cyrilzakka/clinical-trials huggingface dataset:
Levacor™ Ventricular Assist Device (VAD) Bridge to Transplant Study

The Levacor™ Ventricular Assist Device (VAD) has been designed for mechanical circulatory support in heart failure patients. The purpose of this clinical study is to determine its safety and efficacy as a bridge to transplant (BTT) in cardiac transplant candidates with presumed non-reversible left ventricular failure.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must be at least 18 years of age at the time of VAD implantation.
2. Listed for cardiac transplantation as UNOS Status 1A or 1B at the time of VAD implantation or within 72 hours of VAD implantation.
3. Body Surface Area (BSA) 1.2 m2 or greater.
4. If female of childbearing potential must have negative pregnancy test.
5. Patient has signed an Informed Consent.

Exclusion Criteria:

1. Unacceptable surgical risk according to Principal Investigator.
2. Intolerance or contraindication to anticoagulation or antiplatelet therapies.
3. Excessive risk of bleeding as evidenced by INR \> 2.3, or PTT \> 45 sec, or platelet count \< 50,000 U, unresponsive to treatment.
4. Excessive neurologic risk documented as TIA within the last 3 months or stroke within the last 6 months.
5. Evidence of any of the following indicators of end-organ dysfunction: total bilirubin \> 4 mg/dL, ALT/AST \> 3 times upper limit normal, serum creatinine \>3.5 mg/dL.
6. Fixed pulmonary hypertension with a most recent PVR \> 5 Wood units unresponsive to pharmacological intervention.
7. Severe chronic obstructive pulmonary disease as evidenced by an FEV1 \< 1.0 L or restrictive lung disease or prolonged (\> 48 hours) intubation.
8. Presence of mechanical aortic valve that will not be converted to a bioprosthesis during VAD implantation.
9. Planned concomitant surgical procedures other than aortic valve repair or tissue valve placement to treat moderate to severe aortic insufficiency, tricuspid valve repair, mitral valve repair, critical lesion CABG, LV thrombectomy (apical), closure of persistent foramen ovale, atrial septal defect.
10. Cardiogenic shock secondary to acute myocardial infarction.
11. Presence of ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation.
12. Presence of uncontrolled infection.
13. BMI \> 40 kg/m2.
14. Significant peripheral vascular disease accompanied by pain at rest, extremity ulceration or disabling claudication.
15. Illness, other than heart disease, that would limit survival to less than 1 year.
16. Pulmonary embolus \< 2 weeks before VAD implant.
17. Poor/compromising nutritional status in judgment of Principal Investigator.
18. Participation in another clinical trial that, according to the Principal Investigator, is likely to affect the Study outcome or confound the results.
Early Biomarkers for ARthritic PAIN to Guide Improved Treatments for Arthritis

Osteoarthritis (OA) is a condition affecting the whole joint and is a major cause of pain and disability worldwide. Although OA is very common, the initial steps which lead to the development of pain and tissue damage are not fully understood. In this study participants will be investigated for markers in the blood, joint and urine in people who have a diagnosis of osteoarthritis or inflammatory arthritis and are receiving a steroid injection for their condition. Markers will be evaluated in participants with osteoarthritis compared with other types of arthritis, including rheumatoid arthritis and spondyloarthritis.

Osteoarthritis (OA) is the most common form of arthritis worldwide. OA causes major disability and pain and places a huge financial burden on healthcare worldwide. In recent work, the gene expression profile of bone marrow lesions (BML) in osteoarthritis has been evaluated. BML in OA have a novel gene expression profile which includes genes involved in inflammation, neurogenesis and matrix turnover. The plan is to investigate the functional significance of the genes found at the protein biomarker level in studies of joint tissue, blood and urine from participants with knee OA and compare these changes with participants who have other forms of arthritis, including rheumatoid arthritis and spondyloarthritis.

A study amendment was added in April 2020 due to Covid-19. We are studying up to 150 additional participants with or without inflammatory conditions who are being treated with immunomodulatory drugs compared with participants who are not on immunomodulators. We will be evaluating the course of Covid-19 infection in people without autoimmune inflammatory conditions, compared with people who have autoimmune inflammatory diseases who are on immunomodulators.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for OA patients:

* Fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis
* Symptomatic knee pain
* On usual care for knee osteoarthritis including paracetamol and/or NSAIDs

Inclusion criteria for Inflammatory Arthritis Patients:

* Fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of inflammatory arthritis i.e. rheumatoid arthritis (Anti-CCP antibodies \& Rheumatoid Factor checked ), psoriatic arthritis or spondyloarthropathy
* Symptomatic knee pain
* On usual care for arthritis including disease-modifying anti-rheumatic drugs (DMARDs), paracetamol and/or NSAIDs

Exclusion Criteria:

* Other rheumatological diagnosis e.g. systemic lupus erythematosus, fibromyalgia, Polymyalgia Rheumatica, Gout, Giant Cell Arteritis, Sjogren's syndrome
* History of uncontrolled depression
* Recent surgery
* Uncontrolled ischaemic heart disease
* Uncontrolled diabetes mellitus
* Alcohol consumption \> 14 units/week as per UK National guidelines
* Participants unable to give full informed consent
Study About Effectiveness of Silver-Containing Textiles for Treatment of Acute Neurodermatitis

The purpose of this study is to investigate whether the treatment of acute neurodermitis with silver-contained textiles is equivalent or more effective to the conservative exogenous treatment with a corticosteroid. Secondary aim is to define skin comfortability of the textiles.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute Neurodermitis
* Age: 2-70 years
* Patients are mobile
* Patient's information and willingness to participate

Exclusion Criteria:

* Acute viral infection (herpes zoster, eczema herpeticum)
* Acute staphylodermas
* Other skin-diseases affecting outcomes of intervention (e.g. psoriasis)
* Current UV-Treatment
* Current other immunosuppressive or immunomodulated Therapy
* Current antimicrobial Therapy (e.g. antibiotics)
* Severe general diseases (e.g. melanoma, renal insufficiency, autoimmune diseases)
* Pregnancy
* Fertile females without effective contraception
Opsin Receptors in Melasma

Melasma is a hyperpigmentation disorder that is probably exacerbated by visible light. Opsin receptors (OPN 1, 2, 3, 4 y 5) were described in the skin, being capable of activating melanogenesis induced by visible light. The aim of this study was to evaluate the expression of OPN in melasma skin and its changes following treatment with UV-Vis filter and 0.05% retinoic acid for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with melasma, of 18 years of age and older, without previous treatment or photoprotection measures within the previous 4 weeks, who had Melasma Activity and Severity Index (MASI) scores higher than 7

Exclusion Criteria:

* pregnancy or nursing, menopause, coexistence of other pigmentation conditions, heat exposure, regular exercise, diet restriction, consumption of food supplements or any type of drugs (including anti-inflammatories and hormonal treatments) within the previous 2 months, and women who had given birth within 1 year
Early Surgery for Patients With Asymptomatic Aortic Stenosis

Many cardiologists are convinced that early surgery in asymptomatic aortic stenosis (AS) saves lives. However there is currently no direct evidence for this and most recommendations from the ESC/ EACTS or ACC/ AHA in this field are supported by Level-B or C evidence. Therefore, the investigators designed a randomized controlled trial to demonstrate whether early surgery improves mortality and morbidity of patients with asymptomatic severe AS and low operative risk.


Eligibility Criteria:
Inclusion criteria

* Adult patient, aged between 18 and 80 years (18 ≤ age ≤80)
* Low operative risk, defined as EuroSCORE II ≤ 5%
* No symptom potentially attributable to AS: no dyspnea, angina or syncope during exercise
* No class I indication for surgery
* No symptom/ fall in blood pressure during exercise test
* Severe AS according to current echocardiography criteria: Vmax \> 4.0 m/s and/ or MPG \> 40 mm Hg); AVA \< 1.0 cm2 (not mandatory)
* Preserved LV systolic function: LVEF \>50% according to echocardiography ; no LV wall motion abnormality
* Signed informed consent

Exclusion criteria

* Moderate/ high operative risk for aortic valve replacement, defined as EuroSCORE II \> 5%
* Class-I indication for AVR (ESC-EACTS 2012, ACC/ AHA 2014) or fall in blood pressure during exercise testing (Class-IIa)
* Other indication for cardiac surgery (CABG, thoracic aorta)
* Positive exercise test including A/ unmasking of symptoms (angina, dyspnea at low workload, dizziness or syncope) during exercise or B/ Fall in systolic blood pressure during exercise below the baseline value.
* Patients unable to perform the exercise ECG
* More than mild AR (\>grade 2/4)/ other significant valve disease LVEF ≤ 50%
* Serum creatinine \>160 μmol/L
* Serious extra cardiac comorbidity/ life expectancy \<2 years
* Patient included in another trial with signed informed consent
* Patient not affiliated to social insurance
* Pregnancy
MRI With Gadoxetate Disodium in Measuring Tumors in Patients With Liver Cancer

This pilot clinical trial studies magnetic resonance imaging (MRI) with gadoxetate disodium in measuring tumors in patients with liver cancer. Diagnostic procedures, such as MRI with gadoxetate disodium, may help find and diagnose liver cancer and find out how far the disease has spread. It is not yet known whether MRI with gadoxetate disodium provides a more precise measurement of liver tumors than standard computed tomography (CT).

PRIMARY OBJECTIVES:

I. To evaluate the precision of gadoxetate (gadoxetate disodium)-enhanced MRI in evaluating lesion size.

II. To evaluate if there is a subjective improvement in the delineation of hepatocellular carcinoma (HCC) in the hepatocellular phase of contrast administration.

III. To further assess the sensitivity of gadoxetate-enhanced MRI for the detection of HCC.

SECONDARY OBJECTIVES:

I. To evaluate the reproducibility of various tumor measurement techniques in the evaluation of HCC.

II. To further evaluate how administration of gadoxetate affects diffusion weighted imaging.

OUTLINE:

Patients receive gadoxetate disodium intravenously (IV) and then undergo enhanced liver MRI.

After completion of study, patients are followed up at 2, 4, 8, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* CT features suggestive of HCC, including those features which have been described herein; they are also enumerated below:

  * For an arterially-enhancing lesion greater than or equal to 1 cm, but under 2 cm, all of the following criteria must be met:

    * Imaging features of a mass
    * Wash-out on later phases of contrast administration
    * At least 1 cm or more growth
  * For an arterially-enhancing lesion greater than or equal to 2 cm, two of the following criteria must be met:

    * Imaging features of a mass
    * Wash-out on later phases of contrast administration
    * At least 1 cm or more growth
  * All enhancing lesions with expansile, solid, enhancing tumor within vascular structures will be included, including the main portal vein, the main right and main left portal veins, the inferior vena cava (IVC), and the main hepatic veins
* No prior history of treatment of liver lesions
* Able to provide written and verbal informed consent
* Able to tolerate a complete abdominal MR examination, within 3 weeks of CT

Exclusion Criteria:

* Unable to provide written and verbal informed consent
* Unable to undergo MRI due to intraocular metallic foreign body, pacemaker, or other contraindications including objects in the body which are deemed to be unsafe or notable to be assessed, or unable to undergo MRI within 3 weeks of CT
* Pregnancy
* Severe renal insufficiency as defined by an estimated glomerular filtration rate of less than 30 cc/minute
* Severe liver disease as defined by Childs class C cirrhosis
* History of a previous reaction to contrast media
* History of bronchial asthma
* History of allergic disorders
* Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period
Effect of Osteopathic Manual Techniques on the Diaphragm Muscle and Its Repercussions

Determining the effects of an intervention plan on the diaphragm related to the center of gravity and range of motion in the lumbar spine (static and dynamic) in healthy individuals is an area that lacks evidence and proper studies. Has such, the investigators consider this a interesting topic to study, therefore it is intended to improve the knowledge on this area.

All diaphragmatic activity is controlled by metabolic mechanisms and emotional states which may cause restrictions that might be related to disorders in the lower back.

The diaphragm and the lumbar segment of the spine are connected through the diaphgramathic pillars that connect the central tendon and the vertebrae of L2 (left side) and L3/L4 (right side). Consequently, the contraction of the pillars may be related to the fixation of the lumbar spine.

Proper function of the diaphragm is related to better parameters of static balance. It is also possible to conclude that a change in the proper function of the diaphragm is associated with changes in the center of gravity in healthy individuals.

This theme lacks scientific evidence, since no studies were found that focus on the analysis of diaphragmatic treatment only. In this way, the investigators intend to collaborate to increase knowledge in this area, determining the effects of the intervention plan on the diaphragm in relation to the range of motion and center of gravity in the lumbar spine (static and dynamic) in healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 18 and 30 years old;
* Both genders;

Exclusion Criteria:

* Treatments with manual therapy in the last three months or more than three times in the previous year;
* Lumbar spine pathology (infection, spinal fracture or more severe neurological impairment, such as cauda equina syndrome) and respiratory pathologies;
* Psychiatric illness;
* Recent history of trauma;
* History of cancer;
* Systemic inflammatory conditions;
* Recent history of spinal surgery;
* Abdominal pain at the time of the intervention;
* Body mass index (BMI) equal to or greater than 31kg / m2, due to the difficulty in accessing the diaphragm;
* All of those that acquired a higher knowledge within the area of manual therapy, which may compromise its validation.
Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis

There has been great interest in recent years to take advantage of stem cells to treat liver cirrhosis. Mesenchymal stem cells (MSC) has been shown to be safe and effective for liver diseases in some studies. Randomization controlled studies are needed to confirm the long term effect of MSC treatment for liver cirrhosis. This study aimed to investigate the safety and efficacy of mesenchymal stem cells in hepatitis B and C related liver cirrhosis patients.

This study is an open-label multicenter randomized control study. Patients with with decompensated cirrhosis will be randomly assigned to receive MSC treatment plus standard medical care(treatment）or standard medical care (control). Three times of MSC infusion (1x10E6 cells/kg body weight) via peripheral vein will be given to the experimental group (once in 4 weeks). The primary outcome is absolute change in liver function indexes and and scores. Secondary outcomes are cirrhosis-related complications, symptoms, life quality, and survival.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-65 years
2. HBV -related liver cirrhosis
3. Child-Pugh score ≥7
4. With presentations of decompensation
5. Written consent

Exclusion Criteria:

1. Hepatocellular carcinoma or other malignancies
2. Severe problems in other vital organs(e.g.the heart,renal or lungs)
3. Pregnant or lactating women
4. Severe bacteria infection
5. Anticipated with difficulty of follow-up observation
6. Coinfection with HIV or other viral hepatitis.
7. Drug abuse or alcohol abuse
8. History of severe allergy to biological products
9. Other candidates who are judged to be not applicable to this study by doctors -
Early-Onset Sepsis Surveillance Study

In this observational study, the NICHD Neonatal Research Network (NRN) is conducting surveillance of all infants born at NRN centers to identify all newborns who are diagnosed with early-onset sepsis (EOS) and/or meningitis. The study will: establish current hospital-based rates of EOS among term and preterm infants in the era of intrapartum antibiotic prophylaxis; monitor the organisms associated with EOS and meningitis; compare asymptomatic and symptomatic infants by gestational age and pathogen; and monitor sepsis-associated mortality rates by pathogen group.

For more than a decade, the NICHD Neonatal Research Network (NRN) has conducted surveillance of early-onset sepsis (EOS) infections in very low birth weight (VLBW) infants, as part of its very low birth weight registry. Although overall rates of EOS have remained stable over time, the relative importance of different pathogens has changed.

In 2002 the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Centers for Disease Control \& Prevention revised their recommendations for reducing mother-to-child transmission of group B streptococcal (GBS) infections. The new guidelines recommend universal screening of pregnant women at 35 or more weeks' gestation and intrapartum antibiotics for all GBS-colonized mothers (an estimated 30% of mother-to-be in the United States). With the current widespread use of maternal antibiotics, concerns have been raised about the possible emergence of non-GBS pathogens as causes of early-onset sepsis. Several studies have reported a change in EOS pathogens, with the emergence of gram-negative and antibiotic-resistant infections, primarily among VLBW infants.

This observational study expands the NRN's prior work on infection in VLBW infants, conducting surveillance of all infants born at network centers who are diagnosed with early-onset sepsis and/or meningitis. The study will: establish current hospital-based rates of EOS among term and preterm infants in the era of intrapartum antibiotic prophylaxis; monitor the organisms associated with EOS and meningitis; compare asymptomatic and symptomatic infants by gestational age and pathogen; and monitor sepsis-associated mortality rates by pathogen group. Cases will be identified by the medical care team or through research team review of patient, microbiology, or infection control/hospital epidemiology records.

Secondary analyses include:

Serotypic, phylogenetic, virulence and drug-resistance characteristics of contemporary GBS and E. Coli isolate collections will be studied.

Assessing the proportion of neonates born to mothers with chorioamnionitis who are asymptomatic at birth, but later develop signs and/or symptoms of early-onset neonatal GBS and non-GBS disease.

Eligibility Criteria:
Inclusion Criteria:

* Infants \>400g birth weight

Exclusion Criteria:

* Stillbirth or death in the delivery room
Oral Manifestations of Aplastic Anemia

The purposes of this study are threefold: 1) to evaluate the prevalence and risks of oral complications in patients with aplastic anemia; 2) to evaluate if oral problems in these patients can predict their response to treatment; and 3) to review complications of dental treatment in these patients in order to establish treatment guidelines.

This study will be performed through a review of medical charts of 79 patients with aplastic anemia and 67 patients with schizophrenia who were treated at the National Institutes of Health Dental Clinic between 1993 and 1999. The schizophrenia patients will serve as a control population.

Demographic, clinical and radiographic information will be collected for all patients. Additional data collected only for aplastic anemia patients will include medical therapy, disease duration, blood cell counts, oral problems that developed during treatment and treatment response.

The prevalence, risk factors and significance of oral manifestations in aplastic anemia have not been well characterized. Thus, in the present study, through a retrospective chart review, we document the prevalence of oral complications in AA patients and the risks for oral manifestations in a case-control study. Schizophrenic patients represent controls. Information includes the following; demographic, clinical and radiographic information for cases and controls. Additional data collection for only AA patients includes prior medical therapy, CBC and differential, disease duration, new oral manifestations during AA treatment and medical treatment response. We determine if systemic clinical features of AA predict oral manifestations, and if oral manifestations predict treatment outcomes for AA patients. Finally complications following dental treatment are compiled and reviewed to establish initial treatment guidelines for these patients.

Eligibility Criteria:
INCLUSION CRITERIA:

Cases: All aplastic anemia patients evaluated at the NIH dental clinic for consultation between 1993-1999.

Controls: All schizophrenic patients evaluated at the NIH dental clinic for consultation between 1993-1999.

EXCLUSION CRITERIA:

Patients without the diagnosis of aplastic anemia for cases or schizophrenia for the controls.