cyrilzakka/clinical-trials huggingface dataset:
First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging

18F-4FN represents a novel PET agent for imaging inflammation. Acute inflammatory signaling through the TLR axis recruits neutrophils and macrophages to inflammatory sites. Both cells activate the production of high energy reactive oxygen species/reactive nitrogen species (RONS), setting off a cascade that can be leveraged to detect the presence of these inflammatory cells by molecular imaging. 18F-4FN is efficiently oxidized by high energy RONS, leading to retention and accumulation in human neutrophil-like cells in vitro, and at the sites of acute inflammation in vivo. Like 18F-FDG, 18F-4FN clears rapidly through the kidney at 1 hr following i.v. injection

OBJECTIVES:

Primary Objective:

The primary objective of this first-in-human (FIH) study is to determine the safety, biodistribution, and dosimetry profile of a novel positron emission tomography (PET) imaging tracer, 4-\[18F\]fluoro-1-naphthol (\[18F\]4FN), which specifically targets reactive oxygen species (ROS). A currently proposed indication for this radiopharmaceutical (RP) is to non-invasively quantify inflammation by PET/CT imaging.

Exploratory Objectives:

One exploratory objective is to identify preliminary efficacy signals from PET/CT images indicating that the new radiopharmaceutical localized to known or clinically-suspected tissues or regions of inflammation mediated by innate immune-related adverse events (irAE). Another exploratory objective is to determine if a time point other than one-hour post injection will yield clinically meaningful improvements to imaging data.

Eligibility Criteria:
Inclusion Criteria:

* Patient \>/= 18 years of age.
* Patients with histologic diagnosis of solid or liquid tumor treated by ICI with evidence of or clinical suspicion of irAE or patients with suspected inflammation.
* Normal range standard renal and liver function tests for age:

eGFR \>= 60 mL/min/1.73 m2

Adequate liver function:

Bilirubin ≤ the upper limit of normal (ULN) Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ the ULN

Exclusion Criteria:

* Pregnant or lactating women: pregnant women are excluded from this study because the effects of \[18F\]4FN in pregnancy are not known. Urine or serum pregnancy test (female \</= 60 years of age or childbearing potential) within 24 hours of the PET scan.
* Subjects with contraindications to the use of \[18F\]4FN including confirmed allergy.
* Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET/CT scanner, because the hardware is not intended to support that weight.
* Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the physician may significantly interfere with study compliance.
* Children below the age of 18 are excluded because of the unknown but potential risk of administration of radiopharmaceuticals to minors.
Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia

The purpose of this study is to evaluate efficacy and safety of HL140 in patients with primary hypercholesterolemia.

The purpose of this study is to demonstrate that the efficacy of combination drug of rosuvastatin/ezetimibe is superior to single rosuvastatin drug and to confirm the safety of combination drug of rosuvastatin/ezetimibe

Eligibility Criteria:
Inclusion Criteria:

* Aged over 19 years
* Signed informed consent form
* At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyceride ≤ 400mg/dL

Exclusion Criteria:

* At visit 1, BMI ≥ 30kg/㎡
* Has a history of myopathy or rhabdomyolysis cased by statin treatment, hereditary myopathy or family history and hypersensitivity to statin(HMG-CoA reductase inhibitor) and component of ezetimibe
* Has a Severe renal disorder(Ccr \<30mL/min) or nephrotic syndrome
* Creatine Kinase \> 5 x upper limit of normal
* ALT or AST \> 3 x upper limit of normal
* Has a activity/chronic hepatic disease or HIV-positive
* Has a endocrine or metabolic diseases known to affect the serum phospholipid or protein

  * Uncontrolled diabetes mellitus(HbA1c ≥9%)
  * Hypothyroidism (TSH \> 1.5 x upper limit of normal rate at the screening )
* Uncontrolled hypertension (SBP ≥180mmHg or DBP ≥110mmHg)
* Has a acute arteriopathy(history of unstable angina, cardiac infarction, transient ischemic stroke, cerebrovascular disease, coronary artery bypass, coronary intervention within 12 weeks prior to screening)
* Severe heart failure (NYHA Class III or IV)
* Has a drug absorption disorder by gastrointestinal surgery or gastrointestinal disorder
* History of malignant tumor including myelogenous and lymphoma within 5 years (Participation is possible, if the tumor has not recurred for more than 5 years)
* Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
* Female subjects of childbearing potential who disagree with the contraceptive methods(surgical sterilization, intrauterine device or condoms)
* Pregnant or breast-feeding
* Patients who have a drug or alcohol abuse or are being treated for psychological disorder
* Patients who were treated with other investigational drug within 12 weeks prior to screening
* Other patients who are inappropriate to participate in the study considered by the investigator or other study staffs
Clinicopathological Profile of Head and Neck Cancers in Army Hospital of Nepal

This is a observational study conducted at the department of Ear ,Nose and Throat -Head and Neck Surgery (ENT-HNS) of Shree Birendra Hospital ,a tertiary health care centre of Nepal. Head and Neck cancers are the sixth most common cancer in the world. Data was collected from the medical records of Head and Neck Cancer patients who underwent treatment between May 2022 to April 2023.The main aim of the study was to know about the common cancers of head and neck region and their distribution according to the site. Also to know the stage of the presentation with treatment modalities in the tertiary health care centre of Nepal.

This is a retrospective study to know the prevalence of Head and Neck Cancer at the department of ENT- Head and Neck Surgery of Shree Birendra Hospital ,a tertiary health care centre of Nepal .Head and neck cancers are malignant neoplasms that develops in oral cavity, nasal cavities, paranasal sinuses,nasopharynx, oropharynx, hypopharynx, ear, scalp, salivary gland and neck,Data was collected from the medical records of Head and Neck Cancer patients who underwent treatment between May 2022 to April 2023. Data considered of demographic details of age, sex, diagnosis, subsite specific Head and Neck Cancers, treatment modality and histopathology. The data was analyzed using Stastical Package for Social Sciences (SPSS) version 22. Pearson's chi-square test was applied and p value \<0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* All histologically proven cases of head and neck region.

Exclusion Criteria:

* Patient's record with incomplete data.
Treatment of Natural Killer/T Cell Lymphoma-Ⅲ/Ⅳ

The purpose of this study is to evaluate the efficacy and safety of DDGP regiment (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with stage Ⅲ/Ⅳ Natural Killer (NK)/T Cell Lymphoma.

Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. The investigators have been proceeding this trial to evaluate the efficacy and safety of the combination chemotherapy regiment DDGP (gemcitabine，pegaspargase, cisplatin, dexamethasone) in the patients with stage Ⅲ/Ⅳ NK/T cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time \> 3 months
* Histological confirmed NK/T cell lymphoma
* None of chemotherapy or radiotherapy has been previously used
* None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups )
* At least one measurable lesion
* None of other serious diseases, cardiopulmonary function is normal
* Pregnancy test of women at reproductive age must be negative
* Patients could be followed up
* None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
* volunteers who signed informed consent.

Exclusion Criteria:

* Disagreement on blood sample collection
* Patients allergic of any of drug in this regimen or with metabolic disorder
* Pregnant or lactating women
* Serious medical illness likely to interfere with participation
* Serious infection
* Primitive or secondary tumors of central nervous system
* Chemotherapy or radiotherapy contraindication
* The evidence of CNS metastasis
* History of peripheral nervous disorder or dysphrenia
* patients participating in other clinical trials
* patients taking other antitumor drugs
* patients estimated to be unsuitable by investigator
Understanding the Mechanisms of Autism : an MRI and Social Cognition Study

The main goal of this study is to investigate anatomo-functional brain abnormalities associated with autism spectrum disorders using a multimodal brain imaging approach, as well as its links to social cognition difficulties measured using eye-tracking

Autism Spectrum Disorders (ASD) are neurodevelopmental disorders whose first manifestations appear early in childhood. Even if ASDs present a wide heterogeneity in clinical manifestations, abnormalities in social behavior, characterized in particular by a lack of preference for social information, remain the core of difficulties characteristic of autism.

Brain imaging investigations have revealed anatomo-functional abnormalities in autism, particularly in social brain regions. In parallel, eye-tracking studies have provided objective measures of social perception abnormalities in autism. These results illustrate the relevance of these research strategies in the context of ASD. Acquiring objective data on social behavior and linking them with brain imaging data opens up new avenues for research into the evolution of social skills during child development, and the brain changes underlying this process.

In this context, the main hypothesis of this study is that the investigation of the neural bases of autism spectrum disorders, using an approach combining multimodal brain imaging and the investigation of social behavior using eye-tracking, would make it possible not only to better describe abnormalities, but also to identify individual patterns at brain and behavioral level. This could help to better characterize ASDs with and without genetic abnormalities, an area which to date has received very little investigation. In addition, the objective measurements obtained with this approach would also enable the proposal of biomarkers, which would contribute not only to better monitoring of the disorder's evolution, but also to the evaluation of the effectiveness of new therapeutic interventions

Eligibility Criteria:
Inclusion Criteria:

For subjects diagnosed with ASD or suspected of ASD :

* 3 months ≤ age \< 25 years ;
* an MRI required as part of the clinical procedures
* written consent obtained from parents or legal guardians.
* Affiliated to social security

For Healthy control subjects over 3 years of age:

* between 3 and 18 years of age
* no known neurological or psychiatric pathology
* written consent obtained from parents or legal guardian.
* Affiliated to social security

For Healthy control subjects under 5 years of age:

* age between 3 months and 5 years
* who have had an MRI scan in the pediatric radiology department at Necker Hospital, which was found to be normal.
* with no known neurological or psychiatric pathology
* no opposition from legal representative

Exclusion Criteria:

* Contraindication to MRI (pacemaker, intracorporeal metallic body, claustrophobia).
* Impossibility for healthy volunteers to remain still during MRI
Viscosupplementation in Patients With Hemophilic Arthropathy

Hemophilia is a recessive X chromosome linked genetic disorder of blood coagulation that affects about one in every ten thousand people. Hemarthrosis, which you can begin in childhood, promptly leads to degenerative changes of the articular cartilage which culminate in deformity and degenerative changes early, known as hemophilic arthropathy, which is the most common complication of hemophilia. Aside administration of clotting factor, treatment should address the degenerative changes already present in patients joints. Our objective is to evaluate the effectiveness of articular washing followed by infiltration with corticosteroids and hylan G-F 20, followed by a program of home exercises and/or academy as the previous level of hemophilia patients, in relation to pain relief, and improved function and quality of life.

Hemophilia is a recessive X chromosome linked genetic disorder of blood coagulation that affects about one in every ten thousand people. There are two main types of hemophilia. Hemophilia A or classical hemophilia corresponds to 80% of the cases, and is caused by a deficiency or change of factor VIII. Hemophilia B is caused by deficiency or amendment of factor IX, and represents about 20%. Patients with hemophilia type A or B have the same clinical presentation. Cases with moderate or severe hemophilia exhibit a tendency to spontaneous bleeding or after minimal trauma, being the joints the most frequent sites of hemorrhage. The joints most commonly affected are the knees, followed by the elbows, ankles, shoulders and hips. Hemarthrosis, which you can begin in childhood, promptly leads to degenerative changes of the articular cartilage which culminate in deformity and degenerative changes early, known as hemophilic arthropathy, which is the most common complication of hemophilia. The hemophilic arthropathy is highly debilitating and consumes a large amount of resources for the treatment of hemophilic patients. Currently, by the adequate administration of the clotting factor, the hemophilic patient has a life expectancy of next to normal. Therefore other forms of treatment must be researched; they can be palliative or modifiers of the natural history of disease, to try to postpone the need for arthroplasty . Our objective is to evaluate the effectiveness of treatment, consisting of articular washing followed by infiltration with corticosteroids and hylan G-F 20, followed by a program of home exercises and/or academy as the previous level of hemophilia patients, in relation to pain relief, and improved function and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* patients with hemophilia A or B;
* symptomatic arthropathy;

Exclusion Criteria:

* inadequate follow-up;
* Bleeding elsewhere as to not allow for functional evaluation;
* complications of Arthrocentesis (infection).
The Simple ECG Monitoring Trial (Comparison of a Novel Recording System With a Standard Holter Monitor)

The purpose of this research is to simplify the standard recording system of the heart rhythm. The investigators desire to improve the ease of monitoring the cardiac rhythm for 24 hours. The investigators intent is to use a very small, innovative monitoring patch system that relieves the patient of wearing a cumbersome and uncomfortable recording system. This research trial will carry the title "The Simple ECG Monitoring" for Comparison of a Sternal ECG Recording System with a Standard ECG Recording System for Holter Monitoring. The data from the investigational device is for comparative purposes only. It will not be used by medical personnel for study subject treatment or diagnostic purposes.

Externally applied cardiac rhythm monitors are common tools used to diagnose symptoms that may or may not be related to cardiac rhythm abnormalities. Common problems that may lead to the use of cardiac rhythm monitors are syncope (loss of consciousness), near-syncope (near loss of consciousness), palpitations (the sensation of an abnormal heart beat), or monitoring of known cardiac rhythm problems like atrial fibrillation. The purpose of this research is to confirm the clinical value of a much easier-to-use cardiac rhythm monitoring system, hereafter referred to as the Investigational Monitoring System. Prior to discussing the investigational monitoring system, we will review standard electrocardiographic monitoring tools used to evaluate the heart's rhythm.

Excluding a routine 12 lead electrocardiogram that takes a snapshot view of the hearts electrical signal, the most common tool for monitoring the heart rhythm is a Holter monitor. A Holter monitor is also called an ambulatory cardiac monitor. A Holter monitor records every heartbeat for 24 hours. It requires wearing multiple electrodes and carrying a recording system that is usually worn on a belt or on a holster strap. Such systems are relatively bulky and difficult to conceal in public venues. Also, their electrodes often disconnect, especially during sleep when the patient is unaware of electrode detachments that can occur when turning or during exercise. Moreover, they can't be worn during showering. These shortcomings notwithstanding, standard Holters remain the standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Syncope of uncertain etiology or
* Pre-syncope of uncertain etiology or
* Palpitations of uncertain etiology or
* Management of known AF/SVT patients

Exclusion Criteria:

* Any abnormal or friable skin over the anterior thorax and upper abdomen
* Sternal incision within 3 months from the date of enrollment
Conversion From Standard Phosphate Binder Therapy to Fosrenol® (Lanthanum Carbonate) in Chronic Kidney Disease Stage 5

The main aim of this research study is to see if giving Fosrenol®, a chewable tablet, to patients on haemodialysis works as well as other treatments currently used to lower blood phosphorus levels.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects greater than or equal to 18 years of age receiving a stable regimen of haemodialysis for chronic kidney disease (CKD) Stage 5 (defined as haemodialysis two or three times per week for at least two months prior to screening).
* Females of child bearing potential (FOCP) must be non-pregnant, non-lactating, have a negative serum beta human chorionic gonadotropin (HCG) test, and agree to comply with any applicable contraceptive requirements of the protocol.
* Subjects on a stable phosphate binder dose (defined as no change in medication or dosage for at least the one month prior to screening) with a serum phosphorus level between greater than 1.78 and less than or equal to 2.43 mmol/L (5.5 and 7.5 mg/dL).

Exclusion Criteria:

* Subjects with a corrected serum calcium level less than 2.1 mmol/L (8.5 mg/dL).
* Subjects with an intact parathyroid hormone (iPTH) level greater than 500 pg/mL, or a history of previous parathyroidectomy within 12 months of screening.
* Subjects with any significant bowel obstruction, active inflammatory bowel disease, gastrointestinal (GI) motility disorders, abnormal or irregular bowel motion, or a history of major GI surgery within the last 6 months will be excluded.
* Subjects receiving aluminium, magnesium, or combination therapy other than sevelamer hydrogen chloride (HCl) and calcium as a phosphate binder at the time of screening will be excluded.
Surfactant Administration in Preterm Infants

In preterm infants with respiratory distress syndrome, mechanical ventilation is related to increased risk of death and complications. Surfactant is an important methods to reduce mortality and intubation rates. INSURE technique is a standard method to administrate surfactant. However, several preterm infants need two or more surfactant, and therefore one more intubation is needed. How to reduce the times of intubation is an challenges for neonatologists.

INSURE technique meas surfactant administration through intubation-surfactant-extubation. And noninvasive ventilation is immediately used after surfactant.

The differences of modified INSURE compared with INSURE is intubation-surfactant-X-ray relieved-extubation. Extubation and noninvasive ventilation is used after the X-ray relieving.

Eligibility Criteria:
Inclusion Criteria:

* All preterm infants with respiratory distress syndrome

Exclusion Criteria:

* congenital abnormalities or refuse the trials
Quality of Life, Aesthetic Result and Health Economy in Breast Reconstruction

A randomized clinical trial with two arms: irradiated women and non-irradiated women. Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages.


Eligibility Criteria:
Irradiated patients:

Inclusion Criteria:

* Age 18-60
* DIEP is technically possible
* Unilateral mastectomy
* BMI\<30

Exclusion Criteria:

* Scars on abdomen or back
* Bilateral mastectomy
* Previous liposuction abdomen
* 61 years of age or older

Non-irradiated patients

Inclusion Criteria:

-\>18 years of age

* Unilateral mastectomy
* BMI\<30

Exclusion Criteria:

* Bilateral mastectomy
* extensive scars on thorax
ICU Venous Thromboembolism Incidence Study in a Chinese Population

Venous thromboembolism (VTE) is one of the major public health problems in Western country. More than 100,000 Americans die each year from VTE. VTE is also a common complication of critical illness,1-2 and probably related to poor outcome in this patient group. Although there are guidelines about VTE prophylaxis in acutely ill medical patients and patients in medical ICU3, they are overlooked in our daily practice frequently in our country. There are many reasons for our common practice, including inadequate knowledge for the ICU physicians, more patients with bleeding tendency in ICU and low prevalence of VTE in our (eastern) country. However, the true prevalence of VTE in ICU and if thromboprophylaxis still needed in certain high risk patients are not unknown. Besides, if there is a difference in the VTE rate between western and eastern patients, what is the underlying mechanism? The major objective of this application is to answer the first part of the problem, i.e. to delineate the scope of this problem.

The specific aims of this application are as follows:

* prevalence of venous thromboembolism in ICU in Taiwan
* specific risk in subgroups of ICU patients
* prevalence and risk factors for silent pulmonary embolism


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to medical ICU with age over 18 y/o are eligible

Exclusion Criteria:

* Patients who do not sign the informed consent will be excluded from this study