cyrilzakka/clinical-trials huggingface dataset:
An Study of Efficacy and Safety of Clevudine

Randomized, double blind parallel group, positive control, multi-center trial. Patients will be randomized at 1:1 ratio in group A or group B


Eligibility Criteria:
1. Patients are between 18 and 65, inclusive.
2. All the male and female reproductive-aged subjects should use reliable and appropriate contraceptive method from the entrance of screening to at least 3 months within the end of study.
3. Hepatitis B virus Early Antigen (HBeAg) positive patient with HBV DNA \>1 x 105 copies/ml, HBeAg negative patient with HBV DNA \>1 x 104 copies/ml within 30 days of baseline.
4. Absolute neutrophil count \> 1500 /mm3.
5. Alpha fetoprotein within normal laboratory limit at screening.
6. Normal electrocardiogram (ECG) or clinically non-significant changes at screening.
7. Able to participate and willing to give written informed consent before starting therapy.
8. Able and willing to comply with study assessments and restrictions.
9. Normal renal function to take Adefovir without any dose modifications; Creatinine clearance must be \>50 ml/min (based on the Cockcroft-Gault equation.

Exclusion criteria

1. Subjects coinfected with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus
2. Patients previously or currently treated with approved and investigational nucleosides (e.g.: lamivudine, adefovir. entecavir, lobucavir, famciclovir, tenofovir, telbivudine) for any duration.
3. Other chronic hepatic disease. e.g. chronic alcoholism. Wilson's disease.
4. Poorly controlled type I or type 2 diabetes mellitus
5. Donation or loss more than 400 ml blood within 60 days of baseline.
6. Known serious allergies to nucleoside/nucleotide analogs.
7. Subjects who are pregnant, nursing, or unwilling to use appropriate form of contraception.
Lung Tissue Research Consortium

The LTRC will facilitate histopathological research of pulmonary diseases by collecting lung tissues from donors and preparing and distributing collections of tissue specimens to researchers within and outside the LTRC. Collections of specimens will be linked to individual clinical data appropriate to the particular disease. The primary goal of the LTRC is to identify participants with suspected lung cancer or metastatic disease who are willing to provide informed consent for research use of their specimens and data. Secondarily, the LTRC investigators intend to collect clinical data, limited exposure data, physiologic studies, and radiographic studies from these participants.


Eligibility Criteria:
Inclusion Criteria:

* Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases.

Exclusion Criteria:

* Diagnosis of cystic fibrosis or pulmonary hypertension.
* Any other condition that, in the judgment of the investigator, precludes participation.
* Failure to obtain written consent.
Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes

The purpose of this study is to determine the preference of RA patients for the new Enbrel® (etanercept) pre-filled syringe in patients who are already taking Enbrel®.


Eligibility Criteria:
Inclusion Criteria:

* Have established RA diagnosis as determined by ACR criteria
* Be current user of etanercept-lyophilized preparation for at least 4 consecutive weeks of etanercept dosing on either a once weekly or twice weekly regimen
* Subject must be able to self inject
* Give written informed consent

Exclusion Criteria:

* Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
* Subject of childbearing potential is pregnant (e.g., positive HCG test) or is breast-feeding
* Elective surgery is planned during study period
* Subjects allergic to latex
Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies

The primary objective of this study is to assess the safety and outcomes of infants and children who were exposed to retosiban or comparator in utero in the Phase III spontaneous preterm labor (SPTL) treatment studies, to provide assurance that treatment is not associated with significant adverse outcomes in early childhood. The enrolled infants and children will be followed at pre-specified intervals until they reach 24 months chronological age. This study does not require medical interventions or study visits to an investigational site, instead, parents or legal guardians will be prompted at certain time points to complete developmental questionnaires and other data on their children's health status via an electronic device. Data collected during the infant and child follow up study will be managed by a centralized research coordinating center (RCC). Regionally based pediatricians will serve as study principal investigators (referred to as RCC-PIs) for this study. All communications the RCC-PI has with the parent/legal guardian or the child's health care provider (HCP) will occur remotely; there will be no clinic visits.


Eligibility Criteria:
Inclusion Criteria:

* Mother is randomly assigned and dosed (retosiban or comparator) in 1 of the Phase III SPTL retosiban clinical studies.
* Infant is alive at 28 days post EDD.
* Written informed consent is obtained from the parent(s) or legal guardian(s) of the infant. The parent/legal guardian of subjects aged 12 to 17 years must also provide written agreement for the infant to participate in the study where required by applicable regulatory and country or state requirements.

Exclusion Criteria:

* There are no formal exclusion criteria for participation.
Predicitve Use of Spot Urine Protein/Creatinine Ratios in Preeclampsia

The investigators intend to perform a large prospective study looking at the predictability of the random urine protein-to-creatinine ratio compared to the gold standard 24-hour urine protein collection. Furthermore, the investigators plan to investigate whether analysis of proteinuria at shorter time intervals (4 and 8 hours) within the overall 24-hour collection period is predictive of the 24-hour sample. Lastly, the investigators plan to determine whether a combination of the random test with a shorter collection interval is comparable to the 24-hour collection.

Preeclampsia affects approximately 5-8% of pregnancies in the United States with approximately 10% occurring before 34 weeks gestation. The diagnosis of preeclampsia is determined by the presence of hypertension with proteinuria after 20 weeks gestation. The gold standard for measuring proteinuria is a 24-h urine collection for total protein. In the non-pregnant patient, a random urinary protein-to-creatinine ratio has been shown to be a reliable indicator of significant proteinuria. The reliability of this test remains unclear in the pregnant population. Because there are relatively few studies in the pregnant population and many of these studies were poorly designed, limited by sample size, or confounded by other variables, further research in this area is still necessary. The purpose of this study is to determine if there are alternative diagnostic tools for the quantification of total protein excretion in 24-hours to aid in the diagnosis of preeclampsia that can be performed more quickly and efficiently than the gold standard 24-hour urine collection. We intend to perform a large prospective study looking at the predictability of the random urine protein-to-creatinine ratio compared to the gold standard 24-h urine protein collection. Furthermore, we plan to investigate whether analysis of proteinuria at shorter time intervals (4 and 8 hours) within the overall 24-h collection period is predictive of the 24-h sample. Lastly, we plan to determine whether a combination of the random test with a shorter collection interval is comparable to the 24-h collection. The goal would be to make the diagnosis of preeclampsia in a more timely fashion to aid in the prevention of maternal and neonatal morbidity and mortality including eclampsia, HELLP syndrome, acute renal failure, pulmonary edema, DIC, IUGR, IUFD, intracranial bleeding and stroke, Additionally, an earlier diagnosis could also impact patient care by reducing hospital stay, nursing demands, and eliminating the need for cumbersome and likely inaccurate patient 24-h home collections.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women over the age of 18 between 24-42 weeks who are being evaluated for preeclampsia with a 24 hour urine protein

Exclusion Criteria:

* Patients with pre-existing proteinuria (\>300mg)
* Renal disease
* Evidence of a current or recent (within two weeks of admission) urinary tract infection
A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma

This study adopts a novel strategy for first-line treatment of osteosarcoma by combining chemotherapy with anti-angiogenic therapy using bevacizumab (Avastin®), a humanized monoclonal antibody against vascular endothelial growth factor (VEGF). Chemotherapy for localized disease comprises a 3-drug regimen (cisplatin, doxorubicin, and high-dose methotrexate). Chemotherapy for metastatic or unresectable disease comprises a cisplatin-based regimen that includes high-dose methotrexate, doxorubicin, ifosfamide, and etoposide.

This is a comprehensive study that uses a novel agent that targets angiogenesis (bevacizumab) in combination with conventional chemotherapy for the treatment of osteosarcoma. Bevacizumab, a monoclonal antibody against the vascular endothelial growth factor (VEGF), has been shown to stop the growth of new blood vessels of tumors, both in the laboratory and in patients with other types of cancers. Bevacizumab has improved the effect of chemotherapy in adult patients with different types of cancer by increasing tumor response and increasing the chances of survival. This study has two main goals:

* To find out if bevacizumab can be combined safely with chemotherapy for osteosarcoma
* To find out if adding bevacizumab to chemotherapy will be beneficial in treating osteosarcoma.

The chemotherapy drugs used in this study are commonly used to treat osteosarcoma. Patients with non-metastatic and resectable tumors receive bevacizumab and chemotherapy comprised of cisplatin, doxorubicin and high-dose methotrexate. Patients with metastatic tumors or tumors that cannot be removed by surgery receive bevacizumab and chemotherapy comprised of cisplatin, doxorubicin and high-dose methotrexate, ifosfamide and etoposide. If the tumor can be removed by surgery, surgery will be performed after 10 weeks of chemotherapy and will be followed by additional chemotherapy. After completion of active therapy, patient's response to therapy will be followed for approximately 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have newly diagnosed high-grade, biopsy proven, osteosarcoma or malignant fibrous histiocytoma (MFH) of bone with no history of prior chemotherapy or radiation;
* Participant is able to perform tasks and daily activities as defined in the study guidelines
* Patient meets established guidelines for adequate function of the kidney, liver, heart and bone marrow
* Participants meets other requirements defined in the eligibility portion of the study

Exclusion Criteria:

* recent major surgical procedure or injury
* Known bleeding diathesis, platelet disorder or coagulopathy
* Thrombosis
* Cardiac disease or hypertension
* Significant proteinuria
* Central nervous system disease
* Gastrointestinal perforation/abdominal fistula
* Osteosarcoma or MFH of bone as second malignancy
Safety and Efficacy of Posaconazole Oral Suspension in Usual Practice in Korea (P08547)

This study will examine the safety and efficacy of posaconazole in general use in Korea.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility Criteria:
Inclusion Criteria:

* Treated with posaconazole oral suspension within current local label

Exclusion Criteria:

* Contraindication to posaconazole oral suspension according to current local label
Impact of Retrograde Autologous Priming on the Coagulation Profile Assessed by Rotation Thromboelastometry (ROTEM) in Patients Undergoing Cardiac Surgery

Cardiac surgery with cardiopulmonary bypass (CPB) is associated with an increased risk of blood transfusions. The primary setup of the CPB circuit demands a priming volume of approximately 1600 mL of crystalloid solution which leads to a relevant hemodilution. The retrograde autologous priming (RAP) procedure minimizes hemodilution by displacing the crystalloid priming volume of arterial and venous lines via passive exsanguination of native blood prior to CPB initiation, resulting in higher hematocrits and reduction of red blood cell transfusion. RAP can also minimize the dilution of coagulation factors as well as red blood cells. Thus, the investigators hypothesized that RAP could maintain better coagulatory function after CPB. In this study, the investigators investigate the impact of RAP on the coagulation profile assessed by rotation thromboelastometry (ROTEM) in participants undergoing cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 20 years of age undergoing cardiac surgery / vascular surgery using CPB

Exclusion Criteria:

* Emergency operation
* Hemoglobin concentration above 15g/dL
* Anticoagulants such as warfarin within 5 days before surgery, non-vitamin K antagonist oral
* anticoagulant within 2 days, and aspirin / clopidogrel / ticagrelor within 5 days
* Weight less than 45kg, more than 90kg
* Patients with autoimmune disease
* Patients who participated in other clinical studies that could affect prognosis
* Patients who cannot understand the informed consent (eg. Foreigner)
The UCAP 2 Pilot Study

Our research group has found that Canadians with undiagnosed asthma or chronic obstructive pulmonary disease (COPD) have increased respiratory symptoms and worse health-related quality of life.

The investigators recently developed and validated an on-line questionnaire to accurately identify these symptomatic, undiagnosed individuals.

The investigators will advertise in the community asking individuals to complete the on-line questionnaire at home, at their leisure, to determine if they are at risk of asthma or COPD. Those at risk will be invited to participate in our randomized, controlled clinical trial to determine if guidelines-based treatment of newly discovered undiagnosed asthma or COPD will improve their quality of life and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Individuals at least 18 years old
* Individuals must be symptomatic with respiratory symptoms
* Individuals must complete the UCAP-Q questionnaire and score a ≥ 6% probability of having either asthma or COPD.
* Individuals who have given written informed consent to participate in this trial in accordance with local regulations;
* Individual must be able to perform pre and post bronchodilator spirometry to measure lung function

Additional Inclusion Criteria for the Randomized Controlled Trial (RCT):

* Individuals who have undiagnosed airflow obstruction (i.e. Asthma will be diagnosed in subjects with airflow obstruction whose forced expiratory volume in 1 second (FEV1) improves by \> 12% and 200 ml after bronchodilator and COPD will be diagnosed in subjects who do not have a significant bronchodilator response and who exhibit persistent airflow obstruction post bronchodilator) will be asked to participate in the RCT.

Exclusion Criteria:

* Individuals who report a previous diagnosis of asthma, COPD, history of lung cancer, bronchiectasis, interstitial lung disease, cystic fibrosis or other significant diagnosed lung disease.
* Individuals currently under the care of a respirologist
* Individuals currently using inhaled corticosteroids or long-acting bronchodilators.
* Individuals with history of myocardial infarction, stroke, aortic or cerebral aneurysm, or detached retina or eye surgery within the past 3 months (spirometry is contraindicated)
* Individuals who are in the third trimester of pregnancy
* Individuals involved in another interventional trial
Control Post Endovascular Treatment of Aortic Aneurisms Through Magnetic Resonance and Ultrasound (SAFEVAR)

The aims of this study are to verify non-inferiority of magnetic resonance (MR) without contrast agent associated to color-Doppler ultrasound for the diagnosis of endoleaks after endovascular aortic repair (EVAR), to evaluate both the economical and biological cost-effectiveness of such diagnostic algorithm as an alternative to computed tomography (CT) with contrast agent, and to analyze its impact on both patients work-flow and infrastructure logistics

In this prospective observational study, 250 patients who underwent EVAR will be studied. They will be enrolled after referral for a CT with contrast agent at IRCCS Policlinico San Donato or at ASST Santi Paolo e Carlo. Those with absolute contraindications to RM will be excluded.

All enrolled subjects will undergo MR with contrast agent and color-Doppler ultrasound after CT. Before and after each examination, they will be submitted a questionnaire to evaluate their perception towards the former, and both costs and exposure deriving from such examinations will be evaluated along with patients' responses. Moreover, both CT and MR along with color-Doppler ultrasound will be analyzed with regards to human resources management, operational management, patients' clinical workflow and organization.

All CT examinations will be independently evaluated by two radiologists with 4- and 8-year expertise in thoracic or abdominal CT. Results obtained from CT examinations will be used as a reference standard using the "worst case scenario" method: if either reader reported endoleak, the CT will be considered positive. The more experienced reader will anonymously and randomly repeat CT evaluation after 1 month.

For CMR examinations, a 15-minute protocol will be used on a 1.5-T device. The following sequences will be performed:

* steady state free-precession (true-FISP)
* half-Fourier single shot spin-echo (HASTE) All examinations will be independently and blindly evaluated by the same two radiologists as CT examinations, and they will be considered positive if areas (even smaller than 5 mm) of alterate signal in comparison to surrounding muscle in the same slice are present inside the aneurismatic sac. The more experienced reader will anonymously and randomly repeat CT evaluation after 1 month.

Color-Doppler ultrasound will be performed with a 1-5 MHz probe, by a radiologist with 7-year expertise in aortic ultrasound, blinded to MR and CT results. Ultrasound images will be evaluated both directly and through spectral flow study.

The sample size was calculated assuming an alpha error of 5%, 90% power and 10% endoleak prevalence. In order to prove a negative predictive value of MR without contrast agent and color-Doppler ultrasound not inferior to 90%, 250 patients should be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18
* informed written consent
* with either thoracic or abdominal aortic endoprosthesis

Exclusion Criteria:

* lack of informed written consent
* patients with absolute contraindications to magnetic resonance imaging
Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT

This study was a prospective, multicenter, randomized controlled clinical study planned to recruit 266 hematological patients with allogeneic hematopoietic stem cell transplantation (allo-HSCT), who were randomly divided into two groups according to gender, type of transplantation, and type of primary disease. The control group was treated conventionally, and the experimental group increased moxibustion of Zhongji, Guanyuan and Qihai for 30 min qd starting on the first day after HSCT was performed until the 14th day after transplantation. Urine routine tests were performed at the time of admission, +1d, and +14d, and urine BK virus, JC virus, and adenovirus were tested at four time points, namely, +1d, +14 days, onset of hematuria symptoms, and remission of HC, respectively; routine urine tests were performed once every 7 days for all patients within 100days. For patients with Hemorrhagic cystitis (HC), daily severity grading, pain scoring, cystitis symptom scoring, use of antispasmodic and analgesic medications, and major TCM evidence were recorded with the aim of evaluating the efficacy of moxibustion in the prevention of HC in this patient population.


Eligibility Criteria:
Inclusion Criteria:

1. Patients are fully aware of the study, participate voluntarily and sign the informed consent form (ICF);
2. Age: 14-60 years;
3. Patients with pernicious blood diseases undergoing allo-HSCT using the MAC protocol or patients with severe aplastic anemia (Severe aplastic anemia; severeaplasticanimin, SAA) undergoing allo-HSCT;

Exclusion Criteria:

1. refuse to participate in this clinical study;
2. The corresponding skin at the moxibustion site is broken or sensitive;
3. allo-HSCT pretreated with the RIC program;
Expression of Stress Markers During Meth Treatment (EXPRESS+)

This is a non-randomized behavioral trial that aims to investigate whether changes in inflammatory and type I IFN expression coincide with changes in methamphetamine use and viral load over the course of 12 weeks in HIV-positive people assigned male at birth with and without methamphetamine use disorder.

This is a within-subjects, two-arm study with 35 HIV-positive people assigned male at birth receiving contingency management for treatment of methamphetamine use disorder and 20 HIV-positive people assigned male at birth serving as a non-substance-using healthy control (N=55 total). HIV-positive participants with methamphetamine use disorder who meet the eligibility criteria will be assigned to the contingency management treatment group. HIV-positive participants who do not use substances and meet the specific criteria will be assigned to the non-substance-using control group. Participants will be observed over 8 weeks, with another follow-up 4 weeks thereafter.

Eligibility Criteria:
Inclusion Criteria:

For Contingency Management:

1. Assigned male sex at birth
2. 18 to 45 years of age
3. Reports having sex with men in the past 12 months.
4. HIV-positive (confirmed by certification or by HIV rapid test)
5. Has an HIV care provider (last seen in the past 12 months)
6. Has a current antiretroviral prescription
7. Meets the DSM-5 criteria for methamphetamine use disorder using SCID-5
8. Urine test is positive for methamphetamine within 30 days of their screening visit
9. Seeking treatment for methamphetamine use disorder.
10. Ability to attend twice weekly appointments for drug testing and treatment

For Non-substance-using Control:

1. Assigned male sex at birth
2. 18 to 45 years of age
3. Reports having sex with men in the past 12 months.
4. HIV-positive (confirmed by certification or by HIV rapid test)
5. Has an HIV care provider (last seen in the past 12 months)
6. Has a current antiretroviral prescription

Exclusion Criteria:

For Contingency Management:

1. Identifies as (cis- or transgender) female
2. Reports another current or past substance use disorder
3. Reports being in another intervention or clinical trial for substance use
4. Positive test for opioids, cocaine, and/or MDMA

For Non-substance-using Control:

1. Identifies as (cis- or transgender) female
2. Positive test for methamphetamine, opioids, cocaine, and/or MDMA.
3. Reports substance use (methamphetamine, opioids, cocaine, MDMA, hallucinogens, heavy alcohol use, and/or tobacco) in the past 6 months
4. Reports past or current substance use disorder