cyrilzakka/clinical-trials huggingface dataset:
LSFG-SKIN, Laser Speckle Flowgraphy

The purpose of this project is to quantify normal and abnormal skin blood flow regionally in different areas of the body(face, extremities, over burns and wounds) at baseline and over time in response to treatment or environmental changes, such as temperature, light and pressure.

Laser speckle skin blood flow (LSFG-SKIN) will be recorded in normal subjects and in patients with disorders affecting skin capillary perfusion, which may include cardiovascular disorders, dermatologic disorders, skin wounds, ocular disorders, psychiatric disorders, and neurologic disorders.

Eligibility Criteria:
Inclusion Criteria:

Controls

●Healthy normal control subjects ages 18-90

Cardiology Subjects

* Ages 18-90
* History of dysrhythmia, heart failure, cardiac ischemia, hypertension, peripheral vascular disease

Dermatology Subjects

* Ages 18-90
* History of inflammatory and cancerous lesions

Endocrine Subjects

* Ages 18-90
* History of diabetes, thyroid disease

Neurology Subjects

* Ages 18-90
* History of dementia, headaches, Parkinson's, light sensitivity, stroke, TIA, multiple sclerosis

Psychiatry Subjects

* Ages 18-90
* History of bipolar, schizophrenia, anxiety, depression

Surgery Subjects

* Ages 18-90
* History of skin wounds(trauma, chemotherapy, radiation), thermal burns, or plastic and reconstructive surgical procedures.

Ophthalmology Subjects

* Ages 18-90
* History of ocular disorders caused by hypo perfusion or inflammatory disorders

Exclusion Criteria:

Controls

* Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
* Angle closure glaucoma

Cardiology Subjects

* Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
* Angle closure glaucoma

  3. Dermatology Subjects
* Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
* Angle closure glaucoma

Endocrine Subjects

* Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
* Angle closure glaucoma

Neurology Subjects

* Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
* Angle closure glaucoma

Psychiatry Subjects

* Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
* Angle closure glaucoma

Surgery Subjects

* Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
* Angle closure glaucoma

Ophthalmology Subjects

* Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
* Angle closure glaucoma
Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies

Stroke is the first cause of death among Spanish women and main cause of disability. Reperfusion therapies of the occluded artery remain the only useful approach in acute ischemic stroke. However, the efficacy of these strategies is highly time-dependent and due to the need of neuroimaging (CT or MRI) to differentiate between ischemic and hemorrhagic stroke, impossible to be performed at the pre-hospital level. The investigators aim to set-up a point of-care (POC) device to validate a biomarker panel differentiating ischemic and hemorrhagic stroke at the pre-hospital level using a blood sample and to validate a second biomarker panel for the early identification of patients with large vessel occlusions (LVO), which are candidates for mechanical thrombectomy. For that, the investigators will recruit a 300 patients' cohort with pre-hospital blood samples using available POCs for each of those markers.


Eligibility Criteria:
Inclusion Criteria:

* I.1: Patients \> 18 years old.
* I.2: Stroke code activated by the coordinator centre.
* I.3: \< 6 hours from symptoms onset. In the case of stroke with uncertain chronology or wake-up stroke, the initial time will be considered as the last moment the patient was seen fine.

Exclusion Criteria:

* E.1: Prehospital diagnosis different of stroke.
* E.2: Impossibility of getting a prehospital blood sample.
* E.3: Refusal to provide the informed consent by the patient/relative.
DC Vaccine in Pancreatic Cancer

This research study is designed to evaluate the effects of a dendritic cell (kind of white blood cell) vaccine for pancreatic cancer.

This is a single arm open label trial that will assess the safety and tolerability of mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with resected pancreatic adenocarcinoma.

Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production approximately 1 week prior to vaccine infusion. Each study subject will receive cyclophosphamide 300mg/m\^2 intravenously 3 to 4 days prior to the vaccine dose to deplete regulatory T cells. For each vaccine dose, all subjects will receive autologous dendritic cells pulsed with mutant KRAS peptides corresponding to the subject's specific tumor mutation and human leukocyte antigen type. On Day 1, the subject will receive the primer vaccine dose; this will be followed by one booster vaccine dose approximately 8 weeks later. Peripheral blood will be taken weekly, and a second apheresis procedure will be performed at the end of study to monitor the immune response to the vaccine. Information will be gathered from usual clinic visits for approximately 1 year following the End of Treatment Study Visit to evaluate for disease recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically-confirmed KRAS(G12D-), KRAS(G12V-), KRAS(G12R-) or KRAS(G12C-mutated) pancreatic ductal adenocarcinoma who are at high risk of relapse and have no evidence of disease.
* Expression of one or more of the following HLA class I alleles: HLA-A02, HLA-A03, HLA-A11, HLA-B07 and HLA-C08.
* Male or female, age 18+
* ECOG performance status 0-1
* Certain required laboratory values, performed within 14 days prior to consent
* Subjects of reproductive potential must agree to use a medically accepted birth control method during the trial and for at least two months following the trial.
* Provide written informed consent

Exclusion Criteria:

* Prior treatment with more than two lines of cytotoxic chemotherapy. Radiotherapy is not considered a line of therapy.
* Prior malignancy (except non-melanoma skin cancer) within 3 years.
* Pregnant or nursing women.
* Concurrent treatment with systemic immunosuppressants, including corticosteroids (e.g prednisone), calcineurin inhibitors (e.g tacrolimus, cyclosporine), antiproliferative agents (e.g mycophenolate mofetil, azathioprine) within 2 weeks of eligibility confirmation. Local (inhaled or topical) steroids or replacement dose prednisone (≤ 10 mg daily) are permitted.
* Known chronic viral infections including hepatitis B, hepatitis C, and HIV.
* Known allergy to eggs.
* Prior history of uveitis or autoimmune inflammatory eye disease.
* Uncontrolled intercurrent illness.
* Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100

Arm 1:

Primary Objective:

• To determine the safety and tolerability of multiple ascending, supratherapeutic doses of HPN-100.

Arm 2:

Primary Objective:

• To assess the effects of steady-state levels of HPN-100 metabolites (4 phenylbutyric acid \[PBA\], phenylacetic acid \[PAA\], and phenylacetylglutamine \[PAGN\]) on 12-lead electrocardiogram (ECG) parameters in healthy male and female subjects with the primary endpoint being the time-matched change from baseline in the QT interval corrected for heart rate (HR) based on an individual correction method (QTcI).

Assess the effects of steady-state levels of HPN-100 metabolites (4-phenylbutryic acid (PBA), phenylacetic acid (PAA), and phenylacetylglutamine (PAGN) on 12-lead electrocardiogram (ECG) parameters in health male and female subjects with the primary endpoint being the time-matched change from baseline in the QT interval corrected for heart rate(HR) based on an individual correction method (QTcl).

Study acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

* Must be in good health
* Negative hepatitis panel and negative HIV antibody screens
* Females must be non-pregnant, non-lactating, and either postmenopausal or agree to to use adequate contraceptive methods throughout the study
* Males must either be sterile or willing to use adequate contraceptive methods throughout the study
* Willing and able to comply with all trial requirements
* Able to comprehend and willing to sign an Informed Consent Form (ICF)

Exclusion Criteria:

* History or clinical manifestations of significant allergic, metabolic, hepatic, renal, endocrine, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders
* History of hypersensitivity or allergies to any drug compound
* History of stomach or intestinal surgery or resection
* History or presence of an abnormal ECG
* History of alcoholism or drug addiction within 1 year
* Use of any tobacco-containing or nicotine-containing products within 3 months
* Participated in any other clinical trial of an investigational drug (or a medical device) within 30 days
* Use of any prescription medications/products other than contraceptives within 14 days
* Use of any over-the-counter, non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days
* Test positive for drug(s) of abuse, ethanol, or cotinine
* Have donated blood or blood components within 30 days
* Have received blood products within 2 months
* Have a history of unexplained syncope
* Have a family history of unexplained sudden death
Usability of HPV Vaccine Reminders

This study will assess the usefulness of parent-targeted strategies in improving care seeking among parents of 11-12 year old adolescents. Specifically, the study team will focus on reminders (postcard or text message) and motivational interviewing to improve adolescent vaccination.

Despite the impressive cancer preventing potential of human papillomavirus (HPV) vaccines, HPV vaccine coverage rates in the United States remain substantially lower than other vaccines and Healthy People 2020 targets. HPV vaccine initiation can be improved through targeted reminders that motivate parents. Our long-term goal is to maximize HPV vaccination rates among girls and boys within the United States using efficient and sustainable strategies. The objective of this protocol is to evaluate the usefulness of a tiered strategy of a parent-targeted strategies in improving care seeking and receptiveness to vaccine recommendations. Strategies include HPV vaccine reminders via postcard or text message and phone-based Motivational Interview sessions. The central hypothesis is addressing key health beliefs (e.g., perceived benefits and barriers) will increase parental acceptance and, thus, HPV vaccine initiation.

Eligibility Criteria:
Inclusion Criteria:

* Parents of 11-12 year olds who attend the Schiebler CMS clinic at University of Florida in the previous year

Exclusion Criteria:

* Unable to meet inclusion criteria
Spanish Registry of Cryoballoon Ablation

The purpose of this registry is to reflect on standard clinical practice in pulmonary vein cryoablation in Spanish hospitals, the different procedure protocols, details of intervention, complications, long-term follow-up strategy and results in these subjects.

With this study the investigators propose the performance of a prospective registry of pulmonary vein cryoablation in subjects with paroxysmal or persistent AF at Spanish sites to estimate evaluate the efficacy of the cryoablation procedure at 12 months, defined as the absence of recurrences of atrial fibrillation.

Secondary objectives are also defined as:

* Description of the profile of subjects who undergo this type of procedure (demographic factors, cardiovascular risk factors, medication, physical activity, sleep apnea, alcohol, smoking, chronic pulmonary disease, obesity, etc.).
* To evaluate the acute efficacy of the procedure: complete isolation of the pulmonary veins demonstrated by the successful electrical disconnection of the pulmonary veins in the cryoablation procedure.
* Description of the complications related to the procedure.
* To evaluate the use of healthcare resources which this cryoablation procedure entails.

Eligibility Criteria:
Inclusion Criteria:

* Signature of the Data Release Form
* Subjects ≥ 18 years old
* Subjects who meet the indication for the Cryoballoon Ablation procedure.

Exclusion Criteria:

* Subjects with a life expectancy of less than 12 months.
* Subjects who meet the exclusion criteria defined by local legislation (e.g., age, pregnancy, breastfeeding, etc.).
* Subjects who may currently be enrolled, or who plan to take part, in a study with a drug or device that may cause bias during the course of this study.
* Co-participation in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
Normative Database for Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG)

The main goal of the study is to compile a normative database for the Neuro Optic Vision Assessment (NOVATM) Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules. This normalization intends to be included in a probabilistic analysis protocol to allow NOVATM PERG/FERG users to identify patients with results outside the normal ranges.

Investigators plan to enroll 50 subjects at Wills Eye Hospital without any eye diseases.

Participants will undergo a complete eye examination to determine eligibility, including visual acuity testing, intraocular pressure (IOP) in millimeters of mercury (mmHG), and visual field (VF) testing.

Participants will then be tested with Diopsys NOVA™ PERG \& FERG systems. For both tests, two electrodes are placed on the skin underneath each eye below the eyelashes. Participants' skin will be cleaned before electrodes are placed. A small amount of gel will be placed on skin where electrodes are placed for testing. Electrical responses are recorded with electrodes in response to visual stimuli.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers age 18 years
* older with normal eye exam

Exclusion Criteria:

* spherical refraction outside + 5.0 Diopters and cylinder correction outside + 3.0 Diopters.
* IOP (intraocular pressure) ≥ 22 mm Hg (millimeters of mercury)
* history of any type of glaucoma in either eye.
* Intraocular surgery in study eye (except non-complicated cataract or refractive surgery performed more than 1 year before enrollment).
* Best corrected visual acuity worse than 20/40.
* Evidence of diabetic retinopathy, diabetic macular edema, or other vitreo-retinal disease in either eye.
* Evidence of optic nerve, macula and/or retinal nerve fiber layer abnormality in either eye.
* Evidence of reproducible (false positives, fixation losses and false negatives ≤ 25% with no observable testing artifacts).
* Standard Automatic Perimetry (SAP) abnormality in either eye, defined as Pattern Standard Deviation \< 5% level, and/or abnormal Glaucoma Hemifield test result, and/or any other pattern of loss which is consistent with a neurologic and/or ocular disease.
* Current or recent (within the past 30 days) use of an agent (by any administering method) known to affect visual function.
* Inability to obtain reliable PERG/FERG (Pattern Electroretinogram/Flash Electroretinogram) results.
Autonomy Among Physically Frail Older People in Nursing Homes

The purpose of this study is to assess the status of perceived autonomy and to evaluate the effectiveness of individually tailored programmes on perceived autonomy in physically frail older people living in nursing homes.

Experiencing autonomy is recognised to promote health and well-being for all age groups. Perceived lack of control has been found to be detrimental to physical and mental health. There is a lack of evidence-based knowledge elucidating how frail older people in nursing home settings perceive autonomy. Further, there are no studies on the extent to which this perception can be influenced positively by participating in an individually tailored programme based on individual wishes for daily activities.

The purpose of this study was to evaluate the effectiveness of individually tailored programmes on perceived autonomy in physically frail older people in nursing homes.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older
* All kinds of diseases leading to physical frailty
* Dependent on assistance in minimum one P-ADL activity
* Able to understand verbal instructions
* Willing to participate
* Expected to live in the nursing home during the 24 weeks
* Both men and women

Exclusion Criteria:

* Terminal stages of disease
* MMSE-score below 16
Neoadjuvant Treatment Based on Gastric Cancer Molecular Subtyping.

Extensive research employing diverse omics methodologies has unveiled a varied landscape of gastric cancer (GC). Recent progress in next-generation sequencing and other genomic technologies has facilitated a more intricate exploration of GC at the molecular level. This study aimed to identify the most effective drug therapeutics for patients with the mesenchymal subtype of gastric cancer.Based on RNA-seq transcriptome, 234 patients were divided into four molecular subtypes: mesenchymal, immunogenic, metabolic, and classic.Our analysis has revealed that, for neoadjuvant therapy in advanced gastric cancer (AGC), the mesenchymal subtype stands out as the ideal patient population benefiting from Apatinib, without a concurrent increase in postoperative complications.

The advent of immunotherapy and targeted therapies has recently provided new options for AGC treatment. However, not all patients benefit from immunotherapy or targeted therapy, resulting in unsatisfactory overall treatment outcomes during the perioperative period. An ineffective treatment imposes significant financial burden, causes drug-related side effects that deteriorate their quality of life, and potentially delays subsequent treatment.

Evaluate the objective response rate (ORR) of the combination of camrelizumb, apatinib, and neoadjuvant chemotherapy for the treatment of advanced gastric patient Median survival time (OS);

Disease free survival time (DFS);

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with gastric adenocarcinoma and received neoadjuvant therapy

Exclusion Criteria:

* Patients with distant metastases, gastric stump cancer, or missing neoadjuvant chemotherapy data were excluded from the study.
Peripheral Nerve Block Techniques During Cleft Palate

Regional blocks are commonly used in pediatric anesthesia to achieve adequate postoperative analgesia. Suprazygomatic Maxillary nerve block (SMN) and Greater Palatine nerve block (GPN) are regional blocks described for use during cleft palate (CP) repair surgery.The aim of this study was to compare the analgesic effect as well as the incidence of complications associated with the use of bilateral GPN and bilateral SMN blocks in children undergoing palatoplasty surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III scheduled to undergo palatoplasty

Exclusion Criteria:

* bleeding disorders,
* skin lesions or wounds at site of proposed needle insertion,
* congenital heart disease,
* respiratory or
* cardiovascular disorders,
* children scheduled for combined procedures like palatoplasty with cheiloplasty or submucosal alveolar bone grafting,
* known hypersensitivity to local anesthetics or opioids and
* lack of parental consent.
Radioactive Iodide (131I) Treatment of 124I PET/CT Detected Breast Cancers

This is a treatment protocol designed to accompany the ongoing institutional 124I PET/CT pilot imaging study for patients with invasive breast cancer. Women whose tumors express NIS \[Na+I- symporter, sodium iodide symporter\] and demonstrate radioiodide uptake on 124I PET/CT scans will be eligible for 131I treatment if, (1) tumor dosimetry calculations yield a cumulative radiation dose of at least 30Gy in target tumor, (2) estimated cumulative thyroid irradiation is less than 500 cGy and, (3) the therapeutic dose of 131I is in the range of 25 to 100 mCi.


Eligibility Criteria:
Inclusion Criteria:

* Patients with measurable locally advanced or metastatic breast cancer who completed 124I PET/CT imaging study.
* Patients who are 18 years of age or older.
* Patients must have a life expectancy of at least 3 months.
* I 124 dosimetry completed with thyroid dose to 500 cGy or less and tumor dose of 2500 cGy or more.
* I131 therapeutic dose calculated from dosimetry. Dose must be in a range of 25 to 150 mCi.
* Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3 will be eligible.
* Use of concurrent systemic therapy (hormonal or cytotoxic) if associated with stable disease for at least three months prior to treatment.
* Women with locally advanced breast cancer and simultaneous metastases, even if surgery to eradicate local disease has taken place.
* Thyroid stimulating hormone (TSH) must be \< 0.4 uIU/mL.
* White blood cell count \>= 1,500 and platelet count \>= 40,000
* Women receiving thyroid hormone supplements and methimazole.
* Ability to understand and the willingness to sign a written informed consent document.
* Premenopausal women must use contraception while receiving this treatment and during follow-up period of 42 days.

Exclusion Criteria:

* Stage 0-II breast cancer.
* Pregnant or nursing women.
* Not able to sign informed consent.
* Untreated psychiatric disorder.
* Women who have not had I124 PET/CT scan and dosimetry calculations.
* Radioiodide uptake in non-target organs or bone marrow does not exceed 25 cGy by pre-treatment dosimetry.
* Received chemotherapy less than 4 weeks before.
* History of thyroid cancer.
Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients with NAMD (phase I Portion)

Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form.
2. Age≥45 years, ≤80 years，male or femal.
3. The study eye must meet the following criteria: Diagnosis of nAMD;Active MNV lesions secondary to nAMD; Total area of all types of lesions ≤12 optic disc areas; BCVA of the study eye 73\~19 letters.

Exclusion Criteria:

1. Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis, atrophy or dense subfoveal exudation involving the fovea in the study eye.
2. Significant APD or opacity of the refractive medium and miosis in the study eye that affect visual acuity or fundus examination.
3. Aphakia (except intraocular lens) or posterior capsular rupture of the lens in the study eye.
4. The study eye has any eye diseases or medical history other than nAMD that may affect central vision and/or macular examine.
5. MNV caused by non-nAMD exists in the study eye .
6. Active inflammation or infection in either eye before randomization.
7. Known allergy to any component of the study intervention or history of allergy to fluorescein or indocyanine green, any anesthetics or antimicrobial agents used during the course of the study.
8. Abnormal liver and kidney function.
9. Poorly-controlled blood pressure before randomization.
10. History of a cardiovascular and cerebrovascular events, including myocardial infarction, unstable angina pectoris, cerebrovascular accidents (including TIA), other thromboembolic diseases (such as thromboembolic angiitis, etc) within 6 months before randomization.
11. Evidence of significant uncontrolled concomitant diseases.
12. Participated in any drug (other than vitamins and minerals) or device clinical trials within 3 months or the duration of 5 half-lives of the study drug (which is longer) before randomization and have used the test drug or received device treatment.
13. Pregnant, lactating women who can not take contraceptive measures during the trial.