cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Study to Characterize Phenotyping Metrics of the "Basel" Cocktail After CYP Induction or Inhibition

The purpose of this study is to assess how the pharmacokinetic profiles of each drug of a cocktail of six approved drugs (so-called "Basel cocktail") change when the cytochrome P450 system is inhibited or induced.


Eligibility Criteria:
Inclusion Criteria:

* Male aged between 18 and 35 years (inclusive) at screening.
* No clinically significant findings on the physical examination at screening.
* Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) and body weight at least 50 kg at screening.
* Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg and heart rate (HR) 45-90 bpm (inclusive).
* 12-lead electrocardiogram (ECG) without clinically relevant abnormalities at screening.
* Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening.
* Ability to communicate well with the investigator and to understand and comply with the requirements of the study.

Exclusion Criteria:

* Known hypersensitivity to any excipients of the drug formulations.
* Treatment with another investigational drug within 30 days prior to screening.
* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
* Positive results from urine drug screen at screening.
* Excessive caffeine consumption, defined as \>800 mg per day at screening\*.
* African or Hispanic ethnicity.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity.
* Smoking within the last 3 months prior to screening.
* Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to the intended start of study.
* Loss of 250 ml or more of blood within 3 months prior to screening.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* Legal incapacity or limited legal capacity at screening.
Myopia Control Using Optimized Optical Defocus RCTs

The aims of the study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.

The purpose of the current study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.

The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.

The efficacy of the DISC3.5 Plus lens in slowing myopia progression (change in refractive error) will be compared to a spherical (front and back surface) single vision soft contact lenses in this one-year prospective, randomised and double-masked clinical trial. The hypothesis of this study is that the DISC3.5 Plus will slow myopia progression more than spherical single vision soft contact lenses.

Eligibility Criteria:
Inclusion Criteria:

* Age at enrolment: 8-13 year; Hong Kong Chinese
* Spherical equivalent refractions (SER): -1.00 to -5.00D
* Astigmatism: -1.00D or less
* Anisometropia: 1.25D or less
* Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better
* Contact lens corrected monocular VA: 0.1 logMAR or better
* Normal binocular function
* Willingness to wear contact lenses regularly
* Parents' understanding and acceptance of random allocation of grouping and masking

Exclusion Criteria:

* Prior myopia control treatment, e.g. orthokeratology, defocus soft contact lenses, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.
* Strabismus or decompensated phoria (checked by cover test at far and near in screening)
* Known contraindications for contact lens wear
* Have any ocular and systemic diseases and abnormalities that might affect visual function or refractive development
Videolaryngoscopy in Patients With Cervical Spine Immobilisation

Tracheal intubation is more difficult in patients in whom cervical spine immobilisation is maintained during tracheal intubation. The McGrath Series 5 videolaryngoscope offers a potential solution. The relatively short radius of the blade curvature combined with the internal arrangement of optimal components means that the glottis can be seen without the need for alignment of the oral, pharyngeal and tracheal axes.

The investigators propose that the McGrath Series 5 videolaryngoscope will improve the view of the larynx in patients with limited neck movements, making intubation quicker, easier and possibly safer.


Eligibility Criteria:
Inclusion Criteria:

* Elective procedure requiring tracheal intubation
* Over 16 years of age

Exclusion Criteria:

* Emergency procedure
* Less than 16 years of age
* Unable to consent
* Symptomatic gastro-oesophageal reflux disease
* Evidence of raised intracranial pressure
* Known pharyngeal pathology
Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion

The purpose of the trial is to evaluate the safety of microplasmin as well as its ability to open blocked arteries to the brain in patients with acute stroke when given into the artery at the site of the blockage.

Patients with angiographically documented acute intracranial vertebrobasilar artery occlusion presenting within 24 hours of neurological symptom onset will be enrolled into this open-label trial. During study drug administration, angiograms will be repeated at regular intervals to determine degree of clot lysis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with angiographically documented vertebrobasilar artery occlusion
2. Initiation of study drug treatment within 24 hours of the onset of neurological symptoms
3. Age 18-75 (inclusive).

Exclusion Criteria:

1. Patients with coma \> 6 hrs duration and complete loss of brain stem reflexes (corneal reflex, gag reflex, VOR, pupil reflexes) as measured at the last assessment before sedation/intubation
2. Rapidly improving neurologic signs at any time before initiation of study drug administration.
3. Known contrast agent-sensitivity
4. Uncontrolled hypertension defined as a systolic blood pressure \> 180 mm Hg or a diastolic blood pressure \> 100 mm Hg on 3 separate occasions at least 10 minutes apart or requiring continuous IV therapy.
5. History of stroke within the previous 6 weeks.
Prevalence of Strokes Secondary to a Reversible Cerebral Vasoconstriction Attributable to Cannabis Consumption in Young Subjects (≤ 45 Years) Hospitalized for an Ischaemic Stroke

Incidence of strokes has increased these last 20 years in young population. This rise could be linked to alcohol, tobacco or drug use like cannabis. Cannabis has previously been descripted as a potential factor of reversible vasoconstriction. The main objective is to show that an exhaustive assessment of a stroke facing a young person frequently lead to a diagnostic of reversible vasoconstriction due to cannabis use. Evaluation will focus on prevalence of strokes secondary to a reversible vasoconstriction attributable to cannabis in young subjects.

There's a real public healthcare interest in terms of primary and secondary prevention to evaluate the role of cannabis as a risk factor of stroke in young population.


Eligibility Criteria:
Inclusion Criteria:

* Subject between 18 and 45 years old
* Stroke confirmed by medical imaging
* Written informed consent (subject, nearby or emergency procedure)
* Subject affiliate to a local healthcare insurance office
* For female of childbearing potential, an adequate contraceptive measur

Exclusion Criteria:

* Subject with psychiatric disorder, unable to understand the study or cooperate
* Subject under guardianship or forfeiture of liberty
* Pregnant or breastfeeding woman
* Subject in period of exclusion due to another study or still in follow-up of an interventional study
Use of Direct-acting Antiviral to Treat HCV Recurrence After Liver Transplantation (ANRSCO23CUPILT) Infection

The purpose of this study is to evaluate the efficacy, safety and tolerability of direct-acting antivirals therapy in liver transplanted patients who experienced HCV recurrence.

This cohort is multicentric with constitution of biobank (plasma, serum) and the prospective collect of biological and clinical data's in the liver transplanted patients with recurrent HCV infection and treated with direct-acting anti-HCV agents.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years-old
* Liver transplanted patient
* Hepatitis C virus infection before transplantation
* HCV recurrence with a detectable HCV RNA before enrollment in cohort
* Use of at least one direct-acting antiviral agents with or without association with peginterferon and with or without association with ribavirin
* Treated by direct-acting antiviral agents or has been yet completed the treatment but still on follow up
* Affiliated to Health Insurance
* Written Signed consent form

Exclusion Criteria:

* Pregnant or breast-feeding female
Efficacy of Fascia Lata Allograft and Platelet Rich Fibrin on the Periodontal Phenotype Around Dental Implant

To compare between the efficacy of fascia lata allograft and platelet rich fibrin versus subepithelial connective tissue graft on periodontal phenotype (thickness and width of keratinized tissue, labial bone thickness) around dental implant in upper anterior region.

In order to evaluate the effectiveness of fascia lata allograft, platelet-rich fibrin, and subepithelial connective tissue graft on periodontal phenotype (including the thickness and width of keratinized tissue, as well as the thickness of labial bone) around dental implants in the upper anterior region, the purpose of this study is to compare the three types of grafts.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with thin gingival biotype (gingival thickness was ≤1 mm)
2. The height of keratinized gingiva for the site selected should be ≥2 mm.
3. Ability to maintain good oral hygiene as evidenced in recall visits.

Exclusion Criteria:

1. Smoker patient and pregnant or lactating woman.
2. Patient with poor oral hygiene or active periodontal disease.
3. Traumatic occlusion or para-functional habits such as clenching or bruxism.
4. Patient with limited mouth opening
Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder

The study will evaluate the efficacy of agomelatine compared to placebo on the reduction of Obsessive and Compulsive symptoms after 16 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Obsessive Compulsive Disorder (OCD) according to Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR),
* Y-BOCS total score ≥ 20,
* duration of OCD symptoms of at least one year.

Exclusion Criteria:

* Bipolar disorder, Schizophrenic or Psychotic Disorder
* Severe or uncontrolled organic diseases
* Neurological disorder
* Women of childbearing potential who are not using effective contraception
Investigating the Insulin Resistance in Individuals With Type 2 Diabetes

Numerous studies have provided evidence of a correlation between Type 2 Diabetes Mellitus (T2DM) and cognitive dysfunction, specifically in the realms of complex attention, information processing, and executive function. These impairments have been observed in middle-aged and elderly individuals with T2DM, with longer diabetes duration, suboptimal glycemic control, and the presence of diabetic complications being contributing factors. Recent research in young adults and adolescents diagnosed with T2DM has revealed cognitive and brain structural alterations in this growing demographic, suggesting that early disease mechanisms, rather than solely vascular and age-related neurodegeneration, contribute to pathogenesis. However, there remains uncertainty regarding the interplay between central and peripheral insulin resistance and its impact on cognitive dysfunction in individuals with T2DM. This study aims to investigate central insulin resistance in T2DM, elucidating its association with peripheral insulin resistance and the effects on cognitive impairments.

Participants screened through inclusion and exclusion criteria will accept cross-sectional evaluation. The information of demographic data, medical history, previous and current medication regimen, details of complications, and family history regarding metabolic diseases will be collected. The assessments includes physical examination, anthropometry, blood test(blood routine, liver function, renal function, blood lipids, fasting blood glucose, serum insulin，thyroid function and glycosylated hemoglobin A 1c), MRI scan( High-resolution T1-weighted Anatomical Images, Diffusion Tensor Imaging, Resting-state functional MRI and Arterial Spin Labeling) and psychiatry scales(Hamilton Depression Scale, Young Mania Rating Scale and Self-reporting Inventory-90); cognitive function will be assessed by the Measurement and Treatment Research to Improve Cognition in Schizophrenia(MATRICS) Consensus Cognitive Battery; biological samples also will be collected and stored to explore related mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic criteria for Type 2 diabetes: typical symptoms of diabetes plus random blood glucose level of ≥11.1 mmol/l, or fasting blood glucose level of ≥7.0 mmol/l, or 2-hour post-OGTT (Oral Glucose Tolerance Test) blood glucose level of ≥11.1 mmol/l, or HbA1c level of ≥6.5%; for those without typical symptoms of diabetes, re-examination on a different day is required for confirmation.

Exclusion Criteria:

* Having history of substance dependence or abuse or whose symptoms are caused by diagnosable mental disorders;
* Having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system;
* Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting;
* Taking drugs that could affect cognitive function.
* The routine blood tests showing significant abnormal renal, liver function or other somatic disease.
* Pregnant or lactating women.
Understanding the Role of Monoaminergic Neurotransmitters in Cognitive Functions Using Fast-cyclic Voltammetry in Patients with Neurological and Psychiatric Diseases Eligible for Neurosurgical Treatment (COGAMINE)

This study aims at dynamically mapping local variations in the concentrations of monoaminergic neurotransmitters (for e.g. dopamine, serotonin and noradrenaline) in the human brain using fast-scan cyclic voltammetric recordings (FSCV). This study will be carried out on patients with neurological (for e.g. brain cancer, Parkinson disease (PD) or treatment-resistant epilepsy ...) or psychiatric (for e.g. Treatment resistant obsessive compulsive disorder, depression, Tourette syndrome ...) diseases who are eligible to neurosurgical treatment. Typical neurosurgical treatments non-exhaustively include: (1) deep brain stimulation (DBS) electrode implanted as part of the routine management of their pathology (PD, etc.) or as part of clinical trials (treatment resistant depression, resistant obsessive-compulsive disorder, etc.), as well as on patients whose pathology requires invasive exploration by stereotactic-electroencephalography (S-EEG) for therapeutic purposes, either as part of their routine management or as part of a clinical trial. The aim of this mapping is to assess fluctuations in local concentrations of key monoaminergic neurotransmitters involved in cognitive functions at an individual level, with a high temporal (sub-second) and spatial resolution, as well as a sensitivity, that was previously unattainable with other neuroimaging techniques. The data collected in this study will improve our understanding of the role of monoaminergic neurotransmitters in normal human cognition, as well as their dysfunctions in psychiatric and neurological disorders. These data may guide research into new therapeutic targets for the treatment of these pathologies. This study requires a large cohort of patients to build up the most comprehensive database possible, for which access to the information collected is essential.


Eligibility Criteria:
Inclusion Criteria:

* Patient of 18 years old or older;
* Patient undergoing S-EEG invasive exploration OR a neurosurgical procedure (such as DBS or resection neurosurgery in an awake patient) as part of the management of a neurological or psychiatric disease (routine management or participation in a clinical study);
* Patient informed and having signed the consent form;
* Patient able to perform the cognitive tasks proposed.

Exclusion Criteria:

* Patient not affiliated to a social security or other social protection scheme;
* Patient with contraindication to S-EEG or neurosurgery.
Efficacy and Safety Of Different Regimens In Patients With Type 2 Diabetes Receiving Intensive Insulin Therapy

The purpose of this studay is to compare the efficacy of different hypoglycemic regimens versus twice-daily premixed insulin in type 2 diabetes mellitus (T2DM) patients after short-term ntensive Insulin Therapy by using continuous glucose monitoring.

This randomized, positive-controlled, open-label, parallel-group study will enroll approximately 78 male and female patients aged 18-70 years with poorly-controlled T2DM (HbA1c \>9% or FBS\>11.1mmol/L) after short-term intensive insulin therapy. Eligible patients will then be randomized in a 1:1:1 ratio to insulin glargine plus OADs or twice-daily premixed insulin or Insulin Degludec \& Liraglutide for 3 months with metformin maintained throughout the study in both treatment groups. All the patients will wear CGM during short-term intensive insulin therapy and after treatment for 7 days. The primary endpoint is plasma glucose change from baseline to month 3. Secondary endpoints include assessment of fasting plasma glucose, total daily insulin dose, hypoglycemia incidence, body weight change, adverse events, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-70 years with poorly-controlled T2DM (World Health Organization diagnostic criteria)
* BMI 21\~32Kg/m2
* duration of T2DM more than 1 year
* FPG≥11.1mmol/L or HbA1c ≥9% for three months
* fasting C-peptide \>1 ng/mL

Exclusion Criteria:

* acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma) within the past 1 month;
* impaired renal function,defined as (but not limited to) serum creatinine levels ≥1.5 mg/dL for males and ≥1.4 mg/dL for females, or the presence of macroproteinuria (\> 2 g/day)
* pregnancy
* inability to perform self-monitoring of BG (SMBG)
* acute disease or surgery in the past 3months or preparation for the surgey
AZA+Lus VS AZA Monotherapy in HR-MDS

This study is a randomized, prospective, single-center, open-label cohort study involving untreated HR-MDS patients. The patients were divided randomized into AZA+Lus cohort and AZA monotherapy cohort.

The hypomethylating agents (HMA) azacitidine (AZA) and decitabine (DEC) have been shown to improve survival and delay disease progression in patients with high-risk MDS. They are recommended by the NCCN as first-line treatments for patients with high-risk MDS. Clinical trials have demonstrated an OR rate of approximately 40-50% with AZA in patients with high-risk MDS. Despite the efficacy of HMA therapy, the rate of transfusion independence remains low. Anemia remains the most prominent symptom in refractory patients, with very limited options for subsequent treatment. Prolonged anemia affects every organ function and seriously affects the prognosis of patients.

Luspatercept is currently approved for the treatment of patients with both erythropoiesis receptor agonist ( ESA) treatment failures in transfusion-dependent low-risk MDS-RS patients. In a randomized controlled phase III clinical trial, compared to a placebo group, luspatercept significantly improved transfusion dependence and improved hemoglobin and quality of life in refractory MDS-RS patients. A recent conference report suggested that there was no significant difference in efficacy between low-risk and high-risk patients treated with luspatercept and that the HI rate for high-risk patients treated with luspatercept monotherapy was approximately 50%.

Thus this study aimed to compare the efficacy of AZA+luspatercept and AZA monotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Diagnosed as higher-risk MDS (IPSS intermediate-2/high-risk, or IPSS-R \>3.5, or IPSS-M moderate high-, high-, very high-risk)
* Untreated patients
* Liver and kidney function less than 2 times of upper limit of normal
* ECOG≤2 and expected survival more than 6 months
* Informed consent signed

Exclusion Criteria:

* With active infection
* Other malignant tumors
* Obvious abnormal liver and kidney function, or abnormal function of other organs
* Combined with myelofibrosis
* Have undergone bone marrow transplantation
* Pregnant or lactating women, or men who have recent reproductive needs
* Allergic to azacytidine, Rotercept or excipients
* History of polysorbate 80 allergy
* Refuse to sign informed consent
* Researchers consider it inappropriate to participate in the experiment
Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis

To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage


Eligibility Criteria:
Inclusion Criteria:

* Written consent
* Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons.
* Sensitised to grass pollen (positive SPT and RAST level of at least class 2).
* Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12.
* Safety laboratory resuts within the references ranges

Exclusion Criteria:

* Pregnancy, breast-feeding/lactation
* Had received desensitisation treatment for grass pollen
* Treatment by immunotherapy with another allergen within the previous 5 years
* Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies
* Treated with beta-blockers or under continuous corticotherapy