cyrilzakka/clinical-trials huggingface dataset:
A Study to Compare Subject Comfort During and After Injections With the Study Products and the Safety of the Non-FDA Approved Product for the Correction of Nasolabial Folds (NLFs)

The purpose of this research study is to compare subject comfort during and after injection with NADGL and Captique® Injectable Gel, in the nasolabial folds. Captique® is an FDA-approved product without lidocaine and is manufactured by Genzyme Biosurgery (Ridgefield, NJ). NADGL is a new product (not FDA approved) with lidocaine and is also manufactured by Genzyme Biosurgery. We do not know which of these treatments results in less pain during and after injection. The safety of NADGL is also being studied.

45 subjects are planned; a portion of these subjects will have skin of color

Eligibility Criteria:
Inclusion Criteria:

* bilateral nasolabial folds with severity score of 3 or 4 on the 6 point scale.

Exclusion Criteria:

* pregnant/lactating women
* subjects who have an allergy to lidocaine or other amide-type anesthetics
An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants

This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body mass index 18.0 to 32.0 kg/m2
* Weight ≥ 50 kg

Exclusion Criteria:

* Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease
* History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
* Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
* History of administration of live vaccines within 60 days before screening
* Any history or risk for tuberculosis (TB)

Other protocol defined inclusion/exclusion criteria could apply
ACtive Children Enhance LEaRning and AttenTION: A Randomized Controlled Trial (RCT)

The goal of this clinical trial is to test the effectiveness of sport-based physical education (PE) curriculum on activity behaviors (moderate to vigorous physical activity and sedentary behavior), executive functions, and academic performance in elementary school-aged children, particularly among low-income ethnic minorities. The main questions it aims to answer are:

* Whether a school-based sport program can improve child engagement in school-time moderate-to-vigorous physical activity (MVPA) and total daily MVPA, compared to a control group (standard PE class)?
* Whether a school-based sport program can improve child executive functions and academic performance, compared to a control group (standard PE class)?

Participants randomized to receive the ACtive Children Enhance LEaRning and AttenTION (ACCELERATION) intervention (treatment) received

* 45-minute weekly for 10 weeks soccer (ball mastery exercises) curriculum led by trained PE teachers during the school PE lesson time.
* Homework required practicing learned ball mastery skills daily for 15-20 minutes at home. A required ball was provided to them.
* Virtual parent workshops, which required the attendance of parents of study participants to improve their understanding of all about the program

Researchers will compare the control group, who received a regular PE class curriculum, to see if there are any differences in child activity behaviors, executive functions, and academic performance.


Eligibility Criteria:
Inclusion Criteria:

1. Any student enrolled in 3rd or 4th-grade classes were eligible to participate in the study.
2. Participation in an extracurricular sports activity wasn't an exclusion criterion for this study.

Exclusion Criteria:

1. Students were excluded if they had serious physical (e.g., asthma, heart diseases), developmental (e.g., autism, attention-deficit hyperactivity), or learning (e.g., dyslexia, dyscalculia, dysgraphia) disorders that prevented them from participating in intervention activities
2. Students who participated in a physical activity intervention within the last 6 months were excluded.
Sensorimotor Exercises in Virtual Reality Platform in Individuals With Human T-lymphotropic Virus

Testing the effectiveness of an exercise protocol engines sensory performed through a virtual reality platform in individuals infected with HTLV-1

Crossover randomized clinical trial to be conducted with people having a previous diagnosis of HTLV-1, they can remain in standing position without assistance. They will be excluded from those presenting amputation of the lower limbs, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other neurological disorders associated and those that are experiencing difficulty in understanding the assessment tools used. They will also be recruited to a comparative group, healthy individuals, matched for sex, age and education level. It will be performed three assessments, before randomization, after 10 weeks and after 20 weeks, which will be evaluated in balance, functional mobility, gait and posture. The participants infected with HTLV-1, will be divided into two groups by random distribution, a group will begin the treatment protocol with video game immediately after the first evaluation and the other after ten weeks, with the crossing of the groups . Concealment of allocation will be guaranteed to the examiners who will have no contact with the physiotherapist who will apply the exercise protocol and the team member responsible for drawing. Patients will also be instructed to maintain confidentiality of the entry in the exercise program to other patients and examiners.

Eligibility Criteria:
Inclusion Criteria:

* people having a previous diagnosis of HTLV-1, which can remain in standing position without assistance.

Exclusion Criteria:

* amputation of the lower limbs, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other neurological disorders associated and those that are experiencing difficulty in understanding the assessment tools used.
Shared Medical Appointments to Improve Outcomes in Adolescents With Type 1 Diabetes

Adolescents and emerging adults with type 1 diabetes (T1D) experience significant struggles with their diabetes management resulting in worsening diabetes health and increased complications. This population's declining well-being occurs during a time when they should be at their healthiest and enjoying multiple exciting life transitions. Their worsening diabetes management is complicated by the fact they are also learning how to become more independent from their family in preparation for eventually leaving home. Furthermore, the number of people under 20 years of age diagnosed with T1D has increased dramatically over the past 10 years giving rise to increased concern about providing care to this population.

The Team Clinic Intervention is an innovative clinical care approach to address the medical and developmental needs of adolescents with T1D and their families. A group medical appointment format will be used for routine diabetes clinic visits in middle school and high school adolescents with T1D. Parents of these patients will be participating in their own group during these clinic visits. The Team Clinic model incorporates developmentally tailored peer support and novel learning tools, (e.g. games, physical activity, and/or interaction through Internet resources, e.g. blogs, forums) into the shared medical appointment design.

The goal of Team Clinic Intervention is to improve medical and psychological outcomes in adolescents with T1D and their parents. The study will investigate, in a randomized controlled trial, the efficacy of a novel clinical care model that addresses the unique developmental strengths and weaknesses of the T1D adolescent population. The Team Clinic format streamlines clinical care delivery to this often-challenging patient population without placing additional burden on youth, families, or clinics because the intervention will be completed during routine diabetes care visits. Moreover, the Team Clinic approach maximizes the benefits of peer support by delivering care in a group format to address the sense of isolation that teens and families coping with chronic illness often feel.

If successful, the Team Clinic Intervention will not only positively impact adolescents with T1D and their families, but it could be used as a model of care for other adolescents with chronic medical conditions struggling to remain involved and invested in their medical care. Team Clinics may be one approach to successfully engaging adolescents in their diabetes care prior to their transition away from home, which will help them remain invested and active in their medical care through adolescence and young adulthood.


Eligibility Criteria:
Inclusion Criteria:

* T1D \>1 year duration, 6th-10th grade

Exclusion Criteria:

* non-English speaking
* severe behavioral, developmental, or psychological diagnosis making group participation difficult
Behavioural Therapy With Checklist for Overactive Bladder

The aim of this study is to investigate the efficiency of this newly-established checklist for overactive bladder (OAB) and whether determinate to adherence and persistence rate of combination of behavioural therapy and anticholinergic medications in patients with OAB.

Overactive bladder (OAB) can worsen quality of life but it is not life-threatening condition. Although OAB medications effectively decrease disturbing symptoms of OAB, there are a lot of adverse side effects such as dry mouth, cognitive changes, constipation, urinary retention, blurred vision and dyspepsia. Therefore, guidelines have firstly recommended behavioural therapy which are noninvasive and not linked with adverse side effects. These behavioural recommendations include an advice on fluid balance, bladder retraining, urgency suppression or normal voiding techniques, pelvic floor muscle training, caffeine reduction, dietary changes, weight loss and other life style changes to improve lower urinary tract symptoms of OAB.

Educational leaflets, verbal or audio-visual instructions and trainings for behavioural therapy have been recommended for patients with OAB, however, to date these beneficial instructions have not been documented as a written checklist. Therefore, they were collected and developed as a written checklist to instruct the patients. The aim of this study was to investigate the efficiency of this newly-established checklist for OAB and whether determinate to adherence and persistence rate of combination of behavioural therapy and anticholinergic medications in patients with OAB.

Eligibility Criteria:
Inclusion Criteria:

Patients with

* \>8 micturitions,
* \>1 nocturia,
* \>6 urgency or
* \>3 urgency urinary incontinence episodes per 24 h according to 3-day bladder diary.

Exclusion Criteria:

* active urinary tract infection,
* a maximum flow rate of 15 ml. per second or less at least 2 uroflow studies,
* residual volume of 100 cc or more,
* any medications for OAB, benign prostatic obstruction,
* polyuria (\>3 l per 24 hour),
* endocrinological disease such as diabetes mellitus or diabetes insipidus which can cause polyuria,
* neurological or psychological disease disease,
* prostate or bladder cancer, renal disease, hypertension, genitourinary or congenital abnormality,
* history of transobturator or transvaginal tape or pelvic organ prolapse surgery
* pelvic radiation or surgery
BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus

The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral hypoglycemic agents.


Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese men and women with type 2 diabetes mellitus that is managed with oral anti-hyperglycemic agent(s).
* Body mass index (BMI) 27 to 45 kg/m2, inclusive.
* Ability to complete a 1 year study

Exclusion Criteria:

* Pregnancy
* Use of insulin in any form, exenatide (Byetta) or pramlintide (Symlin) within 3 months prior to screening
* History of symptomatic heart valve disease
* Serious or unstable current or past medical conditions
Nutrition and Obesity in Under-Represented Populations: Food Insecurity Research to Advance Science and Improve Health

Food insecurity is associated with obesity in children, and childhood obesity leads to long term health consequences. While existing research shows that food benefit programs reduce food insecurity, little is known about the mediating factors between food benefit programs and child health. The purpose of this study is to understand if the resolution of food insecurity in young children with early onset obesity can improve body mass index (BMI) over one year, and if so, by what mechanisms. The investigators will conduct a randomized comparative effectiveness study among infants (n=228) aged 12 months at risk for food insecurity and deliver two different food security interventions. Both will provide families with $50/week for one year of study enrollment. The first group will receive this as an unrestricted cash benefit ("cash benefit group") and the second group will receive this as a benefit in the form of weekly grocery purchases with the support of a trained nutrition expert to guide healthy grocery purchasing ("grocery benefit group"). The investigators will also construct a contemporary comparison cohort of infants meeting the inclusion/exclusion criteria from the electronic health record, using propensity score matching to allow comparisons between both intervention groups and usual care. The primary endpoint is difference in BMI at 12 months post-enrollment (24 months of age). Secondary outcomes include measures of nutrition, food security, electronic health record data related to general child health, and other factors related to parental stress and unmet social needs. Patients will have the opportunity to participate in post-study interviews to report on intervention satisfaction, and facilitators and barriers of infant feeding. Data analysis will be conducted by a trained statistician (Duke Biostatistics, Epidemiology, and Research Design; BERD) and will employ a two-means test for a repeated-measures design. The benefits to participants outweigh the minimal risks of loss of privacy, and confidential information will be managed carefully to minimize this risk.


Eligibility Criteria:
Inclusion:

* Aged 9-12 months and their primary caregiver "parent".
* Medicaid and WIC-eligible (proxy for "at risk for food insecurity")
* World Health Organization BMI ≥ 85%ile at current or most recent encounter (early-onset obesity) OR ≥ 20 pounds at 9 months old.
* Caregiver speaks either English or Spanish as their primary language.
* Infant was born as a singleton infant.

Exclusion:

* Diagnosed with monogenic obesity.
* Plans to move from the area in the next 12 months.
* Parent is currently pregnant.
Tranexamic Acid During Excisional Burn Surgery

The purpose of this study is to access the efficacy of the drug tranexamic acid in reducing blood loss during burn excision surgery.

This study is a double-blinded, randomized placebo-controlled trial. After informed consent patients will be randomized in either the placebo or the tranexamic acid group (1500 mg). The intervention will be conducted during burn excisional surgery. First, the participant with be anesthetized, whereafter the study medication is administered.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for burn excisional surgery
* An expected blood loss of ≥250ml based on the estimation by the performing surgeon on the basis of: (1) ≥ 2 % body surface area excision planned (100-200 cc / % total body surface area, (2) operation technique used (some techniques show more blood loss than others), (3) time after burn trauma (i.e. expected healing)
* ≥18 year
* informed consent of patient or legal representative
* Patients or legal representative should have enough knowledge of Dutch to provide informed consent

Exclusion Criteria:

* Patients with a recorded coagulopathy in their history
* The use of anticoagulants (except acetylsalicylic acid or (intensive) prophylaxis low molecular weight heparin \>12 hours before surgery)
* Severe kidney failure (creatinine \>500 μmol/L)
* Allergy for tranexamic acid
* Diagnosis of acute venous-/arterial thrombosis within 3 months before inclusion
* Diffuse intravascular coagulation (based on the diffuse intranasal coagulation-score \>5)
* Pregnancy
* Active breastfeeding
* History of epilepsy
The Effects of Age on Wound Healing on Free Gingival Graft Surgery in the Treatment of Attached Keratinized Gingival Deficiency by Determining Clinical and Biochemical Outcomes

This study aimed to assess the effects of age on wound healing on free gingival graft (FGG) surgery in the treatment of attached keratinized gingival deficiency by determining clinical and biochemical outcomes.

Aim of this study was to evaluate the effect of age on clinical and biochemical healing outcomes on FGG surgery in the treatment of attached keratinized gingival deficiency (≤2 mm) at mandibular anterior region. A total of 30 systemically healthy patients, divided into two groups and planned for FGG operations, were included in this study. These groups are; Group l : 15 patients in the age range of 20-35, group 2: 15 patients in the age range of 50-65. Gingival crevicular fluid and wound fluid samples were taken from these patients to analyze VEGF, EGF and TGF-B1 levels by ELISA. Wound fluid samples were taken baseline, 4,7, and 14 days after surgery.

Clinical parameters included measurement of probing depth (PD), clinical attachment level (CAL), bleeding of probing (BOP), plaque index (PI), gingival index (GI) at 6 sites per tooth except the third molars were measured at baseline and l, 3 and 6 months after surgery. Keratinized gingiva width, keratinized gingiva thickness of the operation sites were measured baseline and 1,3 and 6 months after surgery. Vertical dimension of the graft, horizontal dimension of the graft, graft thickness were measured at baseline and 1,3,6 months after surgery. Graft area measurements were calculated on standard photographs by a Java-based analysis program (ImageJ, National Institutes of Health, Bethesda, MD) to determine the shrinkage rate of the grafts. The graft shrinkage ratio was calculated as the difference between baseline to 1-month, baseline to 3-months, baseline to 6-month graft site value. Data were analyzed using appropriate statistical tests.

Eligibility Criteria:
Inclusion Criteria:

* having ≤2mm of keratinized gingiva in at least 1 mandibular anterior tooth
* periodontally healthy with full-mouth bleeding and plaque score ≤ 10%
* no use of any drugs that will affect periodontal tissue health and healing process
* absence of any systemic condition or illness

Exclusion Criteria:

* smokers
* previous periodontal surgery
* a pathology in the apical region of the tooth
* pregnancy, lactation
A Study of Human Monoclonal Antibodies, BRII-196 and BRII-198

The aim of this phase 2 study is to evaluate the safety and efficacy of single dose IV infusion of BRII-196 and BRII-198 given as combination therapy in patients with severe COVID-19, and mild to moderate COVID-19 and asymptomatic carrier.


Eligibility Criteria:
Inclusion Criteria:

* Subject ≥ 18 years, signing the informed consent.
* SARS-CoV-2 infection by PCR ≤ 7 days
* One or more of COVID-19 related symptoms or measured fever present within 48 hours prior to study entry (subjects with mild-moderate COVID-19)

Exclusion Criteria:

* Recurring COVID-19 patients
* Subjects with any unstable conditions, a history of significant hypersensitivity, or known allergy to components of the investigational agent
* Receipt of convalescent COVID-19 plasma, SARS-CoV-2 mAb treatment, SARS-CoV-2 vaccine, or other investigational treatments prior to study entry
Study of T-PRED(TM) Compared to Pred Forte(R) II

Study of T-PRED(TM) Compared to Pred Forte(R)

This study was a multi-center, randomized, double-masked, bioequivalence study. A total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with T-PRED or Pred Forte in the first eye undergoing cataract extraction and the aqueous humor sampling time point.

The investigator determined which eye was clinically suited for the first operative procedure; treatment of this eye was randomized to either T-PRED or Pred Forte. The second eye received the other study treatment (RP if the first eye received T-PRED; T-PRED if the first eye received Pred Forte) at the time of the second cataract extraction.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older

Exclusion Criteria:

* No active or adverse disease
Excision Limits of Oral Cavity Tumor by Narrow Band Imaging

This study evaluates the feasibility of the NBI technique in the detection of early cancer lesions.


Eligibility Criteria:
Inclusion Criteria:

* Primitive epidermoid cancer of the oral cavity, proved by histology, not treated previously, patient having a surgery
* No previous surgery for this cancer
* Age \> 18 years
* Patient affiliated to health insurance
* Consent signed by the patient

Exclusion Criteria:

* Metastatic or recurrent disease
* Health care impossibilities for geographic, social, psychic reasons