cyrilzakka/clinical-trials huggingface dataset:
BNP and Vascular Surgery

Background and rationale of the study:

Patients undergoing non-cardiac major surgery show a perioperative cardiac risk and postoperative complications, that can be stratified based on parameters linked to patient's conditions and to surgery types.

An accurate identification of this risk could offer numerous advantages for these patients, who's 30-day mortality is around 2%. The identification of the correct risk could lead to a better pre- and postoperative management, that could guarantee a better surgery outcome and a faster postoperative recovery.

To this day there is no perfect method to correctly estimate this risk. Various studies show that high BNP levels are linked to cardiac events at 30 and 180 days. Further investigations identify different groups, at low, intermediate and high risk, based on BNP levels.

BNP is released by ventricular myocytes in response to a wall distress, due to an increased volume, pressure or myocardial ischemia.

So BNP plasma levels could be used as a prognostic and diagnostic marker, improving the cardiac risk stratification in patients undergoing surgery and a much more precise management.

This study is determined to do an evaluation of the correlations between pre- and postoperative BNP levels and the incidence of cardiac events in patients undergoing major vascular surgery.

Patient's informed consent signature for adhesion at the study will be initially requested. With their acceptance, parameters will be recorded anonymously in the Case Report Form, identified by their initials and a numeric code, until hospital discharge.

The parameters analyzed will be related to:

* preoperative evaluation: anamnesis, health general conditions, METs, preoperative monitoring, in particularly BNP basal levels;
* intraoperative evaluation: intraoperative monitoring;
* postoperative evaluation: BNP and cTnI levels at 24 and 48 hours, and about pulmonary, cardiovascular, neurological and surgical postoperative complications, based on the medical record.

The data will be transferred on Excel worksheet, utilized for descriptive analysis related at every variable.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide an informed consent
* Age \>18 years old
* Elective abdominal aortic aneurysm surgery

Exclusion Criteria:

* Emergency surgery
* Age ˂ 18 years old
* Creatinine \>2mg/dl
* Diseases of ascending aorta, aortic arch or thoracic aorta
* Chronic atrial fibrillation
* Patient refusal to provide informed consent
CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors

To assess the efficacy of systemic corticosteroids alone as first-line treatment of polyarteritis nodosa and microscopic polyangiitis without poor-prognosis factors as defined by the five-factor score (FFS=0), and to compare the efficacy and safety of azathioprine vs pulse cyclophosphamide as adjunctive immunosuppressive therapy to treat failure or relapse.

All patients initially treated with systemic corticosteroids alone: optional IV methylprednisolone pulse (15 mg/kg) at treatment start followed by oral prednisone (1 mg/kg/day) according to a tapering schedule. Treating physicians allowed to treat minor relapses with corticosteroids without referring the patient for randomization, as long as the prednisone dose did not exceed 0.5 mg/kg for 1 month.

Patients in whom prednisone doses could not be tapered below 20 mg, those who failed to enter remission and those who relapsed were randomized to receive either 6 months of oral azathioprine (2mg/kg/day) or 6 cyclophosphamide pulses (0.6g/m2 D1, D15, D30 then every month)

Eligibility Criteria:
Inclusion Criteria:

* Men and women with newly diagnosed polyarteritis nodosa or microscopic polyangiitis;
* absence of poor prognostic factors as defined by the five-factor score (serum creatinine \> 140 μmol/l or 1.58 mg/dl, proteinuria \> 1 g/day, severe gastrointestinal tract involvement, specific cardiomyopathy and/or central nervous system involvement;
* written informed consent.
* Both genders eligible;
* age ≥ 15 years.

Exclusion Criteria:

* age \< 15 years, previously treated systemic vasculitis;
* history of cancer;
* pregnant or breast-feeding women;
* psychiatric disorders that might compromise compliance with therapy;
* contraindication to study drug;
* other ongoing therapeutic trial;
* concomitant viral hepatitis B or C or human immunodeficiency virus (HIV) infection
Biomarker Study in Participants With Migraine

This is a study of participants with a diagnosis of migraine who completed another clinical trial NCT02163993. The participants received either LY2951742 or placebo. This study NCT02766517 will evaluate how certain biomarkers may be related to the participant's response in study NCT02163993. The study will last about five days.


Eligibility Criteria:
Inclusion Criteria:

* Participants with migraine who have previously participated in study NTC02163993 and received one of the selected doses of galcanezumab or placebo
* Have suitable skin characteristics for the dermal capsaicin challenge

Exclusion Criteria:

* Have a history of significant allergies, in particular to ethanol or sensitivity to the fruits of capsicum plants (for example, chili peppers)
* Have eczema, scleroderma, psoriasis, dermatitis, keloids, tumors, ulcers, burns, flaps, or grafts on their forearm or other abnormality of the skin which may interfere with the study assessments
* Cannot avoid excess tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover forearms for 24 hours prior to each treatment period
* Have excessive hair growth on the volar surface of the forearm or participants currently using lotions, oils, depilatory preparations, or other topical treatments on a regular basis which cannot be discontinued for the duration of the study; has used any topical treatments within 7 days of the start of the study
A Risk Assessment Tool to Increase Statin Use Among High Risk Cancer Survivors: Development and Pilot Testing

The purpose of this study is to collect initial data on what survivors of childhood, adolescent, and young adult cancer think of how information about statins is communicated. Statins are medications that lower cholesterol. The results of this study will be used to improve the communication about statins. This is to aid patients and their providers in making health care decisions together, also known as shared decision making.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* A personal history of cancer, tumor, or a related illness
* Followed in the Adult Long Term Follow Up Program
* Received ≥ 2000 cGy radiation to the heart/chest
* ≥Ten years post-radiation therapy to the heart/chest
* Age ≥ 25 years old

Exclusion Criteria:

* Evidence of active progression of disease or recurrence
* Neurocognitive deficits that impair ability to give informed consent
* Current use of a statin
* Diagnosis of another primary cancer for which the patient is currently undergoing radiation therapy chemotherapy, or bone marrow transplant
* Diagnosis of CVD with or without current statin use
Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With IBS-D

We will use the latest Rome IV criteria to recruit IBS-D patients and evaluate the effects of repeated treatment with rifaximin and sequential treatment with rifaximin and probiotics on different symptoms and quality of life. High-throughput sequencing combined with real-time quantitative PCR will be used to comprehensively analyze the effects of different drugs on intestinal flora. The study has important guiding significance for the treatment of patients with IBS-D.

According to the Rome IV diagnostic criteria, 200 patients with with diarrhoea-predominant irritable bowel syndrome (IBS-D) from the multi-center (8 units in the country) will be enrolled. The IBS Severity Inventory (IBS-SSS) and IBS Quality of Life Scores (QOL) will be used to evaluate the effect of treatments. Retreatment patients who are initially treated and not satisfied with the improvement of symptoms and quality of life will be treated with Rifaximin for 2 weeks. Fecal specimens will be collected from patients who responded to treatment, and the fecal bacteria will be analyzed by real-time polymerase chain reaction (PCR) using 16 S ribosomal ribonucleic acid (rRNA) gene. Patients who responded to Rifaximin treatment will be randomized into A (Probiotics group) and B (Placebo group). IBS symptom grade score and quality of life score will be evaluated before and after treatment, and fecal specimens of the responding patients will be collected for intestinal probiotics and harmful bacteria detection.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old;
* in line with the diagnostic criteria of diarrhea-type irritable bowel syndrome Roman IV；
* blood routine, blood biochemistry, stool examination and colonoscopy within 2 years are no problem;
* no intestinal warning symptoms

Exclusion Criteria:

* suffering from severe heart, lung, liver, kidney, nervous system diseases;
* suffering from mental disorders caused by schizophrenia, brain organic and physical diseases;
* suffering from other diseases that may affect intestinal function (such as diabetes, thyroid disease);
* History of previous abdominal surgery (excluding history of cholecystectomy or appendectomy);
* pregnant or lactating women;
* have undergone colonoscopy in the past month or accept other bowel preparation operations;
* In the past 1 month, have used antibiotics, antidiarrheal agents, intestinal flora regulation, Chinese medicine and other drugs;
* have participated in other dietary treatments;
* understand communication barriers, unable to communicate
Accuracy of Left Subclavian Regurgitation Evaluated by Ultrasound Doppler and 4D Flow MRI

Aortic insufficiency (IA) is defined as an abnormal regurgitation of blood from the aorta to the left ventricle in diastole, due to a lack of tightness of the aortic valves. It represents about 10% of valvular pathologies but the annual mortality of nonoperated patients can be as high as 10% to 20%. The quantification of AI is therefore important as it can remain perfectly asymptomatic for a long time.

Doppler echocardiography is currently the key examination to confirm the presence of valvulopathy, to allow positive diagnosis of valve leakage regardless of location, to specify the etiology and mechanism of regurgitation. The quantification of IA requires, in transthoracic ultrasound, to take into account many parameters that individually have all certain limitations. The recommendations are therefore to have an integrative approach considering a combination of different parameters and an overall interpretation. This makes it possible to evaluate with greater precision the importance of the leak. Thus, there is the difficulty of quantifying moderate and severe AI for lack of a truly unique criterion. One of the evaluation criteria commonly used in transthoracic ultrasound is diastolic regurgitation in the aortic arch but this assessment is sometimes difficult. The left subclavian artery (SCG) is more accessible than the aortic arch in terms of the ultrasound window. The measurements will be easier to record since the vessel is more superficial and there are fewer air interpositions than for the aortic arch. The quantification of the AI based on this new element will be compared to the other previously validated ultrasound criteria. The investigators will use this study to describe the feasibility of collecting coronary flow in the artery (IVA), and they will compare systolic velocity, diastolic rate / systolic rate ratio compared to a control group without severe aortic insufficiency (grades 2 and 3). The flows recorded in the IVA will be compared to the importance of the aortic leakage according to its different modes of quantification (ultrasound and MRI). The aim of the study will be to show that diastolic reflux in the left subclavian artery is a marker of severe AI (grades 2 and 3) by comparing this regurgitation with that measured at the level of the aortic arch and other validated ultrasound criteria and cardiac MRI.


Eligibility Criteria:
Inclusion Criteria:

* Patient able to give informed consent to participate in the study
* Patient with transthoracic echocardiography and MRI prescription

Exclusion Criteria:

* Contraindication to MRI
* Pathologies of the thoracic aorta (aneurism, dissection, stenosis)
* Pathologies of the left subclavian artery (stenosis, narrowing)
* Persistent arterial canal
* Arteriovenous fistula of the upper limb
A Study to Assess the Effects of Itraconazole and Etravirine on JNJ-64417184 in Healthy Adult Participants

The main purpose of this study is to evaluate the effects of itraconazole or etravirine on the single-dose pharmacokinetics (PK) of JNJ 64417184 in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (weight \[kg\]/height2 \[m\]2) between 18.0 and 30.0 kg/m2, extremes included, and body weight not less than 50 kg at screening
* Healthy on the basis of physical examination, medical and surgical history, and vital signs (systolic blood pressure, diastolic blood pressure, and pulse rate \[after the participant is supine for at least 5 minutes\], respiratory rate, and oral body temperature) performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Female participant must have a negative highly sensitive serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test on Day 1
* Female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 90 days after the last study drug intake
* Must not use nicotine-containing substances including tobacco products (example, cigarettes, e-cigarettes, cigars, chewing tobacco, gum, or patch) for at least 3 months prior to screening

Exclusion Criteria:

* History of liver or renal dysfunction (calculated creatinine clearance/estimated glomerular filtration rate (eGFR) less than (\<) 60 milliliter per minute (mL/min) at screening, calculated by the Modification of Diet in Renal Disease \[MDRD\] formula), significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
* - Past history of cardiac arrhythmias (example, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
* Any evidence of heart block or bundle branch block at screening
* Current human immunodeficiency virus (HIV)-1 or HIV-2 infection (confirmed by antibodies) at screening
* History of hepatitis A virus immunoglobulin M antibody, hepatitis B surface antigen, or hepatitis C virus antibody positive, or other clinically active liver disease, or tests positive for hepatitis A virus immunoglobulin M antibody, hepatitis B surface antigen, or hepatitis C virus antibody at screening
A Safety Study of Lirilumab in Combination With Nivolumab or in Combination With Nivolumab and Ipilimumab in Advanced and/or Metastatic Solid Tumors

The purpose of this study is to determine whether lirilumab in combination with nivolumab or in combination with nivolumab and ipilimumab is safe in the treatment of advanced and/or metastatic solid tumors


Eligibility Criteria:
Inclusion Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

* Participants must have histologic or cytologic confirmation of a solid malignancy that is advanced (metastatic and/or unresectable)
* Presence of at least 1 lesion with measurable disease as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) criteria for response assessment
* The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Participants with untreated central nervous system (CNS) metastases
* Participants with an active, known, or suspected autoimmune disease
* Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply
Triathlon All-Polyethylene Tibia Outcomes Study

The purpose of this study is to evaluate the clinical functional results of the Triathlon All-Polyethylene Tibia Knee Device.

This study is a retrospectively enrolled, prospective evaluation of the Triathlon All-Polyethylene Tibia (APT) for patients who meet the eligibility criteria. The enrolled cases will be followed for outcomes measured to 10 years. A modular, Triathlon metal-backed tibia (MBT) and polyethylene insert construct will be used as a historical control.

Eligibility Criteria:
Inclusions:

* Patient underwent primary TKA and is currently implanted with the Triathlon All- Polyethylene Tibia as well as compatible Stryker femoral and patellar components with no pending revision or removal.
* Patient has signed an IRB-approved, study specific Informed Patient Consent Form.
* Patient is a male or non-pregnant female and is 18 years of age or older at the time of study device implantation.
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.

Exclusions:

* Patient had an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
* Patient had distant foci of infection which could have caused hematogenous spread to the implant site at time of study device implantation.
* Patient was skeletally immature at time of study device implantation.
* Patient has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
* Patient's bone stock was compromised by disease, infection, or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
* Patient had severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
* Patient was immunologically suppressed or receiving steroids in excess of normal physiological requirements at the time of surgery (e.g. \> 30 days).
* Patient is a prisoner.
Chidamide Plus Sintilimab for Chemotherapy-refractory Advanced High-grade Neuroendocrine Neoplasm

The purpose of this study is to explore the efficacy and safety of chidamide combined with sintilimab in chemotherapy-refractory advanced high-grade neuroendocrine neoplasm.

This study is a single-arm, multi-center, two-stage, phase II clinical trial conducted in China. This study adopts Simon's two-stage design, and the inclusion criteria and exclusion criteria of the two stages were consistent. Six patients with high-grade neuroendocrine neoplasm will be enrolled in the first stage. If more than one complete or partial responses were seen at planned interim analysis, the additional 17 patients will be recruited in the second stage and a total of 23 patients will be treated.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Histologically confirmed advanced and metastatic high-grade neuroendocrine neoplasm;
3. Receive ≤ 2 types of chemotherapy for high-grade neuroendocrine tumors and had tumor progression;
4. ECOG ≤ 2;
5. Have at least one measurable lesion according to RECIST version 1.1;
6. Absolute neutrophil count ≥ 1.5×109 / L, platelet count ≥ 100×109 / L, hemoglobin ≥ 90 g/L;
7. Provide tumor samples for pathological diagnosis and PD-L1 biomarker detection;
8. Have ability to sign a written informed consent.

Exclusion Criteria:

1. Small cell lung cancer;
2. Have surgery or trauma within 4 weeks before enrollment, or are expected to receive surgical treatment;
3. Previous use of HDAC inhibitors;
4. Previous use of PD-1/PD-L1/PD-L2/CTLA-4 inhibitors;
5. Allergy to related drug components;
6. Have a medical history of immune deficiency diseases, or organ transplantation;
7. Have active autoimmune diseases requiring treatment or a medical history of autoimmune diseases in the past 2 years;
8. Have uncontrolled or significant cardiovascular disease;
9. Abnormal liver function (total bilirubin \> 1.5×upper limit of normal); Transaminases (ALT/AST) \>2.5×upper limit of normal (\>5x upper limit of normal for patients with liver metastases), abnormal renal function (serum creatinine \> 1.5×upper limit of normal);
10. Pregnancy ;
11. Receive any live or live attenuated vaccine within 4 weeks before enrollment;
12. Have serious diseases that may endanger the safety of patients, or affect patients to complete the research;
13. Any serious mental or cognitive disorder;
14. Patients are currently enrolled in another drug clinical trial within 4 weeks prior to enrollment;
15. Any other condition which is inappropriate for the study in the opinion of the investigators.
PCP in Immunocompromised Population in Southern China

To evaluate the sensitivity and specificity of the combined detection system for the diagnosis of pneumocystis infection in immunocompromised population in Southern China.

Pneumocystis jirovecii pneumonia (PJP) is a serious opportunistic infection in immunocompromised patients, with a difficult diagnosis, rapid progression and high mortality rate. The PJP mortality rate is high among patients with delayed diagnosis and treatment, and death is due to severe respiratory failure. Up to now, data regarding Pneumocystis jirovecii infection in immunocompromised patients is limited. In the present prospective study, the investigators aimed to evaluate the sensitivity and specificity of the combined detection system for the diagnosis of pneumocystis infection in immunocompromised population in Southern China.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with immunocompromised conditions, including but not limited to HIV infection, long-term systemic use of corticosteroids, use of immunosuppressive agents, hematologic malignancies, solid tumors, hematopoietic stem cell transplantation, solid organ transplantation, radiotherapy and/or chemotherapy for malignancies,primary immunodeficiency disease.
2. Patients with typical clinical manifestations of PJP such as fever,nonproductive cough, shortness of breath, and progressive hypoxemia.
3. Patients with radiological abnormalities suggestive to PJP in bilateral lungs revealed by chest computed tomography (CT).
4. Respiratory tract samples were collected for qPCR and/or mNGS detection.

Exclusion Criteria:

1. Patients who were unable to obtain a respiratory specimen.
2. Medical record was incomplete.
Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety

As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in combination.


Eligibility Criteria:
Inclusion Criteria:

* Previously enrolled in B1321001 for at least 4 weeks.
* Previously enrolled in B1321003, discontinued from the study.
* Completed the B1321003 study as planned.

Exclusion Criteria:

* Treated with an investigational drug (other than sitaxsentan or sildenafil in either B1321001 or B1321003) or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.