cyrilzakka/clinical-trials huggingface dataset:
TOFAcitinib in SARS-CoV2 Pneumonia

Immune-mediated lung injury plays a pivotal role in severe interstitial pnemumonia related to SARS-CoV2 infection. Tofacitinib, a JAK1/3-Inhibitor, could mitigate alveolar inflammation by blocking IL-6 signal. The aim of this prospective single cohort open study is to test the hypotesis that early administration of tofacitinib in patients with symptomatic pneumonia could reduce pulmonary flogosis, preventing function deterioration and the need of mechanical ventilation and/or admission in intensive care units.

Interstitial Pneumonia is the main complication of SARS-CoV2 infection. Immune system hyperactivation, leading to alveolar inflammation, is the main mechanism in determining lung damage. Evidence are accumulating about the pivotal role played by IL-6 in this disease. Preliminary evidence, indeed, point out the efficacy of an IL-6 receptor inhibitor in improving clinical conditions in a proportion of rapidly deteriorating patients. Our hypotesis is that a precocious inhibition of IL-6 signal, by the administration of tofacitinib (JAK 1/3 Inhibitor), could hinder the progression to more severe grades of lung inflammation leading to pulmonary function deterioration. In a prospective single cohort open study, 50 patients admitted in Hospital due to SARS-CoV 2 symptomatic interstitial pneumonia, but not requiring mechanical ventilation, will be enrolled. Tofacitinb will be administered every day for 14 days, starting within 24 h from the admission. The primary outcome is to evaluate the effect of this drug on the rate of patients who will need mechanical ventilation. Safety in this population will also be actively monitored.

Eligibility Criteria:
Inclusion Criteria:

* SARS-CoV2 Infection diagnosed by rt-PCR
* Rx or CT-scan confirmed interstitial pneumonia
* Hospital admission from less than 24h
* Written Informed Consent

Exclusion Criteria:

* Age \<18 ys or \>65
* Patients in mechanical ventilation at time of admission
* Severe Hearth failure (NYHA 3 or 4)
* Severe History of Chronic Ischemic Hearth Disease, defined as history of Major Adverse Cardiovascular Event and/or recent (one year) revascularization.
* History of recurrent Deep Venous Thrombosis and Pulmonary Embolism
* Active Bacterial or Fungal Infection
* Hematological cancer
* Metastatic or intractable cancer
* Pre-existent neurodegenerative disease
* Severe Hepatic Impairment
* Severe Renal Failure (Creatinine Clearance \<30ml/h)
* Active Herpes zoster infection
* Severe anemia (Hb\<9g/dl)
* Lymphocyte count below 750/mcl
* Neutrophil count below 1000/mcl
* Platelet count below 50000/mcl
* Pregnancy or Lactation
* Inability to give informed consent (severe transitory or permanent mental impairment, incapacitation)
Cardiac Fibroblast Activation Detected by 68Ga-FAPI PET/MR

Myocardial infarction is the most common cause of high mortality in the modern world. The short-term survival rate of ST-elevated myocardial infarction (STEMI) has been dramatically increased in the past decades thanks to primary coronary intervention and standardization of treatment. However, the long-term prognosis of patients with acute myocardial infarction (AMI) is still poor, especially in the aging population, due to heart failure related to inappropriate myocardial fibrosis and subsequent left ventricular (LV) remodeling. Despite the amelioration of STEMI management, LV remodeling still occurs in approximately 1/3 of all STEMI patients. Therefore, early identification of such patients may help the optimization of therapy and eventually the outcomes.

One characteristic of activated cardiac fibroblasts is the expression of FAP (fibroblast activation protein). A tracer (FAP inhibitor) for positron emission tomography that targets FAP has been used to measure relative FAP density indicative of activated fibroblasts in different cancer entities. However, whether it can reliably assess myocardial fibrosis and predict the poor prognosis caused by LV remodeling is not yet known. Therefore, We aim to observe active myocardial fibrosis process in patients with AMI, and analyze its relationship with the patients'prognosis in a longitudinal study through 68Ga-FAPI PET/MRI.


Eligibility Criteria:
Inclusion Criteria:

* between 18-75 years old
* diagnosed with coronary angiography
* performed percutaneous coronary intervention，with successful myocardial reperfusion

Exclusion Criteria:

* unstable hemodynamics
* MR contraindications (such as pacemaker or nerve stimulator or metal foreign body, high fever, severe renal failure, etc.)
* Claustrophobia
A Study of Treatment Patterns and Clinical Outcomes of Psoriasis in Japan

The purpose of this study is to understand current real-world treatment patterns and clinical outcomes, reasons for switching treatment, and participant characteristics using each systemic psoriasis treatment in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of psoriasis
* Can be followed for at least 2 years
* Treated with any of the following systemic therapy for psoriasis at time of follow-up start: Tumor Necrosis Factor (TNF) inhibitors (infliximab, adalimumab, and certolizumab pegol), Interleukin (IL)-12/23 inhibitors (ustekinumab), IL-23 inhibitors(guselkumab, risankizumab, and tildrakizumab), IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab), Apremilast, Methotrexate, Cyclosporine, Etretinate

Exclusion Criteria:

* Enrolled in any clinical trials for psoriasis in their follow-up period
* Developed psoriatic arthritis, guttate psoriasis, erythrodermic psoriasis, and pustular psoriasis at time of start date
* Treated with any of the following systemic therapy before they were diagnosed with psoriasis: TNF inhibitors (infliximab, adalimumab, and certolizumab pegol), IL-12/23 inhibitors (ustekinumab), IL-23 inhibitors(guselkumab, risankizumab, and tildrakizumab), IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab), Apremilast, Methotrexate, Cyclosporine, Etretinate
A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-355.

An open-label, randomized, multiple-dosing parallel study to evaluate the pharmacokinetics, safety and tolerability of CKD-355 with D797 and D324 in healthy subjects

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult older than 19 years and less than 55 years at the time of screening
2. BMI 18.5\~29.9 kg/m2 and body weight more than 50kg
3. Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to two months after the last investigational product and not to provide sperm for men
4. Subjects who sign on an informed consent form willingly

Exclusion Criteria:

1. Subjects who have a clinically significant disease such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nercous and mental disease.
2. Subjects who have acute disease within 28 days prior to the first administration
3. Subjects who have history that may affect the ADME
4. Subjects who have clinically significant chronic disease
5. Women who are nursing, pregnant or positive on pregnancy test
6. Subjects who have clinically significant allergic diseases
7. Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
8. Subjects who are known to be hypersensitive to the drug or its components
9. Subjects who have been found to be positive in serological tests (HBs antigen, HCV antibody and HIV antibody)
10. Subjects with creatinine clearance \<60 ml / min
11. Subjects whose AST or ALT levels exceeded 2.5 times of upper limit of normal range
12. Subjects who taked ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 1 week prior to the first administration
13. Subjects who can not eat standard meals provided by the institution.
14. Subjects who donated whole blood within 60 days, donated the components within 20 days or received blood within 30 days
15. Subjects who taked medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 30 days before the first administration
16. Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days before the first administration (eg, ingestion of grapefruit juice\>1 L / day)
17. Subjects who participate in the other clinical trial within 90 days prior to the first administration
18. Subjects who have a history of regular alcohol(alcohol\>210g/week) or caffeine(caffeine\>5 cups/day)
19. Subjects who smokes more than 10 cigarettes per day within 3 months or cannot discontinue smoking during the clinical trial
20. Subjects who is determined unsuitable to participate in this clinical trial by the investigator
Modeling of Amiodarone Effect on Heart Rate Control in Critically Ill Patients With Atrial Tachyarrhythmias

Aims Amiodarone is the gold-standard medication to control heart rate in critically ill patients with atrial tachyarrhythmias (ATs); however, effective doses and covariates influencing its efficacy remain unknown. The investigators therefore performed pharmacodynamic modeling of heart rate reduction induced by amiodarone in these patients. Methods and Results This observational study included 80 consecutive severely ill patients receiving amiodarone to treat ATs. A total of 1348 time-heart rate observations with 361 amiodarone dose administrations were analyzed during a period of up to 6 days after hospital treatment initiation using a nonlinear mixed-effect model. Pretreatment with amiodarone before intensive care administration, paroxysmal versus persistent AT, catecholamine infusion, and fluid and magnesium loading were among the covariates assessed in the model. In case of paroxysmal AT in a patient not pretreated with amiodarone, a 300 mg intravenous loading dose combined with an 800 mg oral dose on the first day, followed by 800 mg/day orally for 4 days was effective in achieving a heart rate between 80 and 115 bpm within the first day, and to maintain it during the next 4 days. Corresponding doses were twice as high in patients with persistent AT. Use of intravenous magnesium (p\\0.02) and fluid loading (p\\0.02) was associated with an earlier and greater heart rate decrease, while use of dobutamine had an opposite influence (p\\0.05). Conclusions In critically ill patients with AT, the dose of amiodarone required to control heart rate is influenced by the type of AT and by other easily measurable conditions which may allow better individualization of amiodarone dosing.


Eligibility Criteria:
Inclusion Criteria:

* critically ill patients who had received at least one dose of amiodarone to treat or prevent AT during their hospitalization in the ICU.

Exclusion Criteria:

* Patients with paced rhythm or incomplete charts were excluded
Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy

A randomised prospective trial comparing the efficacy of pethidine, Ketorolac, and Xylocaine gel as analgesics for pain control in shockwave lithotripsy.

Pain perception during shockwave lithotripsy (SWL) is affected by patient-related factors like age, gender, and body habitus moreover, young female patients, anxious and depressed patients or thin patients experience more pain during SWL.

Several physical variables influencing treatment-related pain have been identified: the type of the shockwave source, size, and site of stone burden, peak pressure of the shockwaves, diameter of the focal zone, and size of the aperture of the shockwave source reflecting the area of shockwave entry at the skin.

Pain relief during SWL is vital, not only to maintain patient comfort and satisfaction, but also to facilitate stone imaging and targeting by reducing patients' movements during successive shock wave impacts. Reduced patient movement enables increase fragmentation efficiency and reduce the risk of procedure-related morbidity. So, a relaxed, cooperative patient during treatment is paramount in maintaining stone targeting for optimal fragmentation.

Across 21 centers in the United Kingdom (UK), 17 distinct analgesia regimens were reported in SWL analgesia practice.

In 2016 European Association of Urology (EUA) guidelines for SWL Pain control stated that pain control during SWL is necessary to limit pain induced movements and excessive respiratory excursions, However no recommendation for proper analgesia in contrast to clear recommendation for Pain relief in patients with an acute stone episode.

The investigators will try in this trial to identify the best efficacious type of analgesia for patient during SWL in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with renal and upper ureteral stones amenable to SWL.

Exclusion Criteria:

* Allergy to pethidine.
* Allergy to Ketorolac.
* Allergy to Xylocaine gel.
* American Society of Anesthesiologists score ≥ 3 (ASA III or more).
* Pregnancy.
* Patients with a pacemaker.
* Bleeding diatheses.
* Uncontrolled urinary tract infection (UTI).
* Severe obesity which prevent targeting of the stone.
* Body Mass IndexBMI (40 or more)
* Arterial aneurysm in the vicinity of the stone.
* Anatomical obstruction distal to the stone.
Testing Tissue Sodium Stores in CAPD Patients-Aims 1 & 2

The investigators' overarching goal is to improve long-term outcomes for end stage renal disease (ESRD) patients. In this study we focus specifically on patients receiving peritoneal dialysis (PD). Volume regulation in PD patients is related to hypertension, heart failure, nutritional status, and survival. Salt (NaCl) is the body's ion transport target to normally regulate volume via the kidneys; however, in hemodialysis (HD) patients the dialyser or in PD patients the peritoneal membrane, must serve that purpose. Determining volume status in PD patients is not easy and monitoring sodium (Na+) is more difficult still. The investigators have developed a novel, noninvasive approach to this problem involving 23Na+ magnetic resonance imaging (Na-MRI). Na+ is stored bound to proteoglycans in mostly the skin. Our technique measures Na+ in skin and skeletal muscle. In this study, we propose to apply this novel technique to PD patients.

Aim 1. To determine Na+ stores in PD patients, to compare Na+ stores to normal controls using Na-MRI technique, and to correlate Na+ stores by Na-MRI with multifrequency bioimpedance measurements and cross-sectional clinical data.

Hypothesis: Na+ stores are increased in PD patients compared to normal controls; they are increased in PD patients with volume expansion and in those patients with high soluble vascular endothelial growth factor receptor-3 (sFlt-4) levels.

Aim 2. To determine the utility of Na-MRI as an assessment of preserving residual renal function in PD patients.

Hypothesis: Extracellular volume expansion as measured by multifrequency bioimpedance was found to have no utility in predicting preservation of residual renal function in PD patients. The investigators hypothesize that Na+ stores as determined by 23Na-MRI will fulfill that function and will be inversely, rather than directly, related.


Eligibility Criteria:
Inclusion Criteria:

Both subject groups:

* Age 18 to 80 years;
* BMI \< 40;
* Ability to give informed consent;
* Life expectancy greater than 6 months.

PD subjects:

* On peritoneal dialysis for greater than 3 months;
* Using glucose lactate-buffered PD solutions with consistent glucose exposure;
* Stable peritoneal prescription (Kt/V \> 1.7 or Tccr \> 50 ml/week/1.73 m2).

Control subjects:

* Estimated glomerular filtration rate (GFR) ≥ 60 ml/min/1.73m2;
* No proteinuria.

Exclusion Criteria (both subject groups):

* Pregnancy;
* Intolerance to study protocols;
* Severe, unstable, active, or chronic inflammatory disease (congestive heart failure-NY Class IV, active infection, active connective tissue disorder, active cancer or cancer history in the prior 5 years, HIV, liver disease, including active chronic hepatitis B or C);
* Active inflammatory conditions \[systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), minimal change disease (MCD)\];
* Patients prescribed or being treated with spironolactone;
* History of cirrhosis;
* Poor compliance with dialysis prescription.
Lung Cancer Screening Navigation for Homeless People

The investigators will conduct a pragmatic clinical trial to test the effect of patient navigation on lung cancer screening (LCS) low-dose computed tomography (LDCT) completion among Boston Health Care for the Homeless Program (BHCHP) patients at increased risk for lung cancer. Patient navigation is a strategy for guiding individuals through complex health systems, and the investigators hypothesize that this may be a promising approach for helping homeless-experienced people overcome their unique barriers to obtaining LCS.

The investigators will aim to recruit 300 people to participate in this research study; 100 will be randomly assigned to arm 1 (usual care) and 200 will be randomly assigned to arm 2 (patient navigation). Randomization of participants will be stratified by smoking status, housing status, clinical site, and whether they have previously discussed LCS with their primary care provider (PCP) to ensure balance between study groups on these variables. People assigned to the usual care arm will be referred back to their PCP for further management. People assigned to the patient navigation arm will be given the chance to work with a LCS navigator. The navigator will assist participants and their PCPs with all aspects of the LCS process in addition to offering brief tobacco counseling for current smokers.

The primary aim of the trial is to determine-among homeless-experienced people who are eligible for LCS-the effect of patient navigation on 1) LCS LDCT completion at 6 months post-enrollment and 2) LCS LDCT completion at 6 months with diagnostic follow-up of abnormal results within 1 month of the recommended time frame. Study outcomes will be assessed by examining participant health records.

Following the intervention, qualitative interviews will be conducted with 40 participants and 10 BHCHP PCPs to better understand how the LCS process unfolds in the setting of homelessness, the ways in which the navigator facilitated this process, and opportunities for improving the navigation intervention for future use.


Eligibility Criteria:
Inclusion Criteria:

* Currently or formerly homeless
* Have a 30 pack-year smoking history and have smoked within the past 15 years
* Have a Boston Health Care for the Homeless (BHCHP) primary care provider (PCP)
* Proficient in English, assessed with items asking about native language and self-reported comfort communicating in English among non-native speakers

Exclusion Criteria:

* Prior chest computed tomography (CT) imaging in the past 12 months
* Personal history of lung cancer, or current presentation with symptoms concerning for lung cancer (e.g. hemoptysis or unexplained weight loss of \>15 lbs. in the past year)
* PCP is the principal investigator
* Inability to provide informed consent, assessed with knowledge questions about the material presented during the informed consent process that individuals must correctly answer before providing informed consent to participate
Effect of GLP-1 Receptor Agonists on Trabecular Bone Score

This study will help determine the effect of Glucagon Like Peptide-1 (GLP-1)receptor agonists on bone strength in postmenopausal women with type 2 diabetes mellitus (T2DM)

Postmenopausal women with diabetes mellitus have a higher risk of osteoporotic fractures, with significant associated mortality and morbidity. Osteoporosis is underdiagnosed in diabetes, as the bone mineral density (BMD) as currently measured is often normal despite underlying abnormalities. The trabecular bone score (TBS) is a novel modality to assess bone microarchitecture and accurately assess fracture risk in patients with diabetes. Due to increased co-prevalence of osteoporosis and diabetes mellitus, the potential effects of antidiabetic medications on fracture risk assume importance.

Based on findings in animal studies, we hypothesize that GLP-1 receptor agonists increase TBS in postmenopausal women with (T2DM). The investigators propose a prospective non-randomized study by enrolling 48 patients (24 in the GLP-1 group and 24 in the non-GLP group). Dual-energy X-ray Absorptiometry (DXA )scans, markers of bone formation, and resorption, and selected inflammatory markers will be assessed at baseline, six months, and one year.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 Diabetes Mellitus
* Postmenopausal female
* Age \>55 years
* Hemoglobin A1c between 7-10% within 6 months of the first visit.

Exclusion Criteria:

* Patients with type 1 Diabetes mellitus
* Patients with a history of GLP-1 receptor agonist/DPP4 inhibitor use
* eGFR \<30 ml/min in the last 3 months
* Patients with a history of pancreatitis
* Personal or family history of medullary thyroid cancer
* Patients with a history of treatment with anti-osteoporosis agents
* Documented secondary osteoporosis
* Documented presence of prosthesis or devices in the spine
* Unwilling or unable to consent
A Comparison of the C-mac and Bonfils Intubation Fibrescope

The study aims to determine the better device to facilitate intubation in patients with a limited neck movement and small mouth opening. This may help anesthesiology as well as emergency medicine practitioners and departments to decide when choosing between these two conceptually similar device. The hypothesis to be tested is that the C-MAC® is more superior when compared to the Bonfils Intubation Fibrescope in success of intubation, time to intubation and complication rate in patients with a fixed cervical collar.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective surgery under general anaesthesia who require endotracheal intubation

Exclusion Criteria:

* Patients with history of previous difficult endotracheal intubation
* Patients with two or more predictors of difficult mask ventilation or difficult intubation or the combination of both
* Patients with ASA (American Society of Anesthesiologists) grading of III and above are excluded from the study, as well as patients with 2 or more predictors for difficult mask ventilation or difficult intubation or the combination of both.
* Patients needing a rapid sequence induction for rapid securement of the airway
* Pregnant women
* Patients below the age of 21 years old
* Patients unfit to give consent
Progressive Relaxation Exercise Applied to Palliative Caregivers on Coping With Stress,Anxiety

It is important to consider the needs of palliative care caregivers and to plan interventions for psychosocial problems.

Cognitive-behavioral methods, which may be applied as relaxation aids in controlling the anxiety levels.

Eligibility Criteria:
Inclusion Criteria:

* To be able to communicate adequately
* Not having psychiatric problems
* Volunteering to participate in research
* Caregivers whose patients will be in bed for at least 4 weeks

Exclusion Criteria:

* None