cyrilzakka/clinical-trials huggingface dataset:
HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB)

A study to evaluate the antiviral effects, immunogenicity, and safety of HepTcell in treatment-naive patients with inactive Chronic Hepatitis B (CHB) and low Hepatitis B surface antigen (HBsAg) levels.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 to 65 years of age, inclusive
* Inactive CHB with documented HBsAg positivity for at least 12 months before Day 1
* qHBsAg ≥ 10 IU/mL but ≤ 100 IU/mL in the 12 months prior to screening
* HBV DNA ≥ 10 IU/mL at screening
* AST, ALT, INR, albumin, total bilirubin (excluding patients with Gilbert Syndrome) and direct bilirubin within normal limits at screening

Exclusion Criteria:

* Positive hepatitis B e antigen (HBeAg) at screening
* History of a hepatitis B flare or 1-log increase in HBV DNA or HBsAg in the prior 12 months
* Undetectable HBV DNA at screening
* Fibroscan \> 8.5 kPA at screening, or history of hepatic fibrosis or cirrhosis (NB, a Fibroscan is not required if an examination is performed within 12 months or a liver biopsy was performed within 2 years before Screening and no fibrosis \[F1 or greater\] was identified).
Efficacy and Safety of Milk Secretory Supplement in Breast-feeding Volunteers

The objective of this study are to evaluate efficacy and safety of milk secretory supplement containing fenugreek, banana flower, and ginger extract in breast-feeding volunteers

There are 24 volunteers in this study. They are randomly divided into 2 groups which are milk secretory supplement group and placebo group. The volunteers take 2 tablets of the sample 2 times/day for 14 days. Amount of breast milk, calcium, iron, docosahexaenoic acid, quality of life, adverse reaction, and satisfaction before taking and after taking for 14 days.

Eligibility Criteria:
Inclusion Criteria:

* During lactation
* Using only breast pump
* No taking medicine or dietary that has an effect on milk secretary including domperidone, banana flower, fenugreek, and ginger in 48 hours
* No smoking and alcohol drinking
* Can read and write in Thai language
* Can meet researcher at the date of appointment
* No complication after delivering

Exclusion Criteria:

* Have uncontrolled diseases, cancer, or heart disease
* Have immunocompromised disease or use steroid in 2 weeks
* Allergic to fenugreek, banana flower, ginger, docosahexaenoic acid, iron, folate, and iodine
* Cannot follow the protocol
Anti-GD2 ADC M3554 in Advanced Solid Tumors

The purpose of this study is to establish the recommended doses and further evaluate the safety and preliminary antitumor activity of M3554 in participants with soft tissue sarcoma (STS) and glioblastoma, IDH-wildtype.

Study details include:

Study Duration per participant: Approximately 4 months


Eligibility Criteria:
Inclusion Criteria:

* Escalation A: participants with documented histopathological diagnosis of locally advanced or metastatic STS with unresectable disease that has progressed after at least one prior line of systemic therapy for the metastatic setting including anthracyclines. Previous trabectidin, eribulin, pazopanib or any other drug approved for the different STS subtypes in second line (2L) or beyond will not be required for enrollment but will be allowed (for example \[e.g\] trabectedin, pazopanib for leiomyosarcoma (LMS); ifosfamide, gemcitabine-based combinations, trabectedin, eribulin, pazopanib for liposarcoma (LPS); trabectedin, gemcitabine, and docetaxel, pazopanib for undifferentiated pleomorphic sarcoma \[UPS\]). Participants with resectable locally advanced or metastatic disease, who had surgery before study entry will be allowed in the trial if there is residual disease after surgery and if the surgery was performed at least 4 weeks before first dose of study intervention.
* Escalation B: participants with documented histopathological diagnosis of glioblastoma, IDH-wildtype, who have progressed after ONLY one prior line of therapy (including radiotherapy +/- temozolomide, depending on the O\^6-methylguanine-DNA methyltransferase \[MGMT\] status) and relapsing at least 3 months after the end of the radiotherapy treatment.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1
* Participants with adequate hematologic, hepatic and renal function as defined in protocol
* Other protocol defined inclusion criteria could apply

  * Exclusion Criteria:
* Participant has a history of malignancy other than STS or glioblastoma (depending on the escalation/expansion cohort) within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence within 3 years).
* STS only: Participants with history of brain metastasis, leptomeningeal metastasis, or participants with spinal cord compression
* Other protocol defined exclusion criteria could apply
Methadone Maintenance for Prisoners

This five-year study examines the benefits of methadone maintenance treatment initiated in prison and continued in the community to male offenders who were previously, but not currently, heroin-dependent. It is anticipated that such prisoners will have more favorable outcomes in the year following release with regard to drug abuse, crime, and HIV risk behavior than either prisoners who receive counseling only or begin initiation of methadone maintenance in the community

Most prisoners with histories of pre-incarceration heroin addiction do not receive treatment while incarcerated or upon release. Effective treatment for such prisoners is urgently needed because rapid relapse typically follows release. Relapse is associated with increased risk for HIV, overdose death, criminal activity, and reincarceration. Other than three studies of methadone maintenance with short-term jail inmates, the only study of longer-term inmates who were previously, but not currently, heroin-dependent was the investigator's pilot study with pre-release inmates. Based on that pilot study, which found that initiating maintenance treatment is feasible and facilitates post-release treatment entry, the present study provides a more rigorous examination of this unique treatment approach.

Eligibility Criteria:
Inclusion Criteria:

* Heroin dependence in the year prior to current incarceration
* 3-6 months left to serve in prison-male pre-release inmate suitability for methadone maintenance as determined by medical evaluation
* Willingness to enroll in methadone maintenance
* Having a Baltimore address

Exclusion Criteria:

* Pending parole hearing
* Pending charges
* Kidney failure
* Liver failure
Evaluation of Manufacturing Lot of StaphVAX

This study answers a U.S. Food and Drug Administration requirement for evaluation in people of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The antibodies in the blood measure the immunogenicity of the vaccine, and typical vaccine safety information is also collected.


Eligibility Criteria:
Inclusion Criteria:

* 8 wk of hemodialysis for ESRD,
* have written informed consent,
* a negative serum pregnancy test if appropriate,
* and expect to comply with protocol procedures and schedule

Exclusion Criteria:

* known HIV,
* immunomodulatory drugs,
* malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer),
* active infection in the 2 weeks prior to study injection,
* serious S. aureus infection within the last 3 months prior to injection,
* use of investigational drugs, vaccines or devices within the prior 30 days,
* hypersensitivity to components of StaphVAX
Role of Photon Counting CT in Detecting Liver Metastatis From Colorectal Cancer

Colorectal cancer is the first leading cause of cancer death in men and second in women. Its incidence rates also increased by 1%-2% annually in young adults (ages \<55 years). The liver is the most common site of colorectal cancer metastasis, with approximately 25% 50% of patients developing liver metastases during the disease. Maximising resection of liver metastasis using all available techniques remains a key objective and provides the best chance of long-term survival and cure. For unresectable patients, optimal systemic and locoregional chemotherapeutic, biological and radiotherapeutic treatments improve survival, and may convert initially unresectable patients to operability. Computed Tomography is currently the modality of choice for patients staging and restaging for high spatial resolution providing accurate delineation of lesion, vascular structure and relation with surrounding structure. The portal venous phase (approximately 60-70 s after administration of contrast agent) is the most reliable phase for detection of liver metastasis with a detection rate of 85% with lower performance for lesion \<1 cm which are interpreted as too small to characterize. Compared to computed tomography, MRI has superior soft tissue contrast and the possibly of a multiparametric characterization of lesion thanks to the evaluation of diffusivity and the uptake of hepatospecific contrast media, resulting in higher accuracy also for lesion smaller than \< 10 mm. Photon-counting detector computed tomography (PCD-CT), used as standard clinical practice, by employing a reduced radiation dose, allows the acquisition of ultra-high resolution images (up to 169 microns) and spectral information, with a high detection rate of liver metastases and their characterization.

Therefore, aim of the present study is to evaluate the value of PCD-CT in the detection of liver metastasis from colorectal cancer in comparison to MRI as reference standard.


Eligibility Criteria:
Inclusion Criteria:

* adult (\>18 years)
* non- biopsy-proven colon/colorectal carcinoma
* CT performed on a PCD-CT
* MRI with multiparametric protocol and hepatospecific contrast media

Exclusion Criteria:

* pregnancy and breastfeeding
* CT exam performed on a scan different from PCD-CT
* absence of multiparametric MRI
* MRI with non hepatospecific contrast agent
* Absent informed consent signed
Biomarker Analysis in Metastatic Colorectal Cancer Treated With Cetuximab

Prometheus's Onco dX assay platform provides technological breakthrough for immunoassay by obtaining a level of sensitivity down to single tumor cells without compromising specificity. This allows assessment of multiple TKI treatment targets, their activation status, as well as down stream signaling proteins using very tiny amount of tissue that can be obtained by FNA or CTCs.

We planned this study to explore biomarkers predictive of clinical response to cetuximab-based treatment in metastatic colorectal cancer using the Prometheus Platform. We will also elucidate signal transduction pathway attributable to cetuximab resistance, monitor changes in the RTK activation status during cetuximab treatment using circulating tumor cells and analyze correlation between the quantity of circulating tumor cells and treatment response to cetuximab.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed metastatic colorectal cancer
* Cetuximab-based chemotherapy (monotherapy, combination therapy with cytotoxic chemotherapy such as FOLFOX, XELOX, irinotecan, FOLFIRI, XELIRI, first-line, second-line or third-line are all eligible)
* Age \> 18 years.
* ECOG Performance Status of 0-2
* Adequate bone marrow, liver and renal function
* Signed and dated informed consent before the start of specific protocol procedures.
* FNA will be performed in patients with feasible biopsy site; ascites or pleural fluid will be collected in metastatic CRC patients with ascites or pleural effusion

Exclusion Criteria:

* Active clinically serious infections (\> grade 2 CTCAE version 3.0)
* Patients with evidence or history of bleeding diathesis
* Radiotherapy during study or within 4 weeks of start of study drug.
* Prior exposure to the study drug.
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Management of Gastrointestinal and Urogenital (GI/GU) Bleedings in Atrial Fibrillation Patients Using Pradaxa

This study is being conducted to collect data on the management of gastrointestinal and urogenital bleeding events occurring in patients with atrial fibrillation taking dabigatran etexilate.

Purpose:

Eligibility Criteria:
Inclusion criteria:

* \>=18 years of age;
* Confirmed diagnosis of Atrial Fibrillation (AF);
* Documentation that the patient had an acute GI and/or GU bleeding event and having taken at least one dose of dabigatran prior to the event.

Exclusion criteria:

* Confirmed diagnosis of valvular AF (VAF);
* Documentation that the patient was taking dabigatran with other oral anticoagulant;
* Documentation of the patient receiving thrombolytic therapy prior to the event;
* Documentation that the patient was enrolled in an investigational clinical trial at the time of the event;
* Medical record was not available.
A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in China

The purpose of the study is to explore the current incidence rate of retinopathy of prematurity (ROP) in China and to explore more appropriate screening criteria for ROP.


Eligibility Criteria:
Inclusion Criteria:

From December 2024 to May 2025, preterm infants (gestational age \<37 weeks) or low birth weight infants (birth weight \<2500 g) who receive their first ROP screening at Xinhua Hospital or partner institutions will be included.

Exclusion Criteria:

1. Death before the first screening;
2. Death or loss to follow-up before complete retinal vascularization;
3. Presence of other diseases causing incomplete retinal vascularization, such as familial exudative vitreoretinopathy, incontinentia pigmenti, or Coats disease;
4. Coexisting conditions affecting the classification or staging of ROP, such as corneal opacity, congenital cataract, persistent fetal vasculature, retinoblastoma, anophthalmia, Terson syndrome, or other ocular infections or diseases;
5. Poor systemic condition preventing fundus examination;
6. History of ocular trauma or surgery (excluding treatments for ROP);
7. Poor-quality fundus images;
8. Other conditions deemed exclusionary by the investigators.
Initial Effect Size Estimation of a Smartwatch-based Intervention for Physical and Behavioral Activation in Depressed Patients

It is well known that physical activity interventions have a robust, if small-to-moderate effect on the amelioration of chronic diseases, including major depressive disorder (MDD) (Singh et al. 2023). At the same time, behavioral activation is one of the most effective components of digital cognitive-behavioral therapy for depression (Furakawa et al. 2021). Here we leveraged smartwatches to provide an interactive tool for delivering a mixed intervention of physical and behavioral activation, with the former addressing physical activity level and the latter pleasant activities including and beyond physical activity (e.g., social, relaxing activities). Moreover, given the relationship with physical activity level, we additionally incorporated digital insomnia exercises that have also shown promising effects in the amelioration of depression. Our primary aim was to estimate the effects of our digital smartwatch-based intervention in a small sample of depressed patients.


Eligibility Criteria:
Inclusion Criteria:

* Written consent for voluntary study participation
* Between 18 and 65 years of age
* Current diagnosis of a single episode of mild to moderate depressive disorder without psychotic symptoms, according to ICD-10 (F32.0, F32.1)
* Internet access and email address to answer electronic questionnaires
* Ability to read German

Exclusion Criteria:

* Acute suicidality
* Pregnancy and breastfeeding
* Currently undergoing psychological treatment
* Current use of psychotropic medication
* Neurological or internal medical disease
* Diagnosis of a severe major depression or dysthymia according to ICD-10 (F32.2, F32.3, F33.2, F33.3, F34.1)
* Diagnosis of a psychotic disorder according to ICD-10 (F20-F29) in the life history
* Diagnosis of a bipolar disorder according to ICD-10 (F31) in life history
* Acute substance abuse (e.g., drug use or excessive alcohol and nicotine use)
* Diagnosis of dissociative disorder (F44) in life history
Evaluation of Bronchial Inflammation in Allergic Bronchopulmonary Aspergillosis (ABPA)

Chronic bronchial inflammation is an important clinical feature in cystic fibrosis. Approximately 10% of patients with cystic fibrosis suffer from Allergic Bronchopulmonary Aspergillosis. In addition airway inflammation in patients with cystic fibrosis (CF) plays a major role in progression of CF lung disease. In patients with mild disease (Vital capacity \>75%) airway inflammation is often under diagnosed.

Severity of allergy against Aspergillus fumigatus will be examined using radioallergosorbent test and skin Prick-test. Subsequently, in patients with established sensitization (RAST ≥ 0.35 IU/mL) a specific bronchial provocation with Aspergillus will be performed. In addition, exhaled nitric oxide,carbon monoxide, exhaled air temperature and inflammatory cells in sputum is measured. 24 hours after bronchial allergen provocation, exhaled NO, CO, air temperature, and bronchial responsiveness is determined and a second sputum obtained.

This study is designed to characterize patients with CF and sensitization against Aspergillus fumigatus in an early stage to prevent pulmonary complications of ABPA. In addition sputum cytokine profiles in CF patients with mild and moderate disease may be different in patients without and with involvement of small airway disease (SAD).

Since symptoms of Bronchopulmonary Aspergillosis are often identical to bacterial infections, the diagnosis is difficult to make. The disease presents with wheezing, pulmonary infiltrates, and bronchiectasis. The most important diagnostic parameters are asthmatic symptoms with obstruction, positive prick test, elevated total IgE, specific IgE and IgG to Aspergillus fumigatus, eosinophilia and radiological findings. Aspergillus fumigatus acts as an allergen Ig-E mediated allergy. Pathophysiological it is assumed that there are two different mechanisms of allergic inflammation. First, there is a direct effect of Aspergillus fumigatus proteases in the alveolar and bronchial epithelium with release of proinflammatory cytokines (IL-8, IL6, MCP-1) and consecutive chemotaxis of inflammatory cells. Second a CD4+ Th2 response with release of IL-4, IL-5 and IL-13. Recently published studies suggest that Aspergillus spores cause the TH2-dependent inflammation directly. So-called Chitinases (part of innate immunity) induce massive IL-13 stimulation. Induction of chitinase activity (CHIT1) leads to an increased remodeling of the lung. It is currently unclear, to which extent Aspergillus-triggered bronchial inflammation in patients with CF is relevant.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* age between 4 and 45 years
* well-known Cystic fibrosis
* Lung function: FEV1 (% pred.) ≥ 70%

Exclusion Criteria:

* age \< 4 and \> 45 years
* lung function: FEV1 (% pred.)\< 70%
* other chronic diseases or infections (e.g., HIV, tuberculosis, malignancy)
* pregnancy
* known alcohol, drug and/or drug abuse
* inability to capture the scale and scope of the study
* participation in another study
AR vs In Person Simulation for Medical Workplace Training

This study will evaluate the physiologic and emotional effects of an augmented reality (AR) simulation versus an in-person simulation. This is a single institution, non-inferiority, randomized controlled trial. The target enrollment will be 100 participants in each group for a total of 200 participants. One group will wear an AR headset and participate in an AR medical crisis scenario and the other group will participate in the same scenario with a traditional, mannequin based in situ simulation.


Eligibility Criteria:
Inclusion Criteria:

* Hospital providers, including nurses, physician assistants, physicians, physician trainees, and other healthcare workers at Lucile Packard Children's Hospital (LPCH) and affiliated facilities who communicate with patients daily will be included

Exclusion Criteria:

* Participants with reported severe motion sickness
* Nausea
* Seizure disorder
* Currently using chronotropic heart medications, such as β blockers
Lymphoma Follow-up

This follow-up protocol is designed to evaluate participants who have previously been lymphoma patients treated on approved clinical studies of the National Institutes of Health.

The intent of this protocol is to accrue up to 800 volunteers who are interested in participating in NIA research studies as part of follow-up for previous cancer treatment at NIH. Participants will be asked to answer questions regarding their general health status, diagnoses, and admissions to hospital, and to provide possible documentation. They may be asked to come to the NIA Clinical Research Unit at Harbor Hospital to participate in a follow-up evaluation. They will have the opportunity to obtain additional information about studies in which they may wish to participate and to discuss eligibility issues with NIA staff members. Any identified clinical problems in need of care will also be discussed. Volunteers may be referred, with their permission, to their private medical doctor for follow-up. They may be re-evaluated within a year for further follow-up.

The follow-up evaluation may include history and physical, blood and urine tests, questionnaire, MRI or CT.

Eligibility Criteria:
Inclusion Criteria:

* Previously treated on an approved NCI/NIH protocols
* Willing and able to provide informed consent for current NIA protocol
* Rare, unusual, interesting or unknown condition that requires diagnosis

Exclusion Criteria:

* Does not meet the criteria of any previously-approved NIH Protocol.
Couple-oriented Prenatal HIV Counseling in Low and Medium HIV Prevalence Countries

ANRS 12127 Prenahtest is an intervention trial conducted in four countries (Cameroon, Dominican Republic, Georgia and India), where pregnant women are randomized during prenatal care to receive either standard post-test HIV counseling, or an innovative intervention called couple-oriented post-test HIV counseling (COC).

The aim of the COC intervention is to empower women to communicate with her male partner about HIV, and HIV testing in particular, and encourage him to return for HIV testing and/or couple HIV counseling (where both couple members are counseled together).

Prenahtest is the first randomised trial testing a prenatal intervention to increase partner HIV testing.


Eligibility Criteria:
Inclusion Criteria:

* Attending her first ANC visit for the current pregnancy in the study centre
* Accepting to participate in the study and being able to give informed consent ii
* Currently having a partner (the man who the woman considers as her regular partner on the day of inclusion, even if this person is not the baby's father) iii
* Accepting follow-up (including home visits if necessary) by the project staff until 15 months after delivery

Exclusion Criteria:

* Having been tested for HIV during her current pregnancy
* Having a male partner who was tested for HIV during her gestational period v
* Having a partner who works out of the predefined study area or is absent for more then 6 months
* Being unwilling/unable to provide address/contact information
* Having an intoxication and/or mental impairment at the moment of recruitment