cyrilzakka/clinical-trials huggingface dataset:
Gene Therapy for Chronic Granulomatous Disease

The aim of the study is to evaluate the side effects and risks after infusion of retroviral gene corrected autologous CD34+ cells of the peripheral blood of chemotherapy conditioned (busulphan)patients with chronic granulomatous disease (CGD). Also gene corrected and functional active granulocytes in the peripheral blood and the engraftment in the bone marrow of the patients will be monitored an documented.


Eligibility Criteria:
Inclusion Criteria:

* x-linked Chronic Granulomatous Disease
* history of life-threatening severe infections
* no HLA-matched related or non-related donor
* therapy resistent life threatening infections/organ dysfunction
* no other treatment options e.g. BMT

Exclusion Criteria:

* \< 18 years of age
* HIV infection
* life expectancy \> 2 years
* infections treatable by conventional therapy (antibiotics, allogeneic granulocytes)
Developing a Balance Assessment System

To develop a balance device that will work with the inertia sensor to quantitatively assess the balance of individuals and investigate the validity and reliability of the balance data of the device.

In this study, we aim to develop a balance assessment system that will measure the balance quantitatively. For this balance assessment system, a balance board will be developed that will work with inertial sensors and detect the oscillations of the individual trying to stand on balance. The validity and reliability of the balance score determined by the analysis of the oscillation data of this balance board will be investigated.

Our hypothesis is that the correlation between the balance score revealed by the newly developed evaluation system and the results of clinical and instrumental balance assessment methods will be significant. For this, one commonly used clinic and one instrumental balance assessment method will be used. Star Excursion Balance Test as a clinical balance assessment method and Balance Master device (BMc) as an instrumental balance assessment method were evaluated. Limits of Stability Test (LOS) and Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) were used in the BMc.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 - 25
* No neurological or orthopedic diagnosis to affect balance
* Lack of vision and hearing defects that will affect the tests

Exclusion Criteria:

* Existence of refraction problem, visual problem
* Failure to complete the specified tests
* Participant's failure to comply with the study plan
The Study of CM326 in Moderate-to-severe Atopic Dermatitis

This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, tolerance, pharmacokinetics, pharmacodynamics, and immunogenicity of CM326 in moderate-severe atopic dermatitis subjects.

The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week Safety Follow-up Period.

Eligibility Criteria:
Inclusion Criteria:

* With confirmed Atopic Dermatitis (AD) at the screening.
* Age ≥ 18 years and ≤ 75 years, male or female.
* Have the ability to understand the nature of the study and voluntarily sign the informed consent.
* Be able to communicate well with investigators and follow up protocol requirements.

Exclusion Criteria:

* Not enough washing-out period for previous therapy.
* Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline.
* Major surgery is planned during the study period.
* Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.
Evaluation of Serological Markers of Vitiligo Activity

The goal of this case-control study is to evaluate the possible applicability of CXCL10, CXCL9, CCL20, and homocysteine as biomarkers of disease activity in vitiligo patients and to compare the levels of these markers with those in healthy controls.

The diagnosis and prognosis assessment in patients with vitiligo are essentially clinical. There are still no validated and established serological markers to objectively assist in defining disease activity. Objective: To evaluate the potential use of the biomarkers CXCL9, CXCL10, CCL20, S100B, and homocysteine to identify disease activity in vitiligo, comparing their values with controls. Methods: A case-control study using previously collected peripheral blood samples from patients aged 18 years or older with a diagnosis of vitiligo and from controls without the disease. The project was approved by the institution's ethics committee. Tests were conducted using ELISA and Luminex kits to measure CXCL9, CXCL10, CCL20, and S100B. For homocysteine, the chemiluminescence method was used.

Eligibility Criteria:
Inclusion Criteria:

* Vitiligo
* Older than 18 years

Exclusion Criteria:

* Not having diagnosis of vitiligo
* Less than 18 years
Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study

This trial studies how well an interactive survivorship program works in improving healthcare resources in adolescent and young adult cancer survivors. By improving access to survivorship resources, health literacy, self-management skills, and support, an interactive survivorship program may help to improve adherence to adolescent and young adult healthcare guidelines and reduce cancer-related distress.

OUTLINE: Patients who have one or more elevated distress or low cardiometabolic or cancer health care adherence are randomized to Arm I or II.

ARM I (INTERVENTION): Patients receive a personalized Survivorship Care Plan (SCP) and use the Interactive Survivorship Program to Improve Healthcare Resources (INSPIRE) mobile application. Patients may receive telehealth stepped care after 1 month.

ARM II (CONTROL): Patients receive access to a study-specific control website that has annotated links to existing resources for adolescent and young adult (AYA) survivors. After 12 months, patients receive a personalized SCP and have access to the digital INSPIRE intervention program without telehealth calls.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a first invasive malignancy of leukemia, lymphoma, melanoma, sarcoma, breast, thyroid, or colorectal cancer (stage 1-3 for solid tumors) between the ages of 15-39 years
* Current age \>= 18 when approached
* Currently within 1 to 5 years from the time of diagnosis
* Completed active treatment for disease \>= 6 months previously
* Received a therapeutic intervention (with curative intent if advanced stage disease) that included any of the following modalities: surgery, cytotoxic chemotherapy, biological or targeted agents, radiation therapy
* English proficiency adequate to complete assessments
* Access to email and smartphone mobile app and or internet

Exclusion Criteria:

* Diagnosed with a subsequent invasive malignancy other than non-melanoma skin cancer
* Received hematopoietic stem cell transplant
* Health issues prohibiting computer use or ability to comply with study procedures
* Residing in an institution or other living situation where health care decisions are not made by the participant (e.g., hospitalized, prisoners, living in a rehabilitation facility)
* Does not complete baseline patient reported outcome (PRO) assessment items required to determine stratification or whether the survivor meets inclusion and exclusion criteria
The Effect of Mindfulness Intervention Program on Adolescents' Internet Addiction

The Internet shows its presence in areas where human beings are actively involved, from education to health, from entertainment to the investment sector. The integration of the Internet into many areas of human life leads to its intensive use. According to the Global Digital Report, the number of individuals with access to the Internet worldwide at the beginning of 2024 is stated as 5.35 billion, and this number constitutes more than 66% of the total world population. One of the pioneering studies on internet addiction was conducted by Young. In this study, five subtypes of internet addiction were identified. These are cyber sex addiction (obsessive use of adult sites such as cyber sex, cyber porn), cyber relationship addiction (excessive involvement in online relationships), net compulsions (online gambling, shopping and trading), information overload (on websites). and constantly surfing databases) and computer addiction (playing computer games). Considering the sub-dimensions of internet addiction, it is seen that it affects many areas of life, from family life to interpersonal relationships, from social life to economic life. Conscious awareness is the awareness of one's internal state and environment. Mindfulness can help people avoid destructive or automatic habits and reactions by learning to observe their thoughts, feelings, and other momentary experiences without judging or reacting. Acting based on awareness is a much different way of life than the autopilot approach in which the individual carries out his daily routines and activities. In studies, mindfulness is examined not only to prevent the recurrence of addiction, but also as a long-term, ongoing health behavior that supports the recovery of addiction. Determining the effect of a mindfulness-based intervention program applied to adolescent nursing students studying at a university on internet addiction and awareness. is intended.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Being in the adolescent age group (17-19 years old)
* Studying in Turkish nursing department

Exclusion Criteria:

• Previous participation in a mindfulness intervention program for internet addiction
Prevention of Anastomotic Leak in Gastrointestinal (GI) Anastomosis With the Application of Tisseal in the Anastomotic Line

The anastomotic leak is one of the most feared complications in abdominal surgery. Certain control methods have been described but the incidence of that complication remains high and is the first cause of mortality in operations where gut anastomosis are performed.

With the aim to prove that the use of fibrin glue in the gut anastomosis can improve gut cicatrization, the investigators started the recruitment of patients to that clinical trial in 2007 with the study hypothesis that patients with a gut anastomosis where fibrin glue was used, had less anastomotic leaks than that where the fibrin glue was not used.

The investigators have calculated the number of patients necessaries to have statistical significant differences in 200 patients with a rate anastomotic leak expected to be higher than 10%.

The study include all the patients that usually arrive to our surgery department and that are expected to have a high risk gut anastomosis: rectal anastomosis, GI anastomosis in the obese patient, small bowel anastomosis in the obstructed one and esophageal anastomosis.

The study is randomized, simple blind where the patient does not know if they are in the fibrin glue group or not, and prospectively analyzed. All the clinical and laboratory or radiographic finds relative to the occurrence of an anastomotic leak are recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing GI surgery where a high risk anastomosis is preview to be done

Exclusion Criteria:

* Haemodynamic instability
* Advanced oncologic disease
* Proteins below 4 gr/ml
Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement: A Pilot Study

The PREPARE TAVR pilot study will examine the effects of remotely administered physiological reconditioning program (RAPR) on quality of life (QOL) and clinical outcomes at one year post TAVR in frail older adults.

The main objective of this study is to evaluate the effects of a home based exercise and dietary intervention program on the quality of life (QOL) and clinical outcomes in frail adults undergoing Transcatheter aortic valve replacement (TAVR) procedures. Patients will be randomly (1:1) assigned to the standard of care (SOC group) where patients will receive all medical care as decided by their treating physicians or assigned to a home based program known as remotely administered physiological reconditioning (RPR) program which will include receiving personalized instructions for a progressive exercise program and dietary changes. Patients will be contacted for regular phone and in-person follow up for monitoring their progress. The primary endpoint will be quality of life as assessed by KCCQE questionnaires at one-year post TAVR. The secondary endpoints include length of stay post TAVR, all-cause mortality, repeat hospitalization and a composite of all-cause mortality and repeat hospitalization at one year.

Eligibility Criteria:
Inclusion Criteria:

- Short Physical Performance Battery Protocol (SPPB) score \< 9

Exclusion Criteria:

* Severe liver disease defined by Childs Pugh class \>B or MELD score \>15.
* Severe kidney disease defined by eGFR \<30 mL/min.
* Hospital admission during the 4 weeks prior to randomization.
* Montreal objective cognitive assessment (MOCA) score \<18.
* Mechanical fall in the past month.
* Unstable angina during the previous month.
* Myocardial infarction during the previous month.
* Unsuccessful completion of the one-week run-in phase.
* Syncopal episode during exercise during run-in phase
Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain

This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch) compared to placebo in patients with chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of chronic low back pain for more than 3 months
2. If taking non-steroidal anti-inflammatory drugs or non-opioid analgesics, must be on a regular, scheduled dose for at least 4 weeks prior to the first visit and intend to remain on a stable dose of these agents for the study duration
3. Pain intensity score greater than or equal to 5 out of 10 at the first visit
4. Able to apply patches at home
5. Able and willing to complete daily pain intensity ratings using an electronic diary device for the duration of the study
6. Females of childbearing potential must agree to use a medically acceptable method of contraception throughout the study

Exclusion Criteria:

1. History of, or ongoing, alcohol or drug abuse
2. Positive drug test for alcohol, illicit drug use or opioids
3. Primary diagnosis of chronic low back pain due to neuropathic pain
4. History of back surgery or plan for back surgery
5. Use of opioids within 2 weeks of the first visit and during the study
6. Previous ineffective use of lidocaine patches
7. Morbid obesity
8. Moderate or severe depression
9. An open skin lesion within the painful area where patches will be applied
10. Patients with active or resolved back pain litigation or receiving disability payments due to chronic low back pain
11. Pregnant or breastfeeding females
Validation of the ANI in Perpubescent Patients in Pediatric Intensive Care Unit.

The ANI monitor is a medical device allowing to measure the response of the autonomic nervous system to a painful stimulus.

In the pediatric population under general anesthesia, the ANI score can detect failure of locoregional anesthesia; ANI decreases after painful stimulation during surgery, more markedly with smaller doses of Remifentanil.

To date, measurement of ANI in sedated children in pediatric intensive care has not been performed or validated as a method of assessing pain and discomfort.


Eligibility Criteria:
Inclusion Criteria:

* Prebubescent chilren (up to 2 years old) Admited in PICU Sedated, ventilated

Exclusion Criteria:

* Non sinusal rythm
* Atropine
* Pace-macker
Implementation Strategy Resource Package for Behavioral Classroom Interventions: Pilot Test

The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support teachers in using behavioral classroom management interventions for children with hyperactive, inattentive, or impulsive behaviors. Participating teachers will be randomized to receive the resource package or support as usual and the research team will examine, a) teacher implementation of behavioral classroom interventions and b) mental health outcomes for enrolled children.

Schools are an accessible and ecologically valid setting for children with hyperactivity, inattentive, or impulsive behaviors to receive evidence-based interventions to reduce symptoms and improve functioning. Behavioral classroom management interventions are well-established treatments for elementary-school age children with, but they can often be challenging for teachers to use. It is therefore important to develop and test implementation strategies in promoting teachers' use of behavioral classroom management interventions and in improving child outcomes. The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support teachers in using behavioral classroom management interventions for children with hyperactive, inattentive, or impulsive behaviors. Participating teachers will be randomized to receive the resource package or support as usual and the research team will examine, a) teacher implementation of behavioral classroom interventions and b) mental health outcomes for enrolled children.

Eligibility Criteria:
Inclusion Criteria:

Teachers:

* A K-5 teacher at a participating school within the School District of Philadelphia
* Teach at a participating school
* Informed consent

Children:

* Is in a K-5 class of a participating teacher
* Nominated for participation by the participating teacher
* Identified by their participating teacher as displaying impairment related to inattention, hyperactivity or impulsivity
* Informed consent and assent if appropriate

Parents/Legal Guardians:

* Parent or legal guardian of child
* Identifies as familiar enough with the child to fill out measures about the child
* Has mental capacity to provide consent for the participation of child in the study and for their own participation in the study

Caregivers:

* Has been referred by the legal guardian as the primary caregiver that can more accurately complete the measures about the child
* Has mental capacity to provide consent for the participation of child in the study and for their own participation in the study

Exclusion Criteria:

Children:

* Special education classification of 'intellectual disability'
* Primary presenting concern of psychotic or autism spectrum disorders
* Presents as in acute risk of harm to self or others, such that participation in the study is clinically inappropriate because they warrant more intensive intervention
RAE (Realize, Analyze, Engage)

The proposed study will evaluate the detection of digital biomarkers of stress, and drug craving in a population of individuals undergoing treatment for substance use disorder

RAE integrates digital detection of high-risk stress and craving periods by utilizing a mobile phone application and integrated wearable sensor. These detections are paired with interventions (mindfulness based de-escalation tools), support, and monitoring (to identify trends and plan for future). The present study will deploy the technology in a multi-site randomized controlled trial to test the efficacy of the RAE system in on clinical and psychosocial outcomes. Subjects will be randomized to use the RAE system (mobile app and wearable sensor) plus usual care vs usual care plus a fitness tracker only to measure differences retention in treatment, return to substance use, and overall psychosocial functioning. The ultimate goal is to develop a cost-effective, paradigm changing recovery tool that will improve substance use disorder treatment, and prevent related complications and deaths.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Enrolled in an outpatient SUD treatment program
* Enrolled in treatment for \< 90 days
* Fluent in English
* Have access to a smartphone with iOS or Android Capabilities
* Capable of providing informed consent

Exclusion Criteria:

* Pregnancy
* Prisoner Status
* Significant limitation of range of motion of non-dominant arm (amputation or fracture)
Benefit of Elevation of HDL-C on Cardiovascular Outcomes in Women

Several risk factors including high cholesterol contribute to heart disease. We know that lowering triglycerides and raising HDL (protective cholesterol) in men reduces the risk for heart disease. We expect that women will share this same benefit because the combination of high triglycerides and low HDL appears to be a more important risk for heart disease in women. Niacin reduces triglycerides and raises HDL. We also expect to see improvement in markers of inflammation and clot formation and blood vessel health, which we hypothesize should all confer a reduced risk of heart disease in women.

Women already taking lipid lowering statin will receive niacin therapy. We will measure blood lipid levels, markers of inflammation and clotting as well as a non-invasive measure of blood vessel reactivity. After 3 months of therapy we will repeat these measures.


Eligibility Criteria:
Inclusion Criteria:

* Stable women on statin therapy with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl

Exclusion Criteria:

* History of MI, PTCA or surgery within previous 3 months

  * Currently on Niaspan and unwilling to withdraw Niaspan therapy or known intolerance to niacin
  * Active or known gall bladder disease
  * Pregnant or nursing women
  * Significant comorbidity that precludes participation
  * Significant liver disease, active alcoholism, or LFT \>1.5x's ULN at screening
  * Diabetes or glucose \> 126 mg/dl at screening
  * PI perceived inability to comply with protocol
Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria

This study will treat patients who have a short term central catheter that is thought to be infected with a specific bacteria (gram positive bacteria)


Eligibility Criteria:
Inclusion Criteria:

* Patients with a central indwelling catheter with signs and symptoms of infection

Exclusion Criteria:

* Patients with tunneled catheter which cannot be removed.
* Patients with evidence of endovascular infection including endocarditis.
* Patients with infection of permanent intravascular devices.
* Patients who have received more than 1 day of another antibiotic before enrollment.
* Patients with HIV and low CD4 count.