cyrilzakka/clinical-trials huggingface dataset:
Validation of a Laboratory Test Measuring Natalizumab (Tysabri®) Serum Levels in MS

Validating a peptide-based laboratory test enabling the measurement of Tysabri® serum levels (pharmacokinetics, PK) in multiple sclerosis patients undergoing therapy. The results of this newly developed test will be compared to Tysabri® serum levels measured in parallel using an independent test. We will also simultaneously measure a pharmacodynamic marker of Tysabri®, receptor saturation levels on blood immune cells, which is thought to correlate with Tysabri® serum levels.

From a single site, consenting patients with relapsing forms of multiple sclerosis who are currently begin treated with Tysabri® (natalizumab) and meeting the eligibility criteria will be asked to provide blood samples on the same day, and prior to, a scheduled infusion of Tysabri® 300 mg IV. Up to 500 patients will be enrolled in this study. Each patient may be asked to donate blood up to 2 times (one blood draw per cycle) to obtain longitudinal data points. Each patient will also be asked to fill out a wellness patient reported outcome (PRO) questionnaire along with the blood draws

Eligibility Criteria:
Inclusion Criteria:

* Infusing with Tysabri at a single site, Rocky Mountain MS Clinic

Exclusion Criteria:

* If subject donated or received blood, plasma, or any other blood products between the last Tysabri® infusion and the time of sample collection.
Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D484 in Healthy Adults

Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability after Oral Administration of CKD-387 10/1000 mg and D484 10/1000mg in Healthy Adults


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between the ages of 19 and 55
* Body weight ≥ 55kg for male, ≥ 50kg for female
* Body mass index ≥ 18.5 kg/m2 and \< 25.0 kg/m2
* Females who are post-menopausal or underwent sterilization
* Males who agreed to practice contraception until after 28 days of last intake Investigational product
* Ability to provide written informed consent

Exclusion Criteria:

* Subject with clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease and psychosis disorder
* Subject who are weak in dehydration or clinically significant dehydration
* IV injecting examination of radioactive-iodine substances within 48 hours prior to first IP administration
* Subjects who have Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Subjects with history of gastrointestinal disease or surgery that may affect absorption of IP
* Hypersensitive to dapagliflozin/metformin
* At screening,

  * AST(Aspartate Transaminase), ALT(Alanine Transaminase) \> UNL(upper normal limit)\*1.25
  * Total Bilirubin \> UNL(upper normal limit)\*1.5, CPK \> UNL(upper normal limit)\*1.5
  * eGFR(estimated Glomerular Filtration Rate) \< 60 mL/min/1.73m2(Modification of diet in renal Disease calculated)
  * Positive reaction on following tests: Hepatitis B, Hepatitis C, HIV(Human Immunodeficiency Virus) and syphilis
  * SBP(Systolic blood pressure) ≥ 150 mmHg or \< 90 mmHg, DBP(Diastolic blood pressure) \> 100 mmHg or \< 50 mmHg
* History of drug abuse or positive urine drug screening results
* Women with pregnant, breast-feeding
* Caffeine \> 5 cups/day, Alcohol \> 210 g/week, Smoker \> 10 cigarettes /day or who are unable to stop caffeine intake, drinking alcohol and smoking until the last blood drawing for PK
* Subject who took ethical drug/herbal compound within 14 days, over-the-counter drug/vitamin supplements within 7 days and depot injection/implantation within 30 days prior to the first IP administration
* Subject who was enrolled in another clinical trial(including Bioequivalence study) and administered drugs within 90 days prior to the first IP administration
* Subject with whole blood donation within 60 days or component blood donation within 30 days
* Not eligible to participate for the study at the discretion of Investigator
Effect of Vitamin D on Hormonal, Metabolic and Cardiovascular Risk Factors in Patients With Polycystic Ovary Syndrome

This is a double blind randomised placebo-controlled study involving women with polycystic ovary syndrome (PCOS). The patients will be randomised either to Vitamin D 3200 IU or placebo for three months. The main hypothesis of this study is "Vitamin D improves hormonal, metabolic and cardiovascular risk markers in women with PCOS".

Polycystic ovary syndrome (PCOS) is a very common condition in women which could present with irregular periods, excessive hair growth on body, acne and cysts in the ovaries. PCOS is also associated with increased risk of problems later in life like diabetes, high cholesterol levels and heart disease. One of the risk factors for having increased incidence of such problems in PCOS patients could be low vitamin D levels as many women with polycystic ovary syndrome (PCOS) are vitamin D deficient. Vitamin D supplementation may have a beneficial effect on insulin levels and fat around the abdomen. It has been seen in previous research studies that low level of vitamin D is related to a greater risk of diabetes and heart disease. Low vitamin D levels are also associated with fat in the liver. The amount of fat in the liver is a sign of early liver disease. So, in this study the investigators want to supplement women having PCOS and vitamin D deficiency with vitamin D (3,200 IU) and examine the effects on hormones related to PCOS and risk factors for diabetes and heart disease in them.

Eligibility Criteria:
Inclusion Criteria:

1. Caucasian women, aged 18-45 years, with confirmed diagnosis of PCOS based on all three diagnostic criteria of the Rotterdam consensus \[21\].
2. Irregular periods with raised FAI
3. Vitamin D \< 50 nmol/L.

Exclusion Criteria:

1. Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing's disease and androgen-secreting tumours will be excluded by appropriate tests if clinically indicated.
2. Any concurrent illness including type 2 diabetes, subjects who are on any medication (including medications that interfere with calceotrophic hormones) for the preceding 6 months.
3. Women planning to conceive.
4. Women who are using any oral or implantable contraceptives or any other treatments likely to affect ovarian function, insulin sensitivity or lipids for at least 3 months before entering the study. Stable dose of metformin for 3 months is allowed. Subjects will be advised to use barrier contraception during the study period.
5. eGFR\<60.
6. Hypersensitivity to vitamin D or any of the excipients in the product.
7. Peanut or soya allergy.
8. Nephrolithiasis.
9. Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria.
Intensive Psychotherapy for Chronic Depression

The study evaluates whether Intensive psychotherapy show superior effect on chronic depression over TAU

Background: Accumulating evidence indicates that intensive psychotherapy (i.e., greater number of treatment sessions per time unit) improves outcomes for patients with mental health problems. However, few studies have investigated whether patients with chronic depression (CD) benefit from treatment with higher intensity. The main purpose of this study is to investigate if intensive psychotherapy could improve treatment for patients with chronic depression (CD). The primary research question is whether two intensive psychodynamic inpatient treatments, affect phobia therapy (APT) and VITA, are superior to low intensity treatment (TAU) at completion of treatment. To indicate if a potential difference between intensive treatment and TAU is due to the intensity of the therapy, the study contrasts two therapies with similar intensity, but different theoretical rationales. Methods: 280 patients with CD are included in a naturalistic study. Patients are assessed at four time points; assessment, start of therapy, end of therapy and 1-year follow-up. Three comparisons are performed with patients matched across groups; Intensive treatment (APT + VITA) vs TAU during treatment, APT vs VITA during treatment and APT vs VITA during follow-up. The outcome measure is the BDI-II.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria will be liberal and similar to clinical practice criteria at the treatment site which includes patients with the characteristics of chronic depression (CD), thus including patients with

* Persistent depressive disorder as defined by the diagnostic and statistical manual of mental disorders (DSM5)
* Recurrent depressive disorder as defined by the International classification of diseases-10 (ICD-10)

Exclusion Criteria:

* Not having utilized reasonably available treatment in proximity to their residence
* A psychotic disorder
* Cluster A or B personality disorder
* Bipolar disorder,
* Ongoing substance abuse,
* Physical brain disorder
* Not having access to TAU while on the 12 week wait-list period.
The Effects of 12 Weeks Pilates-inspired Exercise Training on Functional Performance in Older Women

The purpose of the present study was to investigate the effects of 12-week Pilates-inspired exercise on functional performance in community-dwelling older women.

Pilates is an exercise system developed over 70 years ago that has been recently received attention due to its beneficial effects on postural stability, coordination, muscle strength and flexibility. The studies published involving Pilates were very different among them regarding intervention period (5, 8, 12 and 24 weeks), frequency (2 and 3 sessions/week) and exercises (mat, mat with accessories, apparatus and others combinations), making meaningful comparison difficult. Furthermore, other important physical features to maintain an independent life at older age, such as cardiorespiratory fitness, were accessed in few studies. So, the effective benefits of Pilates method on physical fitness of community-dwelling older people remain unclear.

Eligibility Criteria:
Inclusion Criteria:

* good health based on clinical examination (doctor's certificate)
* good functional capacity(physical examination)

Exclusion Criteria:

* current smokers
* obese (BMI \>30 Kg/cm2)
* musculoskeletal limitations
* neurologic diseases
* cardiovascular diseases
* condition that contraindicated exercise
* regularly engaged in other physical conditioning program (\>2x/week and/or \>150min/week)
Effects of 12-week Exercise Program on Sleep Quality and Fear of Death in Geriatric Individuals

The aim of this study is to determine the effect of regular aerobic exercise program on tanatophobia and sleep quality in elderly individuals, and to evaluate the relationship between sleep disorder and fear of death.

The effect of regular exercise programs on fear of death in elderly individuals is unknown. The aim of this study is to determine the effect of regular aerobic exercise program on tanatophobia and sleep quality in elderly individuals, and to evaluate the relationship between sleep disorder and fear of death.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 65 and over who volunteered to participate in the study,
* Conscious and without communication problems,
* No orthopedic injury that prevents walking
* Those who are physically inactive according to the International Physical Activity Assessment Questionnaire
* Those who have sufficient motivation to participate in the exercise program (will be evaluated by a one-on-one interview by the researchers)
* Being eligible to participate in an exercise program after a cardiac examination by a cardiologist (resting ECG and questioning of cardiac symptoms, further examinations such as exercise ECG test if necessary)

Exclusion Criteria:

* Having a history of neuromuscular disease
* Serious medical condition (eg advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) that would prevent the person from participating in exercise training.
* Less than 1 year life expectancy
* Having an orthopedic injury that prevents walking
* Presence of advanced sensory deficit
* Having visual and hearing problems
* Not having sufficient communication skills (Mini Mental Test score below 24 points)
* Not having agreed to participate in the study
* Uncontrolled hypertension
* Not being found suitable for exercise in the examination performed by physicians and physiotherapists
Ultrasound Guided Distal Sciatic Nerve Block - a Comparison With Nerve Stimulator Technique

For distal sciatic nerve block this prospective, randomised comparison with ultrasound guided distal subepineural block tested the hypothesis, that intraepineural injection of local anesthetic using nerve stimulation technique is common and associated with high success rate.

Classical methods for nerve localization (loss of resistance, cause of paresthesias, nerve stimulation technique)assumed that the target is a close approximation to the nerve, without epineural perforation. Intraneural injections were considered as evitable, with high risk for nerve damages.

Ultrasound guidance provided for the first time a real-time visualization of the spread of local anesthetic. Some recent studies proved, that an intraneural injection using nerve stimulator technique is common and not necessarily accompanied with nerve damages.

In the ultrasound group (group US) the investigators tested the hypothesis, that an intraneural injection of local anesthetic generate a high success rate and a short onset time without clinical apparent nerve damages.

In the nerve-stimulation group (group NS) the investigators tested the hypothesis, that an intraneural injection of local anesthetic is common, and in case of intraneural injection accompanied likewise with high success rate and shorter onset time.

For the sciatic division the investigators tested the hypothesis, that classical methods of nerve localization (nerve-stimulation technique, cause of paresthesias) are not able to avoid epineural perforation.

Eligibility Criteria:
Inclusion Criteria:

* elective surgery on the foot or ankle
* tourniquet distal of the knee
* adult patients, 18-75 years old
* ASA-risk-groups I-III (American Society of Anesthesiologists)
* informed consent

Exclusion Criteria:

* severe coagulopathy
* systemic inflammatory response
* ASA-risk-groups \> III (American Society of Anesthesiologists)
* drug allergy: local anesthetics
* pregnancy, lactation period
* participation in other studies
* addiction to drugs or alcohol
* non-cooperative patients
Enhancement of Sleep With Wearables

Sleep, specifically deep sleep, plays a central role in healthy brain function, cardio-vascular processes, mood and quality of life. Auditory stimulation during one night of sleep has previously been shown to improve deep sleep and along with memory formation in both young and older adults. Yet, it remains unclear whether long-term auditory stimulation considerably improves sleep quality over longer time periods and how it affects daytime functioning such as cognition, mood, quality of life and peripheral functions (e.g. cardio-vascular). Due to the importance of deep sleep for brain and body and the presence of many conditions that involve reduced deep sleep (e.g. ageing) assessing the beneficial impact of long-term sleep enhancement and its consequences is of central interest.This study will assess the effect of auditory stimulation over two weeks (interleaved with a two weeks washout period) in a cohort of healthy young and older adults using portable recording and stimulation devices.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* For women: Hormonal contraception, if menstrual cycle is still present or has been present less than a year ago
* Good general health status
* Stable home situation (e.g. long-term place to live) that allows for reliable application of intervention for the duration of the study
* Male and Female subjects 18-35 years of age or 60-84 years of age
* German speaking

Exclusion Criteria:

* Women who are pregnant or breast feeding,
* Known or suspected non-compliance, drug or alcohol abuse,
* Intake of sleep altering medication
* Inability to follow the procedures of the study, e.g. due to language problems, cognitive deficits
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Presence or history of diagnosed psychiatric/neurologic disorder/lesion of the central nervous system (CNS),
* Diagnosed internal disease,
* Presence of sleep disorders,
* Shift-work (work during the night) or situations that require several awakenings during the night (e.g. newborn)
* Travelling more than 2 time zones in the last month before intervention starts or during intervention (study start will be shifted accordingly)
* Hearing disability/ hearing aid
* Skin disorders/problems in face region that will worsen with /not allow adhesive electrode application
* Nicotine/Cannabis use
* High caffeine consumption (\> 5 servings/day; including coffee, energy drink)
Analysis of Different Hip Adductors Exercises

Groin injuries present a major problem in sports due to its high frequency, long-lasting symptoms and high risk of re-injury. The most common groin injury is the adductor strain (around two thirds of all groin injuries), while the biggest risk factors are previous injury and lower hip adductors strength. The purpose of this study is to present and biomechanically evaluate several new strengthening exercises targeting hip adductors. Exercises will be performed with the use of our novelty device, which enables eccentric strengthening of the hip adductors in different hip and knee positions. We hypothesize that performing modified hip adductors exercises using the novelty device could enable participants to perform hip adduction throughout larger ROM during eccentric contractions, while changing hip and/or knee angle will differently affect muscle activity and produced joint torques. The latter could be helpful for preventive or rehabilitative training for hip adductors strain injuries, in which therapists want to target specific hip adductor muscle.

Following the general warm-up (light aerobic activity, dynamic stretching exercises and bodyweight strength exercises), the electromyographic (EMG) sensors and kinematic markers will be attached to the participant, who will then perform the maximal voluntary contractions for the purpose of EMG normalization. Then the participant will perform new hip adductor exercises using the novelty device, which enables hip adduction eccentric contractions in different hip and knee positions. The latter is important when trying to target specific hip adductor muscle, since different hip and/or knee angles differently affect individual muscle activity and joint torques. Exercises will be performed in randomized order, while the EMG and kinematic signals will be synchronously captured. EMG muscle activity and joint torques, produced during the exercises, will be analysed. Descriptive statistics will be calculated and reported as mean ± standard deviation. Shapiro-Wilk test will be used for testing of normality and Levene's test for equality of variances. Differences among corresponding variables will be obtained from different exercises and tested with the analysis of the variance for repeated measurements. For pair-wise comparisons, paired 2-tailed post-hoc t-tests with Bonferroni's correction will be used. The level of statistical significance will be set at p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

Performing regular physical activity, experience with strength training.

Exclusion Criteria:

Neural, muscular, skeletal or connective tissue injuries during the last 12 months in the area of the back, hips and legs.
Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery

This trial is to determine the effect of Tranexamic Acid (TXA) on blood loss during endoscopic pituitary surgery. The hypothesis of this study is that TXA will reduce blood loss during surgery compared to a placebo. To answer this hypothesis, the investigators are conducting a randomized controlled trial in which half of participants will receive TXA and half will receive placebo (saline) in a double blind fashion.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing endoscopic pituitary surgery at UNC

Exclusion Criteria:

* Clival invasion
* Giant pituitary tumor (\>4 cm)
* Revision pituitary surgery
* Prior sinus surgery
* Lund McKay score \> 3
* Active thromboembolic disease
* Coagulopathy
* Concomitant pro-thrombotic medications
* Concomitant use of anti-coagulants or anti-platelet agents
* Subarachnoid hemorrhage
* History of severe hypersensitivity to Tranexamic Acid
A PET Study With ORM-12741

The purpose of the study is to evaluate the effect of ORM-12741 on receptor occupancy by positron emission tomography with different doses and plasma concentrations. The pharmacokinetic profile and safety will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Good general health ascertained by detailed medical history and physical examination
* Males between 18 and 45 years
* Body mass index (BMI; weight/height2) between 18-30 kg/m2
* Weight 55-95 kg

Exclusion Criteria:

* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator
* Any condition requiring regular concomitant medication including herbal products or likely to need any concomitant medication during the study
* Regular consumption of more than 21 units of alcohol per week (1 unit = 4 cl spirits, about 13 g of alcohol).
* Current use of nicotine-containing products more than 5 cigarettes or equivalent/day
* Inability to refrain from using nicotine-containing products during the stay at the study centre
* Inability to refrain from consuming caffeine-containing beverages during the stay at the study centre e.g. propensity for headache when refraining from caffeine-containing beverages
* Blood donation or loss of significant amount of blood within 3 months prior to the screening visit
* Abnormal 12-lead electrocardiogram (ECG) finding of clinical relevance
* Any abnormal value of laboratory, vital signs, or physical examination, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk for the subject if he takes part into the study
* Anatomical abnormality in brain MRI which may in the opinion of the investigator interfere with the interpretation of the PET results
* Participation in another clinical drug study within 3 months prior to the start of this study or earlier participation in a clinical study with ORM-12741
* Participation in a prior PET study
* Any contraindication to MRI of the brain
Magnetic Localization of Sentinel Nodes in Squamous Cell Oral Carcinoma.

Sentinel node biopsy has been shown to be a viable alternative to elective neck dissection in the early stages of squamous cell oral carcinoma. The aim of this study was to describe the magnetic localization of sentinel nodes (SN) after peritumoral injection of superparamagnetic iron oxide (SPIO) for treating this type of tumor and to analyze the technique's diagnostic performance in 23 patients. The technique located SNs (with minimal complication) in 95.6 % (22/23) of the patients. Three relapses occurred, one in a patient who had shown negative in magnetic SN location and elective neck dissection. The diagnostic performance of magnetic localization achieved a sensitivity and negative predictive value of 0.80 y 0.94, respectively. Magnetic localization of SNs has been shown to be a reproducible technique that may offer a viable alternative to the conventional technique.


Eligibility Criteria:
Inclusion Criteria:

* Oral squamous cell carcinoma T1-T2, cN0.
* Absence of alterations to iron metabolism.

Exclusion Criteria:

* Previous neck surgery.
* Treatment with iron chelators.
* Pregnant