cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Safety, Tolerability and Pharmacokinetics of PAC-14028 Cream in Healthy Male Subjects

The purpose of this study is to investigate the safety/tolerability and pharmacokinetics of PAC-14028 cream after transdermal administration in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men aged 19 to 65 years at the time of screening
2. Whose weight is 50 kg or more, but less than 90 kg, and whose body mass index (BMI) is 18.0 kg/m\^2 or more but less than 27 kg/m\^2

   * BMI (kg/m\^2) = weight(kg) /{height(m)}\^2
3. Who doesn't have skin disease, skin damage (including tatoos or scars), or excessive hair in application area which can affect drug absorption
4. Who voluntarily decides study participation after receiving detailed explanation about the study and fully understanding it and who provides written consent for compliance with study requirement including proper contraception

Exclusion Criteria:

1. Who has clinically significant medical history or diseases involving liver, kidney, neurological system, respiratory system, endocrine system, urinary system, cardiovascular system,skin, psychical disorders or blood tumor
2. Who has a history of hypersensitivity or allergies to any drug (aspirin, antibiotics, etc)
3. Who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration, or who has taken any over-the-counter (OTC) drugs or vitamins within 1 week before the study drug initiation (Investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/exclusion criteria is satisfied.)
4. Who has drug abuse history or positive result at urine screening tests (cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine)
5. Who has smoked within 3 months before study drug administration (Smoker who has stopped smoking for more than 3 months before study drug administration is eligible to participate)
6. Who has confirmed positive at serological tests (HBs antigen, HCV antibody and HIV antibody)
7. Who consistently consumes alcohol
8. Who has participated in other clinical study within 8 weeks before study drug administration (however, the last dosing day is considered as the end of clinical study.)
9. Who has had bleeding or blood collection and donation over 400 mL within 8 weeks before study drug administration
10. Who donated whole blood within 2 months before study drug administration, who donated via plasmapheresis/plateletpheresis within 1 month before study drug administration, or who received a blood transfusion within 1 month before study drug administration
11. Whose vital sign measured at sitting position after resting at least 3 minutes is as following

    * Low blood pressure (Systolic pressure: less than 90 mmHg, Diastolic pressure: less than 60 mmHg)
    * High blood pressure (Systolic pressure: higher than 150 mmHg, Diastolic pressure: higher than 100 mmHg)
12. Who is determined ineligible for study participation by investigators for any reason including clinical lab test and ECG results.
Low-Dose Total Skin Electron Therapy in Treating Patients With Refractory or Relapsed Stage IB-IIIA Mycosis Fungoides

This clinical trial studies low- dose total skin electron therapy in treating patients with stage IB-IIIA mycosis fungoides that has not responded to previous treatment (refractory) or has returned after a period of improvement (relapsed). Radiation therapy uses high energy electrons to kill tumor cells and shrink tumors. Rotisserie technique is a method in which the patient receives total skin electron therapy while standing on a rotating platform. Giving low dose total skin electron therapy using rotisserie technique may kill tumor cells, while having fewer side effects, and may allow therapy to be repeated in future if clinically indicated.

PRIMARY OBJECTIVES:

I. To assess the skin-related quality of life using an established method (Skindex-29), with comparisons made between pre-treatment and each of follow-up post-treatment skin assessments.

II. To assess the durability of response using an established method (modified Severity-Weight Assessment \[mSWAT\] tool), with comparisons made between pre-treatment and each of follow-up post-treatment skin assessments.

III. To determine side effect profile for low dose total skin electron therapy (TSE) for mycosis fungoides administered via rotisserie technique.

OUTLINE:

The investigational portion of this research study involves collecting quality of life (QOL) questionnaire data and objective measurements of patients' skin responses, which are obtained by the radiation oncologist during the patient's standard of care radiation treatment planning. Patients will also undergo standard of care low-dose total skin electron therapy for under 1 hour daily on days 10-21.

After completion of study treatment, patients are followed up at 6 and 12 weeks, and then every 3 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmed mycosis fungoides stage IB-IIIA
* Skin manifestations of mycosis fungoides that are refractory to or have relapsed on at least one prior therapy, which may include topical steroids
* Life expectancy \> 6 months

Exclusion Criteria:

* Serious medical condition that would make treatment unsafe
* Pregnant or lactating patient
Study to Learn How Different Forms of The Study Medicine Called Danuglipron Are Taken up Into the Blood In Healthy Adults

The purpose of the study is to learn how different forms of a study medication called danuglipron are taken into the blood in healthy adults, following single dose administration.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older and overtly healthy
* Body mass Index (BMI) between 16-32 kg/m2; and a total body weight \>50 kg (110 lb)

Exclusion Criteria:

* Evidence or history of clinically significant medical conditions or laboratory abnormality
* Any condition possibly affecting drug absorption
* Known intolerance/hypersensitivity to a GLP-1 R agonist
* Use of prescription drugs, nonprescription drugs, dietary supplements or herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of danuglipron in each part of the study.
Vasoplegic Syndrome in Cardiac Surgery

Vasoplasmic syndrome in cardiac surgery is one of the major postoperative complications.This syndrome is characterized by persistent low blood pressure despite an optimization of preload and inotropism.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing cardiac surgery with extracorporeal circulation
* Patients covered by a social insurance system.
* Patients who have given oral consent to participate after full information

Exclusion Criteria:

* Cardiac graft.
* Preoperative ECMO / ECLS.
* Cardiac assistance.
* Minor,
* Patient deprived of liberty, or under safeguard of justice.
Serum S100B Protein Assay in Mild Head Injury

Head injuries are a major public health issue, with an estimated annual incidence in Europe of 262 per 100,000 population. Light head injury (SCI), defined by a Glasgow score between 13 and 15, constitutes the majority (71% to 98%) of head injury cases. Despite a generally good prognosis, patients with TCL have a low but real risk of brain damage, whose prevalence is estimated at 5%. Cerebral computed tomography (CT) because of its high sensitivity for the detection of posttraumatic intracranial lesions (LIC), is currently considered the gold standard for the diagnosis of these lesions in patients considered at risk after clinical evaluation. The number of cTCTs performed is high with no lesion in more than 90% of cases. The S100B protein, a marker of brain tissue damage, is reported to reliably exclude the presence of brain lesions in adults as well as antiaggregants. These numerous studies show that its serum assay in combination with the clinical decision algorithms allows, thanks to a sensitivity close to 100% for brain lesions, to reduce the number of CTMc currently prescribed by approximately 30%, and therefore to decrease unnecessary exposure to radiation. Although there is no study on the subject, a gain on the duration of care in emergencies can be expected as well as a reduction on the cost of care by a dosage price three times less higher than the TDMc. Expert opinion for the use of this assay in the management of moderate-risk TCL at threshold ≤ 0.10 μg / L in 3h post-TC to ensure sensitivity of 100%, was published in 2014 in the Annales Françaises de Médecine d'Urgence.

The use of anticoagulants has continued to increase in recent years. In 2013, it is estimated that 3.12 million patients received at least one anticoagulant in France. Currently, the international and French recommendations indicate the achievement of cTCT in anticoagulated TCL because it is an independent risk factor for cerebral injury and is therefore considered to be a high risk TCL. LIC. The hypothesis of this study is that the S100B protein assay could also exclude the presence of brain lesion after TCL under anticoagulation in adults


Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Emergency department patient with mild head trauma (13 ≤ Glasgow score ≤ 15)
* Affiliated to the social security scheme
* Patient having been informed about the study and do not disagree to participate
* Patient on anticoagulant therapy (enteral or parenteral route)

Exclusion Criteria:

-
Continence Care Registry

This observational research study aims to build a multinational electronic patient-reported outcomes (ePRO) registry of adult end users in outpatient and community settings using intermittent catheter(s) to void via the urethra to manage urinary retention and incomplete bladder emptying. Research participants will be asked to self-report on various attributes of their currently prescribed intermittent catheters and other various aspects of using an intermittent catheter.

This observational research study aims to build a multinational ePRO registry of adult end users in outpatient and community settings using intermittent catheter(s) to void via the urethra to manage urinary retention and incomplete bladder emptying. Research resulting from data generated from an ePRO registry will factor in end user perspectives on intermittent catheterization habits and behaviors and intermittent catheter performance to inform and guide healthcare providers, end users, and caregivers in making the most informed healthcare decisions regarding intermittent catheterization. Research participants will be asked to self-report on various attributes of their currently prescribed intermittent catheters and various aspects of habits and behaviors, including health-related quality of life, of using an intermittent catheter.

Eligibility Criteria:
Inclusion Criteria:

1. Is at least 18 years of age; male or female.
2. Is performing transurethral intermittent catheterization.
3. Uses intermittent catheter(s) from any manufacturer as a form of management for urinary retention or incomplete bladder emptying.
4. Must be able to provide informed consent and have no cognitive impairment that would hinder the ability to provide informed consent or self-reported data.
5. Lives and has permanent residence in one of the countries that the study is being conducted at time of enrollment (USA, Canada, UK, Germany, France, The Netherlands, or Italy)
6. Is willing and able to complete electronic questionnaires monthly for the first year of data collection and quarterly thereafter or appoint a caregiver proxy.
7. Is able to read and respond to the questionnaires in the language options provided for a given country (e.g. French Canadian or English for Canada)

Exclusion Criteria:

1. Performs non transurethral catheterization, e.g., stoma.
2. Participating in a clinical study involving transurethral intermittent self-catheterization at the time of enrollment.
3. Employee of Sponsor at the time of enrollment.
Synergistic Effect of Combination Therapy With Cilostazol and Probucol on Plaque Stabilization and Lesion Regression: Serial Intravascular Ultrasound and Virtual Histology Study(SECURE Study)

The purpose of this study is to evaluate the effect of combination therapy with cilostazol and probucol on plaque volume and composition change in comparison with cilostazol alone by serial intravascular ultrasound and virtual histology.


Eligibility Criteria:
Inclusion Criteria:

1. Patients treated with PCI with stent
2. Male or female over 20 years of age
3. Presence of at least one PCI target lesion(lesion length ≤26mm) with ≥50% diameter stenosis that can be covered with a single Endeavor Sprint stent(Medtronic)
4. Other PCI target lesions also should be treated with Endeavor Sprint stents
5. Presence of an intermediate non-PCI target lesion with luminal narrowing of ≥30% and ≤70% by visual estimation
6. Signed written informed consent to participate in the study

Exclusion Criteria:

1. Intermediate (non-PCI target) lesions that might provide difficulty for IVUS evaluation because of following reasons: heavy calcification (\>90° Arc), tortuous vessel with sever angulation, total occlusion, or bifurcation lesions
2. Previous PCI in the last 6 months
3. Previous CABG
4. Patients with AMI undergoing primary PCI or rescue PCI after thrombolysis
5. Cardiogenic shock
6. Inability to take adequate anti-platelet therapy
7. Thrombocytopenia (platelet count \<70 x 109/l)
8. Known hypersensitivity or contraindication to any of the following medications: Heparin, aspirin, clopidogrel, cilostazol, probucol, statin, contrast media\*

   \*Patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.
9. History of severe ventricular arrhythmia
10. Significant QTc prolongation (≥470 ms) on ECG
11. NYHA class III/IV heart failure or LV ejection fraction ≤35%
12. Familial hypercholesterolemia
13. Uncontrolled hypertriglyceridemia (\>400 mg/dL)
14. Chronic renal failure with serum creatinine level ≥2mg/dL
15. Severe liver disease or transaminase level ≥3 times the upper limit of normal.
16. Pregnant or breastfeeding
Clinico-immunological Characterization and Immune Tolerance Breakdown in CV2-autoimmunity

Paraneoplastic neurological syndromes are rare syndromes caused by the remote effects of cancer. They have an immune-mediated pathogenesis, yet the underlying mechanisms are not fully elucidated. CV2/Collapsin response-mediator protein 5 (CRMP5)-IgG paraneoplastic neurological syndrome is characterized by heterogeneous clinical presentations, affecting both central and peripheral nervous system, and the most frequently associate tumor is small cell lung carcinoma. Central nervous system involvement along with CSF and neuroimaging findings have not been fully described in the literature in CV2/CRMP5 patients. Unraveling the complexities of CV2/CRMP5 paraneoplastic neurological syndrome is critical to improve diagnosis, treatment, and patients' care. Our intention is to perform a comprehensive analysis of the clinical characteristics and instrumental investigations of a large cohort of CV2/CRMP5 patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient with paraneoplastic neurological syndromes
* Patient with CV2 antibody in sera and/or CSF

Exclusion Criteria:

* Patient with no data
* Patient without neurological disorder
* Patient without CV2 antibody in sera/CSF
Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema

8 years after the establishment of the therapeutic education program and 14 years after the creation of the National Reference Center for Angioedemas (CREAK), it is necessary to make an inventory in 2021 on the disease experienced by the patient with an assessment the needs and expectations of HAE patients. This assessment would make it possible to see the evolution of these needs and to adjust the price for the overall cost of children and adults in France. It may also allow a comparison of the requests expressed during a similar survey in another French-speaking region such as Quebec.

Main objective is to know the needs and the current satisfaction of the needs, with regard to the disease and the treatment of the targeted patients of hereditary angioedema (HAE)


Eligibility Criteria:
Inclusion Criteria:

* Patient with HAE with or without C1 inhibitor deficiency
* Patient over 15 or parents of a child under 15 with HAE

Exclusion Criteria:

* Patient opposed to the use of their data or refusing to answer the questionnaire
* Adult patients protected by law
Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients

To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 80 years
* Physician diagnosed celiac disease
* Adherence to a gluten-free diet
* Experiencing symptoms of celiac disease over a 1-month period
* Willing to take study medication for 12 weeks
* Willing to comply with all study procedures
* Sign informed consent

Exclusion Criteria:

* Active inflammatory bowel disease
* Active dermatitis herpetiformis
* Use of certain specific medications prior to entry
* History of alcohol or illicit drug abuse in previous 6 months
* Pregnant or lactating
* Received any experimental drug within 30 days of enrollment
* Uncontrolled chronic disease or condition
Evaluation of Diffusion Tensor Imaging and High Frequency 3D Endovaginal Ultrasound

To assess the feasibility of a novel MRI technique- diffusion tensor imaging with fibre tracking in understanding the anatomy of the pelvic floor and levator ani muscle injury. To compare this novel MRI technique with endocavity ultrasound in assessment of pelvic floor anatomy and deficiencies in patients with pelvic floor problems.

The study population is females with symptoms of pelvic floor dysfunction, and with suspected anatomical abnormalities of the pelvic floor muscles, for example following obstetric injury. The participants will be recruited to the study through Pelvic Floor and gynaecology Clinics. Each patient will undergo the same imaging investigations, pelvic floor MRI and three-dimensional high frequency internal ultrasound. As the MRI is regarded the gold standard examination in the assessment of the levator ani muscle (LAM), it will be used as reference in our study. A novel technique in MR imaging, which allows tracking of the pelvic floor muscle fibers, Diffusion Tensor Imaging (DTI) will be performed in addition to the standard scanning protocol. The investigator thinks that MRI with DTI is superior to routine MRI in visualization of LAM.

Moreover, every participant will undergo pelvic floor ultrasound (EVUS), which is believed to be comparable with routine MRI in diagnosis of LAM defects. The investigator hypothesize that this type of ultrasound is not inferior to MRI with DTI in visualizing pelvic floor muscles and their abnormalities.

All images will be assessed independently by two radiologists experienced in pelvic floor imaging, who will not be aware of each other's findings.

Eligibility Criteria:
Inclusion Criteria:

* patients with probable previous obstetric injury
* with symptoms of obstructed defecation
* other pelvic floor dysfunction

Exclusion Criteria:

* claustrophobic patients unable to undergo MRI scan
* patients with general contraindications to MRI
* patients not willing to take part in the study
* patients not able to consent
* pregnant patients
* patients unable to understand verbal and written English
Patient Navigation-based Tobacco Harm Reduction Program Among Cancer Patients

The purpose of this study is to examine the feasibility and preliminary efficacy of patient navigation to promote linkage to smoking cessation treatments in cancer patients.

The investigators plan to conduct a 2-month 1-arm intervention study that will recruit up to 20 smoking cancer patients at Penn State Cancer Institute. All participants will receive a smoking cessation educational brochure and patient navigation intervention (in-person or by phone) delivered over two months. At the first intervention interview, the patient navigators will educate participants about the benefits of quitting, introduce smoking cessation resources, motivate participants to link with treatment, help participants attend smoking cessation treatments, and assess barriers that prevented them from being able to consider smoking cessation. The cessation treatment resources will be discussed include PennState Health Smoking Cessation Clinic, Pennsylvania Quitline, or visiting their primary care provider (PCP) to discuss cessation, prescription medications, and/or nicotine replacement therapy. A follow-up call will be made 1 month later to further assist and motivate to use tobacco treatment services, and assess interim tobacco treatment engagement outcome. At 2 months after baseline, the final questionnaire will be administered to assess participants' smoking behaviors, engagement in tobacco treatments, and satisfaction with the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 years of age
* Diagnosis of cancer
* Current cigarette smoker (smoked cigarettes in last 30 days)
* Be able to read and speak English

Exclusion Criteria:

* Age: \< 18 years of age
* Unable to read and speak English
* Actively using evidence-based smoking cessation treatments
* Known decisional impairment
A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection

This is a Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta virus (HDV) infection. The comparator in this study will be 24-weeks of delayed treatment. During the 24-weeks of delayed treatment, participants will complete the same visits and assessments as those randomized to initiate brelovitug immediately. At the completion of 24-week delayed treatment period, all participants will start treatment with brelovitug.

Study will consist of 3 study arms. Approximately 150 participants will be randomized 2:2:1 to one of the following treatment arms:

* Arm 1: Participants randomized to Arm 1 will receive brelovitug 300 mg subcutaneously once weekly.
* Arm 2: Participants randomized to Arm 2 will receive brelovitug 900 mg subcutaneously once every 4 weeks.
* Arm 3: Participants randomized to Arm 3 will attend study clinic visits and delay treatment with brelovitug. At Week 24, all participants will receive brelovitug 300 mg subcutaneously once weekly.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent.
* Chronic HDV infection
* HDV RNA \>500 IU/mL at Screening.
* Abnormal ALT (\>upper limit of normal) at Screening.
* Willing to take or already taking HBV nucleos(t)ide therapy

Exclusion Criteria:

* Pregnant or nursing females.
* Unwilling to comply with contraception requirements during the study.
* Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
* Presence of other liver disease(s) (does not include HBV or HDV infection) such as non-alcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.
* Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
* Solid organ or bone marrow transplantation Note: other protocol defined Inclusion/Exclusion criteria may apply.