cyrilzakka/clinical-trials huggingface dataset:
APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST

An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449.

Part A: To evaluate the safety of APG-2449 monotherapy in patients with advanced solid tumors.

Part B: To evaluate the safety, tolerability, and efficacy of APG-2449 combined with PLD in the treatment of ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Part A: No gender limitation. Patients with histologically and/or cytologically confirmed ALK/ROS1 gene fusion positive non-small cell lung cancer and various advanced tumors.

   Part B: Female only. Histologically proven ovarian epithelial, fallopian tube, or primary peritoneal carcinoma.
2. At least one measurable tumor lesion.
3. ECOG score is 0\~1.
4. Life expectancy of ≥3 months.
5. AE caused by previous treatment must recover to ≤ grade 1.
6. Sufficient bone marrow, liver, kidney and coagulation function.
7. Female patients must be in a non-pregnant and non-lactating state.
8. Able to understand and willing to sign informed consent.
9. Patients are required to provide fresh or archived tumor tissue samples prior to treatment.

Exclusion Criteria:

1. Undergone major surgery or major trauma within 28 days before first dose or a diagnostic biopsy within 14 days before first dose.
2. Received systemic antitumor drugs, including investigational drugs.
3. Received radiotherapy within 14 days before first dose.
4. Previous treatment with FAK inhibitors.
5. Have tumors at positions other than existing ovarian cancer or of other histological types within 3 years before first dose.
6. Known active central nervous system (CNS) metastases and/or cancerous meningitis.
7. Major cardiovascular and cerebrovascular disease occurred within 6 months before first dose.
8. Patients with pleural effusion, pericardial effusion, or ascites requiring puncture, drainage, or having received drainage within 1 month before first dose.
9. Malabsorption syndrome, or inability to take medications orally.
10. Severe gastrointestinal disease.
11. Any serious or uncontrolled systemic disease; Various chronic active infections.
12. Allergy to APG-2449 or PLD and its drug components.
13. Previous cumulative doses of anthracyclines ≥550 mg/m\^2.
14. Patients using a moderately potent CYP3A4, CYP2C9, or CYP2C19 inhibitor/inducer or P-gp inhibitor within a week before first dose. Patients using CYP3A4 substrates and the drugs of a narrow treatment window within a week before first dose.
15. Other factors that, in the investigator's judgment, should prevent the patient from entering the study.
Interdisciplinary Hospital-home Intervention on Motor Development in Premature Children

Motor development of the premature infant often exhibits deviations that trigger functional limitations and disability. In Colombia, one out of every five births corresponds to premature babies. In preterm infants requiring hospitalization, early clinical interventions focused on home care have been shown to improve motor development and decrease morbidity.

However, interdisciplinary work, supported by information and communication Technologies (ICT), shows a knowledge gap that can be explored. This leads to the following research question: ¿What is the effect of an interdisciplinary Hospital-Home intervention addressing motor development adaptation in premature infants in Colombia in comparison with traditional interventions?

Objective: To determine the effect of an interdisciplinary Hospital-Home intervention addressing motor development adaptation in premature infants in Colombia in comparison with traditional interventions

Methodology Experimental quantitative study with pre-test and post-test to two groups, experimental and control, which compares before and after the intervention. The intervention will be developed in two scenarios: the hospital and the home. The experimental group will receive the intervention and the control group the traditional care established in the institutions for premature children. The calculation of the sample size is 130 participants.

Type of results expected to be obtained It is expected to obtain a supported that justifies the importance of education from hospital stay, post discharge follow-up and parental participation in the adequate stimulation of motor development of the premature. It is expected to incorporate the use of ICT in home monitoring, while implementing the use of a mobile application for this purpose. It is also expected to contribute to the research training of undergraduate and graduate students. In addition, participate in national and international presentations and in the production of scientific articles.


Eligibility Criteria:
Inclusion Criteria:

* Premature infants between 34 and 37 weeks of gestation,
* Infants with weight over 1800gr
* Hemodynamic stability
* Interns in NICU of participants institutions (Colombia and Poland).
* Infants with residence in a places close to the institutional health care services.

Exclusion Criteria:

* Premature child with a musculoskeletal deformity.
* Premature child with diagnosis of a genetic syndrome
* Premature child with congenital heart diseases.
* Premature child with brain injuries.
Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

The primary objective of this study is to identify any changes on the safety profile of adverse events and serious adverse events. And the secondary objective is to evaluate clinical response in the clinically evaluable population at test-of cure (TOC) or at the end of treatment (EOT) assessment, and microbiologic response at the subject level, if available.

Prior to the conduct of this study, the investigator will explain the study objective, etc to prospective subjects on the basis of "explanatory material." The informed consent will be obtained in written form by each subject voluntarily.

Eligibility Criteria:
Inclusion Criteria:

Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :

Adults 18 years of age or older, who have one of the followings:

* Complicated skin and skin structure infections
* Complicated intra-abdominal infections
* Community-acquired bacterial pneumonia

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

* Patients who have known hypersensitivity to tigecycline
* Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
Eplerenone Versus PDT: Comparative Study by OCTA

The study aims to analyze the changes in OCTA parameters and in choroidal thickness in patients affected by central serous chorioretinopathy treated by oral eplerenone and half-fluence photodynamic therapy.

Central serous chorioretinopathy (CSC) is a chorioretinal disease characterized by serous detachment due to the dilatation and hyperpermeability of choroidal vessels resulting in the accumulation of serous fluid between the neurosensory retina and the retinal pigment epithelium.

Several studies reported the efficacy of half-fluence photodynamic therapy (PDT) and oral eplerenone in the CSC treatment inducing a reduction of the choroidal hyperpermeability and remodeling the choroidal vascularization.

This retrospective study aims to perform a quantitative analysis of retinal and CC vessel density by OCTA at baseline, 3 and 6 months in patients underwent PDT and patients underwent eplerenone.

Eligibility Criteria:
Inclusion Criteria:

* age older than 30 years
* diagnosis of central serous chorioretinopathy
* treatment-naïve with half-fluence photodynamic therapy or oral eplerenone
* absence of vitreoretinal and vascular retinal diseases

Exclusion Criteria:

* age younger than 30 years
* absence of diagnosis of central serous chorioretinopathy
* previous treatment with half-fluence photodynamic therapy or oral eplerenone
* presence of concomitant vitreoretinal and vascular retinal diseases
Exploring P-Wave Duration in Arrhythmia Recurrence in Patients Undergoing AF Ablation

The aim of this study is to investigate whether P-wave duration in a baseline surface 12-lead ECGs correlates with recurrence of AF recurrence post successful ablation at the time of the procedure.

Patients with paroxysmal AF are often treated arrhythmia-free (75%) with a single catheter ablation at 12 months post procedure . In contrast, in patients with persistent AF or long persistent AF, catheter ablation is more complex and often yields in lower success rates of around 50% often requiring multiple attempts .

The success rates remain low despite several different ablation sites having been proposed (additional lines plus PVI, epicardial approach).

There is growing evidence that PWD is associated with the extent of left atrial scarring and this can be used a potential predictor of AF recurrence . Moreover, results from the investigators group has previously shown that PWD correlated with the duration of the AF and this could be altered by extensive ablation .

It is uncertain whether PWD prior to any procedure for persistent AF, long persistent or paroxysmal AF can accurately predict failure of procedure.

This is a single centre observational study of persistent, long persistent and paroxysmal AF population who have undergo AF cryoablation in University Hospital Plymouth . All patients receive this current procedure as standard of care.

This study does not involve any patient contact out of the standard routine clinical follow up and therefore no public involvement has been sought.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with persistent, long persistent or paroxysmal AF undergone AF cryoablation from 2016 onwards
2. Age \>18
3. Patient does not meet exclusion criteria -

Exclusion Criteria:

1. Patients whose records cannot be obtained
2. Patients with persistent, long persistent or paroxysmal AF undergone AF ablation prior to 2016
3. Patients with no documented ECG in sinus rhythm prior to ablation
4. Patients not undergoing cryoablation for AF -
Type 2 Diabetes Glucose Biomarker Study With a Continuous Glucose Monitoring System

Current gold standard methodologies for diagnosing type 2 diabetes (T2D) or prediabetes can be unreliable and inaccurate, and require the need for multiple different tests for comparison. It is possible that a simpler and more refined method of diagnosing T2D or prediabetes involves examining the proportional-integral (PI) control system of the body's glycemic function (i.e., a model of the glucose curve). The purpose of this research is to examine how well a PI model can diagnose nondiabetic, prediabetic, or diabetic patients based on glucose data gathered from a wearable glucose monitoring device.


Eligibility Criteria:
Inclusion Criteria:

* Either male or non-pregnant, non-lactating female aged \> 18-60 \<years (both inclusive)
* Subjects willing to give written informed consent
* Healthy Volunteers
* Subjects able to comply with the study protocol
* Women of child bearing potential must have a negative urine pregnancy test prior to study entry
* Minimum 4 subjects in each interval of approx 7 years (18-25/26-32/32-38/39-45/46-52/53-59)
* Minimum 40% subjects of one gender to mark relative distribution

Exclusion Criteria:

* Any person below the age of 18 years
* Suspected or confirmed pregnancy
* Currently breastfeeding
* Diagnosis of any known chronic or acute medical disease of any kind (e.g., cardiovascular disease, respiratory disease, influenza, pneumonia, etc.)
* Diagnosis of any known neurological disease or psychological disorder of any kind (e.g., brain lesion, epilepsy, anxiety, eating disorder, mood disorder, sleep disorder, etc.)
* Any implanted electrical medical device (e.g., pacemaker, insulin pump, deep brain stimulator, etc.)
* Any form of prescription medication
* Use of antibiotics in the three months prior to enrollment
* Any person planning to undergo a Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment during the duration of the study (as per restrictions of the FreeStyle Libre pro device)
Endometrial Carcinoma: Comparison of Surgical Approaches (Laparoscopy Vs Laparotomy)

Since the publication of the LAP2 study, a prospective randomized trial, laparoscopy has been considered the gold standard for treating patients with early-stage endometrial cancer (EC). However, no prospective randomized trials have been published reporting comparable data in patients with EC at high risk of recurrence (advanced stages or non-endometrioid histology). Nonetheless, some retrospective studies and a systematic review of the literature have demonstrated that minimally invasive surgery achieves better perioperative outcomes than laparotomy without compromising survival in patients with EC at high risk of recurrence.

The aim of this multicenter retrospective observational study is to evaluate the safety of minimally invasive surgery in treating EC at low, intermediate, and high risk of recurrence according to the ESMO-ESGO classification, based on cases treated in hospitals within the Emilia Romagna region. Specifically, we aim to assess the effects of a minimally invasive surgical approach compared to laparotomy in terms of:

1. Perioperative and postoperative complications: including the need for transfusions during and/or after surgery, duration of surgery, fever exceeding 38°C for more than 48 hours, and length of hospitalization.
2. Long-term oncological outcomes: including overall survival, disease-free survival, recurrence rates, recurrence sites, and time to recurrence.

This comparison will include patients treated for both endometrioid and non-endometrioid EC to provide a comprehensive evaluation of minimally invasive surgery versus laparotomy.

By delineating the safety and efficacy of laparoscopic techniques, particularly for higher-risk patients, this research could refine surgical standards and guide clinical decision-making, emphasizing evidence-based practices for tailored patient care. The study also aligns with broader efforts to optimize cancer management in regional and national healthcare settings.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of endometrial cancer who underwent surgical treatment between 2000 and 2020

Exclusion Criteria:

* Patients with other types of tumors (e.g., cervical or ovarian cancer).
* Patients for whom surgical and/or post-operative data are unavailable.
* Patients with a follow-up period of less than 6 months.
* Patients who refuse to provide informed consent.
Prognosis of Acute Coronary Syndrome in HIV-infected Patients

Objectives: Evaluate differences for mortality, morbidity and the cardiovascular risk factors between HIV and non-HIV patients with an acute coronary syndromes (ACS) after a 3-years follow up.

Background: There have been many cases of myocardial infarction reported in HIV-infected young adults treated with HAART. Little is known to date, concerning the outcome and prognostic factors of patients with acute coronary syndrome and HIV-infection.

Methods: Prospective cohort study to compare the evolution and prognosis between HIV and non-HIV patients with an ACS.

Duration of the study: Two years for including patients. Three years of follow-up 100 HIV-patients with ACS and 200 non-HIV patients with ACS will be included in the study. All patients will be included in the study from 30 Intensive Care Unit of Cardiology departments in France.

Results: To compare the incidence of total mortality, cardiovascular mortality (myocardial infarction, sudden death, cardiogenic shock, fatal stroke), morbidity (non fatal myocardial infarction, unstable angina, recurrence of ischemia, cardiac failure, non fatal stroke) and revascularization (percutaneous coronary intervention, coronary artery bypass graft surgery) during a 3-year follow-up between HIV and non-HIV patients with ACS. Univariate and multivariate analysis of predictive factors for cardiovascular events will be done.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 year's old
* Man or woman HIV-infected for HIV 1 with or without highly active antiretroviral therapy
* Acute coronary syndromes (STEMI, NSTEMI and unstable angina)

Exclusion Criteria:

* Known atherosclerotic artery disease (MI, ACS, PCI, CABG, coronary stenosis, stroke, peripheral arteriopathy)
Home Self-Testing for HIV to Increase HIV Testing Frequency in Men Who Have Sex With Men (The iTest Study)

The purpose of this study is to determine whether the availability of home self-testing for HIV will increase HIV testing frequency among men who have sex with men without negatively impacting their risk for HIV acquisition.

HIV counseling and testing remains one of the most effective HIV prevention interventions because many individuals newly diagnosed with HIV infection will alter their behaviors to reduce the risk of HIV transmission to others. In the U.S., men who have sex with men (MSM) represent the group with the greatest risk for HIV acquisition despite a high penetrance of testing, in part because their frequent exposures and infrequent testing can result in long intervals between HIV acquisition and diagnosis. Efforts to prevent HIV transmission among MSM must therefore increase the frequency of HIV testing and thereby decrease the time interval that infected individuals are unaware of their status and their potential for transmission. Home self-testing for HIV may increase the frequency of HIV testing, but there are concerns that it may also have negative consequences, including decreased access to risk reduction counseling.

We will randomize 246 MSM at high risk of HIV acquisition either to have access to home self-testing for HIV using the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test or to standard, clinic-based HIV testing for 15 months to determine the effects of home self-testing availability on HIV testing frequency and markers of risk for HIV acquisition and to assess the acceptability and ease of use of home self-testing. After screening to determine eligibility, study visits will occur at baseline and at 15 months. Both visits will include HIV/STD screening and surveys regarding HIV testing and risk behaviors. During follow-up, participants will be asked to complete brief online surveys after testing for HIV.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age ≥18
* Has sex with men
* HIV-negative
* Meets PHSKC HIV/STD Program definition of "high risk"
* Plans to live in Seattle for the next 15 months

Exclusion Criteria:

* Unable to safely and confidentially receive or store a home testing kit
Change in Pain and Quality of Life Following SCS for Chronic Pain

Study Title Subject-reported treatment efficacy and procedure satisfaction (steps) study.BURST study- a prospective observational clinical study examining the changes in quality of life and pain following spinal cord stimulation for the treatment of chronic intractable lower back and lower limb pain.

Objectives The primary objective is changes in lower back and/or lower limb pain patient-reported satisfaction with procedure outcome and treatment efficacy to reduce pain levels following an orthopedic procedure for knees, hips, shoulders, elbows, wrists, or anklesspinal cord (SCS) stimulation. Secondary objectives include changes in physical health, quality of life, and quality of life and pain-related prescription medication usage.

Design and Outcomes This is a prospective observational single-arm study to access the primary outcome variable of lower back and/or lower limb patient satisfaction with procedure outcomes as measured using a modified MacNab scale. Patients will have presented to their healthcare providers with knee, hip, shoulder, elbow, wrist, or ankle pain and will have elected and been assigned a medically-appropriate surgical procedure as part of their standard of care. It is possible for subjects to have multiple areas of pain and subsequent surgeries, and subjects have the option of completing surveys for all medically-indicatedmedically indicated areas being treated.pain

IIIntervention and Duration There will be no study intervention. Subjects will only be monitored and evaluated for pre and post-operative satisfaction, pain, physical activity levels, quality of life, and medication use levels. Subjects will be followed for 12 months following their SCS stimulation implant procedure.

Sample Size and Population Investigators aim for a minimum population size of 1,500 in order to give statistical significance with results. Subjects will be stratified by surgical procedurearea of chronic pain.

Eligibility Criteria:
Inclusion Criteria:

Prescribed spinal cord stimulator implant by their healthcare provider. Previous conservative care such as physical therapy or chiropractic care that failed to provide adequate pain relief.

Willing and able to adhere to the protocol of the study including the survey timeline.

Between the ages of 18-85 years.

Exclusion Criteria:

Unwilling to sign Informed Consent and comply with protocol
A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer

This is a first-in-human, multicenter, Phase 1/1b, 3-part, double-blind study of ZH9 in patients with recurrent NMIBC who are eligible for intravesical therapy. In Part 1, the safety, tolerability, and pharmacology of ZH9 IVI will be evaluated in a single ascending dose (SAD) patient cohort. In Part 2, the safety, tolerability, and pharmacology of ZH9 oral prime followed by ZH9 IVI will be evaluated in 2 patient cohorts at the doses and schedule established in Part 1. In Part 3, the safety, pharmacology, and clinical efficacy of ZH9 will be further evaluated in 2 expansion cohorts of patients with recurrent intermediate- and high-risk NMIBC.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Histologically documented recurrence of NMIBC
* BCG unresponsive (BCG naïve patients may be enrolled if they have received at least 1 line of adequate intravesical standard of care (SOC) treatment and are either not candidates for BCG or do not have access to BCG (e.g., BCG shortage))
* Eastern Cooperative Oncology Group Performance Status 0-1
* Adequate organ and marrow function
* Highly effective contraception if risk of conception exists.
* A female participant is eligible if not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or is a WOCBP that uses highly effective contraception.

Exclusion Criteria:

* Received treatment with any local or systemic antineoplastic therapy within 3 weeks or 5× the plasma half-life prior to first dose of ZH9
* Major surgery or radiation within the 3 weeks prior to Screening (TURBT is not considered major surgery)
* Concurrent urinary tract infection or history of clinically significant polyuria
* Symptoms consistent with typhoid
* Evidence of infection within 2 weeks of the first dose of ZH9
* Significant 12-lead electrocardiogram abnormalities
* History of malignancy within the previous 12 months
* History of allogeneic tissue/solid organ transplant