cyrilzakka/clinical-trials huggingface dataset:
Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity

The purpose of this study is to compare the antibody response and reaction rates in children age 6-23 months when they are given either the currently recommended schedule of two 0.25ml doses of influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month apart.


Eligibility Criteria:
Inclusion Criteria:

* Child healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination
* Child between and including 6 months of age and 23 months of age (up to and including the day before 24 months of age)
* Child is available and can complete all relevant procedures during the entire study period
* Parent or legal guardian is available and can be reached by phone during the entire study period
* Parent/guardian provides written informed consent
* Parent/guardian is fluent in English

Exclusion Criteria:

* Child has history of laboratory-confirmed influenza
* Child has history of any prior influenza immunization
* Child has history of anaphylactic reaction to any component of the vaccine (i.e. egg)
* Child has received immune globulin or other blood products within the prior six weeks
* Child has received injected or oral steroids within the prior six weeks (inhaled or topical steroids allowed)
* Child has a bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection (thrombocytopenia, coagulation disorder, anti-coagulant therapy)
* Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period
* Child is scheduled to receive a live vaccine (notably measles, mumps, rubella or varicella vaccines) during the study period
* Child has a health condition which, in the opinion of the investigator, would interfere with the evaluation or pose a health risk to the child
Cardiovascular Risk Factors and Severe COVID-19. A Nationwide Registry-based Case-Control Study

In this study we cross-reference several nationwide high-quality Swedish registers in order to study risk factors for severe Covid-19 outcomes.

In this nationwide, case-control study we cross-reference several detailed, high-quality Swedish registers in order to study risk factors associated with severe Covid-19 as well as different disease outcomes, with a focus on cardiovascular disease, chronic kidney disease, different treatments and socioeconomic factors. Cases are identified through the Swedish intensive care register (SIR) and controls through the Swedish population register (RTB). Further information on the study participants is gathered by linkage to registers on: prescribed drugs; history of in- and outpatient care; income, education and migration. Follow-up data such as future hospitalization and mortality will be gathered prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Cases: Admitted to intensive care unit in Sweden and registered admission in the Swedish intensive care register (SIR) with a main diagnosis of Covid-19 confirmed by laboratory testing (ICD10: U07.1). (cases)
* Control subjects matched for age, gender,residency: For each case 10 controls matched for age, gender and district of residence will be identified by Statistics Sweden (SCB) in the Swedish population register (RTB).
* Control subjects matched for age and gender: For each case 5 controls matched for age and gender will be identified by by Statistics Sweden (SCB) in the Swedish population register (RTB).

Exclusion Criteria:

* No valid Swedish personal identity number (PIN)
The Effect of Menthol Ice and Frozen Saline Applications After Lumbar Disc Surgery

The aim of the study was to determine the effect of postoperative menthol ice and frozen saline applications on thirst and sore throat in patients undergoing lumbar disc surgery.

In the postoperative period, patients become susceptible to many complications that may develop due to general anaesthesia, endotracheal intubation, surgical intervention and clinical conditions. One of the conditions that patients experience quite intensely in the postoperative period and which is usually ignored in clinics is the feeling of thirst. Another problem that may occur in patients undergoing surgery under general anaesthesia is discomfort due to endotracheal intubation. Patients may experience problems such as sore throat, hoarseness, difficulty swallowing and dry throat in the postoperative period due to endotracheal intubation. Diagnosis and control of postoperative thirst and sore throat contribute to patient comfort and prevention of complications. This study is considered important because it draws attention to postoperative thirst and sore throat, a problem that surgical patients have.

Eligibility Criteria:
Inclusion Criteria:

* Knowing how to read, write and speak Turkish
* Having no obstacle in understanding and communicating the information given
* Agreeing to participate in the research verbally and in writing after being informed about the research
* Ages 18 and over
* Those who underwent surgery under general anesthesia
* Those who have not yet started oral intake in the postoperative period
* Without menthol allergy
* According to the American Society of Anesthesiologists (ASA) classification; Class I, II and III, Normal healthy patient (ASA I); Patient with mild systemic disease (ASA II); Patient with serious systemic disease that does not affect daily activities (ASA III)
* Having no sore throat before surgery
* As a result of the evaluation made with the Safety Protocol for Management Thirst in the Early Postoperative Period , patients who provide appropriate conditions for ice application (the individual must be conscious and oriented after the surgery, the airway must be open with coughing, swallowing and breathing, and there is no nausea or vomiting)

Exclusion Criteria:

* Those who have severe nausea and vomiting at the time of application
* Those with a change in consciousness status/acute confusion after surgical intervention
* Those with chronic disease/diseases related to Ear-Nose-Throat Diseases
* Patients with difficult intubate
* Patients with psychiatric problems
Target-controlled Infusion Model for Cefepime

For this study, a previously developed population pharmacokinetic (popPK) model for cefepime (Jonckheere et al., submitted to JAC) was programmed in Rugloop vII, which is a software program to drive an infusion pump. By entering patient data (such as gender, serum creatinine, age and weight) in Rugloop II, a patient-specific dose will be calculated and given to the patient. This concept is known as Target Controlled Infusion (TCI). The aim of this study is to prospectively validate the popPK model using TCI.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients of 18 years of age or older, admitted to the hospital ICU and requiring administration of cefepime as part of their treatment
* Patients within the weight range of 50 -120kg
* Patients with calculated creatinine clearance within the range 15 to \> 90 ml/min, allocated to one of three groups as described above.
* Written informed consent, or if not possible surrogate consent, or if not possible declaration for inclusion in an emergency, patient informed consent being signed as soon as possible.
* Patient with an arterial catheter in place for other reason than the current study purpose

Exclusion Criteria:

* Patients displaying acute or chronic renal failure requiring renal replacement therapy
* Pregnancy
* Moribund patients
* Known sensitivity or allergy to cefepime
* Inclusion in another study involving antimicrobial treatment.
* Patient participating in a research for which a period of exclusion is currently required by other study protocol, ethical committee or health authority.
* Patient already previously included in the trial
In Vivo Investigation of Initial Stages of Enamel Erosion

This exploratory study is designed to help develop a clinical model to measure the earlier stages of dietary acid medicated enamel loss. The study will use fluoride as positive control to explore the validity of this design.


Eligibility Criteria:
Inclusion Criteria:

* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
* Aged at least 18 years
* Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination.
* Absence of any condition that would impact the participant's safety or well-being, or affect the participant's ability to understand and follow study procedures and requirements.
* Two anterior maxillary teeth, without signs of toothwear or exposed dentine, facial restorations, abutments for fixed or removable partial dentures, full crowns or veneers, orthodontic bands or cracked enamel that would interfere with the study evaluations.

Exclusion Criteria:

* Pregnant or breast feeding women
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
* Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
* Recent history (within the last year) of alcohol or other substance abuse
* Presence of a disease or medication which in the opinion of the investigator, will impact on assessments
* Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening
* Surface irregularities, discoloration due to trauma, restorations and hypo or hyperplasic areas which, in the opinion of the investigator or dental assessor, would prevent accurate impressions and grading
* Daily doses of a medication which, in the opinion of the investigator, could impact the assessment, for example acidic medications
* Any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements
Ammonia N-13 Myocardial Blood Flow Absolute Quantification by PET in Patients With Known or Suspected CAD (Ammonia MAP)

This study is being conducted to provide access to and collect test data for an established nuclear medicine diagnostic imaging test called Positron Emission Tomography (PET), using a specific radioactive drug called Ammonia N-13 (Ammonia), referred to simply as an Ammonia PET scan, which is used to visualize the blood flow through the blood vessels and into the heart muscle in order to identify areas of restricted blood flow within the heart. The scanner used in this study may be a stand-alone PET scanner or a PET/CT scanner, which combines the PET scanner and a Computed Tomography (CT) scanner into a single device. Unless otherwise stated in this consent form, the term PET will be used to refer to both stand-alone PET and PET/CT scanners. While physicians have used the Ammonia PET test for many years to visualize (image) the blood flow into the heart muscle (perfusion), it is now possible to also measure the flow of blood into the heart muscle. Research studies have demonstrated clinical value in reviewing the measured blood flow values in addition to reviewing the perfusion images of blood flow into the heart muscle. Therefore, this study will establish a database of a large number of Ammonia PET measured blood flow values to serve as a future reference.

This is a prospective, multicenter database that will be populated by sites utilizing N-13 Ammonia and sponsored by Ionetix. Each site with access to N-13 produced under an investigational new drug (IND) application will be eligible to participate. Once the site is activated, the site will enroll patients into the database that are scheduled for clinically indicated PET-MPI with N-13 (as determined by their treating physicians). PET-MPI perfusion, MBF, percent ischemia, pharmacologic stress agent, and gated left ventricular ejection fraction/function values will be collected when available, in an anonymous fashion and uploaded into the database. All patient health identifiers (PHI) will be removed prior to upload. No procedures additional to those clinically indicated will be performed for the purposes of this study.

Eligibility Criteria:
Inclusion Criteria:

Adults ≥18 able to give informed consent.

Clinical indication for PET-MPI as determined by the subject's treating physician

Exclusion Criteria:

Any clinical contraindication for pharmacologic stress testing per ASNC/SNMMI/ACC myocardial perfusion imaging guidelines when stress perfusion imaging is required clinically.

Inability or unwilling to give informed consent

Pregnant subjects
Sensitivity Training For Parents of Preterm Infants

Immediately following birth, preterm infants face a period of stressful environmental inputs, which may have negative consequences on early brain development and subsequent neurobehavioral outcomes. This study aimed to assess the effectiveness of training parents in reducing stressful experiences early in life. The investigators hypothesized that this intervention would insulate preterm infants from the harmful effects of acute and chronic stress, which in turn would result in enhanced brain development. The primary aim of the current study was to investigate if this intervention was associated with improved brain development measured by magnetic resonance imaging (MRI) at term-equivalent age. A secondary aim was to assess some possible short-term medical benefits.

A randomized controlled trial of a parental sensitivity training program involving 45 women with infants born \< 30 weeks gestational age. The intervention consisted of 10 individual sessions in the Neonatal Intensive Care Unit (NICU). Post-intervention, at term-equivalent age (40 weeks postmenstrual age), magnetic resonance (MR) imaging was performed to evaluate brain structure and development. Quantitative volumetric techniques were used to estimate overall and regional brain volumes for different tissue types including cerebrospinal fluid (CSF), cortical grey matter (CGM), deep nuclear grey matter (DNGM), unmyelinated white matter (UWM) and myelinated white matter (MWM). Diffusion tensor imaging (DTI) was used to evaluate the integrity and maturation of white matter by apparent diffusion coefficient (ADC) and fractional anisotropy (FA).

Eligibility Criteria:
Inclusion Criteria:

* \> 30 weeks gestation

Exclusion Criteria:

* insufficient English
* congenital abnormality
* triplets and higher multiple births
* residence \> 100 km from study site
Outcome of Patients Treated With ECLS

Extracorporeal life support (ECLS), also called extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique of providing effective circulatory and (or) respiratory failure, with a growing number of critically ill patients benefit from it. The aim of this study is to investigate the outcome of patients treated With ECMO, and to evaluate the short-term and long-term outcomes of patients with ECLS.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving ECMO for circulatory and/or respiratory support

Exclusion Criteria:

* Refusal of consent
Hypofractionated Radiation Therapy for Patients With Breast Cancer Receiving Regional Nodal Irradiation

The primary objective of this study is to document lymphedema rates in patients requiring regional nodal irradiation (RNI) who receive hypofractionated radiation as compared to conventional radiation.

Participants with stage II or stage III node-positive breast cancer, or T3N0 node-negative will receive hypofractionated radiation for 4 weeks. We hypothesize that patients receiving a shorter course of radiation will have reduced lymphedema. Lymphedema is diagnosed when the patient's arm circumference measures 10% or more as compared to pre-treatment (baseline) arm circumference measurement. Secondary endpoints will address the effectiveness, quality of life, and side effect profile of a shortened course of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Karnofsky Performance Status 50% - 100%
* Diagnosis of stage II or III node-positive breast cancer (NOTE: Stages include: T4a-cNany, T3N1, TxN2.) OR T3N0 node-negative breast cancer.
* For patients with TxN1 disease, one of the following criteria must be met: Grade 3; ≤ 45 years of age at time of screening for this study; extensive Lymphovascular Space Invasion (LVSI); 3 lymph nodes positive; hormone-negative disease; positive lymph nodes after chemotherapy; or extracapsular extension
* Prior surgery and chemotherapy allowed, no prior radiation to the target area (breast or chest and nodes). NOTE: Radiation should occur 3-12 weeks after last chemotherapy or surgery, whichever comes last.
* Women of child-bearing potential (WOCP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.

Exclusion Criteria:

* Diagnosis of inflammatory breast cancer
* Previously diagnosed malignancy excluding basal or squamous cell carcinoma of the skin (unless disease-free for 5 years or more)
* Diagnosis of scleroderma
* Diagnosis of lupus
* Diagnosis of active dermatomyositis
* Diagnosis of metastatic disease
* Pregnant or nursing
Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older

The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.

This Protocol Posting has been updated according to Protocol Amendment 3, Sep 2009.

After the analyses for this study were completed, questions arose regarding the integrity of study data from a single study site in Romania, which enrolled 102 subjects in the trial. Because evaluation of data from this site did not reveal irregularities when compared with overall study data and because GSK has no current plans to use the data from the study in support of any regulatory filings, they were not excluded from the analyses reflected in this results summary.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* A man or woman aged 65 years or older at the time of the vaccination.
* Written informed consent obtained from the subject.
* Subjects with residence status allowing free mixing with general community.

Exclusion Criteria:

* Bedridden subjects
* Previous vaccination against influenza since February 2008.
* Previous vaccination in the last three years with an investigational adjuvanted candidate seasonal or pandemic influenza vaccine.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Any contra-indication to intramuscular administration of the influenza vaccines.
* History of hypersensitivity to a previous dose of influenza vaccine.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg and chicken protein.
* Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature \<37.5°C (99.5°F).
Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer with Different HER2 Expression Patterns

The purpose of this observational study is to learn about the HER2 heterogeneity and its impact on benefit from trastuzumab deruxtecan in metastatic breast cancer. The main question it aims to answer is:

- Does the heterogeneity of HER2 expression level and spatial distribution in different tissues affect the efficacy of trastuzumab deruxtecan in metastatic breast cancer?


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced or locally unresectable breast cancer;
* Treated with T-DXd (DS-8201, trastuzumab deruxtecan) regardless of line of therapy, HR, and HER2 expression level;
* HER2 immunohistochemistry staining information of the primary lesion or metastatic/recurrent lesion;
* Measurable lesions with treatment response results that can be evaluated through imaging examinations;
* Able to follow up with the latest progression-free survival or overall survival.

Exclusion Criteria:

* Patients with missing basic clinical information or HER2 immunohistochemistry staining information;
* Patients with missing pathological results for both primary and metastatic/recurrent lesions;
* Patients with no measurable lesions and unable to evaluate T-DXd treatment response;
* Discontinue T-DXd therapy for unacceptable adverse events or other reasons;
* Patients lost to follow-up after T-DXd treatment.
Long LIMA Patch on Left Anterior Descending Coronary Artery in CABG

To assess the effect of LIMA patch as a method for the reconstruction on diffusely diseased LAD in the early and midterm outcomes

It is well-known that coronary artery bypass graft (CABG) surgery significantly increases life expectancy, so complete myocardial revascularization should be the main goal of the surgical intervention process (1). During coronary artery bypass surgery, the surgeon removes a piece of blood vessel from the leg, chest, arm, or belly. Then, the surgeon uses that piece of blood vessel (called a "graft") to reroute blood around the blocked artery. The surgery is called "bypass surgery" because it bypasses the blockage Complete revascularization in CABG is crucial to improve early and late outcomes after surgery. Conventional procedures cannot achieve satisfactory results in severely diseased left anterior descending coronary artery .

Endarterectomy for severely atherosclerotic coronary artery disease (CAD) has a higher surgical risk and poor late outcomes . Reconstruction of diffusely diseased LAD with left internal mammary artery (LIMA) on-lay patch has less risk and complications than endarterectomy technique Ogus and colleagues used LIMA on-lay patches for the reconstruction of LAD based on the superior patency rate of the LIMA over other techniques which are more time-consuming. According to Lüscher and colleagues , the advantage of LIMA on-lay patch is to provide better vasomotor function and adjust the flow rate in proportion to the distal runoff.

In the recent study by Rezk etal., reported that , LAD reconstruction with a LIMA patch could have a better short-term outcome than other techniques as saphenous vein patch without an endarterectomy for a diffusely diseased left anterior descending coronary artery.

Eligibility Criteria:
Inclusion Criteria:

* Any patient male,( or female) and his(or her) age from 30-90 years have Ischemic Heart Disease for CABG with diffusely diseased LAD.

Exclusion Criteria:

* Any patient performed open heart surgery before