cyrilzakka/clinical-trials huggingface dataset:
Resilience Through Interventions for Successful Early Outcomes

Purpose: The purpose of this research is to determine the effects of Attachment and Biobehavioral Catch-up (ABC), an evidence-based parenting program, on stress biomarkers in children.

Participants: The study will involve approximately 150 caregiver-child dyads, with children aged between 24 and 42 months. Participants will include primary caregivers fluent in English or Spanish, along with their children who have experienced social risk factors for adversity.

Procedures (Methods): Participants will be randomly assigned to either receive the ABC parenting program (10 sessions) immediately or be placed on a wait-list, receiving the program after about 4 months. The study procedures include caregivers completing online surveys, engaging in play-based observational tasks with their children, and collecting non-invasive biological samples (saliva, cheek swab, hair) from the children and saliva samples from the caregivers at 2-3 time-points.


Eligibility Criteria:
Parent/Caregiver Inclusion Criteria :

* Aged 18 or older
* Speaks English or Spanish
* Is the parent or legal guardian with legal custody of a child aged between 24 months and 42 months
* Is a primary caregiver/parent
* Has a home-like environment in which to participate in the intervention

Child Inclusion Criteria:

* Aged between 24 months and 42 months at enrollment
* Lives with the parent/caregiver at least 50% of the time
* Has experienced social risk factors, including low income, community or family violence, previous trauma/adversity exposure, prolonged separation from caregiver, significant difficulties in relationship with caregiver Child Exclusion Criteria
* Has a diagnosed genetic or congenital disorders, including but not limited to Down syndrome, cerebral palsy, seizure disorders, endocrine disorders (or is using steroid medications, including human growth hormone), or was born with birth defects
Perioperative Pain Management for Cleft Lip in Children

Single blind prospective randomized comparative study. 76 children between 6 months and 3 years with cleft lip will be divided in two groups. 38 children group C conventional group and 38 children group S infraorbital nerve block group.


Eligibility Criteria:
Inclusion Criteria:

* good physical condition.
* Age 6 months to 3 years.
* Scheduled to undergo operations for cleft lip repair. Genders eligible for study are both .

Exclusion Criteria:

* Children posted for combined procedures like congenital heart correction with palatoplasty .
* Parents refusal .
* Bleeding disorders( platelets count \< 100.000 , international ratio \>1.5).
* Skin lesions or wounds at site of needle insertion .
* Co-morbidities as congenital heart disease , lung pathology or central nervous system
* Known hypersensitivity to local anesthetics or opioids .
The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation

The purpose of this study is to estimate the EC90 of remifentanil blunting hemodynamic changes to head fixation in the patients undergoing neurosurgery.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing neurosurgery that require head fixation with mayfield head holder
* patients who agree to our study

Exclusion Criteria:

* patients who don't agree to our study
* BMI\<16.0 or BMI\>30
* cardiovascular disease, pulmonary disease, renal disease
* alcoholic abuser or drug abuser
* patients who takes any drug having an influence on cardiovascular system or sympathetic nervous system
* any use of local anesthetics or drugs which have an influence on cardiovascular system from beginning of induction to peri-fixation period
A Platform for Multidisciplinary Medical Artificial Intelligence Development

Biomedical deep learning (DL) often relies heavily on generating reliable labels for large-scale data and highly technical requirements for model training. To efficiently develop DL models, we established an integrated platform to introduce automation to both annotation and model training-the primary process of DL model development. Based on this platform, we quantitively validated and compared the annotation strategy and AI model development with the pure manual annotation method performed on medical image datasets from multiple disciplines.


Eligibility Criteria:
Inclusion Criteria:

* have medical imaging record (including ophthalmology, pathology, radiography, blood cells, and endoscopy)

Exclusion Criteria:

* unqualified medical imaging
A Time-to-effect Based Dosing Strategy in Cryoballoon Ablation of Patients With Paroxysmal Atrial Fibrillation

This study aims to validate a new dosage of cryotherapy based on time to effect in pulmonary vein ablation procedures in patients with paroxysmal atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with at least 2 documented episodes of paroxysmal Atrial Fibrillation (AF) which are not responders to at least one antiarrythmic drug

Exclusion Criteria:

* Previous left atrial ablation procedure or surgery
* left atrium diameter \> 50mm
* presence of intracardiac thrombus
* Left ventricular ejection fraction \< 40%
* Heart failure class III-IV
* Severe valvulopathies
* Acute coronary syndrome or cardiac surgery within the previous 3 months of enrollment
* Transient ischemic attack/stroke within the previous 6 months of enrollment
* life expectancy less than 1 year
* Any contraindication to the procedure according to the current clinical practice
EPI-743 in Friedreich's Ataxia Point Mutations

The purpose of this study is to evaluate the effects of EPI-743 in patients with Friedreich's Ataxia point mutations

The primary objective of this study is to investigate whether treatment with EPI-743 has a discernible impact on visual function-including visual acuity, visual fields and color vision as well as on any of a number of functional and subject/clinician-rated scales relevant in the treatment of Friedreich's ataxia, and to determine the safety of treatment with EPI-743.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of genetically confirmed Friedreich's ataxia point mutation.
2. Visual acuity at baseline more than 15 letters on high contrast EDTRS at four meters.
3. FARS score of 20 to 90.
4. Male or female between 18 and 65 years of age.
5. Agreement to use contraception if within reproductive years
6. Hormone replacement therapy, if used, must remain stable for the duration of the study.
7. Willingness and ability to comply with study procedures.
8. Willingness and ability to arrive at study site metropolitan area day prior to evaluations.
9. Abstention from use of dietary supplements and non-prescribed medications at least 30 days prior to initiation of treatment and for the duration of the study. This would specifically include idebenone, Coenzyme Q10 and vitamin E.
10. Abstention from foods or beverages or bars fortified with Coenzyme Q10, vitamin E, super fortified functional foods or beverages at least 30 days prior to initiation of treatment and for the duration of the study.
11. Abstention from use of other investigative or non-approved drugs within 30 days of enrollment and for the duration of the study.
12. Subject can swallow multiple size 0 capsules.
13. Subject has voluntarily signed an IRB approved informed consent form to participate in the study after all relevant aspects of the study have been explained and discussed with the subject.

Exclusion Criteria:

1. Allergy to EPI-743 or sesame oil or nuts.
2. Clinically significant bleeding condition or abnormal PT/PTT INR (INR \> two; PTT \> two-times normal).
3. Liver insufficiency with LFTs greater than three-times upper normal limit at screening.
4. Renal insufficiency with creatinine \> 1.5 at screening.
5. Fat malabsorption syndromes.
6. Any other respiratory chain diseases of the mitochondria or inborn errors of metabolism.
7. Any other ophthalmologic conditions.
8. Clinically significant cardiomyopathy with ejection fraction \< 40 percent at screening.
9. Clinically significant arrhythmia within past two years requiring treatment.
10. Surgery planned through the duration of the study, including follow-up.
11. Pregnancy or breastfeeding.
12. Anticoagulant therapy within 30 days of enrollment.
A Phase 2, Open-Label, Multicenter Study of the GARFT Inhibitor in Patients With Metastatic Non-Small Cell Lung Cancer

The primary objective of this study is to determine safety and activity of a novel anticancer agent in patients with metastatic non-small cell lung cancer who failed 2 or 3 prior systemic treatments.


Eligibility Criteria:
Inclusion Criteria:

* presence of measurable, metastatic non-small cell lung cancer (histologically or cytologically confirmed at the time of original diagnosis)
* treatment failure (recurrence, disease progression, or intolerable toxicity) of 2 or 3 prior systemic treatments. (Note: no more than 3 prior systemic regimens for non-small cell lung cancer including adjuvant chemotherapy)
* capable of understanding the nature of the trial and willing to give written informed consent
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
* hemoglobin level of \>=9 g/dL, absolute granulocyte count of \>=1.5 \&#215; 109/L, and platelet count of \>=100 \&#215; 109/L
* adequate renal function, as documented by a serum creatinine level of \<=1.5 times the institutional upper limit of normal (ULN) and a measured or calculated creatinine clearance of \>=60 mL/min
* adequate liver function, as demonstrated by a total bilirubin level of \<=1.5 times ULN; levels of serum glutamate oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \<=2 times ULN. If the patient has liver involvement then AST and ALT should be \<=5 times ULN
* for men with partners of child-bearing potential and all women of childbearing potential, willingness to use adequate contraception or practice abstinence during the course of the study at least 18 years of age
* life expectancy estimated at greater than 12 weeks

Exclusion Criteria:

* history of blood transfusion within the last 14 days
* need of concurrent administration of allopurinol
* history of radiotherapy or chemotherapy within 4 weeks (nitrosourea or mitomycin C within 6 weeks) of the anticipated first day of dosing (patient must be fully recovered from the acute effects of any prior chemotherapy or radiotherapy)
* any psychological or sociological condition, addictive disorder, or family problems that might preclude compliance with the protocol
* any unstable or severe intercurrent medical condition that in the opinion of the investigator might interfere with achievement of study objectives
* receipt of an investigational agent within 28 days before the anticipated first day of dosing (patient must have recovered from all acute effects of previously administered investigational agents)
* pregnant or breast-feeding
* previous treatment with GARFT inhibitors
* history of radiation therapy to more than 40% of the marrow space
* history of a malignancy (other than non-small cell lung cancer) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years
* active brain metastases (requiring treatment or progressing)
Cognitive-behavioral Intervention to Increase the Practice of Responsive Feeding and Maintain Healthy Weight in Infants

Introduction: Childhood overweight and obesity in Mexico is a serious public health problem. Perceptive eating is a factor in the prevention of obesity and occurs when the caregiver recognizes the signs of hunger and satiety, responds in a timely manner to these needs. However, its implementation is often a challenge for parents. Studies show that there is low knowledge and self-efficacy, as well as erroneous beliefs about food. Teaching perceptive eating can lead to: the development of healthy eating habits, generate warm environments in which the interaction between parents and children is strengthened and promote self-regulation of hunger and satiety sensations and prevent overweight and obesity. Interventions on Responsive Feeding for the prevention of healthy weight in infants under six months of age are null in Mexico. Objective: To evaluate the effect of the intervention: \&#34;Identify and Respond\&#34; aimed at Mexican mothers to increase the practice of Responsive Feeding and maintain a healthy weight in children under 6 months of age. Methodology: The present study will be a pilot clinical trial type intervention study because the preliminary effect will be evaluated where the Experimental Group will receive the intervention aimed at increasing the practice of Responsive Feeding , there will be randomization of repeated measurements by virtue of which measurements will be made at three times: before the intervention (baseline) and follow-up (post-test 3 and 6 months later). The sample consisted of 72 mothers with children younger than 6 months for each group (N=144).


Eligibility Criteria:
Inclusion Criteria:

* Mother/child dyad, apparently healthy.
* Minimum of 12 hours postpartum and/or cesarean section.
* Mother who knows how to read and write.
* Mother who has a smartphone.
* Mother with internet access.
* Mother who agrees to participate in the study.

Exclusion Criteria:

* Hospital stay of the mother/child dyad for more than 7 days after birth.
* Child-related exclusions:
* Gestational age under 37 weeks (SDG).
* Presence of a congenital anomaly.
* Physical disability that could affect feeding (e.g., cleft palate, cleft lip).
* Low birth weight (\< 2,500 g).
The Effects of Ankle Foot Orthoses on Gait Efficiency in Children With Acute Lymphoblastic Leukemia and Foot Drop

This study is designed to see if children with acute lymphoblastic leukemia who have developed foot drop during treatment for their leukemia consume less oxygen when walking with or without an ankle brace designed to support their foot during walking. In this study children with foot drop are asked to walk for six minutes with and without brace on their ankle. During each walk, the amount of oxygen used is measured. The child wears a face mask which is attached to a device that records how much oxygen they use. The amount of oxygen used during the walk with the brace on will be compared to the amount of oxygen used with the brace off.

1. This study will determine the impact of Ankle Foot Orthoses (AFO) wear on gait efficiency in children with ALL and Chemotherapy-Induced Peripheral Neuropathy (CIPN).
2. The study hypothesizes that children with CIPN will have lower net oxygen consumption during the six minute walk test while wearing AFO as compared to their net oxygen consumption during a six minute walk test while not wearing AFO.
3. The study will assess whether gait efficiency while using an AFO persists after one month of use.
4. The study will hypothesize that the benefits of AFO use on gait efficiency persist after one month of wear.

Eligibility Criteria:
Inclusion Criteria:

1. Research participant is diagnosed with childhood ALL and currently being treated on the TOTAL XVI protocol at St. Jude Children's Research Hospital (SJCRH)
2. Research participant is from 6 to 18 years of age at the time of the scheduled evaluation
3. Research participant has chemotherapy-induced peripheral neuropathy resulting in foot drop
4. Research participant will be receiving AFO
5. Research participant has a hemoglobin level greater than 8 g/dL and a platelet count above 50 x 109/L

Exclusion Criteria:

1. Participant has Down Syndrome or other known congenital developmental delays
2. Participant has a platelet count lower than 50 x 109/L and a hemoglobin level less than 8 g/dL
3. Participant has a lower extremity amputation, congenital deformity of the lower limb or an acute fracture of the lower limb
4. Participant has symptomatic osteonecrosis in the lower extremities
Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children

The objective of this study is to compare intraoperative and recovery parameters in patients who receive two different dose combinations of propofol and remifentanil in patients undergoing a lumbar puncture.

Lumbar punctures (LP) are performed in approximately one thousand oncology patients per year at the Hospital for Sick Children. In a previous study, we determined the optimal dose of remifentanil which provides effective anesthesia with little or no movement during LP in children. The present study will determine the optimal dose combination of propofol and remifentanil to keep patients comfortable and still during the procedure while decreasing the incidence of side effects and allows for shorter recovery times and earlier discharge from the recovery room.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of a hemato-oncological disorder
* Scheduled to undergo a lumbar puncture
* Aged 3-12 years
* Unpremedicated

Exclusion Criteria:

* children who are known or suspected to be difficult to ventilate by face mask
* children who are deemed medically unfit to receive either of the two study medications
* children who are obese (weight for height \> 95th percentile)
* children who do not have an indwelling intravenous line
Patient Understanding of End of Life Care

This study aims at assessing factors that affect patient choices for end of life care. 300 patients would be assigned either to a control arm (questionnaire alone) or intervention arm (standardized explanation+ questionnaire). Our intervention is a standardized explanation which explains what code status, advance directive and end of life care mean. Based on patient responses, factors that affect choices of code status would be analyzed. We will also evaluate if a standardized explanation improves patient understanding of end of life issues. This would be determined by generating a composite score of correct responses to a subset of objective questions in the questionnaire


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Admitted to regular nursing floor

Exclusion Criteria:

* altered mental status
* admitted in ICU
* positive screening for depression
* terminal illness defined as life expectancy\< 100 days
* inability to consent
Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use

Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks associated with its use. While treatment programs that focus on stopping tobacco use may be effective, past research has shown that interventions that specifically focus on reducing tobacco use may be equally effective and may motivate individuals to eventually quit using tobacco. This study will compare the effectiveness of a ST reduction treatment program versus a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.

Individuals who use ST are at increased risk for cancer or dying from cardiovascular disease. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Many individuals who use ST recognize the health risks associated with ST, but either do not want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. By participating in a tobacco reduction program, these individuals may be motivated to eventually stop using tobacco altogether. The purpose of this study is to compare a ST reduction treatment program versus a standard tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.

This study will enroll regular users of ST. Participants will be randomly assigned to either a tobacco reduction program or to usual care, a standard tobacco cessation program during the first telephone contact. At the first clinic visit, participants assigned to the tobacco Reduction Group will replace their usual brand of ST with one of two options: an ST brand with less nicotine or nicotine lozenge. Participants will be encouraged to reduce their nicotine intake by at least 50% the first two weeks and encouraged to further reduce their nicotine intake in the following 4 weeks. Participants assigned to the Usual Care Group will be advised to quit and will be asked to set a quit date within two weeks. Telephone counseling, ideas on methods for sustaining cessation, and a self-help manual will also be provided along with a 2 week supply of nicotine patches. Study visits will occur at 2, 4, 8, 12, 26, and 32 (for reduction group) weeks. Outcome assessments will include vital signs, physiological measures related to tobacco use, levels of nicotine reduction, tobacco use status, and measures of motivation and self-efficacy to quit.

Eligibility Criteria:
Inclusion Criteria:

* No interest in stopping ST use within 90 days of study entry
* Daily use of ST in the 6 months prior to study entry

Exclusion Criteria:

* Current use of tobacco or nicotine products, other than ST
* Current unstable medical and mental health conditions
* Use of any medication that may affect tobacco use or be affected by a reduction in tobacco use
* Pregnant or breastfeeding
Diagnostic Yield of Transbronchial Cryobiopsy in Diagnosis of Interstitial Lung Diseases

Evaluation of diagnostic yield, feasibility and safety of transbronchial lung cryobiopsies done via bronchoscopy in the investigation of interstitial lung disease in comparison with videothoracoscopy-assisted surgical lung biopsy.

See above

Eligibility Criteria:
Inclusion Criteria:

* Volunteer subjects with interstitial lung disease in whom a surgical lung biopsy is planned for diagnostic investigation.

Exclusion Criteria:

* Aged less than 18 y.o.
* Pregnancy
* Known coagulatoin disorder or blood dyscrasia
* Aaking antiplatelet agents other than aspirin or therapeutic anticoagulants drugs that cannot be safely discontinued to undergo lung biopsy
* Arterial oxgen pressure less than 60 mmHg on more than 2 liters per minute oxygen
* Known pulmonary hypertension defined as systolic PAP above 40 mmHg on echocardiography
* Unable to provide informed consent