cyrilzakka/clinical-trials huggingface dataset:
Glycaemic Control Effect of BSG and Underlying Gut - Related Mechanism in Singapore Adults With Metabolic Syndrome

The purpose of this research project is to assess the glycaemic controlling effects of consuming BSG and bio-transformed BSG-containing biscuits and its underlying gut - related mechanism in adults with MetS using in-vivo setting.

This is a double-blind, randomised, parallel experiment, all subjects (38 adults in Singapore with MetS) will complete a 12-week intervention period. Subjects will be randomly assigned to consume their habitual diet with biscuit that either does not contain or contains autoclaved BSG or bio-transformed BSG for 12 weeks. Throughout the intervention, subjects will be assessed for glucose, insulin, lipid and amino acid responses, biomarkers of gut health, and as well as other markers of health.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants, aged 35-85 years old
* English-literate and able to give informed consent in English
* Willing to follow the study procedures
* Meet any 3 of the 5 following NCEP-ATP III MetS criteria: waist circumference \> 102 cm (male), \> 88 cm (female) (For Asian population: Waist circumference \> 90 cm (male), \> 80 cm (female)); fasting glucose concentration ≥ 100 mg/dL or on medication; triglyceride ≥ 150 mg/dL or on medication; high density lipoprotein cholesterol (HDL) \< 40 mg/dL (male), \< 50 mg/dL (female); systolic or diastolic blood pressure \> 130/85 mmHg or on medication);

Exclusion Criteria:

* Significant change in weight (≥ 3 kg body weight) during the past 3 months
* Allergy to barley, wheat, corn, egg, or other ingredients found inside the biscuits.
* Acute illness at the study baseline
* Exercising vigorously\* over the past 3 months. \*Defined as having \> 6 metabolic equivalents of exercise daily; approximately 20 mins of moderate intensity exercise (e.g. slow jogging) a day
* Following any restricted diet (e.g. vegetarian)
* Smoking
* Have a daily intake of more than 2 alcoholic drinks per day
* Taking dietary supplements or food which may impact the outcome of interests (e.g. fermented foods, probiotic supplement etc.)
* Consumption of antibiotics over past 3 months.
* Pregnant, lactating, or planning pregnancy in the next 6 months
* Insufficient venous access to allow the blood collection
* Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication which started less than 3 years prior to the intervention participation
* High current intake of fibre\* from brown rice or wholemeal products. \*High, moderate or low intake taken as ≥ 6 servings, 4 - 5 servings, and ≤ 3 servings daily respectively based on My Healthy Plate guidelines
* High current intake of fibre\* from vegetables. \* High, moderate or low intake taken as ≥ 2 servings, 2 servings, and ≤ 1 serving respectively based on My Healthy Plate guidelines
The Study of Acupuncture on Vascular and Functional Neuroimaging in Parkinson's Disease Patients With Sleep Disorders

The purpose of the study is to compare vascular and functional neurological changes of acupuncture in patients with Parkinson's Disease and Sleep Disorders. In the randomized controlled clinical trial study, patients meeting the criteria for inclusion will be randomly enrolled and divided into two groups in a 1:1 ratio: the acupuncture group and the sham acupuncture group. The intervention is going to be executed using the acupoints GV14（Dazhui）and GB20 (Fengchi).The acupuncture needles will be inserted to a depth of 0.8 to 1 cm using GV14（Dazhui）and GB20 (Fengchi) in the acupuncture group. The sham acupuncture group's needles will be inserted to a depth of 0.1 to 0.2 cm with nonacupuncture points located 0.5 cm in lateral to the real acupoint or to the right for midline points.During the study, researchers will observe changes in cerebral blood vessels and neuroimaging before and after acupuncture in the two groups. Using multimodal fusion advanced vascular-neuronal imaging techniques could evaluate the effect of acupuncture on brain blood vessels and function in patients with Parkinson's disease and Sleep Disorders and provide an objective neuroimaging basis for assessing the effectiveness of acupuncture.

Neuroimaging assessment:Subjects are keeping awake, resting flat on the examination table, using rubber earplugs to reduce noise, using foam headbands to fix head movement artifacts, closing eyes to calm breathing, fixing the head and minimizing head and other parts of the initiative and passive exercise.At the same time, it is required not to carry out any thinking activities. After the subject is familiar with the environment, it begins to scan and conduct a comprehensive MRI scan before and after the acupuncture needling.

Eligibility Criteria:
Inclusion Criteria:

1. meeting the above diagnostic criteria for Parkinson's disease and Sleep Disorders;
2. Hoehn-Yahr grade 2-3;
3. Those who voluntarily participate in the project while he/she or his/her guardian sign an informed consent form;
4. Those who have had a junior high school education or above and have a correct understanding of clinical acupuncture research significance.

Exclusion Criteria:

1. Accompanied with sleep apnea syndrome, sleep-behavioral disorders such as sleep-breathing disorders, and other system diseases that cause sleep disorders, such as anemia and other hematological diseases, hypothyroidism, severe heart and lung diseases, tumors, liver and kidney diseases;
2. History of drug use or alcohol addiction, psychosis and sedation for painful illnesses;
3. Severe cognitive impairments and failure to complete scale assessments;
4. There are barriers to communication and communication that affect the evaluation of research, such as speech, vision, hearing and other serious damage to patients;
5. Allergic to needles or alcohol;
6. Those who cannot perform MRI scans, such as claustrophobia.
Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)

Data from this study are expected to demonstrate that Gardasil (V501, Human Papillomavirus \[Types 6, 11, 16, 18\] Recombinant Vaccine), when administered concomitantly with a combined diphtheria, tetanus, pertussis, and poliomyelitis vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.


Eligibility Criteria:
Inclusion Criteria:

* Must be healthy boys or girls, 11-17 years of age
* Must be a virgin with no intention of becoming sexually active during the study period
* Must have been properly vaccinated against diphtheria, tetanus, pertussis and polio

Exclusion Criteria:

* Must not have received a vaccine against diphtheria, tetanus, pertussis and polio in the past 5 years
* Must not have received any prior human papillomavirus (HPV) vaccine
Automated 3D (SonoAVC) Versus 2D Ovarian Follicles Assessment in IVF Cycles: a Randomized Controlled Trial

Accurate assessment of the size of follicles is important in IVF treatment.Timing of oocyte maturation and subsequent egg collection is largely based on follicle size. An accurate assessment of follicle size and appropriate timing of HCG result in retrieval of more mature oocytes, improved fertilization and higher pregnancy rates. in 3D technology- fter the capturing of a 3D image of an ovary, SonoAVC automatically analyzes the volume dataset, identifies the boundaries of hypoechoic follicles, and provides estimates of their absolute dimensions. These measurements include the largest diameters in three orthogonal planes, the mean follicular diameter (MFD), the volume of the follicle, and the volume-based diameter (d(V)) of the follicle. In the current study the investigators aim to evaluate the use of this automated technique of follicle measurement vs. standard 2D technology on the timing of oocyte maturation and subsequent oocyte retrieval. The investigators speculate that 3D assessment will increase the rate of mature oocyte collection, and eventually will improve other treatment outcomes such as fertilization rate.

Not desired

Eligibility Criteria:
Inclusion Criteria:

* Age:18-39, cycle number 1-4

Exclusion Criteria:

* PCOS
* Endometriosis
* Poor ovarian response
* TESA sperm
Running Slopes and Power Performance

The objective of the present study was to determine the effect of interval session running at high intensity with 1% or 10% gradient on the height of the drop jump. The cinematic variables concentric phase, eccentric and contact time were compared after the running session in both conditions in order to explain possible changes in the jump performance. The investigators theorize that the lower eccentric overload in the running to 10% inclination promotes higher deleterious effect on power performance of the lower limbs

Physical training programs are typically composed of activities directed to the development of different valences usually stimulated in the same session. When aerobic activities of long duration prior isokinetic strength exercises, isotonic, or explosive, deleterious effects seem to be induced on performance of these valences. These short and long-term changes in muscle strength and power would be directly associated with repetitive eccentric loads that characterize the endurance running. Gradual increases in the running slope were inversely associated with a proportional reduction in the eccentric loads, which in turn would result in less muscle damage to intra and extrafusal fibers. So, the change in the slope of the race would emerge as an optional way to neutralize the competitive effect on the power performance. The research consisted of five visits. At the initial visit was conducted familiarization to vertical drop jump, and immediately after, the determination of VO2max values and their associated speed (vVO2max). The second visit was a new familiarization for the vertical drop jump followed immediately determining the Time to exhaustion performance in vVO2max (100% of VO2Max). Two jumps were performed on each of the three selected heights (20, 30 and 40 cm) were used in the experimental sessions and control only the height associated with the highest performance. In subsequent visits (third to fifth), participants performed three maximum jumps before and about 10 min after the following conditions: high intensity Interval running a 10% gradient (C10%), 1% grade (C1%) and control condition (CON).

Eligibility Criteria:
Inclusion Criteria:

* age: 18 at 45 years
* no cardiovascular or metabolic problems
* minimum level of aerobic activity recommended by American College of Sports Medicine

Exclusion Criteria:

* no joint or muscle injuries
* no use ergogenic or anabolic resources
Comparison of Men's Prevention Apps to Research Efficacy

A randomized three arm control trial to examine the efficacy of two distinct apps (LYNX and MyChoices) developed for young men who have sex with men (YMSM) compared to standard of care (SOC) information about HIV testing and PrEP (Pre-Exposure Prophylaxis).

COMPARE is part of the iTech NIH U19, which has an overall goal to develop innovative technology-focused interventions addressing the HIV prevention and care continuum for youth. In years 1-2 of the iTech grant, the investigators optimized and pilot tested using a similar study design and identical study outcomes, two distinct mobile apps called LYNX and MyChoices. Each app is designed to increase HIV testing and PrEP uptake among YMSM. In this study, the individual apps are being tested in this follow-on research study to evaluate for efficacy. YMSM will be randomized to receive either MyChoices, LYNX, or SOC. LYNX uses the Information-Motivation-Behavior Skills (IMB) model and is a highly interactive mobile app to promote accurate risk perception, increase HIV/STI testing, and linkage to PrEP. MyChoices is guided by the Social Cognitive Theory (SCT) model, is adapted from HealthMindr and developed using iterative feedback from youth refined to maximize acceptability among YMSM. It includes three major functions that are designed to promote self-efficacy, self-regulation, goal-setting and environmental influences to impact behavior change. The SOC includes information on HIV testing and PrEP with the provision of referrals to local HIV/STI testing and PrEP resources.

Eligibility Criteria:
Inclusion Criteria:

* 15 to 29 years.
* Assigned male sex at birth and male identified.
* Self-report being HIV uninfected or HIV status-unknown at screening.
* Self-report having not had an HIV test in the past 3 months.
* Self-report not currently taking PrEP.
* Self-report at least one episode of anal intercourse with a male or transfemale partner during the last 12 months.
* Able to understand, read, and speak English.
* Owns or leases a phone with Android platform or iOS platform, has an active data plan Has phone setting in English or Spanish, or willing to use an English or Spanish phone setting over the course of the study (Spanish setting is only for bilingual participants who speak both English and Spanish fluently)
* Willing and able to attend an in-person baseline study visit in one of the study site areas, or willing to attend a remote online baseline study visit

Exclusion Criteria:

* Currently enrolled in another HIV intervention study.
* Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product.
* Enrollment in Aims 2 and 3 of the prior MyChoices (UNC IRB# 17-0256) or LYNX (UNC IRB# 17-0170) studies
* Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
* Not willing and/or not able to download the MyChoices and LYNX apps onto their phone
Optimizing Chronic Low Back Pain Exercise Therapies With Cerebral Electrical Stimulation

Chronic low back (CLBP) pain is an important public health and socioeconomic problem worldwide and, despite the volume of research in the area, it remains a difficult condition to treat. The Neuromatrix pain model and new findings on the pain chronification process point to a greater efficacy of treatments that address central and peripheral rather than only peripheral structures.

Transcranial direct current (tDCS) stimulation is a noninvasive neuromodulation technique that has been presenting recent advances in the treatment of chronic pain. However, when applied alone the magnitude of its effect is small in chronic musculoskeletal conditions such as chronic non-specific back pain. One option that could optimize the analgesic effect of tDCS would be the combination with therapeutic exercises, which play a central role in spinal rehabilitation programs as well as higher levels of evidence. The combination of these treatments (tDCS and exercise) may present an analgesic effect superior to the isolated interventions.

This study aims to investigate the efficacy of tDCS combined with therapeutic exercises in people CLBP for pain relief, affective aspect of pain, disability, kinesiophobia and global perception. Sixty patients will be randomized into two distinct groups to receive either tDCS (anodal) + therapeutic exercises or tDCS (sham) + therapeutic exercises for 12 sessions over a four-week period. The primary clinical outcome (pain relief) and secondary outcomes (disability, affective aspect of pain, kinesiophobia, and perception of overall effect) will be collected before treatment and four weeks, three months and six months post randomization. The data will be collected by a blind examiner to the treatment allocation.


Eligibility Criteria:
Inclusion Criteria:

Complaining of back pain for more than three months. Presence of a chronic pain measurable with the number rating scale (NRS 0-10) not less than 4 during a 1 week daily NRS monitoring.

Seeking care for low back pain. -

Exclusion Criteria:

Previous surgery on the spine, spondylolisthesis Previous treatment with TENS \<6 months Previous treatment with tDCS Disc herniation with nerve compression Neurological, psychiatric and rheumatologic diseases Impaired sensibility Use of pacemakers or other implanted devices Pregnancy

-
Florida Pancreas Collaborative Next Generation Biobank

The goal of this study is to partner with individuals known or suspected to have pancreatic cancer to build a biobank dedicated to minimizing disparities and personalizing care for individuals affected by pancreatic cancer. A biobank is a resource that involves collection, processing and storage of blood, other bodily fluids, and tissue.

Doctors, researchers, and patient advocates from numerous institutions throughout the state of Florida have formed a partnership known as the Florida Pancreas Collaborative. The goals of the Florida Pancreas Collaborative team are to find better ways to diagnose and treat pancreatic cancer and improve quality of life. Recent research suggests that pancreatic cancer affects people of various racial and ethnic groups differently, with some groups having more aggressive disease and a poorer prognosis than other groups.

In this research study, the investigators want to partner with individuals known or suspected to have pancreatic cancer to build a 'biobank' dedicated to minimizing disparities and personalizing care for individuals affected by pancreatic cancer. A biobank is a valuable resource that involves collection, processing, and storage of blood, other bodily fluids, and tissue (obtained during biopsy or surgery) to improve the investigator's understanding of health and disease. When combined with information and medical images obtained through routine care, the investigators will be able to investigate biological processes that may underlie differences and poor outcomes and target them with more effective therapeutic strategies tailored to the individual.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Patient presents for evaluation at a participating site with a strong clinical suspicion or diagnosis of a pancreatic cancer primary based on symptoms, imaging, biopsy, and/or blood-work and has not had treatment.
* Patient self-reports as Non-Hispanic White, African American, or Hispanic.
* Able to understand and voluntarily sign the informed consent.
* Willing to complete study questionnaire(s) and donate medical images and biological specimens (including tissue and blood) obtained at the time of standard of care procedures (biopsy, surgery, and/or venipuncture) after signing the informed consent document.

Exclusion Criteria:

* No suspicion or diagnosis of pancreatic cancer.
* Has a diagnosis of pancreatic cancer but and has already undergone treatment (which may include surgery, chemotherapy, and/or radiation).
* Self-reported race/ethnicity other than Non-Hispanic White, African American, or Hispanic.
* Unable to provide informed consent.
* Unwilling to complete study questionnaires(s) and/or donate biological specimens
Platelet Indices in Patients Undergoing Primary PCI and Its Prognostic Value

To assess the platelet indices in patients undergoing primary percutaneous coronary intervention and its relation to the severity of coronary artery disease and short term clinical outcomes

Acute coronary syndromes (ACS) is a type of acute coronary artery disease (CAD), It is a highly prevalent group of emergency diseases, associated with high morbidity and mortality (1)

ACS include ST- elevation Myocardial Infarction (STEMI), non ST-Elevation Myocardial Infarction (NSTEMI) and Unstable Angina (UA) (2).

ACS characterized by plaque rupture and acute thrombosis formation in the coronary arteries (3)

platelet morphology and function have vital roles in the pathogenesis of many diseases related to coagulation, thrombosis, inflammation, and endothelial dysfunction (4)

Platelets play a crucial role in thrombotic episodes, its activation is acritical factor in the creation and evolution of atherothrombosis. (5)

Not only platelets are essential for the thrombotic vascular occlusion at the ruptured atherosclerotic plaque but also they contribute to the obstruction and impairment of coronary micro circulation (6).

Risk stratification plays a crucial role in the management of patients with ACS (7).

Patients estimated to be at higher risk may be managed with earlier and more aggressive treatment, whereas those with lower risk may be managed with less intensive treatment (8).

Many biomarkers have been evaluated, and various scores have been created for risk stratification of ACS patients (9)

Mean platelet volume (MPV) has been proposed as a primary marker for platelet activation, as larger sized platelets have been associated with higher pro-thrombotic risk, and its measurement is easy and time effective (10-14)

* So It may elevate in patients with ACS and its role, It could be a useful bio marker of risk of stratification (15)
* Platelet Distribution Width (PDW) measured on admission is a cheap and generally available biomarker which allows for predicting the development of heart failure in patients with ACS after PCI (16)

showed that an increased level of PDW was related to the severity of CAD in patients with ACS (17).

Numerous studies support the association of Mean platelet volume (MPV) with adverse cardiac outcomes as restenosis stent thrombosis in patients with ACS (19-24) al.2011

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18 years) that presented with acute ST elevation myocardial infarction

Exclusion Criteria:

1. Cardiomyopathy,
2. Previous revascularization procedure
3. Any history of bleeding diathesis
Regulation of Endothelial Progenitor Cells by Short-Term Exercise

Endothelial Progenitor Cells (EPCs) are circulating cells released from bone marrow which are important for maintaining cardiovascular health. The prevalence of cardiovascular disease in older adults is associated with reduced circulating EPC numbers. Studies have shown reduced EPC number and function in old vs. young individuals, and endurance exercise training increases EPC number and function in young adults. Oxidative stress adversely affects endothelial cells and preliminary evidence indicates that oxidative stress negatively affects EPC function. Conversely, regular exercise reduces markers of oxidative stress and may enhance EPC function in older adults. The investigators hypothesize that older endurance-trained athletes and matched sedentary individuals will have markedly divergent EPC function and that altering the physical activity levels of both groups will move them to intermediate points between these two extremes. The investigators also propose that the investigators can "mimic" the effect of exercise training on EPC function in cell culture by altering intracellular levels of a key enzyme and a signaling molecule which the investigators have shown to regulate EPC function with respect to exercise training in young individuals.


Eligibility Criteria:
Inclusion Criteria:

* 50-80 years of age, BMI = 18-35 kg/m2, non-smoking, women must be postmenopausal

Exclusion Criteria:

* history of cardiovascular/cerebrovascular disease, diabetes, cancer, renal, liver disease, HIV; uncontrolled hyperlipidemia/hypertension