cyrilzakka/clinical-trials huggingface dataset:
Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)

The purpose of this study is to evaluate pharmacokinetics (PK) and safety of a single oral dose of ulonivirine in participants with mild or moderate hepatic impairment (HI). It is hypothesized that the area under the plasma concentration-time curve from dosing to (extrapolated) infinity (AUC0-∞) in participants with mild or moderate HI is similar to that of healthy control participants.


Eligibility Criteria:
Inclusion Criteria:

Mild and Moderate HI (Panels A and B):

* Has a diagnosis of chronic (\>6 months), stable HI with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepatic function)

Healthy Controls (Panel C):

* Is in good health

All Participants (Panels A to C):

* Has a body mass index (BMI) ≥18.5 and ≤40 kg/m\^2, inclusive
* If male, uses contraception in accordance with local regulations
* If female, is not pregnant or breastfeeding and one of the following applies: 1) is not a woman of childbearing potential (WOCBP), or 2) is a WOCBP and is abstinent/uses acceptable contraception, has a negative highly sensitive pregnancy test within 24 hours of receiving study intervention, and provides medical/menstrual/recent sexual history for review by the investigator

Exclusion Criteria:

Mild and Moderate HI (Panels A and B):

* Has a history of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study
* Is not in sufficient health
* Is institutionalized/mentally or legally incapacitated
* Is positive for human immunodeficiency virus (HIV)-1 or HIV-2
* Has received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to study start
* Is taking medication for a chronic condition and has not been on a stable regimen for ≥ 1 month

Healthy Controls (Panel C):

* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Is mentally or legally incapacitated
* Is positive for hepatitis B virus surface antigen (HBsAg), hepatitis C antibodies, HIV-1, or HIV-2
* Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to first dose of study drug

All Participants (Panel A to C):

* Has a history of cancer (malignancy)
* Has a history of significant multiple and/or severe allergies
* Has known hypersensitivity to the active substance or any of the excipients of the study drug
* Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to Screening
Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients With Intraductal Papillary Mucinous Neoplasms

The purpose of this study is for researchers to find ways of detecting pancreatic ductal adenocarcinoma/PDAC early to avoid the invasive procedure of surgery. The study researchers think a combination of imaging and a series of blood tests may be an effective way to detect PDAC early. In this study, researchers will look at whether a combination of the following types of imaging with blood tests can detect PDAC in pancreatic cysts:

* The ImmunoPET scan (immune-positron emission tomography scan) with the imaging agent 89Zr-DFO-HuMab-5B1
* The HP MRI scan (hyperpolarized pyruvate magnetic resonance imaging scan)


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged \>18 years
* Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection
* Able to provide informed consent

Exclusion Criteria:

* Pathologic evidence of pancreatic cancer
* Pregnant or breast-feeding patients
* Refusal or inability to tolerate scan (eg anxiety or claustrophobia)
* Inability to lay flat or meet the standard requirements of traditional MRI
* Hepatic function from assays obtained within 6 weeks prior to the study enrollment. For each patient, the upper limit of normal (ULN) value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay

  1. Bilirubin \> 1.5 x ULN
  2. AST/ALT \> 2.5 x ULN
  3. Albumin \< 3 g/dL
  4. GGT \> 2.5 x ULN if Alkaline Phosphatase \> 2.5 x ULN
* Renal function with Creatinine \> 1.5 x ULN or creatinine clearance \< 60 mL/min, from assays obtained within 6 weeks prior to study enrollment
* Cardiac: congestive heart failure with New York Heart Association (NYHA) status ≥2, poorly controlled hypertension, a history of clinically significant EKG abnormalities, or myocardial infarction within 6 months of study enrollment.
Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome

This study evaluates the less invasive surfactant administration (LISA) combined with synchronized nasal intermittent positive pressure ventilation (SNIPPV) technique in the treatment of respiratory distress syndrome (RDS) of preterm neonates. The modified InSurE group will receive "LISA + SNIPPV" technique, while the traditional InSurE group will receive the intubation, surfactant, extubation and CPAP technique.


Eligibility Criteria:
Inclusion Criteria:

1. premature infants with birth weight \< 2500g and gestational age \< 36+6 weeks;
2. High-risk premature infants with early symptoms of RDS or infants who are diagnosed clinically RDS.
3. the participating hospital obtained the consent of the Ethics Committee.
4. parental informed consents were obtained.

Exclusion Criteria:

1. severe congenital malformations.
2. severe cyanotic congenital heart disease (such as transposition of great artery, tetralogy of Fallot, etc.) which affects systemic hemodynamics.
3. congenital hereditary metabolic diseases.
4. parental informed consent was not obtained.
SP2086 Pharmacokinetic Study in Renal Insufficiency Patients

The purpose of the study is to investigate the SP2086 pharmacokinetic in Renal Insufficiency Patients.

This trial adopt in a parallel, open, single dose study design. The subject was divided into one of five groups according to the degree of renal Insufficiency, which including normal, mild, moderate, severe, and end-stage. All subjects were given SP2086 50mg, and collected the blood samples before and after the medicine taken.

Eligibility Criteria:
Inclusion Criteria:

* with a body mass index(BMI) between 19 and 28 Kg/m2;Weight:≥50Kg(male),≥45kg(female)
* The endogenous creatinine clearance of subjects in groups must meet the standards of Ccr in renal function in installment:mild renal insufficiency:60-89 - ml/min;Moderate renal insufficiency: 30 to 59 ml/min;Severe renal insufficiency: 15-29 ml/min;End-stage renal disease: \< 15 ml/min.Normal renal function: 90 ml/min or more.
* Had signed the informed consent himself or herself voluntarily.

Exclusion Criteria:

* Cannot tolerate oral medicine.
* Not control or unstable cardiovascular, respiratory, liver, digestive, endocrine, hematopoietic, the mental or nerve system diseases.
* Had the digestive surgery that could affect drug absorption.
* The clinical significance of arrhythmia.
* Acute hepatitis, chronic liver disease; ALT or AST value was 2 times greater than upper normal limit, Total bilirubin value was 1.5 times greater than upper normal limit.
* HBV surface antigen, HCV antibody, or HIV antibody was positive.
* history of drug allergy or allergic constitution or family history of allergy.
* Had Used hormonal contraception within 3 months;
* Had Used DPP - IV inhibitor within 2 weeks;
* Had Used traditional Chinese medicine (Chinese herbs, Chinese patent medicine) within 2 weeks;
* Had Used acid inhibitors within 2 weeks;
* Alcohol, tobacco, drug abusers;alcohol abuse is defined as a day for regular alcohol consumption more than the following standards: beer 570 ml, light beer 750 ml, red wine 200 ml, white wine 60 ml, which including about 20g alcohol;Tobacco is defined as five or more per day.
* 2 days before the randomization till to the end ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion
* The patient had participated three times or more clinical trial in one year, or one time within 3 months.
* Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test.
* History of blood donation or participate in blood donation, or by blood transfusion in 3 months prior to screening.
* Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.
A Study to Characterize the Disease Behavior of Idiopathic Pulmonary Fibrosis (IPF) and Interstitial Lung Disease (ILD) During the Peri-Diagnostic Period

This international clinical study will enroll participants with a suspected diagnosis of IPF/ILD. This study will characterize the disease behavior of IPF and ILD in the peri-diagnostic period. This objective will be achieved using a multidimensional approach assessing changes in pulmonary function, measured by daily handheld spirometry and site spirometry as well as assessing physical functional capacity at home (accelerometry) and at site (6-minute walk tests \[6MWT\]). Daily handheld spirometry or physical functional capacity assessments are not routinely performed in this participant population. By following participants' lung function before and after diagnosis using home spirometry, levels of physical activity, as well as self-assessment data from the participants (patient reported outcomes; PRO), the study would provide potentially more rapid information on disease behavior and eventually progression compared to usual clinic measurements that occur only every 3-6 months. By receiving data from daily handheld spirometry measurements, treating physicians may have an improved chance of detecting earlier and outside of hospital visits a decline in lung function that could potentially lead to improvements in both diagnosis and treatment for participants with IPF/ILD.


Eligibility Criteria:
Inclusion Criteria:

* Able to comply with the study protocol, in the Investigator's judgment - for example, the ability to use the provided spirometer and tablet and the ability to fill in the required patient reported outcomes questionnaires
* Suspicion of IPF/ILD: radiological evidence of IPF/ILD in symptomatic participants (unexplained dyspnea on exertion and/or cough)

Exclusion Criteria:

* Participation in any investigational study within 28 days prior to inclusion
* History of clinically significant cardiac disease that could explain the patient's symptomatology in the opinion of the Investigator
* Known history of any connective tissue disease, including, but not limited to, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, or mixed connective tissue disease
Exercise and Cardiac Stunning During HD

The purpose of this study is to determine the effect of a 12-week cycling during hemodialysis program on hemodialysis-induced myocardial stunning in adult individuals receiving hemodialysis.

People with kidney failure receiving chronic hemodialysis (HD) suffer from post-HD treatment fatigue, poor functional status and high rates of cardiac failure and death. Previous work has shown that these outcomes are correlated with recurrent ischemic cardiac injury (myocardial stunning) that occurs during HD treatments. Myocardial stunning, identified by regional cardiac wall motion abnormalities (RWMA), is common during HD. Intradialytic cycling (during HD) decreases HD-induced stunning, and may improve adverse outcomes associated with stunning. We will use echocardiography (echo) to understand the effects of intradialytic aerobic exercise on myocardial stunning and HD-related symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Adults greater than or equal to 18 years old (no upper age limit); who are greater than; 3 months after starting maintenance hemodialysis
* No expected change in dialysis modality, elective surgery or relocation outside of study site during the intervention period (16 weeks)
* Assessed to be safe and able to exercise by the hemodialysis unit nephrologist
* Able to communicate in English and provide written informed consent
* Must be dialyzing thrice weekly

Exclusion Criteria:

* Acute coronary syndrome in the past 3 months
* Unstable arrhythmia
* Shortness of breath at rest or with minimal activity (NYHA Class 4)
* Symptomatic hypoglycemia (\&amp;gt;2x/week in week prior to enrolment)
* Participating in clinical intradialytic cycling program in last 3 months (if a clinical program exists)
Voriconazole-Induced QT Interval Prolongation: A Prospective Study

The antifungal voriconazole is effective for the treatment of invasive fungal infections in immunocompromised patients. A serious adverse reaction is QT interval prolongation, which may precede life-threatening arrhythmias, such as torsades de pointes. Although ventricular arrhythmias are mentioned as a possible adverse effect of voriconazole, thus far, the incidence and clear recommendations for QT follow-up have not been published. This prospective observational study aimed at describing the incidence of voriconazole induced- QT interval prolongation in the pediatric population and determine the risk factors for this phenomenon.


Eligibility Criteria:
Inclusion Criteria:

* oral or IV treatment with voriconazole

Exclusion Criteria:

* No data prior to initiation of voriconazole treatment on QT interval (baseline ECG)
* Renal insufficiency or dialysis treatment
Predictive Models of Hepatic Decompensation and Survival Outcomes in Pediatric Patients With Cirrhosis

The aim of this study was to developed and validated models to predict hepatic decompensation and survivals in pediatric patients with cirrhosis and compared these models with currently available models.

Noninvasive liver fibrosis tests such as the NAFLD fibrosis score (NFS), Hepascore, and transient elastography were specifically developed to predict fibrosis and can help predict patients with NAFLD at the highest risk of developing liver-related complications. These tests have been widely applied in adult cirrhosis. The accuracy of these models, however, may be influenced by patient factors including age, body mass index, and diabetes, potentially limiting their prognostic accuracy and clinical practicability in children. Therefore, it is currently unknown how to best predict hepatic decompensation and survival outcomes among pediatric patients with cirrhosis. To fill this knowledge gap, the investigators performed a retrospective-prospective cohort study with the aim of developing and validating a clinical model to predict liver-related complications and survival outcomes in pediatric patients with biopsy-proven with cirrhosis. Secondly, the investigators aimed to compare the predictive accuracy with currently available noninvasive model.

Eligibility Criteria:
Inclusion Criteria:

* Age up to 18 years old
* No previous episodes of clinical decompensation
* With written informed consent

Exclusion Criteria:

* Clinical data missing
* Without written informed consent
SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe Acute Exacerbations of Chronic Bronchitis (AECB)

In this study data of patients with moderate or severe acute exacerbations of chronic bronchitis (AECB) were collected. There were two different cohorts which were compared (Moxifloxacin and other antibiotics) concerning effectiveness and tolerance. It was a prospective study which was accomplished in 100 ambulatory practice offices.

The study design was slightly changed to adapt the target population. Due to these changes the study was restarted on 8th December 2009.

Eligibility Criteria:
Inclusion Criteria:

* Acute exacerbation of chronic bronchitis from Anthonisen type I or II
* FEV1 of \< 50 %
* Patient must be ensured in the statutory health insurance
* Further contraindications of the prescribed pharmaceutical products must be considered

Exclusion Criteria:

* Patients who change from one cohort to the other
12-Week No-Rofecoxib Plus Aspirin Endoscopy Study (0782-003)

This study will look at the incidence of gastric and/or duodenal ulcers in patients with osteoarthritis or rheumatoid arthritis in four different treatment groups (a) MK0782 21 mg plus enteric-coated aspirin, (b) MK0782 42 mg plus enteric-coated aspirin, (c) celecoxib 200 mg plus enteric-coated aspirin, and enteric-coated aspiring alone.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* Has osteoarthritis or rheumatoid arthritis for at least 6 months prior to start of study
* Osteoarthritis (OA): must have diagnosis of OA in knee, hip, hand or spine

Patient is not on chronic aspirin therapy (taking aspirin at any dose, on a daily basis, for a minimum of 4 weeks prior to Visit 2 for any medical condition

* Must be willing to limit alcohol use to no more than 2 drinks per day
* Avoid strenuous physical activity

Exclusion Criteria:

* Mentally or legally incapacitated
* Has systemic lupus erythematosus, Paget's disease
* Has a history of esophageal, gastric biliary, or small intestine surgery (hiatal surgeries and any GI surgery that causes clinical malabsorption or delayed gastric emptying
* Has uncontrolled hypertension
* Has uncontrolled diabetes
* Has had heart attack, unstable angina, coronary angioplasty, stent placement, coronary artery bypass grafting in the last 6 months
* Has congestive heart failure
* Has had active liver disease within the last 2 years
Different Doses of IVIG for Kawasaki Disease

The objective of this study is to investigate the effect of different doses of intravenous immunoglobulin (IVIG) (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease (KD) in a multicentre, prospective,randomised trial.

Kawasaki disease is an acute febrile illness recognized most often in young children. Coronary abnormality is the most serious complication preventable with intravenous immunoglobulin (IVIG) administration. Various treatment regimens of IVIG have been reported.The optimal administrative doses of IVIG deserves more observations.We will conduct a multicenter, randomized, prospective trial to determine the effect of different doses of IVIG (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease. The KD children will be randomly assigned to three groups and were given different IVIG regimen (1g/kg once, 1g/kg twice, 2g/kg once)as initial treatment. Patient age, gender, white blood cell count, hemoglobin, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), red blood cell specific volume (HCT) , serum albumin, the fever days,and the cost of hospital stay will be analyzed among the three groups. The primary outcome is the duration of fever subsided and the incidence of coronary artery lesions .

Eligibility Criteria:
Inclusion Criteria:

* Individual patient's medical file data confirmed the diagnosis of KD using the 5th revised edition of diagnostic criteria for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002.
* the patients aged from 1 months to 12 years old.
* All included patients required to sign an informed consent form.
* the patients didn't receive treatment before.

Exclusion Criteria:

* The patients with the application of hormone or other immunosuppressive agents;
* The patients didn't want to signed informed consent.
Virtual Reality Intervention Procedure Simulator

The purpose of this study is to prove the effectiveness of the virtual reality program in educating lumbar transforaminal epidural blocks to novice doctors.


Eligibility Criteria:
Inclusion Criteria:

* Residents in department of anesthesiology and pain medicine unfamiliar with fluoroscopy guided epidural block

Exclusion Criteria:

* Residents in department of anesthesiology and pain medicine familiar with fluoroscopy guided epidural block
Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis

This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear.


Eligibility Criteria:
Inclusion Criteria:

* at least 3 months of age and less than 13 years of age
* atopic dermatitis of moderate severity

Exclusion Criteria:

* pregnant or lactating
* treatment of atopic dermatitis with topical product in the 14 days prior to Baseline
* treatment of atopic dermatitis with systemic product in the 30 days prior to Baseline
* serious or uncontrolled medical condition
* active infection
* significant use of inhaled, intranasal, or intraocular corticosteroid
Assessment of Service and Hearing Dogs

For persons with impairments and certain illnesses the use of service dogs may have positive effect. The effects of using these dogs to assist in every day life need to be studied further.The aim of the study was to assess how health care consumption was effected by using certified service dogs and to study the cost-effectiveness of having a certified service dog.

This is an exploratory before and after study with the aim to study how health care consumption was effected by using certified service dogs and to study the cost-effectiveness of having a certified service dog. Data was collected before the education of the dog started and the follow-up was made three months after completion of the education. Data was collected on Health care consumption and outcomes in terms Health related quality of life and Health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age over 16 years
* Having a regular companion dog
* Being in need of a certified service dog (due to impairment, diabetes, epilepsy and deafness)

Exclusion Criteria:

* Psychiatric illness