cyrilzakka/clinical-trials huggingface dataset:
Promoting Inclusive Education Through Executive Functions

Background: Recently governments worldwide have been doing enormous efforts to ensuring egalitarian educational opportunities for all children. However, the number of children that remain out of the school or lack proficiency in academic performance is still very worrying. One of the factors that seems to contribute to such inequalities is socioeconomic status (SES). SES strongly impacts the developmental trajectory of both the brain and cognitive abilities as off early childhood, further affecting learning and academic success.

Despite the great interest in building inclusive societies and the promising results of executive functions' training programs for leveling the SES-achievement disparities, only a few studies have actually included schools from low-SES settings and lack a comprehensive, evidence-based background underlying the intervention protocols. Thus, with a preventive emphasis, the current project aims to implementing and evaluating a cost-effective game-based training protocol to promote and boost the development of executive functions in preschool and elementary school-aged children from disadvantaged contexts, ultimately contributing to prevent school dropout and reduce academic inequalities.

A randomized controlled trial will be implemented in Portuguese schools embedded in low-income settings. It will include a total of 396 participants, 132 per age group: 5,6 and 7 years old. At each age group a total of 132 children will be enrolled in the program for 4 weeks, 66 in the active control group, and 66 in the intervention group. The assessment protocol will include demographics, including SES, and evaluation of executive functions. Both groups -control and intervention- will complete the same assessment protocol at three distinct moments -baseline, post-intervention, and 6 months' follow-up. The training program will comprise the following: (i) 3 weekly sessions of 30 minutes each (ii) each session will be dedicated to train a specific domain of executive functions -working memory, inhibition and cognitive flexibility.

Eligibility Criteria:
Inclusion Criteria:

* Typically developed children of 5, 6, and 7 years old attending the regular curriculum at public educational services -kindergarten and elementary school.

Exclusion Criteria:

* Presence or history of cognitive deficits, neurological or psychiatric condition.
A Study of Two Different Formulations of LY3074828 in Healthy Participants

The purpose of this study is to look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828 when given as different formulations. The tolerability of LY3074828 will also be evaluated and information about any side effects experienced will be collected.

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be approximately 13 weeks, not including screening.


Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

* Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
* Must not show evidence of active or latent tuberculosis (TB)
* Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 1 month of screening, or intend to during the study
* Must not have been treated with steroids within 1 month of screening, or intend to during the study
* Must not be immunocompromised
* Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1
* Must not have significant allergies to humanised monoclonal antibodies
* Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or sever post treatment hypersensitivity reactions
* Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
* Must not have had breast cancer within the past 10 years
Cabergoline in Nonfunctioning Pituitary Adenomas

Clinically nonfunctioning pituitary adenoma remains the only pituitary tumor subtype for which no effective medical therapy is available or recommended. We will evaluate the use of cabergoline in a clinical trial, in order to define the efficacy of this treatment in nonfunctioning pituitary adenoma.

Nonfunctioning pituitary adenomas (NFPA) are common tumors of sellar region characterized by the absence of clinically hormonal pituitary secretion. These adenomas are typically not diagnosed until they become very large and cause compressive neurologic symptons (e.g. visual impairment or cranial nerve palsy). Most of them are able to synthesized gonadotropins but not secreted it.

Transsphenoidal surgical resection is the first-choice therapy in NFPA. However, complete removal is difficult and tumor rest is very common. In these cases, the pragmatic use of radiotherapy is effective to reduce residual tumor growth or recurrence, but it is related with severe side effects. Another possibility is the clinical observation, or wait-to-see approach, but it is associated with tumor progression: 40% in 5-10 years. The efficacy of some medical treatment are not defined yet.

Since the identification of dopaminergic and somatostatinergic receptors in NFPA, the pharmacological treatment of the NFPA has been considered as a possibility for treatment. To date, clinical use of dopamine agonist (DA) in NFPA patients has been evaluated in some studies. However, these studies present modest and inconclusive results and the DA role in the NPFA management remains undefined.

In this study, the investigators plan a clinical trial designed to investigate the efficacy of cabergoline in NFPA individuals with remaining tumor after primary neurosurgery. These results could help to define the efficacy of DA in NFPA management.

Eligibility Criteria:
Inclusion Criteria:

* presence of pituitary tumor rest at 6 months after neurosurgery
* absence of previous hormonal pituitary hypersecretion
* absence of previous radiotherapy and/or radiosurgery
* Histopathological exam showing pituitary adenoma

Exclusion Criteria:

* ACTH immunoexpression at histopathological exam
* presence of previous radiotherapy and/or radio surgery
* psychotic psychiatric disease
* moderate or severe alterations in cardiac valves
The Effects of Using Fertile Chip in Sperm Selection for Intracytoplasmic Sperm Injection in Unexplained Infertility

The aim of the current study is to evaluate to effectiveness of sperm selection by using fertile chip in unexplained infertile couples on intracytoplasmic sperm injection (ICSI) cycles.

The aim of the current study is to evaluate to effectiveness of sperm selection by using fertile chip in unexplained infertile couples on intracytoplasmic sperm injection (ICSI) cycles. On study arm sperm selection will be performed by using special microchannel system which is called fertile chip (FC) without using sperm wash procedure. This FC system leads to select lineer motile progressive sperm selection. In control group, sperm selection will be performed by classical way which sperm will be undertaken to sperm wash by gradient method.

After selection of sperm in both arms, ICSI will be performed. The outcomes of ICSI schedule will be assesed by fertilization and clinical pregnancy rates.

Eligibility Criteria:
Inclusion Criteria:

* between 20-37 year-old women
* normal tubal patency, normal uterine cavity, normal ovulation,
* between 20-40 year-old men
* normal semen analyse by WHO criterias
* unexplained infertile couples

Exclusion Criteria:

* poor ovarian reserve which is diagnosed by Bologna criterias
* abnormal semen analyse by WHO sperm criterias
* abnormal ovulation problems,tubal patency or uterine cavity
Oral VT-464 in Patients With Castration-Resistant Prostate Cancer Previously Treated With Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men With ER Positive Breast Cancer

The goal of this clinical study is to determine the safety and efficacy of VT-464, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC) who have been previously treated with Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men with ER positive Breast Cancer.

This is a Phase 2 open-label study of VT-464 in patients with progressive, metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with enzalutamide, female patients with triple negative, AR positive breast cancer and men with ER positive breast cancer. The study consists of five cohorts: patients in Cohort 1 must have never received prior chemotherapy. Patients in Cohort 2 must have received at least one (and not more) prior course of chemotherapy for CRPC. Women with TNBC will be stratified into two cohorts AR 1 to 9% (cohort 3) and AR \> 10% (cohort 4). Cohort 5 will consist of men who have been diagnosed with ER+ breast cancer and have failed at least one prior endocrine therapy.

Eligibility Criteria:
Key Eligibility Criteria:

* Patients must have documented histological or cytological evidence of adenocarcinoma of the prostate.
* Must have progressive, metastatic castration-resistant prostate cancer (mCRPC). There must be radiographic evidence of disease after primary treatment with surgery or radiotherapy that has continued to progress radiographically or biochemically (rising PSA levels on successive measurements) despite adequate androgen-deprivation therapy, which is defined as having undergone bilateral surgical castration or continued treatment on GnRH agonists or antagonists.
* All patients in this trial must have been treated with enzalutamide.
* Patients in Cohort 1 will not be allowed to have received prior chemotherapy; patients in Cohort 2 must have received one (and not more) prior course of chemotherapy for mCRPC.
* Progression must be evidenced and documented by any of the following parameters:

  * PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination
  * Appearance of one or more new lesions on bone scan
  * Progressive measurable disease by RECIST 1.1
Safety and Efficacy Study of Transumbilical Laparoendoscopic Single Site Cholecystectomy

The purpose of this study is to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy.

As the natural orifice during embryonic, the transumbilical surgery not only can mask the abdominal scar and avoid infection produced by puncturing stomach, vagina or rectum in NOTES,but also can be played by the conventional laparoscopic instruments. TU-LESS (transumbilical laparoendoscopic single site surgery), is considered to be the most feasible NOTES(natural orifice transluminal endoscopic surgery)technology at present. Researches about TU-LESS mostly are case reports and small samples or the control experiments up to now,there are not persuasive randomized controlled trail between TU-LESS and conventional laparoscopic cholecystectomy. So the investigators design this prospective randomized controlled trail to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy .

Eligibility Criteria:
Inclusion Criteria:

* 18 Years to 5 Years
* Benign gallbladder diseases
* KPS ≥ 70
* informed consent

Exclusion Criteria:

* Obstructive jaundice
* Broadening of the common bile duct
* Gallstone pancreatitis
* Serious heart,brain,lung, metabolic diseases history
* History of upper abdominal surgery
* Pregnancy or breast-feeding women
* Refuse TU-LESSC
* BMI(Body Mass Index)≥ 30
Impact of Individualized Music Listening for People With Dementia on Anxiety: A Quasi-experimental Study

This pilot study was designed to evaluate the effects of Individualized music listening (IML) implemented on older adults with mild cognitive impairment (MCI) and PwD. This quasi-experimental study used convenience sampling where thirty-two elderly individuals were recruited from five community-based dementia care centers then assigned to experimental (EG, n = 16) or control (CG, n = 16) groups according to the self-reports of importance of music in their lives and according to their personal wishes. The EG received eight treatments of IML (two times per week, 20 minutes per time), while the CG received the usual activities of the care centers for four weeks when EG received IML. The anxiety levels of both groups were investigated before and after first time IML and after eighth time IML. The researcher observed positive and negative behaviors of EG before, during and after each IML per 20 minutes in each time IML.


Eligibility Criteria:
Inclusion Criteria:

1. 50 years or older;
2. Mild cognitive impairment or dementia.

Exclusion Criteria:

1. Can not answer questions by themselves;
2. Have the habit of listening music in the past week.
Cold Therapy for Pain Control Following Caesarean Section

Cold Therapy has been used for a variety of procedures and has been studied in several but not recently studied for reducing postop pain following Caesarean Sections. The hypothesis is that Cold Therapy will reduce postop pain and increase patients mobility and improve care of her newborn.

Cesarean Section (C/S) is one of the most commonly performed surgeries in many parts of the world. In the United States the C/S rate in 1965 was 4.5% and increased to 30.5% in 2010. While the number of C/S has increased, pain management has primarily been via epidural, spinal, local and general anesthesia and narcotic medication for the immediate postpartum period (pp). This has lead to an increase in associated cost and problems with pain management. Limited studies have been performed to evaluate cold compresses on pain relief in the immediate pp and there potential to reduce cost. Cold Therapy (CT) is most often utilized in orthopedics, sports medicine, and in general surgery. CT has been used to improve range of motion (rom) and reduce pain medication utilization. We surmise CT may be useful in decreasing narcotic utilization after C/S, as well as improve mobility and allow for improved care of the newborn. This is significant as Erlanger Baroness Hospital (EBH) is becoming Baby Friendly (BF). This is a National Initiative for Children's Healthcare Quality (NICHQ) which desires having babies rooming in with their mothers and increasing breastfeeding rates. The goal of this study is to evaluate a newer sterile delivery system for decreasing pp pain via CT. This will be done as a Randomized Controlled Trial (RCT).

Eligibility Criteria:
Inclusion Criteria:

* greater than 36 weeks gestation
* primary C/S with Epidural for labor problems or breech presentation
* Repeat C/S with spinal

Exclusion Criteria:

* less than 36.0 week gestations
* vertical skin incisions
* classical or vertical hysterotomy incisions
* failed vaginal births after C/S (VBAC)
* past history of drug or alcohol abuse
* positive drug screens unless medical prescribed drugs
* general anesthesia
* Caesarean Hysterectomy
* primary C/S with spinal anesthesia
Development and Validation of a Digital Optotype for Near Vision in Greek Language.

Primary objective of our study is to develop and validate a computer-based digital near-vision optotype based on the Greek version of the print MNREAD.

Present study aims to develop and validate a computer-based digital near-vision optotype based on the Greek version of the print MNREAD.

Specifically, it aims to evaluate the level of agreement between the conventional printed greek MNREAD chart and the corresponding digital chart, as well as test-retest reliability of the digital optotype.

To address these aims, four reading parameters measured with the print and the digital version are compared. These parameters are the following:

1. Reading Acuity (RA)
2. Maximum Reading Speed (MRS)
3. Critical Print Size (CPS)
4. Accessibility Index (ACC)

All the comparisons take place in two groups: a) a Normal Vision Group (NVG), and b) a Low Vision Group (LVG) in order to estimate the reading capacity in a population with a wide range of vision.

Eligibility Criteria:
Inclusion Criteria:

* adequate literacy of written Greek language

Exclusion Criteria:

* dyslexia
* attention-deficiency
* former diagnosis of mental diseases
* former diagnosis of psychiatric diseases
Gastric Tube in Pyloric Stenosis

Pyloric stenosis is a current condition in pediatric surgery. The medical management prior to surgery consists of ionic correction. The nasogastric tube is commonly used to prevent gastric fluid inhalation before surgery, but there is no study on it benefits in this specific use. Other studies suggest that utilization of a gastric tube in pyloric stenosis may increase the duration of the medical treatment. The aim of the study is to evaluate the benefit of the nasogastric tube to prevent respiratory complications. This retrospective, monocentric and descriptive study include all patients hospitalized for pyloric stenosis in the university hospital in Amiens between 2014 and 2021. Patients with and without nasogastric tube prior to surgery are compared, regarding respiratory complications define as use of antibiotic, or oxygen therapy or infection in the lungs X-ray before surgery. The investigators analyze pre-operative data: vomiting, dehydration, time to ionic disorders correction and pain, and also notice the length of hospital stay. Data during hospitalization are analyzed and will be noticed the last medical contact represent by the post-operative consultation.


Eligibility Criteria:
Inclusion Criteria:

* all patients with hypertrophic pyloric stenosis

Exclusion Criteria:

* refusal of data collection and use from patient's parent or family
HD-Tdcs and Pharmacological Intervention For Delirium In Critical Patients With COVID-19

The goal of this clinical trial Is conducted to evaluate the efficacy and safety of active or sham HD-tDCS in combination with dexmedetomidine in patients with moderate to severe ARDS due to COVID-19 with delirium in intensive care unit (ICU). The hypothesis was that HD-tDCS combined with concomitant dexmedetomidine would reduce delirium rates.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years,
* confirmed clinical diagnosis for SARS-CoV-2,
* delirium confirmed through the CAM-ICU-7 test, applied by trained evaluators

Exclusion Criteria:

* severe psychiatric illness that is not well controlled;
* pregnancy or active lactation,
* refusal of consent
* contraindications for brain stimulation such as: aneurysm clips, pacemaker, epilepsy, dermatitis at the site of stimulation
Photoacoustic Imaging (PAI) of Suspicious Breast Cancers - A Clinical Feasibility Study

After locating the suspicious lesion/mass with standard of care mammography and/or ultrasound, a photoacoustic scan will be performed in the breast where the lesion is located. After the PA scan a biopsy will be performed, if clinically indicated (based on the mammogram and ultrasound only).


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a breast lesion/mass found at physical examination, mammography or ultrasound (US), that has not been surgically resected
* Patients may have any of the following characteristics:

  * Taking hormones (e.g., contraceptives, hormone replacement therapy, post-cancer Tamoxifen)
  * Breast implants
  * Previous breast biopsy
  * Previous breast surgery
  * Previous breast cancer
  * High risk of breast cancer (e.g., breast cancer susceptibility gene (BRCA) mutations, other gynecologic cancer)
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients who have had primary surgical excision of the suspicious finding
* Pregnant or lactating women
High School Start Time and Teen Migraine Frequency

Migraine is common in adolescents and can cause missed school and disability.

The American Academy of Pediatrics (AAP) recommends that high schools start no earlier than 8:30 AM in order to accommodate the physiologic needs of adolescents-whose brains naturally want to fall asleep later and wake up later and who still need to get at least 8 hours of sleep per night to function optimally-however, only about 18% of US high schools comply with this AAP recommendation. There is a relationship between adequate sleep and migraine. The investigators aim to determine whether high school students with migraine who attend high schools that comply with this AAP recommendation have lower migraine frequency than those that do not.

If so, it would argue for advocating for changes in high school policy to optimize health of adolescents with migraine.

Study design: This is an observational study of high-school students in the U.S. who have migraine and who attend a standard high school (i.e. are not home schooled or online schooled). They will complete a one-time online survey answering questions about their headaches and their schedule--particularly schedule aspects related to school and sleep.

Eligibility Criteria:
Inclusion criteria:

1. Live in the U.S.
2. In 9th-12th grade
3. Attends a high school that is outside of the home (i.e. not home-schooled or online schooled)
4. High school has a consistent start time all 5 days of the week
5. Has migraine by International Classification of Headache Disorders criteria
6. Can read and write in English

Exclusion criteria: NA
Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases

The investigators aim to measure the impact of a rehabilitation program in congenital cardiology in terms of health related quality of life. The orginality of the rehabilitation program consists in its design : initial hospitalizationfor a short period of time (5 days) at the rehabilitation center, followed by 11 weeks of rehabilitation at home under the supervision of a specialized sports trainer.

Adolescents and adults with congenital heart disease (CHD) have reduced exercise capacity compared to the general population, even for "simple" heart disease.

Regular physical activity is known to reduce the risk of acquired heart disease.

Cardiac rehabilitation programs have been largely developed to manage adult coronary and heart failure patients, which is not yet the case routinely in patients, adults and children, carriers of DC.

The investigators assume that patients who participate in this program will improve their quality of life compared to controls.

The orginality of the rehabilitation program consists in its design : initial hospitalizationfor a short period of time (5 days) at the rehabilitation center, followed by 11 weeks of rehabilitation at home under the supervision of a specialized sports trainer .

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 13 to 25 years included
* With a congenital heart diseases (CHD) as defined in the international CHD classification.
* Recent (\< 3 months) cardio-pulmonary exercise test (CPET)with maximum oxygen uptake (VO2max) \<80% of theoretical values and/or first ventilatory anaerovic threshold (VAT) \<55% of VO2max.
* Consent of the adult patient or the parents or legal guardians of the minor patient.
* Beneficiary of the social security scheme.

Exclusion Criteria:

* Uncontrolled arrhythmia.
* Cardiac surgery planned during the rehabilitation program.
* Severe musculoskeletal disorders.
* Severe intellectual disability that does not allow the quality of life questionnaire to be completed.
* Pregnancy.
* Patient who already underwent cardiac rehabilitation in the last 24 months.
* All medical contraindications to perform a cardiorespiratory stress test.
* Uncontrolled heart failure (NYHA IV)
* Obesity (BMI \> 30)