cyrilzakka/clinical-trials huggingface dataset:
Impact of Exercise on the Metabolic Consequences of Overeating

The primary purpose of this study is to examine the effects of 1-week of overeating on important clinical metabolic health outcomes (e.g., glucose tolerance, blood lipid profile, and blood pressure) and factors regulating the structure and metabolic function of fat tissue. This study will determine how regular exercise during this overeating period impacts these responses.

If subjects are eligible and decide to participate, they will take part in two identical study trials. One is scheduled before and the other is scheduled after 1 week of overeating controlled by the study team. Subjects who exercise regularly will be instructed to exercise the day before their first study trial - and they will be required to exercise during 6 of the 7 days of the overeating period (including the day before their second study trial). Subjects who do not regularly exercise (no planned physical activity) will remain inactive until the completion of both study trials.

Before each study trial If a subject is a regular exerciser, they will be asked to come to the Substrate Metabolism Laboratory in the afternoon before each of the 2 study trials to exercise in the lab for 45 min at a moderate intensity. The evening before the study trial, all subjects will need to eat a standardized dinner meal and snack. They must eat the meal and snack at specific times as indicated by the research staff. After eating the snack, subjects will need to fast (no food or beverages - besides water) overnight.

During each study trial Subjects will arrive at the Substrate Metabolism Laboratory at 7:00AM and will rest quietly for approximately 30 min. After which, the study team will measure their resting blood pressure and their resting metabolic rate. An intravenous catheter (IV) will then be placed in a vein of the subject's hand or forearm for blood sampling. The research team will then collect a small sample of fat tissue in the subject's abdomen with a needle. Next, subjects will drink a sweet sugar solution for an Oral Glucose Tolerance Test (OGTT) and the research team will collect blood samples every 15 min for 3 hours. After this 3 hour test, the IV catheter will be removed and subjects will be provided breakfast and discharged.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-40
* Body Mass Index: 20-30 kg/m2
* Exercise group: (≥5 days/wk of aerobic exercise; 30-60min/session at moderate and vigorous intensities)
* No Exercise group: no regularly planned exercise/physical activity
* Women must have regularly occurring menses and must be premenopausal

Exclusion Criteria:

* Pregnant or lactating
* Blood pressure \> 140/90 mm Hg
* Evidence/history of cardiovascular or metabolic disease
* Medications known to affect lipid or glucose metabolism
* Tobacco or electronic cigarette user
Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma

The purpose of this study is to assess the safety and efficacy of hypofractionated stereotactic LINAC radiotherapy with 10 fractions at 6 Gy per fraction at the 80% isodose for the planning target volume (PTV) in patients with uveal melanoma. Patients will be followed-up for 10 years after radiotherapy regarding local tumor control, visual acuity, secondary complications and survival.


Eligibility Criteria:
Inclusion Criteria:

* The initial height of the melanoma is 7 mm or higher.
* Juxtapapillary and/or juxtamacular melanomas with a height of 3 mm or higher and if the central tumor distance to the optic disc and/or the macula is 3 mm or less.
* If other forms of conservative treatment of the melanoma are not possible.

Exclusion Criteria:

* Prior/Concomitant Treatment.
* Extrascleral tumor extension is present.
* If the presence of neovascular glaucoma is detected before treatment.
* If metastasis is detected at baseline.
* Previous participation in any study of investigational drugs within 3 month preceding day 0.
* Pregnant women are not allowed to participate in the study.
Interactive Robot on Pre-operative Anxiety and Fear of Children

The aim of this study is to determine the effect of preoperative preparation applied with an interactive robot on children's preoperative anxiety and fear levels.

Hypothesis;

H1: Pre-operative preparation with an interactive robot has an effect on the anxiety level of children H2: Pre-operative preparation with an interactive robot has an effect on the fear level of children H3: The anxiety levels of children in intervention and control groups are different after the pre-operative preparation H4: The fear levels of children in intervention and control groups are different after the pre-operative preparation

The use of interactive robots can be preferred as a remarkable method of communication with hospitalized children. In this way, it will be easier for the children to understand the procedure and they will be able to communicate easily with healthcare professionals. Children may develop a sense of control and the level of anxiety and fear they experience may decrease when they interact with robots. It is reported in the literature that children show more interest in robots than they do in adults. In addition, children see social robots as living creatures, not as devices, and children who spend time with them for a long time adopt them as friends. In a study, a social humanoid robot was used to prepare children aged 7-12 (n = 11) regarding the cancer diagnosis process and interventional procedures. According to the results of the study, the children's stress, depression, and anger during the treatment decreased significantly. Interactive robots positively affect postoperative mobilization in children undergoing day surgery and reduce the anxiety level of children before mobilization. As a result, it may be easier for children to cope with stress with the use of interactive and humanoid robots. Also, interactive robots can facilitate cooperation between the child and the nurse by playing an intermediary role in communication with children. Determining the effects of interactive robots on children by using them before the surgical procedure is important to ensure the active participation of children in the surgical process in pediatric surgery clinics. It is thought that this research is important in terms of interventions which appropriate to the supportive care role of nurses and will contribute to the literature.

Eligibility Criteria:
Inclusion Criteria:

* Those between the ages of 5-10,
* having planned day surgery,
* scheduled for general anesthesia
* have not had surgery before,
* Those who can speak Turkish

Exclusion Criteria:

* Children have mental-cognitive problems,
* Children have hearing, vision and/or speech disabilities
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.

The study consists of a randomized, double-blind, placebo-controlled, parallel-group, single-dose main period followed by an open-label, non-controlled, repeated-dose extension period (Open-Label Extension Period - OLEX).

Eligibility Criteria:
Inclusion Criteria:

* Upper limb spasticity
* Time since stroke greater than 3 months
* Need for 400 U Botulinum toxin type A

Exclusion Criteria:

* Body weight below 50kg
* Fixed contractures of the upper limb
* Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin Type A
* Infection at the injection site
Effect of Postural Insoles on Stability and Leg Muscular Activity

Posturology allows to treat postural problems by using postural insoles, which will have an effect at the neurophysiological level. Pieces of 1 to 3 millimeters are inserted to stimulate specific receptors located on the sole of the foot, which will affect the muscular proprioception and modify the activation of the ascending muscle chains.

The hypothesis of this work is based on the fact that the use of postural insoles with a 2 millimeters metatarsal bar will influence the displacement of the center of pressure and the muscle activity of the leg when compared with a placebo insoles.

Participants will be healthy subjects and will be divided into two groups, control and experimental. Subjects in the control group will be given a pair of flat insoles (placebo insoles) with 1.2 millimeters polyester resin. Those of the experimental group will be made the same insoles but they will include by thermal fusion a metatarsal bar of 2 millimeters polyester resin in the metatarsal zone corresponding to the 1st, 2nd, 3rd and 4th metatarsal head.

Postural stability analysis will be performed with the force platform of the Biomechanics Institute of Valencia (IBV-Spain) and at the same time an electromyographic analysis in the dominant leg with a surface electromyograph system. Subjects will be assessed with their eyes open and closed under two situations, with footwear and with footwear and insoles.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with no discomfort in gait
* Subjects with not muscle and skeletal diseases

Exclusion Criteria:

* Subjects with balance disorders, pain at legs
* Subjects with loss of balance
Role of CMR-FT in Assessment of HCM and Athlete's Heart.

Using cardiac MRI feature tracking to asses myocardial motion differences in athlete's heart and discovered hypertrophic cardiomyopathy patients to increase diagnostic accuracy of hypertrophic cardiomyopathy.

Cardiac MRI is the gold standard for assessing cardiac function without significant limitations of anatomical restrictions. CMR-FT helps in assessment of myocardial deformation on routinely obtained by steady state free precision (SSFP) cine images. CMR-FT is used in cardiac research and became common in clinical practice. It has been used in assessment of wide spectrum of cardiac diseases and provides for comprehensive and reliable assessments of heart function.

Eligibility Criteria:
Inclusion Criteria:

* Patients suspected to be hypertrophic cardiomyopathy by echocardiography..
* Athletes and heavy workers,, healthy volunteers also included.

Exclusion Criteria:

* Patients with absolute or relative contraindications to magnetic resonance imaging (e.g intra-ocular metallic foreign body, claustrophobia, etc) or contra-indication to MRI contrast medium.
* Clinical morbidities with absolute contraindication to anesthesia during the examination in un-cooperative patients where sedation is required.
Therapeutic Drug Monitoring of Anxiolytics in Children

In this study, the therapeutic drug monitoring of anxiolytics is carried out among children to obtain the drug concentration, clinical efficacy and safety data of children patients in different gender and age groups. Then the investigators analyze the relationship between blood drug concentration and efficacy and safety, and provide recommendations for the treatment window of anxiolytics in Chinese children.


Eligibility Criteria:
Inclusion Criteria:

* Anxiolytics was used for therapeutic purposes;
* Age:≤18 years;
* Patients with therapeutic concentration monitoring of anxiolytics.

Exclusion Criteria:

* Patients without therapeutic concentration monitoring of anxiolytics;
* The blood concentrations of the patient was not approved by the quality control center
* Use foods or products that inhibit or induce CYP 3A activity.
Sleep Deprivation : Effects on Driving Performance and Central Fatigue

The effects of sleep deprivation (SD) on performance, while contradictory at first glance, are in reality rather clear when exercise duration is considered, i.e. intense/supramaximal versus prolonged exercises. This latter type of exercise leads to the most important performance decrements after SD.

The effects of sleep deprivation (SD) on performance, while contradictory at first glance, are in reality rather clear when exercise duration is considered, i.e. intense/supramaximal vs. prolonged exercises. This latter type of exercise leads to the most important performance decrements after SD. However, the causes of this accentuated fatigability in endurance exercise with sleep deficit are not known. Several hypotheses have been proposed such as lower pH before exercise, lower ventilation due to depreciated response to hypercapnia/hypoxia, or haemodilution. Yet the most plausible explanation is a lower tolerance to prolonged exercise because SD increases the rate of perceived exertion. Another potential effect of SD is an alteration of central command during exercise. The literature is rather scarce on this topic and is only based on a few animal studies. In humans, no effect of SD on maximal strength has been reported so that maximal voluntary activation should in theory not be altered. Transcranial Magnetic Stimulation (TMS), that allows to induce a motor response from its cortical origin (and to measure the resulting contraction), is a promising tool to explore neuromuscular function. TMS has been used only in three studies after SD, none of them involving exercise and none of them measuring mechanical responses (i.e. only EMG responses, such as motor evoked potential, were measured). In addition, the results of these three studies are contradictory. The effects of SD on central fatigue (i.e. increase of the activation deficit during exercise) have never been investigated. The goal of this experiment is thus to test the hypothesis that an increase in central fatigue (at supraspinal level) in SD can participate to performance alteration during a prolonged exercise. For that purpose, measurements of neuromuscular function particularly dedicated to assess central fatigue will be performed before and after SD but also when combining SD and a fatiguing exercise conducted until exhaustion.

Eligibility Criteria:
Inclusion Criteria:

* no smoking and drugs
* regular physical activity

Exclusion Criteria:

* insufficiency cardiac or respiratory
* carrying a cardiac pacemaker
Parathyroid Cancer Versus Atypical Parathyroid Neoplasm; Investigating Their Clinical Characteristics and Biological Behavior

Objectives:

1. Identify the clinical characteristics of parathyroid (PTH) cancer and PTH atypical neoplasms
2. Investigate if PTH carcinoma and atypical neoplasm present a biological behaviour and have a different impact on the health of the patients

Data between the years of 1/1/2002 and 12/31/2013 will be analyzed. The medical records of all adult patients that had a parathyroidectomy for primary PHPT in MD Anderson Cancer Center will be screened in order to identify patients that had a histopathological diagnosis of parathyroid carcinoma or atypical parathyroid neoplasm.

Eligibility Criteria:
Inclusion Criteria:

* All patients from MDACC diagnosed with PHPT that have a histopathological diagnosis of PTH carcinoma or atypical parathyroid neoplasm between the years 1/1/2002 and 12/31/2013

Exclusion Criteria:

* Pediatric patients
* Cases with incomplete records
* Patients where the follow-up will be less than six months
Single and Multiple Ascending Dose Study of AMG 378 in Healthy Participants

The main objective of the study is to assess the safety and tolerability of AMG 378 as single or multiple doses in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants ≥ 18 to ≤ 55 years (inclusive) at the time of signing the informed consent.
* Body mass index between 18 and 30 kg/m\^2, inclusive, at screening.
* Men (even with a history of vasectomy) with partners of childbearing potential must agree to practice sexual abstinence or use a male barrier method of contraception (ie, male condom with spermicide) in addition to a second method of acceptable contraception by female partner from Check-in until 30 days after the last dose of investigational product.
* Participant must be overtly healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, vital signs, physical examination, laboratory tests, and 12-lead electrocardiogram (ECG) recording(s) at the screening and Day 1 visits.

Exclusion Criteria:

* History of malignancy of any type.
* History of esophageal, gastric, or duodenal ulceration prior to screening visit.
* Evidence of active bacterial, viral, fungal or parasitic infections within the last 30 days prior to study day 1.
* History or evidence of clinically significant arrhythmia at screening, or Day 1 ECG.
* A QT interval corrected for heart rate (HR) based on the Fridericia method (QTcF) interval \> 450 ms in all participants regardless of biological sex or history/evidence of long QT syndrome at screening or study day 1.
* Positive results for human immunodeficiency virus (HIV) antibodies, HIV antigen, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus ribonucleic acid (RNA) at screening.
* History of active tuberculosis (TB) infection, current symptoms concerning for active TB, or positive or indeterminate interferon gamma release assay (IGRA).
* Positive test for drugs, cotinine (tobacco use) or alcohol use at screening or on Day 1.
* Female participants of childbearing potential unwilling to use 2 protocol specified highly effective methods of contraception during treatment and for an additional 30 days after the last dose of investigational product.
* Alcohol consumption from 48 hours prior to study day 1.
* Use of tobacco- or nicotine-containing products within 6 months prior to study day 1.
INTEgRated Health CARE for Patients With Frailty and Heart Failure

Frailty, an aging-related syndrome of physiological decline characterized by marked vulnerability to adverse health outcomes, has attracted increasing attention in cardiology due to the growing elderly population with heart failure. Frail patients are mainly excluded from large cardiovascular intervention studies, and clinical trials addressing frailty and showing an impact on treatment on symptom burden, quality of life and /or outcome has been requested in recent guidelines and consensus documents. The INTEgrRated health CARE for patients with severe frailty and Heart Failure (INTERCARE-HF) is a proof-of-concept study that aims to evaluate the effect of integrated healthcare services for heart failure patients with a severe level of frailty by establishing interdisciplinary and coordinated follow-up teams across the healthcare boundaries. These teams will assess the patient's needs, goals, and risk areas, conduct advance care planning, and develop individualized treatment and follow-up plans. An open-label, non-randomized intervention study aims to recruit 20 patients and heart failure and a clinical Frailty Score (CSF) \>=5. A control-group (N=40) matched on age an clinical frailty scale score will be included. The overall hypothesis is that the intervention is feasible in routine clinical practice with favorable effects on quality of life, symptoms, caregiver distress, and healthcare service utilization.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Admitted to hospital with heart failure with symptoms of decompensation including dyspnoea in NYHA class ≥ II, pulmonary congestion on chest x-ray and/or other signs like oedema or positive rales on auscultation and elevated NT-proBNP concentrations at screening
* Clinical Frailty Score ≥5
* Signed informed consent by patient and closest relatives\* and expected cooperation according to the protocol, ICH/GCP and national/local regulations

  * Although we preferably will recruit both patients and their relatives, participation from the next-of-kin will not be an exclusion criterium.

Exclusion Criteria:

* Inability to comply with all study requirements, due to major co-morbidities or psychosocial issues, or a history of noncompliance, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures.
* Not being able to understand Norwegian.
* Permanent nursing home and estimated to stay alive for less than 6 months
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

The overarching objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial is to assess whether a polypill containing fixed doses of (2/3) antihypertensives, a statin and antiplatelet therapy taken once daily orally would result in carotid intimal thickness regression-a surrogate marker of atherosclerosis, improved adherence, and tolerability compared with 'usual care' group on separate individual secondary preventive medications among Ghanaian first time stroke survivors. Our ultimate objective is to design of a future multi center, double-blinded, placebo-controlled, parallel-group, randomized trial comparing the clinical efficacy of the polypill strategy vs 'usual care' in the African context to derive locally relevant, high-quality evidence for routine deployment of polypill for CVD risk moderation among stroke survivors in LMICs. In this current study, we plan to recruit 120 recent ischemic stroke survivors randomized 1:1 to the polypill or usual care arms.


Eligibility Criteria:
Inclusion Criteria:

* Above the age of 18 years; male or female
* Stroke/TIA diagnosis no greater than two months before enrollment. Ischemic strokes including lacunar, large-vessel atherosclerotic, cardio-embolic subtypes are eligible -
* Subjects with stroke may present with at least one of the following additional conditions: Documented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension \>140/90mmHg or previous treatment with anti-hypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml/min/1.73m2); Prior myocardial infarction
* Legally competent to sign informed consent

Exclusion Criteria:

* Unable to sign informed consent
* Contraindications to any of the components of the polypill
* Hemorrhagic stroke
* Severe cognitive impairment/dementia or severe global disability limiting the capacity of self-care
* Severe congestive cardiac failure (NYHA III-IV)
* Severe renal disease, eGFR \<30ml/min/1.73m2), renal dialysis; awaiting renal transplant or transplant recipient
* Cancer diagnosis or treatment in past 2 years
* Need for oral anticoagulation at the time of randomization or planned in the future months
* Significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation)
* Nursing/pregnant mothers
* Do not agree to the filing, forwarding and use of his/her pseudonymized data.
Cardiometry Versus Fluid and Catheter Treatment Trial (FACTT Lite) on Fluid Management in Acute Respiratory Distress Syndrome Patients

The aim of this study will be to compare the fluid management in acute respiratory distress syndrome ARDS guided by electrical cardiometry (EC) versus the guidance with simplified conservative fluid protocol, Fluid and Catheter Treatment Trial "FACTT Lite". Group (A) consists of 35 patients: Fluid management in this group will follow a simplified conservative fluid protocol, "FACTT Lite" The FACTT Lite provided three possible instructions determined by the CVP and urine output: furosemide administration, fluid bolus, or no intervention. Group (B) consists of 35 patients: Fluid will be allowed according to an FTc-based fluids algorithm protocol and the type of bolus fluids will be determined according to Transthoracic fluid content (TFC), vasopressors and inotropes will be given according to reading of EC reading of systemic vascular resistance (SVR) and index of contractility (I CON).


Eligibility Criteria:
Inclusion Criteria:

* Acute onset within one week
* Mild to moderate ARDS (FiO2/PaO2) less than 300 mmHg and more than 100 mmHg with a minimum PEEP of 5 cmH2O
* Bilateral lung opacities consistent with pulmonary edema on chest radiogram or lung ultrasound, cardiac failure, and fluid overload should be excluded in the absence of a definite cause of ARDS
* ARDS due to pulmonary cause.

Exclusion Criteria:

* Hemodynamic instability, patients on vasopressor,
* Barotrauma
* organ/s dysfunction at presentation.
* Pregnant