cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic / Pharmacodynamic (PK/PD) Study of Multiple Doses of DP-R202 in Healthy Volunteers

The purpose of this study is compare the safety and pharmacokinetic characteristics of DP-R202 (Sarpogrelate HCl 100mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after multiple oral administration in healthy male volunteers.

The number of patient is thirthy-six.Patients were randomly assigned either anplag tablet(Sarpogrelate HCL 100mg, tid)3days first, DP-R202(Sarpogrelate HCL 300mg, qd) 3days Second or DP-R202(Sarpogrelate HCL 300mg, qd)3days first, anplag tablet(Sarpogrelate HCL 100mg, tid) 3days second.

Eligibility Criteria:
Inclusion Criteria:

* 20 to 55 years of healthy volunteers

Exclusion Criteria:

* Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets
Dextrose, Steroid, PRP: Choosing the Right Injection for CRS Relief; a RCT

USG guided injections to relieve carpal tunnel syndrome with dextrose water or steroid or PRP


Eligibility Criteria:
Inclusion Criteria:

* NA

Exclusion Criteria:

* Na
Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy

The goal of this clinical trial is to compare 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT in men with biochemical failure following radical prostatectomy. The main questions it aims to answer are:

* Is there a difference in the number of lesions of prostate cancer recurrence detected between the 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT scans.
* What is the diagnostic accuracy of 64Cu-SAR-bisPSMA PET/CT compared to 68Ga PSMA-11 PET/CT using a standard of care comparator.
* Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11).

Participants will:

* have 3 visits: 1) standard of care 68Ga PSMA-11 dose and PET/CT scan; 2) 64Cu-SAR-bisPSMA dose and PET/CT; 3) 64Cu-SAR-bisPSMA PET/CT only
* have standard of care blood test either at Visit 1 or Visit 2


Eligibility Criteria:
Inclusion Criteria:

* Male patients aged 18 or above
* Ability to provide informed consent documentation indicating that they understand the purpose of, and procedures required for the study, and are willing to participate in the study.
* Prior radical prostatectomy for confirmed adenocarcinoma on histopathology.
* Rising PSA (0.20 - 0.75 ng/mL) following radical prostatectomy with no prior salvage radiotherapy.
* 68Ga PSMA-11 PET/CT within the last 4 weeks for prostate cancer biochemical recurrence.

Exclusion Criteria:

* Prior, or contraindication to, salvage radiotherapy for biochemically recurrent prostate cancer.
* History of current active malignancy as per investigator discretion other than prostate cancer.
* Known or expected hypersensitivity to 64Cu-SAR-bisPSMA
* Systemic therapy for metastatic prostate cancer including androgen deprivation therapy.
A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the safety profile, tolerability, drug levels, drug effects, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab or chemotherapy plus nivolumab in participants with metastatic colorectal and pancreatic cancers.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Must have metastatic colorectal or pancreatic cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
* Ability to swallow pills or capsules
* Required to undergo mandatory pre and on-treatment biopsies
* Adequate marrow function
* Adequate other organ functions
* Ability to comply with study visits, treatment, procedures, pharmacokinetic (PK) and pharmacodynamic (PD) sample collection, and required study follow-up

Exclusion Criteria:

* Histology other than adenocarcinoma (neuroendocrine or acinar cell)
* Suspected, known, or central nervous system (CNS) metastases (Imaging required only if participants are symptomatic)
* Active, known or suspected autoimmune disease
* Condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
* Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity
* Prior treatment with cysteine-cysteine chemokine receptor 2 (CCR2) and/or cysteine-cysteine chemokine receptor 5 (CCR5) inhibitors, programmed death-1 receptor (PD-1), programmed death-ligand 1 \[PD(L)-1\] or cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibodies
* History of allergy to study treatments or any of its components of the study arm that participant is enrolling

Other protocol-defined inclusion/exclusion criteria apply
Program of Digital Accompaniment to Optimize Homework Performances and Increase Familial Quality of Life in 9 to 16 Years Children With ADHD

Attention Deficit Disorder with or without Hyperactivity (ADHD) is a frequent pathology in children that has important consequences on schooling both in terms of academic level (due to the attentional disorder) and behavior (disruption of the class). ADHD also has an impact on family functioning, which can generate stress and family altercations. The homework period can be a particularly tense time and a source of conflict with the child, which has negative consequences on the family atmosphere, learning efficiency and of course academic success.

The investigators wish to evaluate an innovative digital device (a smartphone application) to accompany the child during homework periods.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 9-16 years old with ADHD assessed by Conners 3 scales
* Parents and children giving informed consent
* Patients in follow-up list of participant centers
* Patients with unchanging care for the last 3 months (medication and therapy)

Exclusion Criteria:

* Patients with severe psychiatric disease such as schizophrenia, bipolar disorder, or autism spectrum disorders and suicidal behavior (all assessed by Child Behavior Checklist Scale)
* Patients with no smartphone or not easy access to smartphone (ie patients of social facilities, internship...)
* Patients with mild to severe mental retardation or that may obviously not be able to use the app
* Patients included in special program other the Care as Usual (defined in the ADHD French network) in follow-up list.
* Patients with Methylphenidate treatment or change of titration for less than 3 months.
Effect of Holistic Management on the Patients With Type 2 Diabetes

Two hundreds patients with T2DM from the outpatient clinic of The First Affiliated Hospital of Chongqing Medical University will be enrolled in this study. Participating subjects will be randomly assigned into one of the 2 groups: Group A (n=100) will be placed on the short-term intensive education program alone while Group B (n=100) will be placed on the short-term intensive education as well as a holistic management for 6 months.

Diabetes education: The patients of each group will undergo designated education programs in 4 subgroups. Group A and B will be given the same education classes once a week in the first month (total 4 times), 5 hours per class. The education classes will be taught by a dedicated team of diabetes specialist doctors and nurses, with the contents including a basic understanding of diabetes, diabetic diet, exercise, drug treatments and blood glucose monitoring. At the conclusion of the education classes, the patients in Group B then will undergo a weekly telephone interview with specialist nurses for 6 months to help patients resolve self-management problems while patients in Group A will not. The specialist nurses will talk individually with the patients in Group B for 10-15 min per week. The nurses will ask the patients about their results of self-blood glucose monitoring, help them find the reasons of poor blood glucose control as well as answer the patient's questions.

Clinical examination: All subjects will complete Audit of Diabetes Dependent Quality of Life (ADDQoL) before education classes commence (baseline), at 3 months and 6 months (endpoint) after education classes to evaluate their quality of life. All patients will be examined for height, weight, blood pressure, FPG, PPG and HbA1c at baseline, 3 months after education classes and endpoint. A diabetes specialist nurse will measure the height, weight and blood pressure, and assist the subjects to fill the questionnaire. FPG and PPG will be determined by the hexokinase method, while HbA1c by high performance liquid chromatography.


Eligibility Criteria:
Inclusion Criteria:

* Patients with T2DM for more than 1 year,
* Age from 18 to 75 years old,
* Have fasting plasma glucose (FPG) ≥ 7.2mmol/L or 2 hours postprandial plasma glucose (2hPPG) ≥ 10.0mmol/L,
* Glycosylated hemoglobin (HbA1c) ≥ 7.0%,
* Have the ability to self-care.

Exclusion Criteria:

* Patients with severe liver or kidney dysfunction, severe heart failure, cognitive dysfunction or pregnancy will be excluded.
Tailoring CPP for the Foster Care Setting

The primary objective of this study is to tailor the Chicago Parent Program, an evidence-based parent training program, for the foster care setting and pilot the content in two cohorts of foster and kinship caregivers (Gross et al., 2009).

This study involves the administration of an evidence-based prevention program to prevent and reduce behavior problems in young children (the Chicago Parent Program; CPP). CPP will be tailored by creating additional handouts, discussion questions, and topics that contextualize CPP material to foster care, to meet the needs and social norms of foster and kinship caregivers. The CPP-FC 12-session curriculum will be delivered to two cohorts of foster and kinship caregivers virtually. Data for this study will come from multiple sources, including caregiver participant report and a review of existing electronic databases at CCHMC.

Eligibility Criteria:
Inclusion Criteria:

* Must be a licensed foster caregiver or kinship caregiver to a child ages 2 years to 8 years
* Must be in good standing with the foster care agency
* Must be English-speaking

Exclusion Criteria:

* Not having a foster child ages 2 - 8 years in the home
* Caregiver is unable to commit to participating in CPP-FC
* This foster child age 2 - 8 years was placed in the home more than 45 days prior to enrollment
Phenotypes and Vascular Damage in Chronic Obstructive Pulmonary Disease (COPD)

TOPDOCS is a prospective cohort study including COPD patients from currently six study centers in Switzerland. Patients with COPD GOLD stages I-IV will be enrolled and followed-up annually for at least 3 years. Yearly assessments will include a detailed patient history, quality of life and activity questionnaires, history of exacerbations, lung function, measurements of exercise capacity, measurements of vascular function, exhaled breath analysis and blood sampling. The overall objective of the project is to establish a meticulously characterized cohort of COPD patients living in Switzerland in order to allow high quality research on the pathogenesis, treatment and complications of COPD. The specific aim of the project is to determine clinically relevant COPD phenotypes and biological factors influencing vascular function in COPD patients.


Eligibility Criteria:
Inclusion criteria:

* Proven COPD (GOLD stages I-IV)
* Age: 40-75 years

Exclusion criteria:

* Mental or physical disability precluding informed consent or compliance with the protocol
* Acute or recent (within the last 6 weeks) exacerbation of COPD
Co-administration of CART22-65s and huCART19 for B-ALL

This study will evaluate the safety and efficacy of administering two CAR T cell products, huCART19 and CART22-65s, in children with advanced B cell Acute Lymphoblastic Leukemia (B-ALL).

CD19-targeted CAR T cell therapy has transformed the treatment landscape for children and young adults with chemo-refractory or relapsed B cell Acute Lymphoblastic Leukemia (B-ALL). Despite remarkable initial response rates, approximately 50% of pediatric patients experience a subsequent disease relapse. The prognosis for these patients is dismal with a median survival of less than one year from the time of post-CART19 relapse. The primary mechanisms contributing to CART19 failure include CD19-antigen escape and loss of CAR T cell surveillance due to short CART persistence. This study aims to counter each driver of relapse by co-administering two next-generation CAR T cell products: an anti-CD22 CART (CART22-65s), designed to overcome CD19-antigen escape; and a humanized anti-CD19 CART (huCART19), designed to overcome immune-mediated rejection of murine CART19.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form
2. Patients with documented CD19+ and/or CD22+ ALL/LLy:

   1. Cohort A: Patients with relapsed or refractory ALL/LLy:
   2. Cohort B: Patients with poor response to prior B cell directed engineered cell therapy
3. Patients with prior or current history of Central Nervous System 3 disease will be eligible if Central Nervous System disease is responsive to therapy
4. Documentation of CD19 and/or CD22 tumor expression in bone marrow, peripheral blood, Cerebrospinal fluid, or tumor tissue by flow cytometry at the time of last detectable disease. If the patient has experienced a relapse after CD19-directed and/or CD22-directed therapy, flow cytometry should be evaluated after this therapy to demonstrate CD19 and/or CD22 expression.
5. Age 0-29 years
6. Adequate organ function
7. Adequate performance status defined as Lanksy or Karnofsky performance score ≥50.
8. Subjects of reproductive potential must agree to use acceptable birth control methods.

Exclusion Criteria:

1. Active hepatitis B or active hepatitis C
2. HIV infection
3. Active acute or chronic Graft Vs. Host Disease requiring systemic therapy
4. Concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy or immunosuppression during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well.
5. Central nervous system disease that is progressive on therapy, or with Central nervous system parenchymal lesions that might increase the risk of central nervous system toxicity.
6. Pregnant or nursing (lactating) women
7. Uncontrolled active infection
Comparative Study Between Two Different Approaches of Brachial Plexus Block: Supraclavicular Approach and Retroclavicular Approach

In this study investigators will compare two different approaches of brachial plexus block ;supraclavicular approach and retroclavicular approach regarding success rate, duration of block, complications


Eligibility Criteria:
Inclusion Criteria:

* 100 patients doing distal arm surgery, elective , 18 to 60 years old , will be included in double blinded randomized study.

Exclusion Criteria:

* Patient refusal .
* local infection or deformity at the block site.
* Patient with significant neurological , psychiatric or neuromuscular disease.
* Pregnancy or lactating women .
* Coagulopathy .
* Morbid obesity .
* History of allergy to local anaesthetics
Testing the REThinkACADEMY Interventions in Prevention of Emotional Disorders in College Students.

Entry in the REThinkACADEMY trial will be based on the high distress range on a psychological validate instrument to assess stress. After participants are enrolled in the REThinkACADEMY trial and randomized, those in the experimental condition ill access a ecological momentary intervention (EMI) app for the prevention of emotional disorders for 4 weeks. In the second stage, for the non-responders to the ecological supportive intervention, the online game will be implemented while the rest of the groups will be monitored for another 4 weeks. At the next step, post-test outcomes assessment will be implemented. Long term assessments will be conducted at 6 months for the college student's naturalistic follow-up phase.


Eligibility Criteria:
Inclusion Criteria:

* to a first year student enorlled in Babes-Bolyai University of Cluj-Napoca
* internet and PC access to complete the scales and game
* high level of distress based on PDa scores

Exclusion Criteria:

* no internet or PC access
Caregiver Assessments of the Quality of Home Hospice Care

The Objectives are to administer the Family Evaluation of Hospice Care (FEHC) questionnaire and The Texas Revised Inventory of Grief (TRIG) to caregivers previously enrolled into the parent grant and conduct supplemental analyses to:

1. examine cross-ethnic differences in the caregivers' quality of hospice care assessments.
2. investigate the association between parenteral hydration status of the patient and the quality of care assessments provided by the caregivers after death.
3. examine the association between levels of grief (as measured by the TRIG) and the quality of hospice care assessments provided by the caregiver.

After the death of their loved-ones, caregivers will be asked to report on the care received by their care recipient and the quality of practical and emotional care provided to them by hospice by completing the 25-minute FEHC questionnaire over the phone. Caregivers will also be asked 16 additional questions to assess their attitudes and beliefs about hydration at the end of life, and a brief questionnaire to assess past and current levels of grief (TRIG). The additional questions on hydration and grief can easily be completed in less than 10 minutes over the phone. The entire interview should take no more than 35 minutes to complete.

Bereaved caregivers who have participated in the parent grant and have lost their loved one within 3-23 months will be mailed a letter from Drs. Bruera and Torres inviting them to participate in the voluntary supplemental after-death survey. The letter will include a brief description of the research study and appropriate contact information for the caregiver to call if she/he is interested in participating. The letters then will be followed up by a phone call from Dr. Torres to verify receipt of the letter. If the caregivers express their interest in participating in the study, they will be asked a few screening questions over the phone to verify their eligibility. Once found eligible for the study, a telephone verbal consent will be obtained.

Dr. Isabel Torres will conduct the phone interviews with 128 primary caregivers who had previously completed the parent grant protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Bereaved family caregivers who completed their participation in the parent protocol (2006-0494) and have lost their loved one within 3-23 months.
2. Caregivers who participated in the parent grant met the inclusion/exclusion criteria of the parent grant.

Exclusion Criteria:

1. Bereaved family caregivers who did not complete their participation in the parent protocol or any other caregiver who was never enrolled in the parent protocol (2006-0494).
Vectron T500 (Broflanilide 50WP) for IRS in Tanzania Tanzania

Malaria is a major public health problem in Africa. An important way to control the disease is by Indoor Residual Spraying of insecticide in houses. Insecticide resistance has become a major problem. This trial will evaluate a novel insecticide against those insecticide resistant mosquito vectors in Tanzania E Africa.

Background: Indoor residual spraying (IRS) is one of the major methods of malaria vector control across sub-Saharan Africa, responsible for reducing malaria incidence by 10% since 2000. However, effective vector control is increasingly threatened by the rapid spread of insecticide resistance. Consequently, there have been investments in the development of new insecticides for IRS that possess novel modes of action with long residual activity, low mammalian and environmental toxicity and minimal cross-resistance. VECTRONTM T500, a new IRS insecticide containing the active ingredient broflanilide 50% WP, has been shown to be efficacious against both pyrethroid-susceptible and -resistant vector strains on mud and concrete substrates in phase II experimental hut trials in Tanzania.

Method: A two-arm non-inferiority cluster randomized controlled trial will be conducted in Muheza District, Tanga Region, Tanzania. VECTRONTM T500 will be compared to the IRS formulation Fludora® Fusion (active ingredients: clothianidin 50% WP + deltamethrin 6.25% WP). The predominant malaria vectors in the study area are pyrethroid-resistant Anopheles gambiae s.s., An. arabiensis and An. funestus s.s. Sixteen selected clusters of 75-200 households in each cluster will be pair-matched on baseline vector densities and allocated to reference and intervention arms. Consenting households in the intervention arm will be sprayed with VECTRONTM T500 and those in the reference arm will receive Fludora® Fusion. Monthly CDC light traps will collect mosquitoes to determine vector density, indoor biting, sporozoite and entomological inoculation rates (EIR). Phenotypic resistance to IRS active ingredients will be assessed using CDC bottle bioassays. Molecular and metabolic resistance mechanisms will be characterised among Anopheles field populations from both trial arms. Residual efficacy of both brands of insecticide will be monitored for 12 months post-spraying. A semi-structured questionnaire and focus group discussions will explore social and cultural factors that influence acceptability, perceived adverse effects and benefits of IRS.

Discussion: This protocol describes a phase III non-inferiority evaluation of a novel IRS product to reduce the density and EIR of pyrethroid-resistant Anopheles vectors. If VECTRONTM T500 proves non-inferior to Fludora® Fusion, it may be considered as an additional vector control product for malaria prevention and insecticide resistance management schemes.

Eligibility Criteria:
Inclusion Criteria:

All households who consent to IRS malaria control

Exclusion Criteria:

none