectory to standard treatment
Using Shared Decision Making to Improve Kidney Transplantation Rates

The goal of this clinical trial is to increase shared decision-making between dialysis providers and patients in order to increase patients' probability of transplantation and to reduce socioeconomic/racial disparities in access to kidney transplantation.

Participants will receive educational material over the course of 4-6 months about different aspects of the kidney transplant and waitlisting process.

Kidney transplantation is the preferred treatment choice for patients with end stage kidney disease (ESKD), yet only a small proportion of patients with incident ESKD are counseled about their transplant options. Often, a smaller minority of patients reach the transplant waitlist in a timely manner. Increasing the likelihood of transplantation for patients with ESKD can lead to longer survival, better quality of life, and reduced costs of care.

The kidney transplant and waitlist process is a complex and multi-step process that occurs over an extended period of time. This process involves transitions of care between multiple providers and requires patients to be proactive in their medical evaluations.

This study will deliver educational materials to dialysis care teams and provide quarterly, personalized informational letters to patients, with the aim of increasing shared decision-making between patients and providers by giving them the information needed to initiate conversations about kidney transplantation.

Eligibility Criteria:
Inclusion Criteria:

* On a waitlist or undergoing an evaluation at the Columbia University/New York Presbyterian Hospital (CU/NYPH) Transplant Center or at the Cleveland Clinic (CC)
* Receiving hemodialysis at one of the following dialysis clinics:

  * Fresenius Kidney Care City Dialysis
  * DaVita Kidney Care Haven Dialysis
  * DaVita Melrose Dialysis
  * DaVita Highbridge Dialysis
  * Rogosin Institute East Side Dialysis Unit
  * Rogosin Institute West Side Dialysis Unit

Exclusion Criteria:

* Speaking a language other than English or Spanish
* Younger than 18 years of age
A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.

This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* solid neoplasm, non-Hodgkin's lymphoma or Hodgkin's lymphoma;
* metastatic or locally advanced disease, not curable by any currently available treatment.

Exclusion Criteria:

* severe, uncontrolled systemic disease;
* patients who require treatment with glucocorticoids or immunosuppressive treatment within last 6 months;
* patients with diabetes mellitus.
Spider Phobia Opposite Action Treatment Study

This study tests the effectiveness of exposure therapy for fear of spiders as enhanced by the use of antagonistic or opposite actions during treatment. The goal of the study is to compare the efficacy threat-relevant opposite actions and threat-irrelevant opposite actions in extinguishing fear.

This study tests whether exposure therapy for fear of spiders can be enhanced with the use of opposite actions, which are actions opposite to fear-related action tendencies. The investigators will test two sub-types of opposite actions (a) threat-relevant opposite actions, which are actions antagonistic to specific threats associated with spider phobia, and (b) threat-irrelevant opposite actions, which are actions antagonistic to the fear response, but unrelated to specific threats associated with spider phobia. This exposure therapy enhanced with opposite actions will be compared with two control groups: standard exposure therapy and non-specific anxiety treatment (biofeedback relaxation training).

Individuals between the ages of 18-65 with elevated fear of spiders are randomly assigned to one of four treatment conditions (1) biofeedback relaxation training, (2) standard exposure therapy, (3) exposure therapy with threat-relevant opposite actions, and (4) exposure therapy with threat-irrelevant opposite actions. All participants undergo an online prescreen and a face-to-face screening assessment to determine eligibility and baseline (pre-treatment) symptom severity. Participants additionally complete assessments directly after treatment (post-treatment), and approximately two weeks after treatment (follow-up). The pre-treatment assessment occurs on the same day as treatment, the post-treatment assessment occurs during the treatment visit as soon as the treatment procedure is complete, and the follow-up assessment occurs within a window of 14-21 days after the completion of treatment. Participants complete two behavioral approach tests (in the treatment context and in the generalization context) at pre-treatment, post-treatment, and follow-up. Participants complete a battery of self-report questionnaires at pre-treatment and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* At Prescreen:

  * Total score of greater than or equal to 70 on the Fear of Spiders - Questionnaire (with higher scores indicating higher fear levels).
  * Indicates ongoing fear of spiders and inability to complete close approach towards spiders on brief questionnaire.
* At Screening visit: inability to complete close approach toward spiders as determined by the treatment context and generalization context Behavioral Approach Tests

Exclusion Criteria:

* Currently receiving psychotherapy for spider phobia
Online Food and Beverage Labels and Vending Machine Selections

The aim of this study is to compare the impact of 5 different types of front of package (FOP) food and beverage labels: 1) calorie labels \[control\], 2) green labels on healthy foods, 3) red/yellow/green labels on less healthy/moderately healthy/healthy foods, 4) physical activity calorie equivalent labels, and 5) "High in" nutrient warning labels) on consumers' beverage and snack selections.

This project involves an online randomized experiment. We are working with an external survey company that will recruit 8,000 participants to complete an online survey in which they will be randomized to one of the five different label conditions: 1) calorie labels (control condition); 2) single green traffic light labels (on healthy foods); 3) multiple traffic light labels (red traffic light labels applied to less healthy foods, yellow applied to moderately healthy foods, and green on healthy foods); 4) physical activity labels (calorie content displayed in terms of physical activity equivalents); 5) "High in" warnings (applied to all products exceeding thresholds for calories, saturated fat, sugar, or sodium content). Participants will be instructed to select products to purchase in a mock vending machine. After purchasing their products, they will be asked to answer questions about their perceptions of the different labels.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be US adults
* Ages 18 or older
* With an over-sample of adults with lower educational attainment (some college or less)

Exclusion Criteria:

* Younger than 18
* Non-US
* Educational quota filled
MoTHER Buddy Program

The purpose of the 12-week study is to determine if competing a physical activity program with a buddy helps increase daily physical activity when compared to completing the same physical activity program without a buddy.


Eligibility Criteria:
Inclusion Criteria:

1. Physically inactive,
2. having at least one child aged less than 5 years,
3. having at least one family member or friend who can support physical activity engagement and reside in the same community,
4. having access to computer and phone, and
5. overweight/obese (Body Mass Index: 23 kg/m2 or more)

Exclusion Criteria:

1. Having known medical conditions that prevent regular physical activity and
2. current participation in other lifestyle modification programs
Supporting Tailored And Responsive PrEP in Rural North Carolina

This project consists of two phases to be completed over five years. Phase 1 (Aims 1 and 2) will be completed during Years 1-3 (R61). The Phase 1 study is a randomized trial of a multilevel HIV Pre-Exposure Prophylaxis (PrEP) intervention strategy in rural and peri-urban North Carolina sexually transmitted infection (STI) clinics, with primary outcome of PrEP uptake within 3 months of an index STI clinic visit.

Participants will be randomized 1:1 to an intervention or control condition. Participants enrolled in the intervention arm will receive a multilevel intervention with three components: a PrEP Navigator to facilitate linkage to PrEP services and completion of applications for health insurance/drug assistance; a Digital Health Intervention (DHI) platform (HealthMpowerment) - a HIPAA-compliant evidence-based DHI that provides interactive educational resources, social support, and tools for developing PrEP behavioral skills and self-efficacy; and referral to Telehealth PrEP services as an option for linking to PrEP care.

Control arm participants will receive the standard PrEP referral services available at the STI clinic setting where they were recruited. They will also receive linkage to a limited version of the DHI, with basic PrEP resources and information.

Eligibility Criteria:
Inclusion Criteria:

* Report sexual activity with a male in the past 12 months
* Received HIV testing within 90 days pre-enrollment and not known to be HIV-positive at screening/enrollment by self-report
* Age 18-39 years
* Have daily smartphone access
* Be English speaking
* Deny current PrEP use

Exclusion Criteria:

* Confirmed prior HIV-positive diagnosis
* Prior PrEP use (oral PrEP or injectable PrEP) within the last 3 months.
The Early Stockholm Obesity Prevention Project in China

This is a cohort study where families with infants are followed closely for three years. It aims to assess if parental weight status (normal weight vs. overweight/obesity), their physical activity and eating habit will influence their young children's growth and be helpful in childhood obesity reducing.

The aimed 300 families are invited with half parents in high risk group (one of the parents with BMI\>=28 or both 28\>BMI\>=24) and half in low risk group (both parents with BMI\<24 or one parent 28\>BMI\>=24) living in Wuhan City. Maternal and paternal prepregnancy weight and height are recruited through the Children Systematic Health Management System before the child's first birthday. After getting an oral agreement, a later on family visit will be done by trained staffs. The home visit contains anthropometrics measurement, including weight, height, head circumference, abdominal circumference for both parents and children and blood pressure for parents; it also has some questionnaires that have children's condition during the first years, the caring status, parents' characteristic information, the eating, physical activity and sleeping habits for both parents and children, children's seven day 24 hours' sleeping record in the coming week; at the same time, objectively measured physical activity for parents and children will be done for seven days with accelerometers. The annual visit will range 15 days before or after the children's birthday, and this will begin from the children age one and followed up to aged three.

Eligibility Criteria:
Inclusion Criteria:

* a child in the household being 1 year old (±3 months) at the time of recruitment;
* the parents were Wuhan registered residents;
* the child had no chronic health condition affecting growth, physical activity or eating habits.

Exclusion Criteria:

* none.
Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis

This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have plaque-type psoriasis


Eligibility Criteria:
Inclusion Criteria:

* patients with moderate to severe plaque type psoriasis for at least 6 months before randomization
* patients eligible for systemic therapy with inadequately controlled psoriasis

Exclusion Criteria:

* forms of sporiasis other than plaque type psoriasis
* previous exposure to secukinumab, ustekinumab, or other biologic drugs targeting (IL)-17A or IL-17RA

Other protocol-defined inclusion/exclusion criteria may apply
Advanced Harmonic Generation Microscopy for Treatment Assessment of Cutaneous Pigmentary Disorder

In this study, the investigators demonstrated that in vivo THG microscopy can differentiate Solar lentigos (SL), Nevus zygomaticus(NZ) and normal skin based on the optical nature of melanin. This THG-based procedure provides a valuable tool for noninvasive determination of third-order nonlinear susceptibility of melanin within the skin. It can also provide real-time histopathology information for treatment follow-up, without performing an invasive skin biopsy.

A nonrandomized, controlled, split-face comparative study was conducted to compare the efficacy and safety between quality-switched ruby laser (QSRL) and 532-nm picosecond Nd:YAG laser (532-PSNYL for SL, 1064-PSNYL for NZ) in the treatment of solar lentigo clinically and histologically by harmonic generation microscopy (HGM). After baseline photography and in vivo harmonic generation microscopy (HGM) imaging, QSRL and 532-PSNYL or 1064-PSNYL therapy for solar lentigos and nevus zygomaticus on the left and right side of the face, respectively, were performed for each subject. The subjects underwent follow-up assessment at weeks 3 and 6.

Statistical analysis: All data gathered went through decoding and were analyzed by blinded evaluators using SPSS software (version 20.0; IBM, Armonk, NY). All tests were two-sided. A P value of \< .05 was considered to be statistically significant.

Eligibility Criteria:
1. Main inclusion criteria:

1. Subjects are aged 20 to 85 years at Screening, and can be either sex.
2. Subjects are Fitzpatrick skin type III or IV.
3. Subjects must have been diagnosed to have solar lentigos or nevus zygomaticus, which are larger than 4 mm in diameter on both sides of the face.

2. Main exclusion criteria:

1. Subjects have previous treatments on the solar lentigos or nevus zygomaticus.
2. Subjects have a history of adverse reaction to laser treatments, including allergy to topical anesthesia application.
3. Subjects have a history of chronic inflammatory disorder such as atopic dermatitis on the face.
4. Subjects are pregnant or breast feeding.
5. Subjects have frequent sun exposure (≥4 hours per day).