cyrilzakka/clinical-trials huggingface dataset:
Study on Prediction of Fluid Responsiveness Using an Abdominal Compression-induced Change of Blood Pressure in Children

The purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children.

The purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children.

When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmHg, right upper abdomen is gently compressed for 10 seconds. Changes of blood pressure are continuously recorded during this period. About 3 min later, intravenous colloid fluid 10 mL/kg is infused for 20 min.

To evaluate the change of cardiac output, transesophageal or transthoracic echocardiography is performed before and after fluid administration. In addition, hemodynamic parameters including pulse pressure variation, systolic pressure variation, pleth variability index and central venous pressure are also recorded before and after fluid administration.

Finally, patients will be divided into fluid responder group and non-responder group. If cardiac output measured using echocardiography increases over 15% after fluid administration, the patient is fluid responder. Using ROC curve, diagnostic power of abdominal compression-induced blood pressure change for fluid responsiveness will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients undergoing elective surgery, who require invasive blood pressure and central venous pressure monitoring during surgery

Exclusion Criteria:

* renal, hepatic and pulmonary disease
* preoperative infection: increased CPR, WBC over 10,000, and with fever
* genetic and hematologic disease
* intracardiac and extracardiac shunt
* single ventricle
* right heart dysfunction
* any intracardiac valve pathology
* increased intracranial pressure
Treatment of C. Difficile Infection With Fecal Microbiota Transplantation (FMT)

The purpose of this study is to treat children with severe, moderate, resistant or relapsing C. difficile infection and to determine the changes in the intestinal microbiome (all of the bacteria living in the intestines) in children receiving FMT for C. difficile infection. Data will be collected throughout the FMT procedure to determine effectiveness and to help standardize this procedure. Stool samples will be collected to look at the different bacteria that are in the intestines before and after FMT.


Eligibility Criteria:
Recipient Inclusion Criteria

1. Older than 18 months of age
2. FMT procedure has been decided by the treating gastroenterologist and was based on:

   1. Recurrent or relapsing CDI and:

      * Failure of standard medical therapy with metronidazole, vancomycin and fidaxomicin (over age 18 years. Fidaxomicin is not approved for \<18years and insurance authorization may not be possible).
      * At least 2 episodes of CDI requiring hospitalization
   2. Moderate CDI not responding to vancomycin for at least a week.
   3. Severe CDI with no response to vancomycin after 4 hours.
3. English speaking

Recipient Exclusion Criteria

1. Lack of informed consent/assent.
2. Not eligible for FMT procedure
Aesthetic Outcomes of Single Tooth Implant Using Metal Ceramic Restorations With Either Zirconia or Titanium Abutments

Different studies have proposed the use of zirconia abutments to improve the aesthetic outcomes in the anterior sextant, however the results have been inconclusive. A tendency towards a better aesthetic result with the use of zirconia instead of titanium abutments was observed, although more technical complications were also recorded.The use of zirconia abutments in the anterior maxillary region showed a tendency towards better matching, although differences were not significant. In addition, with these abutments more technical complications were observed, what increased the cost and time. More studies with larger samples and longer observations periods are needed to recommend the use of zirconia abutments for this clinical situation

The purpose of the present study was to evaluate the clinical and aesthetic outcomes of single tooth implant restorations, where different abutment materials were used (zirconia vs titanium) associated with metal-ceramic crowns. The evaluation was carried out by means of an aesthetic composite index combined with patient evaluation

Eligibility Criteria:
Inclusion Criteria:

* mono-edentulism condition in the aesthetic zone
* minimum of 2 mm of keratinized gingiva

Exclusion Criteria:

* systemic diseases
Comparison of Predictive Factors Related to Coronary Artery Disease

In Taiwan, heart disease and cerebrovascular disease ranked the second and third of ten leading causes of death in female in 2007; half of these deaths is due to coronary artery disease (CAD). Postmenopausal status is an independent risk factor for CAD. Early assessment and proper management of risk factors may reduce the prevalence rate of CAD. In the past decade, despite increased attention to CAD in women, most studies focused on certain menopausal status instead of all phases of menopause or on risk factors limited to related metabolic syndrome. Because the prevalence of risk factors related to CAD is influenced by various physiological and lifestyle status in different menopausal statuses, the purpose of this study, at the first stage, is to explore respectively the risk factors of CAD among middle-aged women in three menopausal statuses. At the second stage, the influence of a lifestyle management program on risk factors modification among pre-menopausal women is examined in this study.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of CAD by coroangiography
* LVEF \>30%

Exclusion Criteria:

* impairment of physical activity
* history of psychiatric disorder, vital arrhythmia
Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitor

The purpose of this study is to determine whether the respiratory rate provided by Kai Medical Non-Contact Respiratory Rate Monitors are as accurate as that provided by the currently used methods, including respiratory chest bands.


Eligibility Criteria:
Inclusion Criteria:

* Every patient undergoing an overnight polysomnography study can be included.

Exclusion Criteria:

* None
The Influence of Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers on Renal Function in Patients Undergoing Non-emergent Coronary Angiography

The aim of the current study is to evaluate prospectively whether concomitant administration of RAAS blockers (namely ACE-I and ARBs') influence the change in estimated GFR (eGFR) after administration of contrast media in patients undergoing non-emergent coronary angiography.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age\>18 years
* 2. Subjects on chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file)
* 3. Subjects planned to undergo non-emergent coronary angiography.
* 4. Signed informed consent

Exclusion Criteria:

* 1. eGFR\<30 ml/min at baseline
* 2. Chronic utilization of NSAIDS and Cox-2 selective inhibitors
* 3. Chronic treatment with mineralocorticosteroid receptor blocker
* 4. Systolic blood pressure\<90 mmHg
* 5. Planned staged (repeated) procedure within 48 hours
* 6. Administration of contrast within 14 days prior to the enrollment
* 7. contraindication to stop ACE-I or ARB'S
Genoss DES Prospective Multicenter Registry

This registry is a clinical post-market evaluation of the Genoss DES in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

Percutaneous coronary intervention (PCI) is the main stream of treatment of coronary artery disease. Drug-eluting stents (DES) have dramatically reduced the rates of restenosis and target lesion revascularization (TLR) compared with bare-metal stents (BMS). Newer-generation DES with a durable polymer such as Xience (Abbott, US) and Resolute (Medtronic, US) were widely used. However, the concern about late stent thrombosis due to hypersensitivity reaction from the polymer is still existed. Recently, DES with a biodegradable polymer such as Biomatrix (Biosensors, Switzerland), Nobori (Terumo, Japan), Orsiro (Biotronik, Switzerland), and Synergy (Boston Scientific, US) was rapidly adopted and it is expected to reduce the late stent thrombosis.

Recently, new biodegradable DES with thin struts was developed in South Korea. The Genoss DES (Genoss, Korea) has an L-605 cobalt chromium (CoCr) platform with a strut thickness of about 70 µm and the stent is coated a combination of Sirolimus drug with concentration of 1.15µg/mm2 and an abluminal biodegradable PLA and PLGA polymers.

This study is conducted to evaluate efficacy and safety of Genoss DES in the treatment of patients with coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 19 years
* Subject implanted Genoss DES within 1 month
* Subject has signed informed consent for data release
* Subject is geographically stable and willing to participate at all follow-up assessments

Exclusion Criteria:

* Subject did not sign informed consent for data release
* Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, Sirolimus or contrast media
* Pregnancy
* Subject with life expectancy less than 12 months
* Subject with cardiogenic shock
* Planned surgery within 12 months of PCI unless dual antiplatelet therapy will be maintained
* Currently participating in another study and primary endpoint is not reached yet.
High-dose ICE With Amifostine

The purpose of the study is to evaluate the combination of amifostine and high dose chemotherapy with blood stem cell support. Amifostine is a druf developed to protect normal tissues against the toxicities of chemotherapy and radiotherapy and has reduced the side effects of chemotherapy given at conventional doses.


Eligibility Criteria:
Eligibility Criteria:

* Histologically documented malignancy
* Metastatic or locally unresectable malignancy
* Patient may be responding to therapy

  * Responding Stage IIIC/IV or recurrent/refractory ovarian carcinoma (ineligible for other bone marrow or stem cell transplant protocols)
  * Relapsed germ cell carcinomas
  * Relapsed lymphomas (ineligible for other BMT or SCT protocols
  * SCLC in PR or CR
  * Sarcomas in or near complete remission after induction chemotherapy
  * Stage IIIB NSCLC responding to chemotherapy
  * Responsive bladder, head and neck carcinoma, or carcinoma of unknown primary
  * Other tumors without curative or first line therapy (not eligible for phase II or III studies)
* Aged 18 to 55 Physiologic years

  -- Performance status: PS 0-1
* Prior Treatment

  * \> 1 week since surgery or RT
  * \> 3 weeks since prior CT
* Informed Consent
* Required initial laboratory data:

  * White Cell Count Life ≥ 3000/ul
  * Platelet Count ≥ 100,000/ul
  * Creatinine ≤ 1.5 x normal
  * Bilirubin ≤ 1.5 x normal
  * No current metastases

    * BM Asp \& Bx
    * Brain CAT
  * Creatinine Clearance ≥ 60 cc/min
  * SGOT \< 2.5 x normal
* No other serious medical or psychiatric illness which would prevent informed consent or general anesthesia

  * Uncontrolled or severe cardiovascular disease including recent (\< 6 months) myocardial infarction, or congestive heart failure
  * Active uncontrolled bacterial, viral, or fungal infection; or an active duodenal ulcer; until these conditions are corrected or controlled
  * Pregnancy
  * Unable to stop taking antihypertensive medication 24 hours prior to administration of Ethyol
Blood Collection for COM/BSBS

The objective of this biospecimen collection protocol is the acquisition of blood from adult volunteers. These biospecimens will be transferred to the College of Medicine (COM)/Burnett School of Biomedical Sciences (BSBS) research scientists and their research teams for testing according to their separate IRB-approved/exempted protocols. These separate IRBapproved protocols cannot be for genetic testing.

Research scientists of the University of Central Florida College of Medicine (COM) and Burnett School of Biomedical Sciences (BSBS) conduct laboratory studies in biomedical and translational research for the purpose of understanding human disease and developing innovative methods for diagnosing, measuring, or treating disease or disease symptoms. The key research divisions are cancer, cardiovascular, immunity and pathogenesis, neuroscience, and molecular microbiology. Frequently, these studies require human blood (or its derivatives) for testing of assays and devices.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults
* 18 years old or older
* weigh over 110 pounds
* able to provide informed consent

Exclusion Criteria:

* pregnant/suspect to be pregnant
* prisoners
* have donated blood anywhere in the preceding 16 weeks
A Study To Investigate Safety And Pharmacokinetics Of A Single Dose Of PF-00868554 (Filibuvir) In Japanese Healthy Adult Volunteers

A single dose of PF-00868554 (filibuvir) will be safety and tolerable in Japanese healthy volunteers. The pharmacokinetics in Japanese will be consistent to that available in Western population.

Investigation of safety, tolerability and pharmacokinetics of single oral administration of PF-00868554 (filibuvir) in healthy adult Japanese volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between the ages of 20 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg.

Exclusion Criteria:

* A positive result for Hepatitis B surface antigen (HbsAg) or anti-hepatitis C virus serology, and HIV antigen/antibody.
* Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
* Pregnant or nursing females; females of childbearing potential.
A Study of the Effects of Intravenous Magnesium Sulphate on Anaesthesia and Analgesia in Elective General Surgery Patients

The aim of this double-blind randomized study will be to evaluate the effect an intravenous infusion of magnesium has on recovery outcomes after elective laparoscopic cholecystectomy

Magnesium consists one of the most important electrolytes of the human body, producing effects in various systems, one of them being the central nervous system. It has been shown that the administration of intravenous magnesium sulphate during anesthesia can significantly reduce the requirements for anaesthetic and analgesic agents, perioperatively, and improve the quality of post anesthetic recovery. The present study will examine the effect of administering intravenous magnesium sulphate during anesthesia in patients undergoing elective laparoscopic cholecystectomy surgery. This is a single centre, double-blinded, randomised controlled trial in an adult population, taking place in a tertiary medical centre in Athens. The study consists of three comparison groups of equivalent population, produced by double blinded randomisation. Each comparison arm will be administered a different regimen of magnesium sulphate/placebo. During the perioperative time, depth of anaesthesia will be monitored using the Bispectral Index, (BIS™) and the nociceptive level with nociception level index (NOL®). Dosing of the anaesthetic agent, desflurane, as well as of the analgesic medication, remifentanil, will be adjusted according to the prior indices. Patients included in the study will be monitored in the PACU and the surgical ward for the first 24 hours, postoperatively. Primary outcomes include the requirements for anaesthetic and analgesic agents, time to emergence, time to extubation, time to recovery, quality of recovery variables, pain scores during the first 24 hours and adverse effects and/or complications of magnesium administration. Ethical approval for this trial has been granted by the Ethics Committee of the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Adult patents
* American Society of Anesthesiologists (ASA) class I-III
* elective laparoscopic cholecystectomy

Exclusion Criteria:

* body mass index (BMI) \>35 kg/m2
* systematic use of analgesic agents preoperatively
* chronic pain syndromes preoperatively
* neurological or psychiatric disease on treatment
* pregnancy
* severe hepatic or renal disease
* drug or alcohol abuse
* language or communication barriers lack of informed consent
Optimization of Treatment Priority of the Manchester Triage System

In the emergency department, the urgency for treating patients is determined according to the Manchester Triage System. The parameters collected in this process are deterministically translated into a treatment priority.

The Manchester Triage System (MTS), which has been in use for at least 20 years, is a widely used, validated and standardized procedure for initial assessment in the emergency department - this initial assessment (triage) is done to prioritize medical assistance at a central point. Especially in emergency situations, critically endangered patients often require the deployment of a large part of the available staff at the same time - the medically correct triage of patients according to objective criteria in order to enable an adequate allocation of the available resources at the right time is the main objective. In the optimal case, each patient is treated by medical professionals within the time frame that is adequate for his/her health condition.

Using artificial intelligence methods, it may be possible to increase the accuracy of treatment priority assignment. In the best case, incorrect prioritization of patients can be prevented and medical care can be ensured for those patients who actually need it most urgently.

However, initial assessment, even if standardized and validated, still runs under limited resource conditions - time, space, material and personnel. Last but not least, the very idea of conducting an initial assessment limits its validity, and the results of the allocation fluctuate according to current research, although the determinants of this are currently unknown.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients that were triaged at the emergency department at the Kepler University Hospital in the period between 2015-12-01 to 2020-08-31.

Exclusion Criteria:

* None.
ET 743 (Yondelis) in Men With Advanced Prostate Cancer

The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743) has on men with advanced prostate carcinoma.

* Treatment with trabectedin will be given once a week for three consecutive weeks with one week of no treatment. This four week period constitutes one cycle.
* Trabectedin is given as an infusion through a central venous catheter and is administered over 3 hours.
* On day 1 of each cycle a history, physical exam and blood tests will be performed and trabectedin will be administered.
* On day 8 and day 15 of each cycle blood work will be performed and trabectedin will be administered.
* Patients will continue to receive trabectedin as long as there is no disease progression or unacceptable side effects.
* Scans (CT, MRI or bone) or x-rays may be done while the patient is on the trial at the discretion of the physician.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Radiographically documented metastatic disease
* Surgical or chemical castration
* Prostate specific antigen (PSA) \> 5 ng/ml
* Castration resistant prostate cancer (CRPC)
* One previous taxane-based chemotherapy regimen
* Eastern Cooperative Group (ECOG) performance status 0,1 or 2
* Neutrophil count \> 1,500/ul
* Platelet count \> 100,000/ul
* Serum bilirubin \< 1.0 x upper limit normal (ULN)
* Serum alkaline phosphatase \< 1.5 x ULN
* Asparate aminotransferase/Alanine aminotransferase \< 2.5 x ULN
* Albumin \> 2.5 g/dl
* Serum creatinine \< 1.5 x ULN
* Prior hormonal therapy

Exclusion Criteria:

* Chemotherapy treatment within 4 weeks of study entry
* Patient not employing adequate contraception
* Serious illness or medical conditions, specifically: uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within 6 months; active infectious process; chronic active liver disease, including chronic hepatitis B, C or cirrhosis
* Current anti-cancer treatment with any non-FDA approved investigational drug
Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept.

Phase IIa, open clinical trial, pilot, single arm and proof of concept.

Proof of concept trial evaluating safety and efficacy of treatment with Dolutegravir (DTG) + lamivudine (3TC) once daily in suppressed participants with history of previous treatment with 3TC or emtricitabine (FTC). Half of the participants will have history of failure with 3TC or FTC and M184V/I or K65R/E/N mutations in previous plasma genotypes, although to be eligible these mutations cannot be detectable at study entry in proviral DNA.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 infected patients.
2. Age\> 18 years.
3. Receiving stable antiretroviral treatment for at least 3 months.
4. Current or historical treatment with 3TC or FTC.
5. Willing to change antiretroviral treatment due to intolerance or interest in simplification.
6. Undetectable viral load (\<50 cop/mL) for at least 1 year prior to the inclusion. A single viral load \>50cop/ml (≤500 copies/ml) is allowed before the three months prior to inclusion in the study, preceded and followed by an undetectable determination.
7. Current level of CD4\> 350 cells/μL.
8. Naïve to integrase inhibitors.
9. Patient able to understand and give written informed consent.
10. For those included in group 1 (20 patients): No previous history of virological failure with ART regimen that included 3TC or FTC or previous virological failure had a population genotype without M184V/I or K65R/E/N mutations.
11. For those included in group 2 (20 patients): previous history of virological failure with ART regimen that included 3TC or FTC and historical genotype with M184V/I or K65R/E/N mutations.

Exclusion Criteria:

1. Detection of any of the following mutations in proviral DNA in peripheral blood by conventional sequencing: M184V/I or K65R/E/N.
2. Pregnant, lactating or child-bearing women who do not commit to using an adequate contraceptive method.
Gene Expression Profiling in Type 1 Diabetes

One of the goals of the Kansas City Diabetes Consortium is to identify and characterize genes and their products that are associated with T1DM. Characterization of such genes and their products can aid in developing new tools for risk assessment, development of new prevention strategies and monitoring progression of disease.

Study design: Descriptive, basic science pilot study. The results of this pilot study will be used to help design a much larger study to address the importance of viral response and autoimmune diabetes.

The hypothesis is that viral responsive genes are up-regulated prior to the onset of symptoms of Type 1 Diabetes (T1DM) and may correlate with increased expression of interferon alpha.

Both genetic and environmental factors contribute to risk of development of T1DM. There are a number of conflicting reports associating viral infections and T1DM in genetically susceptible individuals and causality has not been proven. Viruses may not have a large role in the initiation of islet cell autoimmunity but more of a role in acceleration of the disease leading to overt symptoms. There are no studies describing viral responsive gene expression in these individuals.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 7-14 years of age
* New onset T1DM
* Five years post onset of T1DM
* Participant in the TrialNet initiative and either antibody positive or antibody negative sibling control
* Body weight sufficient to tolerate an additional 15ml (1 tbsp) blood loss

Exclusion Criteria:

* Subjects who do not meet the criteria above
* Subjects who have received steroids or other immunosuppressive therapy within the 6 months prior to enrollment into the study