cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in Elderly

Since influenza vaccines are normally administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of adjuvanted influenza vaccine need to be re-evaluated after repeated vaccine administration. In this study, subjects previously vaccinated with Fluarix or the influenza adjuvanted vaccine, will receive a booster dose with the 2006-2007 season's formulations of either Fluarix or the adjuvanted vaccine.


Eligibility Criteria:
Inclusion Criteria:

* The subjects must be healthy elderly \>/= 67 years and previously vaccinated with Fluarix or the adjuvanted vaccine.

Exclusion Criteria:

* Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immunemodifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination, have a history of influenza infection since previous vaccination, or if subjects have acute or chronic clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination
Use of NAVA in Intubated Preterm

The present protocol will demonstrate the feasibility and efficacy of a newly developed mode of mechanical ventilation, Neurally Adjusted Ventilatory Assist, commonly known as NAVA. During NAVA, the timing and magnitude of pressure delivered are controlled by the infants' diaphragm electrical activity (EAdi), a validated measurement of neural respiratory drive. Recent clinical trials in adults and term infants have shown that NAVA is more synchronous than conventional pressure support ventilation, and that NAVA delivers lower mean airway pressures to achieve the same ventilation and respiratory muscle unloading. NAVA has recently been approved for use in neonates by Health Canada and the FDA in the United States, and is commercially available on the Servoi ventilator (Maquet Critical Care, Solna, Sweden). The present protocol is designed as a "case study" where the researchers responsible would like to evaluate the feasibility and efficacy of ventilating a premature baby on NAVA with the Servoi for 12 hours.


Eligibility Criteria:
Inclusion Criteria:

* Preterm newborn (\>1 day postnatal age, gestational age \>23 weeks, birth weight \<1250g), intubated and mechanically ventilated, and breathing spontaneously, as defined by the ability to trigger the ventilator. The infant should be breathing on conventional ventilation (SIMV, assist control, or pressure support) with the following ventilator parameters: assist control/pressure support \< 22 cm H2O, PEEP 4-6 cm H2O Fi02\<.30

Exclusion Criteria:

* Pneumothorax, degenerative neuromuscular disease, bleeding disorders, cardiovascular instability, cyanotic congenital cardiovascular disease, phrenic nerve damage/diaphragm paralysis, esophageal perforation, use of high frequency oscillatory or jet ventilation, contraindication to changing NG tube, or if infant is deemed "too unstable" by the clinical team. The use of narcotics is an exclusion criteria.
Cardiovascular Risk Stratification of Ambulatory Patients in Primary Prevention

This is an observational, cross-sectional, national multicenter study, trying to obtain local data about the global cardiovascular risk profile of patients attending ambulatory offices of general practitioners and cardiologists.

The aim of the study is to describe how physicians diagnose and stratify their patients in cardiovascular primary prevention setting and to highlight if patients are stratify through objective tools (risk scores and in this case, wich of them are used) or in subjective ways (clinical evaluation).

This is an observational, cross-sectional, national multicenter study, trying to obtain local data about the global cardiovascular risk profile of patients attending ambulatory offices of general practitioners and cardiologists.

The aim of the study is to describe how physicians diagnose and stratify their patients in cardiovascular primary prevention setting and to highlight if patients are stratify through objective tools (risk scores and in this case, wich of them are used) or in subjective ways (clinical evaluation).

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age, who give their written consent to take part.
* Patients without known vascular disease (primary prevention) under follow-up by the investigator, whose medical records have been initiated during the last 3 years.
* Patients who have completed their baseline CV risk assessment Lipid lowering treatment naive patients at the time of the stratification.

Exclusion Criteria:

* Incomplete or missing medical record data.
* Subjects with prior cardiovascular disease (peripheral vascular disease, coronary or cerebrovascular disease) symptomatic or asymptomatic.
* Subjects with terminal status disease or short life expectancy.
* Hypothyroidism without proper control.
* Pregnancy.
* Medical records compiled within a period longer than 3 years to the date of inclusion.
Danshen Dropping Pill for Coronary Heart Disease Heart and Artery Structure and Function

The Impact of Compound danshen dropping pill for coronary heart disease (CHD) heart and artery structure and function in patients with hypertension

Compound danshen dropping pill for coronary heart disease (CHD) heart and artery structure and function in patients with hypertension.We can accorand the pwv ,IMT and MDA to assess the impact of heart and artery structure and function.

Eligibility Criteria:
Inclusion Criteria:coronary heart disease，primary hypertension， -

Exclusion Criteria:secondary hypertension，diabetes mellitus，chronic renal disease，cardiac insufficiency

-
ICU Mortality Predictors of Trauma Patients

In this study, the data of the patients who were hospitalized due to trauma in intensive care unit (ICU) were examined in their first development. The mortality rate and the factors affecting mortality in these patients were determined

In this study, 107 trauma patients were examined. Patients were divided into two groups according to ICU results: survivors (Group 1) and deceased patients (Group2). Patients were rated in terms of age, Neutrophil lymphocyte ratio (NLR) , mean platelet volüme (MPV), lactat value, intensive care unit stay, APACHE 2 soring systems. Mortality rate and the factors affecting this rate were examined.

83 of the patients were male (77.58%) and 24 were female (22.42%). The mean age was 46 years. The mean value of lactate level was 3.25. MPV mean value was 10.34. NLR mean value was 8.23 and Apache 2 score mean value was 22.8. The average length of stay in hospital was 11.33 days. When the intergroup mortality was evaluated in terms of the relationship between continuous variables, there was a statistically significant difference in apache 2 score. No statistically significant difference was found between age, lactate, MPV, NRL and length of hospital stay.

NRL, MPV, Lactate levels were not suitable for evaluation of trauma patients as a early prognostic factor in the first day ICU admission. The investigators think that the use of trauma scoring systems such as apache 2 related to mortality during first hospitalization in ICU is more appropriate.

Eligibility Criteria:
Inclusion Criteria:

* trauvma patients

Exclusion Criteria:

* systemic inflammatory diseases
* cancer
* renal failure
* cardiac failure
* serebro vascular diseases
A Pilot Study of the Efficacy of Recombinant Alpha Interferon (IFN-A2b) and Zidovudine (AZT) in the Treatment of Progressive Multifocal Leukoencephalopathy (PML) Complicating HIV-1 Infection

To study the effectiveness of alpha interferon (IFN-A2b) and zidovudine (AZT) in treating progressive multifocal leukoencephalopathy (PML) as a complication of HIV-1 infection.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV seropositivity by both ELISA and Western blot.
* Biopsy proven progressive multifocal leukoencephalopathy (PML).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Intolerant to interferon.
* Prior or concomitant central nervous system disease (CNS) such as toxoplasmosis, multiple sclerosis (MS), or neurosyphilis.

Patients with the following are excluded:

* Intolerant to interferon.
* Prior or concomitant central nervous system disease (CNS) such as toxoplasmosis, multiple sclerosis (MS), or neurosyphilis.

Prior Medication:

Excluded:

* Patients receiving interferon for other reasons.
Neuromuscular Fatigue During Exercise in COPD-HF Overlap

Rationale. Chronic obstructive pulmonary disease (COPD) and heart failure (HF) coexist in approximately one third of patients presenting with one of these conditions. From a clinical standpoint, impaired tissue oxygen (O2) delivery stands as a common pathological mechanism of these cardiorespiratory diseases. Recent evidence suggest that muscle and cerebral blood flow and oxygenation are further impaired during exercise in patients with COPD-HF overlap compared to isolated diseases. However, it remains unknown whether impaired O2 delivery is associated with exaggerated manifestations of peripheral and central fatigue in COPD-HF overlap. In addition, improving cardiopulmonary interactions through non invasive positive pressure ventilation or through the addition of a hyperoxic gas mixture during exercise have been associated with enhanced cerebral and muscle O2 delivery and oxygenation in patients with COPD or HF. It is, therefore, conceivable that improved O2 delivery to these structures have beneficial influence on exercise capacity in patients with COPD-HF overlap due to less peripheral and central fatigue.

Aims. To investigate the influence of impaired O2 delivery during exercise, and its alleviation with different interventions (non invasive positive pressure ventilation or hyperoxia), on neuromuscular fatigue in patients with COPD-HF.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* COPD: mild-to-severe airflow obstruction (forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio \<0.70; post-bronchodilator FEV1 \> 30% predicted);
* HF: reduced left ventricular ejection fraction (\<50%, for COPD-HF patients only);
* HF: New York Heart Association Functional Classification I to III (for COPD-HF patients only);
* Clinical stability for both diseases (COPD and/or HF) and no recent (within 3 months) exacerbation requiring a change in medications;
* Patient benefiting from health care coverage;
* Patient able to provide written informed consent.

Exclusion Criteria:

* Inability to perform cycle ergometry;
* Medical device incompatible with magnetic stimulation;
* Counter-indication to perform exercise test;
* Patient refusing to sign written informed consent;
* Patient not benefiting from health care coverage;
* Patient exceeding the annual ceiling of authorized compensation received following participation to a clinical trial;
* Patient deprived of freedom by judicial or administrative decision;
* Patient subject to a measure of legal protection (safeguard of justice, guardianship, curatorship), who cannot be included in clinical trials;
* Pregnant or nursing woman.
Humeral Head Implants: Radiological and Clinical Evaluation

In the past years several shoulder reconstruction systems with different types of prostheses and fixation methods have been developed to improve shoulder arthroplasty, trying to cover a wide range of pathologies and revision situations. The aim of the present study is to report radiological and clinical outcome with a stemless shoulder implant with hollow screw fixation.


Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 85 years at time of surgery
* Patients with primary or secondary osteoarthritis of the shoulder

Exclusion Criteria:

* Patients with cuff tear arthropathy and axillary nerve lesions
Phase I Study of Adenoviral Vector Mediated Gene Transfer for Ornithine Transcarbamylase in Adults With Partial Ornithine Transcarbamylase Deficiency

OBJECTIVES:

I. Determine the safety, feasibility, and potential efficacy of intravascular adenoviral vector mediated gene transfer in the liver in adults with partial ornithine transcarbamylase deficiency.

PROTOCOL OUTLINE: This is a dose escalation study. Patients undergo a femoral arterial placement of a hepatic intraarterial catheter. Patients then receive adenoviral vector mediated gene transfer intravascularly over 30 minutes.

Cohorts of 3 patients each receive escalating doses of adenoviral vector until the maximum tolerated dose is determined.

Patients are followed at 3, 5, 7, 8, 15, and 29 days, at 2 months, and then every 3 months thereafter.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of partial ornithine transcarbamylase deficiency Female heterozygote with abnormal allopurinol challenge or underlying defect in either N15 urea or N15 glutamine OR Male with childhood/adulthood onset OR Family history of 2 affected children
* Stable for at least 1 month prior to study
* Plasma ammonium levels less than 50 micromoles

--Prior/Concurrent Therapy--

* Concurrent alternate pathway therapy to control hyperammonemia allowed

--Patient Characteristics--

* Hepatic: No history of liver disease
* Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No high level of neutralizing antibodies to the adenovirus
Esketamine for the Treatment of Rett Syndrome

The goal of this interventional study is to learn about the efficacy and safety of Esketamine for treating children with Rett syndrome (RTT).

The main questions it aims to answer are:

* whether Esketamine treatment is effective in improving symptom severity for RTT.
* whether Esketamine is safe in the treatment of RTT. Participants will receive a weekly intravenous infusion of Esketamine for five weeks and will be assessed for disease severity and drug safety.


Eligibility Criteria:
Inclusion Criteria:

* Classic/typical RTT
* Causing mutation in MECP2 gene
* Stable pattern of seizures, or has had no seizures at least 8 weeks

Exclusion Criteria:

* Use of other drugs that interact with Esketamine: thyroxine, meglumine diatrizoate, aminophylline, diazepam or midazolam, drugs for antihypertension or central nervous depressants, halogenated general anesthetics (e.g., halothane), tubocurarine, atracurium
* Condition with hypertension, high cerebrospinal fluid pressure, and high intraocular pressure
* Unstable systemic illness other than Rett syndrome: current clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, type 1 diabetes, or uncontrolled type 2 diabetes), renal, hepatic, respiratory, or gastrointestinal disease (such as celiac disease or inflammatory bowel disease), or major surgery planned during the study
* Clinically important variations in medication use
A Comparison of Injection Pain of Propofol During Endoscopy : LCT Propofol vs MCT/LCT Propofol

The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by long chain triglyceride propofol versus medium/long chain combinated triglyceride propofol on endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* age \>15 yrs
* ASA (American Society of Anesthesiologists risk class III-IV)I-II
* patients undergoing to gastroscopy

Exclusion Criteria:

* significant systemic disease (American Society of Anesthesiologists risk class III-IV)
* history of allergic reactions to any of the study drugs
* chronic use of opioid analgesics
* psychiatric disorder
* arrythmia
* pregnancy
* age \<18 yrs
Fatty Acid Supplementation in Children With ASD (Study 2)

The objective of the protocol is to test the impact of Omega 3-6 on pre-specified biological signatures (IL-1β, IL-2, and IFNγ) and to correlate changes in the biological signatures with changes in ASD symptoms.

Children with ASD suffer from both mental and physical symptoms that affect quality of life and severely disrupt family well-being. The objective of the protocol is to test the impact of Omega 3-6 on pre-specified biological signatures (IL-1β, IL-2, and IFNγ) and to correlate changes in the biological signatures with changes in ASD symptoms. Fatty acid supplements are natural products with anti-inflammatory properties often used for treatment of ASD symptoms, but the efficacy remains unproven.

Eligibility Criteria:
Inclusion Criteria:

* Age 2-6 years old
* ASD diagnosis at Nationwide Children's Hospital within the prior 6 months
* English is primary language

Exclusion Criteria:

* Fatty acid supplementation in the past 6 months
* Consumes fatty fish more than 3 times per week
* Still breastfeeding or formula feeding
* Quadriparesis
* Deafness
* Blindness
* Seizure disorder diagnosis
* Autoimmune disorder including Type 1 Diabetes, Fragile X, Rett, Angelman Syndromes, Tuberous Sclerosis
* Feeding problems precluding consumption of the supplement
* Ingredient allergy (canola, fish, or borage seed)
* Planned surgeries scheduled within the time frame of trial participation
Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Postmenopausal Women

This study aimed at determining the short- (16 weeks) and long-term (36 weeks) health and physical fitness effects and adherence of recreational team handball training for postmenopausal women without previous experience with the sport.

The investigators hypothesized that short-term recreational team handball training would result in positive health and physical fitness adaptations and that the health and physical fitness improvements achieved after the first 16 weeks would be maintained or further improved at the long-term. Moreover, the investigators also hypothesized that the adherence to this exercise mode would be maintained throughout the 36 weeks (long-term) compared to the first 16 weeks (short-term).


Eligibility Criteria:
Inclusion Criteria:

* Inactive postmenopausal women aged +55 years or younger if with menopause for at least 3 years

Exclusion Criteria:

* Any medical contraindications to perform moderate-to-vigorous physical activity
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects

This trial is conducted in Europe. The aim of this first human dose trial is to investigate the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (exposure of the trial drug in the body) properties of NNC0148-0000-0287 (insulin 287) in a GIPET® I tablet formulation in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 18.0-28.0 kg/m\^2
* Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Previous participation in this trial. Participation is defined as randomised
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the investigator
* Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma

* Multi-Center
* Randomized
* Open-Label Study of single agent IMO-2055
* Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)

This is a study of 2 dose levels (0.16 or 0.64 mg/kg) of IMO-2055 administered by weekly subcutaneous (SC) injections in two patient populations, treatment naïve or previously treated patients. Each dose group (treatment naive or previously treated) will be randomized to receive one of the 2 doses being studied.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage IV clear cell renal carcinoma with metastatic or locally recurrent disease that is not surgically resectable.
* At least one measurable lesion
* Adequate organ function
* Any prior treatment of renal cell cancer was concluded at least 4 weeks prior.
* If female and of childbearing potential, a negative serum pregnancy test performed and documented no more than 14 days before the first dose of study drug.

Exclusion Criteria:

* Known untreated central nervous system (CNS) metastasis
* Pre-existing autoimmune or antibody-mediated diseases
* Other significant medical disease.
Clinical Trial of BioBlock COVID-19 Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived From Bovine Colostrum

For an antiviral agent to act as an effective biological barrier on nasal mucosal surface, the formulation preferably has to be maintained on the site of action for several hours, and the nasal spray dispenser can be utilized for administering the solution to the upper respiratory tract. A "first-in-man" clinical study of the nasal spray containing anti-SARS-CoV-2 antibodies derived from bovine colostrum was conducted. The study on healthy volunteers was undertaken to evaluate how long the bovine antibodies would be maintained on the nasopharyngeal surface after administration of nasal spray. In addition, the study enabled to determine which of the two concentrations of antibodies should be used in the final nasal-spray formulation. The volunteers were followed up for 4h after administration of antibody spray and sampling was done at different time-points during this period. The concentration of antibodies from patient samples was measured using ELISA analysis. In addition, as this was a "first-in-man" study any adverse events following the administration of spray were also monitored.

To test the nasal biological availability of the BioBlock® immunoglobulin preparation, 16 healthy volunteers were recruited in the phase 0 clinical trial. The study was conducted in the premises of the Ear Clinic of Tartu University Hospital. The study protocol was approved by Research Ethics Committee of the University of Tartu on March 17, 2021 (No 336/T-1). Written informed consent in accordance with the Declaration of Helsinki was obtained from each healthy volunteer. The study group was divided into two subgroups where the individuals were intranasally administered into both nostrils of BioBlock® formulation which contained either 0.1 mg/mL or 0.2 mg/mL of the colostrum immunoglobulin preparation (n=8 in both study groups). A filter paper with a volume capacity of 15 µL was placed on the medial nasal surface using surgical forceps and it was kept on nasal mucosa for 10 minutes. Following this the BioBlock was administered to the nasal cavity. The nasal mucosal sampling was done at 4 timepoints. The samples were analyzed using a Cow IgG ELISA kit.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Age 18-80
* Have not been diagnosed with SARS-COV-2 infection (lack of positive PCR test)
* Have not been vaccinated against SARS-COV-2 infection

Exclusion Criteria:

* Pregnancy
* Serious allergic or anaphylactic reactions to medications
* Allergies to milk products
* Ear-nose-throat pathologies (anatomic and diseases)
* Immunodeficiency conditions (cancers, hematologic diseases, HIV, congenital immunodeficiency)
* Viral hepatitis A,B and C
* Upper airway infections
* Autoimmune diseases (diabetes, COPD, asthma, rhinitis, RA, psoriasis)
* Concomitant drugs - glucocorticosteroids, biologic drugs, inhalable medications