cyrilzakka/clinical-trials huggingface dataset:
Agility Training on Executive Function, Dual Task Performance and Brain Activation in Healthy Adults

This study will investigate the effect of agility training on executive function, dual task walking and brain activation in healthy adults. Participants (N=70) will be randomly assigned to resistance+aerobic training group (RAeT) or agility training group (AT). Participants in RAeT (n=35) will receive 15-minute lower extremity workout first and then 25-minute moderate intensity (60-75% predicted maximal heart rate) aerobic training. Participants in AT (n=35) will do the agility exercise program consisting of technical drills, pattern running and reactive agility training. The intervention will be twelve-time group intervention (3-5persons) in four weeks, 50 minutes per session (5-minute warmup, 40- minute main training, 5-minute cool-down). Participants will undergo three measurement time points (pre-, post-intervention and one month follow-up). Outcome measures will include executive function (N-back test, stroop test and Wisconsin card sort test), single and dual task walking performance and brain activity (fNIRS on prefrontal cortex, supplementary motor area and premotor cortex). Two-way analysis of variance (ANOVA) with Tukey post-hoc test will be used to examine the group x time interaction on three outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* (1) age between 20 to 30 years, and (2) ability to walk 20 meters independently without an assistive device.

Exclusion Criteria:

* (1) overweight (BMI\>24), (2) any smoker or alcohol abusers, (3) suffering from chronic diseases that loss of control, (4) Unstable physiological conditions, such as abnormal signs like high blood pressure, headache, dyspnea, fever, etc., (5) any neuromuscular or cardiopulmonary diseases that would influent the exercise performance, and (6) suffering from diseases which exercises are their contraindications
Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen

The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in a home-use setting using either an automated mini-doser (AMD) or autoinjector/pen (AI/pen).


Eligibility Criteria:
Inclusion Criteria:

* Fasting LDL-C at screening \> 85 mg/dL
* Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L)

Exclusion Criteria:

* New York Heart Association (NYHA) III or IV heart failure
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Type 1 diabetes or poorly controlled type 2 diabetes
* Uncontrolled hypothyroidism or hyperthyroidism
Effects of Intranasal Oxytocin on Fear Processing in Naturalistic Contexts

The main aim of the study is to investigate the modulatory effects of intranasal oxytocin (24IU) on fear in naturalistic social and non-social contexts and the underlying neural mechanisms.

In a double-blind placebo-controlled between-subject experimental design, 60 adult male subjects will be randomly allocated to receive either intranasal oxytocin (24IU, n= 30) or placebo (n = 30) nasal spray. 45 minutes after treatment the participants will undergo a naturalistic fear induction paradigm during fMRI. During the paradigm video clips of 25s lengths will be presented showing fear-inducing situations in social and non-social contexts as well as corresponding control video clips. Following each clip subjects are required to rate their level of subjective fear on a rating scale ranging from 1 (no fear) to 9 (highest fear). Participants will undergo screening for psychopathological and emotional states before treatment. Together with a randomized assignment to the treatment groups, this will allow controlling for confounding between-group differences.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders
* Right-handedness
* Normal or corrected-normal version

Exclusion Criteria:

* History of head injury
* Medical or psychiatric illness
* Hypertension
* General cardio-vascular alteration or diseases
* Allergy against medications
* Visual or motor impairments
* Claustrophobia
* Drug addiction
* Nicotine dependence
* FMRI contradictions
The Clinical Evaluation of Two Daily Disposable Contact Lenses

The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* They are of legal age (18 years) and capacity to volunteer.
* They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They would be expected to attain at least 6.9 (20/30) in each eye with the study lenses.
* They are able to wear contact lenses which have a back vertex power of -1.00 to -6.00DS.
* They have a maximum of 1.00D of refractive astigmatism (i.e. \< 1.00 DC).
* They have worn soft contact lenses within six months of starting the study.

Exclusion Criteria:

* They have an ocular disorder which would normally contra-indicate contact lens wear.
* They have a systemic disorder which would normally contra-indicate contact lens wear.
* They are using any topical medication such as eye drops or ointment.
* They are aphakic.
* They have had corneal refractive surgery.
* They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
* They are pregnant or lactating.
* They have grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
* They have any infectious disease (e.g., hepatitis) or any immunosuppressive disease (e.g., HIV).
* They have diabetes.
* They are currently taking part in any other clinical study or research.
Microbiota Awareness and Nutrition Education Given to Mothers With Motivational Interview

Complementary nutrition is considered a critical step not only for changes in nutritional requirements but also for the formation of life-long taste preferences, nutrition and eating habits that may affect health in the long run. While the microbiota is developing, in the early stages of life, the wrong food choice negatively affects the microbiota development and causes malnutrition. In this study, the effect of motivational interviews prepared according to the Health Behavior Interaction Model on microbiota awareness and infant feeding attitude will be investigated in primiparous mothers who will start complementary feeding.


Eligibility Criteria:
Inclusion Criteria:

* Mothers over the age of 18,
* Ability to read and write Turkish,
* Absence of any disease in the mother and child,
* The mother's willingness to participate in the research,
* Having a healthy, vaginal and mature delivery,
* Being a primiparous mother
* Feeding only with breast milk,

Exclusion Criteria:

Mothers not participating in at least one training,

* Mothers not participating in the motivational interview,
* Desire to leave the research
* Absence of ambivalent feelings
* Inability to create a food consumption frequency scheme
Pupillometric Evaluation in Patients Declared Brain Dead - a Prospective Quality Control Study

The aim of the study is to verify the reliability of the current purely clinical examination of the pupils (without the support of a pupillometer) in the context of clinically suspected brain death, compared to the results of a non-invasive, automated, and highly precise monocular pupillometric examination.

This prospective quality control study will evaluate the reliability of the clinical exam regarding pupils' reaction to light (as performed by two board certified physicians in Neurology and/or Intensive Care Medicine) as recommended by the SAMW guidelines for brain death diagnosis (SAMW-guidelines) when compared to the results of a noninvasive automated and highly-precise pupillometry in adult patients with clinically suspected brain death. Automated pupillometric measurements will be performed by the PI (RS), or the co-investigator (Dr. Pascale Grzonka) using the NeurOptics® NPi®-200 pupillometer system immediately before and after the standardized diagnostic workup for suspected brain death. In addition, demographics, clinical characteristics , treatment and laboratory data from the patients examined will be anonymously collected.

Eligibility Criteria:
Inclusion Criteria:

* Suspected diagnosis of brain death
* Brain death diagnostic procedures planned
* Treated at the intensive care unit at the University Hospital Basel (USB)
Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea in Participants With Type 2 Diabetes in Japan

The purpose of this study was evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an Sulfonylurea taken QD or twice daily (BID) in type 2 diabetic patients with uncontrolled blood glucose.

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to sulfonylurea in type 2 diabetic patients who had uncontrolled blood glucose despite treatment with an sulfonylurea as well as diet and exercise therapies.

Eligibility Criteria:
Inclusion Criteria:

1. Had been taking a sulfonylurea for at least 4 weeks prior to the initiation of the observation period (Week -12).
2. Had been taking glimepiride at a stable dose regimen (1, 2, 3 or 4 mg/day, once or twice daily in the morning or in the morning and evening, before or after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
3. Had glycosylated hemoglobin (HbA1c) of 7.0% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
4. Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%\* of the value at 4 weeks after the initiation of the observation period (Week -8) (\*rounded off to the first decimal place).
5. Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion Criteria:

1. Had taken other diabetic medications than glimepiride within 12 weeks before the initiation of the treatment period (Week 0).
Effects of Ketone Monoesters on Brain Function

Disturbances in brain insulin-sensitivity are not only observed in obesity and type 2 diabetes (T2D), but also during brain aging and in dementia. Ketone monoester supplements may improve brain insulin-sensitivity, which can be quantified by measuring the gray-matter cerebral blood flow (CBF) response to intranasally administered insulin. We hypothesize that acute ketone monoester supplementation increases (regional) brain vascular function and insulin-sensitivity thereby improving cognitive performance and appetite control. The primary objective is to evaluate in older men the acute effect of ketone monoester supplementation on (regional) brain vascular function and insulin-sensitivity, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labelling (ASL). The CBF response to intranasal insulin is a robust and sensitive physiological marker of brain insulin-sensitivity. Secondary objectives are to investigate effects on cognitive performance as assessed with a neuropsychological test battery, and appetite control as quantified by functional MRI (fMRI) with visual food cues.


Eligibility Criteria:
Inclusion Criteria:

* Men, aged between 60-75 years
* BMI between 25-30 kg/m2
* Fasting plasma glucose \< 7.0 mmol/L
* Fasting serum TC \< 8.0 mmol/L
* Fasting serum TAG \< 4.5 mmol/L
* Systolic blood pressure \< 160 mmHg and diastolic blood pressure \< 100 mmHg
* Stable body weight (weight gain or loss \< 3 kg in the past three months)
* Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
* No difficult venipuncture as evidenced during the screening visit

Exclusion Criteria:

* Women
* Left-handedness
* Following a low-carbohydrate diet or consuming nutritional ketone supplements
* Current smoker, or smoking cessation \< 12 months
* Diabetic patients
* Familial hypercholesterolemia
* Abuse of drugs
* More than 3 alcoholic consumptions per day
* Use of products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators
* Use medication to treat blood pressure, lipid or glucose metabolism, or neurological or mental disorders.
* Use of an investigational product within another biomedical intervention trial within the previous 1-month
* Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
* Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
* Contra-indications for MRI imaging (e.g. pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia).
Simvastatin and Diastolic Dysfunction

Diastolic dysfunction (DD) is an increasingly frequent condition in hypertensive individuals whose treatment remains unclear. Its presence is related to higher morbidity and mortality independent of blood pressure levels. The aim of this study is to investigate the additive effect of simvastatin on enalapril on DD in hypertensive patients with average cholesterol levels.

For this aim, hypertensive patients with DD and LDL-cholesterol \<160 mg/dL will undergo a run-in phase to achieve a systolic blood pressure (SBP) \<135 mmHg and diastolic blood pressure (DBP) \<85 mmHg with enalapril. Hydrochlorothiazide could be added when need to achieve SBP or DBP control. Four weeks after reaching the optimum anti-hypertensive regimen patients will be randomized to receive 80 mg simvastatin or placebo for a period of 20 weeks. Echocardiograms will be performed before and after treatment with measurement of left atrial volume, conventional and tissue Doppler velocities in early diastole and late diastole. The evaluation of these will allow to identify changes of DD severity after treatment.


Eligibility Criteria:
Inclusion Criteria:

* men or postmenopausal women aged between 40 and 65 years old
* normal fasting blood glucose (\<100 mg/dL) and glucose tolerance test (\<140 mg/dL)
* waist circumference \< 102 cm (men) or \< 88cm (women)
* triglycerides \<150 mg/dL, LDL cholesterol ≤ 160 mg/dl
* creatinine \<1.2 mg/dL, sinus rhythm
* the presence of grade 1 or 2 of DD with an ejection fraction of left ventricle \> 55%
* absence of myocardial ischemia during dobutamine stress echocardiography

Exclusion Criteria:

* thyroid dysfunction
* acute or chronic liver disease
* regular use of 3 or more antihypertensive drugs
* secondary hypertension
* symptoms or history of atherosclerotic disease
* valvular dysfunction
* LVH 14 and use of statins in the last 6 months
Prognostic Factors for All Types of Cancer Combined

The purpose of this study is to investigate every possible applicability of flow cytometrical analysis in the intracellular detection of tumor-related material in activated macrophages in the broadest range of cancer types.


Eligibility Criteria:
Inclusion Criteria:

* (Suspicion of) presence of cancer in the broadest sense of the word
* Must be able to understand and sign written informed consent

Exclusion Criteria:

* None
Study on Proton Radiotherapy of Thymic Malignancies

This is a multicentre non-randomized phase II study of proton beam radiotherapy in patients with thymic epithelial tumours (i.e. thymoma and thymic carcinoma) in the post-operative setting or in inoperable patients with localized disease.

Patients not willing or for any reason unsuitable to undergo proton treatment will be asked to participate in a follow-up assessment after the regular photon treatment in the same manner as the included patients.

Primary endpoints are:Toxicity (e.g. cardiac and pulmonary toxicity) and Local control at 5 year Secondary endpoints: PFS, Overall survival, Quality of life, measured by EORTC QLQ 30 + LC 13 and relapse pattern

All doses are recorded in Gy(RBE).

After having checked all eligibility criteria patients will receive:

* Patients with radical surgery and unfavourable histology (B2, B3, C) and/or Masaoka-Koga stage III, IVa: 2 Gy(RBE), once daily, five days a week to a total dose of 50 Gy(RBE).
* Patients with non-radical surgery (R1 resection) regardless of stage and histology: 2.3 Gy(RBE), once daily, 5 days a week to a total dose of 57.5 Gy(RBE)
* Inoperable patients regardless of stage and histology and patients with R2 non-radical resection: 2.5 Gy (RBE), once daily, 5 days a week to a total dose of 62.5 Gy(RBE)
* Patients not willing to participate in study will receive photon therapy according to local practice (≥45 Gy)

Induction or adjuvant chemotherapy may be used according to local practice. Concomitant chemotherapy is not allowed.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of thymoma or thymic carcinoma.
* With radical surgery: stage III and IVa and selected stage II with type B2, B3 and thymic carcinoma according to local routine. With non-radical surgery (R1 or R2) or inoperable patient/ patient refusing surgery: stage I - IVa, any histology
* PS WHO 0 - 2.
* FEV1 \> 1L or \>40 % of predicted and CO diffusion capacity \> 40% of predicted (postoperative measures)
* Age \>18 years, no upper age limit.
* Written informed consent from patients.

Exclusion Criteria:

* Masaoka-Koga stage IVb (distant metastases).
* Pregnancy.
* Serious concomitant systemic disorder incompatible with the study.
* Tumour motion \> 0.5 cm on two repeated 4DCT
Modified Intermittent Fasting in Psoriasis

The complexity of psoriasis is partially affected by dietary effects, and some diets have shown to be beneficial in psoriasis. Intermittent fasting has been shown to improve many of these disturbances, even inflammatory parameters such as TNF and CRP. Individuals with psoriasis have been reported to have impaired intestinal integrity and it has been suggested that gut health affects skin health, pointing towards a gut-skin axis. Understanding how dietary lifestyles can affect epithelial lineages such as the skin and gut, will greatly improve our understanding on the development of psoriasis. Modified intermittent fasting (MIF) of 2 non-consecutive days has shown to have positive metabolic effects, yet its effect on gut and skin remains underexplored.

To study the role of gut health, more specifically the intestinal barrier, in individuals with psoriasis and the effects of fasting on both organs in a prospective cohort cross-over study. The investigators will test whether MIF can improve (i) skin lesions (clinical and molecular level), (ii) intestinal integrity markers such as zonulin, IFABP and sCD14, and (iii) the timing of these improvements. As such, it can be determined whether fasting benefits psoriasis and gut health. MIF will consist of a limited calorie uptake of 500 kcal for 2 days a week. The remaining days of the week are as usual. Gut and skin health will be tested at the molecular level during 12 weeks with another crossover of 12 weeks (alternating between MIF and usual diet).

Eligibility Criteria:
Inclusion Criteria:

* Mild psoriasis (PASI \< 10)
* At least BMI of 20
* Stable weight for last 3 months
* Topical treatment
* Availability of smartphone and willing to install app
* Willing to attend dematology clinic at Ghent University Hospital

Exclusion Criteria:

* Underweight and/or following strict diet
* Use of anti, pre and/or probiotics (last 3 months)
* Use of immunosuppressants (last 3 months)
* Smoking
* Consumption of fish oil
* Diagnosed diabetes (type ½)
* Excessive physical activity
* Pregnancy or breastfeeding
* More than 14 alcohol units/week
* History of cardiac condition(s)
Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in Lateral Epicondylitis

No consensus has yet been built on the treatment of lateral epicondylitis (LE) due to the lack of evidence. Although conflicting results are present, radial extracorporeal shock wave therapy (rESWT) has increasingly been used in the treatment of tendinopathy

ESWT and exercise have beneficial effects on the management of tendinopathies owing to their various mechanisms that showed therapeutic efficacy. Owing to its positive outcomes, extracorporeal shock wave therapy (ESWT) has recently been used in the treatment of musculoskeletal system diseases such as plantar fasciitis, Achilles tendinopathy, calcific rotator cuff tendinopathies, and patellar tendinopathy

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of LE was made in the clinical examination, and the diagnosis was confirmed with the Southampton Diagnostic Criteria of "the presence of epicondyle pain, and epicondyle pain and tenderness on resisted extension of the wrist.
* Patients with symptoms lasting longer than 3 months
* with average pain in the previous week detected as 3 or above on a 10-cm visual analogue scale (VAS)
* who were aged over 18 years

Exclusion Criteria:

* pain in the proximal part of the affected extremity (e.g. shoulder pain, neck pain)
* abnormal neurogenic symptoms (e.g. radicular pain, numbness) on the affected extremity
* presence of posterior interosseous nerve entrapment
* congenital or acquired upper extremity deformities that might affect grip strength
* systemic musculoskeletal system or neurologic disorders
* systemic rheumatologic disease or systemic infection
* presence of malignancy, coagulation disorders, and anticoagulant use
* inserted cardiac pacemaker
* history of surgical treatment on the elbow of the affected extremity
* pregnancy.
* patients who were administered other treatments such as physical therapy or steroid injections in the last 3 months