cyrilzakka/clinical-trials huggingface dataset:
Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.

A trial to characterize the immunogenicity of 2 different formulations of a vaccine from GSK Biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b. A vaccine from Commonwealth Serum Laboratories (diphtheria, tetanus, pertussis) which is co-administered with Haemophilus influenzae type b vaccine will also be used as a comparator. Reactogenicity and safety of all vaccines will be assessed as well.

"The study will be carried out in a partially double blind manner (i.e. double blind with respect to DTPwGöd-HBV/Hib Kft and DTPwCSL-HBV/Hib Kft groups and open with respect to CSL's Triple Antigen \& Hib group). Subjects will be randomly allocated to one of the three following groups to receive:

* GSK Biologicals Kft's combined DTPwGöd-HBV/Hib Kft vaccine.
* GSK Biologicals Kft's combined DTPwCSL-HBV/Hib Kft vaccine.
* CSL's Triple Antigen + GSK Biologicals' Hib vaccines. There will be a specific follow-up of solicited local and general symptoms during 4 days after each vaccination and of unsolicited symptoms for 31 days after each vaccination. Serious adverse events reported during the study period will be recorded.

"

Eligibility Criteria:
Inclusion criteria

* Administration of one dose of hepatitis B vaccine at birth.
* A healthy male or female between, and including, 6 and 12 weeks of age at the time of the first DTPw vaccination.

Exclusion criteria

* 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.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine hepatitis B vaccine for the Triple Antigen + Hib group.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Bacille Calmette-Guérin (BCG) vaccine given after the first 2 weeks of life.
* Previous vaccination against diphtheria, tetanus, pertussis and/or Hib/History of diphteria, tetanus, pertussis, hepatitis B and/ or hib disease.
Profiling and Targeting Epigenetic Marks to Improve Diagnosis and Therapeutic Approaches in Head and Neck Cancer

Investigators have recently shown that epigenetic remodelling enzymes, such as HDAC inhibitors, are feasible drugs in HNC (8, 9). Preliminary data are indicating some deregulated epigenetics marks suggesting the corresponding histone modifiers as possible targets for the treatment of HNC, providing an attractive and feasible option to build upon. Our overarching hypothesis is that unique histone marks distinguish HPV+ and HPV- HNC and that specific histone modifiers are novel mediators of HNC tumorigenesis in an HPV specific manner

Head and neck cancer (HNC) is a highly heterogeneous disease, involving diverse anatomical sites including oral cavity, larynx and oropharynx. HNC risk factors include tobacco smoking and alcohol consumption and, especially for the subtype of oropharyngeal cancers (OPC), human papillomavirus (HPV) infection

Eligibility Criteria:
Inclusion Criteria:• Age: Adults aged ≥ 18 years diagnosed with HNC

* Sex: Both male and female
* Human papilloma virus (HPV) test: Both positive and negative.
* Tumor: primary tumors, treatment naïve, squamous cell carcinoma
* Cancer stage: I-IV
* Anatomic location: oral cavity, larynx, oropharynx
* Tumor fragments not required for diagnostics

Exclusion Criteria:

* Previous radiotherapy, chemotherapy or immunotherapy for HNC
* Unable to provide written informed consent
Validation of the I-UDS Neuropsychological Battery

The current project entails the validation of the Italian version of the Uniform Data Set (I-UDS) neuropsychological in patients with neurodegenerative diseases, specifically in patients with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD). Specifically, the final aim is to explore the ability of the battery to differentiate the cognitive profiles of the two groups of patients.

The harmonization of procedures for neuropsychological assessment in dementia disorders is essential for the development of shared activities and projects within the IRCCS Network of Neuroscience and Neurorehabilitation (RIN). To this end, a previous project of the network was dedicated to the translation and adaptation of the Uniform Data Set (UDS) neuropsychological battery, following the similar initiative of the National Alzheimer's Coordinating Center (NACC) USA . This project led to the creation of the I-UDS, which can be administered via a tablet application and consists of tests aimed at investigating different cognitive domains, namely memory, attention, language, executive and visuospatial skills. Normative data were obtained from a sample of 433 healthy participants. In order to be able to use the I-UDS battery in clinical and research settings, it is essential to validate its application in patients with neurodegenerative diseases. In particular, in line with the NACC initiative, the battery aims to trace and highlight the continuum between Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD). The present multicenter study therefore aims to test the I-UDS battery in patients with clinical diagnoses of MCI and AD, in order to explore its ability to differentiate the cognitive profiles of the two groups of patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of MCI or AD based on diagnostic research criteria after a protocol of clinical, neuropsychological, structural brain imaging evaluation and biomarkers positivity assessment (amyloid-PET and/or CSF);
* performance in the Mini-Mental State Examination (MMSE) above/equal 20 (score corrected for age and education);

Exclusion Criteria:

* prior/current cerebrovascular disorders;
* a history of traumatic brain injury, brain tumors, stroke;
* concomitant medical, sensory and/or motor deficits possibly affecting performance;
* a history of alcohol and/or drug abuse;
* use of medications influencing cognitive functions.
Expanded Access to Triheptanoin

Expanded access may be provided for qualified patients who have limited treatment options and are not eligible for a clinical trial.

Long Chain Fatty Acid Oxidation Disorders (LC-FAOD) and other Non-FAOD conditions, where applicable: Expanded access may be available outside of the US in countries prior to approval by the local regulatory agencies.

For full details, please visit the links provided below.

Eligibility Criteria:
- The participant must not be eligible for a UX007 clinical trial
Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens After Cataract Surgery

In this study, the investigators examined the subjective visual quality including LogMAR uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) ,distance corrected near visual acuity (DCNVA),using logMAR visual acuity chart,and the objective visual quality including Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI), OQAS value (OV),and the tear-film quality dynamics including the tear break-up time and the tear-film OSI between the eyes with multifocal lens and monofocal lenses by optical quality analysis system (OQAS).

50 eyes of 50 cataract patients scheduled for phacoemulsification surgery were recruited, the multifocal group (25 eyes) ，were implantation with Tecnis® ZMB00；and the monofocal group (25 eyes) were implantation with Tecnis® ZCB00.

Methods: All eyes were examined by logMAR visual acuity chart and Optical quality analysis system (OQAS) at 1 week, 1 month, 3 month, 6 month,12 month after surgery for the subjective and objective visual quality Change during the first year.

Measures:Subjective and objective visual quality were evaluated.Tear-film quality dynamicswere evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Eyes with an axial length of 22.00 to 25.00 mm with age-related cataract.

Exclusion Criteria:

* Preoperative exclusion criteria included diabetes, history of ocular surgery or inflammation.
* Patients who could not be available for follow-up.
Dyslipidemia in Type 2 Diabetes (0767-034)

The purpose of the study is to compare the lipid-altering effects of MK0767, glipizide, and pioglitazone after 12 weeks of treatment.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* Men and non-pregnant females
* Age greater than or equal to 21 years
* Stop current diabetes therapy (if applicable)
* Stop current statin therapy (if applicable)

Exclusion Criteria:

* History of type 1 diabetes mellitus or ketoacidosis who are currently being treated with insulin
* Patients on a weight loss program with ongoing weight loss, or starting an intensive exercise program within the last four weeks
* Patients requiring treatment with corticosteroids for more than 14 consecutive days
* Patients taking warfarin or warfarin-like anti-coagulants
* Patients undergoing surgery within 30 days of Visit 1
* Patients with Hepatitis B, Hepatitis C, active liver or gallbladder disease
* Patients with history of pancreatitis or uncontrolled high blood pressure
Effects of the Buddy-Up Dyadic Physical Activity Program on Health Outcomes of Care Dyads of Dementia: A Pilot Study

This project seeks to develop a novel dyadic intervention (titled as Buddy-Up Dyadic Physical Activity; BUDPA), using exercise as the common treatment component to improve the cognitive outcomes of persons with dementia and manage the stress-related symptoms of their family caregivers.

This project is a pilot study that seeks to develop a novel dyadic BUDPA intervention, using exercise as the common treatment component to improve the cognitive outcomes of persons with dementia and manage the stress-related symptoms of their family caregivers. BUDPA has integrated the concept of developing social capital for dementia management. By applying partner exercise, the longer-term provider for this therapeutic care will be shifted from service providers to the family caregivers and the persons with dementia. Helping them to translate the practice to a home-care setting further strengthens the notions of family responsibility and ability in dementia management. BUDPA fully engages the care dyads in a mutual helping relationship during the exercise training. The partner exercise also creates a platform to enable more meaningful encounter within the care dyad. The family caregivers are facilitated to find meaning in the caregiving process, which eventually can benefit their role commitment and mental wellness. Also, the use of mixed-method study design can provide high quality findings to inform both the feasibility and preliminary effects of the BUDPA program.

Eligibility Criteria:
Inclusion Criteria:

For PwD,

* confirmed diagnosed of mild to moderate-intensity dementia
* cognitive impairment as indicated by a HK-Montreal Cognitive Assessment (Hong Kong version; HK-MoCA) score of 8-19 to indicate mild to early moderate dementia will be recruited

For family caregivers

* live together with the PwD
* identify as the primary family caregivers of the PwD

Exclusion Criteria:

* engaging in \> 60 minutes per week of moderate or more vigorous exercise in the previous six months
* acute muscular-skeletal problem, stroke or cardio-respiratory disease.
Diverting Loop Ileostomy: With or Without Rod

Diverting ileostomies are created to protect a rectal anastomosis or in situations with a risk of intestinal perforation. Currently, the application of a rod to hinder slippage of the loop is an established technique to perform a diverting loop ileostomy. However, various "rod-less" techniques have been described and are performed with similar success. The aim of this study is to determine, whether a modification (without rod) of the current standard method of protective loop ileostomy formation (with rod) could improve ileostomy specific morbidity. Secondary endpoints include stoma care, determinants of quality of life and stoma function.

Background

For rectal anastomoses within 6 cm of the anal verge, leakage rates are up to 15%. Here liberal use of protective stomas is widely accepted. Fecal diversion by loop ostomy may also be performed after extended adhesiolysis with serosal lesions and risk of intestinal perforation, in patients with obstructing rectal tumours requiring neoadjuvant radio-chemotherapy or in patients with complex anorectal injuries or fistulas. Generally, diverting loop ileostomies are secured at skin level by means of a supporting device in order to prevent retraction of the loop ileostomy into the abdomen. Nevertheless, due to the supporting rod, difficulties may occur in applying a stoma bag correctly and leakage of feces onto the skin may occur even with correct eversion of the afferent limb. Despite easier application of stoma bags and therefore reduced risk of skin irritation, none of these alternative techniques are established. In various non-randomized studies rodless loop ileostomies were described with an overall morbidity between 3 and 39%. However definition of morbidity varies significantly in these studies and randomised controlled trials are missing so far.

Objective

The aim of this study is to determine, whether a modification (without rod) of the current standard method of protective loop ileostomy formation (with rod) could improve ileostomy specific morbidity. Secondary endpoints include stoma care, determinants of quality of life and stoma function.

Methods

The study is designed as multi-institutional, randomized controlled, two-armed study. Patients scheduled for a protective loop ileostomy and meeting the eligibility criteria will be randomized to creation of a loop ileostomy with or without sustaining rod.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for planned protective loop ileostomy

Exclusion Criteria

* patients with long-term use of corticosteroids (\> 15 mg prednisolone equivalent)
* immunosuppressive agent rapamune
App-Based Mindfulness Intervention for the Improvement of Quality of Life in Patients With Metastatic Renal Cell Cancer

This trial tests the feasibility of an application (app)-based mindfulness intervention and its effect on improving quality of life in patients with renal cell cancer that has spread to other places in the body (metastatic). This trial aims to see whether an app-based mindfulness intervention may help patients cope with their disease.

PRIMARY OBJECTIVES:

I. To assess feasibility of the Am mindfulness app in metastatic renal cell carcinoma (mRCC) patients, with respect to accrual, adherence and engagement in program.

II. To assess preliminary effects of app-based mindfulness intervention in patients with metastatic renal cell carcinoma (mRCC) (the Am Mindfulness-Based Cancer Survivorship \[MBCS\] Journey), on psychosocial outcomes (e.g., anxiety, distress, fear of cancer recurrence), as well as overall quality of life (QOL) and fatigue, among patients with mRCC.

OUTLINE:

Patients participate in a mindfulness-based program by using the Am app for 20-30 minutes every day, a minimum of 4 days each week over 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Sufficiently fluent in English
* Cytologically or pathologically verified diagnosis of renal cell carcinoma (RCC)
* Evidence of metastatic disease (including at a minimum computed tomography \[CT\] of the chest, abdomen and pelvis for staging)
* Undergoing immunotherapy
* A "moderate" or greater fear of cancer progression, as demonstrated by an Fear of Cancer Recurrence-7 (FCR-7) score of \>= 17
* A fear of cancer progression, as demonstrated by a Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety score \>= 13
* Have smart phone with internet access
* Not suffering from current major depressive disorder, bipolar disorder or other psychiatric disorder
* Not currently engaging in meditation one or more times per week within the previous year
* Has not participated in an mindfulness-based cancer recovery (MBCR) or mindfulness-based stress reduction (MBSR) program in the past 5 years
Effects of Eccentric Training for Shoulder Abductors in Subjects With Shoulder Impingement Syndrome

The aim of the study was to evaluate the effect of eccentric strength training for shoulder abductors on force steadiness in subjects with subacromial impingement syndrome (SIS).

Although it is known that shoulder abduction in subjects with subacromial impingement syndrome (SIS) presents alterations in several parameters, as for example, in scapular and glenohumeral kinematics, the strengthening of the shoulder abductors as an intervention strategy is controversial in literature.

Strength training has been shown to be effective in reducing the fluctuations in force and had a positive effect on isometric steadiness in old adults and in healthy young subjects during bed rest. However, there are no studies that evaluated the effects of strength training on the force steadiness in subjects with SIS.

Eligibility Criteria:
Inclusion Criteria:

* subjects diagnosed with Subacromial impingement syndrome by a physical therapist (the diagnosis was confirmed by an orthopaedic physician).

Exclusion Criteria:

* pregnancy
* torn rotator cuff or long head biceps tendons
* ligamentous laxity based on positive Sulcus test or a positive apprehension test
* previous shoulder or neck surgery
* hooked acromion
* systemic illnesses
* corticosteroid injection 3 months prior to evaluation
* physical therapy 6 months prior to evaluation
European Cardiac Resynchronisation Therapy Survey

The European CRT survey represents a joint initiative between two ESC associations; the Heart Failure Association and the European Heart Rhythm Association. The survey will be performed in collaboration with The Institute für Herzinfarktforschung in Ludwigshafen which will handle the data collection and data analysis.

This European CRT Survey was initiated by the Heart Failure Association (HFA) and the European Heart Rhythm Association (EHRA) of the ESC in order to describe current European practice and routines associated with CRT-P/CRT-D implantations based on sample of patients enrolled in 13 countries. The data collected following implantation provides information including clinical characteristics, diagnostic criteria, implantation routines and techniques, adverse experience, and assessment of adherence to guideline recommendations. The single follow-up visit at 1 year (9-15 months) will provide information regarding short-term clinical outcomes.

The primary objective of this Survey is to describe current European practice based on a broad sampling in 13 countries. The information collected will enable practice between centres and countries to be compared and permit benchmarking with national and international practice. The survey provides valuable quality assurance assessment for individual centres, permits limited economic analyses and broadly evaluates adherence to guideline recommendations.

The following 13 European countries contributed patients to the survey: Austria, Belgium, France, Germany, Ireland, Israel, Italy, the Netherlands, Norway, Spain, Sweden, Switzerland and UK. Two national coordinators, one each from the fields of heart failure and electrophysiology, were selected and given the responsibility to facilitate recruitment in their respective countries.

Follow the link for complete list of the members of the Scientific Committee and national coordinators.

Eligibility Criteria:
Inclusion Criteria:

* eligible patients for CRT-P or CRT-D.

Exclusion Criteria:

* none
Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)

The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Signed Patient Informed Consent Form
* Able and willing to comply with all pre-, post-, and follow-up testing and requirements
* Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation\* \[class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)\] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation\*, or intolerable side effects due to AAD
* Subjects with symptomatic paroxysmal atrial fibrillation (PAF)\*

  * PAF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven days.

Exclusion Criteria:

* Atrial fibrillation (AF) secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
* Previous ablation for AF
* History of any valvular cardiac surgical procedure
* Coronary artery bypass grafting (CABG) procedure within the last six months
* Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
* Left atrial thrombus
* History of a documented thromboembolic event within the past one (1) year
* Diagnosed atrial myxoma
* An implanted implantable cardioverter defibrillator (ICD)
* Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
* Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable)
* Acute illness or active systemic infection or sepsis
* Unstable angina
* Myocardial infarction within the previous two months
* Left ventricular ejection fraction (LVEF) \<40% as determined by pre-procedure transthoracic echocardiogram (TTE)
* History of blood clotting or bleeding abnormalities
* Contraindication to anticoagulation (i.e. heparin or warfarin)
* Contraindication to computed tomography/magnetic resonance angiography (CT/MRA) procedure
* Life expectancy less than 12 months
* Enrollment in an investigational study evaluating another device or drug
* Uncontrolled heart failure or New York Heart Association (NYHA) class III or IV heart failure
* An intramural thrombus tumor, or other abnormality that precludes catheter introduction or manipulation
* Presence of a condition that precludes vascular access
* Left atrial size ≥ 50 mm as determined by pre-procedure TTE