cyrilzakka/clinical-trials huggingface dataset:
Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan

The primary goal of the analysis is to estimate the diagnostic accuracy of Gallium 68 (68Ga) -DOTATOC PET/CT for detecting neuroendocrine tumors (NETs) compared to conventional imaging techniques such as Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT). Participants with histologically and/or clinically confirmed and/or suspected NET will be enrolled.

This is a prospective, Phase 2, single center study of participants with Neuroendocrine Tumors (NETs). Study participants will receive 68Ga-DOTATOC. DOTATOC is a somatostatin analogue that localizes on the somatostatin receptors expressed by NETs and is attached to a radioactive material called Gallium 68. Participants will undergo a PET/CT imaging study to investigate 68Ga-DOTATOC's suitability as a positron emission tomography (PET) imaging agent for NETs. The radiation (imaging) dose will be 111-185 megabecquerel (MBq) (3 - 5 mCi) ± 25%. All doses after labeling will be presented in buffered solution for intravenous injection. Imaging will start 90 ±30 minutes after injection.

Sensitivity and specificity of this imaging technique will be compared with those of conventional imaging modality including CT, MRI and In-111 Octreoscan performed within 6-12 months before or after PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Patients of either gender, aged ≥18 years.
* Karnofsky status ≥60.
* Life expectancy of at least 12 weeks.
* Histologically and/or clinically confirmed and/or suspicious of NET.
* A diagnostic CT or MRI of the tumour region or suspected area within the previous 12 weeks prior to dosing day is available.
* Somatostatin-analogue scintigraphy scan with result (positive or negative) within the last 12 weeks.
* Recent Blood test results up to 4-6 weeks as follows:

  1. White Blood Cell (WBC): \>2\*109/L
  2. Haemoglobin: \>8.0g/Dl
  3. Platelets: \>50x109/L
  4. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline phosphatase (AP) each less than, or equal to, 5 times its Upper Limit of Normal (ULN)
  5. Bilirubin less than, or equal to, three times its ULN
* Serum creatinine: within normal range or \<120μmol/L for patients aged 60 years or older.
* Negative pregnancy test in women capable of child-bearing.

Exclusion Criteria:

* Known hypersensitivity to Gallium 68, DOTATOC or to any of the excipients of 68Ga-DOTATOC.
* Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (Long Acting Release) (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug.
* Pregnant or breast-feeding women.
* Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
The OneFlorida Cancer Control Alliance: Implementing the 6As in Pediatric Primary Care

The primary purpose of our study is to conduct a pilot, practice-based intervention focused on increasing adherence to the 6As for youth ages 11 through 17 years. The 6As are: (1) "Anticipate" (future use), (2) "Ask" (about tobacco use), (3) "Advise" (advise the patient to quit using tobacco), (4) "Assess" (the patient's readiness to quit using tobacco), (5) "Assist" (by setting a quit date, providing materials on quitting tobacco, providing tobacco cessation medications, and referring the patient for additional services and/or counseling) , and (6) "Arrange" (by re-contacting the patient after their quit date and arranging a follow-up visit).

Investigators will incorporate American Academy of Pediatrics (AAP) best practice recommendations to screen and counsel parents. The specific aims of this study are to: (1) Develop and deploy an electronic short screening tool for tobacco and nicotine product use into pediatric primary care workflow in conjunction with clinician and office staff training on the 6As and parent screening through the use of trained Clinical Practice Facilitators, clinician-engaged adaptations of the intervention to fit their practice workflow, and support for Maintenance of Certification (MOC) to engage pediatricians in implementing the best practices; (2) Gather pilot data about the effectiveness of the intervention on clinician adherence to best practices and changes in practice capacity for change, adaptive reserve, and clinician self-efficacy; and (3) Examine the congruence between documentation of the intervention in the electronic health record (EHR) and youth report of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* 11-17 years old

Exclusion Criteria:

* 18 years and older
Mindfulness for People With Incurable Cancer

The study will investigate whether a mindfulness course can help people with incurable cancer who are seen by oncologists in a particular National Health Service Hospital Trust in the United Kingdom.

It can be hard to come to terms with living with a life limiting condition such as incurable cancer and individuals are at risk of experiencing high levels of psychological distress, which can often be overlooked when the focus is on managing physical symptoms.

Mindfulness-based interventions have been shown to be helpful in reducing distress for people with cancer generally. This pilot study will use an established mindfulness programme called mindfulness for health with people with cancer which is incurable to see if this type of intervention is acceptable and useful for this group of people.

Eligibility Criteria:
Inclusion Criteria:

* Deemed by the oncologist to have incurable cancer
* Patient of the University Hospitals of Morecambe Bay NHS Foundation Trust
* Treated by an oncologist
* Believe they are able to commit to attending most of the mindfulness course sessions
* Oncologist assesses they are well enough to participate in the intervention

Exclusion Criteria:

* Having any other condition or difficulty which the medical team thinks would compromise their participation in the study.
A Mobile Based Diabetes Prevention Program

The goals of the study are to:

1. Assess effect sizes of our mDPP intervention on weight loss, physical activity, dietary intake, and fasting plasma glucose (FPG) levels from baseline to 5 months as compared to a control group.
2. To explore the association between low heath-literacy levels at baseline and adherence to mobile phone usage.
3. To conduct process evaluation to gain insights into patient compliance to the mobile intervention, including usage barriers and acceptability of our mDPP, at 1 and 5 months using a semi-structured interview method.

The prevalence of type 2 diabetes (T2DM) continues to rise at an alarming rate in the United States. A greater risk of diabetes is observed for ethnic/racial minority and lower socioeconomic status (SES)groups as compared to Caucasians of similar ages. Several clinical trials have tested intensive lifestyle interventions or pharmacologic agents in preventing or delaying T2DM in adults at risk. These trials (e.g.the Diabetes Prevention Program) consistently show impressive diabetes risk reductions using lifestyle interventions, such as relatively modest amounts of weight loss and exercise. However these programs have been expensive to implement and sustain over time in clinical settings or communities.

Mobile technologies are ideal platforms to deliver and disseminate such lifestyle modification programs to a much broader ethnic/racial minority population, making them more cost effective. Today, 87% of adults in the U.S. own a mobile phone. In particular, usage of non-voice services (such as text messaging or mobile internet) in African-Americans and non-white Hispanics is significantly higher than their Caucasian counterparts. In contrast, ethnic /racial minority populations are much less likely to own a computer at home compared to their Caucasian counterparts. Given the rapid diffusion of mobile technologies in ethnic/racial minority populations, we need to understand how to apply mobile persuasive technologies to such lifestyle modification programs.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary lifestyle at work and/or during leisure time
* Intend to be physically active
* Are over 25 years of age
* Access to a home telephone or a mobile phone
* Speak and read English
* Are not physically active
* Have no disabilities that limit physical activity
* Have high blood sugar (fasting blood sugar 100-125) but do not have diabetes

Exclusion Criteria:

* Known medical conditions or other physical problems that need special attention in an exercise program
* Plan a trip abroad during the first 5 months of the study period.
* Pregnant/Delivered a baby during the last 6 months
* Known severe hearing or speech problem
* Currently participate in lifestyle modification programs or research studies that may potentially confound the results of the study
* History of gastric bypass surgery or future plans for gastric bypass surgery in the next 5 months
* Already taking medication for diabetes
* Recovery from addiction
* Known eating disorders
* Bmi over 25 if non-Asian or over 23 if Asian
Meditation and Exercise to Treat Chronic Back Pain

This study evaluates the analgesic effect of a combination treatment of exercise and mindfulness based meditation in patients with chronic back pain. Half of the participants will partake in a 4-week exercise and meditation intervention, while the other half will receive a placebo treatment. The investigators hypothesize that a combination treatment reduces disability and pain more than the control intervention.

Exercise and mindfulness based mediation can both produce analgesic effects in patients with chronic pain, but the mechanisms are not clear.

Combining treatments could produce analgesic effects that are additive, synergistic, or counteractive to each other. Here, the investigators examine the effects of a 4-week intervention in patients with chronic low back pain. Patients are assigned to a meditation/exercise group or a control group. The investigators will measure pain and disability using a variety of tools including surveys (disability, anxiety, mindfulness, and pain), pain VAS scales, and quantitative sensory testing.

Eligibility Criteria:
Inclusion Criteria:

1. Presence of clinically diagnosed nonspecific low back pain for at least 6 months
2. Body mass index within the normal to overweight range (18.5-29.9)
3. Resting heart rate 60 to 100 beats per minute
4. Resting blood pressure less than or equal to 140/90
5. Able to independently ambulate community distances without external support (e.g., walker, cane)

   Exclusion Criteria:
6. Age less than 18 or greater than 60 years
7. BMI ≥ 30 or ≤ 18.4
8. Cardiovascular or respiratory disease
9. Neurological disease, unrelated to low back pain
10. Radicular low back pain
11. Back pain associated with neuropathy
12. Diabetes mellitus, Types 1 and 2
13. Diagnosed with a chronic pain condition, unrelated to low back pain
14. Acute pain
15. Regular participation in high intensity athletic/sporting activities
16. Sedentary lifestyle
17. Currently pregnant
18. Current cigarette smoker
19. On-going litigation associated with back pain
20. Inability to walk independently without external support (e.g. walker).
21. Regular participation in meditation techniques or training in Mindfulness-based stress reduction
Virtual Reality (VR) Self-Hypnosis Software

This single-site study of self-hypnosis software using an off-the-shelf virtual reality (VR) device (OculusGo™) to determine the software's safety, usability, and preliminary efficacy in pain relief for HIV-associated chronic pain patients. This is funded under the i Prism Funding through Mount Sinai Innovations.

The study will be done in two phases - Phase A is the development of the software by the study team and the engineers targeted to be completed by 4/15/2024. Testing will occur with only the study team. No participants will be involved in the testing phase. Phase B is the participant enrollment phase targeted to start 5/20/2024. A request for FDA Exemption of a non-significant risk combination device has been submitted and granted.

Eligibility Criteria:
Patient Eligibility

Inclusion Criteria:

* Adults age ≥18
* Confirmed diagnosis of HIV, currently on a stable antiretroviral regimen ≥ 90 days.
* Documentation of chronic pain associated with HIV for≥90 days
* Stable pain management regimen ≥90 days, or no pain treatments ≥90 days
* Average pain intensity of 3 or greater on the NRS of the mean daily scores reported between Visit 1 and Visit 2
* Access to the internet via smartphone, computer, or tablet 7. Fluent in English
* Capable of giving informed consent and willingness to comply with study procedures.

Exclusion Criteria:

* A co-occurring medical or psychiatric condition which would make participation in the study or complicate measurement of changes associated with the intervention.
* Concurrent participation in another investigational protocol for pain treatment
* A psychiatric disorder, medical condition, or other life circumstance, which in the opinion of the PI, would contraindicate attendance at sessions, or make it unlikely that the participant could successfully complete the study procedures.
* Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, or other neurological conditions contraindicating the use of virtual reality devices.
* A medical condition predisposing prospective participant to nausea or dizziness 6. Lack of stereoscopic vision or severe hearing impairment
* Injury to eyes, face, or neck that impedes using the VR device
* If participant has access to personal VR gear for gaming or other purposes at home, participant fails to agree not to use these personal VR gear during the course of the protocol.
* Currently pregnant or planning to become pregnant during the study period
Health Status of the Oldest-old Population

This study aims to investigate the health status of the oldest-old population and to explore the key factors associated with their quality of life The study will select all the elderly aged 85 years and above from Lanqiying Community, Qinghuayuan Street, Haidian District, Beijing, and enroll them after informed consent. Demographic, sociological, economic, physiological information and disease-related records will be collected through questionnaire interviews, scales, and examinations.

After the first survey, the participants will be followed for 2 years to collect information about deaths or major health events. The baseline survey will be re-conducted two years later.

This study is a population-based cohort study. Oldest-old people (aged 80 and over) will be enrolled.

Data collection Social economics information include: name, gender, age, nationality, marital status, personal habits, occupation, level of education, family living situation, monthly income, way to go to a doctor and medical payment, etc The health status and disease will be obtained by review the medical records as well as the narration of the subjects and their family members. We will focus on diseases with high disability mortality, high social burden. Multiple indicators or abilities will be evaluated through the scale, including life or acting ability, nutritional status, cognitive ability, psychological status, social support, quality of life self-assessment, etc., so as to comprehensively understand the comprehensive information of the participants.

Basic physical examination and special clinical examination will be performed to obtain multiple objective indicators reflecting the subject's physical function The basic health examination includes; Blood pressure, respiration, heart rate, pulse; Height, weight, waist circumference, hip circumference, arm circumference, calf circumference, grip strength, vital capacity, tooth condition, hearing condition, visual acuity, ECG, etc.

Special examinations include the blood, urine, and stool specimens. Imageological examination like MRI, fundus photography, and optical coherence tomography will also be conducted.

Eligibility Criteria:
Inclusion Criteria:

* All the people aged 80 years and above in the target community in Beijing

Exclusion Criteria:

* People who were hospitalized for long period (6 months or more) or at the end of their lives were excluded.
The Efficacy and Safety of Switching to Flumatinib Versus Dasatinib After Imatinib-related Low-grade Adverse Events in CML-CP Patients

The purpose of this study is to explore the efficacy and safety of switching to flumatinib versus dasatinib after imatinib-related low-grade adverse events in patients with chronic myeloid leukemia in chronic phase (CML-CP) in China. This is a post-marketing, interventional, double-arm, prospective, open-label, randomized controlled study in CML-CP patients in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given flumatinib or dasatinib under the conditions of informed consent and frequent monitoring according to the clinical guideline.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Diagnosis of CML-CP with Ph+;
* ECOG 0, 1, or 2;
* Patients with imatinib-related Low-grade Adverse Events for more than 12 months and AE lasting for at least 2 months, or relapsed at least 3 times in the past 12 months;
* Ability to provide written informed consent prior to any study related screening procedures being done

Exclusion Criteria:

* Previously documented T315I mutation;
* Previous treatment with any other tyrosine kinase inhibitor except for imatinib;
* Prior accelerated phase or blast phase CML;
* Loss of CHR or cytogenetic response
Peripheral Heating and Glucose Tolerance

Effect of peripheral heating on glucose tolerance


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years

Exclusion Criteria:

* Open wounds on feet or legs
* Peripheral neuropathy
The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study)

The purpose of this study is to evaluate the effectiveness of once weekly risedronate in the prevention and treatment of bone loss in premenopausal and newly menopausal women with breast cancer who have received chemotherapy.

The hypothesis is that bisphosphonate therapy will prevent bone loss at clinically relevant sites, such as the hip and spine. The investigators also hypothesize that there will be a correlation between biochemical markers of bone turnover and changes in bone mineral density.

Breast cancer is a significant public health problem accounting for approximately 30% of new cancers diagnosed annually. Much advancement has been made in the treatment of these cancers which has significantly decreased the mortality rates. Treatment, including adjuvant chemotherapy and hormonal therapy, prolongs disease free survival and overall survival of patients with breast cancer. The cytotoxic drugs, however, can cause premature ovarian failure and subsequent menopause. This risk has been reported to range from 53% to 89%. Temporary or permanent chemotherapy induced ovarian failure is important because of potential bone loss associated with the estrogen loss. Initiating a potent antiresorptive agent, risedronate, should prevent or improve bone mass in these women.

Comparison: The investigators will compare bone mass/markers of study subjects receiving risedronate with study subjects receiving placebo. All subjects will be provided calcium and vitamin D supplementation as needed.

Eligibility Criteria:
Inclusion Criteria:

* Pre- and newly postmenopausal (up to 8 years) women ages 18 and older
* Breast cancer treated with chemotherapeutic agents, with or without tamoxifen/aromatase inhibitors
* Negative pregnancy test

Exclusion Criteria:

* Stage 4 breast cancer
* Any illness or medications known to affect bone metabolism
* History of osteoporosis or history of vertebral or hip fractures
* Kidney stones in the past 5 years
* Active peptic ulcer disease
JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian Nose

A prospective, open-label, observational study of the safety and efficacy of JUVÉDERM VOLUMA® to enhance the aesthetic appearance of the Asian nose.


Eligibility Criteria:
Inclusion Criteria:

* Asian subjects aged 20 years of age or older with dissatisfaction of their aesthetic appearance due to structural features of their nose
* Subjects who, in the opinion of the Investigator, can achieve a clinically meaningful aesthetic correction of their nose with VOLUMA® treatment

Exclusion Criteria:

* -Subjects requiring filler treatment in or around the tip of the nose or between the eyebrows (glabellar region) to achieve a good aesthetic outcome
* prior nasal surgery, including grafts, implants or filler injection to the nose area
* Subjects with a history of sinusitis or rhinitis
* Subjects unlikely to achieve a meaningful aesthetic result with the prescribed dosage regimen of the study product.
* Subjects receiving botulinum toxin treatment for any indication within 3 months of the study or planning to receive botulinum toxin during the study
* Subjects who have previously received aesthetic treatment in the forehead, glabellar, and/or nose area with any dermal filler
* Subjects with a history of any significant adverse events caused by dermal fillers
* Subjects with a history of allergic responses to lidocaine or fillers
* Subjects who are pregnant or breastfeeding or wish to become pregnant during the study
* Subjects of child-bearing age who are not prepared to practice an adequate form of contraception during the course of the study
* Subjects with traumatic scars in the treatment area or a history of active inflammation, infection, cancerous lesion, or an unhealed wound in the treatment area
* Subjects requiring dental or oral surgery, including dental implants, during the study period
* Subjects with a history of bleeding disorders
* Subjects who are smokers
* Subjects using blood thinning products within 10 days of the screening visit
* Subjects with a history of connective tissue disease (e.g., rheumatoid arthritis, lupus, scleroderma, etc) causing skin scarring
* Subjects with a history of untreated epilepsy or other significant medical conditions
* Subjects with a history of alcoholism or drug abuse of dependence
* Subjects participating or likely to participate in another clinical trial within 30 days of screening or during the 1 year period of the study
* Subjects with any other medical condition, which in the opinion of the Investigator, might compromise the subject's ability to tolerate the injection procedure or comply with requirements of the study