cyrilzakka/clinical-trials huggingface dataset:
'Food, Fun, Fresh, Family' Program for Healthy Eating and Growth for Elementary-age Children.

The goal of this community-based randomized trial in elementary-aged children and a caregiver (parent/guardian) is to test the effect of providing families with produce and grocery store gift cards (family support) in conjunction with an after-school program for physical activity and healthy eating on improving children's overall diet, in comparison to the child only attending the after-school program without the family support.

Participating families will:

* receive weekly produce bags delivered to their home, recipes, and gift cards to a local grocery store (family support)
* the child will attend the after-school program during the school year

Researchers will compare the child's diet and eating scores with those in the after-school program alone.

Children in grades 1 to 5 and enrolled in after-school program offered by the Boys \& Girls Clubs of Austin Area (BGCAA) in selected schools, together with their caregiver (a parent/guardian), will be randomized into one of the two arms:

* Intervention group will receive, for 4 wks, 10 lbs of produce delivered weekly at home and one USD 20 gift card sent bi-weekly (total USD 40). Then, for 15 wks, the caregiver will receive every other week an electronic interactive health goals reminder survey to complete, for which they receive USD10 if completed. The goal sheets are optional activities.
* Control group will receive $120 as grocery store e-gift cards at the end of the study.

Regardless of the allocation arm, the child will attend the BGCAA's afterschool program as part of their family's association with the organization. The program runs daily, and the children are encouraged to attend at least 2x/wk. The "Coordinated Approach to Child Health" (CATCH) program will be delivered as part of the BGCAA program 2x/week.

Primary question: Does a 19-week after-school evidence-based program on nutrition education and physical activity for elementary-aged children improve overall child diet better when resources to encourage healthy eating are also provided to caregivers than when such resources are not provided?

Eligibility Criteria:
Inclusion Criteria:

* Index guardian must be at least 18 years old
* Child must be enrolled in grade 1 to 5 (aged approx. 6-11 y-o) for the 2023-2024 school year
* Child must be enrolled in the BGCAA after-school program at the beginning of the 2023-24 fall semester at one of the 11 sites where BGCAA offers after-school program to elementary school-aged children
* Index parent must be able to speak English and/or Spanish

Exclusion Criteria:

* Already having a sibling enrolled in the study
* Child having serious food allergies or dietary restrictions associated with produce products
Improving Otitis Media Care With Clinical Decision Support

This protocol will prospectively develop a new electronic health record (EHR)-based health information technology (IT) intervention that a) summarizes Otitis Media (OM) care into clinically meaningful episodes-of-care, b) provides clinical decision support based upon evidence-based guidelines to primary care and ENT physicians working within an integrated physician network that uses a common EHR, and c) tests the additive effects on quality and resource utilization of providing feedback to physicians.

Context The high prevalence of Otitis Media (OM) and its enormous cost make it a prime target for cost-effective and evidence-based strategies for disease management.

Objectives

This protocol will prospectively develop a new electronic health record (EHR)-based health information technology (IT) intervention that a) summarizes OM care into clinically meaningful episodes-of-care, b) provides clinical decision support based upon evidence-based guidelines to primary care and ENT physicians working within an integrated physician network that uses a common EHR, and c) tests the additive effects on quality and resource utilization of providing feedback to physicians. The specific aims are:

Aim 1: To develop and pilot test the OM health IT intervention; Aim 2: To examine the overall effect of the health IT intervention and the independent contribution of physician feedback on quality of OM care (primary outcomes); Aim 3: To assess the effects of the intervention on the secondary outcomes of health care resource utilization and clinician adoption of the health IT.

Study Design/Settings/Participants A cluster randomized trial and multi-level statistical modeling will be used to estimate health IT intervention effects on study outcomes. The proposed project will be conducted in the Children's Hospital of Philadelphia's (CHOP) health care system. The heath IT intervention will be tested in the Pediatric Research Consortium (PeRC), which includes 28 primary care practices in the CHOP network, both urban and suburban, and the CHOP ENT clinical sites. Randomization and implementation of the intervention will occur at the practice level. Study outcomes of quality of care and resource utilization will be reported at the levels of the practice, individual practitioner, and episode-of-care (patient-level).

Study Measures Our main study measures include the quality of otitis media care provided during episodes of OM.

Our secondary outcomes include measurement of clinician adoption of the health IT intervention and resource use.

Eligibility Criteria:
Inclusion Criteria:

* All CHOP primary care pediatric and ENT practice sites are eligible for inclusion in this study. We expect 35,000 patients to receive care for otitis media by CHOP clinicians at these sites during the study period however, they are not the subjects of this research.

Exclusion Criteria:

* There are no exclusion criteria. All CHOP primary care pediatric and ENT sites are eligible for participation. Data for all clinicians providing OM care and data on all OM encounters will be included in our data set.
Stimulating Catheter for Lumbar Plexus

Stimulating catheters have been introduced to reduce the incidence of secondary failure after continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating catheters is still controversial. Furthermore no volume-response study has compared the success rates of the two techniques for continuous lumbar plexus block. The aim of this prospective, randomized, blinded study is to detect if stimulating catheters decrease the minimal effective volume (MEAV) of 1.5% mepivacaine required for successful lumbar plexus block (LPB) in 50% of patients compared with conventional non-stimulating catheters.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing total knee arthroplasty

Exclusion Criteria:

* diabetes
* coagulation disorders
* allergy to local anesthetic
Dosing of Tenofovir and Efavirenz in Antiretroviral Therapy

Tenofovir+lamivudine+efavirenz is still the first line regimen of combination antiretroviral therapy in developing countries. Based on our previous data, we aim to evaluate whether reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects while not scarifying their virological efficacy.


Eligibility Criteria:
Inclusion Criteria:

* HIV antibody positive
* Chinese nationality
* Naïve to antiretroviral therapy
* Willing to start antiretroviral therapy
* Provision of written informed consent

Exclusion Criteria:

* Pregnant, breastfeeding, or lactating
* Females try to get pregnant during the research period
* Subjects who allergic to any of the research drugs
* Subjects that taking other drugs that known to impact the absorption, distribution, metabolism and excretion of the research drugs
* Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with treatment, assessment, compliance with the protocol, or subject safety. This would include any active clinically significant renal, cardiac, pulmonary, vascular, or metabolic (thyroid disorders, adrenal disease) illness, or malignancy
* Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
* Laboratory blood values:
* Haemoglobin \<9.0 grams/decilitre (g/dL)
* Neutrophil count \<1500/mm3
* Platelet count \<75,000/mm3
* Aspartate aminotransferase or Alanine transaminase \>3 times Upper Limit of Normal (ULN)
* Total bilirubin \>3 times Upper Limit of Normal (ULN)
* Subjects with an estimated creatinine clearance of \<90 mL/minute
Add-on Study for Protocol G200802 (NCT02463032): Effect of GTx-024 on Maximal Neuromuscular Function and Lean Body Mass

This is a multiple site, proof of concept feasibility study to describe the effect of GTx-024 9 or 18 mg on physical function in female subjects, from protocol G200802, with ER+/AR+ breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. In screening for, and ultimately randomized into, protocol G200802
2. Give voluntary, written and signed, informed consent for this add-on study
3. Age 18 to 70 years old
4. Physically capable of mounting and riding a stationary bicycle
5. Subject agrees to not significantly alter physical activity or current physical training during the study period

Exclusion Criteria:

1. Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator
2. Subjects unwilling to or unable to comply with the protocol
3. Any other condition which per investigators' judgement may increase subject risk
Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer

The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System by comparing its performance to permanent section Hematoxylin and Eosin (H\&E) and IHC staining.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients, over the age of 18, diagnosed pre-surgically with T1 or T2 breast cancer and scheduled for surgery including sentinel node dissection.
* Patients who have read and understand the informed consent form and are capable and willing to provide written informed consent.

Exclusion Criteria:

* Patients diagnosed pre-surgically with large or locally advanced (T3 and T4) breast cancers.
* Patients diagnosed with inflammatory breast cancer.
* Patients diagnosed with ductal carcinoma in situ (DCIS) when breast conserving is to be done.
* Patients who are pregnant, as confirmed by a patient/treating physician interview.
* Patients with suspicious palpable axillary lymph nodes.
* Patients currently being treated for or previously diagnosed with, another type of carcinoma.
* Patients who have undergone prior non-oncologic breast surgery or axillary surgery.
* Patients who have received pre-operative systemic therapy.
* Patients who are incapable of providing written informed consent.
* Patients who have been judged to be inappropriate by a medical care provider (i.e. surgeon, oncologist, pathologists, etc.).
A Prospective, Observational, Multicentre, 2 Year Study Evaluating the Use of Eylea (Aflibercept) for the Treatment of Neovascular (Wet) Age-related Macular Degeneration in UK NHS Opthalmology Clinics

To assess the use of aflibercept over a 2 year period in VEGF inhibitor naive and prior treated wet AMD patients managed in 'real wold' clinic settings.


Eligibility Criteria:
Inclusion Criteria:

- Age greater or equal to 50 years Active choroidal neovascularisation secondary to AMD in one or both eyes which in the opinion of the investigator will benefit from treatment with aflibercept Subject willing and able to provide informed consent

Exclusion Criteria:

- Patients must not have had any prior use of either bevacizumab or aflibercept

Other protocol-defined inclusion/exclusion criteria may apply
BKM120 for Patients With PI3K-activated Tumors

The purpose of this signal seeking study was is to determine whether treatment with BKM120 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.


Eligibility Criteria:
Inclusion Criteria:

* Patient had a confirmed diagnosis of a solid tumor or hematological malignancy with the exception of endometrial cancer, glioblastoma, nonsmall cell lung cancer, prostate cancer or breast cancer.
* Patient's tumor was evaluated and pre-identified to have activation of the PI3K pathway, at a CLIA certified laboratory
* Patient must have received at least one prior treatment for recurrent metastatic and /or locally advanced disease and for whom no standard therapy options was anticipated to result in a durable remission.
* Patient must have had progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines
* Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

Patient had received previous treatment with BKM120 Patient had symptomatic CNS metastases Patient had mood disorder as outlined in Section 5 Patient had received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug.
Hepatitis B Vaccine Genetics: A Substudy of ATN 024 and ATN 025

This laboratory-based substudy of an effectiveness trial of two Hepatitis B vaccines in HIV-negative youths is being done to evaluate the genetic contribution to the individualized immune response.

This laboratory-based substudy of ATN 024 and 025 will evaluate the genetic contribution to highly individualized immune responses to hepatitis B vaccine in individuals and confirm the correlation of specific human leukocyte antigen (HLA) alleles and haplotypes with Hepatitis B Virus (HVB) antibody concentrations and antibody decay kinetics in vaccinated adolescents. Approximately 5 ml of whole blood will be collected from study participants at the time of the week 28 visit or at any subsequent study visit or clinic visit following successful completion of the week 28 visit. Peripheral blood mononuclear cells will be obtained and QIA amp Blood kit will be used to extract high-quality genomic DNA for polymerase chain reaction-based genotyping by the PEII laboratory.

The study is expected to be available for the duration of the parent studies which is approximately 2 years. This study requires one visit that may be arranged to coincide with a study or routine clinic visit. There are no follow up visits.

Eligibility Criteria:
Inclusion Criteria:

* Subjects currently enrolled in ATN 024 or ATN 025 are eligible for enrollment in ATN 052 beginning at or following completion of the week 28 visit.
* Subjects previously enrolled in ATN 024 or ATN 025 are eligible for enrollment in ATN 052, unless the subject was prematurely discontinued from the study prior to the first post-vaccination serology assessment which is performed at week 28.
* Current pregnancy is permitted.
* A signed informed assent/consent must be obtained from the subject.
* Written parental or guardian permission must be obtained where required by the institutional review board/ethics committee (IRB/EC).

Exclusion Criteria:

* Inadequate post-vaccination serology evaluation in ATN 024 or ATN 025.
* Unable to obtain informed consent and/or parental/legal guardian permission where required by the local IRB/EC.
Binaural Beats Dysmenorrhea And Sleep Quality

The research is a randomized controlled trial. The sample group will consist of 120 people; 60 participants will be included in the experimental group, and 60 will be included in the control group. In the study, the participants in the experimental group will listen to the alpha sound for pain for 10 minutes and the delta sound for sleep for 15 minutes via the mobile application three days a week. The researchers will not intervene with the control group during the study. During the study, only the data collection tabs of the mobile application will be active for the control group, and the use of the sounds will be opened at the end of the study. The study data were used in the personal identification form, menstruation symptom scale, Pittsburgh sleep quality index, and Women's Health Initiative Insomnia Scale.

Binaural beats are based on creating a physiological response by applying sound at different frequencies to both ears. The brain perceives the sound given at different frequencies to both ears as a single frequency. The perception of different frequency sounds as a single frequency is called binaural integration. EEG studies suggest that binaural beats can affect electrocortical activity; that is, they can modulate the frequency of neuronal oscillations without requiring prior training. Binaural beats application reduces pain, anxiety, and stress and improves sleep quality in individuals. Binaural beats is a non-pharmacological application that does not require any training before application. No side effects have been reported in the studies conducted in the literature, and it is also emphasized that it is an effective, cheap, safe, and non-pharmacological application. From this point of view, this study aims to determine the effect of binaural beats on sleep quality and dysmenorrhea during menstruation.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Having headphones (for the experimental group)
* Having pain of 4 and above according to the numerical pain scale
* Taking a Women's Health and Diseases Nursing Course
* Not using medication during menstruation
* Not using sleeping pills
* Being single
* Not using contraceptives
* Not having a hearing problem
* Not having a psychiatric problem
* Not having alcohol or substance addiction constitutes the inclusion criteria of the study.

Exclusion Criteria:

* Not listening to binaural sounds for two days or more on the days specified in the mobile application
* Using analgesics during menstruation while the study is ongoing
* Experiencing irregular menstrual bleeding in the last three months constitutes the study's exclusion criteria.
68Ga-OPS202 Study for Diagnostic Imaging of GEP NET

The purpose of this study is to assess the safety and tolerability of 68Ga-OPS202 used for the diagnosis of gastroenteropancreatic neuroendocrine tumors (GEP NETs).


Eligibility Criteria:
Inclusion Criteria:

* A diagnostic CT or MRI of the tumor region within the previous 6 months prior to dosing day is available.
* A somatostatin receptor scan with results in the previous 6 months prior to dosing day.
* At least 1 lesion detected by the previous somatostatin receptor scan.
* Not exceeding 30 lesions / organ detected by the previous somatostatin receptor scan.
* Blood test results as follows (WBC: ≥ 3\*109/L, Hemoglobin: ≥ 8.0 g/dL, Platelets: ≥ 50x109/L, ALT, AST, AP: ≤ 5 times ULN, Bilirubin: ≤ 3 times ULN)
* ECG: any abnormalities have to be clarified by a cardiologist.
* Serum creatinine: within normal limits or \< 120 μmol/L for patients aged 60 years or older.
* Calculated GFR ≥ 45 mL/min.
* Negative pregnancy test in women capable of child-bearing.

Exclusion Criteria:

* Known hypersensitivity to 68Ga, to NODAGA, to JR11 or to any of the excipients of 68Ga-OPS202.
* History of, or current active allergic or autoimmune disease, including asthma or any condition requiring long-term use of corticosteroids.
* Presence of active infection at screening or history of serious infection within the previous 6 weeks.
* Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B and C.
* Any condition that precludes raised arms position for prolonged imaging purposes.
* Neuroendocrine tumor specific treatment between last somatostatin receptor imaging and start of this study. Exception is the therapeutic use of any somatostatin analog (see below).
* Therapeutic use of any somatostatin analog, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug. If a patient is on Sandostatin® a wash-out phase of 2 days is required before the injection of the study drug.
* Administration of another investigational medicinal product within 30 days prior to entry.
* Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study.
* Current \> grade 2 toxicity from previous standard or investigational therapies, per US-NCI "Common Terminology Criteria for Adverse Events v4.0".
* Pregnant or breast-feeding women.
* History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
* Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.
* Current history of malignancy; patients with a secondary tumor in remission of \> 5 years can be included.
Degenerative Scoliosis

Several deformities of the spine exist such as degenerative lumbar scoliosis. These deformities can generate functional discomfort and limit the patient's quality of life.

In the event of severe trunk imbalance and progression of the deformity, operative correction of the spinal deformity by instrumentation and posterior arthrodesis may be indicated.

Surgical techniques and instrumentation have evolved over the past 5 years. These changes in surgical strategies have a potential impact on the patient's quality of life and the correction results in the medium and long term.

The aim of the study is the analysis of surgical corrections obtained and radiological changes over time with classic 2-rod techniques versus modern 4-rod instrumentation techniques


Eligibility Criteria:
Inclusion criteria:

* Major subjects\> 18 years old
* Subject with a surgical indication for arthrodesis and surgical correction of degenerative scoliosis
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice
Behavioral Therapy Development for Methamphetamine Abusers

The purpose of this study is...to assess whether placing a substance abuse intervention for HIV+ methamphetamine users within an HIV medical care setting improves rates of follow-up on referral to treatment by primary care physicians; reduces drug use and sexual risk behaviors more than treatment-as-usual; and increases rates of adherence to HIV medication regimens.


Eligibility Criteria:
Inclusion Criteria:

1. HIV-seropositive, GBM receiving medical treatment for HIV for at least 30 days prior to signing informed consent at the UCLA CARE clinic, aged 18-65
2. Willing to give informed consent and comply with study procedures;
3. Willing to provide consent to contact treating physicians and pharmacies to assess adherence to HIV medications;
4. Diagnosed with current methamphetamine abuse as determined by MINI; and
5. Interested in seeking treatment for their methamphetamine abuse and in participating in this research project.

Exclusion Criteria:

1. Unwilling to give, or withdrawal of, informed consent;
2. Inability to understand nature of study;
3. A psychiatric condition that, in the principal investigator's judgment, warrants additional intervention to ensure participant safety (e.g., meets DSM-IV-TR criteria for current bipolar disorder or a psychotic disorder);
4. Current suicidal ideation or suicide attempt within the past 3 months; and
5. Concurrent dependence on opiates, alcohol, or benzodiazepines as determined by MINI.
6. Total lack of any type of healthcare coverage. These potential participants will be given low-fee treatment referrals.