cyrilzakka/clinical-trials huggingface dataset:
Scrub Typhus Infection Induced Cardiovascular Disease

Scrub typhus infection has been considered as seasonal and endemic infectious disorder with benign feature. However, the increasing mortality rate of scrub typhus has been recently reported in Southeast Asia and cause of death could be a fetal complicating cardiovascular disease. Therefore, the association and predictors for scrub typhus induced cardiovascular disease should be investigated to provide a timely and appropriate diagnosis and to reduce the mortality rate of complicated scrub typhus infection. Therefore, investigators prospectively investigate the association and predictors of cardiovascular disease in the participants with scrub typhus infection.

Scrub typhus is a zoonotic disease caused by Orientia tsutsugamushi confined to East Asia including South Korea. It is characterized by fever, headache, rash, and eschar and the majority of patients without complications can recover with an early diagnosis and proper management with antibiotics. However, the increasing mortality rate of scrub typhus has been recently reported in Southeast Asia. Severe complications can be manifested by respiratory distress syndrome, renal failure, hepatic failure, and cardiovascular disease. Especially, cardiovascular complications can lead to cardiogenic shock and sudden cardiac arrest. Therefore, the association and predictors for scrub typhus induced cardiovascular disease should be investigated to provide a timely and appropriate diagnosis and to reduce the mortality rate of complicated scrub typhus infection. Therefore, investigators prospectively investigate the association and predictors of cardiovascular disease in the participants with scrub typhus infection admitted to 3rd referral centers in South Korea.

Eligibility Criteria:
Inclusion Criteria:

* any participants with scrub typhus infection

Exclusion Criteria:

* patients under age of 18
* pregnancy
Combination With Gemcitabine in Advanced Pancreatic Cancer

Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.

Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.

Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints: response duration, disease control rate, time to progression, progression-free survival, overall survival, safety and tolerability.

Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and weekly throughout the study; Safety follow-up visit 30 days after the last dose of study treatment; Survival follow up monthly for up to 8 month after LPFV.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥18 years of age
* Histological or cytologically confirmed locally advanced, inoperable or metastatic pancreatic adenocarcinoma not amenable to curative radiotherapy or surgery
* Patients must have at least one uni-dimensional measurable lesion by CT or MRI according to RECIST, Version 1.1
* Resolution of all acute toxic effects of any prior local treatment to Common Terminology Criteria for Adverse Events (CTCAE) Grade \</= 1
* Eastern Cooperative Oncology Group performance status (ECOG PS) \</= 2
* Patient has cardiac function, within normal range, as measured by an echocardiogram

Exclusion Criteria:

* Known history of, or symptomatic metastatic brain or meningeal tumors
* History of cardiac disease
* Active clinically serious infections
* Clinically significant (ie. symptomatic) peripheral vascular disease
* Pregnant or lactating women; women of childbearing potential not employing adequate contraception
* Use of strong inhibitors or inducers of CYP3A4
* Prior systemic therapy for metastatic or locally advanced, unresectable pancreatic cancer, or other malignancy
* Previous gemcitabine or 5-fluorouracil (5-FU) given concurrently as radiosensitizers to radiation therapy in adjuvant intention if given within 6 months from start of study treatment
* Thrombotic or embolic events such within 6 months prior to start of study treatment
A Multicenter Cross-sectional Study on Mental Health of Patients With Multiple Myeloma

Multiple myeloma patients with normal ability of communication and understanding will be enrolled. DT, GAD-7, PHQ-15 and PSQI scales are designed to assess the mental health status of the patients. Demographic and disease data of patients will be collected as well. The main aim is to explore the factors affecting the mental health of myeloma patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with symptomatic multiple myeloma were diagnosed according to the criteria of Chinese multiple myeloma diagnosis and treatment guidelines (revised in 2022).
2. Age ≥18 years, with junior high school education or above. Patients have normal ability of communication and understanding.
3. Informed consent has been signed.

Exclusion Criteria:

1. Who has kinship with other enrolled patients.
2. Life expectancy of\< 6 months.
ZOOMit-fMRI Identifies Language Functional Cortex

This Study was designed to collect a series of patients with gliomas which were involved in language related cortex to analyze difference accuracy of language related cortex localization between BOLD-fMRI and ZOOMit-fMRI.

Gliomas can cause language dysfunction when they are involved in language related cortex. However, tumor resection also have risk to lead postoperatively language function deficits if destroy patients' language related cortex when tumor removed. Hence, it is important for neurosurgeon to realize the situation of patients' language related cortex locations in order to determine personal operative protocol.

The blood oxygen level dependent fMRI (BOLD-fMRI) is a prevalent preoperative method to localization language related cortex. It shows language relevant cortex by the change of blood oxygen level when patients cooperate to finish language tasks. The advantage of BOLD-fMRI includes higher time and spatial resolution, higher sensitivity, non-invasive. However, its accuracy of localization has not been satisfactory because neurovascular uncoupling. The ZOOMit-fMRI is a novel technic which is evolved from conventional BOLD-fMRI to localize language functional cortex.The advantage of ZOOMit-fMRI is smaller field of view (FOV) and higher spatial resolution comparing with BOLD-fMRI which helps to reduce other region of brain interference and elevate accuracy of localizations.

In this study, the investigators plan to enroll 60 patients, whose gliomas are involved in language related cortex, to acquire their BOLD-fMRI and ZOOMit-fMRI data in order to analyze their difference in the accuracy of language related cortex localization.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years;
2. no history of surgical treatment or radiotherapy;
3. no contraindication to MRI scanning;
4. agreeable to receive the fMRI scanning and awake craniotomy with DCS

Exclusion Criteria:

1. basing on the anatomic MRI, the distance from the tumor to the hand-knob area lower than 20 mm;
2. disable to finish the task of clenching fist during fMRI scanning.
Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients

The incidence of thrombocytopenia in ICU patients with severe illness ranged from 8.3% to 67.6%, and ranged from 14% to 44% during ICU treatment.Severe patients with thrombocytopenia also have significantly increased bleeding events and blood transfusions, and even a significantly increased risk of death.This study examines whether elevated platelets benefit patients with pneumonia


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of pneumonia (community acquired pneumonia, hospital acquired pneumonia or ventilator associated pneumonia);
* Voluntarily signed informed consent;
* ≥18 years old;
* Platelet count ≤75×109/L

Exclusion Criteria:

* A history of hematopoietic stem cell transplantation or solid organ transplantation such as liver, kidney or lung;
* Hematological malignancy;
* Immune thrombocytopenia, such as SLE, ITP, TTP, etc.
* The length of stay in ICU is less than 24h;
* Pregnant or lactation patients;
Assessment of the Impact of TIP Score on Thromboprophylaxis in Patients With Non-surgical Lower Leg Trauma.

Traumatic lesions are the leading causes of admission to the emergency center (39%), isolated non-surgical lower limbs trauma are in the foreground. Two recent meta-analyzes suggest the value of Low Molecular Weight Heparins (LMWH) which would reduce symptomatic Thromboembolism Events (TE) in patients with lower limb trauma. However, many recent studies conclude to the need of stratifying the TE risk according to the patient and the nature of his trauma to obtain an individualized therapeutic decision.

The retrospectively established L-TRIP (cast) score allows stratification of the risk without taking into account the type of trauma. The TIP score (Trauma, Immobilization and Patient) was established by consensus of international experts via the Delphi method.

We suggest that the application of the TIP score to rationalize indications of thromboprophylaxis in patients with isolated non-surgical trauma of a lower limb should reduce the rate of anticoagulation prescription without increasing the risk of symptomatic thromboembolic complications with a direct benefit for patients and medico-economic for the society.

All patients admitted to the Emergency Departments for a nonsurgical isolated lower limb trauma necessitating rigid or semi-rigid immobilization, will be assessed for possible participation.

After the physicians had obtained the no-opposition of the patient, they will fill a questionnaire. This questionnaire includes the treatment chosen by the physician, the type of trauma, the type of immobilization chosen, and the patient's thromboembolic risk factors in order to calculate the TIP and L-TRIP (cast) scores retrospectively.

Phone follow-up will occur within 3 months to gather clinical event data (any signs of VTE, any bleeding events).

Eligibility Criteria:
Inclusion Criteria:

* Consultation in one of the emergency departments of the participating centres
* Isolated unilateral lower limb injury not requiring surgery
* Lower limb rigid or semi-rigid orthopedic immobilization (i.e. brace of plaster cast) for at least 5 days.
* Full insurance cover

Exclusion Criteria:

* Any anticoagulant or antiplatelet treatment prior to trauma
* Contra-indication to fondaparinux or LMWH
* Factors rendering 3-month follow-up impossible
* Imprisonment
* Inability to provide informed consent
Living Donor Liver Transplantation in Children

Evaluate the outcome of pediatric living donor liver transplantation (LDLT) regarding portal vein reconstruction, ABO-compatibility and impact of maternal donation on graft acceptance.

Data from 250 pediatric LDLT recipients (and their donors), transplanted at Cliniques universitaires Saint-Luc between July 1993 and June 2012, were collected retrospectively using electronic data files. Results were analysed according to ABO matching and portal vein complications. Uni- and multi-variate analysis was used to study the impact of immunosuppression, gender match and maternal donation on acute rejection rate.

Eligibility Criteria:
Inclusion Criteria:

* Children receiving a living donor liver transplant
* Adult living donors

Exclusion Criteria:

* No one
A Phase Ib Study of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Moderate Renal Impairment

A study to investigate the effects and safety of AZD5462 on top of dapagliflozin in participants with heart failure and moderate renal impairment.

This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate the safety, pharmacodynamics, and pharmacokinetics of AZD5462 on top of dapagliflozin in participants with heart failure and renal impairment.

The study will include 5 periods and approximately 9 study site visits:

* Screening Period of up to 4 weeks (at least one study visit)
* Run-in Period of up to 4 weeks (one study visit)
* Inpatient Treatment Period of 4 days (one study visit)
* Outpatient Treatment Period of up to 4 weeks (three study visits)
* Follow-up Period of up to 4 weeks (three study visits)

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a pre-existing diagnosis of heart failure (HF).
* Participants must have a left ventricular ejection fraction (LVEF) of ≤ 40% based on echocardiography taken within the last 9 months.
* Participants must have an estimated glomerular filtration rate (eGFR) of 30 to 60 milliliters per minute per 1.73 meters squared (mL/min/1.73 m2) (inclusive) at Screening as assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 (creatinine) equation.
* Participants must be on stable HF standard of care (SoC) medication for at least 4 weeks prior to Screening. If the participant is currently taking diuretics, then diuretics must also be stable for at least one week prior to Screening.
* Participants must be on stable Sodium-glucose co-transporter-2 inhibitors (SGLT2) inhibitor treatment for at least 12 weeks prior to Screening.
* Minimum BMI of 18 kilograms per meter squared (kg/m2) at Screening.

Exclusion Criteria:

* Historical or current evidence of a clinically significant disease or disorder.
* Participants with a known hypersensitivity to AZD5462 or dapagliflozin, or to any of the excipients of these drug products.
* Congenital long QT syndrome or history of QT prolongation associated with other medications that required discontinuation of that medication.
* Cardiac ventricular arrhythmia that requires treatment. However, participants with atrial fibrillation or flutter and controlled ventricular rate (eg, resting heart rate \< 110 beats per minute) are permitted. Participants with cardiac ventricular arrhythmia that are treated with antiarrhythmic agents (eg, amiodarone) and are stable are permitted.
* History of or anticipated heart transplant.
* Any planned highly invasive cardiovascular procedure (eg, coronary revascularisation, valve repair/replacement, aortic aneurysm surgery).
* Any evidence of clinically important disease or disorder which in the Investigator's opinion makes it undesirable for the participant to participate in the study.
* Positive hepatitis C antibody, hepatitis B virus surface antigen, or hepatitis B virus core antibody at Screening.
Early Enteral Nutrition in Severe Acute Pancreatitis

to compare different time points for enteral nutrition in SAP patients

There is increasing evidence that indicates Early Enteral Nutrition（EEN） may be associated with improved outcome in acute pancreatitis patients. However, some SAP patients failed to EEN. The researchers of this study aim to investigate the opportunity of EEN on the clinical outcomes of SAP patients.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of pancreatitis: Typical pain increase in serum lipase or amylase
2. Onset of abdominal pain within \<=72h before admission
3. moderate severe or severe Acute Pancreatitis according to Atlanta criteria revisited in 2012 ffff

   Exclusion Criteria:
   * 1. Pregnancy 2.tumor 3. acute onset of chronic pancreatitis
4. chronic disease of any organ （heart lung gastrointestinal renal etc.） 5. Pre-existing disease with life expectancy \< 3 months 7.receive parenteral nutrition or enteral nutrition before admitting
A First in Human Study for the Versa Device for Tricuspid Regurgitation

This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical candidates.


Eligibility Criteria:
Inclusion Criteria:

* Tricuspid regurgitation (TR) associated symptoms despite optimal medical treatment.
* TR ≥ 3 as determined by the assessment of a transthoracic echocardiogram or transesophageal echocardiogram.
* The local multi-disciplinary heart team agrees that the participant is a poor candidate for surgery.
* Age ≥ 18 years at the time of consent.
* Ability and willingness to provide written informed consent prior to any study related procedure(s).

Exclusion Criteria:

* Severe pulmonary hypertension.
* Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mmHg.
* Any condition that would interfere with the Versa procedure, such as prior tricuspid valve repair or tricuspid valve leaflet anatomy which may preclude successful device implantation, pacemaker or Implantable Cardioverter Defibrillator (ICD) leads that would prevent appropriate placement or visualization of Versa implant, Ebstein Anomaly (normal annulus position, but valve leaflets attached to walls and septum of the right ventricle), tricuspid valve anatomy non-evaluable by echocardiography.
* Known allergy to antiplatelet therapy, heparin, or to device materials.
* Femoral venous mass or thrombus or vegetation.
* Tricuspid valve anatomy not compatible with the Versa implant
* Undergone any heart valve surgery within prior 60 days.
* Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 4.0 cm2.
* Severe mitral regurgitation.
* Left Ventricular Ejection Fraction (LVEF) ≤ 20%
* Active endocarditis, other ongoing infection requiring antibiotic therapy.
* Myocardial infarction or percutaneous coronary intervention within prior 30 days.
* Cardiogenic shock or the need for inotropic support or hemodynamic support device (e.g., intra-aortic balloon pump).
* Cerebrovascular Accident (CVA) within prior 30 days
* Active gastrointestinal (GI) bleeding
* Life expectancy of less than 12 months independent of tricuspid valvular disease.
* Subject currently participating in another clinical study (not yet completed primary endpoint).
* Pregnant or nursing subjects or those who plan pregnancy during the study.
* The presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the eye of the investigator, limits the subject's ability to participate in the clinical investigation or comply with follow-up requirements.
* Absence of appropriate venous access.
* Unwillingness to complete the required follow-up visits.
AS703569 and Gemcitabine Combination in Advanced Malignancies

In clinical practice and research, combination of anticancer agents is often used to improve efficacy of treatment. In vitro and in vivo experiments have shown additive-synergistic anti-tumour effects of AS703569 treatment when combined with gemcitabine. Specifically, additive-synergistic anti-tumour effects were noticed when the two agents were given sequentially and not concomitantly i.e. AS703569 given the day before or the day after gemcitabine. This trial was designed to investigate in parallel two regimens testing sequential administration of AS703569 either the day after gemcitabine infusion, (Regimen 1) or the day before (Regimen 2).


Eligibility Criteria:
Inclusion Criteria:

Histologically/cytologically confirmed diagnosis of measurable or assessable malignancy, who meets one of the following conditions:

Subject with a tumour for which gemcitabine is approved, Subject with a tumour for which gemcitabine is considered standard of care, Subject with other tumour type either refractory or intolerant to or for whom there is not an accepted standard treatment.

Male or female with at least 18 years of age. Life expectancy of at least 3 months.

Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2.

No more than 3 prior chemotherapy regimens for advanced/metastatic disease.

At least 4 weeks since last chemotherapy, hormonal therapy, immunotherapy, biological or any other pharmacological or investigational treatment or radiotherapy (6 weeks wash-out for nitrosoureas and mitomycin C, 5 half-lives for non-cytotoxics). Subjects on chronic hormonal therapy may continue with the same treatment unchanged.

Adequate renal, hepatic and bone marrow functions (assessed 7 days before inclusion in the trial) as defined by:

Serum creatinine
A Food-Drug Interaction Study of Serum Urate After Oral Inosine

The purpose of this study is to assess the effects of food on the amount of urate in the body after a single oral dose of inosine.

Eighteen (18) eligible healthy male subjects will be randomly assigned to two groups with 9 subjects per group to receive a single oral dose of 1000 mg inosine with or without food on day 1 after an overnight fast. Subjects who receive inosine with food on day 1 will receive a second dose of inosine without food on day 8 after an overnight fast. Subjects who receive inosine without food on day 1 after an overnight fast will receive a second dose of inosine with food on day 8 after an overnight fast.

Subjects will be admitted to the clinic before dinner on days 0 and 7, the days before dosing, and will stay in the clinic for 48-h post-dose. During the clinic stay, blood samples will be taken for urate measurements.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects between the ages of 18 and 65 years
2. Body-mass index between 18.0 kg/m2 and 32.0 kg/m2
3. If not surgically sterile, willing to refrain from donating sperm and willing to use appropriate birth control when engaging in sexual intercourse for a period of 90 days following the last dose of the study medication
4. Serum urate \< 6.1 mg/dL (approximately 360 μM) at screening
5. Non-smokers for at least 6 months prior to screening
6. Adequate venous access at multiple sites in both arms

Exclusion Criteria:

1. History of alcohol or drug dependence in the past 2 years
2. Had 400 mL of whole blood collection within four months or 200 mL of whole blood collection or who had blood component collection within one month of the screening test
3. Used prescription or over-the-counter (OTC) drugs within 14 days prior to screening
4. Used vitamin preparations or supplements (including St. John's Wort and ginseng) within 28 days prior to the screening test
5. Not willing to refrain from alcohol, grapefruit, grapefruit juice or related products, caffeine consumption (including chocolate), and strenuous exercise within 72 h prior to day 1 and through the end of the PK study
6. Treated with an investigational drug within 30 days or 7 half-lives of the investigational drug, whichever is longer, prior to the first dose of study drug
7. Previously received inosine supplement within three months from the screening or subjects who have had any inosine and suffered an adverse reaction due to it
8. Known HIV disease
9. Had a febrile illness within 5 days prior to the first dose of study medication
10. Vaccinated within 30 days prior to the first dose of medication
11. Has gout or a history or suspicion of kidney stones
12. Determined by the investigator or sub-investigator to be unsuitable for participating in the study based on medical conditions