cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety and Immunogenicity of MG1109 in Healthy Adult Volunteers

This study was designed in two steps with Step 1, a single-center, double-blind, randomized clinical Pilot study and Step 2, a multi-center, single-blind, randomized clinical Pivotal study. The investigator evaluate the immunogenicity and safety of the investigational vaccine in the subjects during their participation in the study.

MG1109 is purified, inactivated influenza viral antigen.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults who are available for follow-up during the study

Exclusion Criteria:

* Subjects with history of exposure to the H5N1 subtype or H5N1 subtype vaccine
* Subjects with immune system disorder including immune deficiency disease
Relationship Between Pelvic Floor Dysfunctions and Lower Limb Strength and Activation in MS Patients

we aim to investigate the relationship between pelvic floor dysfunctions, core endurance, hip external rotation muscle strength, and tibialis posterior and tibialis anterior muscle activation in patients diagnosed with MS


Eligibility Criteria:
Inclusion Criteria:

* EDSS score between 0 and 4.0
* Having access to the internet via a high-speed smartphone or computer
* Scoring at least 21 points on the MoCA
* Having a score of Stage 3 or higher on the Functional Ambulation Scale.

Exclusion Criteria:

* Having hearing or vision problems.
* Participating in any exercise program.
* Having accompanying other neurological, cardiovascular, or orthopedic disorders.
* A history of an MS relapse or medication change within the last 6 months.
* Being in a physical condition that prevents participation in exercises.
* Comorbid conditions that negatively affect oxygen transport (e.g., severe anemia, peripheral artery disease, etc.)
Effect of Nutriose Supplementation on Satiety, Weight Loss and Adiposity in Overweight Subjects

NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this ingredient is a "soluble dietary fiber." Recent work in China in overweight volunteers have shown an effect of NUTRIOSE on satiation and satiety, and demonstrate an effect on reducing weight and fat mass. By its action on satiety and reduced food intake, the NUTRIOSE be of interest in the management of overweight or obese. Among the possible mechanisms of action, are the metabolites produced by colonic fermentation of NUTRIOSE.

The goal of this biomedical research is to study the effect of a dose of 14g/day of NUTRIOSE FB06 for 12 weeks on the evolution of weight, percentage of body fat and digestive tolerance in Caucasians overweight subjects. To gather evidence to support mechanisms of action, it is proposed to measure before consumption, then every 4 weeks, the effects of NUTRIOSE FB06 on satiety and satiation and changes in colonic flora and its metabolites.


Eligibility Criteria:
Inclusion Criteria:

* healthy people
* aged between 20 and 50 years
* BMI between 27 and 29 kg/m2
* without metabolic syndrome
* no pregnant nor nursing women
* covered by Social Security
* negative serology for hepatitis B/C and HIV
* who signed the informed consent form

Exclusion Criteria:

* persons abusing drugs (laxatives, anti-diarrheal, agents acting on satiety)
* person who doesn't want to stop taking food supplements containing pre- or probiotics during time of the study
* person intolerant to gluten and / or allergic to wheat flour
* person in diet during the last 3 months
* person in vegetarian or vegan diet
* person who donated blood during the 3 months preceding the study
* Inclusion in another clinical study
* subjects receiving over 4,500 Euros in the last 12 months (including the present study)
* subjects presenting risk of non-compliance in the opinion of the recruiting doctor.
A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus

The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).

This is a Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of escalating single subcutaneous doses of MEDI-570 in adult subjects with moderately to severely active SLE.

Eligibility Criteria:
Inclusion Criteria:

* Meet or have met at least 4 of the 11 revised American College of Rheumatology (ACR) classification criteria for systemic lupus erythematosus (SLE)
* Score greater than or equal to (\>=) 6 points on the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Screening
* Ability to complete the study period, including follow-up period through Day 169
* Willingness to forego other forms of experimental treatment during the study.

Exclusion Criteria:

* History of cancer except basal cell carcinoma treated with apparent success with curative therapy \>=1 year before randomization into the study
* Evidence of active or latent tuberculosis (TB)
* History of primary immunodeficiency
* Evidence of infection at any time with hepatitis B or C virus or human immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at Screening
* History of sepsis or serious, recurrent, chronic infection, current signs and symptoms of clinically significant chronic infection, or recent (within 6 months before Baseline visit) serious infection
* Any history or evidence of opportunistic infection within 6 months of Screening including severe cytomegalovirus (CMV) or herpetic infections (such as disseminated herpes, herpes encephalitis, ophthalmic herpes)
* Receipt of cyclophosphamide (intravenous or oral) within 6 months of Screening
* Have any absolute contraindications to skin punch biopsies, for example, a history of coagulation disorders.
Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE in Sweden

This study aims to estimate the burden of RV GE. The study will focus on children hospitalized for severe RV GE, Children acquiring RV GE in the hospital and the household contacts of children hospitalized with RV GE. It is expected to enrol 500-600 subjects in the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from parent or guardian
* A male/ female child aged less than 5 years. On the day of fifth birthday the subject is not eligible for participation
* Hospitalised for acute GE
* Developed symptoms of acute GE 72 hours after hospitalisation
* Stool sample should be positive for the presence of rotavirus, which will be detected either by Vikia test or by ELISA

Inclusion criteria for household members:

* Family members including care-takers and sibling staying in the same house and who spend most of the nights (50%) with the sick child.
* Written permission from care-takers or siblings or their parents.

Exclusion Criteria:

- All children in the neonatal wards.
Vigorous or Moderate Exercise in Enhancing Active Surveillance in Patients With Localized Prostate Cancer

This randomized pilot clinical trial compares vigorous or moderate exercise in enhancing active surveillance in patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Active surveillance involves watching the patient's condition but not giving any treatment unless test results show that the patient's condition is getting worse. Exercise may improve fitness, quality of life, brain health, and blood biomarkers in patients with prostate cancer on active surveillance. It is not yet known whether vigorous or moderate exercise works better in enhancing active surveillance in patients with localized prostate cancer.

PRIMARY OBJECTIVES:

I. To determine the feasibility of performing vigorous intensity aerobic exercise using progressive, high-intensity interval training (HIIT) with standard stationary cycling and 'cybercycling' compared to moderate intensity aerobic exercise with standard stationary cycling in prostate cancer (PCa) survivors on active surveillance (AS).

II. To explore the potential effects of vigorous intensity aerobic exercise (HIIT) using standard cycling and 'cybercycling' compared to moderate intensity standard cycling on changes in quality of life (QoL), cognition, fitness circulating inflammatory biomarkers and PCa-specific markers of progression (prostate specific antigen \[PSA\], time to AT) in PCa survivors in active surveillance (AS); and, to explore if these effects may be mediated by changes in body fat.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.

ARM II: Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.

ARM III: Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.

After completion of study, patients are followed up at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult men of all races and body size with histologically confirmed localized PCa on AS
* Approved to be contacted by the treating urologist
* Meet screening criteria

  * Complete American Heart Association (AHA)/American College of Sports Medicine (ACSM) exercise questionnaire
  * Undergo cardiopulmonary exercise (CPX) testing utilizing a cycle ergometer. If the CPX test is terminated secondary to hemodynamic instability, arrhythmias or ischemic signs, the patient will be ineligible.

Exclusion Criteria:

* Patients unable to provide informed consent
* Patients participating in a structured exercise program in the past 6 months
* Patients not available for follow-up tests
* Patients with pre-existing medical conditions that would be a barrier to exercise
Expanded Access With Trappsol(R) Cyclo (TM) for an Individual Patient With Late Onset Alzheimer's Disease

To afford urgent access to a potential-disease modifying treatment, Dr. Diana Kerwin, in partnership with CTD Holdings, the manufacturer of Trappsol (R) Cyclo(TM), will administer the product to a patient with Alzheimer's Disease who has no other disease-modifying treatment options.

Trappsol(R) Cyclo(TM) will be administered via intravenous (IV) infusion. The initial dose will be 500 mg/kg (T=Day 0). Subsequent dosing is anticipated to increase over 9 months, with all subsequent doses given monthly at the maximum dose determined by tolerability, lack of toxicity or adverse event, pharmacokinetic analysis and patient preference. So long as the overall risk/benefit profile favors continued dosing, the patient will continue to receive Trappsol (R) Cyclo (TM) for a minimum of 12 months, if not perpetually.

Risk/benefit assessments will include:

* Vital signs, ECG and laboratory parameters (CBC, chemistry panel, hematology, urinalysis, lipids, coagulation)
* Brain MRI without gadolinium for safety monitoring
* Amyloid and Tau PET (positron emission tomorgraphy) imaging
* Adverse Events
* Mini-mental status score
* Digital Cognition Technologies (DCT) Clock
* Changes in blood biomarkers
* Pharmacokinetic data

Eligibility Criteria:
Inclusion Criteria: Patient with Alzheimer's Disease who continued to decline neurologically and had no other treatment options with intent to halt progression available. All other medical conditions stable \& well-managed.

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Exclusion Criteria:

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Effect of Extraneal (Icodextrin) on Triglyceride Levels in PD Patients

Patients with chronic kidney disease (CKD) have a markedly higher prevalence of cardiovascular disease (CVD) than the general population. Dyslipidemia is considered a major cause of CVD in patients with CKD. Especially for peritoneal dialysis (PD) patients, the use of glucose as the osmotic agent in PD solutions has been associated with a variety of metabolic consequences ranging from acute hyperglycemia and hyperinsulinemia to dyslipidemia and weight gain. Among lipid abnormalities, hypertriglyceridemia is the most common in PD patients. A study showed that patients with high triglyceride levels were more insulin-resistant than those with normal triglyceride levels.

Insulin resistant is associated with atherogenic response represented high plasma levels of monocyte chemotactic protein-1 in a large cohort of dialysis patients. Therefore, high triglyceride level may play an important role to CV outcome of PD patients. PD solution decreasing triglyceride levels is essential in PD patients.

Icodextrin, a starch-derived high molecular weight glucose polymer was found to increase ultrafiltration compared to glucose solutions. Furthermore, a low peritoneal absorption of icodextrin, which is catabolized into maltose, considerably reduces caloric uptake. Therefore, icodextrin may have an additional favorable effect on triglyceride level.

There are several studies regarding the effect of icodextrin on triglyceride level in PD patients. However, the outcomes are controversial, some studies showed no association between icodextrin and triglyceride change, even the others showed positive results but these also have study design limitations such as non-randomized study or secondary primary outcome. It is not clear about the effect of icodextrin on triglyceride especially in PD patients without diabetes.

The investigators therefore want to conduct a randomized, cross-over, controlled multicenter trial comparing icodextrin solution and glucose solution in PD patients with and without diabetes, focusing on triglyceride change.


Eligibility Criteria:
Inclusion Criteria:

* PD patients agree with written informed consent
* Incident and prevalent PD patients on dialysis for at least 3month
* PD patients treated with two glucose solutions including 2.5% or 4.25% dextrose solution at least 4hour

Exclusion Criteria:

* PD patients with allergy to starch-based polymers
* PD patients with glycogen storage disease
* PD patients with maltose or isomaltose intolerance
* PD patients with active alcohol/substance abuse
* Pregnant or nursing PD patients
* PD patients with an episode of peritonitis and active systemic infection within 4weeks before study initiation
* PD patients newly prescribed with lipid-lowering medications, including statins, omega-3 fatty acids or sevelamer hydrochloride within 3 months before randomization
* PD patients with triglyceride level\> 500 mg/dL/L or \<100 mg/dL
* PD patients with albumin level \< 3.0 gram/dL
* PD patients treated with automated PD
* PD patients had been treated or are treating with icodextrin PD solutions
Use of Decision Aids in Clinical Encounters

The active strategy for dissemination and implementation of Share Evidence Based Medicine (EBM) will yield greater reach of clinicians, be adopted by the practices more readily, and a greater uptake of use amongst encounters will be seen.

The Institute for Clinical Systems Improvement (ICSI) is a nonprofit organization with expertise in large-scale practice improvement at the state and national level. Largely funded by health organizations in Minnesota, ICSI has a sustainable model to translate evidence into practice, through clinical practice guidelines, shared decision making, and practice redesign. A partnership between these two organizations (ICSI and Mayo Clinic) may lead to a sustainable and innovative approach to the dissemination of evidence-based health information at the point of care.

The objective of the current study is therefore to leverage the expertise of these two organizations to compare the impact of an active to a passive dissemination and implementation strategy of the ShareEBM toolkit. The aim of the study is to disseminate evidence-based information through the use of decision aids during encounters. The overall purpose of the qualitative evaluation is to understand why decision aids were used more or less in certain practices and what factors contributed to or hindered this uptake.


Eligibility Criteria:
Inclusion Criteria:

* Practices meeting the following criteria will be deemed eligible for the study if they have:

  1. At least 2 primary care clinicians committed to participate in the study. Clinicians are defined as any healthcare professional providing patient care (i.e., physicians, nurse practitioners, physician assistants, diabetes educators)
  2. A designated site champion and support staff that can provide the support needed to conduct the study
  3. An IRB approval from their institution or are covered under Mayo Clinic IRB
  4. Leadership is committed to this research and has endorsed the study
* Any clinician caring for patients with a chronic condition and who has opportunities to discuss medication management with their patients will be deemed eligible

Exclusion Criteria:

* Major barriers to participating or to providing informed consent
Preventive Health Behavior in Women

The overall goal of the proposed research is to explore behavioral correlations between colorectal cancer screening and screening mammography.

The overall goal of the proposed research is to explore behavioral correlations between colorectal cancer screening and screening mammography and to develop an innovative approach for reducing barriers colorectal cancer screening in women, using screening mammography, an existing non-colon cancer related screening test that has widespread public acceptance, as a "teachable moment." Although screening for colorectal cancer (CRC) has been shown to decrease the incidence of CRC and CRC associated mortality, adherence to screening guidelines from the American Cancer Society and the American Gastroenterological Association remains poor.1-5 Barriers to adherence are not fully defined, but may include poor understanding of the relative benefits and risks of CRC screening, absence of physician recommendation, lack of insurance coverage for screening procedures, and poor patient acceptance of screening procedures. A potential challenge in increasing patient knowledge may be the milieu in which the educational intervention is administered. This study will be the first prospective study to evaluate the effectiveness of an educational intervention designed to increase CRC screening administered at a cancer screening visit unrelated to CRC.

Eligibility Criteria:
Inclusion Criteria:

1. Women between the ages of 50 and 75 years old.
2. Scheduled for a screening mammogram.

Exclusion Criteria:

1. CRC screening current (FOBT within preceding 12 months, FS within 5 years, or colonoscopy within 10 years).
2. Family history of CRC in a first-degree relative.
3. Personal history of colonic adenomatous polyps, CRC or inflammatory bowel disease
Impact of Melatonin on IVF/ICSI Outcomes in Prospective Poor Responders

The purpose of this study is to investigate the impact of melatonin administration on in vitro fertilization (IVF/ICSI) outcomes namely the total number and quality of the oocytes and embryos in the prospective poor responders.

The prospective poor responders have been associated with lower number and poorer oocyte quality. Melatonin is suggested to have antioxidative effects which may contribute to improving the IVF/ICSI outcomes in this group of patients who expected to have poor outcomes. However, the expected beneficial effects of melatonin have not yet been investigated. The purpose of this study is to investigate the impact of melatonin administration on IVF/ICSI outcomes namely the total number and quality of the oocytes and embryos in the prospective poor responders. A randomized, double-blinded, placebo-controlled study is used to investigate the impact of melatonin on the IVF/ICSI outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Prospective poor responder with AMH \< 1 ng/ml and AFC \< 8 (in both ovaries).

Exclusion Criteria:

* Severe male factor infertility.
Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Treprostinil subcutaneous (under the skin) infusion is a very good medication for treating pulmonary arterial hypertension but infusion site pain may be very severe in some patients. The investigators plan to treat patients receiving treprostinil with a subcutaneous infusion of lidocaine (a local anesthestic) to treat the pain.


Eligibility Criteria:
Inclusion Criteria:

* PAH
* Treprostinil treatment for at least 3 months
* Severe infusion site pain

Exclusion Criteria:

* Pregnancy/breastfeeding
* Decompensated heart failure
* Chronic liver disease
* Abnormal electrolytes
* Heart block (2/3 degree), sino-atrial block, idioventricular rhythm
* Systolic systemic BP \<90mmHg
* Bradycardia HR \<55
* Adverse reaction to lidocaine or other amide local anesthestic
* Interacting medications (anti-arrhythmics, CYP1A2 inhibitors)
Tracking Mood: The Effects of Daily Mood Tracking VAS on Alcohol Consumption in Adult Heavy Drinkers

The study aims to investigate the effects that mood tracking may have on the alcohol consumption of adults who consume more than 20 UK units of alcohol per week, classifying as high-risk drinkers. The intervention group will track their mood on a daily basis with a visual analogue scale, while the control group will report their daily time spent online. The hypothesis, based on a series of prior pilot studies on alcohol tracking methods, is that mood tracking can reduce alcohol consumption in high-risk drinkers and therefore be a suitable addition to interventions related to decreasing alcohol consumption in heavy drinkers. The study will be conducted online through the Prolific platform.

Participants will be recruited through Prolific. All participants will complete a series of demographic and psychometric questionnaires before beginning the study. Participants will also complete some of the psychometric questionnaires (RCQ, GAD-7, PHQ-9) at the end of the study to track any potential changes. Participants will be pre-screened for their motivation using a modified MTSS (Motivation to Stop Smoking) scale. Participants will also be asked to report their primary source of motivation regarding wanting to quit or reduce drinking, in addition to reporting their main goal regarding alcohol, where the options will be wanting to quit, wanting to reduce drinking, wanting to be more in control of their drinking, and not wanting to quit, reduce, or be more in control of drinking. All participants will also report their alcohol consumption using a timeline followback task with the ability to view both a calendar and a reference image of UK alcohol units. They'll report their alcohol consumption from the week before the study and complete two TLFBs during the study.

Intervention group participants complete daily visual analogue scales of their mood. Control group participants complete daily reports of how many hours they spent online the previous day.

Eligibility Criteria:
Inclusion Criteria:

* Speaking fluent English
* being over 18 years of age
* High completion rates of previous studies on the Prolific platform
* Being located in the United Kingdom
* Consuming over 20 UK units of alcohol per week

Exclusion Criteria:

* Having an ongoing mental health condition