cyrilzakka/clinical-trials huggingface dataset:
The Fever and Antipyretic in Critically Illness Evaluation Study

The purpose of this multination multicenter observational study is to determine the impact of fever and antipyretic on outcomes in critically ill patients.

Fever is common in critically ill patients.Antipyretic therapy for fever is routinely performed in intensive care.There are studies to assess the relationship between fever and mortality in non-neurological ICU. However, all of them did not have any information of antipyretic therapy. There are two small, single center RCT, which suggested a potential risk for antipyretic therapy. Thus, a large RCT might be ethically difficult.

It is unfortunate that there is not enough information on how the investigators should control body temperature in non-neurological critically ill patients, because fever is a very common physiological abnormality in this cohort. From the beginning, it would, therefore, be desirable to understand several aspects of fever and antipyretic therapy in ICU patients, as 1)How often fever occurs in our ICUs, 2)To what degree fever is independently associated with mortality?, 3)How often antipyretic therapy is prescribed?, 4)How effectively antipyretic can decrease temperature?, 5)How different is lowering temperature with medications compared with cooling?, 6)To what degree antipyretic is independently associated with mortality?

Thus, the investigators plan to address these questions by conducting a multi-national multi-center prospective observational trial, named "The Fever and Antipyretic in Critically illness evaluation study" (The FACE study)

Eligibility Criteria:
Inclusion Criteria:

* Adult non-neurological critically ill patients (20 years old or older).
* ICU patients expected to require intensive care for more than 48 hour.

Exclusion Criteria:

* Patients with brain injury (suspected or proven)
The Effect of Late Na Current Blocker Mexiletine on Giant T-wave Electrical Alternans(STOP-TWA)

The electrocardiogram is one of the most basic tests for cardiovascular disease. T wave alternans (TWA), which reflects abnormal ventricular repolarization, can easily trigger ventricular tachycardia (VT) and ventricular fibrillation (VF), which are important warning clues for sudden cardiac death (SCD). The late sodium current (INaL) is an important component of the frequency-dependent regulation of cardiac repolarization, and various causes of delayed repolarization can increase INaL. Our study on long QT syndrome (LQTS) found that INaL abnormalities can lead to abnormal myocardial repolarization, producing a giant TWA that triggers VT and VF. VT and VF, and INaL inhibition by the INaL blocker mexilate can terminate this process. This suggests that pharmacological blockade of INaL may be a potential target for the prevention of SCD by ameliorating the different causes of giant TWA and its triggering ventricular arrhythmic events. In this study, we propose to randomize patients with VT/VF triggered by giant TWA to conventional treatment and conventional treatment adds mexiletine treatment to compare the effects of the two treatment regimens on giant TWA and its triggered nonsustained VT, sustained VT, and VF; at the same time, we will compare the effects of mexiletine on giant TWA and its triggered ventricular arrhythmias of various etiologies by intra-group control before and after treatment. The safety and efficacy of the treatment of TWA and its triggered ventricular arrhythmias are compared.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of macroscopic TWA

Exclusion Criteria:

* The patients who do not agree to participate in the study,
* Patients with acute coronary syndrome or with progressive myocardial ischemia according to clinical manifestations, electrocardiogram or myocardial biochemical markers;
* Those who have used other class I antiarrhythmic drugs or who are contraindicated by mexiletine.
Efficacy and Safety of Corticosteroids in COVID-19

There is still controversy about the effective of glucocorticoids for the treatment of novel coronavirus pneumonia. This is a prospective randomized controlled trails. The aim is to explore the effectiveness and safety of glucocorticoids in the treatment of novel coronavirus pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* age more than 18 years old
* accord with the clinical diagnosis and/ or etiological diagnosis diagnostic criteria of Novel coronavirus pneumonia (COVID-19).
* admitted in the general wards
* be able to sign informed consent

Exclusion Criteria:

* severe immunosuppression (HIV infection, long-term use of immunosuppressive agents
* pregnant or lactation period women
* glucocorticoids are needed for other diseases
* unwilling or unable to participate or complete the study
* participate in other study
A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in patients with Advanced Primary Hyperoxaluria Type 1 (PH1).


Eligibility Criteria:
Inclusion Criteria:

* Has documented diagnosis of primary hyperoxaluria type 1 (PH1)
* Estimated glomerular filtration rate (eGFR) ≤45 mL/min/1.73 m\^2 for patients ≥12 months of age (\<12 months of age, must have serum creatinine considered elevated for age)
* Meets plasma oxalate level requirements
* If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 90 days
* If on dialysis, may be on hemodialysis therapy only and must have been on a stable regimen for at least 4 weeks

Exclusion Criteria:

* Hemodialysis/peritoneal dialysis combination therapy or peritoneal dialysis alone
* Diagnosis of conditions other than PH1 contributing to renal insufficiency
* History of liver transplant
* History of kidney transplant and currently receiving immunosuppressants
Basimglurant (NOE-101) in Children, Adolescents, and Young Adults With TSC

The study intends to show that basimglurant (NOE-101) provides effective seizure control in children, adolescents and young adults with Tuberous Sclerosis Complex (TSC).

The study drug (NOE-101, basimglurant) is a potent inhibitor of metabotropic glutamate receptor 5 (mGluR5) which controls a wide range of processes in the brain, spinal cord, retina, and peripheral nervous system. In animal studies, the inhibition of this receptor has shown therapeutic potential for the treatment of Tuberous Sclerosis Complex (TSC). This receptor's inhibition decreases the frequency of seizures. In previous clinical trials, the study drug has shown an advantageous safety profile in children and adolescents.

The objective of this study is to find an optimal dose at which the study drug will lead to a decrease in the duration, frequency and intensity of seizures in children, adolescents and young adults with TSC, while being well tolerated. All patients who positively respond and tolerate the medicine will be offered the possibility to continue in an open label extension.

Eligibility Criteria:
Inclusion Criteria (summary):

* Ability and willingness to provide informed assent or written consent or consent from their legal representative.
* Fluency in the language of the study staff
* Age 5 to 30 years at study entry
* A documented history of TSC
* Refractory seizure history
* Currently receiving one or more anti-epileptic drugs (AEDs)
* Stable medications or interventions for epilepsy
* Willingness to complete Patient Reported Outcome assessments
* For female patients of childbearing potential:

  1. Willingness to undergo serum or urinary pregnancy testing at screening and during the trial period.
  2. Willingness to use contraception.

Exclusion Criteria (summary):

* Neurologic disease other than TSC
* Recent anoxic episode
* Patient weight below 15kg
* Clinically significant unstable medical condition(s)
* Pregnancy or lactation
Postoperative Continuous Non-invasive Haemodynamic Monitoring on the Ward

The patient's clinical care will not be altered apart from an the use of a non-invasive monitor for a short time, without any biological sample acquisition, or follow-up. This is low risk.

The device works through a complex pressure measurement in the fingers and by slightly squashing the fingers it can cause minor impairments to circulation. This represents a very small risk. To mitigate this risk the investigators will exclude patients with impaired circulation to the fingers and fingers will be monitored.

The approach is necessarily on the day of surgery and for many people this is an anxious time. The investigators have a lot of experience of approaching patients on the day of surgery for providing consent for observational studies - the investigators use caution and sensitivity. The investigators do not approach patients who the clinical team consider anxious or where there is significant pressure on time.

Enrolled patients will have the CNAP sited in the post-anaesthetic care unit (PACU) and it will stay on their arm until at least 12 hours have passed. The device will collect continuous heart rate, blood pressure, and nominal cardiac output; it also derives a range of values from these measurements. There is minimal risk attributable to the use of the CNAP device. These devices are already in routine clinical use in the UK in intensive care units, high-dependency units and operating theatres.

To reduce burden on the patient, no additional HR/BP monitor is required and whenever the usual care team would like to know the HR or BP these values will be displayed. The additional parameters (related to measurement of cardiac output) will not be shared with the clinical team - they will remain blinded to these data because otherwise there is the risk that they would use this additional information to alter clinical management.

Medical notes will be examined to provide information about demographics, physical characteristics (height, weight), and previous medical history - please see case report form (CRF, appendix 1) for more details.

There are no blood tests, or other acquisition of biological samples.

Eligibility Criteria:
Inclusion Criteria:

* Has capacity to provide informed consent
* Surgery: planned or unplanned; all types including gastrointestinal, urology, orthopaedics and gynaecological
* Due for an inpatient stay (i.e. not day case surgery) on either Frensham or Bramshott wards (staff will have had training with the device on these wards)
* Aged 18 years or over

Exclusion Criteria:

* Admission to intensive care unit ICU / high dependency unit HDU
* Declines consent to participate, or lack capacity to provide consent
* Impaired circulation of the hands: Raynaud's disease or severe peripheral vascular disease.
Real-life Use of the Crohn's Disease Exclusion Diet (CDED) in Adult Patients With Crohn's Disease

This study explores the effectiveness od the Crohn's Disease Exclusion Diet (CDED) as a tretament for adults with mild-to-moderate Crohn's disease (CD). The hypotesis is that CDED, by excluding specific dietary components thought to exacerbate gut inflammation, can induce remission in CD patients more effectively than a control diet based on the Mediterranean pattern. Conducted as an open-label randomized trial, the research aim to provide real-world evidence of CDED's safety and its inpact on clinical remission, body composition and overall quality of life for CD patients.


Eligibility Criteria:
Inclusion Criteria:

* mild-to-moderate Crohn's disease activity (HBI between 5 and 16)

Exclusion Criteria:

* concomitant treatment with corticosteroids, antibiotic therapies and nutraceutical supplements, treatment with biological drugs and traditional immunosuppressants started less than 24 weeks before enrollment, presence of active fistulas or abscesses, gastrointestinal tract surgery less than 6 months to randomization, coeliac disease, type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus, acute coronary disease (unstable angina, myocardial infarction), advanced acute or chronic liver disease, congestive heart failure (NYHA class III-IV), acute and chronic nephropathies (GRF\<30 ml/min according to the CKD-EPI formula), presence of acute infectious diseases and pregnancy.
A Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies

We wish to determine whether biopsies obtained with the technique of fluorescence-aided confocal endomicroscopy will detect more patients with specialized columnar epithelium than random biopsies among patients with Barrett's esophagus who are being monitored with endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Age at least 18.
* Barrett's esophagus
* Acid suppressive therapy
* Endoscopic surveillance

Exclusion Criteria:

* Pregnancy or lactation
* Allergy to fluorescein
* Endoscopic esophagitis Los Angeles classification A to D
* Mucosal irregularity or nodules suspicious for dysplastic or cancerous lesion
* Obvious mass lesions or cancer
Monitoring Epstein-Barr Virus (EBV) Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs

PBMNC DNA is considered a limit above which patients will develop EBV associated post transplant lymphoproliferative disorder.

we showed that methotrexate tended to decrease EBV load over time, but this did not reach significance and that TNFa inhibitors did not significantly modify EBV load over time.

Our objective is to monitor Epstein Barr Virus load over time in patients with Rheumatoid arthritis under Orencia\* (abatacept) or RoActemra\* (tocilizumab), to detect possible immunosuppression associated EBV dysregulation, as seen in post transplant lymphoproliferative disease.

Current treatment of RA routinely includes potentially immunosuppressive medications like methotrexate and TNFa inhibitors. New immunosuppressive drugs are at disposal, Orencia\* (abatacept) which is a T cell co-stimulation modulator (CTLA4Ig) and RoActemra\* (tocilizumab), an antibody against IL6 receptor. In solid organ transplant recipients under immunosuppressants, emergence of lymphoma can be predicted by monitoring EBV load in peripheral blood mononuclear cells (PBMNCs). EBV load above 1000 copies per 500 ng PBMNC DNA is considered a limit above which patients will develop EBV associated post transplant lymphoproliferative disorder, a condition characterized by polyclonal EBV positive B lymphocyte proliferation which can evolve into EBV positive B cell lymphoma .

In a first study, we showed that Rheumatoid arthritis patients have 10 fold systemic EBV overload, very similar to that observed in healthy organ transplant recipients. More recently, we showed that methotrexate tended to decrease EBV load over time, but this did not reach significance and that TNFa inhibitors did not significantly modify EBV load over time.

Our objective is to monitor Epstein Barr Virus load over time in patients with Rheumatoid arthritis under Orencia\* (abatacept) or RoActemra\* (tocilizumab), to detect possible immunosuppression associated EBV dysregulation, as seen in post transplant lymphoproliferative disease.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis patients
* treated with new immunosuppressive drugs : Orencia\* (abatacept) and RoActemra\* (tocilizumab)
* Disease longer than one year

Exclusion Criteria:

* Rheumatoid arthritis patients treated with ciclosporin in two years preceding the study
* Transplanted patients
* Disease shorter than one year
* Histories of lymphoma
Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study

Phase II multicentric study

The aim of this prospective Phase II multicentric study is to assess feasibility and early complications rate of "total laparoscopic/robotic" interval debulking surgery in patients with a clinical complete/partial response to neoadjuvant chemotherapy for advanced ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years,
* Advanced ovarian cancer submitted to neoadjuvant chemotherapy,
* Clinical or serological complete/partial response (RECIST; GCIG),
* PS ≤ 2 (ECOG),
* Informed consent

Exclusion Criteria:

* Borderline and non-epithelial ovarian tumors,
* Stable/progressive disease,
* ASA 3-4,
* Severe cardiopulmonary disease,
* BMI \> 40
The Comparison of the 3 Minutes Ramp Walk Test With 6 Minutes Walk Test in Stable Patients After Valve Replacement

In view of assessing the uphill walking capacity and to provide a functional stress test with better sensitivity the investigators need a short term functional stress test over the gold standard six minute walk test....

To demonstrate the significance of 3 minutes ramp walk test over 6 minutes walk test as a functional stress test.

The investigators hypothesize that the investigators three minutes ramp walk test (3MRWT) will be superior to the existing six minutes level walk test (6MWT) in the measurement of functional capacity of post valve replacement patients.

The patients who have undergone valve replacement surgeries face difficulty in their functional activities especially during climbing stairs, walking uphill.

The six minute level walk test has been a gold standard in the assessment of functional capacity in cardio respiratory conditions like, coronary heart diseases , valvular heart diseases, chronic respiratory illness.

Moreover, six minute walk test has been framed to assess the functional capacity in level walking.so far, no test have been developed to assess the functional capacity of the patients during uphill walking and stair climbing.

Though ramp walking ( uphill walking) can be trained using treadmill, it is not feasible for the indian patients as they are not familiar in the treadmill and their fear may also show variation in the functional assessment.

Hence this study has been proposed..

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* 30 to 65 years
* Patient in step down unit(5th post operative day)
* Aortic and Mitral valve replaced patients

Exclusion Criteria:

* Vitally unstable patients, \[pyretic, abnormal BP, SpO₂, X-Ray and pain\]
* Any arrthymia
* Orthopaedically disabled patients
* Neurologically impaired patients
* Patients with psychologically impaired
Exploring the Feasibility of Kōmmour Prenatal to Reduce Maternal and Infant Health Disparities

The purpose of the study is to culturally adapt and examine the feasibility of a group prenatal program (Kōmmour Prenatal) to reduce maternal and infant health disparities among Marshallese Pacific Islander women in the US. The study will also gather information from providers of Kōmmour Prenatal and stakeholders in the Marshallese community familiar with the program to learn of their experience with the program.


Eligibility Criteria:
Inclusion Criteria

* Women who self-identify as Marshallese
* 18 years of age or older
* And 8-20 weeks pregnant

Exclusion Criteria

* Women who do not self-identify as Marshallese
* Not 18 years of age or older
* And not 8-20 weeks pregnant
CAB-AXL-ADC Safety and Efficacy Study in Adults with NSCLC

The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC

This is a multi-center, open-label, Phase 2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3011, a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC), alone and in combination with PD-1 inhibitor in patients with metastatic non-small cell lung cancer (NSCLC).

Eligibility Criteria:
Inclusion Criteria:

* Patients must have measurable disease.
* Age ≥ 18 years
* Adequate renal function
* Adequate liver function
* Adequate hematological function
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least three months.

Exclusion Criteria:

* Patients must not have clinically significant cardiac disease.
* Patients must not have known non-controlled CNS metastasis.
* Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
* Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
* Patients must not have had major surgery within 4 weeks before first BA3011
* Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
* Patients must not be women who are pregnant or breast feeding.
Hemodynamic Changes in Off-pump Coronary Artery Bypass Grafting

The purpose of this study is to study the positioning and stabilization of different cardiac walls performed during off-pump coronary artery bypass grafting (CABG) may have dissimilar impact on hemodynamics.

The objective is to evaluate hemodynamics during distal coronary anastomoses in different cardiac walls.

* Twenty patients undergoing off-pump CABG monitored with pulmonary artery catheter and esophageal doppler will be enrolled.
* Patients with a left ventricular ejection fraction \<50%, age \>80 yr, creatinine \>1.4 mg/dl, reoperation, valvular heart disease or chronic obstructive pulmonary disease were excluded
* Data will be collected after volemic and hemodynamic adjustments, after heart positioning and establishment of a suction stabilizer and before its removal in anterior, lateral or posterior wall artery anastomosis.
* Data was compared by means of two-way repeated measures ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* Normal left ventricular function
* Minimal to moderate surgical risk according to criteria proposed by Higgins et al. (JAMA. 1992 May 6;267(17):2344-8)

Exclusion Criteria:

* Patients with a left ventricular ejection fraction \<50%,
* Age \>80 yr
* Creatinine \>1.4 mg/dl
* Reoperation
* Valvular heart disease
* Chronic obstructive pulmonary disease
* High surgical risk according to criteria proposed by Higgins et al. (JAMA. 1992 May 6;267(17):2344-8)
Machine Learning for Identification of Future Disease Development: A Nationwide Cohort Study (MILESTONE)

To develop machine learning algorithms for the identification of future development of cardiovascular and metabolic disease

The MILESTONE trial is retrospective and data review study with health checkup data from the National Health Insurance Services(NHIS) in Korea. The data will be included general health examination for individuals , type of health insurance, medical bill details, medical histories, treatment and prescriptions about 514,795 individuals who were over 40 years old.

Eligibility Criteria:
Inclusion Criteria:

* The Subject who is got health checkup between 2002 and 2013, and had been recorded the health checkup result to the National Health Insurance Service(NHIS) in South Korea.

Exclusion Criteria:

* Persons whose disease development is not identified from the records due to emigration or disappearance