cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Viral Shedding Patterns and Clinical Outcomes of Influenza Patients

The objective of the study is virological assessment (e.g., proportion of prolonged viral shedding, median days to viral clearance, and viral load) in laboratory-confirmed adult influenza patients admitted to the general ward and/or to the ICU and to assess the correlation with the clinical manifestations and prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Hospitalized or admitted to ICU for influenza
* Age ≥18 years
* Laboratory confirmation of influenza A or B

Exclusion Criteria:

* Informed consent not given
Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)

This randomized study compares operative techniques in chronic rhinosinusitis with polyposis (CRSwNP) surgery. It aims to evaluate outcomes in asthma and CRSwNP, safety and costs. The investigators want to see if patients with certain clinical and/or genetic predispositions will benefit from extended surgery. They also aim to find biomarkers for detection and management models for of severe airway inflammation and to further develop markers for progressive disease forms.

Please see study protocol

Eligibility Criteria:
Inclusion Criteria:

* Patient not responding to conservative treatment of 3 months of nasal steroid drops
* Nasal polyp score ≥ 4/8
* SNOT-22 ≥ 30
* Lund-Mackay CT score ≥ 14
* One previous endoscopic sinus surgery or at least one peroral corticosteroid course or at least 3 courses of antibiotics within 2 years

Exclusion Criteria:

* Age \<18 years, age \> 65 years
* Complication of CRS (f.e. mucocele, invasive fungal rhinosinusitis)
* Other diagnosis than CRSwNP (inverted papilloma, antrochoanal polyp etc.)
* Previous external sinus surgery or Draf 3 procedure (or indication for external approaches or Draf 3
* Bleeding diathesis
* Pregnancy/ breastfeeding
* Cystic fibrosis
* Primary ciliary dyskinesia (PCD)
* Sarcoidosis
* Granulomatosis with polyangitis (GPA)
* Eosinophilic granulomatosis with polyangitis (EGPA)
* Immunosupression (diagnosed Spesific Antibody Deficiency (SAD), common variable immunodeficiency (CVI), HIV or use of biologicals/immunosuppressive medication)
* Immunotherapy
* Daily use of systemic corticosteroids
* Communication problems (f.e. neurological/psychiatric disease, language skills)
* Unlikely to comply
* Other severe disease
* Inability to be operated.
A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population

A prospective, single-center, open-label, randomized controlled trial to demonstrate the safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study hypothesis is that OptiVein IV Catheter use will be superior to the control in successful venous access after first attempt.

The OptiVein System uses transillumination of skin tissue to aid in cannulation and consists of the OptiVein IV Catheter with an integrated optical fiber, and an electronic unit. The electronic unit is a portable internally powered generator of low power visible laser light of green color. The electronic unit generates visible light, which is released from the tip of the needle into the soft tissue around the tip of the IV catheter. Light is visible through the skin and helps mark the location of the tip of the needle under the skin and against the vein.

In addition to pinpointing the exact location of the tip of the needle, the OptiVein System informs the user of the exact moment of penetration of the tip of the needle into the blood vessel. Hemoglobin in blood strongly absorbs visible light of specific wavelengths, so when the needle enters the blood vessel, the light is instantly absorbed by blood, which causes instant fading of skin transillumination. Instant disappearance of tissue illumination indicates successful venipuncture. The user can then lower the angle of the needle and start to advance the cannula over the needle into the blood vessel. Such optical confirmation is much faster than the traditional observation of blood in the flashback chamber of the needle and should lead to increased first-attempt success rates and decreased cannulation-related complications.

The use of OptiVein device will be compared to the use of a traditional IV catheter to explore the potential increase of effectiveness of cannulation with OptiVein versus traditional IV catheters.

Eligibility Criteria:
Inclusion Criteria:

* Aged newborn to 12 years
* Has written or verbal order for insertion of an IV
* Requires peripheral IV therapy (catheter)
* Has an insertion site in the hand, forearm, foot, leg, or head free of deformities, phlebitis, infiltration, dermatitis, burns, lesions or tattoos
* Demonstrates cooperation with a catheter insertion and the study protocol

Exclusion Criteria:

* In the newborn nursery or intensive care units (neonatal or pediatric)
* On patient-controlled analgesia pump
* Patient is anesthetized
* Terminally ill
* Transferred from the operating room less than 8 hours postanasthesia
* Any child the research staff deem unobservable
* The study IV catheter site will be placed below an old infusion site
* The study IV site needs to be immobilized with a splint or other devices
* Has or has had a previous IV catheter related phlebitis or infiltration during current hospitalization
* Will require a power injection for a radiologic procedure during participation in this study
Improving Information Extraction From EEG on Cerebral Anesthetic Drug Effects

This is an interventional, randomized controlled study in health volunteers that involves collecting data on raw EEG waves measuring various combinations of anesthetic drugs during standardized drug titration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged 18 to 70 years
* Concerning the cognitive function: Volunteers are considered to have sufficient cognitive reserve if they are able to read and comprehend the patient information form, if they can adequately answer the anamnestic questions during the screening process and if they are allowed to provide legitimate written informed consent
* No selection will be made regarding ethnic background.
* For this study no control group has been selected as EEG is compared between episodes rather than between individuals (each volunteer is his/her own control)

Exclusion Criteria:

Volunteer refusal

* Volunteer \< 18 years and \>70 years
* Pregnancy
* Exclusion criteria are weight less than 70% or more than 130% of ideal body weight
* Neurological disorder (epilepsy, the presence of a brain tumor, a history of brain surgery, hydrocephalic disorders, depression needing treatment with anti-depressive drugs, a history of brain trauma, a subarachnoidal bleeding, TIA or cerebral infarct, psychosis or dementia , schizophrenia, alcohol or drug abuse).
* Diseases involving the cardiovascular system (hypertension, coronary artery disease, prior acute myocardial infarction, any valvular and/or myocardial disease involving decrease in ejection fraction, arrhythmias, which are either symptomatic or require continuous medication/pacemaker/automatic internal cardioverter defibrillator
* Pulmonary Diseases
* Gastric Diseases
* Endocrinologic diseases
* Recent use of psycho-active medication (benzodiazepines, anti-epileptic drugs, parkinson medication, anti-depressant drugs, opioids) or more than 20g of alcohol daily
A Study of Patients Who Recently Have Been Infected With HIV

The purpose of this study is to find out if anti-HIV drugs, taken by patients who are newly infected with HIV, can make the level of HIV in the body too low to detect.

Studying patients who recently have been infected with HIV may help researchers understand how HIV infection works and how anti-HIV drugs may help these patients. Approved anti-HIV drugs can reduce the amount of HIV, but more research needs to be done in newly infected patients. This study will look at recently HIV-infected patients to study the progression of HIV disease and to see whether anti-HIV drugs can reduce the level of HIV.

Primary and early HIV infection represents a potentially unique opportunity to better understand the pathogenesis of HIV infection, as well as to potentially prevent the establishment of latent infection. Approved antiretroviral therapy is able to reduce plasma viremia to unmeasurable levels in established infection and several groups have observed comparable effects in recently infected adults. This study is designed to evaluate and follow a cohort of patients with primary or early HIV infection and to evaluate the time course of latent infection and whether latent infection in CD4 cells will allow viral persistence despite antiretroviral therapy.

Patients begin antiretroviral therapy within 7 days of enrollment. All patients are evaluated for treatment compliance and complete a compliance questionnaire regularly. Clinical evaluations, including CD4, CD8, and HIV RNA counts also are done regularly. Antiretroviral therapy is discontinued if there is no detectable virus by ultrasensitive assay and culture techniques in plasma, PBMCs, and lymphoid tissue. In a subset of patients, genital secretions and CSF (cerebrospinal fluid) are evaluated. If relapse occurs, antiretroviral therapy is re-instituted. In addition, virology and immunology substudies are performed.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Have had certain tests indicating that they recently have been infected with HIV.
* Agree to use effective methods of birth control during the study and for 3 months after.
* Are at least 18 years old.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have taken anti-HIV drugs.
* Take erythropoietin, G-CSF or GM-CSF within 30 days of study entry.
* Take interferons, interleukins, cytotoxic chemotherapy, or HIV vaccines within 30 days of study entry.
* Take medications that should not be taken with their prescribed anti-HIV drugs.
* Have had radiation treatment within 30 days of study entry.
* Are pregnant or breast-feeding.
Transcranial Photobiomodulation for Adult ADHD

This study aims to assess the behavioral as well cognitive changes in ADHD symptoms in terms of improvement of inhibitory control and attention in adults with ADHD

This study is a randomized double blind trial. After selection and enrollment, participants will be screened at baseline with a complete diagnostic and clinical assessment, and randomized to receive active or placebo t-PBM.

At visit 1 patients will undergo a (pre-treatment) neuropsychological testing followed by the first t-PBM session. After the first t-PBM session, the patients will undergo another (post-treatment) neuropsychological testing. After visit 1, which includes the first treatment, patients will receive additional 4 weeks of t-PBM treatments. After the last treatment, patients will come to clinic for undergo a clinical and neuropsychological assessment (visit 2). After the visit 2, patients will receive other 4 weeks of t-PBM treatments. After the last t-PBM treatment session, patients will come to clinic to undergo the final clinical and neuropsychological assessment (visit 3).

At the visits 1, 2 and 3 patients will be asked if they believe they received active or sham treatment.

Eligibility Criteria:
Inclusion Criteria:

• subjects diagnosed with ADHD

Exclusion Criteria:

* schizophrenia or other psychosis
* current acute depressive episode
* bipolar disorder with current manic or depressive episode
* active substance use disorder
* autism
* dementia.
Assessment of the Incidence of Hemorrhagic and Ischemic Events in Post-angioplasty in Anticoagulated Coronary Patients with Atrial Fibrillation

Atrial fibrillation (AF) is a supraventricular arrhythmia characterized by uncoordinated and fast atrial activity, and coronary artery disease (chronic and acute coronary syndrome) is characterized by a generally atheromatous narrowing of the coronary arteries. Angioplasty is necessary to restore arterial circulation in coronary artery disease. A dual anti-aggregating therapy is then initiated in these patients in parallel with treatment of AF with anticoagulation. This triple therapy exposes the patient to an increased risk of hemorrhage. The combination of oral anticoagulation with antiplatelet inhibitor in long-term anticoagulated patients requiring stent placement has been studied in several recent trials (e.g. WOEST, PIONEER AF PCI, REDUAL PCI and AUGUSTUS). The results of these studies have formed the basis of the European recommendations of 2017 and 2020, whereby the therapeutic strategy depends on the risk of hemorrhage or ischemia. However, the hemorrhagic risk assessment factors included in the scores overlap with those for ischemic risk. It is therefore difficult to determine the predominant risk for each patient. Thus, uncertainties persist as to the optimal duration of a triple therapy and the optimal recommended dose.

In this study, the investigators aim to establish an inventory of the current practices by evaluating the incidence of hemorrhagic and ischemic events in post-angioplasty in anticoagulated coronary patients in the context of atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Patient on anti-coagulating therapy before or during hospitalization for atrial fibrillation
* Patient hospitalized in the cardiology ward admitted for acute or chronic coronary syndrome requiring coronary angioplasty
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* The subject is in a period of exclusion determined by a previous study
* The patient has already been included into this study
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient pregnant, parturient or breast feeding
Phase II of Lenvatinib Plus PD-1 Antibody for Advanced HCC

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody in patients with advanced hepatocellular carcinoma (HCC)

Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and PD-1 antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated the efficacy and safety of lenvatinib plus PD-1 antibody. Thus, the investigators carried out this single-arm, prospective, phase II study to find out it.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* Barcelona clinic liver cancer-stage C
* Eastern Cooperative Oncology Group performance status of 0 to 2
* with no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:
* Platelet count ≥ 75,000/μL
* Hemoglobin ≥ 8.5 g/dL
* Total bilirubin ≤ 30mmol/L
* Serum albumin ≥ 30 g/L
* ASL and AST ≤ 5 x upper limit of normal
* Serum creatinine ≤ 1.5 x upper limit of normal
* INR ≤ 1.5 or PT/APTT within normal limits
* Absolute neutrophil count (ANC) \>1,500/mm3
* Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease
Stromal Vascular Fraction (SVF) Injection in the Treatment of Patellar Tendinopathy

The aim of the study is the evaluation of clinical and radiological results after the treatment of patellar tendinopathy through the injection of autologous ultrasound-guided, intra- and peri-tendon stromal vascular fraction.

After being informed about the study and potential risks, all patients giving written informed consent will be treated according to the study protocol.

Every patients will undergo to a single peri- and intra- tendon injection with Autologous Stromal Vascula Fraction (SVF).

At baseline and at every follow-ups patients will be evaluated clinically and radiologically.

In particular, clinical evaluation and questionnaires will be performed at baseline, 1, 3, 6, 12 and 24 months visits, Ultrasound will be performed at baseline, 6 and 12 months visits. MRI will be performed at baseline and 6 months visits.

Eligibility Criteria:
Inclusion Criteria:

* Ultrasound or MRI signs of patellar tendon pathology

Exclusion Criteria:

* BMI \> 30
* Patients suffering from: rheumatic diseases, diabetes, infectious processes, epilepsy, severe osteoporosis
* Patients undergoing intra-tendon infiltration of another substance within the previous 6 months;
* Patients who had patellar tendon surgery within the previous 12 months;
* Immunodepression
* On going systemic inflammatory diseases (stabilized outcomes of such diseases are not considered absolute contraindications).
Irbesartan and Atenolol in Hypertensive Heart Disease

The renin-angiotensin-aldosterone system has been implicated in the control of structural changes of the heart and the vasculature, beyond the effects on blood pressure.

This projects examines the importance of the renin-angiotensin-aldosterone system and the sympathetic nervous system in the control of cardiac and vascular structure and function in subjects with hypertension.Patients with hypertension and left ventricular hypertrophy were randomized to an angiotensin receptor blocker or a beta adrenergic receptor blocker for 48 weeks. Repeat investigations of blood pressure, structure and function of the heart and the vascular tree, and neurohormones were performed. Two control groups, consisting of normotensive subjects and of hypertensive subjects with no cardiac hypertrophy were also examined for comparison.

We included 115 patients with hypertension and cardiac hypertrophy, established by echocardiography. Extensive echocardiographic examinations, ultrasonography of the carotid arteries, 24h Holter registrations, 24h ambulatory blood pressure monitoring monitoring, neurohormones and blood samples for inflammation and hemostasis markers and endothelial function were done at weeks 0, 12, 24, and 48. Matched control groups (1:3, i.e. 38 normotensive subjects and 38 hypertensive subjects with no signs of hypertensive heart disease were examined at one occasion. All patients obtained irbesartan or atenolol for 12 weeks; a diuretic and a calcium antagonist was added when needed thereafter in order to obtained a blood pressure below 140/90 mm Hg. All analyses were performed central in a core laboratory.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 ys old
* Male or female with no child bearing potential
* Seated blood pressure diastolic 90-115 mm Hg
* Left ventricular mass above 131 g/m2 for men, above 100 g/m2 for women
* Informed consent

Exclusion Criteria:

* Coronary artery disease, heart failure or other significant cardiac disorder
* Cerebrovascular accident within the past 6 months
* A seated systolic blood pressure above 200 mm Hg
* Significant renal disease, collagen or vascular disease, or gastrointestinal condition
* Significant allergy or intolerance to study drug
* Alcohol or drug abuse
* Uncontrolled diabetes mellitus
A Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy Adults

This study evaluates whether YM443 causes any changes in the electrocardiogram of healthy adults.

Each subject participates in all four treatment periods separated by washout periods.

In order to maintain the blind between arms, all subjects will receive the same number of tablets per day in each period of either active drug or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Male or non pregnant, non lactating female
* Weighing at least 45 kg
* Body Mass Index (BMI) between 18 and 32 kg/m2

Exclusion Criteria:

* The subject has evidence of any cardiac conduction abnormalities
* The subject has a previous history of any medical or psychiatric condition that would preclude participation in the study
* The subject has participated in another clinical trial in the last 30 days
* The subject anticipates an inability to abstain from alcohol, or caffeine use, or from grapefruit and grapefruit juice from 48 hours prior to the administration of the first dose of YM443 on Day 1 of Period 1 and throughout the duration of the study
* The subject has used tobacco-containing products and nicotine or nicotine-containing products within six months prior to Screening
* The subject consumes more than 5 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week or has a history of substance abuse, drug addiction, or alcoholism within 2 years prior to Screening
* The subject has donated any whole blood or cellular blood component or has undergone significant loss of blood or has received transfusion of any blood or blood products within 56 days of Day -1 of Period 1 or has donated plasma within 7 days of Day -1 of Period 1