cyrilzakka/clinical-trials huggingface dataset:
Effect of the Level of Dietary Protein on Infant Growth

The purpose of this study is to determine whether infants fed a formula with protein levels different than a standard infant formula have similar growth and development.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age at least 37 weeks
* Singleton birth
* Birth weight between 2500g and 4500g
* Weight at enrolment is at or above the 5th percentile (CDC)
* Infant has been exclusively formula fed for at least the last 14 days
* Having obtained informed consent of legal representative

Exclusion Criteria:

* Congenital illness or malformation that affects infant feeding and/or growth
* Significant pre-natal and/or post-natal disease
* Suspected or confirmed allergy to cow milk protein
* In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen)
* Currently participating in another clinical trial
The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy

The primary aims of this study are to determine if treatment with Gabapentin taken systemically (oral tablets) in patients who have photorefractive keratectomy (PRK) surgical treatments reduces post surgical neuropathic pain and discomfort. The investigators main Hypothesis is that gabapentin given prior to and after refractive surgery prevents central sensitization and local allodynia.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be at least 18 years of age
2. Subjects must not have any corneal disease or degeneration
3. Subjects must be candidates for LASIK or PRK refractive surgery

Exclusion Criteria:

1. History of topical ocular medications within 4 weeks prior to enrollment
2. History of conjunctivitis or ocular inflammation within 4 weeks prior to enrollment
3. History of a previous refractive surgery
4. History of previous diagnosis of corneal disease, degeneration, or glaucoma
5. History of autoimmune disease
6. History of oral anti-histamines currently or within 1 week of study enrollment
7. History of systemic anti-inflammatory or pain medication currently or within 4 weeks of study enrollment
8. Use of oral diuretics or betablocker currently or within 1 week of study enrollment
9. Current diagnosis of dry eye
10. Patients whose Best corrected vision is less than 20/20
11. Patients whose target post operative refraction is not plano
12. Pregnant and lactating
Effects of Nap Restriction on Preschoolers' Empathy, Prosocial Behaviors and Executive Function

Cross-sectional evidences suggest a relationship between early childhood sleep and cognitive as well as socio-emotional functions. However, the casual relation has not been fully revealed. The current study aims to perform a randomized lab-based crossover nap restriction study on preschoolers, to determine the effects of sleep restriction on preschoolers empathy, prosocial behaviors as well as executive functions.

The study will enroll preschoolers with regular nap habits. Under a randomized repeated-measures crossover design, they follow a strict sleep schedule (≥ 12.5 hours' time in bed every 24 hours) for 5 days, before each of two pseudorandomly assigned afternoon assessments following nap-rested or nap-restricted conditions. Actigraphy is applied to monitor sleep, and occipital alpha power is detected from resting-state EEG to objectively measure sleepiness. Empathy (Empathic for Pain Event-related Potential Paradigm) and prosocial behaviors (Concern for Others Behavioral Paradigm) were measured at each assessment. The effects of nap restriction were analyzed with paired t-test/Wilcoxon matched-pairs sign rank test and repeated-measures ANOVA.

Eligibility Criteria:
Inclusion Criteria:

1. healthy, typically developing, Intelligence quotient (IQ) ≥ 85;
2. never diagnosed with emotional-behavioral problems;
3. sleeping on a regular daily schedule;
4. reported napping three or more times every week, ≤ one nap in one day;
5. able to fall asleep by themselves.

Exclusion Criteria:

1. not able to fall asleep alone;
2. travel beyond two time zones within 3 months of the study;
3. use of medications influencing sleep or alertness;
4. reported or diagnosed sleep problems (such as obstructive sleep apnea (OSA), narcolepsy, parasomnia, insomnia, etc.) ;
5. history of neurodevelopmental diseases, including developmental delay, epilepsy, chronic medical conditions, lead poisoning and head injuries involving loss of consciousness;
6. conceptual age \<35 weeks or \> 45 weeks;
7. birth weight \< 2,500 grams;
8. Children's Behaviors Checklist (CBCL) total score \> 70;
9. a first-degree family history of diagnosed narcolepsy, psychosis or bipolar disorder.
Study of Circulating Tumoral DNA in Ovarian Cancer

Circulating tumor DNA detection and quantification in patients with ovarian cancer.

Technique development:

In a first step, the different available techniques will be evaluated for specificity and sensibility using serial dilutions of cell lines with or without TP53 mutation.

Validation:

The tumor DNA detection rate will be estimated from patient's blood with ovarian cancer.

The investigators will study 25 patients to obtain at least 15 patients bearing a TP53 mutation that could be characterized in the primitive tumor or metastasis. With those 15 patients, the investigators will determine the most sensitive technique and the best cost/efficiency ratio.

Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years.
* Patient with invasive ovarian cancer stage II to IV from FIGO classification.
* Patient treated by surgery.
* Patient with tumor or metastasis available for TP53 status characterization
* Patient able to stand a blood collection.
* Signed written informed consent approved by AFSSAPS and CPP.

Exclusion Criteria:

* Patient without social protection / insurance.
* Borderline ovarian tumor.
* Non carcinoma ovarian tumor
* Patient with invasive ovarian cancer 5 years before diagnosis
* Current pregnancy and lactation.
* All social, medical, psychological, situations making the study impossible.
* Person deprived of liberty.
Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus

Primary Objective:

To evaluate the efficacy and the safety of insulin glulisine in type I Diabetes Melittus (DM) patients

Secondary Objective:

To evaluate the insulin glulisine doses To assess the patient satisfaction


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen
* 6.5 \<=HbA1c \<= 11% at visit 1
* BMI \<35 kg/m²
* Provision of signed and dated informed consent prior to any study procedures
* Ability and willingness to complete study diaries and questionnaires
* Demonstrated ability to use the self-glucose-monitoring device, and to self-inject insulin
* A negative pregnancy test for all females of childbearing potential.

Exclusion criteria:

* Hypersensitivity to insulin Glulisine, insulin Glargine or one of their excipients
* Pregnant women
* Active proliferative diabetic retinopathy
* Impaired hepatic or renal function

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Immunomodulation of E.Coli Nissle 1917 in Patients With Grass Pollen Rhinoconjunctivitis

Due to the worldwide increasing prevalence of the allergic rhinoconjunctivitis, new therapeutical strategies are needed. The symptomatic treatment with topical and systemic antihistamines and corticosteroids are often insufficient. E.coli Nissle 1917 has immunomodulatory capacities and reveals less side effects. E.coli Nissle 1917 has no sedative properties and exhibits no hepatotoxic qualities. Thus, E.coli Nissle 1917 represents a new relevant therapeutical agent.


Eligibility Criteria:
Inclusion Criteria:

* clinical relevant grass pollen allergy with required treatment since 2 years
* positive skin prick test to grass
* positive sIgE towards grass (CAP 2)
* written informed consent

Exclusion Criteria:

* perennial rhinoconjunctivitis
* sinusitis
* chronic diarrhoea and other existing severe gastrointestinal diseases
* current specific immunotherapy to grass pollen
Effect of Kinesiotaping on Force Irradiation

The study is assessed the electromyographic activity response of non-dominant biceps brachii muscle during unilateral-dominant concentric, eccentric and isometric biceps brachii muscle contractions under kinesiotaping and non-taping conditions. The aim of the study is to determine the synergistic effect of kinesiotaping which is applied on non-dominant biceps brachii muscle on force irradiation.

Fourty healthy subjects with no history of neurological or recent musculoskeletal injury will participate the study.

Healthy subjects are arranged in two groups of stimulation: kinesiotaping group (kinesiotaping and force irradiation) and control group (only force irradiation). The electromyographic response of the resting arm (non-dominant) will be assessed during the dominant arm movement for all subjects. Additionally, in kinesiotaping group, kinesiotaping will be applied 24 hours before the experiment.

The electromyographic response of the resting arm will be assessed under three contraction type movement (isometric, eccentric and concentric contractions) The SEMG signals are analysed by using MATLAB®, suitable signal proccessing techniques (linear envelope, Root Mean Square etc) are chosed. The statistical analysis are done by using SPSS®, according to data distribution, "Independent Sample T Test" or "Mann-Whitney U Test" is utilized for comparing outcomes of control and KT groups.

Eligibility Criteria:
Inclusion Criteria:

* To be right-handed-dominant
* To have normal or corrected vision
* To have no formal history of any resistance training.

Exclusion Criteria:

* To have history of neurological or recent musculoskeletal injury
Collections of Blood and Stool Samples in Patients With Acute Hepatitis

Hepatitis is an inflammation of the liver. Hepatitis can be caused by an infection with a virus, but poisonous (toxic) substances can also cause it. Researchers have identified several of the viruses responsible for hepatitis, however some patients with hepatitis show no evidence of being infected with known hepatitis viruses. Researchers call conditions like this, seronegative hepatitis. It means that a patient has hepatitis but he/she does not have evidence in their blood of a viral infection.

Seronegative hepatitis is often complicated by autoimmune disorders and associated severe disorders especially, fulminant hepatitis of childhood and post-hepatitis aplastic anemia.

Researchers have attempted to identify the cause of these conditions but have been unsuccessful. Therefore, this study was developed to collect blood and stool samples from patients with seronegative hepatitis in order to help identify the virus responsible.

While several viruses have been identified as agents of liver inflammation, some proportion of cases of acute hepatitis are seronegative and show no evidence of prior infection with known hepatitis viruses A, B, C, or E. Seronegative acute hepatitis is often complicated by autoimmune phenomena or late severe consequences, especially fulminant hepatitis of childhood and post-hepatitis aplastic anemia. Efforts in the Hematology Branch to identify an infectious agent in these latter two syndromes have been unsuccessful, probably because they are immune-mediated and also accompanied by massive tissue destruction. We now propose systematic collection of blood and fecal samples from patients with seronegative acute hepatitis for purposes of virus identification research. Samples will be collected from patients in United States Army clinics; patient identifiers will be employed.

Eligibility Criteria:
Collection of blood samples.
Cryoablation of Small Breast Tumors in Early Stage Breast Cancer

This study examines the use of cryoablation as an alternative to surgery in the treatment of early stage invasive breast cancer. The hypothesis is that cryoablation will complete ablation and destroy the tumor in a selected population of women who may otherwise be adequately treated with surgery.

PURPOSE:

To determine the rate of successful tumor ablation in patients treated with cryoablation and endocrine therapy in a subset of patients with early stage breast cancer.

OUTLINE:

1. Core Biopsy (Pre-Registration)
2. Magnetic Resonance Imaging (Pre-Registration)
3. Tumor Cryoablation
4. Core Biopsy (Post-Cryoablation)
5. Magnetic Resonance Imaging (Post-Cryoablation)
6. Postoperative Follow-up
7. Evaluation of outcomes

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 50
2. Unifocal primary invasive breast carcinoma diagnosed by core needle biopsy
3. Maximum tumor size ≤1.5 cm in its greatest diameter
4. Ultrasound visible lesion(s)
5. Clinically node negative, hormone receptor positive (+). HER2 negative (-), with \<25% intraductal component in the aggregate.
6. Unilateral or bilateral disease meeting study criteria
7. Physical and emotional ability to undergo baseline and follow-up breast MRIs and serial breast cosmesis analysis
8. Patient agrees to receive a 5 year minimum course of endocrine therapy following cryoablation for control of systemic disease

Exclusion Criteria:

1. Prior treatment (e.g., open surgical biopsy, lumpectomy) of index cancer
2. Ductal carcinoma in-situ with microinvasions (T1mic)
3. Multifocal or multicentric invasive breast carcinoma
4. Prior or planned neoadjuvant systemic therapy for breast cancer
5. Tumor with ≥25% IDC components
Mindfulness Approach for Reducing Anxiety and Gloom in Ocular Inflammatory Diseases

The proposed study is a block-randomized, controlled trial to evaluate the effects of a digital meditation and mindfulness practice on mental health in patients with non-infectious uveitis.

Non-infectious uveitis is an immune-mediated inflammatory disease of the eye that can occur alone or be associated with other autoimmune diseases. This chronic condition can be isolating and complex for patients to manage, leading to increased rates of anxiety and depression symptoms in uveitis patients compared to the general population.

In collaboration with Calm Health, the investigators aim to evaluate the efficacy of Calm Health's meditation, mindfulness, and clinical programs in reducing symptoms of anxiety and depression, as well as perceived stress, in patients. Overall, the investigators aim to collect data on the value of supplementing medical care with an accessible digital mental health resource.

Eligibility Criteria:
Inclusion Criteria:

* Is 18 or older at time of enrollment.
* Is willing to download Calm Health on their smartphone
* Is able to operate a smartphone \&amp; Calm Health without assistance
* Is able to read words on a screen without assistance
* Diagnosis of non-infectious uveitis

Exclusion Criteria:

* Is under 18 at time of enrollment.
* Has started taking a new anti-depressant, anti-anxiety, or other psychiatric medication to improve mood within the past month.
* Plans to start taking a new anti-depressant, anti-anxiety, or other psychiatric medication to improve mood in the next 12 weeks.
* Has started any type of psychotherapy within the past 3 months.
* Plans to start any type of psychotherapy within the next 12 weeks.
* Already has a mindfulness/meditation app on their smartphone.
* Is unable to operate a smartphone or read words on a screen without assistance.
* Is unable or unwilling to download the Calm Health app on their smartphone.
* Does not consent to their anonymized data being collected via Calm Health app.
Exposure Therapy Combined With Cortical Interventions for CRPS-II

Consecutive patients with long-standing complex regional pain syndrome II in a lower limb are treated with graded exposure therapy in vivo in combination with methods targeting cortical reorganisation.

Complex regional pain syndrome, CRPS, is an uncommon but often very handicapping chronic pain syndrome. Most often, a single extremity is affected. The diagnosis is subdivided in CRPS type I where no nerve injury has been identified, and CRPS type II when a major nerve injury has been verified. With the exception of spontaneous pain, several of the symptoms related to CRPS may be connected to the inactivity and immobilization often seen in the history of CRPS patients.

Exposure in vivo, a form of behaviour therapy where the patient is gradually confronted with the avoided movements and activities, has been shown safe and effective for patients with CRPS type I. The present study uses a combination of exposure in vivo and interventions targeting a supposed cortical reorganisation with the hypothesis that the functional impairments would decrease, independent of possible changes in pain levels.

Consecutive patients with long-standing CRPS-II, diagnosed according to the Budapest criteria, in a lower limb are included. Treatment comprises daily graded exposure therapy in vivo, in combination with methods targeting cortical reorganisation: mirror therapy, desensibilisation training, and sensory re-education. The treatment is implemented at an in-patient ward during four plus four weeks, separated by a home training period of 6-8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Complex regional pain syndrome II

Exclusion Criteria:

* Severe psychiatric disorder drug abuse
SDSU MOVE/Me Muevo Project

The purpose of this study is to design, implement, and evaluate a recreation site-based obesity prevention \& control intervention for 7-9 year old children and their families by targeting physical activity and dietary behaviors.

The primary aim is to evaluate the effectiveness of a multi-level intervention to prevent the onset of overweight and obesity in 7-9 year old children. The recreation center site intervention emphasizes changes in quantity and quality of physical activity and nutrition-related offerings within the centers. The home site intervention targets the home environment and household rule setting delivered via Family Health Coaches and tailored to the needs of the family. Five hundred forty one (541) families were recruited to participate in this project. Participants were selected in part based on residence in proximity to participating recreation centers. Eighteen (18) families living up to 3 miles from each of the 30 recreation centers involved in the project were be recruited to participate. For each family, one child was recruited between the ages of 5 and 8 years old and this child's primary caregiver was enrolled in the study. The study's primary outcome is Body Mass Index (kg/m2).

Comparisons: Control vs. Intervention

Eligibility Criteria:
Inclusion Criteria:

* Primary residence within 3 miles of recreation center
* Children ages 5-8 at baseline
* Commit to participate in study for 3 1/2 years
* Participating parent must be a legal guardian of the child
* Parent and child must be able to speak and read English or Spanish
* Willing to be randomly assigned to control or intervention

Exclusion Criteria:

* Child has a medical/health/psychological condition or is taking a medication that may impact the child's physical activity, diet or weight to confound BMI
* Parent or child is unable to read and speak English or Spanish
* Family plans to move during the next 3 1/2 years
The Effect of Mindfulness Programs on Postoperative Pain

Participants undergoing hand surgery will be assessed and compared for postoperative pain. The patients' experience of going through surgery will be evaluated. The patient satisfaction and patient assessed outcomes will be measured.

Participants undergoing hand surgery will be randomized into either a control group or one of two groups that undergo mindfulness training during the perioperative period. One of the treatment groups will be enrolled in the program "Prepare for Surgery, Heal Faster" provided by NYU. The other treatment group will be enrolled in Wim Hof Method, a meditation program. This program is not provided by NYU, but instructions will be provided to the patient on how to complete the meditative exercises involved in this established method. Postop pain medication and pain scores will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Patient seen in Dr. Paksima's office
* Scheduled for hand surgery
* Aged 18+
* Able to provide consent

Exclusion Criteria:

* Less than 18 years old
* Inability to consent
* Not fluent in English
The Implantable Cardioverter-defibrillators (ICD)/Device Expectations, Adaptations, and Successes Study

The introduction of pacemakers and implantable cardioverter-defibrillators (ICDs) has substantially changed the medical and surgical management of patients with cardiac rhythm disease. In the case of patients with ICDs, these devices are programmed to deliver a strong electrical shocks. In adults, multiple studies have suggested that patients at risk of receiving shocks from their device have an increased prevalence of anxiety and depression. Very few studies have looked at this question in children. We propose to evaluate a cohort of patients age 6 to 20 with ICDs, compared to a cohort of patients with pacemakers, assessing each group for the presence of depressive and anxiety disorders, including post-traumatic stress disorder (PTSD).


Eligibility Criteria:
Inclusion Criteria:

* Age 6 through 20 at the time of enrollment for patients.
* Age ≥18 for caregiver
* Functioning pacemaker or ICD (explanted or inoperative devices do not qualify)
* Informed consent of parent or guardian as well as assent of study participant

Exclusion Criteria:

* Lack of English language fluency in patient and caregiver
* Hospitalization within 4 weeks of visit
* First implantation of ICD or pacemaker within 6 months of study enrollment
"Clinical Trials to Enhance Elders' Oral Health" ("TEETH")

The purpose of this study is to determine if regular rinsing with chlorhexidine is effective as a long-term preventive method for reducing the incidence of tooth loss in low income older adults. The true end-point of the study is tooth loss after five years of regular rinsing with chlorhexidine or a placebo; surrogate endpoints are periodontal disease, root and coronal decay.

"TEETH" is a double-blinded, randomized clinical trial, supervised by a Data \& Safety Monitoring Board, designed to provide unequivocal evidence regarding the impact of regular rinsing 0.12% chlorhexidine solution on tooth loss in low income, community-dwelling older adults who are irregular users of dental services. Of the 1101 subjects enrolled in the study in Seattle, WA and Vancouver, B.C., one/half have been assigned to the active rinse condition; the other half to the placebo rinse which looks and tastes like the chlorhexidine rinse but does not have the active ingredient. Subjects receive two bottles of rinse every six months; the first to be used daily for one month, the second weekly for five months. Reminder calls are designed to help subjects maintain this rinse regimen. Subjects return yearly to research clinics at each participating university, where they are examined by a dentist who is trained in clinical research methodology and calibrated annually. The purpose of these visits is to examine subjects for tooth loss (followed by contacts with extracting dentists to determine the dentist's reasons for extracting the tooth), pocket depth, recession, caries and restorations on root and coronal surfaces. Interviews are also conducted annually with participants to assess health status, health behaviors, and oral health quality of life. A panoramic radiograph was taken at baseline of each subject and is to be done again at the five-year (final) yearly exam. These radiographs are used to confirm tooth loss and possible reasons for extractions

Eligibility Criteria:
Inclusion Criteria:

* Age at entry 60-75
* Four or more natural teeth
* No preventive dental visits in the past 18 months
* Scores \> or = 60 on a measure of oral health self-efficacy (max possible=100)
* willing to participate in a five-year study
* willing to use rinses on a prescribed regimen and to return for yearly cleaning and exam appointments.

Exclusion criteria:

* Not having a phone at home for follow-up calls