cyrilzakka/clinical-trials huggingface dataset:
PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS

Extracorporeal life support (ECLS) is used as a last resort intervention in patients with severe cardiac, circulatory and/or respiratory failure with high (\>80%) expected mortality. Despite considerable improvements in patient selection and outcomes, mortality and morbidity after ECLS remain high. An improved selection and management of patients who are supported with ECLS is therefore unquestionably needed from a perspective of optimal patient care and the socio-economic impact of this costly intervention.

This observational multicenter study was designed to serve the following objectives:

1. Develop a (dynamic) prediction tool for survival and quality of life outcomes 1 year after ECLS support for the situation at baseline and 7 days after ECLS initiation
2. Study the association between application of left ventricular unloading and ECLS support duration and weanability
3. Description of the incidence of VA ECLS weaning failure and identification of predictors for VA ECLS weaning failure

Under this umbrella research protocol, the data collected by this observational multicenter study can also be reused for potential novel substudies with the objective to improve the quality of care and the efficiency of current treatment strategies involving ECLS.

Eligibility Criteria:
Inclusion Criteria:

* Having received (VA and/or VV) ECLS
* All ECLS indications (refractory cardiac, circulatory and/or respiratory failure)
* Surgical and medical patients

Exclusion Criteria:

* \< 18 years of age
* ECLS confined to cardiac surgery in the operating room (OR) or in the catheterization laboratory
* Objection against use of clinical data (opt-out principle)
OLE Study to Evaluate Safety / Efficacy of ZD4522

The purpose of this study is to assess the long term safety of Crestor.


Eligibility Criteria:
Inclusion Criteria:

* Completion of previous Crestor study as listed in the protocol.

Exclusion Criteria:

* Pregnant or breast feeding women, or not using appropriate contraception.
* Abnormal lab values as listed in the protocol.
B-Thalasaemia Trait and Its Possible Cardioprotective Role

Our purpose is to investigate whether thallasaemia trait offers protection against cardiovascular events and whether this can be applied to specific characteristics of these people ( better lipid profile , better blood pressure profile) as scientific literature suggests.

Thallasaemia is a major problem , especially in countries around the Mediterranean sea.On the other hand ,thallasaemia trait has been shown ,in a small number of studies , to have a possible protective role against CAD and stroke.These kind of studies have been contacted in Greece also ,and usually they enroll a small number of participants. In the study, investigators will enroll 2500 subjects who serve in military units in Thesally Greece. Firstly investigators will estimate the prevalence of thallasaemia trait in this population , as it is very high in this region and at the same time investigators will retrospectively record data from their personal files (which are annually recorded).

Eligibility Criteria:
Inclusion Criteria:

1. voluntary participation,
2. Subjects with Thalassemia treat will be confirmed of their treat by electrophoresis -

Exclusion Criteria:

-
Visualase Visualization Database (VIVID-1)

The purpose of the VIVID-1 data collection study is to establish a database of clinical images and associated technical files from commercial cases using the Visualase Thermal Therapy System (VTTS). All data collected will be de-identified. No safety or effectiveness assessments will be completed.


Eligibility Criteria:
Inclusion Criteria:

1. Patient correlating with the de-identified data set to be collected received standard of care treatment using the Visualase System prior to the date of site activation.

Exclusion Criteria:

1. Patient correlating with the de-identified data set to be collected is a minor (less than 18 years old, or as defined by local policy) that is not allowed to participate in this type of research project (eg, IRB approval with waiver of consent) per IRB policy
2. Patient correlating with the de-identified data set to be collected is enrolled in the Medtronic SLATE trial
Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis

This study aims to estimate the effectiveness of Rotarix™ vaccine against Rotavirus severe gastroenteritis (RV SGE) among hospitalised children aged between 12 weeks and \< 5 years, in Venezuela and to assess the current disease burden after introduction of the vaccine.

The data generated in this study will be useful for public health officers and policy makers in confirming the country-wide public health benefit of Rotarix™.

No vaccine will be administered during this study.

Eligibility Criteria:
Inclusion Criteria:

For SGE subjects:

* A male or female child aged 12 weeks to \< 5 years at the time of hospital admission/ ED stay. The subject becomes ineligible on the fifth birthday.
* Subject admitted to (or who will have an ED stay at) the study hospital(s) for SGE during the study period.
* Onset of SGE ≤ 14 days prior to admission/ ED stay.
* Written/thumb printed informed consent obtained from the parent(s)/legally acceptable representative(s) (LAR (s)) of the subject.

For Cases:

• Laboratory confirmed (i.e. by ELISA) RV-positive stool sample collected at hospital admission/ ED stay or during the first 48 hours of hospitalisation.

For Controls:

* Subject admitted to (or who will have an ED stay at) the same study hospital(s) for SGE as that of the case during the study period.
* Laboratory confirmed (i.e. by ELISA) RV-negative stool sample collected at hospital admission/ ED stay or during the first 48 hours of hospitalisation.
* Subjects born within ± 2 weeks from the date of birth of the case.

Exclusion Criteria:

For SGE subjects:

* Child in care.
* Hospitalisation is unrelated to GE.
* Onset of SGE \> 48 hours after admission to (or ED stay at) the hospital.
* Subject has digestive tube anomalies, chronic gastrointestinal disease or uncorrected congenital abnormalities.
* Subject with immunodeficiency.
* Subjects who live out of the federative entity where hospital(s) are located.

For Controls:

• Subject has previously participated as case in this study.
Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation

Compare the effect of an intravitreal injection of bevacizumab previous or posterior of panretinal laser photocoagulation (PRLP) with a pattern laser; to prevent and reduce diabetic macular edema (DME) in patients with proliferative diabetic retinopathy (PDR) with DME.


Eligibility Criteria:
Inclusion Criteria:

* Patients with proliferative diabetic retinopathy
* patients with macular edema

Exclusion Criteria:

* patients with previous treatments
* patients with ocular surgeries
Subthalamic Nucleus Connectivity in Parkinson's Disease With Ultra-high Field Magnetic Resonance Imaging

The purpose of this study is to investigate the segregation of the subthalamic nucleus into its motor and non-motor regions in patients with Parkinson's disease and healthy controls with the aid of ultra-high field magnetic resonance imaging.


Eligibility Criteria:
Inclusion Criteria:

Both groups:

* Mental competence

Group 1:

* Parkinson's disease patients scheduled for deep brain stimulation surgery

Group 2:

* Age and gender matched volunteers

Exclusion Criteria:

Both groups:

* Head injury
* Stroke
* Other neurological diseases other than Parkinson's disease
* Metallic prostheses or pacemaker in the subject's body or other contra indications for MRI

Group 1:

* Inability to abstain from dopaminergic drug use

Group 2:

* Parkinson's disease
* Use of medication affecting the central nervous system
A Phase 1 Study of the HSP90 Inhibitor, STA-9090 in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous Leukemia

An open-label phase 1 study to assess safety and efficacy of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a pathologic confirmation of the diagnosis of AML, ALL, or blast-phase CML
* ECOG Performance Status 0-2
* Adequate organ function as defined in the protocol.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* Hyperleukocytosis
* Acute Promyelocytic Leukemia (FAB-M3) subtype
* Uncontrolled Disseminated Intravascular Coagulation (DIC)
* Active central nervous system leukemia
* Concomitant radiation therapy, chemotherapy, or immunotherapy
* Women who are pregnant or lactating
* Neuropathy ≥ grade 2 (NCI CTCAE) at time of enrollment
* Chemotherapy (with the exception of hydroxyurea) or radiotherapy within two weeks or within six times the agent's half life
* Require ongoing therapy with either G- or GM-CSF, or long-acting versions of these molecules
* Use of any investigational agents within two weeks or within six times the agent's half life --Treatment with chronic immunosuppressants
* Other medical/psychiatric condition that may increase the risk associated with study participation as defined by the protocol.
Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography

To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA, a comparative study between healthy and diabetic patients

A prospective study of 30 patients with senile or complicated cataract scheduled to do phacoemulsification surgery in Tanta University Hospital

Two groups will be divided:

1. Group (1): Cataract will no diabetic retinopathy
2. Group (2): Cataract associated with diabetic retinopathy.

All patients will be subject to Full ophthalmologic examination before the surgery. Imaging will include OCTA. OCTA will be performed using cirrus OCT (Zeiss, Inc., USA). High-quality 6 x 6 mm OCTA macular scans and 3 × 3-mm papillary scan with strong signal-noise ratio with adequate centration on the fovea and optic nerve head respectively will be selected.

Segmentation will be used to evaluate superﬁcial and deep capillary retinal plexus projections in addition to the choriocapillaries. If errors in segmentation were detected, manual correction would be performed. The superﬁcial retinal capillary plexus (SCP) will be delineated with an inner boundary at the internal limiting membrane (ILM) and an outer boundary 10 µm inside the inner plexiform layer (IPL). The deep retinal capillary plexus (DCP) will be segmented with an inner boundary 10 µm inside the IPL and an outer boundary at 10 µm beneath the outer plexiform layer (OPL).

The vessel density metric from enface OCT angiogram will be used as an indicator of macular retinal and papillary perfusion. Vessel density (VD) analysis computes the percentage of area occupied by OCTA detected vasculature in a measured area. Choriocapillaries flow voids will be computed to assess choriocapillaries circulation.

The measurements of the OCTA, axial length, intraocular pressure will be obtained before the phacoemulsification surgery. Optical coherence tomography and IOP measurements will also be obtained 1 week after surgery.

Eligibility Criteria:
Inclusion Criteria:

* - Presence of a nuclear, cortical cataract or complicated cataract due to diabetic mellitus
* Intraocular pressure (IOP) of 21 mm Hg or lower
* Axial length (AL) between 20.0 mm and 25.0 mm.

Exclusion Criteria:

* Eyes with an AL longer than 25.0 mm or shorter than 20.0 mm,

  * IOP higher than 21 mm Hg,
  * History of ocular trauma or intraocular surgery, or any abnormal intraocular findings
  * Poor OCT-A images because of severe cataracts or unstable fixation
  * Any signs of intraoperative or postoperative complications
Screening of Niemann-Pick Disease, Type C in a Psychiatric Population

Niemann-Pick disease, Type C is a rare genetic disorder characterized by a failing in intracellular cholesterol transport, inducing an accumulation of sphingolipids in the brain.

Neurological signs are at the forefront of the disease. There are also psychiatric signs of psychotic kind among 28 to 45 % of patients according to studies, and a thirty cases were published. These signs can be concomitant with neurological signs or precede them.

Is is likely that psychotic disorders are the first signs of a Niemann-Pick disease not yet non encore diagnosed for some patients. Yet, no prevalence study for this disease in a psychiatric population of patients currently exists. In response to this problem this study proposes to search patients whose disease could be of organic origin or patients whose disease is suspected, based on clinical data. The diagnosis will be confirmed certified with a genetic and/or biochemical test.

The aim of this study is to search among a population psychotic adult patients, the ones that present a Type C Niemann-Pick disease in order to to estimate the prevalence.

Eligibility Criteria:
Inclusion Criteria:

* Hallucinations visual
* Confusion
* Catatonia
* Significant fluctuation of symptoms
* Unusual or paradoxical reaction to the treatment
* Progressive cognitive deterioration

Exclusion Criteria:

* Patients under 18 years
* Patients unable to give their free consent and without a legal representative
* Breastfeeding or pregnant women
Project Get Fit With MS: Guidelines for Exercise Training and Fitness Outcomes in MS

The purpose of this study is to test different types of exercise training for people with multiple sclerosis (MS). The exercise program is based on physical activity guidelines that have been developed specifically for people with MS. The investigators believe these guidelines will be effective for improving physical fitness and function in persons with mild-to-moderate MS.

Most adults with multiple sclerosis (MS) are physically inactive. One approach to address physical inactivity in this population has involved the provision of physical activity guidelines. Such physical activity guidelines are an important tool for exercise prescription, promotion, and monitoring, and recommend that people with MS "participate in at least 30 minutes of moderate intensity aerobic activity 2 times per week and strength training exercises for major muscle groups 2 times per week." The guidelines were developed from a systematic literature review and have yet to be tested for efficacy in improving fitness or other outcomes. This study will test that efficacy of aerobic and resistance training alone and in combination (based on the MS physical activity guidelines) for improving physical fitness and other outcomes (e.g., walking, thinking, MS symptoms) in persons with MS who have mild-to-moderate disability. Such an examination will be important to confirm the efficacy of the exercise prescription for people with MS and health-care providers. The investigators will further perform an exploratory analysis of blood biomarkers and eye imaging parameters to examine some of the mechanisms of exercise training effects in persons with MS.

Eligibility Criteria:
Inclusion Criteria:

* a definite diagnosis of MS
* self-reported Expanded Disability Status Scale (EDSS) score \< 6.0 or Patient Determined Disability Steps (PDDS) scale score ≤ 3.0
* relapse free in past 30 days
* willing and able to visit the University of Illinois at Urbana-Champaign for on seven occasions (two testing visits; five training visits) and participate in a 6-month home-based exercise program
* non-exerciser
* asymptomatic and physician approval for undertaking exercise testing and training

Exclusion Criteria:

* currently pregnant
Risperidone vs. Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression

The purpose of this study is to evaluate the comparative effectiveness of Risperdal (risperidone) or bupropion ER (extended release) combined with a SSRI medication and to test the relative safety of the combinations.

Major depression is a severe disorder with serious consequences. Effective treatments are available; however, in clinical trials 30-40% of patients do not experience even a 50% reduction in depression severity scores, while 50-70% fail to achieve a full therapeutic response. Futhermore, impairment from the disorder continues essentially unabated in patients who are treated but do not fully remit. If anything, the situation is at least as bad or not worse in clinical practice. Clearly, alternatives are needed to manage this common clinical condition.

The addition of bupropion ER (extended release) to an SSRI has empirical support, and has become the most common augmentation strategy in the US. A comparative trial of the combination of risperidone or bupropion ER added to an SSRI in treatment resistant deperssion could help support risperidone for this condition; such a trial seems warranted at this time.

Patients who are currently on a SSRI at an adequate dosage for at least 3 weeks with no response, will be randomly assigned (open-label) to either risperidone or bupropion ER augmentation for a period of 6 weeks. Patients will be followed weekly at the beginning and bi-weekly towards the end of the trial to compare the response of each group.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years or older
* DSM-IV diagnosis of major depressive disorder of at least moderate severity, but without psychotic features
* Ham-D 17 score of 18 or above
* Have a documentable history of 2 prior adequate trials of antidepressants including an SSRI without sufficient response. A clinically adequate trial is defined as having taken a minimum effective dose of an antidepressant for at least 3 weeks without a significant change in depressive symptoms.
* Must be currently on an serotonin uptake inhibitor (to include venlafaxine or duloxetine) at an adequate dose for at least 3 weeks.
* Ability and willingness to provide consent for participation in the study.

Exclusion Criteria:

* Any medical condition that would preclude treatment with an SSRI, risperidone, or bupropion ER
* Any clinically significant unstable medical condition
* Diagnosis of bipolar disorder or a primary diagnosis of any psychotic disorder
* Current psychotic symptoms (hallucination or delusions)
* Alcohol or drug abuse or dependence in the last 3 months (excluding nicotine and caffeine dependence/abuse) or abuse within the last month
* Documented non-response to the combination of a novel antipsychotic or bupropion ER and a SSRI
* Concomitant use of any psychotropic other than an SSRI or zolpidem (PRN for sleep)
* Score of 4 on the suicide item of the Ham-D scale and determination by the investigator of significant suicide risk
* Known sensitivity to risperidone or bupropion ER
Evaluation of Hepatitis B Virus (HBV) DNA Test As Point of Care Tool

This is a cross sectional observational study to asses the performance of two novel HBV DNA testing methodologies; a) dried blood spot sampling and b) fingerstick capillary blood using the Xpert® Hepatitis B Virus viral load assay. Both novel testing methodologies will be compared with venous blood tested using a gold standard HBV DNA assay. The sensitivity and specificity of the two novel testing will be evaluated.

HBV viral load tests are essential to guide antiviral treatment eligibility and effectiveness. However, many people are unable to access these tests, particularly those living in remote or limited resources settings given high cost, or unavailable infrastructure. Simple, affordable and accessible HBV viral load tests are required to increase global access to HBV testing and treatment to meet the WHO HBV elimination targets. The GeneXpert Diagnostic Systems, the most common molecular point-of-care platform globally, has the potential to provide simple and affordable HBV viral load tests. Dried Blood Spot testing is also an affordable and accessible testing methodology particularly suited to remote and resource limited settings. This proof-of-concept study will assess the feasibility and diagnostic performance of Xpert® HBV Viral Load test and Dried Blood Spot testing for the quantitation of HBV DNA from fingerstick capillary samples.

This study will be a cross-sectional observational study and will assess the performance of a novel fingerstick HBV Viral Load and Dried Blood Spot tests within a total of 300 participants who will be recruited across a network of hepatitis clinics in Sydney, Australia. No treatment will be administered as part of this study.

The Xpert HBV cartridge will be adapted to use fingerstick capillary blood instead of processed whole blood, and it's performance measured against a gold standard venous blood HBV DNA assay. Dried Blood Spot HBV DNA testing performance will also be measured against the gold standard venous blood HBV DNA assay.

Secondary objectives of the study are to: 1) evaluate diagnostic performance of the Xpert® HBV Viral Load assay compared to standard of care testing, by patients' hepatitis B e-antigen status (among e-antigen positive and e-antigen negative patients). 2) Evaluate diagnostic performance of the Xpert® HBV Viral Load assay compared to standard of care testing, by HBV treatment status (among treatment naïve patients and those receiving treatment). 3) Evaluate diagnostic performance of the Xpert® HBV Viral Load assay compared to standard of care testing, by HBV DNA levels (among patients with HBV DNA \<20 IU/mL; between 20 and 2,000 IU/mL, between 2,000 and 20,000 IU/mL; between 20,000 and 200,000 IU/mL; and \>200,000 IU/mL).

Eligibility Criteria:
Inclusion Criteria:

* Have voluntarily signed the informed consent form, 18 years of age or older, HBsAg positive

Exclusion Criteria:

* Nil
Food-for-Families: Experimental Grocery Store Study

This is a study about how the price of foods affects buying choices at the grocery store. The price of foods can have a big impact on what people choose to buy and prices change over time. This study is being done to see how changes in food prices affect what mothers choose for their families.

It is well known that the price of a given food affects the amount of that item individuals will purchase. Yet little is known about how specific groups, such as obese/overweight individuals and those with lower incomes, change their food purchasing decisions depending on food price changes. Evidence shows that these groups have lower quality diets and worse health outcomes than their normal weight and higher income counterparts. Therefore, it is important to gain a better understanding of how food price changes affect purchasing decisions among these population groups in order to develop targeted nutrition interventions to improve their diet quality. To investigate this, the researchers will create a laboratory-based grocery store, in which pictures of foods will be used in lieu of actual foods. Food prices will be indicated on each picture. The participants will be given play money and a budget, and asked to "purchase" foods in the mock grocery store. The price of foods will be changed throughout the study to investigate how participants change their purchasing decisions based on these price changes.

Eligibility Criteria:
Inclusion Criteria:

* Have at least one child up to 18 years of age residing in the household
* Primary grocery shopper for the household
* No health conditions or food practices that substantially limit food choice
* Not currently pregnant
* Consent to the study design

Exclusion Criteria:

* Male
* \< 18 years of age
* Not a mother, or children not living with subject in their household
* No children below the age of 18 years of age
* Not the primary grocery shopper for their household
* Health conditions or food practices that substantially limit food choice
* Currently pregnant