cyrilzakka/clinical-trials huggingface dataset:
Comparison of Moderate-Intensity Statin Plus Ezetimibe Vs. High-Intensity Statin for Coronary Plaque Stabilization

This study is a prospective, multicenter, randomized clinical trial aimed at comparing the effects of moderate-intensity statin plus ezetimibe combination therapy versus high-intensity statin monotherapy on coronary plaque stabilization. Using advanced imaging techniques such as near-infrared spectroscopy-intravascular ultrasound (NIRS-IVUS), the trial evaluates whether the combination therapy is non-inferior to monotherapy in stabilizing coronary plaques over 52 weeks. The primary endpoint is the percentage change in coronary atheroma volume (PAV), with secondary outcomes including changes in lipid core burden, inflammatory markers, and clinical events like myocardial infarction and ischemic stroke. The study plans to enroll 330 patients undergoing coronary intervention across 9 domestic institutions, with rigorous follow-up protocols and adherence to international research guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women over the age of 18 years.
* Patients with coronary artery disease undergoing a coronary intervention procedure using intravascular imaging.
* At least one major native coronary artery ("target vessel") meeting all the following criteria for intracoronary imaging immediately following a qualifying PCI procedure:

  * Angiographic evidence of coronary artery stenosis ≥30% by angiographic visual estimation.
  * Target vessel is accessible to the imaging catheter and suitable for intracoronary imaging in the proximal 50 mm segment.
  * Target vessel is not a bypass graft (aortic or arterial) or a bypassed graft vessel.
  * Target vessel has not undergone PCI within the target segment.
  * Target vessel is not a candidate for PCI at the time of the procedure or for 6 months thereafter (per investigator's judgment).
* Patients who have provided written informed consent to participate in the study.

Exclusion Criteria:

* Left main stem lesion: Left main coronary artery stenosis ≥50% by coronary angiographic visual estimation.
* History of coronary artery bypass graft surgery (CABG).
* Unstable clinical condition (hemodynamic or electrical instability).
* Severe coronary artery calcification or tortuosity interfering with IVUS, NIRS, or evaluation.
* Uncontrolled cardiac arrhythmia (recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response) not controlled by medication within 3 months prior to screening.
* Active liver disease or liver dysfunction.
* Known allergy to contrast media, heparin, aspirin, ticagrelor, or prasugrel.
* Active infection or major hematologic, metabolic, or endocrine dysfunction as determined by the investigator.
* Planned surgery within 12 months.
* Currently enrolled in another investigational device or drug study.
* Estimated life expectancy of less than 2 years.
* Women of childbearing potential (under 50 years of age) who:

  * Had their last menstrual period within the last 12 months.
  * Have not had tubal ligation, oophorectomy, or hysterectomy.
Combined Haploidentical-Cord Blood Transplantation for Adults and Children

The primary objective is to assess the rate of engraftment with combined haploidentical-cord blood transplantation. The secondary objective is to evaluate the incidence and severity of acute and chronic graft-versus-host disease (GVHD).


Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible for this study if they have any one of the diseases that are known to be cured after allogeneic stem cell transplantation.

1. Relapsed or refractory acute leukemia (myeloid or lymphoid)
2. Acute leukemia in first remission at high-risk for recurrence
3. Chronic myelogenous leukemia in accelerated phase or blast-crisis
4. Chronic myelogenous leukemia in chronic phase
5. Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
6. Chronic lymphocytic leukemia, relapsed or with poor prognostic features
7. Multiple myeloma
8. Myelodysplastic syndrome
9. Chronic myeloproliferative disease
10. Hemoglobinopathies
11. Aplastic anemia

Exclusion Criteria:

1. Zubrod performance status \> 2
2. Life expectancy is severely limited by concomitant illness
3. Patients with severely decreased LVEF or impaired pulmonary function tests(PFT's)
4. Estimated Creatinine Clearance \<50 ml/min
5. Serum bilirubin\> 2.0 mg/dl or SGPT \>3 x upper limit of normal
6. Evidence of chronic active hepatitis or cirrhosis
7. HIV-positive
8. Patient is pregnant
9. Patient or guardian not able to sign informed consent
Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving Surgery

The purpose of this study is to determine whether accelerated partial breast irradiation (APBI) with multi-catheter brachytherapy is safe and effective.


Eligibility Criteria:
Inclusion Criteria:

* pT1/2 (≤ 3 cm)
* pN0 or pN1 mi
* M0 and no contralateral BC
* Clear margins (≥ 2 mm)
* Age ≥ 35 years
* ER and/or PR positive

Exclusion Criteria:

* Multifocality or Multicentricity
* EIC
* Lymphovascular invasion
* Poorly differentiated tumors
* Diffuse microcalcifications
Developing and Validating a Patient-reported Outcome Instrument to Monitor Symptom Management in Pulmonary Exacerbation in CF

The aim of this study is to develop a reliable and valid instrument to measure symptom management (experience and / or management strategies) during exacerbation episodes in CF patients. For the development a sequential exploratory two phase mixed-method study will be applied. In a first step, up to 25 CF patients will be interviewed: approximately 15 CF patients who experienced at least one episode of exacerbation in the past year and approximately CF 10 patients who are currently experiencing an exacerbation. The latter group will be interviewed up to 3 times during and after the antibiotic treatment. The instruments initial item list will be developed on basis of the interviews. Up to five health professionals will rate the items' relevance. In a further step, items' clarity and relevance will be assessed by cognitive debriefing interviews with no more than 10 patients. In the last step (part III), the instrument's preliminary construct and concurrent validity and reliability will be tested in a larger sample up to 150 patients experiencing exacerbation. Patients will be asked to complete the newly developed questionnaires and a set of other questionnaires at one time point. For part III, ethic approval will be asked at a later date (2015).


Eligibility Criteria:
Inclusion Criteria:

Part I A \& II:

1. Patients with a confirmed diagnosis of cystic fibrosis
2. Age ≥ 18
3. Experience of at least one exacerbation during the last year requiring antibiotic treatment (oral or intravenous)

Part I B:

1. Patients with a confirmed diagnosis of cystic fibrosis
2. Age ≥ 18
3. Experience of an acute exacerbation requiring antibiotic treatment (oral or intravenous)

Exclusion Criteria:

Part I \& II

1. Do not speak or understand German
2. Inability to verbally communicate
3. Cognitive impairment
Hydrocortisone Vs Prednisolone in AI (HYPER-AID)

This study is designed to collect data on individuals with adrenal insufficiency who are changing treatments from hydrocortisone to prednisolone, or vice versa. It will compare anthropometric, biochemical and subjective health outcomes between both treatments.

In the UK, oral immediate release hydrocortisone divided in three doses daily has been the traditional treatment. The most common regimen in clinical practice uses doses of 10 mg on waking, 5 mg at lunch time and 5 mg in the afternoon. Once daily prednisolone is another regimen in clinical use and now prescribed at less than 5mg daily. It has a longer duration of action and a smoother pharmacokinetic profile compared to hydrocortisone. Moreover, prednisolone is much more cost-effective than hydrocortisone with 5mg tablets. Prednisolone is less commonly used due to perceived concerns regarding loss of bone mineral density leading to osteoporosis, increased insulin resistance leading to steroid induced diabetes, and rises in blood pressure and weight leading to increased cardiovascular risk. This belief is perhaps driven by the fact that most clinicians encounter prednisolone in the context of the treatment of asthma, rheumatoid arthritis etc. where far higher doses are employed. Where effects on bone health have been noted, they have been in association with higher doses of prednisolone (7.5mg) than those employed today (2-5mg).

Although conventionally prednisolone 5 mg is assumed to be bioequivalent to HC 20 mg (ratio 1:4), newer studies suggest that the ratio may be nearer 1:6-8 i.e. lower doses can be used.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 - 85 years
* Male or female
* Diagnosed with adrenal insufficiency (AI) for over 6 months according to standard diagnostic criteria
* Established on stable hydrocortisone or prednisolone replacement, dose not altered for at least 4 months
* Individuals taking other hormone replacements are accepted providing that their replacement doses have not altered for at least 3 months;
* Individuals who are able and willing to give written informed consent to participate in the study

Exclusion Criteria:

* Individuals who are unable to give informed consent
* Pregnancy (determined by patients self-reporting pregnancy status)
* Patients using the combined oral contraceptive pill
Efficacy and Safety of Luo-Fu-Shan Plaster in Patients With Rheumatoid Arthritis

The aim of this study is to assess the efficacy and safety of Luo-Fu-Shan Plaster in patients with Rheumatoid Arthritis.

The investigators are inspired by Chinese traditonal herb, an therapy for thousands of years, and take its advantage to make Luo-Fu-Shan Plaster in order to get an effective and safe treatment for active RA patients. The study is a multicenter, randomized, double-blind, placebo-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 to 75 years (time of get informed consent)
* Documented diagnosis of rheumatoid arthritis, as defined by the American Rheumatism Association 1987 Revised Criteria.
* Documented diagnosis of damp-heat syndrome according to Traditional Chinese Medicine.
* If patients are receiving Disease-modifying anti-rheumatic drugs (DMARDs), then the doses should have been kept stable for at least 12 weeks.
* If patients are receiving non-steroidal anti-inflammatory drugs (NSAIDs) or orally Chinese herbal medicine, then the doses should have been kept stable for at least 4 weeks.

Exclusion Criteria:

* Skin allergies or broken skin;
* Taking glucocorticoids,more than 10 mg daily.
* Female patients who are pregnant, breast-feeding or planed to be pregnant;
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder


Eligibility Criteria:
Inclusion Criteria:

* Subject has completed the treatment period in either the ALKS 3831-A311 or the ALKS 3831-A312 study within 10 days of enrolling into this extension study, or subject had terminated early from Study ALKS 3831-A312 due to the clinically significant weight gain criterion.
* Subject will benefit from continued therapy with OLZ/SAM per clinical judgment.
* Subject is able to be treated on an outpatient basis.
* Subject must not be a danger to self or others (per Investigator judgement) and has family support available to be maintained as an outpatient.
* Subject's parent(s)/legal guardian(s) is considered reliable by the Investigator and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures.
* Subject agrees to abide by the contraception requirements specified in the protocol for the duration of the study.

Exclusion Criteria:

* Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale by a response of "Yes" to question numbers 4 or 5 with ideation or suicidal behavior since the last visit.
* Subject has any finding that in the view of the Investigator or Medical Monitor would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirement.
* Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine
* Subject has a positive test for opioids.
* Subject has a positive urine pregnancy test, is currently pregnant or breastfeeding, or plans to become pregnant or begin breastfeeding at any point during the study and for 90 days after any study drug administration.
Effect of Trimetazidine on Radiotherapy-induced Heart Damage.

This is a randomized controlled trial. 80 patients with thoracic radiotherapy will be included. Participants will be randomly divided into experimental group or control group. Before radiotherapy, echocardiography, 2D STE, CK, CK-MB, cTnT, NT-proBNP, electrocardiogram (ECG), and hs-CRP will be detected. During subsequent follow-up, echocardiography, 2D STE, CK, CK-MB, cTnT, NT-proBNP, ECG, and hs-CRP will be collected at every follow-up time.

This is a randomized controlled trial. 80 patients with thoracic radiotherapy will be included in Peking University Third Hospital from May 15, 2021 to August 31, 2022. Participants will be randomly divided into experimental group or control group. Before radiotherapy, echocardiography, 2D STE, CK, CK-MB, cTnT, NT-proBNP, electrocardiogram (ECG), and hs-CRP will be detected. All participants will be followed up after completion of RT, 3 months after RT, 6 months after RT, and 12 months after RT. During subsequent follow-up, echocardiography, 2D STE, CK, CK-MB, cTnT, NT-proBNP, ECG, and hs-CRP will be collected at every follow-up time.

Eligibility Criteria:
Inclusion Criteria:

* lung tumor patients; 18-80 years old; will be treated by stereotactic body radiotherapy

Exclusion Criteria:

* Prior radiotherapy; ACS; heart failure (NYHA III-IV); arrhythmia requiring intervention; echocardiographic images that could not be satisfactorily obtained; significant valvular heart disease (defined as more than mild valvular regurgitation or stenosis).
Pharmacokinetics and Safety of Ertapenem in the Postpartum Period

The investigators are doing this study to learn more about the dosing and safety of ertapenem in women with suspected serious infections less than 42 days from the delivery of their infant.

Ertapenem has received FDA approval for the indication of acute pelvic infection, though there is no pharmacokinetic data to guide dosing of ertapenem in postpartum women. The physiologic changes of the postpartum period make it likely that this special population requires dosing modification to achieve desired therapeutic targets. The objective of this study is to obtain a detailed knowledge of the pharmacokinetics of ertapenem during the postpartum period that will result in improved guidelines on maternal dosing and neonatal exposure. This is a prospective, open-label, single center, pharmacokinetic study of ertapenem in women diagnosed with postpartum endometritis. Subjects will include up to 24 women receiving treatment for a diagnosis of postpartum endometritis with ertapenem in the Duke University Hospital Labor \& Delivery Unit. Each patient will participate in the study for approximately 7 days, though the total study duration is expected to be approximately 12 months. Descriptive statistics for the subjects will be calculated. The appropriate non-compartmental pharmacokinetic parameters will be computed, including AUC24, AUCss, Cmax, CL, Vss, t1/2. All subjects who receive one dose of study drug will be followed for safety, with planned internal review of safety data following the completion of 12 patients. Nursing infants of study subjects will also be followed for safety due to the potential for exposure to study drug through breastmilk.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at the time of enrollment.
* Postpartum period \< 42 days at the time of enrollment.
* Sufficient venous access to permit administration of study medication.
* 2 clinical signs of postpartum endometritis:

  * Oral body temperature of \> 101oF at any time, or a temperature of 100.4 on two occasions 6 hours apart.
  * Maternal tachycardia that parallels the temperature.
  * Uterine tenderness
  * Purulent vaginal discharge
* Findings of advanced endometritis: dynamic ileus, pelvic peritonitis, pelvic abscess, bowel obstruction, necrosis of the lower uterine segment.

Exclusion Criteria:

* History of previous hypersensitivity reactions to beta lactams.
* Receiving valproic acid or divalproex sodium.
* Creatinine clearance \< 30 mL/min as calculated by the Cockroft-Gault equation.
* Subject with a medical condition that, in the opinion of the investigator, would interfere with the pharmacokinetic evaluation of the medication, place the subject at an unacceptable risk of injury, or render the subject unable to meet the requirements of the protocol.
* Previous participation in the study.
* Exposure to ertapenem in the week prior to the study
Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over

This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

The study contains 6 parallel groups, stratified by two age groups: 65-74 years and ≥ 75 years and by two influenza vaccination histories: no influenza vaccination in the last 3 seasons and at least one influenza vaccination in the last 3 seasons.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female aged 65 years or older at the time of the vaccination.
* Written informed consent obtained from the subject.
* Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
* Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to Visit 2 after vaccination.
* Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
* Vaccination against influenza since January 2007 (including the Northern Hemisphere NH 2006/2007 or NH 2007/08 influenza vaccine).
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of hypersensivity to a previous dose of influenza vaccine.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
* Any medical conditions in which intramuscular injections are contraindicated.
Genetic Causes and Clinical Features of Childhood Interstitial Lung Diseases in China

Recruitment of a carefully characterized cohort of chILD patients, to generate a database and biobank via collecting data on chILD in China. Importantly, compatibility with ongoing United States and Europe chILD data base developments will be factored in.

Children Interstitial lung disease (chILD) is a heterogeneous group of rare respiratory disorders of known and unknown etiologies that are mostly chronic and associated with high morbidity and mortality. ILD are characterized by inflammatory and fibrotic changes of the lung parenchyma structure that typically result in the presence of diffuse infiltrates on lung imaging, and abnormal pulmonary function tests with evidence of a restrictive ventilatory defect and/or impaired gas exchange.

Genetic factors are important contributors to chILD. Genetic variations have been mainly described in genes encoding (or interacting with) the surfactant proteins (SP): SP-C (SFTPC) and the ATP-binding cassette-family A-member 3 (ABCA3) (ABCA3), and less frequently in the genes encoding NKX homeobox 2 (NKX2)-1 (NKX2-1), SP-B (SFTPB), SP-A (SFTPA) ,MARS and other genes.

To investigate genetic defects and clinical features of chILD in China, wide recruitment and interdisciplinary critical peer review of all diagnoses from discharge diagnosis coding system of Children's Hospital of Fudan University will be included. Each case will be given a diagnosis independently; if no firm diagnosis is possible, the investigators will review the case periodically as new information becomes available. During the first year of the study, clinicians´ decisions according to clinical practice and outcomes will be independently monitored and assessed.

The investigators will systematically optimize and clarify the relative weight of a large spectrum of single and composite clinical outcomes, sequential limited chest CT (to minimise radiation exposure), lung function testing, histopathological categorization of lung biopsies, serum markers and genetic tests. Variability, reproducibility and the effects of training on reading images will be investigated.

This project will analyse in detail treatment and outcomes within and between subjects using data collected. Analysis of the collected data will support the definition of trial protocols planned in the future.

Eligibility Criteria:
Inclusion Criteria:

* The chILD syndrome exists when a child with DLD has had the common causes of DLD excluded as the primary diagnosis and has at least three of the following four criteria: (1) respiratory symptoms (e.g., cough, rapid and/or difficult breathing, or exercise intolerance);(2) respiratory signs (e.g., resting tachypnea, adventitious sounds, retractions, digital clubbing, failure to thrive, or respiratory fail- ure); (3) hypoxemia; and (4) diffuse abnormalities on CXR or a CT scan.

Exclusion Criteria:

* These include cystic fibrosis, congenital or acquired immunodeficiency, congenital heart disease, bronchopulmonary dysplasia, pulmonary infection, primary ciliary dyskinesia presenting with newborn respiratory distress and recurrent aspiration.