cyrilzakka/clinical-trials huggingface dataset:
64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE)

The aim of this study is to determine the safety and efficacy of 64Cu-SAR-BBN and determine the ability of 64Cu-SAR-BBN Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with PSMA-negative biochemical recurrence of prostate cancer following definitive therapy.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age.
2. Signed informed consent.
3. Life expectancy ≥ 12 weeks as determined by the Investigator.
4. Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
5. Suspected recurrence of prostate cancer (PC) based on rising Prostate specific antigen (PSA) after definitive therapy on the basis of:

   1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per American Urological Association recommendation) or
   2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per American Society for Therapeutic Radiology and Oncology-Phoenix consensus definition).
6. Negative or equivocal findings for PC on (1) approved PSMA PET and (2) anatomical imaging (CT and/or magnetic resonance imaging) and (3) if available, any other conventional imaging performed as part of routine standard of care imaging workup within 60 days prior to Day 0.
7. The Eastern Cooperative Oncology performance status 0-2.
8. Adequate recovery from acute toxic effects of any prior therapy.
9. Estimated Glomerular Filtration Rate of 30 mL/min or higher.
10. Adequate liver function.
11. For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.

Exclusion Criteria:

1. Participants who received other investigational agents within 28 days prior to Day 0.
2. Participants administered any high energy (\>300 kiloelectronvolts (keV)) gamma-emitting radioisotope within 5 physical half-lives prior to Day 0.
3. Ongoing treatment or treatment within 90 days of Day 0 with any systemic therapy (e.g. androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist) for PC.
4. Participants who are known to require prohibited treatment (e.g., initiation of androgen-deprivation therapy due to rapidly rising PSA) before the 64Cu-SAR-BBN PET/CT results can be verified via histopathology or follow-up imaging.
5. Known or expected hypersensitivity to 64Cu-SAR-BBN or any of its components.
6. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
VR-PAT and FNIRS to Identify CNS Biomarkers of Pain

This study aims to use functional near-infrared spectroscopy (fNIRS) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (VR).

The objective of this study is to develop central nervous system (CNS) biomarkers of pain experience during inpatient pediatric (age 6-17 years) burn dressing changes and pain relief induced by virtual reality (VR). We plan to use innovative functional near-infrared spectroscopy (fNIRS) to identify and quantify the targeted CNS biomarkers. The ultimate goal of this project is to optimize the CNS biomarkers for predicting and/or monitoring response to VR-based pain reduction approaches for pain management in clinical trials.

We will collaborate through a team science model to recruit n=4 pediatric burn injury subjects to address the following three specific aims:

Aim 1: To quantify the central nervous system (CNS) responses associated with self-reported pain intensity during a standard clinical procedure (burn dressing changes).

Aim 2: To assess brain response patterns to virtual reality (VR)-based interventions for pain management.

Aim 3: To assess the degree to which objective brain measures and brain responses to VR intervention modulate objective brain markers of pain.

Eligibility Criteria:
Inclusion Criteria:

1. Being treated for acute burn injury
2. Age 6-17 years, inclusive
3. Admitted to NCH burn unit for treatment
4. Have a dressing that requires daily changes over 3 days
5. Patient and family caregivers can communicate (read and write) using English

Exclusion Criteria:

1. Any wounds that may interfere with study procedures
2. Vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
3. History of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
4. Minors in foster care, prisoners, or currently pregnant
5. Suspected child abuse
6. Unable to communicate in English
Risk Factors for Recurrence of Primary Bile Duct Stones

Recurrent common bile duct stone is one of the risk factors of recurrent cholangitis. However, the exact pathophysiology or mechanism of recurrent cholangitis has not been established. Periampullary diverticulum and narrow angle of common bile duct have been postulated as risk factors of recurrent common bile duct stone. The aim of this study was to evaluate the association between periampullary dierticulum, angle of common bile duct and recurrent common bile duct stone.

Recurrent common bile duct stone is one of the risk factors of recurrent cholangitis. However, the exact pathophysiology or mechanism of recurrent cholangitis has not been established. Periampullary diverticulum and narrow angle of common bile duct have been postulated as risk factors of recurrent common bile duct stone. The aim of this study was to evaluate the association between periampullary dierticulum, angle of common bile duct and recurrent common bile duct stone.

This study is patient-control setting study. Firstly, from July 2007 through February 2014, all the patients who were performed ERCP will be enrolled. The inclusion criteria is the patients with common bile duct stone. The exclusion criteria is patients with biliary stenosis, PSC, retained GB stone, or who were lost to follow-up. The main outcome is the association between periampullary diverticulum, common bile duct angle, and recurrent CBD stone. This will be evaluated by univariate and multivariate analyses.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were performed ERCP due to CBD stone or calculous cholangitis

Exclusion Criteria:

* Patients with biliary stricture, PSC, retained GB stone, or who were lost to follow-up.
Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation

This study is investigating skin conductance and respiration during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years old.
* Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation.
* Cognitive and language functioning enabling coherent communication between the examiner and the participant.

Exclusion Criteria:

* Patients with impaired skin integrity at the fingers.
* Patients with major psychiatric problems.
A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas

This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma.

This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma. Four weeks after radiotherapy, newly diagnosed WHO III-IV glioma patients will be randomised into two groups: TMZ group or TMZ+ α-IFN groups.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years to 75 years
* newly diagnosed WHO III-IV glioma after operation and radiotherapy
* Karnofsky Performance Score ≥ 60
* Adequate bone marrow, liver and renal function
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent
* anticipating survival ≥2 months

Exclusion Criteria:

* Refusal to participate the study
* Known hypersensitivity or contraindication to temozolomide
* Incompletely radiation
* Pregnant or lactating females
* Malignant tumor other than brain tumor
* Contraindicated for MRI examination
* Unable to comply with the follow-up studies of this trial
* Purulent and chronic infected wounds
* Uncontrolled psychotic disorders or epilepsy
Inpatient Screening Mammography for Non-adherent and High Risk Women

The investigators propose to pilot a program that will evaluate the feasibility of an inpatient screening mammography for non-adherent and high risk hospitalized women age 52-74 admitted to the medicine services at Johns Hopkins Bayview Medical Center and Howard County General Hospital. The two key activities include: inpatient breast care education with educational handouts and offering inpatient screening mammography. Inpatient screening mammography will be offered to non-adherent (last screening mammogram more than 24 months ago) and high risk (Gail 5-year risk of breast cancer 1.6 or greater) women. This pilot program will thus evaluate the feasibility of an inpatient screening mammography as an innovative approach to increase breast cancer screening among non-adherent and high risk women.


Eligibility Criteria:
Inclusion Criteria:

* women between 50 and 74 years of age who were non-adherent to breast screening guidelines

Exclusion Criteria:

* Patients with a history of breast cancer or mastectomy
* history of other cancers (except skin)
* serious comorbidities making patient's life expectancy \<10 years
Evaluation of Treatment for Leukoderma by Cellular Level Resolution Full-field Optical Coherence Tomography

OCT is an optical technology that emerged as a non-invasive skin imaging for the skin. In this protocol, the investigators plan to study the optical imaging features of leukoderma. An estimated 65 subjects will be included in this trial.

This is an observational, non-randomised, non-controlled, prospective cohort study to observe the feasibility of in vivo OCT as a image tool in the diagnosis of leukoderma. Use of the device will not affect the clinical management of the subjects.

Scientific Aim:

To evaluate the feasibility ApolloVue S100 image system as a tool in the differential diagnosis of leukoderma..


Eligibility Criteria:
Inclusion Criteria:

1. Age ≧ 20
2. Subject with at least one leukoderma lesion
3. Willing to participate in the trial with informed consent

Exclusion Criteria:

1. Age \< 20
2. Pregnant woman or woman wishing to be pregnant during the study, or during breastfeeding period
3. The investigators consider inappropriate to participate in the trial.
4. Open wound lesion.
Tearing of Membranes Before Birth - a Comparison Between Two Ways of Induction of Labor Pitocin Opposite Prostaglandin

Premature rupture of membranes (PROM) is a common occurrence that occurs in the incidence of 8-10% of births. Since the duration until delivery is important in avoiding the risk of complications, several studies have been performed in order to understand what is the preferred way to manage this condition of PROM in women that are not in active labor. In the largest random study that has been performed 20 years ago, there was found an advantage for labor induction with oxytocin over labor induction with Prostaglandin or waiting. However, the most important component - the BISHOP score, that affects the decision of the labor induction way, was not reported and was not taken into consideration.

Premature rupture of membranes (PROM) is a common occurrence that occurs in the incidence of 8-10% of births. Since the duration until delivery is important in avoiding the risk of complications, several studies have been performed in order to understand what is the preferred way to manage this condition of PROM in women that are not in active labor. In the largest random study that has been performed 20 years ago, there was found an advantage for labor induction with oxytocin over labor induction with Prostaglandin or waiting. However, the most important component - the BISHOP score, that affects the decision of the labor induction way, was not reported and was not taken into consideration.

Therefore, the aim of the study is to compare randomly the perinatal outcomes in women with PROM and low BISHOP between women who undergo labor induction with Oxytocin and women who undergo labor induction with Prostaglandin E2.

Eligibility Criteria:
Inclusion Criteria:

1. rupture of membranes in BISHOP score lower than 7.
2. Pregnancy week 34+0 and onward.
3. Singleton pregnancy.
4. Verifying fetal monitoring.
5. Normal maternal temperature (lower than 37.8)
6. Without vaginal bleeding or suspected placental separation
7. Contractions in frequency of less than 3 in 10 minutes
8. Signed consent form.

Exclusion Criteria:

1. Multiple pregnancy.
2. Maternal age below 18 or over 42.
3. Active labor
4. Contractions in frequency of more than 3 in 10 minutes or cervical dilation ≥2 cm.
5. Lack of consent to participate in the study
A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study

The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Has normal/impaired sensation in the urethra
* Self-catheterises at least 4 times per day
* Has used clean self-intermittent catheterisation for at least 14 days
* Is able to open and prepare the catheters for catheterisation
* Has signed the informed consent before any study related-activities.

Exclusion Criteria:

* Has a symptomatic urinary tract infection as assessed by the investigator
* Is mentally unstable as assessed by the investigator
Assessment of the Effect of Food on ABT-143 Bioavailability

Single-dose, open-label, two-period crossover study of ABT-143


Eligibility Criteria:
Inclusion Criteria:

* 18-55 years of age (inclusive)
* BMI 19 to 29 inclusive

Exclusion Criteria:

* Asian ancestry
* Concurrent participation in another study
* Females pregnant or breastfeeding
RAdiation Dose In percutANeuos Coronary Procedures Through Transradial Approach (RADIANT Observational Study)

Radiation issue during percutaneous coronary interventions is an important issue for operators due to the long term stochastic risk of cancer induction, but is often under-evaluated. Many factors may be associated with the radiation dose adsorbed by operators. In particular the most important are the position taken by the operator, the use of dedicated X-ray shield and the duration of the procedure. However other factors (as operator height or the angulation of the radiation tube) might have some important effects but are often under-evaluated .

Aim of our observational study is to evaluate the most important determinants of the radiation dose adsorbed by operators during different coronary procedures (diagnostic coronary angiography or percutaneous coronary interventions) and through different vascular accesses (right or left transradial approach or transfemoral approach).

All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this observational study.

Each operator will be equipped with dedicated dosimeters placed at left wrist, at thorax level outside the lead apron and at head level to evaluate the radiation dose at crystalline. Effective doses delivered to patients will be expressed as dose area product (DAP) and measured in Gycm2.


Eligibility Criteria:
Inclusion Criteria:

All patients who underwent to percutaneous coronary diagnostic or interventional procedures

Exclusion Criteria:

hemodynamic instability, age \<18 years
The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)

The primary objective of the the study is to investigate the changes in bone remodeling during Velcade treatment.

20 patients will be included in the study over a 2 year period. Before, during and after treatment we will measure NTX-I, CTX-I, CTX-MMP, bALP, DKK-1, PINP, TRAcP and PTH. NTX, CTX and CTX-MMP are measured to estimate bone degradation. TRAcP is measured to estimate the activity of the osteoclasts. bALP and DKK-1 is measured to evaluate the activity of the osteoblasts and PINP is measured as a marker of new bone formation. PTH is measured in order to evaluate if the positive effects that is observed in bone formation in relations to velcade treatment is due to the pulsative way velcade is administered.

The effect of the velcade treatment will be evaluated by x-ray, bone marrow and m-component.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated multiple myeloma

Exclusion Criteria:

* Use of bisfosfonates
The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety

A phase 1, Randomized, Double-blind, Parallel group, Sing-dose study to compare the Pharmacokinetics and Safety of CMAB008 and Remicade in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject (male) between the ages of 18 and 45 years.
* Subject with a body weight of ≥50 kg and ≤ 80 kg and a BMI between 19.0\~26.0 kg/m2 (both inclusive);
* Healthy as determined by pre-study medical history, physical examination, vital signs and 12-lead electrocardiogram;

Exclusion Criteria:

* Those who have surgered 4 weeks before signing the informed consent;
* Those with mental, respiratory, cardiovascular, digestive, urinary, reproductive, skeletal and motor, blood, endocrine, nervous and other system diseases, or those with any previous immune diseases;
* Those who have received any drug treatment (including prescription drugs, over-the-counter drugs, biological products, Traditional Chinese medicine, vitamins, dietary supplements, etc.) and health care products within 4 weeks before signing the informed consent;
* Those who accepted biological drugs within 6 months before signing the informed consent, or accepted the TNF monoconal antibody drugs;
* Any one of HIV antibody, HBsAg, HBeAg, HBcAg, HCV antibody and Treponema pallidum antibody is positive;
* Either T cell immunospot test (T-SPOT) or antinuclear antibody is positive;
* Those who have infected within 30 days before administration, or serious infection associated with hospitalisation and/or which required inrravenous antibiotics within 3 months before administration.
* Vaccinated within 30 months before signing the informed conset, or plan to vaccinate during the trail;
* Those who have used soft drugs within 3 months prior to signing the informed consent or hard drugs within 1 year prior to the trail; those who have positive drug abuse test results;
* Those who drinking too much tea, coffee and/or caffeinated beverages (more than 8 cups, 250ml per cup) every day;
* Those who have a blood donation history of 400 ml within 3 months, or 200 ml within 1 month;
* Those who have a history of drug or food allergy, or are known to be allergic to any component of the test drug or latex, etc.
* Those who are addicted to smoking or smoke more than 10 cigarettes per day on average within 6 months before signing the informed consent;
* Alcoholics or regular drinkers within 3 months before the trail, i.e. those who drink more than 14 units of alcohol per week (14 bottles of 360 ml beer or 630 ml spirits with 40% alcohol), or whose alcohol breath test is positive;
* Those who plan to donate sperm within 6 months after the adminstration of the test drug;
Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Chronic Graft Versus Host Disease

The primary purpose of the study is to evaluate the safety and efficacy of mesenchymal stem cells (MSC) for the treatment of patients who have developed an extensive chronic graft versus host disease (with skin and/or liver damage) after HSCs transplantation and do not respond to first-line therapy.

The secondary purpose of the study is to evaluate the effect of mesenchymal stem cells (MSC) on one-year survival rate, long-term survival rate, life quality and recurrence of patients who have developed an extensive chronic graft versus host disease (with skin and/or liver damage) after HSCs transplantation and do not respond to hormone treatment.

Chronic Graft-versus-host disease (GVHD)， with the incidence of 30%-60%, is a serious late complication of allogeneic hematopoietic stem cell transplantation (HSCT) and is the major cause of death in the late stage of transplantation. According to targeted organs, cGVHD is divided into two types, limited cGVHD and extensive cGVHD. Extensive cGVHD needs systemic immunosuppressant treatment. However, currently standard first-line regimen including cyclophosphamide and prednisolone is only effective for some patients. Novel treatment is urgently needed. Our previous study has shown that mesenchymal stem cells (MSCs) are effective for cGVHD patients with multiple skin damage. To further explore the therapeutic effect of MSCs for extensive cGVHD, we plan to conduct a multi-center clinical trial. Patients who developed an extensive cGVHD (with skin and/or liver damage) after HSCs transplantation and do not respond to first-line therapy are enrolled. They will be randomly divided into two groups which will receive MSCs and routine second-line drugs respectively. We will evaluate the efficacy and safety of MSCs for extensive cGVHD by comparison of symptom improvement, survival rate, recurrence as well as side effects in the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Extensive cGVHD with skin and/or liver damage developed after allogeneic hematopoietic stem cell transplantation
* cGVHD that do not response to conventional immunosuppressant treatment for two months
* KPS\>= 30
* informed consent from the patient

Exclusion Criteria:

* Extensive cGVHD without skin or liver damage
* With other acute severe complications
* In pregnancy or lactation
* Disease relapses
* With non-hematological malignancy
* Have a history of mental disorder, drug or alcohol abuse over the past five years
* Allergic
* Participate in other clinical trial within three months before the start of this trial
* With bone marrow fibrosis
* Have undergone hematopoietic stem cell transplantation to treat solid tumor