rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
VIDeOS for Smoking Cessation
Status: Not yet recruiting

The purpose of the current study is to pilot the efficacy, feasibility, and acceptability of an evidence-based smoking cessation intervention adapted for cancer patients and delivered via video. Investigators aim to assess if this intervention is considered acceptable by participants, feasible to implement, and effective at increasing knowledge about smoking cessation before conducting a fully powered clinical trial.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 18 or older Diagnosed with cancer (any type) Receiving care at Medical University of South Carolina Reads and understands English language Currently smoking cigarettes (any amount)  Exclusion Criteria:  - Unstable or poorly managed medical or psychiatric conditions that impair cognition and ability to provide informed consent (e.g., dementia, active psychosis). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors
Status: Not yet recruiting

The goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. The main questions it aims to answer are:

What is the feasibility of this intervention in an online, private setting?
What is the effect of this intervention on reducing menopausal symptoms, improving sexual functioning, and enhancing body image?

Participants will participate in a nurse-led psychoeducational intervention for 8 sessions lasting approximately an hour each over the course of 8 - 10 weeks. Each participant will complete survey items at the beginning, end, and six-weeks after the last session. Participants will be compensated up to $150 in gift cards as a thank-you for their time.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed with breast cancer (stages I - III) between ages 18 - 50 Completed active treatment (chemotherapy and/or radiation) within the last five years Can read/speak English Access to talk in quiet, safe environment for privacy On hormonal therapies (aromatase inhibitors, tamoxifen) Currently partnered (i.e., in a relationship)  Exclusion Criteria:  Currently undergoing active treatment (chemotherapy and/or radiation) More than five years have passed since completing active treatment (chemotherapy and/or radiation) History of advanced breast cancer (stage IV) or a breast cancer recurrence Women without access to the internet Cannot read/speak in English - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Participant eligibility is based on gender at birth. - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult
A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
Status: Not yet recruiting

The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer. The study will consider participants who:

have advanced or metastatic breast cancer that is spread to other parts of the body.

have HR+/HER2- (hormone receptor positive* / human epidermal growth factor receptor 2 negative**) breast cancer types.

Hormone receptor positive (HR+): are cells that have a group of proteins that bind to a specific hormone. For example, some breast cancer cells have receptors for the hormones estrogen or progesterone.

These cells are hormone receptor positive, and they need estrogen or progesterone to grow. This can affect how the cancer is treated. Knowing if the cancer is hormone receptor positive may help plan treatment.

Human epidermal growth factor receptor 2 negative (HER2-): cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2 negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface. Checking to see if a cancer is HER2 negative may help plan treatment.

have started treatment in the period between January 2017 and December 2021.

The study will describe the treatment effect for different patient groups in terms of age and comorbidities. Comorbidity is the condition of having two or more diseases at the same time. The data is collected by the Danish Breast Cancer Group in the period between 2017 to 2023.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with breast cancer (ICD-10: C50) A diagnosis of HR+/HER2- locally advanced or metastatic breast cancer Endocrine sensitive, endocrine resistant, or de novo mBC patient Inclusion date: Date of relapse/stage IV disease/progression leading to initiation of palbociclib+AI  Exclusion Criteria:  There are no exclusion criteria for this study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The full dataset consists of endocrine sensitive, endocrine resistant and de novo HR+/HER2- mBC patients treated with palbociclib as first-line treatment (01 January 2017- 31 December 2021). Patients will be censored for OS and PFS by 31 December 2023. - SamplingMethod: Non-Probability Sample
Ultrasound-Guided Erectro Spinae Plane Block Versus Stellate Ganglion Block for Patients With Upper Limb Acute Herpes Zoster Pain.
Status: Not yet recruiting

Herpes zoster (HZ) is a painful, eruptive, viral condition results from reactivation of the latent varicella zoster virus after the primary infection. The selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. The stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. It lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of C7. The erector spinae plane (ESP) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  patients over the age of 21 with upper limb herpetic eruption lasting shorter than a week along with moderate to severe pain who got adequate antiviral medications  Exclusion Criteria:  We will exclude patients who refuse to participate, those who are taking anticoagulant medications, have secondary bacterial infections of the dermatome, those who have an allergy to local anesthetics or serious disease of the heart ( e.g. heart block), lung, kidneys and those who had a history of neck surgery, such as thyroid cancer. - HealthyVolunteers: No - Gender: All - MinimumAge: 21 Years - StdAgeList: Adult, Older Adult
A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004)
Status: Not yet recruiting

The primary objective of the study is to compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Has histologically or cytologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell or papillary histology. Has intermediate-high-risk, high-risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading: Intermediate-high-risk RCC: pT2 Gr4, N0, M0; pT3 Gr3/4, N0, M0 High-risk RCC: pT4, N0, M0; pT any stage, N1, M0 M1 NED RCC participants who present not only with the primary kidney tumor, but also solid, isolated, soft tissue metastases that can be completely resected at 1 of the following: the time of nephrectomy (synchronous), or ≤2 years from nephrectomy (metachronous) Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants. Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization and recovered from surgery and any post-operative complications before randomization. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.  Exclusion Criteria:  Has had a major surgery other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization. Has residual thrombus post nephrectomy in the vena renalis or vena cava. Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. Received prior treatment with a cancer vaccine. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Has a history of brain or bone metastatic lesions. Has severe hypersensitivity to study medication or any of the substances used to prepare the study medication. Has an active autoimmune disease that has required systemic treatment in the past 2 years. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. Has an active infection requiring systemic therapy. History of allogeneic tissue/solid organ transplant. Has not adequately recovered from major surgery or has ongoing surgical complications. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Internet-based Support for Informal Caregivers of Patients With Head and Neck Cancer - Carer eSupport
Status: Not yet recruiting

The aim of this randomized controlled trial is to investigate the effects of internet-based support (Carer eSupport) on preparedness for caregiving in informal caregivers of patients with head and neck cancer. The main question[s] it aims to answer are:

What are the effects of internet-based support on informal caregivers preparedness for caregiving?
What are the effects of internet-based support on informal caregivers burden and wellbeing?

Informal caregivers who are randomized to Carer eSupport will have access to Carer eSupport for 18 weeks and they will be asked to complete questionnaires (outcome measures) at:

baseline (before randomization)
18 weeks (post-intervention) and at
3 months after the intervention is completed (long term follow-up).

Informal caregivers in the intervention group will be compared to informal caregivers who receive standard care support regarding preparedness for caregiving, caregiver burden and wellbeing.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Informal caregivers who have been identified as an informal caregiver by a patient who have consented to that the informal caregivers is approached. Informal caregivers of patients with head and neck cancer who are about to start radiotherapy or have undergone at most five radiotherapy treatment session. Radiotherapy may be combined with surgery and/or medical oncological treatment.  Exclusion Criteria:  Informal caregivers who do not understand and read Swedish or suffer from cognitive impairment, and informal caregivers with who need support or treatment that cannot be provided by Carer eSupport. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Value of mNGS in Diagnosis of Pulmonary Infection
Status: Not yet recruiting

Retrospective analysis of clinical data from 50 hospital-admitted patients with suspected pulmonary infection (as judged by clinical manifestations and imaging findings) was performed on study participants who had collected two different samples of alveolar lavage fluid (BALF) and sputum and underwent metagenomic next generation sequencing (mNGS) and routine pathogen detection, respectively. The positive rate of pathogen detection and the consistency of pathogen detection results of the two detection methods were compared to evaluate the clinical manifestation and role of mNGS in pathogen diagnosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Inclusion criteria: Patients meeting diagnostic criteria for pulmonary infection between January 1, 2020 and October 31, 2023. Patients with pulmonary infection were diagnosed with new or worsening focal or diffuse infiltrating lesions on chest CT accompanied by at least one of the following four pneumonic-related clinical manifestations: (1) Recent cough, sputum, or aggravation of existing respiratory symptoms with or without purulent sputum, chest pain, dyspnea, and hemoptysis; ② Heat, T≥38℃; ③ Signs of lung consolidation and/or smell and moist rales; ④ Peripheral blood white blood cell count > 10*109/L or < 4*109/L.  Exclusion criteria: ① The patient did not undergo bronchoscopy; Absence of clinical or laboratory data. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients whose symptoms, signs, imaging, and infection indicators met the diagnostic criteria for pulmonary infection while routine etiological detection of sputum and pulmonary alveolar lavage fluid mNGS were performed. - SamplingMethod: Probability Sample
Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation (BETA Trial)
Status: Not yet recruiting

Emergency intubation is routinely performed in the prehospital setting. Airway management in the prehospital setting has substantial challenges, such as hostile environment or lack of technical support in case of first attempt intubation failure, and inherent risk of complications, such as hypoxemia, aspiration or oesophageal intubation. This risk is higher when several attempts are needed to succeed endotracheal intubation. Thus, a successful first attempt intubation is highly desirable to avoid adverse intubation-related events. Noteworthy, prehospital emergency intubation is associated with a lower rate of first attempt intubation success when compared to emergency intubation in the emergency department (ED). Research is needed to overcome the specific challenges of airway management in the prehospital setting, and to improve the safety and efficiency of prehospital emergency intubation. Literature reports that the use of assistive devices such as bougie may increase the rate of first-attempt intubation success in the ED. To date, no randomized trial has ever studied this device in the prehospital setting. Thus, the aim of the BETA trial is to compare first attempt intubation success facilitated by the bougie versus the endotracheal tube alone in the prehospital setting.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Managed by a physician staffed mobile intensive care unit (MICU). With an indication of emergency prehospital endotracheal intubation.  Exclusion Criteria:  Pregnant women Patients with a "not to be resuscitated" indication. Patients with predictors of difficult intubation (that can be collected in the prehospital setting, including previous history of face, neck, throat surgery or pathology, limited mandibular protrusion, cervical spine trauma, facial trauma, ear-nose-throat malignancy, head or neck burns, history of previous difficult airways) for whom the use of a bougie is indicated on first intubation attempt. Patients under guardianship, trusteeship or safeguard of justice and patients with no health insurance. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures
Status: Recruiting

'Patient-reported outcomes' (PROMS) and 'patient-reported experiences' (PREMS) are increasingly important parameters in evaluating and adjusting clinical procedures and strategies in healthcare.

Validated disease-specific PROMS related to bronchoscopic procedures are not available and examples in the medical literature are very scarce.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age above 18 years Patient referred for diagnostic flexible bronchoscopy Procedure performed in outpatient setting  Exclusion Criteria:  Patient unable to adequately respond to the contents of the patient questionnaire. Procedure performed in hospitalised setting Patient with active pregnancy - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Out-of-hospital care - SamplingMethod: Non-Probability Sample
Perceptions and Experiences of (Family Members of) People With Mental Illness About the Chance for Mental Illness in (Future) Children, and Needs for Care and Research
Status: Not yet recruiting

Despite consistent evidence that mental illness runs in families, intergenerational transmission of risk of mental illness is rarely considered in clinical practice. Neither preventive programs for children of parents with mental illness are usually implemented in care, nor supportive programs for parenting. Furthermore, parents with mental illness are not always aware of how their disorder may impact the well-being of their children. To date, the needs for counseling, care and research in parents with mental illness and family members of people with mental illness are unclear. Therefore, this prospective qualitative interview study aims to gain insights into the perceptions and experiences of (future) parents with mental illness, partners and family members of people with mental illness about risk for and resilience against mental illness in (future) children, as well as their needs for counseling, care and research.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Having (a partner or relative with) a diagnosis of a mental illness in the mood-psychosis spectrum, i.e., psychotic disorder, bipolar disorder, or severe depression At least 18 years old  Exclusion Criteria:  Insufficient proficiency of the Dutch language No demonstration of adequate understanding of the purpose, procedures, risks, benefits, emergency contacts, and payment issues (in accordance with criteria to assess capacities to consent from Appelbaum & Grisso, 1988). Unable to give consent to all aspects of the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The following participants will be included: (Future) parents with (a partner with) mental illness in the mood-psychosis spectrum (psychotic disorder, bipolar disorder, severe depression); ≥ 18 years old.  If including (future) parents with mental illness and their partners will turn out to be difficult given our timeframe, we will mitigate this by additionally including family members of people with mental illness, e.g. siblings or grandparents. - SamplingMethod: Non-Probability Sample
Trends of Contraception Methods in Urban Medical Center in el_Balyana
Status: Not yet recruiting

family planning is avital primary Health care intervention that saves lives of mothers and infants empowers women and support their choices regarding their health public life and additional education .In addition family planning is considered as a short term intervention to limit population growth and manage overpopulation problems.Globally the contraception prevalance rate an indicator for family planning programs continue to face challenges in developing countries.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - currently married woman in the child bearing period (15_49) years old attending El_Balyana urban medical Center  Exclusion Criteria:  women who are divorced or widowed or beyond age of fertility will be excluded - - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 15 Years - MaximumAge: 49 Years - StdAgeList: Child, Adult - StudyPopulation: currently married woman in the child bearing period (15_49) years old attending El_Balyana urban medical Center  Exclusion Criteria:  women who are divorced or widowed or beyond age of fertility will be excluded - - SamplingMethod: Probability Sample
Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations
Status: Not yet recruiting

During this 36-month R34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (PTSD) intervention (STAIR-NT) and layer it into a methadone maintenance treatment (MMT) program (START Treatment and Recovery centers) in New York City for use among individuals engaged in stimulant-opioid polysubstance use. The study aims to adapt STAIR-NT to a massed treatment schedule. Once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and PTSD symptomology outcomes in a pilot randomized control trial (RCT) of 80 participants. Participants who screen eligible and consent will be randomized 1:1 to the adapted STAIR-NT intervention or treatment as usual (TAU) using randomization blocks of two and two and four via a computer-generated randomization sequence. Participants assigned to the intervention will receive the adapted massed delivery of STAIR-NT by trained counselors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  must be 18 years or older, be a patient at the START clinic receiving methadone for treatment of opioid use disorder, self-report 10+ days of co-use of cocaine and illicit opioids in the past 30-days, meet the criteria for stimulant use disorder (cocaine type; mild, moderate or severe) and a score of 3≥ on the PC-PTSD-5.  Exclusion Criteria:  cognitive impairment that would interfere with their ability to understand study participation as assessed by the researcher, does not speak/understand English at a conversational level, plans to leave the START clinic in the next 60 days, patients who missed methadone doses (inactive) for 30 days or more, or having received clinical care from the interventionist(s) in the past 30 days - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Comparative Study of New Classification and Traditional Classification of Radioactive Oropharyngeal Mucositis
Status: Recruiting

Radiation oropharyngeal mucositis is one of the most painful side effects of radiotherapy in patients with head and neck tumors. However, the traditional radioactive oropharyngeal mucositis grading system has the problem of poor evaluation consistency. To solve this problem, we innovatively classify radiation oropharyngeal mucositis into four types according to the four-stage histopathological changes of acute radiation injury: (1) congestive; (2) Scattered erosion type; (3) Fusion erosion type; (4) Ulcer type. We intend to conduct a multicenter observational cohort study to compare the consistency of different physicians in the assessment of radiation oropharyngeal mucositis with new and traditional classifications, and to explore changes in blood markers of different types of oropharyngeal mucositis using clinical residual blood samples.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Voluntarily sign informed consent; Age 18 or older on the date of signing the informed consent; Histologically confirmed head and neck tumor, radiotherapy or chemoradiotherapy.  Exclusion Criteria:  They also have other uncontrolled serious medical conditions, such as unstable heart disease requiring treatment, poorly controlled diabetes (fasting blood glucose > 1.5× the upper limit of normal), mental illness, and a history of severe allergies - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The subjects in this study were head and neck tumor patients receiving radiotherapy - SamplingMethod: Probability Sample