cyrilzakka/clinical-trials huggingface dataset:
Effects of the D3 Antagonist GSK598809 on Food Reward and Reinforcement

This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

This novel compound is being developed for the treatment of substance dependence and potentially other impulse control disorders.

This is an fMRI study designed to examine the behavioural and physiological effects of a single dose of novel compound on food reward and reinforcement in relation to food seeking behaviour under conditions of fasting, using fMRI, neurocognitive and metabolic endpoints in overweight and obese subjects. These main objectives will be evaluated in the principal part of the study, Part A. The study will also consist of a follow up period of weight management with a dietician where exploratory objectives are considered, Part B.

Part A, will be a single-blind, randomised, placebo controlled, multi-centre, two-period cross-over study. Approximately 24 subjects will be enrolled such that a minimum of 20 subjects complete dosing and critical assessments. All subjects will be required to complete questionnaires, perform a series of behavioural tasks and scanning procedures. Safety and tolerability will be assessed by monitoring subjects for adverse events, vital signs, ECGs, movement disorders (EPS, Akathisia) and laboratory parameters. The pharmacokinetic profile of the compound in this subject population will be determined by blood sampling over a 72 hour period post dosing, in both sessions. Part B will consist of 12 weeks weight management directed by a dietician on an outpatient basis. Subjects will have fortnightly visits with a dietician and at the end of the 12 weeks complete three questionnaires (TFEQ-18R, DBEQ and YBOCS-BE) and have their weight measured to assess weight loss.

Eligibility Criteria:
Inclusion Criteria:

* generally healthy
* right handed
* binge eating episode
* use appropriate contraception method
* willing to see a dietician
* overweight or obese (BMI 27 - 40 kg/m2)

Exclusion Criteria:

* pregnant or breast feeding female
* recent weight loss or gain
* recent use of weight loss drugs
* surgery for obesity
* abuse alcohol or drugs
* cannot do MRI scans
* smokers
* certain emotional problems being treated with medications
* medical, surgical or neuropsychiatric illness
* ECG abnormality
* sudden unexplained death or syncope in first degree relatives
Kimel Family Centre for Brain Health and Wellness

Participants (n=450; aged 50+; without a diagnosis of dementia; sufficiently fluent in English to complete the assessments and engage in programming) receive a comprehensive dementia risk assessment, including nonmodifiable and modifiable risk factors, from which they receive a Personalized Dementia Risk Report and Program Strategy, indicating their health conditions increasing and their risk level in five modifiable risk domains: physical activity, brain- healthy eating, cognitive engagement, social connections, and mental wellbeing. Equipped with this information, participants enroll in programs within the Centre to address their risk factors. Changes to their dementia risk, cognition, and Personalized Program Strategy are communicated through re-assessments of risk factors every six months (risk and cognition) and every year (comprehensive assessment).

Participants (n=450; aged 50+; without a diagnosis of dementia; sufficiently fluent in English to complete the assessments and engage in programming) complete a baseline assessment consisting of three parts. A biosample session in which blood is drawn to measure HbA1c, cholesterols, thyroid levels, c-reactive protein, interleukin-6, homocysteine, and BDNF, and a saliva sample is provided to provide a polygenic risk score for AD. A questionnaire session is completed on a tablet or from home asks about demographics, health conditions, and five targeted modifiable factors: physical activity, brain-healthy eating, cognitive engagement, social connections, and mental wellbeing. A clinical session measures vitals, sensory function, frailty markers (grip strength, DXA, ultrasound of right quadriceps muscle), dual-task gait, and cognition (MoCA and Cogniciti's Brain Health Assessment). From that assessment, participants receive a Personalized Dementia Risk Report and Program Strategy, outlining conditions that are known to increase dementia risk, with resources provided on how to get them addressed, as well as their risk level in the five targeted domains. Participants then take a SMART goal setting workshop to identify SMART goals addressing their dementia risk factors, and then sign up for programming in the centre to reduce their risk. After six months, their risk in the five targeted domains, cognition (Brain Health Assessment), and satisfaction are re-assessed, and every year, most of the baseline assessment is repeated. We expect that this personalized approach will result in reductions in risk in the five targeted domains within the first six months, improvements in health factors within the first year, and improvements in cognition within two years.

Eligibility Criteria:
Inclusion Criteria:

* Aged 50 years or older
* Sufficiently fluent in English to complete the assessments and participate in programming.

Exclusion Criteria:

* Diagnosis of dementia.
Using the Optovue OCT to Select IOL Power

Many patients with endothelial dysfunction also present with cataracts. It is therefore common practice to perform cataract extraction and intraocular lens (IOL) implantation during the same operation and immediately prior to Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK), in order to minimize trips to the operating room and the associated risks of ocular surgery. However, the unique posterior corneal anatomy of the DSAEK recipient makes it difficult to predict pre-operatively the proper power of IOL to place, and some patients end up with a mismatched lens that requires spectacle correction. The current gold standard for IOL power calculation (A-Scan optical biometry) takes measurements of the anterior surface of the cornea and makes assumptions about the posterior surface that are violated by the unique hourglass shape of the donor DSAEK graft. New optical coherence tomography (OCT) technology provides us with the ability to measure curvature in both the anterior and posterior aspects of the cornea in order to generate an IOL calculation that has the potential to give more accurate results for our DSAEK patients.

The investigators will be using the Optovue to perform corneal power analysis on patients who have already received DSAEK and cataract surgery, in order to compare the post-op Optovue power calculations to the pre-operative power calculations provided by the A-Scan. If the OCT is shown to provide accurate IOL power calculations, then some patients might be better served by a two-stage procedure where DSAEK is performed and then followed six months later by cataract surgery using the OCT to calculate IOL power.


Eligibility Criteria:
Inclusion Criteria:

* 18 year of age or older
* Diagnosis of Fuchs' Endothelial Dystrophy with cataract
* Recent history of DSAEK with concurrent phacoemulsification \& intraocular lens (IOL) implantation

Exclusion Criteria:

* Diagnosis of ocular comorbidity that might be limiting to visual acuity (glaucoma, retinal disease, surface irregularities, etc.)
Comparison of the Efficacy of Leflunomide and Azathioprine for the Maintenance Therapy of ANCA Associated Vasculitis

This study is a prospective, open-labelled, randomized, controlled,multi-center clincial trial. The aim of this study is to verify that the remission rate of patients treated with Leflunomide is not inferior to that of patients treated with Azathioprine.

Background The basic theme of AAV is relapse and remission. The maintenance therapy of AAV aimed to reduce or prevent relapse is very challenge. Although many medications have been used for the maintenance of AAV, Leflunomide (LEF) has not studied thoroughly yet. So far, only one study tested the efficacy of LEF in the maintenance therapy for AAV. However, the sample size of this study is small, so large size clinical study is needed to clarify the role of LEF in the maintenance of AAV.

LEF is one of the most frequently prescribed DMARDs in the treatment of rheumatic diseases in China. It is cheap and widely available. Many experiences have been accumulated about its efficacy and safety in Chinese patients with rheumatic diseases. But there is no study to show its effectiveness in the reduction of the relapse of AAV in China. In this study, we try to compare the effectiveness of LEF and AZA, the gold standard for maintenance therapy, in the maintenance of AAV.

Objectives To verify that the effectiveness of LEF in reducing relapse is not inferior to AZA by comparing the relapse rate of LEF and AZA during the 18 month maintenance treatment of AAV.

Study Design This is a prospective, randomized, open-label, control, non-inferiority study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age 18 to 75 years, both genders can be included.
2. Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis, microscopic polyangiitis, or EGPA in complete remission after combined treatment with glucocorticoids and pulse cyclophosphamide or Rituximab. Remission is defined as a Birmingham Vasculitis Activity Score(BVAS version 3) of 0.
3. Patients must fulfill the 1990 ACR classification criteria of GPA, EGPA and 2012 modified Chapel Hill classification criteria of MPA.
4. Patients have to be ANCA-positive at diagnosis or during the course of their disease.
5. Patients must sign the informed consent.

Exclusion Criteria:

1. Patients with TPMT gene mutation；
2. Patients who had been treated with either AZA or LEF but relapsed in the past;
3. Patients who had been treated with either AZA or LEF but had to stop due to adverse events or intolerance;
4. Patients who have planned for pregnancy in next 2 years;
5. Patients with severe liver dysfunction(defined as the elevation of liver enzyme 3 times the upper limit or Child grade III) or ESRD；
6. Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection;
7. Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection;
8. Patients who are not eligible according to the judge of the principal investigators or site investigators.
Oxymatrine Plus Lamivudine Combination Therapy Versus Lamivudine Monotherapy for Chronic Hepatitis B Infected Subjects

The purpose of this study is to evaluate the efficacy of Oxymatrine plus Lamivudine Combination Therapy and whether it could lower the incidence of Lamivudine long-term resistance compared to Lamivudine Monotherapy.

Group A (Lamivudine Monotherapy): Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd.

Group B (Oxymatrine + Lamivudine Combination Therapy): Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd; oxymatrine Capsules (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) 200 mg, po, tid.

Total subjects: 200, 100 patients randomized in each group.

Eligibility Criteria:
Inclusion Criteria:

1. 18 to 60 years old.
2. Subjects diagnosed as chronic hepatitis B according to 2000 Xi'an Conference Guidelines: Management of chronic hepatitis B. Alanine transaminase \>80 IU/L, total bilirubin\<85.5 mmol/L, Hepatitis B virus DNA \>1×10\^5copies/mL; haven't been treated with antiviral therapy within 6 months before screening.
3. able to give written informed consent and to comply with the study protocol.
4. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.

Exclusion Criteria:

1. Evidence of hepatocellular carcinoma
2. Clinical symptoms of Decompensated liver disease at screening, including but not limited to: Serum bilirubin≥1.5 x upper limit of normal, prothrombin time of greater than 2 seconds prolonged, a serum albumin\< 32g/L, or a history of ascites, variceal bleeding, or hepatic encephalopathy;
3. Alanine transaminase\>10 x upper limit of normal at screening or history of Transient hepatic decompensation caused by acute exacerbation;
4. hemoglobin\< 10g/dL, Neutrophil count\<1.5 × 10\^9/L, platelet count\< 80 × 10\^9/L;
5. Evidence of active liver disease from other causes, including co-infection with hepatitis A virus, co-infection with hepatitis E virus, co-infection with hepatitis C virus, co-infection with hepatitis D virus, co-infection with HIV, autoimmune hepatitis (antinuclear antibody titer\> 1:100);
6. Use of immunosuppressors, immunomodulators (including interferon or thymosin) within 6 months before enrollment.
Neuroplasticity:Melatonin and Transcranial Current Stimulation in Healthy Subjects.

Pain exerts a tremendous cost in healthy care, rehabilitation and lost productivity. It is is associated with a wide range of diseases and their social consequences is a public health problem.

With the progress of neuroscience and studies on the plasticity of the central nervous system, it has been provided a better understanding of the neurobiological mechanisms of pain.

The neurohormone Melatonin stands by having systemic and diverse mechanisms of action, both in physiological and pathological situations, with modulating effects on the process of nociceptive signaling and neurochemical mechanisms such as serotonergic, opioidergic and GABAergic, exerting anti-inflammatory action, analgesic activity among others.

The advent of neuromodulation techniques such as transcranial direct current stimulation (tDCS), which promote changes in neuronal activity and signaling to be effective in conditions of chronic pain by attenuating changes in cortical excitability.

There is clinical evidence of the analgesic effect of Melatonin and tDCS alone. Thus, considering the potential for each isolated intervention and the lack of knowledge of their combined effect, the authors propose the present study to investigate the effect of this combination on the heat-pain detection threshold and the neuroplasticity in the healthy subjects.

The methods are according to the CONSORT guidelines.

Heat pain threshold and tolerance : Quantitative Sensory Testing (QST) will be used on a computer Peltier-based device thermode.

Conditioned Pain Modulation (CPM)-task: Immerssing the non-dominant hand cold water for 1 minute.

Serum Brain Derived Neurotrophic Factor (BDNF).

Transcranial Magnetic Stimulation (TMS) assessment: motor threshold, motor evoked potential, Short intracortical inhibition and intracortical facilitation.

Statistical analyses: Descriptive statistics, Linear and multiple regression analysis, performed with SPSS version18.0.

Eligibility Criteria:
Inclusion Criteria:

* Male 18-40 years old
* Healthy
* Without medication
* Sign the informed consent

Exclusion Criteria:

* Patients who did not understand the Portuguese
* Acute or chronic pain conditions
* Medical or psychiatric disorders
* History of alcohol or substance abuse
* Neurological disorder
* Use of medications affect in the central nervous system
* Traumatic brain injury
* Neurosurgery
* Metallic implant in the brain
Effects of BMS-986256 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil

A Study to Investigate BMS-986256 at steady state and its effect on Mycophenolate Mofetil exposure in Healthy Male Participants


Eligibility Criteria:
Inclusion Criteria:

* Healthy participant, defined as having no clinically significant active or ongoing medical condition, physical examination abnormality, abnormal ECG finding, with no current use of tobacco
* A negative QuantiFERON-TB Gold® test result at screening or documentation of a negative result within 3 months of the screening visit and a weight ≥ 50 kg and BMI between 18.0 and 32.0 kg/m2 inclusive at screening.
* Participants must not be current users (within 6 months before screening) of tobacco or tobacco- or nicotine-containing products; they must also be willing to refrain from using any of these products during their participation in the study.
* Men who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception (APPENDIX 4) for the duration of treatment with BMS-986256 or MMF, plus 5 half-lives of BMS-986256 (19 days) plus an additional 90 days (duration of sperm turnover) for a total of 109 days post treatment. In addition, participants must be willing to refrain from sperm donation during this time.

Exclusion Criteria:

* Any significant acute or chronic medical illness or condition, in the opinion of the investigator in addition to prior exposure to BMS-986256
* Major surgery within 4 weeks before study treatment administration, drug abuse or drug addiction.
* Participants who have smoked or used smoking cessation or other nicotine-containing products within 6 months before the first dose of study drug.
* History or presence of malignancy including hematological malignancies. However,participants with a history of basal cell or squamous cell carcinoma of the skin that has been completely and successfully treated with no evidence of recurrence may not be excluded, at the discretion of the investigator.
5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas

The goal of this observational study is to evaluate disease-free survival (DFS) in patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy

The investigators are proposing a study that provides descriptive understanding of patients with High-Grade Gliomas in Ecuador. The primary objective of this pilot study is to lay the foundations for the development of a multicenter registry patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy, which will provide high-quality real data and serve as a basis for the application to future projects and elaboration of public policies in the medium and long term.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 75 years (in pediatric cases will be included in the Central Nervous System (CNS) tumor board to make decisions on therapeutic management)
* Patients with radiological suspicion (contrast uptake) of high-grade glioma (Grade III-IV)
* Patients with high-grade and residual glioma following surgery for gross total resection
* Patients with recurrent gliomas with reoperation criteria who previously received radiotherapy and chemotherapy
* Patients for whom at least one postoperative magnetic resonance imaging (MRI) was available (up to 28 days after surgery and strictly before the start of radiotherapy)
* Progressing, low-grade infiltrative gliomas with one of the following criteria:
* Anaplastic foci with contrast uptake in MRI
* Spectroscopy study in anaplastic suspected area with high malignancy criteria
* Positive choline PET-CT (positron emission tomography / computer tomography)

Exclusion Criteria:

* Tumors extending across midline
* Basal ganglia tumor
* Brainstem tumor
* Multifocal gliomas
* Suspected low-grade glioma without anaplastic foci
* Neuraxial dissemination (ependymoma)
* Karnofsky grade less than 60%
* Infants or pregnant women
* Acute or chronic types of porphyria
* Non-acceptance of Fluorescence-Guided Surgery
* Renal insufficiency confirmed by nephrological assessment
* Hepatic impairment confirmed by gastroenterological assessment
* Severe heart disease confirmed by cardiological assessment
* Decompensated diabetes confirmed by endocrinological assessment
* Known allergy to any contrast agent and/or previous history of anaphylactic shock
* Hypersensitivity to the active substance or porphyrins
* Asthma confirmed by pulmonological assessment
* Pacemaker use
Covid-19 Airway Management

The study has a retrospective and a prospective component. The retrospective component aims to review data of all airway management related SAEs in COVID 19 patients (between April and July 2020); hypoxemia, hypotension and cardiac arrest within 15 min of intubation. The prospective component aims to assess the incidence of COVID-19 infection in Airway Management Team members by means of an interview assessing their COVID19 status after participating in airway management in the period outlined above. This prospective interview component is starting in December 2020.

Approximately 5-10% of all patients affected by COVID-19 develop severe respiratory distress. This has already involved hundreds of people in Ontario and thousands worldwide. In this situation, support with a mechanical ventilator is required. The first essential step to provide this support is to insert a breathing tube in the patent's trachea (windpipe), a process called 'endotracheal intubation' or more broadly, 'airway management'. While a fundamental lifesaving resource, endotracheal intubation in COVID-19 patents is a highly specialized procedure that carries risk both to patents and attending healthcare providers as follows. a) Clinicians involved in airway management for patients with coronaviruses are at extremely high risk of infection due to aerosol and droplet exposure during the procedure. b) Rapid administration of drugs that put the patent to sleep is usually required for prompt and safe endotracheal intubation. However, in physiologically compromised patents, life-threatening side-effects may occur, such as very low oxygen levels (in as many as 70% of patients), low blood pressure (18-22% of patients), and cardiac arrest (2%); these can significantly affect outcomes. No definitive data are presently available to accurately quantify the risk posed by such procedures to healthcare professionals and patents, nor the associated factors. We have developed a retrospective study reviewing data all airway management related SAEs in COVID 19 patients (between April and July 2020); hypoxemia, hypotension and cardiac arrest within 15 min of intubation. Additionally, we are going to prospectively interview Airway Management Team members that were involved in the airway management of COVID19 patients in the period described above, in order to assess whether they developed signs and symptoms and/or a confirmed COVID19 infection. This prospective interview component is starting in December 2020.

Eligibility Criteria:
Inclusion Criteria:

All Suspected or confirmed Covid-19 patients that require intubation Health care workers from the airways management team who performed an intubation on confirmed or suspected Covid-19 patients

Exclusion Criteria:

Lack of Health Care Provider Consent
Catecholamine Blockade Post-burn

Severe burn is associated with a wide array of stress, metabolic, and physiologic processes in an attempt to restore homeostasis. The catecholamine induced stress response following severe burns is particularly exaggerated and manifests detrimentally as inflammation, insulin resistance, hypermetabolism, and associated profound protein catabolism. The investigators hypothesize that catecholamine blockade will lead to restored IR signaling and result in improved post-burn morbidity. The investigators will further determine the molecular mechanisms mediating these effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 90 years of age
* \>25% TBSA burn

Exclusion Criteria:

* Death upon admission
* Decision not to treat due to burn injury severity