cyrilzakka/clinical-trials huggingface dataset:
Daily Imaging, Target Identification, and Simulated Computed Tomography-Based Stereotactic Adaptive Radiotherapy Workflow in a Novel Ring Gantry Radiotherapy Device

The investigators propose here to evaluate the feasibility of a novel cone-beam CT (CBCT)-guided online adaptive radiotherapy (ART) workflow on the Halcyon device.


Eligibility Criteria:
Inclusion Criteria:

* At least one disease site deemed to be suitable for simulated treatment with online adaptive radiotherapy per radiation oncology evaluation.
* Scheduled to receive radiation therapy to the thorax (n = 8), pancreas (n = 8), non-pancreas abdomen (n = 8), or pelvis (n = 8).
* At least 18 years of age
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol PI, documentation of this exception is sufficient in lieu of a pregnancy test.
Functional Magnetic Resonance Imaging Study of Jaw-tapping Movement on Memory Function

The purpose of this study is to examine the possibility of using jaw-tapping training as a self-exercise for developing memory and preventing dementia in elderly subjects with memory disturbances using functional magnetic resonance imaging (fMRI).

Right-handed female volunteers over the age of 50 years with subjective memory complaints are included in the study. Volunteers with dentures, psychoactive medication, history of stroke, or other neurologic disorders are excluded.

The protocol was approved by the Institutional Review Board of university-based hospital.

After administering the Seoul Neuropsychological Screening Battery (SNSB), Mini-Mental State Examination (MMSE) scores above 24 and Clinical Dementia Rating Scale (CDR) scores of 0 are considered subjective memory complaints (SMC), and MMSE scores above 23 and CDR scores of 0.5 are considered MCI.

All subjects undergo two MRI scans. After the first MRI, the subjects are trained to tap their jaws vertically at 1.6 Hz at home twice a day for 30 seconds every day during four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed female volunteers over the age of 50 years with subjective memory complaints

Exclusion Criteria:

* Volunteers with dentures, psychoactive medication, history of stroke, or other neurologic disorders
Immunogenicity of a Trivalent Influenza Vaccine in Chronic Kidney Disease Patients Undergoing Hemodialysis

During the 2013-2014 influenza season, CKD patients undergoing HD participated in the study. The patients were randomized into two groups (MF59-adjuvanted vaccine group or non-adjuvanted vaccine group) and were immunized with the respective vaccine. Sera were collected prior to vaccination and at 1and 6 months post vaccination. Levels of hemagglutination inhibition (HI) antibodies were measured.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease patients undergoing hemodialysis
* Who have given written informed consent at the time of enrollment

Exclusion Criteria:

* Recipients of influenza vaccine of 2013-2014 season before the study
* History of egg allergy
RGD-PET-CT in Cancer Angiogenesis

The goal of this clinical research study is to look at 2 new methods of scanning and see whether they can help researchers predict which tumours will respond to drugs that attack tumour blood supply.


Eligibility Criteria:
Inclusion Criteria:

1. Patients should have advanced or metastatic RCC confirmed by histological diagnosis
2. Patients considered suitable for therapy with TKI for RCC according to responsible clinician
3. Measurable tumour according to RECIST v1.1 criteria
4. Standard staging CT scan performed within 28 days of first research scan
5. The patient has not received chemotherapy, radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to recruitment
6. Age ≥18 years
7. Adequate renal function (creatinine \<1.25xULN)
8. Patient is able to tolerate and comply with scanning procedure
9. Patient is not lactating or pregnant
10. Absence of any psychological, familial, sociological or geographical condition which in the opinion of the Investigator may potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
11. Able and willing to give informed consent

Exclusion Criteria:

* Not applicable
Study of Evobrutinib in Participants With RMS

The study was to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Interferon-beta-1a (Avonex®), once a week intramuscularly in participants with Relapsing Multiple Sclerosis (RMS).


Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with RMS (relapsing-remitting multiple sclerosis \[RRMS\] or secondary progressive multiple sclerosis \[SPMS\] with relapses) in accordance with 2017 Revised McDonald criteria (Thompson 2018).
* Participants with one or more documented relapses within the 2 years before Screening with either: a. one relapse which occurred within the last year prior to randomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesion within 6 months prior to randomization.
* Participants have EDSS score of 0 to 5.5 at Baseline. Participants with an EDSS score \<= 2 at screening are only eligible for participation if their disease duration (time since onset of symptoms) is no more than 10 years.
* Participants are neurologically stable for \>= 30 days prior to both screening and baseline.
* Female participants must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either: post-menopausal or surgically sterile or use an effective method of contraception for the duration of the study.
* Participants have given written informed consent prior to any study-related procedure.
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria as follows: a). Participants with Primary Progressive MS. b). Participants with secondary progressive MS without evidence of relapse.
* Disease duration more than (\>) 10 years in participants with an EDSS =\< 2.0 at screening.
* Immunologic disorder other than MS, or any other condition requiring oral, intravenous (IV) , intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled Type 2 diabetes mellitus or well controlled thyroid disease.
* Other protocol defined exclusion criteria could apply.
Blueberries, Inflammation, Motivation, and Physical Activity

The purpose of this study is to determine the feasibility and preliminary efficacy of daily supplementation of freeze-dried blueberry to modulate inflammation-driven lack of motivation in 40 sedentary, older adults with depressive symptoms.

The investigators will conduct a 14 week, single-site, randomized, double-blind, parallel pilot study in 40 sedentary, older adults with depressive symptoms. Participants will first enter a 2-week washout period where they will avoid consumption of foods high in fiber and anthocyanins (e.g., blueberries) and will also be wearing an activity monitor. Participants will then be randomized to consume either 48 g of freeze-dried blueberry powder (\~600 mg of anthocyanins and \~8 g of fiber) or 48 g of a nutritionally matched placebo powder (devoid of anthocyanins and fiber) each day for a total of 12 weeks.

At baseline, participants will be undergo assessments for mood/well-being, relevant symptoms, motivation to engage in physical activity, and provide a blood sample for the evaluation of inflammatory biomarkers. For the entire duration of the study, participants will continue to wear the activity monitor. After 4, 6, 8 and 12 weeks of consuming the powder there will be study visits that assess mood/well-being, relevant symptoms, motivation to engage in physical activity and compliance with the intervention. Additionally, a blood sample for the evaluation of inflammatory makers will be taken after 6 and 12 weeks of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥65 years
* Self-reporting ≥ 8 hours of sitting per/day (e.g., sedentary behavior)
* Depressive symptoms (defined as ≥4 and \<16 points on the center for epidemiological studies depression-scale)

Exclusion Criteria:

* Unwilling to follow the study protocol
* A median daily step count \>7,500 steps per day (as measured by the ActiGraph), or per discretion of the PI
* Cognitive impairment (defined as Montreal Cognitive Assessment, MoCA \<22 points)
* Self-reporting a history of inflammatory bowel disease/syndrome, major depression, bipolar, schizophrenia, or other psychotic disorders, or per discretion of the PI
* Self-reporting type 1 or type 2 diabetes
* Allergic to intervention or control products
* Recent use (within the last 3 months) of antibiotics, or per discretion of the PI
* Recent use (within the last 3 months) of pro-biotics, or per discretion of the PI
* Current substance use disorder (Drug Abuse Screening Test, DAST-10\>2 points)
* Current alcohol use disorder (Alcohol Use Disorders Identification Test - Consumption, AUDIT-C≥4 points)
* Unstable anti-depressant use (e.g., change in medication within last 3-6 months), or per discretion of the PI
* Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener)
* Current psychosis (via the Psychosis and Hallucinations Questionnaire, PHQ\>12 points)
* Manic symptoms (assessed by the Mood Disorder Questionnaire, MDQ \>5 points)
Intrabdominal Hyperthermic Chemotherapy and Pancreatic Cancer

A randomized, multidisciplinary study, Phase II-III clinical trial.The study is opened to the incorporation of other centers that would increase the power of the obtained results . Our hypothesis considers that using Hyperthermic Intra-abdominal Chemotherapy,HIPEC, with gemcitabine after cytoreductive surgery ,will decrease tumor progression of pancreatic cancer by reducing the neoplastic volume and subpopulation of pancreatic cancer stem cells, improving the survival of patients with pancreatic cancer, and decreasing the recurrence of the disease

According to the incidence in the area of the University General Hospital, Ciudad Real, HGUCR, authors will include a population of 42 patients, n = 21 in each group, I and II, with diagnosis of adenocarcinoma of the pancreas, which will be surgically resected with curative intention, in the next two years, 2017-2018, with extended follow-up for at least two years more for survival study Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 21 subjects were required in the first group and 21 participants in the second Group to detect as statistically significant difference between two proportions, for group I is expected to be 0.05 and for Group II 0.4, in relation to survival in five years. It has been estimated a rate of loss of patients of 10%

* Group I. After cytoreductive surgery, R0, and intestinal reconstruction, the patient after multidisciplinary study will receive adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles
* Group II.After a R0 cytoreductive surgery, HIPEC is performed with gemcitabine, 120mg / m2 for 30' + adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles The aim is identifying morbidity and mortality associated to treatment by cytoreductive surgery and HIPEC with gemcitabine+ systemic chemotherapy,Group II, respect to a conventional treatment group that includes cytoreductive surgery with systemic chemotherapy, Group I,and identifying survival of the experimental Group with treatment with cytoreductive surgery and HIPEC with gemcitabine ,respect to the conventional treatment group,GI

Eligibility Criteria:
Inclusion Criteria:

· Resectable pancreatic adenocarcinoma

Exclusion Criteria:

* Voluntary refusal to participate in the trial
* Existence of distant disease that contraindicates the surgical treatment
* Patients with preoperative or intraoperative locoregional unresectable pancreatic cancer
* Existence of synchronous neoplastic disease
* Exclusion after perioperative anesthetic study
Lean Muscle Function

This pilot study is designed to determine the relationship between intra-myocellular lipids and muscle contractility in fibers from obese and non-obese older adults. Obese participants are being recruited for an on-going weight loss intervention study and this application seeks approval to recruit and enroll a lean comparison group of non-obese older adults. The primary goal of this study is to characterize the contractile properties of single muscle fibers and whole muscle in healthy, non-obese individuals under the same recording conditions the investigators used for the obese population to begin to determine whether fat infiltration accounts for diminished force.


Eligibility Criteria:
Inclusion Criteria:

* Age=65-75 years
* BMI=18-24 kg/m2
* No resistance training for past 6 months
* Normal cognitive function (MMSE \>24)
* No contraindications for participation in weight loss or weight lifting exercise including severe arthritis or musculoskeletal disorders, knee or hip replacement or spinal surgery in past year
* Able to provide own transportation to study visits
* Not involved in any other research study involving strength training or undergoing physical therapy
* Not dependent on a cane or walker
* Willing to provide informed consent

Exclusion Criteria:

* Weight loss or gain (±5%) in past 6 months
* Body mass \>136 kg (DXA limit)
* Current smoker (No nicotine within past year) or evidence of alcohol or drug abuse
* Insulin dependent or uncontrolled diabetes (FBG \>140 mg/dL)
* Uncontrolled hypertension (BP\>180/100 mmHg)
* Abnormal kidney function or liver blood tests
* Serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (\>2 mm) on ECG
* Past or current cardiovascular disease, including uncontrolled angina or dysrhythmia, hypertrophic cardiomyopathy, congestive heart failure, PAD, stroke, history of myocardial infarction, use of defibrillator or major heart surgery, or deep vein thrombosis or pulmonary embolus. These will be reviewed on a case by case basis.
* Past or current respiratory disease (requiring steroid treatment or supplemental oxygen)
* Past or current clinical diagnoses of neurological or hematological disease
* Use of any medications that could influence study variables (growth/steroid hormones, prescription anti-inflammatory medications, or beta blockers, Coumadin or any other blood thinner, including Plavix, Ticid, and Aggrenox)
* Cancer requiring treatment in past 2 years, except non-melanoma skin cancers
* Clinically evident edema or anemia
OCT Explores Vascular Response and Healing Profile After Stenting in CTO

True-false-true occurred during wire penetration in coronary CTO procedure. Subintimal stenting influences vascular response. Intravenous ultrasound confirmed wire position in the procedure. Then stenting procedure was performed. Optical coherence tomography was used for exploring long-term vascular response and healing profile after successful coronary stenting in CTO lesions.

Chronic total occlusions (CTOs) are defined as coronary lesions with thrombolysis in myocardial infarction (TIMI) grade flow of 0 and present for more than 3 months. CTO is commonly recognized as the toughest lesion subset to be treated by percutaneous coronary interventions. With the remarkable progress in the technologies and techniques achieved in the PCI for CTO over the last decade, the rate of procedural success increased to 80-90%. Chronic total occlusion is associated with a higher incidence of malapposition and uncovered stent struts. At present, four strategies were used for CTO lesions, including: ante-grade wire escalation, ante-grade dissection reentry (ADR), retro-grade wire escalation, and retrograde dissection reentry (RDR). True-false-true occurred during wire penetration. Subintimal stenting influences vascular response. Intravenous ultrasound (IVUS) confirmed wire position in the procedure. Then stenting procedure was performed according to standard routine. Optical coherence tomography (OCT) was used for exploring long-term vascular response and healing profile after successful coronary stenting in CTO lesions.

Eligibility Criteria:
Inclusion Criteria:

* 18\~85 years old;
* Agree percutaneous coronary intervention without related contraindications;
* Chronic total occlusion confirmed by clinical and angiographic data, predicted high successful rate of stent implantation;
* Subjects (or legal guardians) understanding the testing requirements and procedures, and providing written informed consent.

Exclusion Criteria:

* Subjects associated with drugs allergy (such as contrast, sirolimus, or structure-related compounds fluorinated polymers, thienopyridine or aspirin);
* Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy;
* Subjects being suffered from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 12 months;
* Pregnant or breastfeeding women;
* Refused this trial;
* Subjects with severe liver or renal dysfunction (ALT \>5×ULN，eGFR\< 30ml/min/1.73mm2 or Scr\>200 mmol/L);
* Active bleeding;
* Bleeding diathesis or coagulopathy, malignant tumors;
* Contraindication of anticoagulant drugs;
* Subjects with other situation not suitable for the study.
CONFIRM: Magnetic Resonance Guided Radiation Therapy

This research is being done to determine the safety and feasibility of using a type of radiation guided by magnetic resonance imaging (MRI) and chemotherapy to treat patients with gastric and breast cancer. The name of the radiation machine involved in this study is the MRIdian Linear Accelerator.

This is a master clinical protocol evaluating magnetic resonance (MR) image guided radiation in patients with gastric and breast cancer.

In this research study, the investigators are researching if getting an MRI during radiation is a feasible way to delivery radiation. In this research study, a MRI done during treatment will help doctors adapt the radiation to target the most precise spot where the cancer is located.

The research study procedures include:

* Screening for eligibility
* Study treatment including evaluations
* Follow up visits
* Questionnaires

This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of investigational radiation treatment and also tries to define the appropriate dose of the investigational radiation treatment to use for further studies. "Investigational" means that the way the radiation treatment is delivered is being studied.

This research study is a Feasibility Study, which means it is the first-time investigators at this institution are examining this type of MR-guided radiation. Investigators at other hospitals and academic centers are already using this type of radiation.

The U.S. Food and Drug Administration (FDA) has approved this radiation machine and these drugs as treatment options for gastric and breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologically or cytologically confirmed malignancy requiring radiation
* Age 18 years of older
* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
* Ability to understand and the willingness to sign a written informed consent document.
* Any further criteria listed in the specific disease site cohort

Exclusion Criteria

* History of allergic reactions attributed to gadolinium-based IV contrast

  -- Note: If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility
* Severe claustrophobia or anxiety
* Participants who cannot undergo an MRI
* Any other exclusion criteria listed in the specific disease site cohort
A Clinical Study of TQB3824 in Subjects With Advanced Cancer

TQB3824 blocks function of a specific protein called Cell Division Cycle 7 (CDC7) kinase in the human body, which plays important roles in the maintenance of DNA replication forks and DNA damage response pathways. This study will evaluate the safety, tolerability and pharmacokinetics of TQB3824.


Eligibility Criteria:
Inclusion Criteria:

1. Understood and signed an informed consent form;
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
3. Life expectancy \>=3 months;
4. Progressed after standard treatment or no standard treatment with an established survival benefit is available;
5. Adequate organ/system function;
6. Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.

Exclusion Criteria:

1. Diagnosed and/or treated additional malignancy within 3 years before the first dose;
2. With factors affecting oral medication;
3. Toxicity that is \>=Grade 2 caused by previous cancer therapy;
4. Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the first dose;
5. Arterial thromboembolism and/or venous thromboembolism within 6 months;
6. A history of psychotropic drug abuse or have a mental disorder;
7. Any severe and/or uncontrolled disease;
8. Has received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first dose;
9. Has received Chinese patent medicines with anti-tumor indications that National Medical Products Administration (NMPA) approved within 2 weeks before the first dose;
10. Has received CDC7 inhibitors;
11. Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage;
12. Brain metastases ;
13. Has participated in other clinical studies within 4 weeks before the first dose;
14. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Vascular Function, Insulin Sensitivity, and Vitamin D

The overall objectives of this study are to examine the relationships between circulating vitamin D, insulin sensitivity, and multiple indices of vascular function and to examine whether vitamin D deficiency in African Americans (AA) and White Hispanics (WH) is responsible for ethnic differences in insulin sensitivity and hypertension in AA, WH and European Americans (EA), as well as mechanisms underlying the association between insulin resistance and blood pressure. We hypothesize that 1) serum 25(OH)D is associated with insulin sensitivity and vascular functioning, independent of adiposity, 2) lower insulin sensitivity and vascular functioning in AA and WH relative to EA is due to lower circulating 25(OH)D in AA, and 3) the relationship between insulin resistance and vascular dysfunction is mediated by 25(OH)D.

Acronyms: African American (AA), European American (EA), White Hispanics (WH), Serum 25-hydroxy vitamin D (25()H)D, Body mass index (BMI), Alabama (AL).


Eligibility Criteria:
Inclusion Criteria:

* African American (AA), White Hispanic (WH), and European American (EA) race
* Ages 19-60 years
* Negative urine pregnancy test
* No evidence of diabetes
* Not on medications that can affect vascular functioning or insulin sensitivity

Exclusion Criteria:

* BMI \> 32 kg/m2
* Diabetes or any chronic diseases
* Use of medication(s) known to influence body composition, vascular function, or glucose metabolism
* Regular smoking
* Regular use of illegal drugs and pregnancy