cyrilzakka/clinical-trials huggingface dataset:
Study of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate Cancer

In this study, 18F-Florastamin PET/CT will be performed in patients with at least intermediate risk prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET/CT imaging.

This study will first carry out the pilot study (including pharmacokinetics and radiation dosimetry).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects fully understood the content, process, and potential risks of the study and voluntarily signed an informed consent form (ICF).
2. Male subjects aged 18 or older.
3. Subjects with histopathological diagnosis of prostate adenocarcinoma.
4. According to clinical judgment, radical prostatectomy and pelvic lymph node dissection (which can include patients with localized, regional lymph node metastasis or oligometastatic prostate cancer) are planned, and there is no surgical contraindication.
5. If it is localized prostate cancer, according to the Prostate Cancer Diagnosis and Treatment Guidelines of 2021 Chinese Society of Clinical Oncology, it is necessary to meet any of the following criteria:

   Intermediate Risk: Has at least one intermediate risk factor: T2b-T2c; Gleason pattern 2 or 3; PSA 10-20 ng/mL, and does not include feature of high-risk or very-high-risk groups.

   High Risk: Has no very-high-risk features and has at least one high-risk feature: T3a; Gleason Grade Group 4 or 5; PSA \>20 ng/mL.

   Very High Risk: Has at least one of the following: T3b-T4; Primary Gleason pattern 5; More than 4 punctures with Gleason Grade Group 4 or 5.
6. ECOG score 0 or 1.
7. Subjects who meet the following conditions in hematology, renal function, and liver function:

   * Platelet count\>100 \* 10\^9/L
   * Urea nitrogen and creatinine\<1.5 times upper limits of normal
   * AST and ALT\<2.5 times upper limits of normal.
8. Expected survival time ≥ 6 months.
9. Subjects and their partners must use effective contraceptive measurements and avoid sperm donation from the date of signing ICF to 3 months after administration.

Exclusion Criteria:

1. Subjects who have participated in other interventional clinical trials before signing ICF and were within the 5 half-lives of the investigational drug, or who are currently participating in other interventional clinical trials or have participated in clinical trials of radioactive drugs within 1 year before signing ICF and have been discontinued for less than 3 months until the signing date of ICF.
2. Intravenous injection of iodinated contrast medium within 24 hours, or any high-density oral contrast medium (Such as barium sulfate. Oral water contrast is acceptable, such as compound meglumine diatrizoate oral liquid) within 5 days, prior to study drug administration.
3. Subjects administered any high energy (\>300 KeV) gamma-emitting radioisotope within five physical half-lives prior to study drug administration.
4. Patients with prior androgen deprivation therapy or any other neoadjuvant agent.
5. The investigator determines that there are any medical diseases or other conditions that affect the safety or compliance of the subjects.
Maternal Music Exposure During Pregnancy Influences Neonatal Behaviour

Auditory stimulation during pregnancy has been found to influence foetal behaviour with a potential of being carried forward to neonatal period. This study evaluated the effect of ante-natal music exposure to primigravida healthy mothers on the behaviour of their term appropriate-for-date newborns. This was a single centre, randomized, open-label controlled trial. Primigravida mothers aged 19-29 years, free of chronic medical diseases or significant deafness, with singleton pregnancy, with a gestation of 20 weeks or less were randomized to listen to a pre-recorded music cassette for approximately 1 hour/day in addition to standard ante-natal care (intervention arm) or standard care only (control arm). Peri-natal factors with adverse effect on neonatal behaviour were deemed as protocol violations. The infants born to mothers exposed to music during pregnancy performed significantly better on 5 of the 7 BNBAS clusters. The maximal beneficial effect was seen with respect to orientation and habituation.

Conclusion:

Music exposure to mother during pregnancy significantly influences neonatal behaviour.

Objective:

Auditory stimulation during pregnancy has been found to influence foetal behaviour with a potential of being carried forward to neonatal period. This study evaluated the effect of ante-natal music exposure to primigravida healthy mothers on the behaviour of their term appropriate-for-date newborns assessed using Brazelton Neonatal Behavioral Assessment Scale (BNBAS).

Methods:

This was a single centre, randomized, open-label controlled trial. Primigravida mothers aged 19-29 years, free of chronic medical diseases or significant deafness, with singleton pregnancy, with a gestation of 20 weeks or less were randomized to listen to a pre-recorded music cassette for approximately 1 hour/day in addition to standard ante-natal care (intervention arm) or standard care only (control arm). Peri-natal factors with adverse effect on neonatal behaviour were deemed as protocol violations. Outcome measure included scores on 7 clusters of BNBAS. Primary analysis was per protocol.

Results:

One hundred and 26 newborns in the music group and 134 in the control group were subjected to BNBAS assessment. The infants born to mothers exposed to music during pregnancy performed significantly better on 5 of the 7 BNBAS clusters. The maximal beneficial effect was seen with respect to orientation (ES 1.13, 95% CI 0.82-1.44, p\<0.0001) and habituation (ES 1.05, 95% CI 0.53-1.57, p=0.0001).

Conclusion:

Music exposure to mother during pregnancy significantly influences neonatal behaviour.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive primigravida mothers of 19 to 29 years of age with singleton pregnancy attending the ante-natal clinic of the study institution first time, before 20 weeks of gestation were eligible for inclusion.

Exclusion Criteria:

* Mothers with significant co-existing medical diseases or severe to profound hearing loss were excluded
Molecular and Clinical Response to a Single Bout of Aerobic Exercise in a Multimorbid Population: a Study From the Consortium on Precision EXercise in Aging

The combination of data from different origins (biological, health, patient-related) has the potential to improve care for the elderly. Precision approaches that are emerging in health are based on the premise that a better understanding of the biological responses to interventions will make it possible to optimize the treatments. In the field of exercise, this type of approach is emerging. This pilot study aims to collect preliminary data to demonstrate that a patient-centric vision with data from multiple sources is mandatory to personalize exercise intervention and improve health care. Older adults with end-stage chronic disease treated by hemodialysis represent a population of choice that requires personalized care since they are multimorbid and exhibit a complex health profile.

On the other hand, the beneficial effects of exercise are still little understood and the avoidance of adverse effects in response to exercise such as hypotension during dialysis remains uninvestigated.Objective: Demonstrate the feasibility of an integrative approach by combining "omics", clinical data, patient-related outcomes (PRO) as well as exercise variables (e.g., intensity, duration) Methods: A total of 10 people aged 60 and over will be recruited to randomly perform 2 experimental conditions: hemodialysis alone (CONT) or hemodialysis + aerobic exercise (EX), which will be carried out over 2 visits one week apart. These visits will take place at the scheduled time of the hemodialysis treatment. The variables of interest are: blood pressure response to a single bout of exercise exercise (during and post-exercise), symptoms (with visual analogue scales within 36 hours of the visit + Dialysis symptom index for the 7 days after the experimental visit), dialysis efficiency (Kt/V) and biological response (proteomics and metabolomics). Health-related quality of life (KDQOL questionnaire), medical data (electronic medical record), and level of physical activity (PASE questionnaire and smart watch; Apple Watch) will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* being treated by hemodialysis for end-stage kidney disease for at least 3 months
* medically eligible

Exclusion Criteria:

* diagnosed neurocognitive decline
* hip fracture with recent hemiarthroplasty preventing hip flexion while pedalling,
* COVID-19 positive,
* already included in another study.
Does Psychoeducation Improve the Pain Relief Derived From a Brief Intervention

This project is a single-site, five-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room psychoeducation about mindfulness impacts the degree of pain relief they experience during a mindfulness-based intervention.


Eligibility Criteria:
Inclusion Criteria:

* Receiving pain treatment at Tallahassee Orthopedic Center
* Understanding English instructions fluently
* Being 18 years of age or older

Exclusion Criteria:

* Unable to consent because of physical or mental incapacity.
End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography

To meet the needs of both operators and patients, moderate and deep sedation has been widely used in digestive endoscopy, which is invasive and painful. With its pleasant effects, sedation has complications nevertheless. And respiratory depression is the most common one, which makes respiratory monitoring significant. SpO2 and respiratory motion are regularly monitored without satisfying timeliness or sensitivity. Capnography with current device is only able to detect either oral or nasal breathing. The present study was designed to test the effect of the investigator's modified End-Tidal Carbon Dioxide (ETCO2) monitoring device for sedation during endoscopic ultrasonography-guided fine needle aspiration.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for ultrasonography-guided fine needle aspiration
* Adult patients aged 18 to 65 years
* American Society of Anesthesiologists (ASA) Physical Status Classification I-III
* Subjects provide informed consent

Exclusion Criteria:

* Full stomach or upper gastrointestinal tract obstruction
* Baseline pulse oximetric saturation (SpO2) \<95% while breathing room air
* Obesity （BMI≥28kg/m2）or anticipated difficult airway
* Cardiovascular or cerebrovascular events within 3 months
* Pregnancy
* Chronic opioid user
* Allergic to anesthetics
Towards Early Detection of Breast Cancer in High Risk Population

Breast cancer is a major and growing health challenge, and the leading cause of cancer in women. As population obesity rates increase, the number of new breast cancer diagnosis continues to rise. Despite treatment advances, breast cancer remains an important cause of premature mortality, taking women in the prime of life. Although underlying susceptibility caused by mutation in the genes including BRCA1/2 is increasingly identified, current pre-symptomatic screening for the general population and those at high genetic risk remains sub-optimal, with high false negative and positive rates.

Alteration of breast lipid composition has been observed by us and others in patients with breast cancer and is thought to precede onset. We have developed and tested a novel method to allow a standard 3T MRI scanner to perform quantitative 3D mapping of specific lipid molecules in the breast.

We will investigate if this method can detect very early breast cancers, and compare the amount and spread of lipid composition in breast tissue of premenopausal women with very high genetic risk of breast cancer, women with breast cancer and women with obesity.


Eligibility Criteria:
Inclusion Criteria:

-

Women with BRCA1/2 genes:

* female 18-55 years old, premenopausal
* BRCA 1/2 gene carriers
* not having any metabolic disorders (e.g., diabetes)
* not on any long term medications that may affect lipid metabolism (e.g., statins)
* BMI \< 30

Women with breast cancer (no obesity):

* females 18-55 years old, premenopausal
* confirmed diagnosis of invasive ductal carcinoma of the breast
* not having any metabolic disorders (e.g., diabetes)
* not on any long term medications that may affect lipid metabolism (e.g., statins)
* BMI \< 30

Women with breast cancer (obesity):

* BMI \> 30
* otherwise as women with breast cancer

Women with obesity:

* females 18-55 years old, premenopausal
* not having any metabolic disorders (e.g., diabetes)
* not on any long term medications that may affect lipid metabolism (e.g., statins)
* BMI \> 30

Exclusion Criteria:

* females under 18 or over 55 years old, postmenopausal
* males
* have metabolic disorders (e.g., diabetes)
* on long term medications that may affect lipid metabolism (e.g., statins)
* contraindicated for MR investigation (poor renal function and metal implants)
* (for patients) concurrent cancer in other sites
* (for patients) started hormone treatment, chemotherapy or breast surgery
* non-English speakers
Exploring the Effectiveness to Web-based Exercise Among Community-dwelling Adults With High Body Fat

The study findings can derive an effective exercise type either web-based or supervise exercise as well as build a series of exercise video that can promote self-exercise at home for health promotion for community residents.

Background: Web-based exercise is effective alternative training for community residents on health improvement; however, adherence to their performance is challenging.

Purpose: This study aimed to (1) compare the effectiveness of 16-week exercise on improving blood samples, body composition, and anthropometric parameters between web-based exercise and supervised exercise; and (2) examine the trajectory of exercise adherence of web-based exercise for attendance and intensity over time for community-dwelling adults with high body fat.

Design: A two-arm randomized control trial. Method: Participants who received 16-week supervised exercise for aerobic exercise training on 2020 in our previous project was served as one of control groups (n = 34). In present project, purposive sampling will be used to enroll a target of 66 community-dwelling residents aged 40-64 years with inactive habits and body fat percentage ≧ of 25% for males and ≧ 30% for females in study. Eligible participants will be stratified by sex and then block randomly divided into web-based exercise or a control group (without any exercise intervention). The web-based exercise will prescribe a 30-minute of aerobic exercise at least moderate intensity prescription for three times per week. Heart rate reserve and self-perceived exertion will be self-recorded on the web by participants. Generalized estimating equations will be used to explore the effectiveness of web-based exercise.

Implications: The study findings can derive an effective exercise type either web-based or supervise exercise as well as build a series of exercise video that can promote self-exercise at home for health promotion for community residents.

Eligibility Criteria:
Inclusion Criteria:

* aged from 40 to 64 years.
* have a body fat percentage of ≧25% if a man or ≧30% if a woman.
* can use the internet for watching the exercise video online.
* with inactive habit (≤ 3 days of physical activity per week and ≤ 30 min per session).

Exclusion Criteria:

* blind.
* currently under diet control.
* with any unsafety concern for their condition, such as pregnancy, myocardial infarction, stroke, or body fat percentage of ≧40%.
Sequential Therapy of Atorvastatin Improve Outcomes of ST-elevated Acute Myocardial Infarction

Statins have been approved to benefit patients underwent percutaneous coronary intervention (PCI). The current study is designed to evaluate the effectiveness and safety of Sequential Therapy of Atorvastatin in patients with ST-elevated myocardial infarction and receive PCI treatment.


Eligibility Criteria:
Inclusion Criteria:

* Sighed informed consent
* Diagnosised as acute myocardial infarction
* Time frame less than 12 hours since the occurance of chest pain
* Aggred to receive sirolimus-eluted coronary stents
* Patients willing to accepte follow-up

Exclusion Criteria:

* Allegy to statins or with a history against statin therapy
* Allegy to any products that will be used during PPCI
* Disagreed to receive PPCI and other related therapy
* Existing sever liver dysfuntion that statins can not be used according to the guildlines
* Sever kidney dysfunction (creatinine \>3mg/dl or eGFR\<30ml/min)
* Sever left ventricular dysfunction (Killip grade 3)
* Patients are currently taking medicine that may influence the use of statin
* Patients with a history of alcohol abuse or durg abuse
* Woman during pregnancy or lactation
* Patients who has attended other clinical trials
* Patients who has received PCI or CABG previously
* Patients who can not agree to accept study protocol
* Other conditions that may not sutible for the current study
Muscle Tone Change in Obstructive Sleep Apnea

The study aim of the project is to investigate the differences in respiratory functions, orofacial muscle tone changes, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome. At the same time, to examine the reliability of the use of the MyotonPro evaluation method, which takes place rapidly in the literature and clinic, in the orofacial pharyngeal muscle group.

Obstructive sleep apnea (OSA) syndrome is a common but often unrecognized disorder caused by pharyngeal collapse during sleep and characterized by frequent awakenings, disrupted sleep, and consequent excessive daytime sleepiness. Upper airway resistance increase during sleep and upper airway inspiratory muscle activity decrease especially during bursts of rapid eye movements in REM (Rapid Eye-Movements) sleep. In this study, the differences in respiratory functions, orofacial muscle tone changes, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome will be investigated. The project is planned to be carried out with participants who applied to the Bitlis State Hospital Chest Diseases Clinic and were diagnosed with OSA by polysomnography and other diagnostic methods. Based on "the Apnea-Hypopnea Index OSA rating scoring for adult individuals", participants will be divided into three groups: mild, moderate, and severe OSA. Healthy participants will form the fourth group on the control level. The respiratory functions of the participants will be evaluated with spirometry and a standard application procedure will be used. With the MyotonPro device, the tone of the orofacial muscles (m. digastricus venter anterior and m. mylohyoideus, tongue and m. masseter, m. temporalis) will be evaluated and data transferred to the computer will be reported. In the muscle tonus evaluations, standardization in cervical positioning will be provided by a dual digital inclinometer. The Hospital Anxiety and Depression Scale (HAD) will be used to evaluate the anxiety/depression levels of the participants, and the Short Form-36 (SF-36), which is prescribed as the global gold standard, will be used in the assessment of the quality of life. MyotonPro reliability investigation will be done by two separate researchers. The researchers will perform measurements independently, at the baseline, and after 1 week. MyotonPro evaluations will be based on anatomical localization points. During the measurement, both researchers will use the standard positioning protocol at both evaluation times.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old.
* Getting a diagnosis of OSAS with polysomnography.
* Agree to participate in the study.

Exclusion Criteria:

* Having respiratory system disease (COPD, asthma, bronchiectasis, lung cancer, etc.).
* Sedative, hypnotic drug intake. Use of medical supplements such as diazepam.
* Hypothyroidism, acromegaly.
* Diagnosis of a psychiatric illness.
* Uncontrolled arrhythmia causing symptoms or hemodynamic impairment.
* Pulmonary edema.
* Pregnancy
TENS for Endometriosis Pain in Adolescents and Young Adults

The goal of this project is plan to investigate the utility of Transcutaneous Electrical Nerve Stimulators (TENS) for the reduction of pain and the improvement of quality of life in adolescents and young adults with chronic pelvic pain related to endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent girls and young women (13-25)
* Diagnosis of endometriosis,
* Current pelvic pain (score ≥ 3 on Visual Analog Scale, where 0 represents absence of pain and 10 indicates unbearable pain) present for ≥ 14 days/month over the 2 months prior to study enrollment.
* Personal smart phone or mobile device
* Speak either English or Spanish.
Needs Navigation for Caregivers of AYAs

The overall aim of the study is to address unmet health-related social needs and reduce outcome disparities among AYA (adolescent and young adult) cancer survivors. Aim 1 aimed to refine a needs navigation model in partnership with expert consultants. Aim 2 and 3 will involve the deployment and pilot testing of the adapted needs navigation intervention among caregivers of younger AYAs with cancer.

Financial toxicity, the negative personal financial impact of healthcare, is a highly prevalent adverse effect of cancer treatment, and AYA cancer survivors experience disproportionately higher rates of financial toxicity compared to older cancer survivors. Financial toxicity is associated with poorer overall survival and bankruptcy, and AYA survivors are 10 times more likely to file for bankruptcy than older cancer survivors. Thus, financial toxicity and unmet HRSN (health-related social needs) are key contributors to employment and health outcome disparities seen among AYA survivors living in areas of persistent poverty.

The study team has focused on addressing unmet HRSN and reducing outcome disparities among AYA cancer survivors, many of whom live in areas of persistent poverty. The investigators have adapted a model of financial navigation that reduces financial toxicity among older adults with cancer, informed by qualitative research among Spanish- and English-speaking AYAs and their caregivers from the local community. The investigators have identified community and clinical partners poised to address these unique unmet needs. These partners have expertise in educational navigation and caregiver community resources - both cited as unmet needs in our pilot study. Using mixed methods, this study will refine (Aim 1 - already completed) and pilot test (Aims 2 and 3) a tailored version of the intervention among 30 English and Spanish-speaking caregivers of younger AYAs who screen positive for severe financial toxicity or unmet HRSN.

Eligibility Criteria:
Inclusion Criteria: We are enrolling dyads (AYA and caregivers) for this study.

AYA patient participants:

* Age 15 - 26 years old
* English or Spanish-speaking
* In between 3-months of diagnosis of cancer date and up to 1-year post-treatment completion without progression or recurrence of cancer

Caregiver/financial partner participants:

* Parent or financially-responsible adult of non-adult AYA (\<18 years) OR
* Identified by the AYA as caregiver, parent, or partner who is financially-responsible or a financial partner for AYA

Exclusion Criteria:

* Dyad with caregiver or younger AYA that previously participated in study AAAU2405
* Unable to complete financial survey questions or contraindicated (as outlined in Protection of Human Subjects)
* Dyad with younger AYAs who are enrolled on hospice or receiving other end-of-life care