cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Prevalence of anomalIes of Glucose Metabolism in Patients Undergoing a Coronary Artery Bypass Graft (CABG)

The aim of this study is to determine the prevalence of diabetes and non-diabetic glucose metabolism anomalies (glucose intolerance, non-diabetic fasting hyperglycaemia in patients about to undergo coronary artery bypass grafting (CABG).

In addition, the effect of these anomalies on post CABG morbi/mortality in the short term will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* persons who have provided oral consent
* patients about to undergo coronary artery bypass grafting
* age \>18 years

Exclusion Criteria:

* persons without national health insurance cover
* Adults under guardianship
* Pregnant or breast-feeding women
Impact of a Front-of-pack Nutrition Label on the Nutritional Quality of Purchases in Campus Cafeterias

This study evaluates the impact of the introduction of a front-of-pack nutrition label on fods and beverages sold in a campus cafeteria in France on the nutritional quality of purchases. The design involves one site with the intervention and one control site with the same consumer and product characteristics.

The introduction of front-of-pack nutrition labelling is thought to help consumers making healthier choices at the point of purchase.

Recently, the French government is considering the introduction of the 5-Colour Nutrition Label as a front-of-pack nutrition label.

Evaluations of the 5-CNL suggest it is efficient in helping consumers making healthier choices. However, its impact in vulnerable populations has not yet been tested.

Students are thought to be a vulnerable population due to their limited resources and to their unhealthy food choices.

The objective of the present study is to investigate the impact of the introduction of the 5-CNL in campus cafeterias on the nutritional quality of food purchases.

The intervention is conducted during several months, with another similar cafeteria serving as control for the intervention.

Data on purchases is collected regularly, and the nutritional quality of purchases is evaluated over time between the intervention situation and the control situation

Eligibility Criteria:
Inclusion Criteria:

* All subjects purchasing foods or beverages in the selected campus cafeterias

Exclusion Criteria:

* None

No individual data is collected. Only purchases data is collected (cash register sales data)
A Study of YM178 in Patients With Symptomatic Overactive Bladder

Examine which dose of YM178 is the best in terms of efficacy, safety and tolerability compared to placebo

To investigate the dose-response relationship of YM178 in terms of efficacy, safety and tolerability, and also the superiority of YM178 over placebo.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 20 years suffering from overactive bladder

Exclusion Criteria:

* Pregnant and breastfeeding women
* Any clinically significant abnormal conditions which in the opinion of the investigator makes the patient unsuitable for the study
A Follow-up Evaluation Study of PRI-724-1101

The purpose of this study To evaluate the safety and efficacy of PRI-724 administration in patients with cirrhosis due to hepatitis C by 12-month follow-up.

This is a single-center, nonintervention, open-label, observational study in subjects who received the study drug (identification code: PRI-724) in Study 1101 to follow up the safety and disease condition of cirrhosis after administration for 12 months.

In Study 1101, one cycle consisted of 2 weeks with one-week continuous i.v. administration of PRI-724 followed by a one-week observation period. Treatment with a total of six cycles (duration of treatment, 12 weeks) was performed.

In this study, the subjects in each cohort in Study 1101 (PRI-724 dose: Cohort 1, 10 mg/m2/day; Cohort 2, 40 mg/m2/day; Cohort 3, 160 mg/m2/day) were followed up and observed for 12 months after administration.

In Study 1101, target number of subjects was 6 subjects in each cohort, a total of 18 subjects. However, the number of registered subjects was 7 subjects in Cohort 1, 7 subjects in Cohort 2, and 2 subjects in Cohort 3, a total of 16 subjects. Safety analysis set was 6 subjects, 6 subjects, and 2 subjects, respectively, a total of 14 subjects. Target number of the subjects in this study was the same as that in Study 1101; however, of the subjects in Study 1101, 5 subjects in Cohort 1 and 3 subjects in Cohort 2 consented to participate in this study (Study 1102).

Eligibility Criteria:
Inclusion Criteria:

1. Having been administered PRI-724 in Study 1101 after being confirmed to meet the inclusion criteria and not to meet the exclusion criteria and consenting to participate in the study.
2. Having provided voluntary written consent for participation in this study.

Exclusion Criteria:

1. Patients who are pregnant or may be pregnant, or who desire to become pregnant or may be pregnant during the clinical study \[excluding patients who have undergone a sterilization procedure or postmenopausal patients (if amenorrhea without medical reasons continues more than 12 months), patients who are nursing.
2. Patients who do not consent to practice birth control during the clinical study (including male patients).
3. Patients with serious allergy to contrast media or a history thereof.
4. Patients with a history of drug or alcohol addiction within five years at the time of providing written consent or a history of drug or alcohol abuse within the past one year.
5. Patients contraindicated for liver biopsy. However, this criterion will not apply to a patient who has turned out to be contraindicated for liver biopsy after having been administered PRI-724 in Study 1101.
6. Patients who participated in another clinical trial, except PRI-724-1101 trial, within 30 days at the time of providing written consent.
7. Patients who have discontinued administration of PRI-724 in Study 1101 due to death or other reasons and become lost for follow-up.
8. Other, at the point when Study 1101 has been completed (or discontinued), patients who are judged inappropriate for inclusion in the study by the investigator for such reasons as the presence of serious pathological condition.
Sweet Consumption and Subsequent Sweet Food Preferences and Intakes

This study will assess the effects of repeated sweet versus non-sweet food consumption on subsequent sweet and non-sweet food preferences and intakes.

Participants will be randomized to receive instructions to either increase, decrease or make no change to sweet food consumption for 6 days, and impacts on food preferences and intakes will be assessed at baseline and after 1 week. Preferences for sweet and non-sweet foods will be assessed during a taste test at each assessment time, where six different foods will be rated. Sweet and non-sweet food consumption will also be measured at a subsequent breakfast at the assessment time. Buffet meals composed of sweet and non-sweet foods suitable for consumption at breakfast will be provided ad-libitum.

A subset of participants (selected at random) (10 participants randomized to increase sweet food consumption and 10 participants randomized to decrease sweet food consumption) will also be assessed via MRI and fMRI scanning to investigate brain structure and functional connectivity.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18-65 years;
2. habitually consume breakfast;
3. able to provide consent and complete all study materials;
4. able to attend Bournemouth University for testing.

Exclusion criteria:

1. individuals who are pregnant or breastfeeding;
2. underweight (BMI \<18.5);
3. have pre-existing clinical conditions such as diabetes mellitus, eating disorders, Crohn's disease and other illness's leading to participants receiving external nutritional advice and dietary restrictions;
4. have pre-existing medical conditions affecting swallow ability, taste and smell perception;
5. currently or within 3 months of starting the study are following a specific dietary programme (e.g.: Slimming World);
6. current smokers or have smoked within 3 months of the study start date.
A Prospective Natural History and Outcome Measure Discovery Study of Charcot-Marie-Tooth Disease, Type 4J

This is a multicenter, longitudinal, prospective observational natural history study of subjects with a molecularly confirmed diagnosis of CMT4J. The study will enroll 20 subjects of any age into a uniform protocol for follow-up and evaluations. Subject visits will occur every 12 months + 4 weeks for up to 2 years.

This is a multicenter, longitudinal, prospective observational natural history study of subjects with a molecularly confirmed diagnosis of CMT4J. The study will enroll 20 subjects of any age into a uniform protocol for follow-up and evaluations. The study will obtain demographic and medical history information. Natural history data will be collected prospectively on an annual basis and may include physical/neurological exams, standard laboratory tests, CMT outcome and disability measures, neuropsychological tests, nerve conduction studies (NCS), and imaging studies (muscle MRI). Pulmonary function test (PFT) and scoliosis series x-ray Subject visits will occur every 12 months + 4 weeks for up to 2 years. Subjects who terminate from the study prior to Visit 3 will undergo an early termination/end of study visit (EOS) if possible. The early termination/end of study visit is comprised of the Visit 3 assessments. If needed, the Investigator may conduct unscheduled visits with Sponsor's approval. No investigational product will be used during the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, all ages
2. A molecularly-confirmed diagnosis of CMT4J (confirmed by a CLIA certified, CE-marked, or equivalent lab): Genomic DNA mutation analysis demonstrating 1) bi-allelic pathogenic and/or likely pathogenic variants (by ACMG criteria) in the FIG4 gene, or 2) bi-allelic variants with one pathogenic and/or likely pathogenic variant in trans with a variant of uncertain significance if laboratory evidence and expert consensus exits in support of loss of FIG4 function exists.
3. Informed consent from patients 18 years or older who are able to provide consent and from caregivers; parent(s)/guardian(s) providing consent for subjects younger than 18 years at Screening and patients older than 18 years unable to provide informed consent
4. Informed assent of patients younger than 18 years at Screening who are able to provide assent
5. Able and willing to comply with the study protocol, including travel to Study Center, procedures, measurements and visits

Exclusion Criteria:

1. Any known genetic abnormality, including chromosomal aberrations that confound the clinical phenotype
2. Current participation in an interventional or therapeutic study
3. Receiving an investigational drug within 90 days of the Baseline Visit
4. Prior or current treatment with gene or stem cell therapy
5. Any other diseases which may significantly interfere with the assessment of CMT4J
6. Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion or could interfere with the subject participating in or completing the study
Predictors and Outcomes of In-hospital HFpEF in AMI Patients

This retrospective observation is to investigate the incidence,clinical outcomes and prognosis of hospitalized heart failure with preserved ejection fraction (HFpEF) in patients with acute myocardial infarction(AMI).

1. Patients with first AMI undergoing primary percutaneous coronary intervention (PCI) in our hospital since January 2013 were retrospectively evaluated. The enrolled subjects were divided into two groups (AMI patients with HFpEF and AMI patients without HF).
2. The investigator collected the clinical data of participants' demographics (age, sex), previous history,risk factors for AMI (hypertension, hyperlipidemia, diabetes mellitus, smoking and stroke), laboratory biomarkers, echocardiographic measurements, clinical characteristics,medical procedures and treatments, as well as in-hospital complications.
3. Two sub-investigators independently analyzed these data by using SPSS software.

Eligibility Criteria:
Inclusion Criteria:

* First AMI patients undergoing PCI with HFpEF or without HF.

Exclusion Criteria:

* First AMI patients with heart failure with reduced ejection fraction.
* First AMI patients with severe inflammatory diseases, valvular heart disease, non-cardiac caused symptoms, serious hepatic and renal failure, congenital cardiomyopathy,or pericardial diseases.
Efficacy Study of Dextromethorphan to Treat Rheumatoid Arthritis

Rheumatoid arthritis were randomized to a 6-month treatment of oral dextromethorphan hydrobromide or placebo as an add-on therapy to traditional disease-modifying anti-rheumatic drugs (DMARDs). Disease activity were assessed.

Biologic-naïve rheumatoid arthritis (RA) patients who fulfilled the 2010 criteria of the American College of Rheumatology (ACR) for RA were enrolled. All patient were randomized to a 6-month treatment with either oral DXM \[dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan) with T1/2 = 7.75h, Tmax = 4.83h, Cmax = 14.6 ng mL-1 and mean residual time = 5.86 h, 120mg per day with once daily dose taken after breakfast\] or placebo pills with the same appearance as DXM tablets. The randomization was performed by the pharmacy of the Taichung Veterans General Hospital. Non-study medications were not changed during the course of study.

Twenty-four patients received add-one DXM therapy and the other 24 patients received traditional DMARDs alone in stable dose. Disease activity was assessed by the 28-joint disease activity score (DAS28) before starting add-on DXM therapy (as a baseline) and at the end of 6 months of therapy with or without add-on DXM. Patients were categorized as good, moderate or poor responders based on the amount of change in the DAS28 and the level of DAS28 reached. Good responders were defined as patients who had a decrease in DAS28 from baseline (∆DAS28)\>1.2 and a DAS28≦3.2 at evaluation time; moderate responders had either ∆DAS28\>1.2 and a DAS28\>3.2 or ∆DAS28 of 0.6-1.2 and a DAS28≦5.1 at evaluation time; and poor responders were those who had either ∆DAS28\<0.6 or a DAS28\>5.1 at evaluation time.

Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling the 2010 criteria of the American College of Rheumatology (ACR) for RA

Exclusion Criteria:

* Receive biological therapy for RA, including Etanercept, Adalimumab, Golimumab, Tocilizumab, Rituximab, Abatacept.
Evaluation of Novel Risk Factors and Clinical Outcomes of Acute Myocardial Infarction

The aim of this study is to investigate the potential novel risk factors for acute myocardial infarction. Predictors of poor outcomes will be also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Less than 12 hours after the onset of myocardial infarction symptoms
* Myocardial necrosis, as evidenced by increased Creatine Kinase Isoenzyme (CK-MB) or troponin levels

Exclusion Criteria:

* Age under 18 years-old
Shear-wave Elastography of Hip Stabilizers in Healthy Individuals

The aim of this study is to provide a scientific basis for Shear-wave elastography measurements of hip stabilizing muscles on healthy individuals. To assess the inter- and intra-user validity, 12 healthy volunteers were recruited for ultrasonographic assessment by two experienced physiatrists.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Individuals
* Age 18-30 years
* Volunteering for the study
* Absence of musculoskeletal pathologies involving pelvic, hip, and/or knee joints.

Exclusion Criteria:

* Recent complaints of pelvic, hip, and/or knee pain.
* Previous history of trauma or surgery, including the lumbar, pelvic, hip, or knee region.
* Congenital or acquired pathologies of pelvis or lower extremity.
Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia

Micafungin (a new class of antifungal drugs) is compared to fluconazole (current standard treatment) in the treatment of patients with serious fungal infections (invasive candidiasis and candidemia) to determine its efficacy and safety. Patients, both male and female, aged over 16 and with confirmed disease by the doctor could be recruited and evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of candidemia and invasive candidiasis
* Patients could be newly diagnosed with candidiasis who received no more than 48 hours of prior systemic antifungal therapy
* Inpatients aged 16 and above

Exclusion Criteria:

* Patients with serious invasive candidiasis whose prognoses are considered to be poor (life expectancy judged to be less than 5 days).
* Patients with severe complications in the liver
* Pregnant or lactating women
* Patients who have received at least 5 days of prior systemic treatment of fluconazole or echinocandin with no response.
* Patients who have prior antifungal infection requiring treatment with systemic antifungal agents for conditions other than candidemia and invasive candidiasis.
Feasibility of the Adapted H-GRASP Feedback Program in the Chronic Phase Post Stroke.

In a recent cross-sectional study, it was shown that people with a good observed upper limb (UL) motor function but low perceived UL activity show a reduced daily-life UL activity. The investigators will now investigate the feasibility of a phone-monitored home exercise and feedback program for the UL following stroke and the preliminary effects on the perceived UL activity and actual daily-life UL activity for participants with good observed UL motor function but low perceived UL activity in the chronic phase post-stroke.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures
2. First-ever unilateral, supratentorial stroke, as defined by the American Heart Association/American Stroke Association
3. Minimum six months after stroke
4. Living in the community
5. ≥18 years old
6. Good observed UL motor function but low perceived UL activity. Good observed UL motor function is defined as a score \>50/66 on the Fugl-Meyer Assessment-Upper Extremity (FMA-UE). Low perceived UL activity is defined as a score ≤75/100 on the hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand).

Exclusion Criteria:

1. Other neurological condition than stroke
2. Musculoskeletal disorder that affects UL use
3. No informed consent
4. Participation in an interventional Study with an investigational medicinal product (IMP) or device
Cross-Sectional Iloperidone IVGTT

This study aims to utilize state of the art procedures such as the frequently sampled intravenous glucose tolerance test (FSIVGTT), Bergman's Minimal Model Analysis, lipoprotein analysis, and DEXA scans to demonstrate that a newer agent, iloperidone, is devoid of the metabolic abnormalities associated with other atypical antipsychotic treatments, namely olanzapine and risperidone, and offers an advantage over these other agents.

This one-month research study examines how Fanapt® (iloperidone), Zyprexa® (olanzapine), or Risperdal® (risperidone) affect glucose metabolism in patients with schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder. This study requires 3 research visits and includes a physical exam, medical history, vitals, an EKG, cognitive testing, psychological rating scales, a DEXA scan, a nutritional assessment, a 3-hour intravenous glucose tolerance test (IVGTT) and a fasting blood draw.

Eligibility Criteria:
Inclusion Criteria:

1. Male/Female ages 18-65 years
2. Capacity to provide informed consent
3. BMI between 20 and 30 kg/m²
4. Diagnosis of a serious mental illness, including schizophrenia, any subtype; schizoaffective disorder, any subtype; major depressive disorder, bipolar disorder, psychosis NOS, delusional disorder and paranoid disorder
5. Treatment with iloperidone, risperidone, or olanzapine for at least 6 months
6. Stable dose of antipsychotic agent for at least one month
7. Well established compliance with out-patient medications and clinically stable
8. Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study.

Exclusion Criteria:

1. Inability to provide informed consent
2. Current substance abuse
3. Psychiatrically unstable and/or hospitalized in the past month
4. History of significant and untreated medical illness including severe cardiovascular, hepatic, renal, or untreated thyroid disease; hepatitis; or HIV
5. Current insulin treatment for diabetes
6. Currently taking the following medications: birth control pills containing norgestrol, steroids, thiazide diuretics, or treatment with agents that induce weight loss
7. Intentions of donating blood during or within 30 days of completion of the study.
8. Use of valproate or carbamazepine within four weeks of the study
9. History of immunosuppression
10. Current or recent radiation or chemotherapy treatment for cancer
11. Pregnancy or breastfeeding
Virtual Physical Activity for Type 1 Diabetes

A virtual group of teens with type 1 diabetes, led by young adults with type 1 diabetes, will play active videogames and discuss activity and health. This study will evaluate the program for feasibility and user satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Age of 14-19 years
* Diagnosis of type 1 diabetes or other absolute insulin deficiency diabetes for ≥6 months
* Inadequate moderate-to-vigorous physical activity levels (defined as ≤3 days per week achieving ≥60min daily, which is ≤50% of the recommended 7 days per week)
* English literacy
* Own a continuous glucose monitor (Dexcom G4, G5, G6 \[San Diego, CA\], Abbott Freestyle Libre 2, 14-day \[Chicago, IL\], Medtronic Guardian 3, Enlite \[Dublin, Ireland\]) with enough supplies for 6 weeks (when available, we will provide these to those who do not own them, in which case they will be considered to meet this criteria).
* Access to television or computer with HDMI or USB port.
* Under regular care by a healthcare provider (defined as attending at least one appointment in the past year, plus access to verified 24hr phone number to reach the provider's team for insulin dose adjustments if assistance is needed)

Exclusion Criteria:

• A condition or disability besides type 1 diabetes that would preclude participation in group moderate-to-vigorous physical activity (e.g., cerebral palsy, current pregnancy)