cyrilzakka/clinical-trials huggingface dataset:
Pre-Approval Expanded Access Study for TAR-200 Treating Physician Use

The purpose of this pre-approval access program is to provide access to TAR-200 prior to its marketing authorization for the treatment of participant(s) with high-risk non-muscle invasive bladder cancer (HR-NMIBC).


Eligibility Criteria:
Inclusion criteria:

* Participant has exhausted all clinically appropriate alternative forms of treatment and is not eligible for, or does not have access to, a clinical trial
* Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle-invasive bladder cancer (HR-NMIBC), carcinoma in situ (CIS) (OR Tis) with or without papillary disease (T1, high-grade Ta), within 12 months of completion of the last dose of BCG therapy, in participants who have received adequate Bacillus Calmette-Guérin (BCG)
* All visible papillary disease must be fully resected (absent) prior to initiation of treatment
* Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC)
* Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2

Exclusion criteria:

* Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV)
* Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200. Participants with tumors involving the prostatic urethra in men will be excluded
* Evidence of bladder perforation during diagnostic cystoscopy
* A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (\>4000 mL)
* Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than HR-NMIBC
Current Status of Porcine Derived Products in Surgery

Porcine derived products are being used as biological grafts in mainly in orthopedic surgery, neurosurgery, cardiovascular surgery and general surgery. It is well known that consuming pork or porcine products are prohibited in some religions or divisions of religions. It may be a tender point for patients undergoing surgery in which porcine derived products are utilized.In this survey study we aimed to determine the level of awareness and perception of surgeons with an international anquette. The study will also reveal the choices of surgeons about this issue both in elective and emergency procedures

In the survey study an online anquette form will be sent through online surgery networks both professional and social media. The questionnaire will not include questions defining the responders individually. The questions are related to frequency of utilization of porcine derived products in surgery, surgeons' level of awareness about utilization of porcine products, surgeons' level of religiousity and surgeons' choices about porcine derived product utilization and consent of patients. After collection of responses the data will be analyzed to discover current status of porcine derived surgical product utilization and surgeons' perception about the issue. The anquette will be distributed worldwide to surgeons in different branches of surgery. Literature seems to be lacking of that kind of study

Eligibility Criteria:
Inclusion Criteria:

* Being volunteer and responder of at least 80% of the study questionnaire

Exclusion Criteria:

* Responding less than 80% of the questionnaire
Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)

The purpose of this study is to evaluate the proportion of Rheumatoid Arthritis (RA) subjects achieving a "good" or "moderate" DAS28 response (EULAR28 criteria) at Week 16 with etanercept 50 mg subcutaneously (SC) once weekly in patients who have failed infliximab.


Eligibility Criteria:
Inclusion Criteria:

* Adults with RA (ACR criteria) for greater than or equal to 6 months
* Infliximab treatment for at least 18 weeks
* Infliximab infusion prior to screening at an increased dosing regimen: 5 mg/kg every 4-8 weeks (dose), OR, 3 mg/kg every 4-6 weeks (frequency)
* Failing infliximab defined by ALL of the following at screening and baseline visit: Disease Activity Score (DAS 28) greater than or equal to 4.5, greater than or equal to 5 swollen joints, greater than or equal to 5 tender joints
* Subjects must be receiving stable methotrexate (MTX), at a dose of greater than or equal to 10 mg/week at least 10 weeks prior to screening
* Stable disease modifying anti-rheumatic drugs (DMARD) therapy (including sulfasalazine, hydroxychloroquine), greater than or equal to 8 weeks prior to screening
* Stable dose corticosteroids, less than 10 mg/day at greater than or equal to 4 weeks prior to screening
* Stable dose of non-steroidal anti-inflammatory drugs (NSAIDs) greater than or equal to 1 week prior to screening

Exclusion Criteria:

* ACR functional class IV - Prior treatment with etanercept
* Receipt of any investigational drug/biologic within 28 days of study drug initiation
* Active infection or predisposition to infection
* Elective surgery planned during study period
* Intra-articular, soft tissue, or intramuscular corticosteroid injections during 4 weeks prior to screening
* Contraindications to etanercept as defined in the package insert
* Severe co-morbidities: History of cancer within 5 years; Diagnosis of class III or IV congestive heart failure (CHF); Uncontrolled hypertension (HTN); CNS-demyelinating events suggestive of multiple sclerosis (MS); Known HIV-positive status; Oxygen-dependent pulmonary status; Chronic hepatitis B or C; Systemic Lupus Erythematosus (SLE); Active or prior history of tuberculosis (TB) (or known exposure) or positive PPD without adequate TB prophylaxis
Prospective Multicenter Registry of Gender, Diversity and Inclusion (GEDI) of Women With Acute Coronary Syndrome

Create a multicenter prospective registry that collects information from women affected by acute coronary syndrome (ACS). This registry aims to understand the diversity in the presentation of women with ACS. It proposes to conduct a thorough characterization of the women involved in the study through genetic, biochemical, and molecular analysis.This approach aims to identify any differences in the characteristics of women with ACS and to identify disease subtypes that may influence treatment options and clinical outcomes.

Create a multicenter prospective registry that collects information from women affected by acute coronary syndrome (ACS) from a wide range of cultural and ethnic backgrounds distributed across various Italian regions. This registry aims to understand the diversity in the presentation of women with ACS in Italy, providing valuable data for a better understanding of the disease.

Additionally, it proposes to conduct a thorough characterization of the women involved in the study through genetic, biochemical, and molecular analysis. This analysis will be stratified by age and the etiology of coronary artery disease, distinguishing between obstructive and non-obstructive coronary artery disease.

Specific aims of this proposal are:

1. To create a multicenter prospective registry including women with ACS from a variety of cultural and ethnical backgrounds in different Italian regions
2. To deeply characterize women with ACS through clinical, imaging, genetic, biochemical, and molecular phenotyping stratifying for age, etiology (obstructive vs non-obstructive CAD) and diversity.
3. To assess socioeconomic status, health literacy and awareness of risk factors among enrolled patients.

Eligibility Criteria:
Inclusion Criteria:

* Women \>/= 18 years with ACS (STEMI, NSTEMI or Unstable Angina).

Exclusion Criteria:

* age \< 18 years and/or unwillingness to sign informed consent and/or unwillingness to make follow-up visits
Prospective Multicenter Cohort Study Evaluating the Incidence and Risk Factors for Problem Gambling Among Young Adults With First-episode Psychosis

The aim of this observational study is to get a better understanding of the association between problem gambling psychotic disorders among young adults with firs-episode psychosis. The main questions to be answered are:

1. What are the incidence and risk factors for problem gambling in this population?
2. How effective are the current treatments for problem gambling in adults with first-episode psychosis?

To do so, comparisons will be made among the study cohort for various factors:

* Use of dopamine partial agonists;
* Psychiatric comorbidities;
* Socioeconomic status;
* Sex;
* Gender;
* Gambling history.

The nature of the treatments for problem gambling offered and received by the subjects, as well as their effectiveness, will also be documented.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 35 years old;
* Diagnosis of first-episode psychosis (i.e., DSM-5 diagnosis of schizophrenia spectrum and other psychotic disorders, as well as DSM-5 bipolar disorder with psychotic features).

Exclusion Criteria:

* DSM-5 diagnosis of psychotic disorder due to a medical condition;
* Severe intellectual disability.
Biomarkers of Exposure to Air Pollutants (AEROTOX-2)

Nowadays, an increase of inflammatory chronic diseases and/or tumors incidence has been reported in part due to the rising in life expectancy. For instance, exposure to air pollution, and in particularly to fine particles has been classified by the International Agency for Research on Cancer (IARC) as a risk factor for cancer, being the elderly population particularly sensitive. However, no validated biomarkers have been identified to assess the exposure to fine particles maybe correlated to cancerogenesis.

AEROTOX-2 is a prospective pilot study on the ex vivo effects of the atmospheric pollution exposure. The study aims to identity new biomarkers after an exposure of leukocytes to doses of fine particles.

Secondly, the study aims to analyze, according to age, the leukocytes response to the urban pollution exposure.

To estimate the influence of the atmospheric pollution on the whole adult population, subjects will be recruited in a wide range of age (20 - 80 years).

Samples of atmospheric particles will be collected in Dunkerque (North of France), one of the most important industrial areas in France. This city is influenced by car traffic, urban and industrial activities, and the wide sea traffic of the North Sea. Therefore, Dunkerque is a reference site to study the atmospheric pollution and its impact on health.

These markers will be searched in association with the different mechanisms involved in the toxicity of the fine particles such as: inflammatory response, genotoxicity, metabolic activity and epigenetic changes after exposure of leukocytes isolated from patients to doses of fine particles.

The study of the correlation between biological observations and conditions of exposure to air particles will bring answers about the impact of the environmental pollution on the health of vulnerable populations.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-30 years, 45-55 years or 70-80 years
* Signature of an informed consent
* Non-smoker or ex-smoker for more than 10 years
* Homogeneous repartition between men and women
* Social insurance affiliation
* Understanding or being able to speak French

Exclusion Criteria:

* Pregnant or breast feeding woman
* Treatment with parenteral corticoids in the 30 days prior to inclusion visit, treatment with immunosuppressant drugs, radiotherapy, chemotherapy
* Occupational exposure (metallurgy, petrochemistry, house painter) for more than 10 years and having ceased all activities in these areas for less than 10 years ago.
Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib

The purpose of this study is to determine the best confirmed response rate of daily administration of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR and VEGFR2) XL647 in subjects with NSCLC who have progressed after responding to treatment with either erlotinib or gefitinib.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of unresectable Stage IIIB or Stage IV relapsed or recurrent NSCLC.
* Subjects must have:

  1. documented (radiological or clinical) progressive disease (PD) following a prior response (including stable disease) to monotherapy with erlotinib or gefitinib that was administered for at least 12 weeks prior to progression OR
  2. a documented T790M EGFR mutation
* Measurable disease defined according to RECIST
* ECOG performance status of 0 or 1.
* Sexually active subjects must use an accepted method of contraception during the course of the study.
* Female subjects of childbearing potential must have a negative pregnancy test at enrollment.

Exclusion Criteria:

* Received radiation to ≥25% of his or her bone marrow within 30 days of XL647 treatment.
* Received erlotinib or gefitinib, or other anticancer therapy within 14 days of the first dose of study drug.
* Received an investigational drug (excluding erlotinib or gefitinib) within 30 days of the first dose of study drug.
* Receiving anticoagulation therapy with warfarin.
* Not recovered to Grade ≤1 from adverse events (AEs) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study enrollment.
* Corrected QT interval (QTc) of \>0.45 seconds.
* Progressive, symptomatic, or hemorrhagic brain or leptomeningeal metastases.
* Requires steroid or anticonvulsant therapy for the treatment of brain metastases.
Metabolism and Excretion of Liraglutide in Healthy Male Volunteers

This trial is conducted in Europe. The aim of this trial is characterise the metabolic profile of liraglutide in plasma, urine, and faeces after a single injection of \[3H\]-liraglutide.


Eligibility Criteria:
Inclusion Criteria:

* Good general health as judged by the Investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, and blood and urinary laboratory assessments
* BMI (Boday Mass Index) of 20.0-27.0 kg/m\^2, both inclusive

Exclusion Criteria:

* History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator
* Impaired renal function
* Active hepatitis B or active hepatitis C
* Positive human immunodeficiency virus (HIV) antibodies
* Any clinically significant abnormal ECG, as judged by the Investigator
* Any clinically significant abnormal laboratory test results, as judged by the Investigator
* Acute infection or inflammation or other illness that may influence the metabolism and excretion pattern of the trial product, as judged by the Investigator
* Known or suspected allergy to trial product(s) or related products
* History of alcoholism or drug abuse or positive results in alcohol and drug screens
* Smoking of more than 5 cigarettes per day
* Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the Investigator
* Excessive consumption of a diet deviating from a normal diet, as judged by the Investigator
Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study

This clinical study will involve performing a series of medical imaging procedures of the abdomen using both ultrasound and MRI modalities in subjects at risk for or already diagnosed with Nonalcoholic Fatty Liver Disease (NAFLD). The primary objective of this clinical study is to evaluate the clinical feasibility of an investigational ultrasound technique for quantifying liver fat by comparing specific ultrasound-derived biomarkers with the liver fat percentage obtained from MRI Proton Density Fat Fraction (MRI-PDFF) measurements. All subjects enrolled in this study will undergo two investigational abdominal ultrasound examinations using the Philips EPIQ Ultrasound System and one MRI PDFF examination according to the clinical standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years old and able to provide written informed consent
* Must attest to absent or minimal alcohol consumption (i.e. \< 2 alcoholic beverages per day for women and \< 3 alcoholic beverages per day for men, where an alcoholic beverage is defined as 12 oz. of regular beer, 5 oz. of wine, or 1.5 oz. of distilled spirits).
* Must be eligible for a standard abdominal ultrasound examination and standard non-contrast MRI examination.
* At least one of the following criteria must also be met: Overweight or obese (BMI ≥ 25); Diagnosed with Type 2 diabetes; Diagnosed with hypercholesterolemia; Diagnosed with or clinically suspected of having NAFLD/NASH

Exclusion Criteria:

* Evidence of moderate/heavy/binge alcohol consumption exceeding the thresholds above
* Evidence of hepatotoxicity
* History of chronic liver disease (e.g., viral, cholestatic, or autoimmune).
* Use of drugs associated with hepatic steatosis
* Subjects anticipated or planned to undergo any diagnostic or therapeutic intervention during enrollment period that, at discretion of the Investigator, may affect liver fat content
* Hepatic lesions that cannot be excluded from the imaging field during ultrasound LFQ data acquisition
* History of previous liver surgery or hepatic implants that, at the discretion of the Investigator, may adversely impact ultrasound or MRI image quality or the subject's eligibility to undergo ultrasound or MRI
Long-term Treatment Outcome for Stage III NPC Patients and Risk Grouping by Plasma EBV DNA

No previous study reported the treatment outcome of stage III nasopharyngeal carcinoma (NPC) patients. The investigators try to investigate the long-term treatment outcome of stage III NPC patients and do risk grouping by plasma Epstein-Barr virus (EBV) DNA assay for future therapy improvement.

The stage III NPC patients were the majority group of the patient population of NPC. But most clinical trials focused on the treatment of American Joint Committee on Cancer (AJCC) 7th edition stage IVA/IVB treatment for high risk of recurrence or metastasis. No previous study reported the treatment outcome of stage III NPC patients. The investigators tried to investigate the long-term treatment outcome of stage III NPC patients and do risk grouping by plasma EBV DNA assay for future therapy improvement.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven stage III nasopharyngeal carcinoma (NPC)
* Finished curative chemoradiotherapy
* Have Pre-treatment and post-radiotherapy plasma EBV DNA

Exclusion Criteria:

* No tissue proven NPC
* Not finished curative treatment
* No Pre-treatment and post- radiotherapy plasma EBV DNA
A Study to Assess the Pharmacokinetics, Metabolism and Excretion Routes of ASP3652 in Man, After Administration of 14C Radio Labeled ASP3652

This study measures how much of the trial drug enters the body and how long it takes for the body to remove it via the feces and urine. In addition, the different breakdown products after a single oral dose of radio-active ASP3652 will be identified.

This is an open-label, one-period, single-dose study with 14C labeled ASP3652.

Screening takes place between Day 22 to Day 2, and subjects are admitted to the clinic on Day -1.

On the morning of Day 1, each subject receives a single oral dose of 14C-labeled ASP3652. Blood, urine and feces samples for analysis of 14C radioactivity are collected until at least 120 h after dosing. Blood samples for the analysis of ASP3652 and metabolites are collected until 120 h after dosing.

The subjects remain in the clinic until Day 6 (or up to Day 13 in case discharge criteria are not met on Day 6) and return for an End of Study Visit (ESV) 7 to 14 days after (early) discharge.

Eligibility Criteria:
Inclusion Criteria:

* Subject is white and of Caucasian origin.
* Regular defecation pattern (minimum once per day).
* Subject must agree to use a condom during sexual intercourse until 3 months after dosing. In addition to using a condom, subjects must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy.

Exclusion Criteria:

* Known or suspected hypersensitivity to ASP3652 or any components of the formulation used.
* Donation of blood or blood products within 3 months prior to admission to the Clinical Unit.
* Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a clinical study in the previous year.
The Impact of Fitness on Vascular Dysfunction in Adolescents With Type 1 Diabetes

The principal hypothesis of this study is that the micro and macro vasculature of young diabetes mellitus type 1 (DM1) patients is particularly susceptible to atherogenic factors which cause vascular dysfunction at multiple levels of the arterial vasculature and that this dysfunction is demonstrable using state-of-the-art ultrasound methods. The investigators further hypothesize that interventions, such as exercise, that are readily integrated into the daily life of individuals with DM1 can mitigate or reverse these early vascular changes and thereby diminish the otherwise predictable longer-term development of cardiovascular disease (CVD) in type 1 DM


Eligibility Criteria:
Inclusion Criteria: You may be eligible if you are:

* Male or female, 12-18 years of age
* Healthy, no chronic illness other than DM1
* No medications that would affect the blood vessels
* Non-smoker
* Normal height and weight

Requirements for both groups (study 1)

* Two outpatient visits lasting \~1 to 1 ½ hours
* 1 outpatient admission lasting \~ 10 hrs
* Most visits require blood draws Requirements for second part of study for DM1 group (study 2)
* Two additional outpatient visits (one requires blood draw)
* 12 weeks of an exercise program (5 days per week, 3 of them here at UVA)
* Maintain healthy diet for those 12 weeks-you will have diet instruction
* Repeat outpatient admission as described above

Exclusion Criteria:

* under 12 or over 18 years of age
* medication that could affect the blood vessels
* smoker
* above average BMI
* chronic illness other than DM1
Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients

This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.


Eligibility Criteria:
Inclusion criteria

* Male and female patients of any race 18 years or older
* Adult recipients of a kidney transplant from a deceased or from a living donor
* Recipients of a functioning Kidney:. Graft must be functional no later than 36h after transplantation.

Exclusion criteria

* Need for medication prohibited by the protocol
* Patients or donors infected with hepatitis B or C, or with HIV.
* Patients with a history of cancer
* Patients with severe systemic infections Patients with heart diseases (own or family history) which are associated with an increased risk for arrhythmias.

Other protocol-defined inclusion/exclusion criteria may apply