cyrilzakka/clinical-trials huggingface dataset:
Cortical Dynamics of Inhibitory Control: A Concurrent tDCS-MEG Study

This study aims to use concurrent Transcranial Direct Current Stimulation (tDCS) and Magnetoencephalography (MEG) with measures of impulsivity to examine the neurobiological underpinnings of rapid response impulsivity (RRI) and how these can be modified using tDCS in healthy subjects.

Concurrent tDCS-MEG parallel arms single-blinded experimental design (right anodal v sham tDCS) will be employed in this study. The study will be conducted at the University of Nottingham, using a sample of student volunteers. This study aims to examine the influence of anodal tDCS on beta-band and alpha-band oscillatory activities, using an anti-saccade task administered before, during and after tDCS stimulation. It can potentially help understand the neurobiological mechanisms underpinning rapid response impulsivity and how these can be influenced by tDCS.

The research hypotheses are that (i) a generalised mechanism for top-down inhibitory control will play a vital role, whereby prefrontal beta-band activity initiates alpha-band activity for functional inhibition over the frontal eye fields and other areas in the neurocircuitry involved in RRI; (ii) anodal tDCS (as opposed to sham) delivered over the right DLPFC will enhance this mechanism; and (iii) there will be no significant correlations between measures of self-report impulsivity and performance on the anti-saccade task and measures of oscillatory activity.

Eligibility Criteria:
Inclusion Criteria:

* University students and staff
* Aged 18-40

Exclusion Criteria:

* Individuals with epilepsy and other neurological conditions, history of significant head injury, substance misuse, major mental disorder and those receiving psychotropic medication.
* Contraindications to use of Magnetic Resonance (pacemakers, metal implants, aneurysm clips)
* Pregnancy.
Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (0518-023)

This is a treatment use study to provide early access to MK0518 for the treatment of HIV-1 infection in patients who have limited or no treatment options due to virological failure, resistance, or intolerance to multiple antiretroviral regimens. Enrollment in this study is patient driven. Investigators are not proactively assigned. There is no target sample size and duration of the study is indefinite. For information on how to enroll in the study, see link below.


Eligibility Criteria:
Inclusion Criteria:

* HIV positive patients who have limited or no treatment options and have documented resistance

Exclusion Criteria:

* Patient has previously been on MK0518 therapy
Study of Immune Responses to Influenza Vaccination

Better understanding of the immune responses to influenza vaccination is needed in order to understand situations of poor vaccine response. Adults will receive influenza vaccination and then have peripheral blood drawn at pre-defined intervals in order to study the lymphocyte responses.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling adults able to provide consent who need influenza vaccination for standard of care

Exclusion Criteria:

* febrile illness at time of vaccination
* active malignancy
* use of immunosuppressing medications
* blood donation in the past 60 days
* influenza vaccinated during the preceding 6 months
* allergic reactions to influenza vaccination
Effect of N-acetylcysteine on Brain Glutamate

A double-blind, placebo controlled, crossover study to determine whether a single dose of N-acetylcysteine (a nutritional supplement) can reduce brain glutamate levels in patients with a psychotic disorder. Secondary outcomes are to determine the pattern of alteration in brain perfusion and activity following a single dose of N-acetylcysteine.

This is a physiological, proof-of-concept study designed to investigate whether a single administration of N-acetylcysteine can reduce brain glutamate levels in people with psychotic disorders.

Previous research suggests that poor response to antipsychotics may be linked to increased levels of glutamate in the brain (Egerton et al., 2012; Demjaha, Egerton et al., 2013). Reducing brain glutamate levels may therefore be therapeutic. This study tests whether it is possible to reduce brain glutamate levels in psychotic disorders.

This is a small pilot study to determine whether a single administration of NAC can reduce brain glutamate levels in psychosis. At the same time, we will also examine the effects of NAC on brain resting perfusion and activity, to gain more information about how NAC may be acting.

This study will recruit participants with a previous diagnosis of a psychotic disorder. There will be three study visits, 1-2 weeks apart. The first visit will involve a physical health check, blood sample and an interview to assess current symptoms and confirm medical history. On the second and third visits participants will have an MRI scan, lasting one hour, after taking capsules containing either 2400mg NAC or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Diagnosis of a psychotic disorder
* Have mental capacity to consent

Exclusion Criteria:

* Diagnosed drug or alcohol dependency, with the exception of nicotine
* Pregnancy, as determined through a urine pregnancy test
* Presence of any physical health abnormality which may impact on safety to participate in the research, as determined by a study clinician on the basis of the physical health check and the available medical information.
* Presence of electronic or metallic implants contraindicated to MRI scanning at 3 Tesla, or presence of any other contraindication to MRI
* History of asthma
* History of epilepsy or any other seizure
* Under 18 years of age
* Lacking mental capacity to consent
* Current or previous use of NAC
* Currently prescribed clozapine
A Registration Study on Depression in Patients With Epilepsy

The aim of this study is to register the drug treatment of depression in patients with epilepsy in East China.

As the treatment rate for depression in epilepsy is unclear and the discordant voice of choosing antidepressants for most doctors, this prospective observational cohort study was designed to better understand the current situation of drug treatments in patients with the comorbidity of epilepsy and depression in East China. The secondary outcome was to investigate whether baseline depressive symptoms had an influence on seizure-control in patients with epilepsy at follow-up.

Eligibility Criteria:
The inclusion criteria were as follows: (1) age 18-75, no gender limited; (2) diagnosis of epilepsy according to the definition by ILAE in 2014; (3) the score of 17-item Hamilton Depression Rating Scale greater than 7; (4) Obtaining informed consent of participants. The exclusion criteria were any of the following: (1) having psychiatric symptoms such as hallucination or delusion; (2) progressive neurological diseases and malignant tumors; (3) severe cognitive dysfunction (the score of MMSE less than 10).
Glucocorticoids and Bone in Graves' Ophthalmopathy

Continuous use of systemic glucocorticoids decreases bone mineral density and increases fracture risk. Graves' orbitopathy is treated with weekly infusion of high-dose intravenous glucocorticoid. The investigators aim at investigating whether this treatment regimen also affects bone metabolism.

Systemic glucocorticoid increases bone resorption and decreases bone formation and thereby decreases bone mineral density and increases fracture risk. This effect is evident with a daily dose of 5 mg for three months or an accumulated dose of 450mg. There is, however, less evidence that intermittent use of glucocorticoids is harmful to bone.

Graves orbitopathy is treated with a weekly infusion of the glucocorticoid methylprednisolone and the accumulated dose over a 12-week course sums up to 4,500mg.

The investigators therefore want to investigate if that treatment regimen affects bone turnover, bone mineral density, or bone structure in 30 patients with Graves' orbitopathy.

Eligibility Criteria:
Inclusion Criteria:

* Graves Ophthalmopathy that requires treatment with intra-venous methylprednisolone

Exclusion Criteria:

* Treatment with osteoporosis medication
* Primary hyperparathyroidism
* Hypoparathyroidism
* Vitamin D \< 20mmol/L
* Estimated glomerular filtration rate \< 30 mL/min
* Liver disease
* Peroral treatment with glucocorticoids within last three months prior to inclusion
Potassium Supplementation to Reduce Blood Pressure

The aim of this study is to conduct a definitive trial to assess the efficacy of consuming 1L/day of water rich in potassium to reduce blood pressure in mild to moderately hypertensive adults. The objective is to assess the potential effect of the intervention on reducing systolic blood pressure. This study will comprise of a 4 week, double-blind, parallel randomised controlled trial. Participants will be adults with systolic blood pressure measurements of 130mmHg or greater. The intervention comprises advice to consume bottled water rich in potassium. The comparator will be regular bottled mineral water.This study will recruit 40 people with elevated systolic blood pressure (≥130mmHg) who are not regularly taking antihypertensive medication.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* Between 20 to 64 years old
* English speaking
* Adults who are not receiving antihypertensive pharmacological treatment
* Recent (within 6 months) and latest systolic blood pressure measurement ≥130mmHg and/or diastolic ≥85 mmHg
* Have access to internet and equipment for video calling
* Able to post samples and equipment to OxBCNH
* Physically able to take own body measurements and blood pressure

Exclusion Criteria:

* Participation in another research study
* Unable to read and understand the instructions provided in English
* Unable to comply with experimental procedures or not follow testing safety guidelines
* People with cardiovascular conditions: heart attack or stroke within the last 3 months, heart failure of grade II New York Heart Association and more severe, or prolonged QT syndrome, angina, arrhythmia or atrial fibrillation.
* Uncontrolled type 2 diabetes (HbA1c\> 9%)
* Type 2 diabetes controlled using exogenous insulin
* Previous or current diagnosis of diabetes complications such as nephropathy, retinopathy and neuropathy.
* People with type 1 diabetes
* Currently on any medication that may lead to hyperkalemia or fluid retention
* Currently being assessed for diagnosis of hypertension (not receiving treatment for high blood pressure)
* Already on clinician/HCP supervised diet or restricted diet
* They are planning on going away from home (holiday or other) during the 4 week intervention period and will not be able to take water during this time.
* Currently prescribed antihypertensive medications, or have been in the last 6 weeks
* Chronic kidney disease stage 1 (G1A2 or G1A3), 2 (G2A2 or G2A3), 3a, 3b, 4 or 5 based on UKKA (we will ask whether participants have been diagnosed with kidney disease by a clinician based on this criteria)
* They are planning to go on a diet or begin taking supplements containing potassium during the intervention
* Pregnant women (including women suspected of being pregnant) and breast-feeding woman.
Bevacizumab Neoadjuvant Therapy for New High-grade Gliomas in the Brain

Glioblastoma (GBM) usually grows in a diffuse fashion and infiltrates the surrounding brain. The inability to completely excise the tumor often leads to tumor recurrence within a few months of the initial surgery, which ultimately results in the death of the GBM patient.GBM histologically appears to be a tumor of vascular origin characterized by necrosis and microvascular proliferation, and neoangiogenesis is a key factor in the growth and poor prognosis of GBM. Bevacizumab can inhibit the biological effects of VEGF, including the permeability and proliferation of blood vessels, as well as the migration and survival of endothelial cells, so as to inhibit tumor angiogenesis, growth and metastasis. The aim of this study is to evaluate the efficacy and safety of bevacizumab in the preoperative adjuvant treatment of patients with new-onset high-grade gliomas.

Glioblastoma (GBM) usually grows in a diffuse fashion and infiltrates the surrounding brain. The inability to completely excise the tumor often leads to tumor recurrence within a few months of the initial surgery, which ultimately results in the death of the GBM patient.GBM histologically appears to be a tumor of vascular origin characterized by necrosis and microvascular proliferation, and neoangiogenesis is a key factor in the growth and poor prognosis of GBM. Therefore, inhibition of neoangiogenesis has received increasing attention from researchers as an important potential therapeutic target for GBM. Bevacizumab specifically binds to VEGF (mainly to VEGF-A), attenuates or prevents VEGF from binding to VEGFR-1 and VEGFR-2 on the surface of vascular endothelial cells, and blocks VEGFR-mediated downstream signaling pathways, inhibiting their biological activities, reducing tumor neovascularization and limiting tumor growth. Based on this background, the aim of this study was to evaluate the efficacy and safety of bevacizumab in the preoperative adjuvant treatment of patients with new-onset high-grade gliomas.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Male or female.
* Imaging diagnosis of high-grade glioma.
* KPS score ≥60.

Exclusion Criteria:

* Prior treatment with anti-angiogenic targeted drugs;
* Comorbid serious cardiac, pulmonary, hepatic, or renal disease;
* History of an arterial/venous thrombotic event within 6 months prior to screening;
* Combination of infectious diseases such as tuberculosis and viral hepatitis;
* Comorbid infectious diseases such as tuberculosis, viral hepatitis, uncontrolled high blood pressure, bleeding disorders, and long-standing unhealed wounds or incompletely healed fractures;
* Patients with a history of psychotropic substance abuse that cannot be stopped or patients with mental disorders;
* Abnormal coagulation function, with bleeding tendency
* Patients who, in the opinion of the investigator, are not suitable for inclusion in the study (e.g., pregnant and lactating women).
Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children

Neuroborreliosis (NB) is the second most frequent manifestation of Lyme disease. Painful meningoradiculitis is the most common neurologic manifestation in adults while facial nerve palsy (FP) and lymphocytic meningitis is predominant in children. FP is a common reason for pediatric consultation and FP due to Lyme borreliosis (LB) represents about 50% of the child's FP in an endemic area.

The action to be taken is not formally defined for a child consulting for FP in a Lyme disease endemic area.

The new recommendations of the High Authority of Health of June 2018 recommend to carry out a blood serology in first intention, in search of a NB in a child consulting for a peripheral facial paralysis. If this is positive, a lumbar puncture will be performed in search of meningitis. In the case of negative serology, a close clinical surveillance and sometimes serological control is necessary, in order to reassess the diagnosis. In adult recommendations, a lumbar puncture is performed first in any patient consulting for facial paralysis in LB endemic area.

The main objective of this study was to describe the clinical and biological characteristics of pediatric NB with FP. Others objectives were to describe the diagnostic and therapeutic behavior of a child consulting at university hospital for a facial nerve palsy, to compare the initial gravity of facial nerve palsy, the duration of the paralysis and sequels depending on the diagnosis and treatment initiated.


Eligibility Criteria:
Inclusion Criteria:

* Children consulting for peripheral facial palsy

Exclusion Criteria:

* Children consulting for central facial palsy
* Children with congenital peripheral facial palsy
* Children with surgery and trauma in the area of the facial nerve,
* Children with peripheral facial palsy with previous diagnosis
* Children whose parents refuse the study participation
Dyadic Sleep Study

The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.


Eligibility Criteria:
Inclusion Criteria:

* The eligibility criteria for patients are:

  * newly diagnosed with stage I to IV of a GI cancer (anus, colon, esophagus, gallbladder, large and small intestine, liver, pancreas, rectum, stomach, other biliary or digestive organs)
  * diagnosis in the past 12 months at the time of enrollment
  * having a consistent sleep partner.
* The eligibility criterion for caregivers is:

  * a sleep partner of the patient.
* Additional eligibility criteria for both patients and caregivers are:

  * Pittsburgh Sleep Quality Index (PSQI) ≥ 5,
  * willing to change sub-optimal sleep habits,
  * 18 years or older,
  * able to speak/listen English at the 8th grade level for intervention sessions,
  * able to read English or Spanish at the 8th grade for self-reported questionnaires,
  * \> 4 weeks after surgery, if any, prior to enrollment, and no surgery planned in the next 5 weeks during the study period because surgery affects sleep.

Exclusion Criteria:

* Exclusion criteria for both patients and caregivers are having had a diagnosis of major depressive disorder, psychosis, or bipolar disorder that is not currently treated;
* Active suicidality, or substance or alcohol dependency in the past year;
* Currently have narcolepsy, restless leg syndrome, or untreated sleep apnea that is screened using the Sleep Health Screen;
* Both patients and caregivers have an extreme chronotype, or do shift work to have no overlap in sleep schedule between them; and plan trans-meridian travel during the period of data collection blocks; and having hearing or visual impairment, dementia, or cognitive dysfunction.
* Adults unable to consent, individuals who are not yet adults, pregnant women, or prisoners will be excluded.
Safety and Efficacy of IV Diazoxide as an Additive to Hyperkalemic Cardioplegia in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

This study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. The investigators hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced myocardial stunning compared with standard cardioplegia alone. The investigators will randomize 30 patients in a 2:1 fashion to treatment vs control. Safety will be assessed by comparing mean arterial blood pressure measurements, glucose levels and incidence of adverse events between the two groups. Efficacy will be assessed by comparing right and left ventricular function in pre-operative vs post-operative transesophageal echocardiograms, need for mechanical circulatory support, ease of separation from bypass and Vasoactive Inotrope Score (VIS) between the two groups. The information gained could pave the way for the use of Katp (Potassium-atp) channel openers to prevent stunning, improve patient outcomes, and reduce health care costs related to myocardial stunning that requires inotropic and mechanical support following cardiac surgery.

This is a randomized blinded Phase I clinical trial. Thirty patients total will be randomized on a 2:1 basis to treatment (IV Diazoxide added to cardioplegia) vs control (cardioplegia alone). Diazoxide will be added to the first dose of cardioplegia only. Subsequent doses of cardioplegia will not contain additives.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Scheduled for cardiac surgery with cardiopulmonary bypass and cardioplegic arrest
* Patient scheduled for elective cardiac surgery

Exclusion Criteria:

* Patient with Diabetes Mellitus on sulfonylurea medications
* Scheduled for left ventricular assist device (LVAD) or heart transplant
* Left ventricular ejection fraction \< 30%
* Pre-operative placement or planned use of mechanical circulatory support during surgery
* Allergy to Thiazide and its derivatives
* History of gout
* Patient is pregnant or breastfeeding
Stress, Dietary Lapse and Weight Loss Among Adults With Type 2 Diabetes

A clinical trial that uses personal digital assistants (PDAs) to assist in examining the relationship between self reported stress, an objective biochemical indicator of stress (salivary alpha amylase) and self-reported dietary lapse among type 2 diabetic adults who are interested/undergoing in weight loss.

In the study, all participants will be provided with a personalized ADA-based diet plan and a pre-programmed PDA. They will be required to record their mood and activities into the PDA whenever PDA prompts, they break their diet plan, and/or and face significant stress. They will also be required to collect saliva samples periodically. In addition to this they will be administered the Trier Social Stress Test once during the study, where they will perform certain stress inducing tasks like delivering a speech and solving maths problems. Salivary samples will be collected before and after these tasks. They will also take various questionnaires during each of the 15 to 16 visits. The completed questionnaires, PDA records and reports of salivary alpha amylase levels will be analyzed to examine the corelation between stress, dietary lapse and weight loss.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 to 65 years, seeking weight loss.
* Type 2 diabetes diagnosis by American Diabetes Association standard criteria. (Confirmed by physician's note or blood glucose reports in previous year or Prescriptions for medications to control blood glucose dated in participant's name within last year).
* BMI \> 30 kg/m2.

Exclusion Criteria:

* Major depression.
* Cognitive impairment severe enough to preclude informed consent or valid self report.
* Use of medications that significantly affect appetite.
* Eating disorder.
* Inability or unwillingness to use PDA for 6 months.
* Inability or unwillingness to collect saliva samples.
Educational Videos to Improve Patient Decision Making and Race Disparities in Implantable Cardioverter Defibrillator Use

The investigators will examine whether an educational video increases patient knowledge about heart failure and the risk of sudden cardiac arrest and leads to greater satisfaction with information provided as compared to usual care. Additionally, the investigators will look at whether racial concordance (physician and patient being of the same race) improves satisfaction with the patient's treatment decision and disease knowledge. Our hypothesis is that a video in which participants are of the same race as the patient will provide better education and more satisfaction with the treatment decision and may lead to more patients choosing ICD therapy.


Eligibility Criteria:
Inclusion Criteria:

* Class I primary prevention indications for an implantable cardioverter defibrillator (ICD). These include:
* Patients with ejection fraction \<35% due to prior myocardial infarction (MI) who are at least 40 days post-MI and with New York Heart Association (NYHA) functional class II or III;OR
* Patients with nonischemic dilated cardiomyopathy (DCM) who have an LVEF \< 35% and who meet criteria for NYHA functional class II or III; OR
* Patients with left ventricular dysfunction due to prior MI who are at least 40 days post-MI, have an left ventricular ejection fraction (LVEF) \<30% and are in NYHA functional class I-III; OR
* Patients with nonsustained ventricular tachycardia (VT) due to prior MI, LVEF \<40%, and with inducible ventricular fibrillation (VF) or sustained VT at electrophysiological study; AND
* Self identified race as black/African American or white/Caucasian