rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Safety and Pharmacokinetic Study of ARTS-011 in Chinese Healthy Volunteers
Status: Recruiting

This single- and multiple-ascending dose study is a Phase 1, first in human study of ARTS-011. The goal of the study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of ARTS-011 after single and multiple oral doses of ARTS-011 in Chinese healthy volunteers.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Healthy female and male subjects between the ages of 18 and 55 years. Body Mass Index (BMI) of 19.0 to 28.0 kg/m2; and a total body weight male ≥50.0 kg, female ≥45.0 kg. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. No evidence or history of clinically significant abnormalities of , vital signs (body temperature, pulse and blood pressure), laboratory tests (blood hematology and biochemistry, urine and coagulation function), 12-lead ECG and other examinations. Subjects has no fertility and sperm donation, egg donation plan and takes highly effective contraception during correctly for the duration of the active treatment period and for at least 90 days after the last dose of investigational drugs.  Exclusion Criteria:  Evidence or history of clinically significant hematological, renal, endocrine pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Any condition possibly affecting drug absorption (eg, gastrectomy). A positive urine drug screen. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 150 mL) of wine or 360 mL of beer or 45 mL of hard liquor within 3 months of screening. History of tobacco/nicotine containing products in excess of >5 cigarettes/day within 3 months of screening. Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product, whichever is longer. 12-lead ECG demonstrating QTc >450, or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc (or QRS) values should be used to determine the subject's eligibility. Screening laboratory abnormalities as defined by the protocol. Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol. Subjected is not appropriate to be enrolled in the study per investigator's assessment. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Study of APR-1051 in Patients With Advanced Solid Tumors
Status: Not yet recruiting

The purpose of this study is to assess the safety and effectiveness of APR-1051 through the performance of a Phase 1, open-label, safety, PK, and preliminary efficacy study of oral APR-1051 in patients with advanced solid tumors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years Diagnosis of advanced/metastatic solid tumor Measurable or evaluable disease per RECIST version 1.1 (radiographic disease progression per PCWG3 criteria for patients with mCRPC) Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 or Karnofsky Performance Status (KPS) ≥ 70% Patients must have recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade ≤ 2 neuropathy, alopecia, or skin pigmentation Adequate bone marrow and organ function Women of child-bearing potential (WOCBP) or men of child-fathering potential must agree to use adequate contraception prior to study entry  Exclusion Criteria:  Patient has had prior systemic anti-cancer therapy (cytotoxic chemotherapy, immunotherapy, targeted therapy) within 3 weeks (6 weeks in cases of mitomycin C, nitrosourea, lomustine) or at least 5 half-lives (whichever is shorter, but no less than 2 weeks) prior to Day 1 Prior radiation therapy at the target lesion unless there is evidence of disease progression. If patient has had prior radiation therapy for disease progression, see Exclusion Criterion 1 for allowed interval between radiotherapy and Day 1 and recovery of AEs Treatment with any investigational agent administered within 30 days or 5 half-lives, whichever is shorter, before the first dose of APR-1051 Major surgery within 21 days prior to Day 1 Concomitant treatment with other anti-cancer therapy, including chemotherapy, immunotherapy, biological therapy, radiation therapy (except palliative local radiation therapy), or other novel anti-cancer agents. Note: endocrine therapy for breast and prostate cancer is allowed along with agents to treat or prevent skeletal related events (zoledronic acid, pamidronate, denosumab) Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Histological Segmentation of the Superficial Femoral Artery From Microscan to CT Using Artificial Intelligence
Status: Not yet recruiting

The femoropopliteal artery segment (FPAS) is one of the longest arteries in the human body, undergoing torsion, compression, flexion and extension due to lower limb movements. Endovascular surgery is considered to be the treatment of choice for the peripheral arterial disease, the results of which depend on the physiological forces on the arterial wall, the anatomy of the vessels and the characteristics of the lesions being treated. The atheromatous disease includes, in a simple way, 3 categories of plaques: calcified, fibrous, and lipidic. The study of these plaques and their differentiation in imaging and histology in the FPAS has already been the subject of research. To treat them, there are angioplasty balloons and stents with different designs and components, with different mechanical properties and different impregnated molecules.

There is no non-invasive method (imaging) to accurately differentiate lesions along the FPAS. The analysis is performed from the preoperative CT scan, but there are high-resolution scanners that allow a quasi-histological analysis of the tissue.

This microscanner can be used ex vivo. In the framework of a project, the learning algorithm was be créated (Convolutional Neural Networks) to automatically segment microscanner slices: after taking FPAS from amputated limbs, we correlated ex-vivo microscanner images of the arteries with their histology. The correlation was then performed manually between the microscanner images, and the histological sections obtained. the algorithm well be trained on these slices and validated its performance. The validation of the CT and microscanner concordance was the subject of scientific publications.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  Male or female of legal age Subject with a planned transfemoral amputation in the vascular surgery department of the Hôpitaux Universitaires de Strasbourg as standard care Subject with a CT as part of standard care Subject who has given his/her non-opposition to participate in the study  Exclusion criteria:  - Impossible to give the subject informed information (subject in emergency situation, difficulties in understanding) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
IUA Committee Research Project on the Management of TASC C and D Aortoiliac Lesions
Status: Not yet recruiting

This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with peripheral arterial/atherosclerotic disease of the aorto-iliac sector undergoing direct, hybrid or endovascular surgical correction with TransAtlantic Inter-Society Consensus (TASC II) type D classification(12).  Age >18 years old  Exclusion Criteria:  Synchronous aortoiliac aneurysmatic/ectasic disease (aorta AP diameter >25 mm) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients undergoing revascularization of the aorto-iliac sector for peripheral arterial disease at any of the center in study starting in January 2016 until December 2023.A consecutive sample will be prepared, containing all patients at the recruiting centers, fulfilling the following criteria - SamplingMethod: Non-Probability Sample
Questionnaire of Lower Urinary Tract Symptoms Among Women Before and After Surgical Correction of Uterine Prolapse
Status: Recruiting

. The study will include patients who underwent Pelvic reconstructive surgery for advanced pelvic organ prolapse (POP-Q ≥ 3). Data regarding preoperative evaluation, surgical procedure, and post-operative management will be collected. women will receive a follow up questionnaire. . The baseline questionnaire included data on age, urinary incontinence, daytime frequency, nocturia, postmicturition dribble, straining, urgency, incomplete bladder emptying, and hesitancy. Women were asked about leakage caused by coughing or sneezing, moving, lifting, sleeping, sexual intercourse, urgency, and rest.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age; greater than or equal to 18 years women with urogenital prolapse grade 3 or more indicated for surgical repair for pelvic organ prolapse Willing and able to sign an informed consent Willing to comply with the study protocol  Exclusion Criteria:  Anti-incontinence surgery Lower urinary tract anomaly Active urinary tract infections Bladder tumor. Bladder stones - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: only female cases will be eligible to participate - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: female cases at women health hospital at assuit university - SamplingMethod: Probability Sample
The Effect of Clinical Experience on the Quality of Obturation and Periapical Changes of Teeth Treated With Matched Cones in Combination With Bioceramic Sealer
Status: Recruiting

Evaluation of the impact of clinical experience on the quality of obturation and periapical changes of clinical cases using lateral compaction with bioceramic sealers and matched cone obturation with bioceramic sealers both clinically and radiographically.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  patients with symptoms of irreversible pulpitis without apical periodontitis related to the maxillary first premolar ranging from 20 to 40 years old and with separate roots were selected from patients referred to the diagnosis clinic, Faculty of dental medicine Al-Azhar University, Cairo, Boys branch.  Exclusion Criteria:  Patients with any systemic disorders. Pregnancy. teeth with positive response to palpation test Non vital teeth. Teeth with positive response to percussion test. Teeth with mobility of grade II or III. teeth with probing depth more than 3 mm. Teeth with abnormal morphology. Teeth with root curvatures more than 20 degree (according to Schneider's method). Teeth with internal or external root resorption. Teeth with vertical root fracture. Teeth with open apices. Teeth with any root canal type other than type I. Patients with (VDS) test with score 4 or less. 15- teeth with fused roots or single root. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 40 Years - StdAgeList: Adult
Data Collection in Lutetium Treated Prostate Cancer: Recording of Progression and Tumor Characteristics
Status: Not yet recruiting

This prospective study aims to collect data and blood biomarkers from patients undergoing Lu-PSMA therapy at the Erasmus MC. In doing so, it will provide real-world efficacy and safety data on the drug, gather dosimetry data and explore putative biomarkers to identify patients who most benefit from Lu-PSMA treatment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants should be at least 18 years old. Participants should be able to understand the written information and be able to provide informed consent. Participants are planned to start treatment with Lu-PSMA as a part of regular clinical care.  Exclusion Criteria:  None applicable - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients diagnosed with metastatic castration resistant prostate cancer set to receive treatment with Lutetium-177 Prostate Specific Membrane Antigen (Lu-PSMA) as a part of regular clinical care. - SamplingMethod: Non-Probability Sample
Serratus Anterior Plane Block and Costotransverse Block for Analgesia Following Modified Radical Mastectomy Surgeries
Status: Not yet recruiting

Adequate pain management following modified radical mastectomy (MRM) is crucial for early ambulation and patient satisfaction. Breast cancer is the most common malignancy in females, with an increasing incidence in recent years. Surgery is one of the mainstays of therapy for breast cancer, and modified radical mastectomy (MRM) is the most effective and common type of invasive surgical treatment. Post-mastectomy pain syndrome (PMPS) is a surgical complication of breast surgery characterized by chronic neuropathic pain. The aim of this study is to investigate the efficacy and safety of single injection CTB versus SAPB on post-operative acute pain as a part of a multimodal analgesia plan in patients undergoing MRM.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  American Society of Anaesthesiologists (ASA) Physical Status Class I, II. Scheduled for modified radical mastectomy (MRM). Body weight ranging from 60 to 100 kilograms.  Exclusion Criteria:  Declining to give a written informed consent. History of allergy to the medications used in the study. Contraindications to regional anesthesia (including patient: refusal, coagulopathy, and local infection). Psychiatric disorders. Significant cognitive dysfunction. American Society of Anesthesiologists (ASA) Physical Status Class III and IV. Daily use of opioids. Obesity (BMI > 35 kg/m2). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Wolf-Parkinson-White Syndrome and Asymptomatic Pre-excitation in Africa (a Multicenter WPW African Registry)
Status: Recruiting

The purpose of this prospective observational study is to characterize the clinical profile of patients with WPW syndrome and patients with asymptomatic WPW pattern on ECG in different African countries and how these patients are managed across Africa Participants would include many different ethnicities at centers where the number of cardiac patients treated is high. All patients attending outpatient cardiology clinics or referred to Cath Lab for electrophysiological studies who are diagnosed to have a Wolf-Parkinson white pattern on the ECG are either symptomatic or asymptomatic. All patients fulfilling the eligibility criteria will be approached by the research team and asked if they wish to take part in the study.

The exclusion criteria will be any participant who does not consent to the study.

A baseline cardiovascular history (including hypertension, diabetes, heart failure, coronary artery disease, hyperlipidemia, smoking, valve disease, and arrhythmia) will be recorded.

A detailed history will be taken about symptoms, medications and presence of family history of similar cases or sudden cardiac death 12-lead ECG will be recorded to confirm the presence of pre-excitation and determine the localization of the accessory pathway using the modified Aruda algorithm. This will be done by two of the research teams in each center.

Then other data from the electrophysiological study and ablation will be filled in by the research team from the data systems of each center.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients who have a preexcitation (WPW) pattern on an ECG.  Exclusion Criteria:  any participant who does not consent to the study. Any participants who have structural heart disease History of other arrhythmogenic diseases like Brugada syndrome, Arrhythmogenic AR dysplasia, long QT syndrome..etc Any implantable cardiac rhythm devices - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Participants are recruited from outpatient cardiology clinics and inpatient cardiology wards at twenty cardiac centers in 17 countries spread across all African regions. They all belong to the Africa Heart Rhythm Association (AFHRA) network, and participants were included if they have preexcitation (WPW) pattern on an ECG either they have symptoms, documented tachyarrhythmias or asymptomatic and accidently discovered - SamplingMethod: Non-Probability Sample
National Observatory of Mycoplasma Infections in Children Under 18 Ages in France
Status: Recruiting

This study was set up because of an unusual increase in the number of cases of mycoplasma infections in France between June and November 2023.

Clinical data from children with mycoplasma infections will be collected to characterise this infection and facilitate hospital management.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age <18 years (only hospitalized children) Documented mycoplasma infection (positive multiplex PCR and/or positive serology)  Exclusion Criteria:  Refusal by one of the parents or by Child in understanding age - Gender: All - MinimumAge: 1 Day - MaximumAge: 17 Years - StdAgeList: Child - StudyPopulation: hospitalised children under 18 age, with Mycoplasma infection - SamplingMethod: Non-Probability Sample
Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging
Status: Recruiting

This study aims to validate a structured report for cervical cancer anchored to the FIGO staging system. A structured report is hypothesized to aid in uniformly applying FIGO staging, reducing staging discrepancies and improving patient care and outcomes.

Furthermore, we believe that the participation of the clinicians will improve the quality of the report to minimize the need for multidisciplinary team discussion

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 years old; Overt biopsy-proven diagnosis of cervical cancer, at any stage; Signed written informed consent to personal data treatment for research purposes  Exclusion Criteria:  Age <18 years old; Uncertain diagnosis of cervical cancer; MRI scan not according the standard acquisition protocol (ESUR guidelines); Patients candidate to non-standard treatments; Refusal to sign the written informed consent to personal data treatment for research purposes - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with biopsy-proven cervical cancer (any FIGO stage) undergoing staging MRI afferent to the participating centers satisfying the following inclusion/exclusion criteria. - SamplingMethod: Probability Sample
CommunautAry Pediatric bacteRial Infection in Intensive CarE Unit
Status: Recruiting

Severe bacterial infections are a worldwide scourge. However, the epidemiology of this type of infection varies over time. It is therefore essential to monitor them in order to prevent them more effectively. At this time, in France, no monitoring exists for this kind of infections.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age <18 years (only hospitalized children) Severe communautary bacterial infection defined by hospitalization in a pediatric intensive care unit (documentation of infection by identification of the bacteria in a sterile environment).  Exclusion Criteria:  Refusal by one of the parents or by Child in understanding age Nosocomial infection - HealthyVolunteers: No - Gender: All - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: Children under 18 ages, with severe communautary invasive bacterial infections, hospitalized in pediatric intensive care unit. - SamplingMethod: Non-Probability Sample
Physical Activity Intervention for the Improvement of Pain in Young, Hispanic Breast Cancer Survivors
Status: Recruiting

This clinical trial tests whether increased activity throughout the day can improve the chronic pain and associated symptoms that breast cancer survivors may experience after surgery. Staying active is a key factor of one's physical, mental, and social health and well-being. Moving more could also reduce pain and associated stress, anxiety, or depression. Using a fitness tracker may help patients to move around more, whether or not they choose to exercise. Information gathered from this study may help researchers learn how the use of a Fitbit tracker with health coaching may improve physical activity and reduce pain in young, Hispanic breast cancer survivors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Women who have completed surgery for invasive breast cancer >= 6 months prior to enrollment Any breast surgery (lumpectomy or mastectomy) Baseline low to moderate activity level (exercise less than 120 minutes a week) PBSPS defined as pain in the area of breast surgery of at least moderate intensity (>= 4 on a scale of 1-10), located in the ipsilateral beast/chest wall, axilla or arm, lasting at least 6 months, and occurring at least 50% of the time Self-identified as Hispanic/Latinx Age, >= 18 and =< 60 years Endocrine therapy and ovarian suppression is allowed  Exclusion Criteria:  Metastatic or locally recurrent disease with no option for curative intent treatment Meeting or exceeding physical activity guidelines (> 150 minutes per week of moderate-intensity exercise) Unable to speak, read, and understand English or Spanish Severe impairments (in seeing or hearing) or pre-existing medical limitations for engaging in daily physical activity. This is defined as the ability to walk 3 blocks without stopping to rest and without using an assistive device Unwilling to use a study provided smartphone (if do not already own one) and wear activity trackers/monitors Adults not able to consent are excluded from participation Based on the age criteria (18 years and older), individuals who are not yet adults (infants, children, teenagers) may not participate in this study due to the same age criteria above Pregnant women Prisoners may not participate in this study as this is a study of free-living individuals - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Female - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult