rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Activity of Chronic Inflammation in PCOS
Status: Recruiting

Chronic inflammation in polycystic ovary syndrome (PCOS) may be the result of dysregulation of cytokine production (due to insulin resistance, excess visceral fat and hyperandrogenemia), i.e., overproduction of pro-inflammatory factors (e.g. TNF, IL-1, IL-6) in relation to anti-inflammatory ones (IL-10). This condition may be an important link between obesity and insulin resistance, which is crucial in the etiopathogenesis of the syndrome. However, it is not known whether it results from the tendency to accumulate adipose tissue or is a feature of the syndrome itself. There is no data indicating the relationship between chronic inflammation and the severity of metabolic disorders and the value of ovarian reserve in women with various PCOS phenotypes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age 18-45 years PCOS syndrome confirmed by the Rotterdam criteria  Exclusion Criteria:  absence of at least one ovary diagnosed and/or treated other metabolic disease diagnosed and/or treated other endocrine disease - Gender: Female - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult - StudyPopulation: Women aged 18-45, treated at the University Hospital in Krakow, diagnosed with PCOS confirmed by the Rotterdam criteria, phenotypes A, B, C, D, without other metabolic and endocrine diseases. - SamplingMethod: Non-Probability Sample
Study of Oral ABBV-932 Capsules to Evaluate Dopamine D2 and D3 Receptor Occupancy in Brain in Adult Healthy Volunteers
Status: Not yet recruiting

The main objective of this study is to evaluate the dopamine D2 and D3 receptor occupancy in the brain as measured by PET with radiotracer [11C]-(+)-PHNO up to 14 days of once-daily oral doses of ABBV-932 in healthy subjects.

ABBV-932 is a prodrug of DCAR (desmethyl-cariprazine), which is a dopamine D3 receptor-preferring D3/D2 receptor partial agonist. Approximately 12 adult healthy volunteers will be enrolled in the United Kingdom.

Participants will receive ABBV-932 oral capsules once daily for 2 weeks and followed for 60 days.

Participants will be confined for approximately 15 days. Participants will receive 3 [11C]-(+)-PHNO PET scans during the study. Adverse Events and blood tests will be performed.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Body Mass Index (BMI) is >= 18.0 to <= 35.0 kg/m2. Supine pulse rate >= 50 bpm and <= 100 bpm obtained after a 5-minute rest at Screening. Supine systolic blood pressure (SBP) <= 160 mm Hg and >= 90 mm Hg and supine diastolic blood pressure (DBP) <= 90 mm Hg and obtained after a 5-minute rest at Screening.  Exclusion Criteria:  Orthostatic (SBP decrease of >= 30 mmHg, DBP decrease of >= 20 mmHg, or pulse increase of >= 30 bpm) as determined after standing for 5 minutes. Current or history of suicidal ideation as indicated by answering "Yes" answer to Suicidal Ideation Questions #4 or #5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening in the past 3 months or any "Yes" answer to Suicidal Behavior Questions #1-5 in the past year. Non-suicidal self-injurious behavior is not exclusionary. History of suicide attempt(s) within 1 year prior to study drug administration as evidenced by answering "Yes" to any Suicidal Behavior Questions (a "Yes" to Non-Suicidal Self-Injurious Behavior is not exclusionary). Contraindications to MRIs (metal implants, paramagnetic objects contained within the body, claustrophobia, etc.) Clinically significant findings as determined from screening brain MRI. History of previous radiation exposure for research purposes such that participation in this study will result in cumulative ionizing radiation exposure >10 mSv in the past 12 months, in additional to normal background exposure. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 23 Years - MaximumAge: 55 Years - StdAgeList: Adult
Assessment of Patients Not Concluded After Neonatal Screening of Cystic Fibrosis.
Status: Not yet recruiting

Assessment of the outcome of patients not concluded fir cystic fibrosis, either symptomatic patients or asymptomatic children detected by newborn screening for cystic fibrosis. The aim is to identify patients potentially at risk of progressing to the clinical spectrum of cystic fibrosis

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  patients not concluded for the diagnosis of Cystic fibrosis either because of intermediate sweat test or because extensive genetic study has identified 2 vrainats at least 1 being not CF causing  -  Exclusion Criteria:  patients carrying 2 CF causing variants of the CFTR gene patients carrying only 1 or no variants of CFTR - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: children of adults not concluded for the diagnosis of Cystic fibrosis - SamplingMethod: Non-Probability Sample
10th Mountain Healthy Minds Program App Study
Status: Not yet recruiting

The purpose of the study is to evaluate the acceptability, feasibility, and preliminary effects of the Healthy Minds Program (HMP) App in approximately 150 active duty military members.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Active duty military at the 10th Mountain Division  Exclusion Criteria:  N/A - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Prevalence and Impact of Sarcopenia in Patients With Inflammatory Bowel Disease
Status: Recruiting

Sarcopenia is a condition characterized by significant muscle loss resulting in impaired muscle function. This condition is likely associated with a biological deviation leading to reduced reserves to withstand stressors, resulting in a poorer prognosis. The incidence of sarcopenia among patients with inflammatory bowel diseases (Ulcerative Colitis and Crohn's disease) is currently approximately 40-60%. This is likely a consequence of the preference for drug treatment over surgery, while many patients have continuous inflammation in their intestines leading to muscle loss and subsequently increased morbidity and mortality.

The purpose of the study is to identify the prevalence of sarcopenia among patients experiencing a severe flare-up of their bowel disease and to evaluate whether the removal of the colon results in improved nutritional status. Furthermore, the investigators aim to investigate whether there is a specific microbiota composition related to an unfavorable course.

The participants are longitudinally monitored with measurements taken at the flare-up/before surgery and one year afterward, including body composition, function, dietary recording, quality of life, blood tests, fecal samples, and intestinal biopsies that will be analyzed. The investigators plan to correlate body composition with a biological profile and then evaluate if there is an association. Additionally, the investigators aim to analyze if these markers are linked to different outcomes after colectomy. This study will contribute to an enhanced understanding of patients with advanced IBD and possibly change the perspective on how the clinicians should prioritize these patients for surgery. The investigators believe this study will lead to an improvement in healthcare quality and an enhanced understanding of how these disease processes function.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All adult patients experiencing an acute flare-up of their bowel disease (ulcerative colitis or Crohn's disease) admitted to a hospital in the Region Västra Götaland and Stockholm are invited to participate in the study.  Exclusion Criteria:  Not wishing to participate in the study Inability to understand the language or study procedures - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adults with severe IBD. - SamplingMethod: Probability Sample
Exercise and Health Counseling in Pediatric Hematopoietic Stem Cell Transplantation
Status: Not yet recruiting

Thanks to medical advances, survival rates >5 years in children/adolescents undergoing hematopoietic stem cell transplant (HSCT) exceed 70%. However, these patients are at high risk of suffering sequelae associated with the underlying disease and/or the HSCT itself, which negatively affects their physical capacity. These patients also tend to spend too much time inactive, which further accelerates functional decline in addition to producing fatigue and impairing quality of life. Therefore, new strategies are needed to minimize the morbidity associated with HSCT. In this effect, although physical exercise represents an interesting adjuvant treatment option for HSCT, scientific evidence in this area is still scarce. Implementation of physical exercise intervention in pediatric HSCT units is challenging due to the lack of research on the effectiveness, affordability and accessibility of this type of intervention. Therefore, establishing the effectiveness of physical exercise under controlled conditions is an important step. The investigators therefore aim to assess the impact of a physical exercise and health counseling program, compared to health counseling only (control group), in pediatric patients with cancer undergoing HSCT on physical-functional, behavioral, psycho-cognitive and clinical outcomes, and blood biomarkers. The investigators will also determine to what extent the benefits of this intervention are maintained over time. Additionally, the investigators will determine the feasibility of implementing the proposed intervention in a real clinical situation in 3 different pediatric HSCT units.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age between 4 and 21 years. Undergoing hematopoietic stem cell transplantation (HSCT) for cancer diagnosis in complete remission or without remission, in 3 recruiting Hospitals in Madrid Undergoing treatment and follow-up in the same hospital. Speaking Spanish. Providing signed informed consent.  Exclusion Criteria:  Not being able to participate in the trial according to protocol. Comorbidity or acute condition not associated with the diagnosis and that contraindicates the practice of physical exercise, such as severe deficiencies in the locomotor, neurological, cardiovascular and pulmonary systems. Serious or chronic medical or psychiatric condition that may increase the risk associated with participation in the trial or that may interfere with the interpretation of the results and, in the opinion of the investigator in discussion with the team, makes having such condition inappropriate for entry to this study; inability to understand the study requirements. Not being able to attend hospital visits to perform assessment tests, nor participate in the physical exercise and health counseling program as stipulated in the protocol.  Inability to understand the requirements of the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 21 Years - StdAgeList: Child, Adult
Assessing the Efficacy of Repeat, Monthly Treatments of Cutaneous Neurofibromas (cNFs)
Status: Not yet recruiting

This study will evaluate the tolerability and effectiveness of four FDA-approved treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 1064nm laser, a 755nm laser, and Kybella and Polidocanol injections. Each patient will have a treatment and a control site.

This study is designed with the goal of improved efficacy/tumor reduction via multiple treatment visits. If there is minimal to no clinical improvement in tumor size with one treatment after three treatment visits, the subject will be given the option of crossover treatment with the most effective of the four treatments. Three treatment visits with the crossover treatment will then take place.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult ≥18 years of age  Have a diagnosis of NF1 based on germline genetic testing or by meeting ≥ 2 the following criteria:  Family history of NF1 Six or more light brown ("cafe-au-lait") spots on the skin Presence of two or more neurofibromas of any type, or one or more plexiform neurofibromas Freckling under the arms or in the groin area Two or more pigmented, benign bumps on the eye's iris (Lisch nodules) A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behind the eye, or dysplasia of long bones, often in the lower leg Tumor on the optic nerve that may interfere with vision Patients must be seeking treatment for cNF Patients must have ≥ 6 paired cNF (3 to be treated and 3 untreated) that are visible and measure between 2-8mm in size. These must be in areas amenable to treatment and surveillance with digital photography cNF must be located on the trunk, arms or legs of the patient Able and willing to comply with all visit, treatment and evaluation schedules and requirements Able to understand and provide written informed consent  Exclusion Criteria:  Individuals who cannot give informed consent or adhere to study schedule. Actively tanning during the course of the study. Known allergy to deoxycholic acid or polidocanol. Women who are pregnant. Those with acute thromboembolic diseases. Those with bleeding abnormalities or those who are currently being treated with antiplatelet or anticoagulant therapy. Any condition which, in the Investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this research study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
Status: Not yet recruiting

The goal of this clinical trial is to to learn about different combinations of immunotherapy in patients with colorectal cancer whose cancer has spread to their liver and are planning to have surgery to remove tumor metastases from their liver. The main questions it aims to answer are:

whether these combinations of immunotherapy change the tumor microenvironment in the liver
whether these combinations of immunotherapy are safe and effective when used in colorectal cancer with liver metastases

Participants will be randomly assigned to one of the following:

Botensilimab and balstilimab
Botensilimab, balstilimab, and AGEN1423
Botensilimab, balstilimab, and radiation

Participants will be asked to come in to receive drug infusions (and radiation, if applicable) before and after their surgical resection. Participants will be followed for up to 2 years.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of metastatic colorectal adenocarcinoma with liver metastases Participant must be planning to undergo a surgical resection of their liver metastases. Tumor is non-MSI-H/dMMR Presence of measurable disease Participants must be willing to consent to additional molecular analyses of tumor samples removed during surgery for research purposes Women of childbearing potential (WOCBP), or anyone with a uterus, must not be pregnant or breastfeeding. All participants of childbearing potential must agree to use highly effective contraception during this study Participants may not receive chemotherapy, growth factor support, transfusions, or albumin administration within 14 days of start of study treatment.  Exclusion Criteria:  Not eligible for surgery Any medical condition such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. Previous allogeneic tissue/organ transplant Previously received PD-1, PD-L1, or CTLA-4 therapy including experimental immunologic agents Participants must not have any contraindications to immune checkpoint inhibitors Participants must not have active autoimmune disease that has required systemic treatment within 2 years prior to registration. Some exceptions are allowed - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Randomized Controlled Trial of Alert-Based Computerized Decision Support for Patients With Peripheral Artery Disease Not Prescribed Lipid-Lowering Therapy
Status: Recruiting

This single-center, 400-patient, randomized controlled trial assesses the impact of a patient- and provider-facing EPIC Best Practice Advisory (BPA; alert-based computerized decision support tool) to increase guideline-directed utilization of statin and statin-alternative oral LDL-C lowering therapies in patients with PAD who are not being prescribed LDL-C-lowering therapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All patients ≥ 18 years old Seen in Cardiovascular Medicine Clinic, Primary Care, Podiatry, Vascular Surgery, and Diabetology Medical history entry, visit diagnosis, or problem list entry of PAD Not prescribed LDL-C-lowering therapy  Exclusion Criteria:  Patients taking a statin, ezetimibe, bempedoic acid, a PCSK9 inhibitor, inclisiran or a combination will be excluded - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Effects of Jaw Thrust on the Time to Successful Fiberoptic Pediatric Orotracheal Intubation During Residents Training Program
Status: Recruiting

In this study, the authors aim to investigate the effect of adding jaw thrust maneuver on time to successful orotracheal fiberoptic intubation of pediatrics during resident training program.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children more than 1-year of age American Society of Anesthesiologists physical status I-II scheduled for elective surgery under general anesthesia.  Exclusion Criteria:  Patients known or suspected difficult intubation. Patients with syndrome known to be associated with difficult intubation. Patients with severe pulmonary or cardiac diseases. Patients at risk of aspiration (patients with lower esophageal disease such as Hiatus hernia, or GERD and DM). Body mass index (BMI) greater than 35 kg/m2. Refusal of the patient guardians. - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Year - MaximumAge: 15 Years - StdAgeList: Child
Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC
Status: Not yet recruiting

Phase II, single-arm, open-label study that assess clinical feasibility and safety of neoadjuvant almonertinib followed by 3 cycles neoadjuvant adebrelimab plus chemotherapy in EGFR-mutant stage IIA-IIIB NSCLC followed by surgery, adjuvant treatment was upon investigators' decisions.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female，Age: 18 Years and older, Subjects voluntarily joined the study and signed informed consent, pathological proven resectable stage II-IIIB non small cell lung cancer (AJCC 8th edition), ECOG PS=0 or 1, resectable or potentially resectable, or resectability discussed by MDT, harboring EGFR mutation: Ex19del, L858R, T790M, G719X, Exon20 insertions, S768I or L861Q measurable lesion as per RECIST1.1.  Exclusion Criteria:  pathologica or cytological proven small cell lung cancer, mixed small cell lung cancer or other than non small cell lung cancer, non small cell lung cancer harboring other driver gene alteration with approved targeted drugs, with malignant plural effusion, previous treatment to non small cell lung cancer other than this regimen, received thoracic radiotherapy, currently enrolled in other clinical trial, active or known or suspected autoimmune disease. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery
Status: Not yet recruiting

This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to patients undergoing breast-conserving cancer surgery. SRG-514 will be investigated utilizing a 3+3 convention dose escalation cohorts.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 18 years or older Body weight >50kg Have a history of histologically confirmed diagnosis of breast carcinoma or ductal carcinoma in situ, except inflammatory breast cancer. Plan to undergo breast-conserving surgical treatment of breast cancer with curative intent. Adjuvant or neoadjuvant chemotherapy is allowed. Have Eastern Cooperative Oncology Group (ECOG) Performance Status <2 Have adequate organ and bone marrow function at screening  Exclusion Criteria:  Any known contraindication to ketorolac or other non-steroidal anti-inflammatory drugs (NSAIDs) Patients anticipated to require the use of a drain after breast-conserving surgery (BCS) Patients undergoing immediate reconstruction surgery, intraoperative radiation therapy (IORT) or brachytherapy requiring the placement of balloons or catheters during the lumpectomy procedure. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
IAMA-6 Oral Dose Study in Healthy Adults
Status: Recruiting

The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of IAMA-6 administered orally to healthy adults.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Healthy male and female subjects. Aged between 18 and 55 years. Written informed consent; willing and able to comply with procedures. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception. Body mass index of 18.0 to 30.0 kg/m2, inclusive; and a total body weight >50 kg up to a maximum of 110 kg. The subject must be willing to return to the study centre for study treatment and study-related follow-up procedures as required by the protocol.  Exclusion Criteria:  Current or past history of a clinically significant (as judged by the Investigator) cardiovascular, cerebrovascular, respiratory, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease/condition, as determined by the Principal Investigator or Designee. Any history of central nervous system problems (e.g. epilepsy, head injury, loss of consciousness). Any history of malignancy in the previous 5 years involving any organ system (other than localised basal cell carcinoma of the skin). Body Mass Index: <18 kg/m2 , or >30 kg/m2. Abnormal vital signs, including known history of hypertension, resting oxygen saturation <95% by pulse oximetry. ECG at screening or on Day -1 showing QTcF interval >450 msec in males or >470 msec in females, or presence of any clinically significant dysrhythmia. History of hypersensitivity to any medicinal product(s) or severe hypersensitivity/anaphylaxis with unclear aetiology. Any clinically significant abnormal chemistry values. Any clinically significant abnormal haematology values. Blood donation within the past 3 months. Seropositivity for HBsAg, HCV, HIV 1, or HIV 2. Has a positive nasopharyngeal test for SARS-CoV-2 within 48h before unit admission. If female, has a positive highly sensitive urine pregnancy test at Screening or Day 1. If female and of child-bearing potential, and not meeting the approved criteria for highly effective methods of birth control. Receipt of any Investigational Drug within the past 6 months. Use of prescription medication within 14 days prior to dosing and antibiotics within 30 days prior to dosing. Intake of OTC preparations, vitamins, minerals, herbal remedies within 48h prior to dosing. Current smokers or history of smoking in previous 6 months. Current or history of drug, alcohol, nicotine abuse, or excessive coffee (>5 cups/day) or tea drinking (>5 cups/day). Inadequate comprehension of study risks and requirements. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult