cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study of Prednisone Priming to Treat Asian Chronic Hepatitis B Patients

Patients with chronic hepatitis B constantly produce the virus in the body. The disease of chronic hepatitis B is the body responding to the virus. Use of steroids can adjust this response. After taking steroids, viral production usually increases and liver function tests increase. After stopping steroids, viral production usually decreases. Many studies in the past have studied taking a low dose steroid before treating hepatitis B. Those studies have shown that low dose steroids help your body to clear the virus. The goal of this study is to improve the liver function by slowing viral growth.

Asian patients who are older than 16 years of age and have HBeAg-positive chronic hepatitis B and good liver function will be entered in this study. Qualified patients also have positive hepatitis B surface antigen (HBsAg) for at least 24 weeks before screening, evidence of chronic hepatitis on a baseline liver-biopsy sample obtained within 52 weeks before entry, evidence of HBV DNA by any commercial tests at least 4 weeks before screening, an high HBV DNA level (at least 20,000 IU/mL) at screening, and a high serum ALT level (1.0 to 5.0 times the upper limit of normal) at screening.

This study involves experimental use of an approved drug (Prednisolone) on chronic hepatitis B patients. Patients will be involved in the study for up to 96 weeks from enrollment. There is no external sponsor, commercial sponsor nor federal agency on this study. The study will be conducted only at Maimonides Medical Center, its GI clinic and faculty practice. About 40 subjects will be involved in the study overall. All the subjects will be filled up locally.

Eligibility Criteria:
Inclusion Criteria:

This study is seeking patients with the following:

* Asians older than 16 years of age
* HBeAg-positive chronic hepatitis B, and
* Good liver function
* Positive hepatitis B surface antigen (HBsAg) for at least 24 weeks before screening
* Liver biopsy in the past year showing of chronic hepatitis
* Blood testing showing HBV DNA in the past 4 weeks before screening
* Blood test showing high HBV DNA level (at least 20,000 IU/mL); AND
* Liver function test showing high serum ALT level (1.0 to 5.0 times the upper limit of normal).

Exclusion Criteria:

* Ongoing drug abuse
* Active alcoholism
* Coinfection with hepatitis C, hepatitis D, or HIV
* Presence of other forms of liver disease
* Use of interferon alfa, thymosin, or antiviral agents with activity against hepatitis B within 24 weeks before randomization
* Prior lamivudine therapy lasting more than 12 weeks
* Previous treatment with Adefovir dipivoxil
* AFP level greater than 100 ng/mL
* Decompensated liver disease
* History of ascites requiring diuretics or paracentesis
NATURE (EnVast As an Adjunct PPCI in Subjects Presenting with STEMI)

This study is designed to compare the safety and effectiveness of blood clot (thrombus) removal in subjects presenting with ST-segment elevation myocardial infarction (STEMI) with the enVast coronary system versus conventional intervention.

A prospective, multi-center, randomized clinical trial designed to assess the safety and effectiveness of the enVast coronary thrombectomy system as an adjunctive measure to conventional intervention in subjects presenting with ST-segment elevation myocardial infarction (STEMI).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Chest pain for \> 20 min with an electrocardiographic ST-segment elevation ≥ 1 mm in two or more contiguous electrocardiogram (ECG) leads or an infero-lateral myocardial infarction (MI) with ST segment depression of ≥ 1 mm in ≥ 2 of leads V1-3 with a positive terminal T wave.
3. TIMI Thrombus Grade ≥ 3 in the infarct related artery. In cases where TIMI Thrombus Grade is equal to 5 (i.e. TIMI 0 flow in the infarcted artery), TIMI Thrombus Grade of at least 3 has to be re-confirmed with AWI. Patients showing TIMI Thrombus Grade of less than 3 upon AWI are no longer eligible for randomization.
4. Start of intervention within 8 h of symptom onset
5. Subject is willing and able to provide informed consent prior to the intervention

Exclusion Criteria:

1. Unconscious patients
2. Infarct related artery diameter, at visual assessment, smaller than 2.5 mm
3. Presence of severely calcified plaque(s) proximal to or at the site of the culprit lesion(s)
4. Presence of extreme vessel tortuosity proximal to or at the site of the culprit lesion(s)
5. Women of child-bearing potential (e.g. below 55 years of age, who have not undergone tubal ligation, ovariectomy or hysterectomy and last menstruation within the last 12 months)
6. Stent thrombosis as culprit lesion
7. Previous myocardial infarction in the same territory (i.e. same target vessel)
8. Participation in another interventional clinical trial
Phase Ib, Administration the IOP Injection for MRI Contrast Agent in Healthy Subjects

The objective of the study is to assess the dose dependent changes in MRI signal intensity (SI) in liver after IOP Injection intravenous administration in healthy volunteers.

Find the max. signal change after IOP administration

Eligibility Criteria:
Inclusion Criteria:

1. Male, age ≥ 20 \~40 years, BMI=18\~27.
2. The biochemistry test results, complete blood count (CBC) test results, urinalysis test results, coagulation time test results must within normal range or considered clinically normal by the clinical investigator at screening.
3. Male subjects must take reliable contraceptive method(s) during and after the study for a period of 14 days.
4. No screening of drug or alcohol abuse within one year prior to study enrollment.
5. Subjects are willing to comply with the protocol and sign informed consent form.

Exclusion Criteria:

1. Subjects have serious allergic history or known allergy to MRI contrast agent.
2. Subjects with HBV, HCV, HIV.
3. Imaging and/or functional abnormalities of liver and/or spleen.
4. Subjects have alcohol or caffeine consumption within 48 hours prior to the administration of study contrast agent.
5. Subjects have electronically, magnetically and mechanically activated implanted devices.
6. Subjects have participated in other investigational trials or receive any contrast agents within 28 days prior to study enrollment.
7. Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption and elimination of investigational contrast agent.
8. Subjects have taken any food 6 hours prior to administration.
Next-generation Sequencing of Small Cell Lung Cancer to Identify Susceptibility Gene and to Assess Treatment

Participants will be consented into the study after they are found to meet the study inclusion criteria. The clinical staff will schedule a tissue biopsy and a blood draw for the participant to give NGS(Next-generation Sequencing).One is according to the germline mutation data to screen susceptible gene in SCLC(Small Cell Lung Cancer); two is to explore the extensive consistency detection of blood and tissues in patients with SCLC gene mutation information; three is to conduct dynamic monitoring of blood ctDNA(circulating tumor DNA) in patients with SCLC during treatment, by changing the types of mutations / abundance (for example: the clonal evolution of typical samples analysis) and change of tumor load, , investigating the patients treatment effect , for the significant change of mutations, to study whether it can be used as molecular marker; four is to analyze of the molecular typing of SCLC, according to the clinical and pathological features of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients must understand the rigors of the study and provide written informed consent and HIPAA authorization prior to initiation of any study procedures
* Life expectancy \> 10 months
* Karnofsky Performance Status ≥ 70
* Diagnosis of histological or cytologically confirmed SCLC,
* Age ≥ 18 years
* Good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy.

Exclusion Criteria:

* Poor compliance, reluctant to undergo research medication, or follow-up.
* Tumor inaccessible for biopsy
* It is currently included in clinical trials of other drugs, or at the same time, into other medical studies that are considered incompatible with the study.
* It has a history of other cancers, unless the cancer is completely relieved and has not been treated for more than 3 years.
Comparison of Alfredson and Silbernagel Protocol in Competitive Athletes With Achilles Tendinopathy

A 6-week randomized clinical trial (RCT) with a 46-week follow-up compared the effect of Alfredson and Silbernagel eccentric programs for the treatment of AT. The primary outcome was a change in the Victorian Institute of Sport Assessment - Achilles (VISA-A) scale from baseline to 12 months. The study was approved by the Ethics Committee of the Faculty of Physical Education and Sport, Charles University (Project number: 254/2021). All participants provided written informed consent before participation.


Eligibility Criteria:
Inclusion criteria:

* Athletes performing track and field, tennis or football at the competitive level
* Age 18 to 40 years
* Unilateral Achilles tendinopathy
* Pain lasting more than 2 months
* Diagnosis of Achilles tendinopathy established by pain on function at the Achilles region and ultrasound assessment (tendon thickening, swollen tendon) by one researcher
* Participants trained at least 3 times per week before the onset of Achilles tendinopathy
* Less than 3 months without training and less than 6 months from the last competition/match
* Wish to return to original sport level
* Willing to stop with other treatments 2 weeks before the start of the clinical trial

Exclusion criteria:

* Achilles tendon rupture in past
* Corticosteroid injection in Achilles tendon region in last 6 months
* Having other lower limb musculoskeletal injuries or surgery in the last 6 months (e.g., muscle rupture, bone fracture)
* Having a neurological, systemic or autoimmune disease (e.g., neuropathy, type 1 diabetes, rheumatoid arthritis)
Impact of a Transmission Checklist in Post Anesthesia Care Unit on Immediate Respiratory Complications

This work highlighted the beneficial role in terms of carers' satisfaction, quantity and quality of information transmitted.

Communication and information transmission problems are responsible for the majority of serious adverse events. The use of a checklist in the operating theatre has demonstrated its benefit in terms of reducing morbidity and mortality Regarding transmissions between caregivers, numerous studies have shown the great difference between the medical data of a patient in their file and the information transmitted.

The authors recommend using checklists in order to standardise transmissions. This work highlighted the beneficial role in terms of carers' satisfaction, quantity and quality of information transmitted. On the other hand, no study has looked at the reduction of immediate postoperative complications in post anaesthesia care units (PACU).

Eligibility Criteria:
Inclusion Criteria:

* Male or Female over 18 admitted to PACU
* Patient having understood the aims and the methods of the research

  * Patient having expressed their consent to the use of their data.
  * Subject registered with or beneficiary of a social security scheme

Exclusion Criteria:

* Patient participating in another clinical study
* Acute or chronic respiratory insufficiency preoperatively
* Protected patient: adult under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant or lactating women
A Trial of Bedside Placement of Nasal Jejunal Tube Confirmed by Ultrasound Compared to Placement by Endoscope in Patients With SAP

The investigators assessed the utility of ultrasonography in confirming the position of nasal jejunal tube after bedside placement when compared with endoscopic placement in patients with severe acute pancreatitis.

Primary endpoint:

Success rate.

Secondary Endpoint:

Adverse effects, Change of intra-abdominal pressure (1h before, 1h after and 3 days after placement), Tolerance of enteral nutrition, Time to approach the target calories.

We set this randomised trial to assess the safety and utility of ultrasonography in confirming the position of nasal jejunal tube after bedside placement when compared with endoscopic placement in patients with severe acute pancreatitis.

Primary endpoint:

Success rate.

Secondary Endpoint:

Adverse effects, Change of intra-abdominal pressure (1h before, 1h after and 3 days after placement), Tolerance of enteral nutrition, Time to approach the target calories.

Eligibility Criteria:
Inclusion Criteria:

* acute pancreatitis patients who need enteral nutrition;
* patients in acute phase of pancreatitis (within 2 weeks from onset);
* the severity of pancreatitis is equal to or above moderate (according to the revised classification of pancreatitis).

Exclusion Criteria:

* diagnosed with IAH(Intra-abdominal pressure) IV grade, abdominal compartment syndrome (ACS);
* patients who have circulatory failure;
* patients who have gastrointestinal bleeding;
* patients who have specific diseases such as chronic digestive diseases and autoimmune diseases;
* patients in pregnancy.
Asciminib RMP Study

This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Asciminib in the real-world clinical setting in Korean Chronic myeloid leukemia (CML) patients.

The dosage and duration of treatment may be considered and decided by the investigator in accordance with prescribing information of Asciminib.

This study will enroll all patients by total enumeration for those prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice for 2 years after the market launch.

Eligibility Criteria:
Inclusion criteria

1. Adult patients diagnosed with Ph+ CP-CML and currently receiving or going to receive Scemblix® treatment according to locally approval label
2. Patients who are willing to provide written informed consent prior to study enrollment

Exclusion criteria

1. Patients with contraindication according to locally approved label of Scemblix®
2. Patients who receive or are going to receive any investigational medicine during the observation period
Estradiol Plus Olaparib for Breast Cancer (PHOEBE)

Determine the safety and recommended Phase II dose of olaparib in combination with 17b-estradiol in post-menopausal patients with advanced ER+/HER2- breast cancer.

Patients with endocrine-resistant ER+/HER2- breast cancer are eligible. Patients will be treated with the combination of 17b-estradiol and olaparib for 2 cycles, and then treated with single-agent 17b-estradiol until disease progression. Clinical benefit, progression-free survival, objective response, tumor metabolic response, and toxicity will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women with ER+/HER2- breast cancer.
* Metastatic or locoregional recurrence not amenable to treatment with curative intent.
* Received ≥1 prior line of endocrine-based therapy in the advanced/metastatic setting.

Exclusion Criteria:

* During study treatment, no concurrent anti-cancer therapies are allowed with the following exceptions:

  o Anti-resorptive bone therapies (e.g., bisphosphonates, denosumab) permitted.
* Any investigational cancer therapy or systemic chemotherapy in the last 3 weeks.
* Any radiation therapy in the last 2 weeks.
* Known CNS disease, unless clinically stable for ≥ 3 months.
* Concomitant use of known strong or moderate CYP3A inhibitors.
* Persistent toxicities (≥CTCAE grade 2) caused by previous cancer therapy.
* History of any of the following:

  * Deep venous thrombosis
  * Pulmonary embolism
  * Stroke
  * Acute myocardial infarction
  * Congestive heart failure
  * Previous malignancy not treated with curative intent, or with an estimated recurrence risk ≥30%
  * Severe renal impairment (creatinine clearance ≤ 30 mL/min).
Unruptured Cerebral Aneurysm: Prediction of Evolution

The protocol has many assets. A prospective nationwide recruitment allows for the inclusion of a large cohort of patients with UIA. It will combine accurate clinical phenotyping and comprehensive imaging with CAWE screening. Besides, it will enable to exploit metadata and to explore new pathophysiological pathways of interest by crossing clinical, genetic, biological, and imaging information.

Management of small (\<7mm) unruptured intracranial aneurysms (UIA) remains controversial. Previous retrospective studies have suggested that post gadolinium arterial wall enhancement (AWE) of unruptured intracranial aneurysms on MR imaging may reflect aneurysm wall instability, and hence may highlight a higher risk of UIA growth over time. This multicentric prospective cohort aims at exploring vessel wall imaging findings of UIAs with consecutive follow-up to substantiate these assumptions.The objective is to develop diagnostic and predictive tools for the risk of IA evolution. The aim is to demonstrate in clinical practice the predictive value of (AWE) for UIA growth. The growth will be determined by any modification of the UIA measurement. Both UIA growth and the UIA wall enhancement will be assessed in consensus by two expert neuroradiologists.The French prospective UCAN project is a non-interventional international wide and multicentric prospective cohort. UIA of bifurcation between 3 and 7 mm for whom a clinical and imaging follow-up without occlusion treatment was scheduled by local multidisciplinary staff will be included. Extensive clinical, biological and imaging data will be recorded during a 3 years follow-up (visits at 1 and 3 years after inclusion).

Eligibility Criteria:
Inclusion Criteria :

* Subject carrying unruptured, asymptomatic and untreated typical IA of bifurcation, measured on conventional imaging (MRI, CTA or DSA) between 3 and 7 mm of larger diameter.
* Ability to be followed-up during 3 years decided in consensus multidisciplinary gathering.
* Age \> 18 years old.

Exclusion Criteria :

* A failure to obtain informed consent
* Contraindications for undergoing an MRI scan include : (heart pacemaker, a metallic foreign body (metal sliver) in their eye, or aneurysm clip in their brain, severe claustrophobia)
* Contraindications for a gadolinium contrast medium injection (:eGFR below 30 mL/min/1.73 m2, Previous or pre-existing nephrogenic systemic fibrosis, Previous anaphylactic/anaphylactoid reaction to gadolinium containing contrast agent, Acutely deteriorating renal function, Pregnancy and breast-feeding)
* A mycotic, fusiform-shaped, or dissecting IA, an IA in relation with an arteriovenous malformation
* A family history of polycystic kidney disease, Ehlers-Danlos syndrome, Marfan's syndrom, fibromuscular dysplasia, or Moya Moya disease
* Intra-cavernous UIA because the sinus cavernous that is fulfilled with venous blood precluded a reliable assessment of aneurysmal wall enhancement (AWE)
ADI-PEG20, Obesity and Prediabetes

Th purpose of this study is to determine whether ADI-PEG20 (PEGylated arginine deiminase), an arginine catabolizing enzyme preparation, improves insulin sensitivity, mitochondrial respiration, and energy utilization in adolescents with prediabetes.

Obesity, insulin resistance, and their complications are major causes of morbidity and mortality in children, adolescents, and adults. Although caloric restriction is an effective treatment, intensive lifestyle changes are rarely durable. The investigators and others have shown that: (i.) fasting incites arginine catabolism, and forced arginine catabolism recapitulates several therapeutic effects of fasting, (ii.) exogenous, forced arginine catabolism improves metabolic health, and (iii.) ADI-PEG20 (PEGylated arginine deiminase) is an arginine catabolizing enzyme preparation that improves insulin sensitivity, mitochondrial respiration, and energy utilization in obese mice. The study will determine whether ADI-PEG20 also exerts beneficial effects on metabolic healthy in people. The investigators will perform a 12-week, randomized, double-blind, placebo-controlled trial in boys and girls with pre-diabetes to evaluate the efficacy of ADI-PEG20 treatment on: 1) body composition; 2) resting energy expenditure; 3) multi-organ insulin sensitivity; 3) β-cell function; and 4) muscle mitochondrial function.

Eligibility Criteria:
Inclusion Criteria:

* age: ≥18 and ≤22 years;
* BMI 25.0 - 44.9 kg/m2;
* Prediabetes, defined as fasting plasma glucose of ≥100 mg/dL, or HbA1C ≥5.7%, or HOMA-IR ≥2.5.

Exclusion Criteria:

* HbA1C ≥6.5%;
* Intolerance or allergies to ingredients in ADI-PEG20 or placebo;
* Taking dietary supplements or medications known to affect our study outcomes;
* Evidence of significant organ system dysfunction or diseases,
* Metallic implants, which would preclude MRI
The Role of OXytocin in Acute Ischemic Stroke reconvAlesceNcE: The ROXANE Study

Evidence suggests that oxytocin has a neuroprotective role on a systemic and cellular level in the context of acute ischemic stroke (AIS). The investigators therefore hypothesize that high levels of circulating oxytocin measured within the first 72 hours after symptom onset are associated with lower mortality and favorable outcome in acute ischemic stroke.

The preliminary data suggest a possible neuroprotective role of oxytocin via endocrine as well as paracrine effects, underscoring that oxytocin levels in the acute phase of stroke may have a considerable influence on patient outcomes. However, the role of oxytocin in acute ischemic stroke patients has, to our knowledge, never been investigated. If oxytocin really shows a strong associated with functional outcomes after stroke and given the fact that commercially available oxytocin can be safely administered via nasal spray, oxytocin would become an innovative and highly interesting novel therapeutic agent for ischemic stroke patients in the near future. For the ROXANE cohort the investigators plan to recruit patients with acute ischemic stroke from the University Hospital in Basel. The study is designed as an observational cohort study, because an observational study is currently at this stage of knowledge (effect of oxytocin in vitro and in vivo (animal models)), the best study design. It harbors minimal harm, but still allows us to adequately estimate the association of oxytocin levels in humans with stroke outcome. If it is possible to establish this association in humans based on results of the planned observation study, the investigators will be able to plan an interventional trial, which may directly beneficially impact clinical outcome of stroke patient.

Eligibility Criteria:
Inclusion Criteria:

* Rapid onset of a focal neurologic deficit, with signs or symptoms persisting beyond 24 hours and not associated with infection, trauma, or tumor of the brain, severe metabolic disorders, or chronic degenerative neurologic disease; or
* the development of an acute focal neurologic deficit persisting \>24 hours in conjunction with brain imaging consistent with acute ischemic stroke. The CT or MRI may either show a new infarct or no change from the study performed at entry, i.e., the diagnosis is clinical and does not require CT/MRI confirmation. Secondary hemorrhagic infarction is permissible.
* First blood sample at the stroke unit is taken within 24 hours from symptom onset.

Exclusion Criteria:

* Patients below 18 years
* Hemorrhagic stroke or patients discharged from the hospital with a diagnosis different from ischemic stroke (i.e., stroke mimics)
* Missing informed consent