cyrilzakka/clinical-trials huggingface dataset:
Task-Based Grounding Program

The purpose of this study is to improve the availability of brief interventions to help children with defiant, aggressive and disruptive behaviors by creating a brief scalable intervention for parents delivered via telehealth. As phase 1 study, we are conducting a 2-arm pilot feasibility RCT in order the intervention, measures, and procedures to be used in a larger efficacy trial. The first arm will include a 3-session behavioral therapy treatment we call Task-Based Grounding and the second arm will be an enhanced treatment as usual comparison group.

The investigators have developed a 3-session psychosocial intervention for parents of children between 9-14 with disruptive behaviors. The intervention uses telehealth visits along with written and online resources to teach them parent management skills. To evaluate the acceptability of this intervention and the feasibility of our methods, the investigators will recruit 20 parent-child dyads to participate in this study. This is a mixed methods pilot feasibility RCT design. The investigators designed this study to test the acceptability of the intervention to parents and test the feasibility of our recruitment, retention, measurement, and delivery mechanisms for both the experimental and comparison conditions. The investigators will use a block randomization method to separate parent-child dyads into either treatment or comparison groups. The treatment condition involves 3 telehealth visits and a set of parenting resources. The enhanced treatment as usual condition will involve contact with a "care navigator" that will assess behavior problems in the child and help the parents find an appropriate referral to care in their community. Both groups will be followed for 10 weeks, provide outcome data, and participate in semi-structured qualitative interviews to accept acceptability.

Eligibility Criteria:
Inclusion Criteria:

* Participating parent-child dyads must include a child between the ages of 9-14 years old and adult over the age of 18.
* The child must have a Vanderbilt Oppositional Defiant Disorder score \>3
* The participating caregiver must be a legal guardian of participating child

Exclusion Criteria (child refers to the primary participant's child)

* Child ever been hospitalized for a psychiatric problem
* Child ever attempted suicide or stated that they had a plan to attempt suicide within the past year.
* Child ever engaged in self-harm behaviors
* Child has significant legal history such as adjudicated of a crime or been in diversion
* Child has ever been diagnosed with: Obsessive Compulsive Disorder, Post Traumatic Stress Disorder, Intellectual Disability or Developmental Delay, Speech or Hearing Delay, Autism Spectrum Disorder, Schizophrenia or another psychotic disorder, A substance abuse disorder (or had serious concerns about substance use).
* Parent can communicate in spoken English
* Parent is under the age of 18.
Prediction of Peripheral Neuropathy With Functional Testing

Diabetes and chronic kidney disease (CKD) are two distinct pathologies. The former is defined as an impairment in insulin production and/or utilization, while the latter refers to structural or functional abnormalities of the kidneys. However, these two diseases share a common complication: peripheral neuropathy. This condition affects between 50% and 60% of patients with diabetes or CKD.

Peripheral neuropathy involves the destruction of sensory and motor neurons, leading to a wide range of painful symptoms while also reducing force production capacity. Among the diagnostic tests used, the most accessible clinical tests suffer from high variability due to human subjectivity (e.g., the tuning fork test, which requires examiner expertise and verbal patient feedback), whereas laboratory electrophysiological tests can only detect the largest neurons, which are affected at later stages. Although composite clinical tests have been developed to improve neuropathy screening performance, they still inherit the limitations of their individual components. In other words, they remain subject to variability related to the examiner's experience and the patient's ability to understand instructions, while also being performed through various procedures that lack a standardized consensus. Moreover, these composite scores are particularly time-consuming and are therefore rarely used in clinical practice. As a result, no method currently allows for large-scale, early, and reliable screening of peripheral neuropathy.

Our recent work and emerging studies suggest that assessing functional capacities could serve as an objective and early marker of neuropathic impairment, even before clinical diagnosis. Specifically, the quantification of postural balance performance using stabilometric methods (i.e., center of pressure displacement area) and unipedal balance time could predict the presence of diabetes-related peripheral neuropathy with over 95% accuracy compared to diagnosis with a composite clinical method (unpublished results).

Therefore, the aim of this study is to evaluate physical and balance capacities assessed during routine care in adapted physical activity settings, in order to determine whether the development of a composite score could help estimate the risk of peripheral neuropathy in individuals with diabetes and CKD.


Eligibility Criteria:
Inclusion Criteria:

* CKD stage 4-5 and / or diabetes (Type I or II)
* Able to walk 20 m
* BMI \< 35

Exclusion Criteria:

* Currently or planning dialysis
* Musculoskeletal, osteorarticular and neurological disease(s)
* Cognitive impairment
* Low-limb amputation
Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction

Neoadjuvant radiotherapy(NART) followed by mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. However, reports of NACT followed immediate implant-based breast reconstruction are rare. Some studies have shown that NART followed immediate implant-based breast reconstruction seems feasible and can be safely attempted. It's well known that radiotherapy after implant-based breast reconstruction have negative effects on implant and cosmetic results. So, investigators conducted a polit study to learn about acute post-surgical complications following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART.

Radiotherapy after implant-based breast reconstruction have negative effects on implant and cosmetic results, including severe capsular contracture, mastectomy flap necrosis ,reoperation and so on. Postmastectomy radiotherapy( PMRT )is associated with implant reconstruction failure. PRADA study has shown neoadjuvant radiotherapy followed by skin-sparing mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. The investigators assume that neoadjuvant radiotherapy can avoid the negative effects of PMRT on an implant and the capsule of an implant and would lead to better cosmetic results and less complications compared to PMRT. Furthermore, some studies have shown that NART could potentially result in shorter time between diagnosis and treatment completion. So, investigators conducted a polit study to learn about acute post-surgical complications following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART.

Eligibility Criteria:
Inclusion Criteria:

Women \>18 years with histopathologically-confirmed breast cancer, who:

* require mastectomy for any reason
* a known indication for (adjuvant) radiotherapy
* require implant-based breast reconstruction

Exclusion Criteria:

* Inability to give informed consent
* MDT unable to make recommendation for radiotherapy based on pre-operative histopathological and imaging findings
* Previous history of breast cancer or another malignancy for which radiotherapy of the breast or axilla
* Pregnant or lactating
* inflammatory breast cancer
Education and Group Support for Diabetic Hispanics

The purpose of this ongoing work in Starr County, located on the Texas-Mexico border, is to conduct clinical studies to determine the effectiveness of diabetes self-management programs designed specifically for Mexican Americans. The programs meet national standards for diabetes self-management education. They are provided in community settings with the primary purpose of improving the health of Mexican Americans with diabetes and their family members, who either have diabetes or are at risk for developing diabetes.

The diabetes self-management programs are provided in Spanish and are directed by bilingual Hispanic clinical nurse specialists, dietitians, and community health workers. Key elements of the programs include instruction on nutrition, self-monitoring of blood glucose, exercise, and other diabetes self-management topics, as well as group support to promote behavioral changes.

In the original study (1994-1998), 256 Mexican American adults diagnosed with type 2 diabetes and 256 family members or other support persons were enrolled. For one year, the people with diabetes, along with their family members, attended small group sessions held in churches, community health clinics, adult day care centers, and schools. Information on the effectiveness of the program was collected at 3, 6, and 12 months; and annually thereafter.

Findings of the original study suggested that the program had a positive impact on diabetes metabolic control. Levels of diabetes knowledge and rates of glucose self-monitoring and attendance suggested that a shorter program - one that incorporated critical elements of the previous successful strategy - might result in similar improvements. Thus, the goal of the new study, funded in June 1999, was to shorten the original program and to compare it to the previous successful program in terms of short- and long-term health outcomes.

To identify key components of the previous program, we are exploring differences between subjects who successfully integrated self-care components of the program and who experienced significant improvements in metabolic control and those who were not as successful. The program is being revised and shortened, based on this information. Beginning in April 2000, we will start recruiting participants for the clinical trial of the revised program.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes (\[a\] two verifiable FBS test results of 140 mg/dl or above or \[b\] taking or have taken insulin or hypoglycemic agents for at least one year in the past)
* Willing to participate
* A family member, preferably a spouse or first-degree relative, who agrees to participate

Exclusion Criteria:

* Migrant farm workers (not available for the year-long program)
* Pregnant
* Medical conditions for which changes in diet and exercise levels would be contraindicated
Alveolar Cleft Grafting Using Two Different Alloplastic Grafts

P-patients with unilateral alveolar clefts I-purabone with -β-tricalcium phosphate graft C-β-tricalcium phosphate graft alone O-clinical out come Outcome name Measurement device Measurement unit Esthetic satisfaction (Primary outcome) Numerical rating scale(NRS) Number 0-10

Radiographic outcome:

Outcome name Measurment Device Measurment unite Bone volume

(Secondary out come) (CBCT)machine Cranex 3D Sordex Cubic millimeter Bone Density

(Secondary Outcome) (CBCT)machine Cranex 3D Sordex Hounsfield Unite Research Question Would purabone addition to β-tricalcium phosphate be more effective and esthetically satisfying than tricalcium phosphate alone in alveolar cleft grafting?


Eligibility Criteria:
Inclusion Criteria:

1. Patients with unilateral alveolar cleft indicated for bone grafting.
2. Patients age range between 8-12years.

Exclusion Criteria:

1. Patients with any systemic diseases that can affect normal bone and/or wound healing.
2. Patients with bilateral alveolar clefts.
Pre-Op THA Modelling

Replacing diseased hip joints with prosthetic implants in a procedure called total hip arthroplasty (THA) is associated with high rates of patient satisfaction, pain relief, and functional improvement when the implant is appropriately placed. Incorrect implant size or placement may lead to a breadth of negative outcomes, which could result in the need for implant revision. It is difficult to assess the precise orientation of patient hips on the operating table, with one study revealing that only 26% of acetabular cups placed without technological assistance are correctly positioned. Using computer navigation as a guide to achieve optimal implant alignment may improve successful placement rates. The additional incorporation of real-time modeling software may further help realize higher rates of successful implant placement. This study, therefore, aims to investigate a computer navigation system coupled with real-time modeling software to establish the benefit of such technology in the operating room, and further improve positive patient outcomes following THA. We hypothesize that including technological assistance in THAs will yield better patient outcomes compared to surgeries performed freehand.


Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of the hip requiring primary THA
* 40 years of age or older
* BMI \<40 kg/m2
* able to provide informed consent, able and willing to do study assessments and follow instructions

Exclusion Criteria:

* prior surgery on the indicated hip with insertion of hardware
* prior surgery on the lower spine with insertion of hardware
* hip and/or spinal fixed deformities or inflammatory/ossification processes of the spine (e.g. DISH, ankylosing spondylolisthesis)
* limitations to range of motion of the contralateral hip
Changes in Cerebral Oxygenation During Laparoscopic Pyloromyotomy

A prospective study that will assess the effect of laparoscopy on tissue oxygenation in the patients undergoing a laparoscopic pyloromyotomy at Nationwide Children's Hospital. Tissue oxygenation will be assessed non-invasively using near infrared spectroscopy, a device that is commonly used in our operating rooms to assess cerebral and tissue oxygenation.

This prospective study will include 50 patients under the age of 18 years who are having laparoscopic pyloromyotomy. There will be no change in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (NIRS). Prior to anesthetic induction, the NIRS monitor will be placed on the forehead. The device is non-invasive like pulse oximetry using a non-painful adhesive sticker. The device can be applied to different sites on the body to measure cerebral, tissue or even organ oxygenation. For the purpose of the study, the investigators will place one monitor on the forehead to measure tissue oxygenation and a second over the lower back to measure tissue (muscle or renal) oxygenation. These devices are used routinely in the operating room and the cardiothoracic intensive care unit for cardiac patients. Although not used on every surgical procedure, NIRS monitoring can be used on all patients who are undergoing major surgical procedures. Tissue and cerebral oxygenation will be recorded continuously starting just prior to anesthetic induction until the completion of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Children at Nationwide Children's Hospital under the age of 18 years who are having laparoscopic pyloromyotomy

Exclusion Criteria:

* None
Novel Approaches to Target MECOM/EVI1 in AML

This is an academic, no-profit, multicenter, biological, non-pharmacologic study aimed at characterizing genome, transcriptome and proteome of patients affected by AML with MECOM or atypical 3q26 rearrangements.

This is an academic, no-profit, multicenter, biological, non-pharmacologic study aimed at characterizing genome, transcriptome and proteome of patients affected by AML with MECOM or atypical 3q26 rearrangements. To this end, BM samples and formalin fixed/paraffin-embedded BM biopsies will be collected at enrolment, before and after treatment, at relapse.

Eligibility Criteria:
Inclusion Criteria:

* AML with MECOM or atypical 3q26 rearrangements.
* Age ≥18.
* Signed written informed consent according to ICH/EU/GCP and national local laws.

Exclusion Criteria:

* None
Mental Imagery Tasks to Reduce Internet Gaming Disorder (IGD) Cravings

To test whether visual and auditory imagery tasks can effectively reduce the craving for IGD.

This project is to use imagery tasks to reduce the craving of internet gamers. To test whether visual and auditory imagery tasks can effectively reduce the craving for IGD. This project will be conducted in Beijing, China, based on a large sample of internet gamers.

Eligibility Criteria:
Inclusion Criteria:

* The scores of the 9 items of The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5) recommended diagnosis for Internet gaming disorder ≥ 5.
* Engagement in popular Internet games (e.g. Arena of Valor, League of Legends and Player Unknown's Battle Grounds) for over 20 hours per week for a minimum of 12 months.
* The scores of the Young-Internet Addiction Test(Y-IAT) ≥ 50

Exclusion Criteria:

* Current or history of use of illegal substances and gambling;
* Current or history of psychiatric or neurological illness;
* Current use of psychotropic medications.
Study of Autoimmune Disease Complications Following Ipilimumab Treatment Among Melanoma Patients With Underlying Autoimmune Diseases

The research questions to be addressed by this study are as follows:

1. What is the prevalence of ipilimumab use among adults with a history of autoimmune disease that received treatment with ipilimumab for advanced melanoma?
2. Do melanoma patients with a history of autoimmune disease experience complications that require hospitalization related to their underlying autoimmune disease following treatment with ipilimumab?


Eligibility Criteria:
Inclusion Criteria:

* Received ipilimumab therapy between 03/01/2011 and 6/30/2014
* Aged 18 years or older at index date (initiation of ipilimumab)
* Diagnosed with melanoma before index
* Documented history of an autoimmune disease
* Have at least 6 months of continuous pharmaceutical and medical benefit enrollment prior to the index
* Have at least 3 months of continuous pharmaceutical and medical benefit enrollment following and including the index date

Exclusion Criteria:

* Diagnosed with melanoma but NO record of exposure to ipilimumab
* No exposure to nivolumab (Opdivo ®) at any time
Evaluating a New Echocardiography Imaging Procedure for Evaluating Heart Function

Magnetic resonance imaging (MRI) and echocardiography are two imaging methods that are used to obtain pictures of the heart and assess heart function. This study will evaluate a new, four-dimensional echocardiography approach of obtaining heart images to determine if it is as effective at evaluating heart function as MRI.

MRI is a non-invasive method of obtaining images of the body. An MRI is conducted by having a person lie down on a narrow table, which then slides into a large tunnel-like tube. Powerful magnets and radio waves scan the body and a computer records the resulting signals. An echocardiography is a non-invasive ultrasound test that uses sound waves to create images of the heart. It is performed by having a doctor move a wand-like device over a patient's chest. The device then converts sound waves into pictures of the heart. Currently, a special MRI technique is used to evaluate heart function; however, MRI is expensive and cannot be used on critically ill patients. Echocardiography can be performed at a patient's bedside and it may be a more effective way of assessing heart function. The purpose of this study is to determine the effectiveness of a new four-dimensional echocardiography approach at evaluating heart function. Results from this study may be used to diagnose and treat patients more effectively in the future.

This study will enroll healthy people who do not have heart disease and people who are receiving chemotherapy who do not have heart disease. Participants will have a physical examination and a medical records review. MRI scans and a four-dimensional echocardiography of the heart will be performed. There will be no additional study visits.

Eligibility Criteria:
Inclusion Criteria:

* No evidence of underlying cardiac disease based on history or electrocardiogram (ECG)
* Adequate intravenous access in one arm

Exclusion Criteria:

* Pregnant or breastfeeding; if pre-menopausal, not practicing acceptable method of birth control
* History of any other medical condition that is likely to hinder study conduct or pose a safety concern, in the opinion of the investigator
* History of cardiac disease, including heart attack or heart valve disease
* Uncontrolled high blood pressure, defined as systolic blood pressure higher than 160 mm Hg and/or diastolic pressure higher than 100 mm Hg
* Abnormal ECG or chest pain syndrome
* Claustrophobia
* Resting heart rate greater than 110 bpm
* Unable to undergo MRI procedure (e.g., pacemaker, metallic implants)
A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib

This is an open-label extension study (Extension Study) designed to allow patients to continue to receive poziotinib treatment who have had previous exposure to poziotinib and/or are still receiving clinical benefit from treatment, as judged by the Investigator or treating physician. Patients must begin treatment in this study within 28 days after their last dose of poziotinib.

This extension protocol is intended to provide clinical benefit of poziotinib to patients who are responding to treatment. The additional treatment is optional and voluntary.

Patients who wish to participate in the extension study must provide written Informed Consent. Treatment will begin after completion of the End of Study (EOS) or End of Treatment (EOT) visit of the Original Study. The assessments obtained at the EOS or EOT visit will serve as Baseline data for the extension study.

Patients will continue to receive poziotinib treatment at the last dose received or at the standard starting dose of 16 milligrams (mg) poziotinib, once daily.

Patients may receive treatment as long as the patient is deriving clinical benefit, as judged by the investigator or treating physician (case-by-case decision with approval of Spectrum), death, withdrawal of consent, unacceptable toxicity, lost to follow-up, or poziotinib receives commercial approval in their country of residence or development is terminated by the Sponsor, whichever occurs first. There will be an EOS Visit 35 (±5) days after the last dose of poziotinib.

Eligibility Criteria:
Inclusion Criteria:

* Patient has had previous exposure to poziotinib and is still receiving clinical benefit from treatment, as judged by the Investigator or treating physician.
* Patient must have completed the End of Treatment or End of Study visit if enrolled in a previous (original) poziotinib study.
* Investigator or treating physician opinion indicates that extended therapy with poziotinib is clinically appropriate for the patient and the patient is suitable for this Study.
* Patient agrees to continue study treatment.
* Patient must provide written Informed Consent, must be able to adhere to dosing and visit schedules, and meet protocol-defined study requirements.
* Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 30 days after the last dose of poziotinib.

Exclusion Criteria:

* Patient has any ongoing adverse event that hasn't improved to Grade ≤1 and could impact the patient's tolerability to poziotinib.
* Patient has an active uncontrolled infection, bleeding disorder, underlying medical condition, or other serious illness that would impair the ability of the patient to receive poziotinib.
* Patient has any medical or non-medical condition that may not be suitable for poziotinib treatment, as determined by the investigator or treating physician.
* Patient last dose of poziotinib was more than 28 days prior to Day 1 of the study.
* Patient is pregnant or breastfeeding.