cyrilzakka/clinical-trials huggingface dataset:
CD19/22 Bi-specific CAR-T Cell Therapy

The purpose of this study is to assess the feasibility, safety and efficacy of anti-CD19/22 bi-specific CAR-T cell therapy in patients with CD19 and/or CD22 positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19/22 bi-specific CAR-T cells and their persistency in patients.

Patients with refractory and/or recurrent B cell malignancies have poor prognosis despite complex multimodal therapy. Despite impressive progress, more than 50% of patients treated with CD19-targeting chimeric antigen receptor T cells (CAR19) experience progressive disease. Further, more than 40% patients with progressive large B cell lymphoma (LBCL) experienced reduced or lost expression of CD19 on the tumor cells after CAR19 treatment; low surface CD19 density before treatment was associated with progressive disease. Therefore, novel curative approaches are needed. The investigation attempts to use genetically modified T cells to express a 4th generation lentiviral anti-CD19/22 bi-specific CAR (bi-4SCAR-CD19/22). The CAR molecules enable the T cells to recognize and kill tumor cells through the recognition of a surface antigen, CD19 or CD22, which is expressed at high levels on tumor cells but not at significant levels on normal tissues.

To overcome tumor escape of single target antigen and enhance in vivo CAR-T efficacy, a novel bi-specific CD19/22 CAR-T therapy regimen is developed to include booster and consolidation CAR-T applications to target highly-refractory B cell cancer. The aim is to evaluate safety and long term efficacy of the bi-CAR-T therapy strategy in CD19 and/or CD22 positive cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. age older than 6 months.
2. malignant B cell surface expression of CD19 or CD22 molecules.
3. the KPS score over 80 points, and survival time is more than 1 month.
4. greater than Hgb 80 g/L.5. no contraindications to blood cell collection.

Exclusion Criteria:

1. accompanied with other active diseases and difficult to assess patient response.
2. bacterial, fungal, or viral infection, unable to control.
3. living with HIV.4. active HBV or HCV infection.

5. pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. prior failed CD19 and CD22 CAR-T treatment.
Benefits of Observing Point-light Displays in Postoperative Rehabilitation of the Total Knee Prosthesis.

The LOARAL project concerns patients who have undergone total knee arthroplasty to treat symptomatic osteoarthritis. Patient will be divided into two groups: a control group where patients will do standard rehabilitation and an experimental group where patients will do standard rehabilitation associated with the judgement of point-light display. The aim of this study is to validate the use of point-light display for the Rehabilitation of patients with a totalarthroplasty of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers over 18 years of age who have undergone knee surgery

Exclusion Criteria:

* Any locomotor condition not due to knee surgery
* Uncorrected visual disturbances
* Comorbidity altering locomotion (history of stroke, neurological condition, inflammatory rheumatism)
HIV UPBEAT: Understanding the Pathology of Bone Disease in HIV-infected Patients.

Despite the prevalence of osteopenia and osteoporosis in the HIV positive population, relatively little is known about the underlying pathology. This prospective cohort study aims to gain further understanding about a number of issues relating to low bone mineral density in HIV-infected subjects.

This study will follow HIV positive and negative subjects annually for 5 years. The aims of this study include:

* to describe the pathology underlying low bone mineral density
* to assess the relationship between low bone mineral density and antiretroviral therapy exposure
* to assess the relationship between low bone mineral density and vitamin D /PTH status and/or markers of bone metabolism
* to assess the relationship between osteopenia and subsequent changes in bone mineral density and markers of bone metabolism
* to assess the validity of the currently available fracture risk assessment tool in predicting fractures in HIV positive populations

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* be able to provide written, informed consent
* be able to attend the research centre in a fasting state and undergo DEXA scanning

Exclusion Criteria:

* Subjects on bisphosphonate therapy at screening
* Pregnant or breastfeeding female subjects
* Subjects with a previous clinical history of primary hyperthyroidism or HIV negative subjects with elevated parathyroid hormone at screening
* HIV-negative subjects with a prior history of osteoporosis
Internet-based Intervention for Skin Self-Examination in Participants With Increased Risk for Melanoma

This trial studies an internet-based intervention for skin self-examination (SSE) in participants at increased risk for melanoma. Early detection of suspicious growths on the skin can be done by performing regular SSE checks. Using an internet-based intervention, such as mySmartCheck, may help to promote regular, thorough checks on the skin in individuals at increased risk for melanoma.

PRIMARY OBJECTIVES:

I. To evaluate the impact of mySmartCheck versus usual care on skin-self-examination (SSE) behaviors among individuals at increased risk for developing melanoma.

SECONDARY OBJECTIVES:

I. To evaluate the impact of mySmartCheck versus usual care on patients barriers and benefits to conducting SSE, SSE self-efficacy (confidence), level of worry about developing melanoma, and number of health care consultations (visits, telephone calls, and emails).

II. To evaluate whether mySmartCheck effects are moderated by the patient's Total Body Photography (TBP) status.

III. To identify barriers and facilitators to using mySmartCheck.

OUTLINE:

PHASE I: Participants complete a telephone based usability testing of the online program. Participants complete between 1-5 user testing sessions of the mySmartCheck program (about 45-60 minutes per session) to provide feedback on acceptability, satisfaction, comprehension, and usability.

PHASE II: Participants are randomized to 1 of 2 groups. Both the intervention and control group complete a baseline survey as well as a 13 weeks post-baseline survey.

GROUP I: After completing the baseline survey, participants receive access to the mySmartCheck program, and continue to receive standard of care. Participants are asked to complete another survey 13 weeks post-baseline.

GROUP II: After completing the baseline survey, participants receive standard of care. Participants are asked to complete another survey 13 weeks post-baseline.

Study duration is 13 weeks for all participants.

Eligibility Criteria:
Inclusion Criteria:

* At increased risk for melanoma due to a personal history of treated melanoma without current evidence of disease, a family history of melanoma in a first-degree relative, and/or having a high-risk mole phenotype (i.e., \>= 50 normal moles or \>= 1 abnormal mole \[dysplastic nevus\]).
* Access to a computer connected to the Internet.
* Not adherent to SSE recommendations (i.e., did not conduct a thorough SSE during each of the previous 3 months).
* Able to speak and read English.
* Able to provide informed consent.
Leisure Physical Activity and Barriers to Physical Activity

People with disabilities are less physically active than the general population. Currently, the level of leisure physical activity of people who are members or users of APF France handicap and their barriers to physical activity are unknown. The APF France handicap association is a national movement for the defense and representation of people with disabilities and their families. It represents all types and severities of disability.

The objective of this study is to describe the level of leisure physical activity of people who are members or users of APF France handicap and their barriers to physical activity.

This is a national transversal study aiming at studying the level of leisure physical activity among people with disabilities, members or users of APF France handicap.

The study is based on a survey by questionnaire to the APF France handicap community. The survey is distributed between April and June 2023 through a public communication campaign (emails, posters, website, social networks, etc.). Data on leisure physical activity, barriers to physical activity and quality of life will be collected.

The questionnaire has been translated in simplified French to facilitate its understanding.

This is a survey that collects data anonymously and follows the MR004 methodology.

Eligibility Criteria:
Inclusion Criteria:

* Members or users of APF France handicap
* People with disability
* Agreeing to participate in the survey

Exclusion Criteria:

* None
Antimicrobial Photodynamic Therapy as an Adjunct for Management of Deep Caries Lesions

Alternatively to conventional treatments, chemo-mechanical caries removal agents can be used. A modality of treatment that has been increasing in dentistry is antimicrobial photodynamic therapy (aPDT). Bixa orellana, is being researched for application in aPDT. This protocol aims to determine the effectiveness of aPDT with Bixa orellana extract in deep caries lesions. Methods and analysis: A total of 160 teeth with deep occlusal dental caries will be selected and divided in 3 groups: G1 - control group (Caries removal with a lowspeed drill); G2 - Partial Caries Removal with Papacarie; G3 - Partial Caries Removal with Papacarie and application Bixa orellana extract (20%); G4 - Partial Caries Removal with Papacarie and application Bixa orellana extract (20%) with LED (aPDT). After treatment, all the teeth will be restored with glass ionomer cement and followed up clinically and radiographically, with evaluations at immediately, 1 week, 1, 3, 6, and 12 months. Dentin samples before and after treatment will be analyzed microbiologically. The data will be submitted to descriptive statistical analysis of the association between the categorical variables using the chi-square test and Fisher exact text. The Student t test and analysis of variance will be used for the comparison of mean signs and symptoms of reversible pulpitis. Pearson correlation coefficients will be calculated for the analysis of correlations among the continuous variables.


Eligibility Criteria:
Inclusion Criteria:

* Adequate health with no systemic conditions;
* Adequate cooperation;
* Clinically presenting at least 1 permanent molar with an acute, active caries on the dentin not surpassing 2/3 and only involving the occlusal face, with direct view and access as well as no clinical or radiographic signs of pulp involvement.

Exclusion Criteria:

* Systemic adverse health condition;
* Uncooperative behavior;
* Class II, III, IV, or V carious lesion based on Black classification;
* Clinically: caries involving enamel, deficient restorations, small carious lesions on dentin with no access for manual scalers, hidden caries, sign or symptom of pulp involvement, clinical impossibility of restoration;
* Radiographically: evidence of pulp involvement, carious lesion extending beyond 2/3 of dentin.
Feasibility of the Utilization of Buprenorphine in the Emergency Room to Treat Clinical Opioid Withdrawal

The investigators are trying to determine whether they can effectively treat patients suffering from acute opioid withdrawal in the Emergency Department at Virginia Commonwealth University Health System (VCUHS) and subsequently transfer them to an outpatient addiction clinic within the existing infrastructure. This will be a descriptive investigation of the process to reveal areas of success and opportunities for improvement in order to determine feasibility of the study procedures in preparation for a larger clinical investigation.

Currently, patients in the Emergency Department at VCUHS experiencing opioid withdrawal, after reversal of opioid intoxication by naloxone, do not receive any direct treatment to stop the symptoms. They do receive indirect treatment aimed at each specific symptom, such as an anti-emetic to stop vomiting. The investigators propose directly treating all of the symptoms with the medication Suboxone, (buprenorphine/naloxone). Buprenorphine is a partial agonist on the Mu-receptor, which means it will provide less opioid effect than morphine, but should provide enough to make opioid withdrawal more tolerable. This is very important because stopping the withdrawal symptoms early will prevent the patient from quickly leaving and using opioids again, continuing their addiction cycle. The naloxone is included with buprenorphine as a deterrent to prevent intravenous injection of the drug for abuse. The investigators believe that if the patient is treated with Suboxone for withdrawal in the emergency department, and transported to the outpatient addiction treatment center at VCU, called the MOTIVATE clinic, the investigators can potentially break that cycle and help the patient work toward recovering. If successful, the investigators hope to improve the quality of life, prevent further overdose and death in those suffering from this deadly addiction.

Buprenorphine effectively treats the opioid withdrawal state. This has been demonstrated in many studies during the initial induction period with buprenorphine. Many of these patients are experiencing opioid withdrawal during this time. The sublingual dose can effectively be increased to resolve symptoms. According to many protocols and guidelines, acute opioid withdrawal is the preferred state of the patient when buprenorphine should be started.

Eligibility Criteria:
Inclusion Criteria:

* Opioid overdose only, of any formulation or route, with complete reversal of toxicity after naloxone by any route.
* RR ≥ 12
* Pulse oximetry \> 95%
* GCS 15
* Clinical Opioid Withdrawal Scale (COWS) score ≥ 8

Exclusion Criteria:

* Pregnancy
* Prisoner
* Incomplete reversal of toxicity related to metrics above
* Police custody
* Known allergy to buprenorphine
* Emergent psychiatric condition including active suicidality that requires admission
* Emergent medical condition that requires admission
A Multi-Component Behavioral Nutrition Intervention for Homebound Elderly

The purpose of this study is to evaluate the efficacy and feasibility of a multi-level self-management intervention to improve nutritional intake in a group of homebound older adults (HOAs) who are at especially high risk for undernutrition. The study will be guided by the theoretical approaches of the Ecological Model and Social Cognitive Theory and will use a prospective randomized controlled design to estimate whether individually tailored counseling focusing on social and behavioral aspects of eating results in increased caloric intake and improved nutrition-related health outcomes in a sample of 104 HOAs. The investigators hypothesize that intervention at these levels will improve caloric intake and indirectly improve health outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. at least 65 years of age
2. homebound (based upon Medicare's definition of homebound status)
3. able to communicate or have a caregiver who is able to communicate
4. living in a private residence
5. experiencing either an acute illness or chronic condition
6. not consuming enough calories to maintain body weight or weight loss of \> 5% over past 6 months (if known)

Exclusion Criteria:

1. significantly cognitive impaired (MMSE \< 24 if living alone or MMSE \< 15 if living with caregiver) (if known)
2. terminally ill
3. any cancer diagnosis within the past five years (melanoma excluded)
4. end-stage renal disease
5. gastric or enteral tube-feedings
6. dependent on a ventilator
A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RGX-501

This long-term observational study is designed to follow subjects who, during another Clinical Study, received gene therapy treatment used to treat their Homozygous Familial Hypercholesterolemia (HoFH) disease. This study is intended to follow those subjects for up to 5 years since they received treatment to look for any long-term safety concerns. There is no investigational drug or therapy provided as part of this study.

Homozygous Familial Hypercholesterolemia (HoFH) is a rare genetic metabolic disorder characterized by absent or severely reduced capacity to catabolize circulating LDL particles by the hepatic LDL receptor. As a consequence, HoFH subjects present abnormal total plasma cholesterol (LDL-C) levels, resulting in severe atherosclerosis often leading to early onset of cardiovascular disease. Early initiation of aggressive treatment for these patients is therefore essential. Unfortunately, despite existing therapies, treated LDL-C levels could remain well above acceptable levels. Thus, the functional replacement of the defective LDLR via AAV-based liver-directed gene therapy, RGX-501, may be a viable approach to treat this disease and improve response to current lipid-lowering treatments.

This is a prospective, observational study to evaluate the long-term safety and efficacy after a single administration of RGX-501. Eligible participants are those who previously have enrolled in a clinical study and received a single intravenous infusion of RGX-501.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible to participate in this study, a participant must have previously received RGX-501 in a separate parent trial, and the participant or participant's legal guardian(s) is/(are) willing and able to provide written, signed informed consent after the nature of the study has been explained, prior to any research-related procedures.

Exclusion Criteria:

* None
Suction Cups and Foam Roller in the Improvement of the Flexibility in Basketball Players

Introduction. Basketball is a predominantly anaerobic exercise that exposes to high intensity actions (jumps, speed control, accelerations and decelerations, and changes of direction). A lack of flexibility can affect the appearance of muscle injuries. Foam roller is a myofascial self-release technique using a foam roller. The suction cups are an instrumental technique where the negative pressure produces an increase in the blood flow of the tissues.

Goals. To evaluate the effectiveness of a physiotherapy intervention through suction cups and foam roller in amateur basketball players.

Study design. Randomized, single-blind clinical study with a follow-up period. Methodology. The 20 basketball players that are expected to be recruited will be randomly assigned to the two study groups: experimental (suction cups and Foam roller) and control (Foam roller). The intervention will last 4 weeks, with 2 weekly sessions. The study variable will be: hamstring flexibility (measured with finger-ground, Well and Shober tests). The analysis of normality will be carried out with the Shapiro-Wilk test. In case of homogeneity of the groups, we will use parametric tests: t-student test of repeated measures (difference between evaluations) and ANOVA of repeated means (intra and intersubject effect).

Expected results. An intervention using suction cups and foam roller is effective in improving the flexibility of the hamstring muscles in basketball players.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 25 years
* Amateur basketball players
* Belong to the Celeste club
* Not having any injury to the hamstring musculature at the time of the study

Exclusion Criteria:

* At the time of the study they are included in a program of individualized strength training in lower limbs
* Subjects with alterations in venous return or congenital coagulopathies
* Subjects who present hypermobility
* Not signed the informed consent document
A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)

This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in combination with MK-3475, a PD-1 inhibitor in patients with solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy which has progressed on standard therapy or for which no standard therapy is available.
* Measurable disease per RECIST v1.1.
* Adequate bone marrow, renal and liver functioning

Exclusion Criteria:

* CNS primary malignancies, active seizure disorder or spinal cord compression, or carcinomatous meningitis.
* History of any of the following toxicities associated with a prior immunotherapy:

  * Grade 3 immune mediated adverse event that was considered related to previous immunotherapy and required immune suppressive therapy;
  * Grade 2 hepatic function related adverse event that persisted more than 1 week, was considered related to immunotherapy, or required treatment discontinuation or immunosuppressive therapy
* Any of the following within the 12 months prior to registration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
* History of or known presence of extensive, disseminated/bilateral or Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, or pulmonary fibrosis, but not including a history of prior radiation pneumonitis. Patients with clinically significant lung disease requiring oxygen therapy (eg, COPD).
SPARK- a Digital Platform to Improve Self-management of Gestational Diabetes

Gestational diabetes mellitus (GDM) is an increasing public health challenge. Innovative, effective and scalable lifestyle interventions to support women with GDM to manage their disease and to prevent adverse obstetric and neonatal outcomes as well as later morbidity are requested.The aim of this project is to evaluate whether a novel, mobile health (mHealth) platform (SPARK) can improve self-management of GDM and prevent adverse maternal and offspring outcomes. SPARK is a multi-centre randomised controlled trial recruiting women diagnosed with GDM in South Eastern Sweden. Women will be randomised to the control or intervention group. All women will receive standard care. The intervention group will also receive support through the SPARK platform for healthy eating, physical activity and glycaemic control. Pregnancy outcomes are glycaemic control (primary), diet, physical activity, metabolic and inflammatory biomarkers in gestational week 36-37 as well as adverse obstetric and neonatal outcomes. Secondary outcomes also include cardiometabolic risk, physical activity and healthy eating behaviours one-year postpartum.


Eligibility Criteria:
Inclusion Criteria:

* a confirmed diagnosis of GDM detected by oral glucose tolerance test in accordance with the World Health Organization guidelines

Exclusion Criteria:

* known pre-pregnancy diabetes
* twin pregnancy
* \<18 years of age
* severe co-morbidities that would limit participation or a previously diagnosed severe psychiatric illness.