cyrilzakka/clinical-trials huggingface dataset:
Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis

This study is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS) after their brain surgery. It will be optional for patients to have a pre-surgery 18F-Fluciclovine PET/CT scan. The goal of the study is to determine whether a specific imaging agent, known as 18F-Fluciclovine, will help physicians evaluate the extent of surgery and determine if there is any visible tumor above what MRI alone can identify as well as improve the physicians' ability to detect recurring disease. This agent (18F-Fluciclovine) is investigational for the imaging of brain metastases.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Performance status, Eastern Cooperative Oncology Group (ECOG) 0-3
3. Radiographic diagnosis of brain metastasis
4. Patient planned for surgical intervention for at least 1 metastasis
5. Patient planned for postoperative SRS

Male or female patients of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18F-Fluciclovine PET/CT. Highly effective and acceptable forms of contraception are:

* Male condom plus spermicide
* Cap plus spermicide
* Diaphragm plus spermicide
* Copper T
* Progesterone T
* Levonorgestrel-releasing intrauterine system (e.g., Mirena®)
* Implants
* Hormone shot or injection
* Combined pill
* Mini-pill
* Patch

Postmenopausal people on the study (that will not need contraception) is defined as at least one of the following:

* Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments
* Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50
* Radiation-induced oophorectomy with last menses \> 1 year ago
* Chemotherapy-induced menopause with \>1 year interval since last menses
* Surgical sterilization (bilateral oophorectomy or hysterectomy).

Exclusion Criteria:

1. Prior anaphylactic reaction to 18F-Fluciclovine
2. Evidence of leptomeningeal disease
3. Prior whole-brain radiation therapy
4. Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
5. Pregnant at the expected time of 18F-fluciclovine administration
6. Expecting to be breastfeeding at the time of 18F-Fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after the time of imaging is allowed.
Epiretinal Proliferation in Eyes With Full Thickness Macular Hole

We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was detected and detection of EP was correlated to the visual improvement.

We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was detected and detection of EP was correlated to the visual improvement.

Eligibility Criteria:
Inclusion Criteria:

* Eyes with macular hole

Exclusion Criteria:

* Eyes with retinal detachment, retinal vascular disease, glaucoma, proliferative diabetic retinopathy
Influence of Coffee on the Health and on the Heart of Normal, Diabetics e Coronary Artery Disease Patients

Coffee is a worldwide drink, been part of any culture. There are some concerns about effects of coffee on the health. Recently, epidemiological studies have shown benefits of coffee drinking to diabetics and also to prevent diabetes in populations. We aim to understand some effects of coffee and not only caffeine over vascular system, in special coronary artery disease patients, diabetics end normal people.

Patients will have a wash-out period (21 days) with no coffee or other caffeine-drinks. Then they will be submitted to treadmill test, MAPA, Holter-ECG and vascular reactivity study, biochemical and inflammatory plasma dosages, as basal. Then they will start a period of coffee drinking over 4 weeks; and all exams will be repeated. We will study two types of coffee, arabica and robusta; with two types of toasted beans(regular and soft). Also regular and decaffeinated coffee. A total of 300 (100 normal people, 100 diabetics, 100 coronary disease) individuals will be tested.

Eligibility Criteria:
Inclusion Criteria:

Normal Volunteers:

1. Healthy volunteer.
2. Age between 20 and 80 years.
3. No addict to drugs.
4. Absence of chronicle diseases.
5. No alcohol abuse.
6. No smoker.

Coronary artery disease:

1. Presence of coronary artery disease, by coronary angiography
2. Stable angina, class 1-3 of CCS.
3. Age between 20 and 80 years.
4. Treadmill effort test with ischemia.
5. No alcohol abuse.
6. No smoker.

Diabetes:

1. Presence of type II Diabetes on oral treatment.
2. Age between 20 and 80 years.
3. Absence of chronicle diseases, except diabetes.
4. No alcohol abuse.
5. No smoker.

Exclusion Criteria:

Normal Volunteers:

1. Any blood test with twice or more the upper limit range.
2. Presence of enlarged QRS.

Coronary artery disease:

1. Any blood test with twice or more the upper limit range even with treatment.
2. Presence of enlarged QRS.
3. Ventricular dysfunction (EF \< 45%).

Diabetes:

1. Blood glucose greater than 160 mg/dL.
2. Others blood tests with twice or more the upper limit range even with treatment.
3. Presence of enlarged QRS.
Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth

Atypical cavities, which involve more than two surfaces being one of them vestibular or lingual/palatine, are a challenge for restorative dentistry, since the risk of failure of the restorations are related to the number of surfaces involved. Thus, the objective of this project is to conduct a randomized clinical trial in order to evaluate the efficacy and patient-centered outcomes of a chemically-activated alkasite composite resin in atypical lesions of deciduous molars. Deciduous molars of children between 4 and 7 years of age with at least one atypical cavity lesion in deciduous molars will be selected for the ECR. The selected teeth will be randomly divided into two groups: Chemically activated composite resin Alkasite and resin-Modified glass ionomer cement. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The efficacy of the treatments will be evaluated by the longevity of the restoring procedures and the arrestment of the caries lesions. Patient-centered outcomes will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

• Children will be included who have at least one posterior tooth with atypical caries lesion.

Exclusion Criteria:

* Patients with special needs
* Patients general health conditions that may affect the oral cavity
* Patients non-cooperating in relation to the examination
* Patients with orthodontic apparatus
* The parents/guardians or children not to consent to their participation in the study.
* Teeth with pulp exposure
* Teeth with spontaneous pain
* Teeth with mobility
* Teeth with presence of swelling or fistula close to the tooth
* Teeth with furcation or cervical injury
* Teeth with restorations, sealants or enamel formation defects will be excluded.
A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery

The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy.


Eligibility Criteria:
Inclusion Criteria:

* Female;
* Documented history of previous breast surgery (either complete or partial mastectomy);
* Available harvest sites for fat grafting as documented by plastic surgeon;
* BMI \> 20;
* Anticipated harvested fat volume \> 50cc;
* Competency and willingness to provide consent

Exclusion Criteria:

* Suspected or known to be pregnant
An Intervention on Healthy Adults of Probiotics on Gut Flora Metabolisms of Choline

The aim of the study is to examine the effects of probiotics intervention on choline metabolites and intestinal microbiota composition using a randomized double blind clinical trial. Also, we proposed to explore the real-time change of choline metabolites after probiotics intervention through a PC challenge test. Our study will clarify the biochemical pathway involved in metabolic diseases and hope to provide a new targeted-preventive and therapeutic strategy for chronic metabolic diseases.

Dietary choline (mainly refer to phosphatidylcholine, PC) produce trimethylamine (TMA) through the action of gut flora in vivo. TMA then readily absorbed into systemic circulation and oxidized by hepatic flavin monoxygenases (FMO3) to trimethylamine-N-oxide (TMAO). The elevated levels of circulating TMAO is identified as a risk factor for the prevalence and development of metabolic diseases such as cardiovascular diseases and nonalcoholic fatty liver diseases. Targeting gut flora for reducing TMAO may be a promising approach for preventing chronic metabolic diseases. Recent studies found that some strains representing two different phyla (Firmicutes and Proteobacteria) are capable of producing TMA from choline in vitro. On the other hand, TMA intervention can change the structure of intestinal flora, reducing the abundance of bifidobacterium and lactobacillus. Probiotics can improve the ecological balance of the gut flora, which might be beneficial to human health and disease prevention. However, whether probiotics could inhibit the TMA-producing bacterias and reduce the TMA and TMAO levels through balancing the gut flora was unclear.

In order to explore whether probiotics can reduce the TMA and TMAO levels, we are proposed to recruit 50 volunteers aged from 18-30 years old to participate in the randomized double-blind trial. The volunteers are randomized allocated into different intervention groups. The probiotics intervention group is provided once daily orally-taken powder in a sachet, which contains 4 strains of probiotics. The non-probiotic control is provided with a powder without probiotics , but has same look, color, taste, flavor and weight as the probiotics intervention group. A PC challenge test will be hold before and after the 4 weeks intervention. The blood and fecal sample will be collected before and after the trial and analyzed by appropriate method. The dietary assessment is assessed by a 3-day dietary record.The statistic analysis is by SPSS 23.0.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males at 18 to 30 years old;
* Free from antibiotics and probiotic products for at least 1 month;
* Willing to participate in the study, consume the test product and perform all measurements.

Exclusion Criteria:

* Sever physical diseases;
* Intolerance to probiotics or eggs
The Relationship Between Post Dural Puncture Headache and Joint Laxity

Post-spinal headache is divided into 3 according to the severity scale. It is divided into 3 groups as mild, moderate and severe according to the presence of symptoms such as nausea, vomiting, and dizziness that prevent daily activity.

It has been reported that CSF leakage may be higher due to the weakness of the regional dural sac in primary connective tissue diseases with joint laxity and isolated joint hypermobility. Joint laxity is scored according to the level of motion in 5 different joints and a maximum of 9 points is obtained.

In this study, it was aimed to investigate whether joint laxity contributes to the development of post-spinal headache by questioning the correlation between joint laxity examination score and postspinal headache in patients with post-spinal headache.

Post dural puncture headache (PDPH), also known as post lumbar puncture (LP) headache, is a common complication of diagnostic LP. It also can occur following spinal anesthesia or, more commonly, inadvertent dural puncture during attempted epidural catheter placement. The headache is usually positional (worse when upright, better when lying flat) and is often accompanied by neck stiffness, photophobia, nausea, or subjective hearing symptoms.

In various studies, common patient risk factors for PDPH have included female gender, pregnancy, age 18 to 50 years compared with older or younger ages, and a prior history of headache

Additionally it has been thought that joint laxity contributes to the development of post dural puncture headache. However, no study has been found in the literature examining this relationship between them. In thıs study it was aimed to investigate the relationship between joint laxity and post dural puncture headache.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 age
* the patients who develop PDPH

Exclusion Criteria:

* \<18 and \>65 age
* the patients refused to participate in the study
Latin American Multicenter Cardiovascular Magnetic Resonance Reference Study

This study was designed to investigate the physiological properties of adult heart using cardiovascular magnetic resonance imaging in normal volunteers in Latin America.

Evaluation of myocardial mass, volumes and function is essential in the management of cardiovascular diseases. While 2D and 3D echocardiography play a major role in determining these parameters cardiovascular magnetic resonance (CMR) has become a widely accepted gold standard for these measurements due to its high accuracy and reproducibility.

However, determining normal reference standards for CMR is crucial for proper use of the method. Previous reports have established normal ranges for both fast low angle shot techniques6 and the more commonly used steady state free precession methods including values normalized not only to body surface area but to age and gender as well. Despite these general references, variability in normal ranges have been reported previously when ethnicity is taken into account. The ongoing Multi-Ethnic Study of Atherosclerosis (MESA) trial has measured cardiovascular function in participants with different ethnical backgrounds, reporting differences in the African-American and Asian-American groups.

Latin-American populations have generally been underrepresented in most clinical cardiovascular trials despite representing a growing percentage of heart disease patients in the world and, particularly, in the USA12-15. While the MESA trial evaluated cardiac function by CMR in Hispanics, data was limited to participants living in USA, within a restricted age group and representing only a small fraction of their entire cohort. It is thus essential to acquire specific data for this population regarding normal CMR values in order to permit not only precise clinical evaluation of Hispanic patients but also accurate assessment of ventricular function figures from Latin American countries in future CMR and drug trials.

To accomplish this goal, we propose a multicenter study to collect CMR data from countries in Latin America in normal participants with 20-80 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic subjects with 20 to 80 years of age with no history of cardiac disease, no known risk factors with normal physical examination and ECG

Exclusion Criteria:

* Current smokers or smokers with \< 10 years of quitting
* Systolic blood pressure \> 120mmHg or diastolic blood pressure \> 80mmHg
* Fasting blood glucose \> 100mg/dL
* Total cholesterol \> 240mg/dL
Effects of Pursed Lip Breathing With and Without Mat Pilates Training in Obese Women

Obesity is defined as BMI more than or equal to 30kg/m2. It is responsible for manifestation of serious health problem. Accumulation of adipose tissue in thorax and abdomen causes stiffness of chest, reduction in lung compliance and favoring airway closure. As result, reduction in lung volume and capacity occurs which requires increased breathing to maintain adequate oxygenation. These changes lead to limitations in activities of daily life. A Randomized Control study will be conduct to see the effects of Pilates exercise and pursed lip breathing to improve the breathing and thoracoabdominal expansion. The study will be completed within 10 months after approval of synopsis. The sample size of 34 subjects will be taken: 17 with Pilates method and 17 without Pilates method with 12% attrition rate. Pre assessment and Post assessment will be made through IPAQ questionnaire for physical activity measurement, Borg's scale (CR-10) for dyspnea measurement and Cirtometry for thoracoabdominal expansion. Study will be conducted at Star gym for women Al-Rehman Garden community, Lahore. Data will be analyzed through SPSS 25.


Eligibility Criteria:
Inclusion Criteria:

* Age(25-55 years)
* Female
* Dyspnea during intense exercise 0-10
* No experience of Pilates exercise training
* BMI \> 30 kg/m2

Exclusion Criteria:

* Smoking
* Pregnancy
* Practice of high intensity endurance training (squats, planks, lunges)
Development of a New Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Death Rates

This phase I trial investigates the development of a new early detection test to reduce racial disparities in endometrial cancer death rates. DNA samples collected from a tampon may be able to be used to detect endometrial cancer. Studying information from focus groups and vaginal samples of African American and white women may help researchers develop a less invasive and painful test to detect endometrial cancer. The purpose of this trial is to perform a demonstration project of tampon self-collection, assess percentage of samples returned; total and endometrial derived DNA quantity and quality, preliminarily test previously validated DNA methylation markers that may discriminate endometrial cancer from normal endometrium in tampon specimens.

PRIMARY OBJECTIVES:

I. To conduct focus groups to elicit perceptions and knowledge among African American women (AAW) and white women (WW) concerning abnormal uterine bleeding (AUB)/post-menopausal bleeding (PMB), endometrial cancer (EC) risk factors, barriers to seeking medical evaluation, sources of medical information and acceptance and feasibility of tampon self-collection for laboratory testing.

II. To perform a demonstration project of tampon self-collection from 25 AAW and 25 WW with AUB/PMB in Jacksonville.

OUTLINE:

AIM 1: Participants attend a focus group over 2 hours about endometrial cancer including knowledge of abnormal uterine bleeding, post-menopausal bleeding, risk factors, sources of medical information, barriers to seeking gynecologic care, and acceptance of tampon self-collection for endometrial cancer detection.

AIM 2: Participants receive a tampon kit for collection of vaginal samples.

After completion of study enrollment, participants may be followed up annually for 10 years.

Eligibility Criteria:
Inclusion Criteria:

* AIM 1: Self-identified white women (WW) or African American women (AAW) (will record Hispanic ethnicity)
* AIM 2: Self-reported history of abnormal uterine bleeding (AUB) or post-menopausal bleeding (PMB)

Exclusion Criteria:

* AIM 1: Women who do not identify as WW or AAW
* AIM 1: Women who are unable to speak and read English
* AIM 2: Prior hysterectomy
* AIM 2: Prior pelvic radiation or are unwilling to comply with instructions
* AIM 2: Pregnant women
Three Channel Food Concept: the Effect Meal Service on Food Intake During Hospitalization

The goal of this observational study is to assess food intake in hospitalized patients.

The present study will evaluate the impact of a novel in-hospital meal concept (three channel food concept) on total energy and protein intake, macronutrient distribution, and patient appreciation

Food intake will be assessed (as part of usual care) by weighing all leftovers (e.g. food that patients did not consume).

There are various possible strategies to increase protein intake during hospitalization, such as providing more protein-rich foods, fortifying meals and/or food products, supplementation with oral nutritional supplements (ONS), and/or providing well-timed snacks. An appropriate in-hospital meal service is regarded as a key element of the strategy to minimize deterioration of the nutritional status. Conventional hospital meals, 3 main meals a day prepared by a central kitchen, are often low in protein and energy and are not appreciated by patients due to lack of taste, colour and flavour, resulting in inadequate food intake particularly protein intake. There are a number of avenues to improve nutritional intake, with type of meal service and existence of individual contact with catering staff, like mealtime assistance, as important factors. The MUMC+ has adapted it's in-hospital meal system and the present study will evaluate the impact of this novel in-hospital meal concept (three channel food concept) on total energy and protein intake, macronutrient distribution, and patient appreciation.

The aim of this study is to assess whether a novel in-hospital meal concept can effectively increase daily total protein and energy intake during hospitalization, when compared to a historic control.

Eligibility Criteria:
Inclusion Criteria:

* \>18y
* Admitted to surgical nursing wards of MUMC+
* Expected hospital stay of at least 3 days

Exclusion Criteria:

* Receiving (par)enteral nutrition
* "NPO" (nil per os) policy
Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective ABBV-668 is in treating adult participants with UC. Adverse events and change in disease activity will be assessed.

ABBV-668 is an investigational drug being developed for the treatment of moderate to severe UC. Approximately 40 adult participants diagnosed with UC will be enrolled in approximately 30 sites globally.

Participants will receive oral capsules of ABBV-668 twice daily for 52-weeks and will undergo a 30 day follow-up period.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ulcerative colitis (UC) for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the Investigator, must be available.
* Participant meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review).
* Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunosuppressants and/or targeted immunomodulators (including biologics and non-biologics)

Exclusion Criteria:

* Current diagnosis of crohn's disease (CD) or inflammatory bowel disease-unclassified (IBD-U).
* Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.