cyrilzakka/clinical-trials huggingface dataset:
The Prognostic Value of 18F-PFPN PET Imaging in Patients With Malignant Melanoma

This is a monocentric prospective study. This study aims to investigate the prognostic value of the novel melanin-targeted imaging modality 18F-PFPN PET in patients with melanoma and seek independent prognostic factors for progression-free survival (PFS) and overall survival (OS). The patients with clinically highly suspected or confirmed melanoma who underwent 18F-PFPN and 18F-FDG PET scans will be enrolled consecutively. Patients' PET images, clinical characteristics, and follow-up information will be collected for prognostic analyses. This study plans to set the sample size as 100 cases.

Melanoma is an aggressive malignancy with a high mortality rate. Accurate diagnosis and prognostic risk assessment are essential to the clinical management of melanoma. Melanin is present in most melanoma and has become a potential target for melanoma. This team has successfully synthesized a positron nuclide targeting melanin probe named 18F-PFPN (18F-N-(2-diethylaminoethyl)-4-(2-\[2-ethoxy\]-ethoxy) pyridine), which has been proven to be safe and well-tolerated. It has shown excellent diagnostic value in both primary and metastatic melanoma. This prospective study was designed to further investigate the prognostic value of 18F-PFPN for melanoma and compare it with the general metabolic imaging agent 18F-FDG. In this study, patients with clinically highly suspected or confirmed melanoma who underwent 18F-PFPN and 18F-FDG PET scans will be enrolled consecutively. Patients' PET images, clinical characteristics, and follow-up information will be collected for prognostic analyses.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histopathologically confirmed melanoma;
* Patients with complete clinical and follow-up data (including TNM stage, subtypes, and treatment strategies).

Exclusion Criteria:

* Uncertain histopathology;
* A history of other malignancies.
Measurement of Pro-angiogenic Markers in Patients With Hepatic Metastases Undergoing SIRT

This study is being done to investigate the influence of giving radiation to the liver on tumors involving the liver. Investigator is specifically looking at this effect on the blood vessels within the tumor. This effect will be measured by studying substances in the blood that the tumors produce and that cause blood vessels to grow. The effects seen on these substances may help design other treatments to improve the results of the radiation used to treat these tumors.

Subjects are invited to participate in this study that have undergone a procedure as their standard of care. This procedure is known as Selective Internal Radiation Therapy (SIRT), a procedure designed for the treatment of cancer in the liver. This includes cancer that has started in the liver as well as cancer that has spread to the liver. The purpose of the study is to collect blood samples to assess for "biological markers," or substances within the blood that may promote cancer growth by causing new blood vessels to form. This study will also use a new method of analyzing medical imaging (CT scan, PET scan) to try and better understand how cancer in the liver forms new blood vessels. SIRT is standard therapy and not part of this study. This study involves blood draws only.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18-85 who have been referred for SIRT as standard of care treatment for hepatocellular carcinoma or colorectal metastases to the liver and qualify for treatment with SIRT
* Life expectancy of at least 3 months

Exclusion Criteria:

- Patients are excluded from participation in this study if they are not undergoing the SIRT procedure
Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease

The purpose of this study is to assess how alternating-frequency Deep Brain Stimulation (DBS) works to improve postural instability and gait, while also treating other motor symptoms of Parkinson Disease (PD).

Postural instability, gait impairment, and falls are among the greatest unmet needs in Parkinson disease (PD). A single fall can be catastrophic, and impairments that limit mobility lead to social isolation or depression, and adversely affect bone and cardiovascular health. Unfortunately, postural instability and gait disorders are refractory to current pharmacological and surgical treatments, including deep brain stimulation (DBS). This project will directly address this pressing need. We will recruit participants to perform a gait task, using a new, alternating DBS frequency paradigm, while body movements and neural signals are recorded. The findings will lead to improved therapies to address these symptoms in the future.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral STN DBS for PD
* Medtronic Percept PC implanted DBS battery/pulse generator/recording system
* Presence of balance and/or walking impairment and/or freezing of gait
* Can walk without assistance, OFF meds, based on yes/no verbal response

Exclusion Criteria:

* Severity of gait impairment should not require dependency to walker or cane
* Cannot tolerate monopolar stimulation at either of the two middle electrode contacts (prerequisite for the recording mode of the DBS) at high frequency (130 Hz) or low frequency (60 Hz).
* Concomitant conditions that may affect significantly the evaluation of balance or gait, including orthopedic, rheumatologic or other neurological diseases
* Contraindication to physical therapy
* Age \< 21
* Diagnosis of dementia
* Not agreeable to having video taken of entire research visit
Woodsmoke Exposure, Influenza Infection, and Nasal Immunity

This study will investigate the effects of woodsmoke (WS) exposure on human nasal mucosal immune responses to viral infection. The study tests the hypotheses that WS exposure modifies biomarkers of nasal mucosal immune function, increases in Live Attenuated Influenza Virus (LAIV) -induced nasal symptoms, and reduces mucosal antibody production.

This study will investigate the effects of woodsmoke (WS) exposure on human nasal mucosal immune responses to viral infection. The study tests the hypotheses that WS exposure modifies biomarkers of nasal mucosal immune function, increases LAIV-induced nasal symptoms, and reduces mucosal antibody production. Healthy volunteers will be randomized for a 2-hr exposure to WS or placebo (filtered air) and then inoculated with either live attenuated influenza virus (LAIV) or placebo. Nasal mucosal samples, symptoms, and peripheral blood will be collected on days 1,2,3,7, and 21 post-exposure/LAIV and assessed for a) mucosal antiviral responses using targeted and non-targeted analysis of the secretome and tissue-level gene expression; b) symptoms, virus quantity, differential cell count, and virus-specific antibody levels; and c) biomarker signatures associated with infection outcomes using computational modeling tools.

Eligibility Criteria:
Inclusion Criteria:

* Normal lung function,
* oxygen saturation of \>94%,
* normal blood pressure,
* no respiratory symptoms on history, no abnormalities on exam, normal pulmonary function testing,
* 18-49 Years of age.

Exclusion Criteria:

* A history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or asthma, hypertension)
* Positive pregnancy test within 48 hours of the time of challenge
* Use of any inhaled substance (for medical or recreational purposes).
* Nonsmokers must have been abstinent from smoking for the prior 12 months, having not smoked more than 1 pack over the course of the previous year.
* History of allergy to eggs
* Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 3 weeks
* Unspecified illnesses, which in the judgment of the investigator increase the risk associated with the experimental LAIV infection, will be a basis for exclusion.
* Expected exposure of subject to immunocompromised individuals (who can be infected by LAIV) for the 3 weeks following LAIV inoculation.
* Use of immunosuppressive drugs within the past 6 months.
* Previous Woodsmoke exposure \<3 weeks, which is considered to an appropriate washout period
Internet-based Intervention for Complicated Grief: A Pilot Study

A considerable proportion of bereaved individuals experience chronic and disabling grief (so-called complicated or prolonged grief). Complicated grief is associated with severe mental and physical health problems as well as impaired social and occupational functioning. Interventions based on cognitive-behavioral therapy and applied via the internet have shown to be efficacious for this condition, but have not yet been adapted and evaluated in Norway. The aim of the current study is to adapt an internet-based cognitive-behavioral intervention for complicated grief and evaluate its effectiveness as a pilot study.


Eligibility Criteria:
Inclusion Criteria:

* Complicated grief
* Internet access
* Fluent in Norwegian
* No concomitant psychological treatment

Exclusion Criteria:

* Severe depression
* Psychotic symptoms
* Dissociation
* Suicidality
Ultrasound-guided Erector Spinae Plane Block: A Comparative Study to Assess Its Analgesic Efficacy in Pediatric Patients Undergoing Aortic Coarctation Repair

The study will include 40 patients who fulfil all the points in the inclusion and exclusion criteria will be randomized into two equal groups, each consisting of 20 patients, namely group (B) and group (C).

* Group (B): will receive erector spinae plane block.
* Group (C): will not receive any block. Postoperative pain score will be assessed using the FLACC scale or Face, Legs, Activity, Cry, Consolability scale immediately after extubation and at 1, 2, 4, 6, 8, 12, 18, and 24 hours. Routine postoperative analgesia in the form of intravenous paracetamol 7.5 mg/kg/6 hours will be given to all patients (the first dose is given after skin closure). Rescue analgesia in the form of 1 ug/kg fentanyl intravenously for patients if FLACC scale \> 4, and the time for the first rescue analgesic administration will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients presented for aortic coarctation repair via left thoracotomy.

Exclusion Criteria:

Hypersensitivity to local anesthetic.

* Mental or neurologic disorders.
* Preoperative critically ill patients.
* Parents or legal guardian refusal.
* Infection at the site of injection.
* Any liver disease.
* Any coagulopathy.
An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment

The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥ 18 years of age
2. Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
3. Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS)
4. Patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol
5. CML-CP patients initiated on any dose of imatinib
6. Ability to provide written informed consent prior to any study related screening procedures being done

Exclusion Criteria:

1. Loss of CHR or cytogenetic response
2. Prior accelerated phase or blast phase CML
3. Previously documented T315I mutation
4. Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+.
5. Previous treatment with any other tyrosine kinase inhibitor except for imatinib.
6. Treatment with other investigational agents within 30 days of Day 1.
7. History of non-compliance to medical regimens or inability to grant consent.
8. Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib.

Other protocol-defined inclusion/exclusion criteria may apply
Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock

To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge, versus subjects who receive standard medical care alone.


Eligibility Criteria:
Inclusion Criteria:

* Hypotension requiring vasopressor support
* The subject must have received intravenous fluid resuscitation
* Documented or suspected infection
* Endotoxin Activity Assay ≥ 0.60 EAA units
* Evidence of at least 1 new onset organ dysfunction

Exclusion Criteria:

* Inability to achieve or maintain a minimum mean arterial pressure (MAP) of 65mmHg
* Subject has end stage renal disease and requires chronic dialysis
* There is clinical support for non-septic shock
* Subject has had chest compressions as part of CPR
* Subject has had an acute myocardial infarction (AMI)
* Subject has uncontrolled hemorrhage
* Major trauma within 36 hours of screening
* Subject has severe granulocytopenia
* HIV infection with a last known or suspected CD4 count of \<50/mm3
* Subject has sustained extensive third-degree burns
* Body weight \< 35 kg (77 pounds)
* Known hypersensitivity to polymyxin B
* Subject has known sensitivity or allergy to heparin
* Subject has screening MOD score of ≤9
Living With Cervical Cancer: Assessing Utilities Associated With Common Treatment Complications

The objective of this study is to establish patient preferences in regards to common complications of cervical cancer treatments, and to compare these preferences to those of medical providers who care for cervical cancer patients. These preferences will be determined via a interview using the Standard Gamble, which is a well-recognized method for establishing utilities.


Eligibility Criteria:
Inclusion Criteria:

* A subject has to have been diagnosed with early cervical cancer (Stage I or II) within the last 3 years and/or take care of patients with cervical cancer and identify her or himself as one of the following: gynecologic oncologist, radiation oncologist, physician's assistant or nurse.
* Subjects must be ≥18 and \<61 years old.

Exclusion Criteria:

* Subjects who are unable to read and speak English proficiently will be excluded. Proficiency will be assessed by the investigator enrolling patients.
* Subjects who do not have capacity to consent will not be included in this study.
* Subjects may not be investigators on this study.
Impact of Short-course Colchicine Versus Placebo After Pulmonary Vein Isolation (IMPROVE-PVI Pilot)

Recurrence is a common problem after catheter ablation for atrial fibrillation, affecting at least one out of three patients. Inflammation due to the procedure may contribute to pulmonary vein reconnection and, thus, failure of catheter ablation.

This pilot study will assess whether a randomized, placebo-controlled, double-blind trial investigating a 10-day treatment with colchicine, a potent anti-inflammatory drug, to improve patient relevant outcomes after catheter ablation for atrial fibrillation is feasible.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Symptomatic atrial fibrillation and planned catheter-guided first or repeat ablation (pulmonary vein isolation) for atrial fibrillation (radiofrequency or cryoablation energy; concomitant ablation of the cavotricuspid isthmus and other lesions left at the discretion of the treating physician)
3. Written informed consent

Exclusion Criteria:

1. Ablation for left atrial tachycardia or isthmus-dependent atrial flutter only (i.e. without pulmonary vein isolation)
2. Administration of a strong inhibitor of CYP3A4 or p-gp (clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole)
3. Known hypersensitivity to colchicine
4. Serious gastrointestinal disease (severe gastritis or diarrhea)
5. Clinically overt hepatic disease
6. Severe renal disease (eGFR\< 30ml/min/1.73m2)
7. Clinically significant blood dyscrasia (e.g., myelodysplasia)
8. Absolute indication for or ongoing treatment with colchicine
9. Pregnant or breastfeeding women, or women of child-bearing potential who do not use a highly effective form of birth control
Body Image After Head and Neck Cancer Treatment

This is a pilot study of the Body Image after Head and Neck Cancer Treatment Program \[BIHNC\]. It is a six-week, psychoeducational, web-based program that includes e-learning didactic modules and personal reflection activities for participants to complete.

Specific Aim 1: To assess the feasibility and acceptability of \[BIHNC\] in patients who have completed treatment for head and neck cancer and who have body image concerns.

H1a: Eighty percent of enrolled study participants who complete baseline self-report measures will complete the BIHNC Program.

H1b: Eighty percent of study participants completing the BIHNC Program will rate it acceptable on the intervention evaluation form.

Specific Aim 2: To assess the preliminary efficacy of BIHNC for reducing body image concerns in patients who have completed treatment for head and neck cancer and who have body image concerns.

H2: Body image scores will improve from pre- to post- intervention

Eligibility Criteria:
Inclusion Criteria:

* Completion of any form of head and neck cancer treatment between 3 and 24 months previously at study enrollment
* Answer in the affirmative to at least one of two questions concerning dissatisfaction with the way their body looks or function
* Have clinically significant body image concerns as defined by (BIS score \> 10)

Exclusion Criteria:

* Undergoing head and neck cancer treatment at time of study enrollment
* Cognitive impairment that would preclude ability to provide informed consent
* Unable to read text on a computer screen
* Not able to read and understand English
Omegia Softgel Clinical Research Program

Evaluate the improvement of regulation of skin and blood index composition after consumption of Omegia® Softgel

The blood biochemical analysis at Weeks 0 and 12, including Catalase, Tumor necrosis factor-α, Cholesterol, Triglyceride, High-density lipoprotein-Cholesterol and Low-density lipoprotein- Cholesterol.

The Skin assessment at Weeks 0, 4 and 12, including Skin brightness, Skin redness sensitivity index, Skin moisture, Skin elasticity, Facial skin pores, Facial skin texture and Skin collagen content.

Eligibility Criteria:
Inclusion Criteria:

● Female subjects older than 45 years

Exclusion Criteria:

* Involuntary subjects
* Skin disease, liver cirrhosis or chronic renal failure
* Those with known cosmetic, drug or food allergies
* Pregnant women and nursing mothers.
* Those taking chronic disease medication
* The subject has received laser facial treatment, fruit acid facial peeling, long-term sunlight, etc. within four weeks of the test
Real Time Molecular Characterization of Diffuse Large B Cell Lymphoma (DLBCL)

The trial will enroll 194 previously untreated DLBCL patients over 20 months, with the objective to send to the local investigator an extensive molecular tumor characterization by D38 in at least 80% of enrolled patients.

The feasibility and efficiency will be demonstrated by deploying and operating a nation-wide network of dedicated multidisciplinary platforms.


Eligibility Criteria:
Inclusion Criteria:

* DLBCL patients that will be eligible in front-line treatment for a combination of anthracycline-based chemotherapy plus anti-CD20 monoclonal antibody,Rituximab: R-CHOP 14, R-CHOP 21, R mini-CHOP, R-ACVBP, R-COPADEM. Patients treated with R-CHOP associated with an experimental drug ((polatuzumab, tazemetostat, venetoclax, entospletinib, lenalidomide, ibrutinib, anti PD1/anti PDL1 ....)
* A short corticotherapy (prednisone, maximum 7 days) given during pre-phase therapy is allowed.
* Eligible histological subtypes: in particular DLBCL NOS, PMBL, high grade B-cell lymphoma (HGBCL) withMYC and BCL2 and/or BCL6 rearrangements, HGBCL NOSFL grade 3B and untreated transformed low grade NHL.
* ≥ 18 years old, IPI = 0-5
* With available tumor Biopsy (FFPE) that can be sent to RT3 platform at the time of inclusion (or the say after inclusion at the latest).
* Patient that underwent needle core biopsy samples are not excluded if sufficient material is available for molecular and histopathological explorations

Exclusion Criteria:

* No available FFPE biopsy material or insufficient quality/quantity tumor samples according to prerequisite
* No signed informed consent
Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Heart Disease Death

The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary death associated with use of monotherapy low dose ASA (single antiplatelet) as well as concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in patients with serious coronary heart disease using two UK primary care databases.

Number of Anticipated Subjects: In case-control analysis: 10.000-15.000 participants

Eligibility Criteria:
Inclusion Criteria:

* As above ( study population description).
* All individuals aged 50-84 years with at least one year of enrolment with the primary care physician (PCP) and a computerized prescription history of at least one year before the start of the study.

Exclusion Criteria:

* Recorded diagnosis of cancer prior to study start.
* Patients aged ≥ 70 years with a follow-up longer than one year if having fewer than two recorded consultations with a primary care physician (PCP) during their entire follow-up (proxy for incomplete and invalid data recording
Impact on Influenza Vaccination Rates of a Telephone Text Message Recall From the Attending Physician

This study is a clinical trial designed to assess the impact on influenza vaccination rates among people aged over 65 of a telephone text message recalling them to be vaccinated by their GP. Twenty-two GPs will be randomly selected in each arm (recall versus usual care, 1:1). Each GP will include a maximum of 210 patients by random selection from their patient list. A difference of 4 percentage points is expected between the two arms at the end vaccination campaign in the vaccination rate.

This is an open-label trial with 2 arms: an interventional or "recall" arm and a "usual care" or control arm. Cluster randomization at the physician level was chosen to avoid contamination within the same patients group. Physicians will be randomized at the start of the vaccination campaign in one of the two arms (1:1), and all patients eligible (with a maximum of 210 per doctor) to be vaccinated will be recalled or not, depending on their GPs arm.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria for physicians are:

* To be a GPs
* To be based in Ile-de-France (Paris region, France)
* To be a user of the Eo medical software

The patients inclusion criteria are:

* belonging to the list of attending physicians of the participating GPs
* being 65 years of age or older
* having a medical file in the GP's Eo medical software
* having been selected at random if the number of patients aged 65 or over exceeds 210 patients (for 44 participating GPs).

Exclusion Criteria:

* Patients for which their attending physicians considers participating inappropriate (e.g. palliative care)