cyrilzakka/clinical-trials huggingface dataset:
Clinic-Based School Readiness Coaching

The goal of this clinical trial is to examine how a clinic-based school readiness coaching session conducted by a community health worker for parents of 3-5-year-olds affects children's School Readiness (SR) skills and parents early SR knowledge and behaviors. The main questions it aims to answer are: What impact does the clinic-based coaching session have on preschool-aged children's school readiness skills and their parents' confidence in supporting and practicing early math and literacy behaviors at home? Participants will receive a 1-hr coaching session at their pediatric clinic and return after three months for a follow-up session. Researchers will compare pre-and-post child and parent SR outcomes between these two sessions.

The goal of this clinical trial is to examine how a clinic-based school readiness coaching session conducted by a community health worker for parents of 3-5-year-olds affects children's school readiness (SR) skills and parents early SR knowledge and behaviors. The main questions it aims to answer are: What impact does the clinic-based coaching session have on preschool-aged children's school readiness skills as measured by the Brigance Early Childhood Screen III? and What impact does the clinic-based coaching session have on parents' confidence in supporting and practicing early math and literacy behaviors at home using the DREME Parent Beliefs Survey? The secondary question this study aims to evaluate is: Does the 1-hr school readiness coaching session affect rates of well-child checks at the pediatric clinic? Participants will receive a 1-hr coaching session at their pediatric clinic and return after three months for a follow-up session. Researchers will compare pre-and-post Brigance scores for the child and pre-and post parent SR confidence DREME scores.

Eligibility Criteria:
Inclusion Criteria:

* Receives primary care at one of 2 clinic sites
* Parent or caregiver of 3-6-year-old
* Child is eligible for Medicaid services
* Parent and child can communicate in English or Spanish

Exclusion Criteria:

* Child is too ill to participate
* Parents who are unable to complete study activities
Education on BDNF on Pain Levels

The promotion of neuroplasticity in conjunction with strategies for restructuring maladaptive cognitions that largely cause the activation of neural networks that contribute to the perpetuation of pain is therefore a fundamental neurophysiological principle for establishing a neurophysiological basis for pain.

perpetuation of pain, is therefore a fundamental neurophysiological principle for establishing physiotherapy therapeutic to establish therapeutic strategies from physiotherapy that contribute to improve the quality of life of patients with chronic pain. patients with chronic pain.

Based on the theory that neurotrophic factors such as BDNF play a fundamental role in the initiation and or maintenance of hyperexcitability of central neurons in pain, we consider that the levels of this neurotrophic factor, such as BDNF, may have an important role in the perpetuation of pain.

that the levels of this neurotrophic factor may be modified by the application of a therapeutic education protocol, favoring therapeutic education protocol, favoring a reduction in pain intensity.


Eligibility Criteria:
Inclusion Criteria:

* males and females aged 18 to 65 years with musculoskeletal pain for a minimum of 3 months
* patients recruited by information pamphlets from the university clinic of the Rey Juan Carlos University, and CSEU La Salle
* not having received physiotherapy treatment for this same process in the last 3 months.
* ability to perform all the clinical tests and to understand the study process, as well as to obtain informed consent.

Exclusion Criteria:

- Systemic, neurological, oncological or inflammatory diseases; psychiatric pathologies, pregnancy, type II diabetes.
Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for HER2-negative Breast Cancer

This is an prospective, multicenter, single-arm clinical study.

Prospective, multicenter, single-arm clinical study of chemotherapy combined with bevacizumab neoadjuvant therapy for early or locally advanced HER2-negative breast cancer

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old;
2. Signed the informed consent and volunteered to join the study with good compliance;

3, histopathologically confirmed HER2-negative invasive breast cancer (including triple-negative breast cancer; Or Luminal breast cancer, that is, ER/PR positive and HER2 negative) :

* HER2 negative was defined as 0/1+ on standard IHC test; HER2/CEP17 ratio was less than 2.0 or HER2 gene copy number was less than 4.
* ER positive and/or PR positive were defined as the proportion of positively stained tumor cells in all tumor cells ≥1%;

  4. According to the American Joint Committee on Cancer (AJCC) 8th edition TNM stage II-IIIC (T2-T4 plus any N, or any T plus N1-3, M0);

  5. The main organs function well and meet the following standards:

A) Hemoglobin (HGB)≥90g/L;

B) Neutrophil absolute value (NEUT)≥1.5×109/L;

C) Platelet count (PLT)≥ 100×109/L;

D) leukocyte ≥3.0×109/L;

E) Total bilirubin \<1.5 ULN (upper limit of normal)

F) Creatinine \< 1.5×ULN

G) AST/ALT \< 1.5×ULN;

6. Cardiac ultrasound: left ventricular ejection fraction (LVEF≥55%);

7. The investigators determined that the patients were suitable for treatment with bevacizumab.

Exclusion Criteria:

1. Stage IV (metastatic) breast cancer;
2. Received treatment for the disease, including chemotherapy, endocrine therapy, radiotherapy, immunotherapy, etc.;
3. Patients who are participating in other intervention studies;
4. Women with confirmed pregnancy or lactation;
5. According to the judgment of the investigator, the subjects have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or the subjects think that there are other reasons that are not suitable for inclusion.
Mutations of Glucocorticoid Receptor in Bilateral Adrenal Hyperplasia

As the investigators observed a case of glucocorticoid mutation revealed by incidentally discovered bilateral adrenal nodular hyperplasia, it was postulated that this molecular anormality could be more frequent than previously described. To validate this hypothesis, it was decided to study 150 multicenter consecutive patients, presenting with incidentally discovered bilateral adrenal masses without clinical signs of Cushing's disease. In all these patients GR gene will be studied, mutations will be detected and described, functional disturbance will be tested. Usual polymorphisms will be described. Correlation between clinical signs, hormonal and morphological abnormalities and presence or absence of GR mutations will be searched.


Eligibility Criteria:
Inclusion Criteria:

* patients more than 18 years of age
* patients with bilateral adrenal masses

Exclusion Criteria:

* Refusing to participate in the study
* Protected by law
* Have obvious signs of Cushing's syndrome
* No progressive neoplastic disease
Measurement of a Systolic Pressure Index at the Toe After a Walking Test

The main objective of this study is to evaluate the concordance of the variation in systolic pressure indices measured at the toe and ankle after a walking test in healthy volunteers.

Our secondary objectives are:

* to evaluate the concordance between left- and right-side measures: systolic pressure indices measured at the toe after a walking test (healthy volunteers)
* to evaluate the concordance between left- and right-side measures: systolic pressure indices measured at the ankle after a walking test (healthy volunteers)
* to evaluate the concordance of the variation in systolic pressure indices measured at the toe and ankle during the recuperation phase after a walking test (5 and 10 minutes after end of walking test) in healthy volunteers

Eligibility Criteria:
Inclusion Criteria:

* The subject must have given his/her informed and signed consent
* The subject must be insured or beneficiary of a health insurance plan

Exclusion Criteria:

* The subject is in an exclusion period determined by a previous study
* The subject is under judicial protection, under tutorship or curatorship
* The subject refuses to sign the consent
* It is impossible to correctly inform the subject
* The subject is pregnant, parturient, or breastfeeding
* The subject has a contraindication for a walking test
* Presence of mediacalcose objectified by a Doppler examination of the anterior and posterior tibial arteries, performed on the test day
* Known history of cardiovascular disease
* Poorly controlled diabetes or hypertension
* Neurological, muscular or rheumatic pathology contra-indicating a walking test
* Acute transient infection (cold-rhinitis, flu, etc.)
Risk Stratification of VT / VF After Myocardial Infarction Based on Cardiac MRI 2

Implantable cardioverter-defibrillators (ICD) are currently recommended (ESC guidelines 2015) for the primary prevention of sudden cardiac death (SCD) in patients with a remote myocardial infarction (MI) and a low (≤35%) left ventricular ejection fraction (LVEF). Ventricular tachycardia (VT) and/or ventricular fibrillation (VF), which are responsible for most SCDs, result from the presence of surviving myocytes embedded within fibrotic MI-scar. The presence of these surviving myocytes, as well as their specific arrhythmic characteristics, is not captured by LVEF. Consequently, most patients with a prophylactic ICD do not present VT/VF requiring ICD therapy prior to their first-ICD battery depletion. Thus, many patients are exposed to ICD complications, such as inappropriate shocks, without deriving any health benefit. As a consequence, the current implantation strategy of prophylactic ICDs, based on LVEF, needs to be improved in post-MI patients. Stratification of the rhythmic risk after IDM is therefore still a major public health issue.

Late gadolinium enhancement cardiac magnetic resonance (LGE-MRI) is a strong risk-stratifier of VT/VF risk in post- MI patients. In a recent multicenter retrospective study, the investigators showed that the presence of a critical surface of intramural scar (which is consequently neither epicardial nor endocardial) at the infarct border (measured by LGE-MRI) has a major association with the occurrence of VT/VF in post-MI patients with a LVEF≤35%.

The aim of the TVScreen 2 study is therefore to validate the relevance of the MRI criterion in a new independent cohort of patients.


Eligibility Criteria:
Inclusion Criteria:

* Person who has received full information on the organization of the research and who has not objected to the use of this data;
* Person having had an ICD implantation for primary prevention before 12/31/2017 after myocardial infarction;
* Person with LVEF ≤35% at the time of ICD implantation.

Exclusion Criteria:

* Patient with a history of persistent atrial fibrillation.
Genetic Mutation in Epithelial Ovarian Cancer

Little is known about the characteristics of genetic mutation in a large multi-gene panel in epithelial ovarian cancer. This study is to explore the targeted genetic mutations via a multi-gene panel, which consists of more than 500 hundred genes. The mutation characteristics are to be revealed in single nucleotide variants, copy number variations, insertion-deletion variations, and genomic structural variations. The total mutation burden (TMB) will be calculated. The status of microsatellite instability, expression of PD-1 and PD-L1 antibodies are also tested. These findings will be studies in association with the patients' prognosis and sensitivity to platinum-based chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Pathology confirmed of recurrent cervical adenocarcinoma, squamous carcinoma or adenosquamous carcinoma
* With available materials for analysis
* With detailed clinicopathological information
* Given consent to participate the trial

Exclusion Criteria:

* Not meeting all of the inclusion criteria
Timing of Dietary Acid Intake, Brushing Teeth and Acid Erosion.

This is a questionnaire based study investigating the relationship between the timing of dietary acid intake toothbrushing and erosive tooth wear. Data will be collected on the timing, nature, frequency and duration of dietary acid intakes and timing and frequency of the participants toothbrushing. Signs of the participants erosive tooth wear will then be recorded

The study group will consist of two cohorts, those presenting with tooth wear and a control group. Participants will be recruited from the care planning clinic of the Dental Institute King's College London. Suitable participants meeting the inclusion criteria will be approached on the clinic, given the patient information sheet and asked to consider participating. Written consent will be obtained from those accepting the request. An interviewer-led, previously validated questionnaire will question their frequency and timing of dietary acid intake, tooth brushing and any habits associated with dietary acid intake. This will be followed by a Basic Erosive Wear Examination.

The process will take 7-8 minutes and the participant is free to withdraw at any time

Eligibility Criteria:
Inclusion Criteria:

1. Severe tooth wear with a BEWE score of 12 and at least one score of 3 in three quadrants
2. Adult 18 years or older
3. No missing anterior teeth
4. minimum of at 10 teeth in the upper and 10 teeth in the lower jaw
5. No anterior crowns/ bridges or implants
6. Written consent to the study

Exclusion Criteria:

1. Pregnancy
2. Participation in other research within 30 days
3. Unable to speak or understand English
4. Presence of periodontal disease or caries on more than one tooth
Effectiveness of Synchronized Tele-exercise

The aim of this study is to determine the effect of telehealth-synchronized group exercise on sleep and quality of life, and secondarily, on the health and body perception of healthy young adults. This study is planned as a randomized double-blind controlled clinical study.

The aim of this study is to determine the effect of telehealth-synchronized group exercise on sleep and quality of life, and secondarily, on the health and body perception of healthy young adults. This study is planned as a randomized double-blind controlled clinical study. The sample size was calculated using G\*power 3.1.9.2, which required 42 patients and a size effect of 0.8, 80% power, 1:1 allocation ratio, and an error probability of 0.05. Forty-eight participants were planned to be included in the study, based on the probability that 15% of the patients could be excluded.

Eligibility Criteria:
Inclusion Criteria:

* being a volunteer,
* being in the age range of 18-25,
* having no barriers to online sessions through a computer,
* having no visual impairment.

Exclusion Criteria:

* having experienced a physical injury in the last 3 months
* having any major disorder,
* learning difficulty,
* having a mental disorder that could affect the results
Improving the Quality of Paediatric Hospital Care in the Kyrgyz Republic

A cooperation agreement between the Ministry of Health (MOH) of Kyrgyz Republic and WHO-EURO was established, for the implementation of a WHO Project to improve the quality of pediatric care in the referral hospitals. The pilot regions selected for this intervention are the three northern regions of Thalas, Chiu and Issik-Kul Region in Kyrgyz Republic. The MOH project will be implemented at a first stage in a group of 10 pilot hospitals, randomly selected among the existing hospitals in the above cited regions. Pilot Hospitals will be compared to "control hospitals", which are the hospitals in the region not receiving the intervention, using a pre-defined set of indicators of quality of care. The results of the present evaluation on the pilot hospitals will provide data that will inform the MOH on how better to scale up this project at a national scale.


Eligibility Criteria:
Inclusion Criteria:

* The study will evaluate Quality of Care delivered to children at hospital level. This will be assessed by a direct review of patients' charts, in comparison with pre-defined standard. At the hospital level children's charts will be randomly chosen among children 2 months to 59 months, hospitalized with common diseases, such as acute respiratory diseases, diarrhoea, and fever.

Exclusion Criteria:

* Children not included in the above criteria.
Effect of Lidocaine in Antiarrhythmic Dosage on Postoperative Cognitive Dysfunction in Supratentorial Craniotomy Dysfunction in Supratentorial Craniotomy

The purpose of this study is to investigate the effect of lidocaine in antiarrhythmic dosage on postoperative cognitive dysfunction in supratentorial craniotomy.


Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old, ASA physical status I or II, BMI\<30
* Scheduled for elective supratentorial craniotomy
* MMSE\<24 before operation
* Cooperative and given informed consent in person

Exclusion Criteria:

* History of mental or psychiatric disorders
* Contraindicated to internal jugular venous catheterization
* Pregnant or lactating female
* History of systemic malignant tumor or diabetes
* Previously treated with this protocol or participated in another study within previous 30 days
* Suspected history of allergic reaction or intolerance to amides or other anesthetic agents in this study
* History of alcohol abuse and/or drug abuse within previous one year
* History or a family history of malignant hyperthermia
Genetic Modulation of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD)

In this study the investigators will measure the functional brain activity of adult Attention Deficit Hyperactivity Disorder (ADHD) patients, genotyped according to the COMT genotype, during a Working Memory Paradigm, before and after a placebo controlled treatment with MPH for 6 WEEKS. Within this design, the investigators will be able to evaluate the therapeutic effect of MPH treatment on cognitive functions.


Eligibility Criteria:
Inclusion Criteria:

* Only participants will be included who (1) fulfil the diagnostic criteria defined in guidelines for the diagnosis of ADHD in childhood and adulthood and who (2) would be treated with MPH also for clinical indications outside the study.
* Provision of written informed consent
* A diagnosis of a ADHD (314.xx) by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
* Females and males aged 18-50 years
* Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment
* Able to understand and comply with the requirements of the study
* Right-handed according Edinburgh Handedness Inventory (Oldfield, 1971)
* German as first language
* Caucasian ethnicity

Exclusion Criteria:

* Pregnancy or lactation; women capable of childbearing are required to use a reliable method (Pearl-index \< 1%) of contraception (e.g. hormonal treatment, intrauterine device, vasoligation in the partner, sexual abstinent)
* Any current DSM-IV Axis I disorder not defined in the inclusion criteria requiring current additional treatment
* Motoric tics, siblings with tics or positive family history or diagnosis of a Tourette syndrome
* Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
* Known intolerance or lack of response to methylphenidate, as judged by the investigator
* Present pre-treatment with methylphenidate (within the last three month prior to study treatment)
* Intake of MAO-inhibitors within the last 14 days prior to study treatment
* Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
* Unstable or inadequately treated medical illness (e.g. Congestive Heart Failure / CHF, angina pectoris, hypertension, narrow angle glaucoma, hyperthyroidism, thyreotoxicosis, cardiac arrhythmia, cardiac infarction) as judged by the investigator.
* Epilepsy
* An absolute neutrophil count (ANC) of minor 1.5 x 10 exp 9 per litre
* Involvement in the planning and conduct of the study
* Previous enrolment or randomisation of treatment in the present study
* Participation in another drug trial within 4 weeks prior to enrolment into this study
* Moderate, severe, or profound mental retardation
* Heart pacemakers, cochlea implants, other metal parts in the head outside the mouth
Hyaluronic Acid Gel in Ridge Preservation

hyaluronic acid gel applied at the extraction socket after extraction immediately to preserve the socket from post extraction resorption. hyaluronic acid has ability for osteogenesis and new bone formation.

twenty-four patients with one hopeless tooth at least, first CBCt before extraction to evaluate the dimension of the socket, then atraumatic extraction of the tooth to preserve the bony wall of the socket, after extraction and curettage the socket applied hyaluronic acid gel inside the socket and applied collagen membrane to secure the socket. After 4 months of extraction, CBCt was done to evaluate the dimension of the socket and the effect of hyaluronic acid. Furthermore, The core biopsy was taken by trephine bur at the time of implant placement for evaluate the histological appearance of the bone to evaluate the secondary outcome. then after three months the crown was delivered as a prosthetic part.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire
2. Both genders.
3. Age from 20 -50 years old.
4. Having at least one hopeless teeth indicated for extraction.
5. Esthetic zone teeth (anterior or premolar).
6. Sockets type 1 or 2 .
7. Patient should agree to sign a written consent after the nature of the study will be explained.

   -

   Exclusion Criteria:

1- Smokers. 2- Pregnant and breast-feeding females. 3- Mentally retarded Patients. 4- Prisoners and handicapped patients. 5- Patients with malocclusion.

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High-protein Oral Supplement Improves Normalized Protein Catabolic Rate and Inflammation Markers

The investigators propose to determine the impact of high-protein beverages on protein status and inflammation markers among CKD patients undergoing hemodialysis. A 12-week double-blind randomized cross-over trial will be used in which participants (n=22) will consume a 4-ounce high protein supplement with either whey (20 g total protein) or soy (20 g total protein). Outcomes of interest include serum urea nitrogen and inflammation markers (CRP and IL-6). The findings will contribute to the knowledge gap regarding the effect of different protein types in CKD populations which can be translated to the development of affordable supplements to prevent malnutrition in adults with non-communicable diseases.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* diagnosed with stage 5 CKD for at least 3 months prior to the starting date of the trial
* 3 sessions of hemodialysis per week for at least three months prior to the starting date of the trial
* All participants have the ability to provide signed informed consent
* have not been newly diagnosed
* not present with symptomatic infection of COVID-19
* have no dietary restriction
* no food allergies
* no chewing/swallowing difficulties

Exclusion Criteria:

* CKD patient stages 1-4.
* CKD patient undergoing peritoneal hemodialysis.
* In isolation due to COVID-19 or other infectious disease
* Adult pregnant and/or lactating for the duration of the study.
* Any other renal disease autoimmune or otherwise.
* Use of other IP within 3 months prior of the eligibility screening.