rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis
Status: Recruiting

Head and neck squamous cell carcinoma (SCC) is the sixth most common cancer worldwide, with more than 700,000 new cases and more than 350,000 deaths each year. At present, radiotherapy is an important measure to control the recurrence of head and neck tumors, but almost all patients with head and neck squamous cell carcinoma will have acute inflammatory reactions such as radiotherapy-induced oral mucositis (RIOM) after radiotherapy, which seriously affects the quality of life and radiotherapy efficacy of patients. Serum amyloid A1 (SAA1) is an acute phase protein associated with inflammation. Our previous basic research found that serum SAA1 expression levels can be used as biomarkers to assess the dose received by the receptor in the early stages of radiation damage. At the same time, we confirmed that the serum level of SAA1 in patients with nasopharyngeal carcinoma increased after radiotherapy. Therefore, we intend to conduct a prospective, multicenter, observational study to further explore the predictive power of plasma SAA1 levels for radiotherapy-induced oral mucositis, with a view to early screening and prevention of RIOM patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Over 18 years of age. Voluntarily sign informed consent. The pathological diagnosis was nasopharyngeal carcinoma, head and neck tumor. Need to be treated with radiotherapy. ECOG PS Score: 0/1.  Exclusion Criteria:  There are contraindications to radiotherapy. Combined with other tumors. Patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor disease status, uncontrolled diabetes (fasting blood glucose > 1.5 × ULN), and mental illness. At the investigator's discretion, those who was not considered to be suitable for participation in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with nasopharyngeal carcinoma and head and neck tumors requiring radiotherapy. - SamplingMethod: Probability Sample
Intermittent Fasting on Body Fat and Quality of Life
Status: Recruiting

The purpose of this investigator-initiated study to check the feasibility that intermittent fasting has on body fat loss and quality of life.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  • In good health  Exclusion Criteria:  • Diabetes or Metabolic Syndrome - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
European Registry of Transcatheter Repair for Tricuspid Regurgitation
Status: Recruiting

To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients treated with one of the following transcatheter devices for TV repair or replacement (e.g. PASCAL, TriClip, TricValve, Evoque, LuX-Valve)  Exclusion Criteria:  Age < 18 years - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients treated with one of the following transcatheter devices for TV repair or replacement (e.g. PASCAL, TriClip, TricValve, Evoque, LuX-Valve) - SamplingMethod: Non-Probability Sample
Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA
Status: Recruiting

Solid tumors pose significant challenges in current therapeutic approaches. Targeted therapy has emerged as a promising avenue, aiming to enhance treatment efficacy while minimizing adverse effects. This clinical trial focuses on an innovative combination of two targeted inhibitors, Palbociclib and Bevacizumab, for their potential synergistic effects in addressing these challenging malignancies. Moreover, this study incorporates a molecular approach by considering Long Non-Coding RNAs (LncRNAs) as biomarkers. Initiating with a focus on colorectal cancer, the study aims to expand its scope to other solid tumors, including lung, breast, ovarian and other cancers. Palbociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, disrupts the cell cycle progression, particularly in cancer cells with specific molecular characteristics. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, targets angiogenesis-a critical process for tumor growth and metastasis. The rationale behind combining these agents lies in their complementary mechanisms of action, potentially leading to enhanced antitumor effects. LncRNAs have shown promise in predicting treatment response and prognosis in various cancers, providing an additional layer of precision to the treatment strategy. By elucidating the molecular basis through LncRNA analysis, the trial aims to tailor the treatment to the specific molecular profile of each patient, ultimately striving for better outcomes and improved survival rates. This novel combination therapy, coupled with a personalized biomarker-driven approach, represents a cutting-edge strategy in the pursuit of more effective and individualized treatment for solid tumors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Individuals of white ethnicity. Age between > 18 Both males and females. Diagnosis of selected cancer type (e.g., colorectal cancer, lung cancer, genitourinary cancers, breast cancer). Cancer stage III/ IV with or without metastasis or lymph node dissemination at the time of enrollment. Unrelated patients.  Exclusion Criteria:  History of hematological cancer types or previous cancers, recurrent or relapse. Diagnosis of inflammatory bowel diseases. Pre-existing cardiovascular diseases or coronary artery diseases. Confirmed treated or untreated autoimmune diseases. Metabolic disorders, diabetes, or hypertension. Neurological diseases. Evidence of cardiac, renal, bone, or cerebral damage. Presence of more than one type of malignancies. Active infections or myositis. Familial polyposis. Alcohol or smoking habits. Body mass index (BMI) >30. Significant weight loss within the last 2 years. History of surgeries. Pregnancy. Related patients. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
HAAL: HeAlthy Ageing Eco-system for peopLe With Dementia
Status: Recruiting

HAAL project aims to test several technological devices in order to improve the quality of life of older people with dementia and their informal and formal caregiver.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  being the caregiver of a person with cognitive impairment or dementia; availability of time to participate; visit the assisted person at least two times at week or live with him/her.  Exclusion Criteria:  Lack of written informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult
Assessing the Convenience of Natural Proliferative Phase Frozen Embryo Transfer
Status: Recruiting

This study will assess the convenience of the natural proliferative phase frozen embryo transfer (NPP-FET) in terms of number of number of appointments needed before cycle scheduling.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Endometrial thickness ≥ 7 mm on the day of starting progesterone-based luteal phase support (LPS) Serum progesterone levels <1.5 ng/ml on the day of starting progesterone-based LPS LPS with micronized progesterone 400mg b.i.d. Regular cycles (>24 days, ≤ 38 days) IVF/ICSI with donated oocytes Single blastocyst stage embryo transfer First or second embryo transfer from the same cohort  Exclusion Criteria:  Use of exogenous ovarian stimulation during FET Untreated hydrosalpinx, polyp, submucous myomas or severe adenomyosis Recurrent pregnancy loss (≥ 3 previous pregnancy losses) Recurrent implantation failure with embryos from oocyte donation (≥ 3 previous failed embryo transfers) Personalized initiation of exogenous progesterone according to a previous endometrial receptivity assay test - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 49 Years - StdAgeList: Adult - StudyPopulation: The study group will include a prospectively recruited cohort of ovulatory patients undergoing their first or second FET attempt following oocyte donation in a natural proliferative phase protocol. The control group will include a retrospective cohort of ovulatory patients undergoing a natural cycle frozen embryo transfer following oocyte donation. - SamplingMethod: Probability Sample
Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers
Status: Recruiting

This is an exploratory experimental multicentre study on archived serum samples and on prospectively collected serum samples and blood samples.

General objectives of the study are: to identify specific biomarkers in order to develop more accurate serological tests for the screening of Leishmania infections that does not present cross-reaction with other infectious diseases; to unveil the Antigen Recognition Patterns (ARPs) of Leishmania infection in humans; to verify whether the ARPs and the new biomarkers are common to different Leishmania infantum strains isolated in Italy as well as in other part of the World and to different strains of L. donovani isolated in Sudan as well as in other part of the World and discard any possible cross reaction with other infectious diseases such as Chagas, TB, leprosy or malaria.

Eligibility:
- EligibilityCriteria: CASES:  Inclusion criteria:  Leishmania positive patient from Italy (n=30) and from Sudan (n=30); patient with a clinically or laboratory confirmed diagnosis of leishmaniasis; signed informed consent (criteria not applied in case of samples stored at the Tropica Biobank at the DITM) being clinically classified as leishmaniasis patient by an experienced clinician or being laboratory confirmed as leishmaniasis patients, giving positive to at least two different serological tests or to a molecular test for Leishmania sp. adult subjects (equal or older than 18 years)  Exclusion criteria:  lack of the necessary data and/or of biological samples subjects younger than 18 years  COMMUNITY CONTROLS:  Inclusion criteria:  Cryo-preserved serum samples stored at the Tropica Biobank at the DITM , IRCCS Sacro Cuore Don Calabria Hospital, Negrar (Vr), from subject from Italy (n=30) and from Africa (n=30) with no infection due by Leishmania spp. signed informed consent to Tropica Biobank adult subjects (equal or older than 18 years) being negative to two different serological tests for leishmaniasis  Exclusion criteria:  subjects younger than 18 years being positive to one serological tests for leishmaniasis.  VALIDATION CONTROLS (VC):  Inclusion criteria:  serum samples stored in Tropica Biobank at the DITM from subjects that have been clinically diagnosed with Chagas's disease, or TB, or malaria or leprosy. informed consent signed to Tropical Biobank adult subjects (equal or older than 18 years) being negative to two different serological tests for leishmaniasis. being clinically diagnosed with Chagas disease or TB, or malaria or leprosy  Exclusion criteria:  younger than 18 years positive result to one serological test for leishmaniasis. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Clinical Study of Multi-mode Thermal Ablation for the Treatment of Pancreatic Cancer With Liver Metastasis
Status: Recruiting

Clinical evaluation of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.
Construction of a combined treatment system of multimodal ablation therapy combined with immunotherapy and chemotherapy.
Transformation and clinical application of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age 18-70 years old, gender is not limited; Newly diagnosed pancreatic cancer with liver metastasis confirmed by pathology or consistent with clinical diagnosis, and no metastases to organs other than the liver; Imaging evaluable tumors with safe access to puncture; The number of half liver tumors ≤3 and the size of each tumor ≤3 cm; ECOG PS score ≤2 points, expected survival > 3 months.  Exclusion Criteria:  Liver function Child-Pugh grade C, severe jaundice, especially obstructive jaundice; The liver is significantly atrophy, the tumor is too large, and the ablation range needs to reach one-third of the liver volume; Expected survival < 3 months; serious heart, lung, liver and kidney dysfunction and coagulation dysfunction; Uncontrolled co-morbidities, including poorly controlled hypertension or diabetes, persistent active infections, or mental illness or social conditions that may affect participants' compliance with the study; refractory ascites, pleural fluid or bad fluid; Pregnancy or breastfeeding; The researcher considers that there are any other factors that are not suitable for inclusion or affect the participant's participation in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Improving Care for Uncomplicated URinary Tract Infection-associated Symptoms in Primary Healthcare Settings in INDOnesia
Status: Not yet recruiting

In the present study, we aim to analyze the impact of the introduction of a urinary dipstick test for patients presenting with uncomplicated UTI-associated symptoms on antibiotic prescription in primary health care in Indonesia. In addition, the knowledge of HCW regarding antibiotics and prudent use of antibiotics in the community setting will be investigated.

Specific aims of the study:

To analyze the quality of antibiotic prescriptions for uncomplicated UTI in the primary health care settings in Indonesia, before introduction of urinary dipstick testing compared to after introduction of urinary dipstick testing.
To analyze the knowledge level of healthcare workers on uncomplicated UTI and prudent antibiotic use in primary health care settings in Indonesia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All adult patients with uncomplicated urinary tract infection  Exclusion Criteria:  patients who have recurrent episodes of uncomplicated UTI, pregnant women, and patients with recent antibiotic use (any antibiotic use within 3 months before visit) - HealthyVolunteers: No - Gender: All - GenderBased: Yes - GenderDescription: Female and male patients will be included, but women suffer more from uncomplicated UTI. - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients that come to a public health center with symptoms of an uncomplicated urinary tract infection - SamplingMethod: Non-Probability Sample
Sistas Informing Sistas on Topics About AIDS and Prevention (SISTA-P)
Status: Recruiting

In this project, the investigators will provide a new HIV prevention training and empowerment sessions to Black women in Washington D.C. who are at high risk for getting HIV. This training is tailored to the experience of Black women and seeks to reduce the high HIV transmission rates in the Black community.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Black women are eligible if you: Have sex with men Are age 18+ Live in Washington D.C. Are not HIV+  Exclusion Criteria:  HIV+ - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Black women are eligible for this study. - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Evaluating What's My Method? in Barbados
Status: Not yet recruiting

The purpose of this study is to measure the impact of the What's My Method game on participants' sense of agency, education, and empowerment around contraceptive decision-making. Patients receiving standard of care contraceptive counseling will be compared to those who play the game in addition to counseling.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - English-speaking Capable of using a tablet Childbearing individuals Individuals/Couples seeking family planning counseling (one response collected per couple)  Exclusion Criteria:  Unable to provide informed consent due to intellectual or physical impairment - Under the age of 18 unless accompanied by a parent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Persons who can become pregnant - MinimumAge: 18 Years - MaximumAge: 48 Years - StdAgeList: Adult
Observational Clinical Study of Letermovir for Preventing CMV Infection After Allo-HSCT
Status: Recruiting

The goal of this observational study is to get a series of clinical data related to the prevention of CMV infection after allo-HSCT with letemovir. The main question it aims to answer are:

Efficacy and safety of letemovir for the prevention of CMV infection after allo-HSCT.
Optimal initiation of letemovir to prevent CMV infection. Participants will be categorized into high-risk and intermediate-risk groups based on risk factors for CMV infection.Initiate letemovir prophylaxis on day +1 in high-risk patients and on days +7 to +14 in non-high-risk patients.(240 mg, qd in patients with concomitant cyclosporine; 480 mg, qd in patients with concomitant tacrolimus) to +100 days. For patients with comorbid GVHD who require intensive immunosuppression, consider extending the regimen to +200 days.Treatments they will be given and use bullets.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Biological age not less than 14 years. Positive CMV serology. No detectable CMV-DNA from plasma samples taken 5 days prior to randomization into groups.  Exclusion Criteria:  severe hepatic impairment; estimated creatinine clearance of less than 10 ml/min; current or recent recipients of antiviral medications with anti-CMV activity; and any other factor that affects the impact of obtaining data. - HealthyVolunteers: No - Gender: All - MinimumAge: 14 Years - MaximumAge: 100 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Patients who underwent hematopoietic stem cell transplantation at the Department of Hematology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China - SamplingMethod: Non-Probability Sample
Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in GAVE
Status: Not yet recruiting

The researchers are trying to find out more about Gastric Antral Vascular Ectasia (GAVE). This is a condition that affects the blood vessels in the stomach, leading to their enlargement and possible bleeding. It can also cause symptoms such as abdominal pain and nausea. By participating in this study, you will help us learn how often these symptoms occur and how they relate to stomach functioning.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients >18 years of age with endoscopic evidence of Gastric Antral Vascular Ectasia. Willingness to participate in the study Capacity to provide informed consent. No evidence of organic, systemic, or metabolic disease (e.g. diabetes mellitus) to explain the symptoms on routine investigations  Exclusion Criteria:  Patients with active bleeding. Patients with severe decompensated liver disease. Patients with chronic kidney disease. Presence of other diseases (structural or metabolic) which could interfere with interpretation of the study results. Pregnant or lactating women due to radiation exposure. - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients who have undergone an endoscopy and found to have GAVE will be included. Patients with underlying cirrhosis and GAVE in comparison to control patients with cirrhosis and no GAVE. - SamplingMethod: Probability Sample
UNC Metastatic Cancer Radiation Therapy Registry
Status: Not yet recruiting

The purpose of this registry is to collect clinical data from participants attending UNC Hospitals who present with metastatic cancer and are evaluated to receive radiation therapy as part of their standard of care treatment. The goal of this study is to provide a foundation for studies designed to identify projects across the translational continuum related to metastatic cancer and radiation therapy treatment. The relevant clinical data will be linked to patient-reported outcomes (PROs) thus allowing for a unique and robust dataset. Ultimately, this registry will provide current and future studies with the ability to analyze the correlation of radiation therapy regimens with metastatic cancer outcomes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  1. Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information. Ability to understand and willingness to sign informed consent 3. Has been diagnosed with or is suspected to have metastatic cancer. 4. Age ≥ 18 years at the time of consent. 5. Evaluated to receive radiation therapy as part of their standard of care treatment plan.  Exclusion Criteria:  All participants must not meet any of the following exclusion criteria prior to enrollment to participate in this study:  1. Any serious medical or psychiatric disorder that would interfere with the participant's ability to give informed consent. - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Subjects with metastatic cancer receiving palliative radiation therapy at the University of North Carolina Chapel Hill. - SamplingMethod: Non-Probability Sample
Bioavailability of Aronia Melanocarpa
Status: Recruiting

The main objective of this study is to study the bioavailability and kinetics of acute Aronia Melanocarpa supplementation in healthy young (18-35 years) and older adults (55-75 years) adults. During the test day, participants will ingest a drink consisting of Aronia Melanocarpa extract (AME). The bioavailability and kinetics of AME will be assessed via frequent blood sampling, urine collection, and faecal sampling, in which AME and metabolite profiles will be quantified.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  BMI between 18-35 kg/m2 Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg Stable body weight (weight gain or loss < 3 kg in the past three months) Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study  Exclusion Criteria:  Smoking or smoking cessation < 12 months Severe medical conditions, including asthma, kidney failure, auto-inflammatory diseases, rheumatoid arthritis, diabetes mellitus, cardiovascular disease, gastrointestinal disorders such as Crohn's disease, colitis Use of dietary supplements or medication affecting the main outcomes of the study (e.g. affecting gut metabolism, blood pressure medication) Use of an investigational product within another biomedical intervention trial within the previous month Abuse of drugs More than 3 alcoholic consumptions per day Known pregnancy or lactation Known allergy to study product Difficult venepuncture - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult