cyrilzakka/clinical-trials huggingface dataset:
Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery

The purpose of the study is to determine the opiate sparing effects of intravenously administered dexamethasone in outpatient knee surgery. Dexamethasone is a glucocorticoid with well known antiemetic effects. However, the analgesic effects of dexamethasone have not been adequately researched. Following surgery, patients are typically discharged home with PO opiates to manage post-operative pain. The investigators believe that by using VAS (Visual Analog Scale) for Pain the investigators can show that a single dose of dexamethasone can reduce pain scales and opiate consumption post-operatively, on Post Operative Day (POD 1) when compared to placebo.

Findings of Modest improvement in pain scores and postoperative nausea at 24 hours with Dexamethasone

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing ambulatory knee arthroscopy surgery
* Must provide phone contact number and agree to phone followup on post operative day 1

Exclusion Criteria:

* Patients with major systemic disease
* Allergy or intolerance to study drug
Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement

Proportional dose of sublingual fentanyl tablet (Narco®) based on daily opioid requirement versus intravenous PCA for breakthrough cancer pain: A prospective, randomized, open-label, noninferiority trial.

Based on the previous around-the-clock analgesic demand compared to IV PCA in cancer pain patients to prepare the basis for the administration of fentanyl sublingual tablets with an initial dose.

Eligibility Criteria:
Inclusion Criteria:

* Age 19-80
* Cancer pain
* Admission for the control of cancer pain or consultation for the treatment of cancer pain
* Stable vital sign
* ECOG status ≤ 3 for more than 1 or 2 months
* Opioid-tolerant state
* No history of using sublingual fentanyl

Exclusion Criteria:

* Noncancer pain
* Opioid naive
* baseline NRS pain score\> 4
* Current using sublingual fentanyl
* Difficult to assess cancer pain
* no evidence of disease(cancer)
* Planned surgical resection of cancer
* Allergy to fentanyl
* Severe renal and/or liver function
* Severe respiratory depression or uncontrolled COPD
Selecting Patients Who May Benefit From Immunotherapy by Tissue-based Biomarkers.

We have established a machine learning model based on effective TIIC signature which could select GC patients who may benefit from immunotherapy.

The current study aims to enroll 300 GC patients as a validation cohort to vertify the accuracy of TIIC signature in predicting immunotherapy efficacy


Eligibility Criteria:
Inclusion Criteria:

* Having signed informed consent
* Age:18-80 years old
* Histologically confirmed gastric adenocarcinoma
* Unresectable recurrent or metastatic gastric cancer
* Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
* Measurable disease according to the RECIST criteria
* Karnofsky performance status ≥70
* Life expectancy of ≥3 month
* No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
* ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)
* Serum albumin level ≥3.0g/dL
* Serum AKP \< 2.5 times ULN
* Serum creatinine \<ULN, and CCr \< 60ml/min
* Bilirubin level \< 1.5 ULN
* WBC\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl

Exclusion Criteria:

* Previous systemic therapy for metastatic gastric cancer
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
* Allergic constitution or allergic history to protium biologic product or any investigating agents.
* Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
* Pregnancy or lactation period
* Other previous malignancy within 5 year, except non-melanoma skin cancer
* Legal incapacity
Multimedia Based Information to Parents in a Pediatric Acute Ward: A Randomized Controlled Trial

The aim of this study is to determine whether multimedia based health information presented in a pediatric acute ward to parents of children with breathing difficulties due to lower respiratory tract infections, is more effective than verbal information to reduce the parent's anxiety and to increase satisfaction with nursing care and health information.

The intervention website www.syktbarn.no is an open Norwegian online resource for parents of small children, and the site contains videos, audio clips, animations, illustrations, pictures and text materials regarding children's illnesses and normal development. In addition, the parents can use an interactive symptom checker that will help them to decide what to do and when to seek medical advice when their child is sick. The uniqueness of the website is the authentic video clips of sick children with common childhood symptoms like breathing difficulties, signs of dehydration, rash, cough and fever.

Eligibility Criteria:
Inclusion Criteria:

* parents of 0-15 years old children with breathing difficulties caused by LRTI (bronchiolitis, laryngitis or pneumonia) or asthma exacerbation
* ability to communicate and read Norwegian

Exclusion Criteria:

* parents of children with chronic diseases who have direct access to the acute ward, children with oxygen saturation less than 90 %, or other very sick children who need urgent treatment
Current Situation and Analysis of ICU Management for Severe Trauma Patients in China

Over the past 10 years, there has not been a consensus on ICU nursing management based on the concept of injury control. Case management for patients with serious trauma continues to be initiated in general services and after discharge.There is no critical care unit case management strategy for the high-risk population following acute intake. Consequently, there is an urgent need to develop and enhance ICU nursing best practice after injury control.


Eligibility Criteria:
Inclusion Criteria:

* Registered nurses, doctors, and rehabilitation technicians on the job;
* Formally hired, and working in ICU for more than 6 months, with ICU patient management experience;
* Voluntary participation in this survey.

Exclusion Criteria:

* retirees, interns/nurses/rehabilitation technicians, staff on leave, regular training doctors, and departmental nurses;
* those who are unwilling to participate in this survey.
COVID-19 in Patients With Chronic Liver Diseases

This study seeks to determine how COVID-19 affects the clinical outcome of patients with chronic liver disease, and whether the clinical course of COVID-19 is influenced by underlying chronic liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of COVID-19
* Personal history of either

  * Chronic hepatitis C
  * Chronic hepatitis B
  * Alcoholic liver disease
  * Non alcoholic liver disease
  * Autoimmune hepatitis, Primary biliary cholangitis, Primary sclerosing cholangitis
  * Cryptogenic cirrhosis
  * Hepatocellular carcinoma

Exclusion Criteria:

* Non-COVID-19 patient
Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy

The investigators could hypothesize that age-related changes in body composition parameters play a role in the variable tolerance to chemotherapy in the elderly.

However none of the studies relating body composition and chemotoxicity included elderly as a specific subpopulation. Furthermore in the majority of studies, body composition analyses are based on the estimation of muscle mass by CT scanner (axial L3 section). This method is to date not validated in the elderly cancer patients. Nevertheless some studies used Dual Energy X-ray Absorptiometry (DEXA), which is considered the gold standard in the assessment of body composition in older adults.

The investigators main hypothesis is that the appendicular muscle mass (I.e. muscle mass of the 4 limbs) operationalized as an index by dividing the muscle mass by squared height following Baumgartners' approach (Baumgartner, 1998) measured by DEXA (total of muscle mass of 4 limbs / height ²) represents a predictive factor of chemotoxicity in the elderly.

The finding that body composition is associated with poor tolerance of chemotherapy could lead to consider these parameters in the treatment decision of the elderly cancer patients and improve the current decision-making algorithms when treating older adults.

Eligibility Criteria:
Inclusion Criteria:

* Breast, prostate, bladder, colo-rectal, ovarian cancers, and lymphoma
* Metastatic or locally advanced neoplasm
* Initiation of first line chemotherapy
* Performance status World Health Organization (WHO) 0-3
* Capacity to give a written informed consent
* Life expectancy \> 3 mouths

Exclusion Criteria:

* Concomitant targeted therapy
* Concomitant targeted radiotherapy
* Height \> 196 cm, weight \> 136 kg (DEXA not feasible)
* Hemopathy excluding lymphoma
* Cognitive impairment compromising the well proceeding and security of the study
* Cognitive impairment compromising the obtaining of a written informed consent
VITROS Immunodiagnostic Products hs Troponin I

The purpose of this clinical study is to collect data to substantiate the use of the VITROS hs Troponin I test as an aid in the diagnosis of myocardial infarction (MI). The test is further indicated for risk stratification of mortality, myocardial infarction or coronary revascularization in patients with acute coronary syndrome.

A prospective clinical sample collection and cardiac troponin I testing will be conducted in individuals presenting to the Emergency Department (ED) with signs and/or symptoms suggestive of acute coronary syndrome (ACS) at geographically dispersed sites in the US. Individuals who meet the inclusion/exclusion criteria, including having signed an informed consent form will be included in the study.

Clinical and laboratory data will be collected to demonstrate product performance compared to an adjudicated clinical diagnosis.

Sample collection and testing of clinical samples with the VITROS hs Troponin I test will be performed under two separate protocols.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be ≥22 years of age at the time of consent.
2. Subject presenting with symptoms suggestive of acute coronary syndrome including chest pain, or chest pain equivalent.
3. Must have an Electrocardiogram (ECG) ordered as part of the subject's standard of care.
4. Subject willing and able to provide informed consent.

Exclusion Criteria:

1. Subject is unable to comply with the study requirements.
2. Any samples which were not obtained under IRB approved protocol.
Effect of Transcranial Direct Current Stimulation (tDCS) on Post-stroke Patients on Neuromotor Recovery

The aim of the study is to evaluate whether a non-invasive brain stimulation technique (Transcranial Direct Current Stimulation) can influence the secondary neurodegeneration observed after a stroke (assessed based on serum concentration of neurofilaments) and can improve the functional outcome.

The present preliminary study aims to evaluate the effects of tDCS (transcranial direct current stimulation) on functional recovery in subacute stroke patients and on neurodegeneration, measuring Neurofilament light chain (NfL) in blood.

It will evaluate:

* baseline NfL levels in patients with subacute stroke;
* the correlation between motor recovery and the blood concentration of NfL in subjects treated with tDCS compared to the control group.
* the effect of tDCS on motor recovery and NfL levels in the 3 months after the stroke event;

Eligibility Criteria:
Inclusion Criteria:

* partecipants with a first episode of ischemic or hemorrhagic stroke
* partecipants must be enrolled within 30 days from the stroke

Exclusion Criteria:

* partecipants with previous episodes of ischemic or hemorrhagic stroke (evaluation by neuroimaging required)
* uncooperative patients
* medically unstable patients
* partecipants with any other neurodegenerative diseases
* epilepsies
* multiple ischemic lesions
* encephalic trunk ischemic lesions
Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine

A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children in the age group six to eight weeks
* Born after a normal gestational period (36 - 42 weeks)
* Mother's HBsAg (hepatitis B surface antigen) assured negative.
* Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.

Exclusion Criteria:

* Administration of immunoglobulin or any blood products since birth.
* Use of any investigational, un-registered drug, or vaccine other than the study vaccine (with the exception of oral polio vaccination OPV \& BCG vaccine) during the study period or within 30 days preceding the first dose of the study vaccine.
* Previous vaccination or evidence of infection with DTP or Hib.
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics.
* Major congenital or hereditary immunodeficiency.
* Infants born to mothers known to be HIV positive.
* Infants having evidence of disease or fever, history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a CNS disorder at the time of vaccination.
* Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.40C, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy and hypersensitivity reaction.
* Parent/s or guardian of subject unable to maintain diary card
Nelfinavir, a Phase I/Phase II Rectal Cancer Study

The aim is to study safety and activity of nelfinavir , added to standard chemoradiotherapy in patients with locally advanced rectal cancer. Furthermore analysis of the effect of nelfinavir combined with chemoradiation on tumour tissue will be studied

Objective of the study:

The aim is to study safety and activity of nelfinavir, added to standard chemoradiotherapy (28x1.8 Gy and capecitabine 825 mg/m2 BID) in patients with locally advanced rectal cancer. Furthermore analysis of the effect of nelfinavir combined with chemoradiation on tumor tissue will be studied.

Study design:

This is an open label, single-center phase I/II trial. During phase I the toxicity of 2 dose levels will be studied (750 mg BID and 1250 mg BID). During phase II the activity of nelfinavir in combination with capecitabine and radiotherapy will be studied, using the MTD from phase I. With respect to translational research, phosphorylation of Akt in monocytes and tumorcells will be measured at different timepoints during treatment. Furthermore, dynamic CT-PET scans will be obtained at different time points to get an impression of changes in SUV and perfusion during treatment and to correlate these changes with pathological response.

Study population:

Patients with locally advanced rectal cancer, who are candidates for chemoradiotherapy. In phase I, 6 patients will be included. In case of the occurrence of dose limiting toxicity, extra patients will be included, according to the rules described in the protocol. In phase II, 55 patients will be included.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of the rectum (tumor \<15cm from anal verge)
* Age \>= 18 years
* UICC T3-4 N0-2 M0
* WHO performance status 0-2
* Less than 10 % weight loss the last 6 months
* No recent (\< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
* Serum bilirubin = or \< 3x normal
* ASAT and ALAT = or \< 2,5x normal
* Creatinin clearance \>50 ml/min
* Willing and able to comply with the study prescriptions
* No history of prior pelvic radiotherapy
* No known HIV infection
* No hemophilia
* No concurrent medication that is metabolized by the CYP3A4 isoenzyme (calcium channel blockers, antifungal agents, macrolide antibiotics, gastrointestinal prokinetics, terfenadin, midazolam)
* Statins should be stopped (except pravastatin and fluvastatin),
* No concurrent use of St. John's Wort (Hypericum perforatum)
* Women should not be pregnant or lactating
* Being willing and able to undergo one extra biopsy
* Have given written informed consent before patient registration

Exclusion Criteria:

* the opposite of the above
The Polish Version of the Alberta Infant Motor Scale: Cultural Adaptation and Validation

The aim of the study was to derive a Polish version of the AIMS through its cultural adaptation and validation. This process was based on an analysis of intra- and interrater reliability, as well as concurrent validity, using PDMS-2.

The monitoring infant motor development allows for detecting delays and disturbances, enabling, if necessary, early therapeutic interventions to prevent further structural and functional disorders. However, the developmental assessment should be performed using standardised tools, which need to undergo cultural adaptation adapted and validation. This process is necessary to ensure their reliability in countries, cultures, populations, and languages different than initially intended.

The Alberta Infant Motor Scale (AIMS) is a diagnostic tool for the developmental evaluation of infants from the time of birth, to the period of independent walking (0-18 months), based on the observation of spontaneous motor performance \[9,10\]. It is based on several assumptions of the neuromaturational model and the concepts of the dynamic systems development theory. The AIMS was created in the early 1990s by Piper and Darrah, validated and standardised on the Canadian population \[9,10\]. Moreover, a 2014 re-evaluation of the scale noted that the normative values in this population remained stable.

The intended uses of the AIMS comprise: 1) identification of infants with motor delay, 2) providing medical professionals and parents information on motor achievements of the infant (both currently developing activities and those not observed in the infant's repertoire), 3) measurement of motor performance over time, or before and after an intervention, 4) as a research tool for the estimation of rehabilitation program efficacy in infants with motor delays .

The scale has been used (as an outcome measure) in numerous studies in healthy infants and those affected by or at risk of developmental disorders.

So far, research on the reliability and validity of the AIMS has been performed in Japanese, Chinese, Brazilian, Spanish, Thai, Greek, Dutch, Flemish and Serbian sample groups. However, there has not yet been a study conducted in any Middle European population.

The aim of the study was to derive a Polish version of the AIMS through its cultural adaptation and validation. This process was based on an analysis of the intra- and interrater reliability, as well as concurrent validity, using PDMS-2.

Eligibility Criteria:
Inclusion Criteria:

* a gestational age between 37 and 42 weeks
* birth weight of ≥ 2500 g
* five-minute Apgar score ≥ 8.

Exclusion Criteria:

* a gestational age \< 37 weeks,
* a birth weight \< 2500 g,
* five-minute Apgar score \< 8
* the presence of any neurological, orthopedic, genetic, metabolic, and sensory disorders.
Procalcitonin-Guided Antimicrobial Discontinuation

The current study aims to validate the diagnostic use of PCT assessing its capability to individualize and shorten the duration of antibiotic therapy in critically ill patients with suspected or confirmed sepsis.

In particular, no well-designed intervention study has properly examined the following hypothesis: A PCT-guided antibiotic discontinuation strategy enables to reduce antibiotic treatment duration in critically ill patients with suspected or documented sepsis, without harming patient safety.

Primary objective:

To assess the effect of repeated PCT measurements in critically ill patients with clinically suspected or microbiologically documented sepsis on duration of antimicrobial use and to compare this strategy to standard clinical practice, by using an improved PCT assay with a sensitivity of 0.06 ng/ml.

Secondary objectives:

To determine the impact of repeated PCT measurements on patient outcome (morbidity, mortality, emergence of antibiotic resistance and nosocomial super-infections).

Main measures:

Primary:

1. Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)

   Secondary:
2. Cure and failure rate of infection (in N recurrent infections per 100 patients)
3. 28-day case-fatality rate (in N deaths per 100 patients)
4. Length of hospital stay (in days)
5. Costs of antimicrobial therapy (in CHF)
6. Rate of nosocomial super-infection (in N super-infections per 100 patients)
7. Isolation of multi-resistant microorganisms (in clinical isolates per 100 patient-days)

Eligibility Criteria:
Inclusion Criteria:

1. Patients with clinically suspected or microbiologically confirmed bacterial sepsis
2. Informed consent

Exclusion Criteria:

1. Patients with microbiologically documented infections caused by the following microorganisms: Listeria spp, Legionella pneumophilia, Mycobacterium tuberculosis, Staphylococcus aureus
2. Patients with fungal infections
3. Patients with severe infections due to viruses or parasites (e.g. hemorrhagic fever, malaria)
4. Patients with suspected or confirmed bacterial meningitis or endocarditis
5. Patients with localized, deep-seated abscesses (e.g. brain abscess) without systemic sepsis
6. Patients with chronic, localized infections (e.g. chronic osteomyelitis) without systemic sepsis
7. Neutropenic and other severely immuno-compromised patients (patients infected with human immunodeficiency virus and a CD4 count \< 200; patients on immuno-suppressive therapy after solid organ transplantation; patients with cystic fibrosis)
8. Withholding of life-support
9. Early discharge or death (\< 24 hours after admission)
10. Complete absence of antimicrobial treatment despite suspicion of sepsis
Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

The purpose of this study is to determine whether ublituximab is safe and effective in patients with relapsed or refractory B-cell lymphoma who were previously treated with rituximab.


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or Refractory B-cell Lymphoma
* Measurable or Evaluable Disease
* Previously treated with at least one line of rituximab or a rituximab based therapy
* Patients ineligible for high dose or combination chemotherapy + stem cell transplant
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
* No active or chronic infection of Hepatitis B or C and no history of HIV based on negative serology

Exclusion Criteria:

* Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study entry
* Prior autologous or allogeneic stem cell transplantation within 3 months of study entry
* History of severe hypersensitivity or anaphylaxis to prior rituximab
* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, brain metastasis, or psychiatric illness that would limit compliance with study requirements
* Pregnant women