cyrilzakka/clinical-trials huggingface dataset:
Safety Study of a Single IVT Injection of QPI-1007 in Chronic Optic Nerve Atrophy and Recent Onset NAION Patients

This is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where active study drug (QPI-1007) will be given to all patients who participate.

This study will determine whether QPI-1007 is safe when it is injected into the eye. The study will also reveal if there are any side effects of the drug and how long it takes for the body to clear the drug.

Patients will be enrolled according to one of two sets of criteria designated as Stratum I and Stratum II.

1. Stratum I will enroll Optic Nerve Atrophy patients who meet necessary criteria. Stratum I will consist of a maximum of 6 cohorts and each cohort will enroll 3 to 6 evaluable patients. Enrollment in Stratum I is now closed.
2. Stratum II will enroll patients diagnosed with acute Non Arteritic Anterior Ischemic Optic Neuropathy (NAION) within 28 days of symptom onset who meet necessary criteria. Stratum II will consist of a maximum of 3 cohorts and each cohort will enroll up to 10 evaluable patients. Enrollment in Stratum II is still open.

Eligibility Criteria:
Key Stratum I (Chronic Optic Nerve Atrophy) Inclusion Criteria:

* "Legally blind" in the study eye as the result of an irreversible condition affecting the posterior segment of the eye.
* Clear ocular media and able to undergo adequate pupil dilation.
* Visual acuity and visual field in the non-study eye are better than or equal to the study eye
* At least 21 years old.

Key Stratum I (Chronic Optic Nerve Atrophy) Exclusion Criteria:

* For the study eye only: history of any IVT injection or vitrectomy, vitreous hemorrhage, retinal detachment, or active inflammatory condition (e.g. conjunctivitis).
* For either eye: history of uveitis.

Enrollment is now closed in Stratum I.

Key Stratum II (Acute NAION) Inclusion Criteria:

* Positive diagnosis of NAION with symptom onset within 28 days prior to planned dosing with QPI-1007.
* Visual acuity in the study eye is between 20/40 and light perception.
* Clear ocular media and able to undergo adequate pupil dilation.
* At least 50 years old.

Key Stratum II (Acute NAION) Exclusion Criteria:

* For the study eye only: Macular disease, retinopathy, or other eye disease limiting visual acuity; prior intraocular surgery (other than Lasik) and cataract surgery within 3 months prior to dosing; glaucoma laser surgery within 1 month prior to dosing; pain on or aggravated by eye movement; history of vitreous hemorrhage; history of retinal detachment; any active inflammatory condition (e.g. conjunctivitis); glaucoma or ocular hypertension; or intraocular pressure \> 26 mmHg.
* For either eye: History of optic neuritis; or history of uveitis.
* Received any treatment for NAION prior to dosing.
* Any other abnormality which in the opinion of the investigator is suggestive of a disease other than NAION in the study eye only.
* Clinical evidence of temporal arteritis.
* History of collagen vascular disease or other inflammatory disease, or history of multiple sclerosis.

Enrollment in Stratum II is still open.
Comparison of Postoperative Analgesic Effect of Intrathecal Magnesium and Fentanyl Added to Bupivacaine in Patients Undergoing Lower Limb Orthopedic Surgery

Magnesium has been suggested that NMDA (N-methyl D-aspartate)receptor antagonists induce preemptive analgesia when administrated before tissue injury , thus decreasing the subsequent sensation of pain.

Following Ethics Committee approval and informed patients consent, Ninety patients 20-60 yr old ASA physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,the fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl\[25microgram\] and the placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water intrathecally . Time to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension, ephedrine requirements, bradycardia ,hypoxemia \[Saturation of peripheral oxygen (SpO2)\<90\], postoperative analgesic requirements and Adverse events, such as sedation, dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, methadon5 mg intravenously , was to be given for post-operative pain relief as needed .


Eligibility Criteria:
Inclusion Criteria:

.patients with American Society of Anesthesiologists(ASA) physical status I and

II, undergoing elective femur surgery

-

Exclusion Criteria:

* significant coexisting disease such as hepato-renal and cardiovascular disease
* any contraindication to regional anesthesia such as local infection or ''''bleeding disorders
* allergy to opioids
* long-term opioid use
* history of chronic pain.
Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly Subjects

The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151 after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and elderly male Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body weight: ≥50.0 kg and \<85.0 kg
* Body mass index (BMI): ≥17.6 and \<26.4 kg/m2

Exclusion Criteria:

* Subjects with a complication of any diseases
* Subjects with a history of hepatic disease
* Subjects with a history of heart disease
* Subjects with a history of respiratory disease
* Subjects with a history of alimentary disease
* Subjects with a history of renal disease
* Subjects with a history of cerebrovascular disorder
* Subjects with a history of malignant tumor
* Subjects with a history of drug allergies or allergies disorders excluding pollinosis
* Subjects with a history of drug dependency or alcohol dependence syndrome
* Subjects who developed genital herpes or herpes zoster within 90 days before the initial dosing
* Subjects who do not meet any of the criteria for laboratory tests
* Subjects who received medications within 14 days before the initial dosing.
* Subjects who received any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or the initial dosing
* Excessive alcohol drinking or smoking habit
* Subjects who previously received administration of ASP2151 (including placebo)
* Abnormalities detected on an ophthalmological examination
* Subjects who deviate from the normal range of standard 12-lead ECG at screening
Real Life Study in Myopic Neovascularization

This is a multi centre, single arm, prospective observational phase 4 study in naive or pretreated patients with myopic neovascularization. The patients will be treated with intravitreal injections of Aflibercept following a real life protocol.

This sudy aims to evaluate the visual acuity during a 36 months period of time.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged 18 years and more under reliable method of contraception for woman with childbearing potenteial (hormonal or any intrauterine devices).
* High myopy defined by refractive error ≤ -6 D or History of high myopia among pseudophakic patient or patient treated with refractive surgery
* Patient with active CNVm
* • Patients naïve or Patients pretreated with previous history of laser photocoagulation or PDT or by other anti-VEGF treatments who did not receive injection since the last 3 month

  * with OCT or angiography examination

Exclusion Criteria:

* Treatment with an anti VEGF administrated by intravitreal injection within 1 months prior to baseline in the study eye.
* Treatment with PDT or laser administrated within 6 months prior to baseline in the study eye.
* History of vitrectomy in the study eye
* History of any other retinal disease
* VA less than 20/250
Efavirenz to Nevirapine Switch and Low-Density Lipoprotein (LDL)-Dyslipidemia

Dyslipidemia and coronary heart disease (CHD) are increasingly recognized in persons with human immunodeficiency virus (HIV) infection. Many antiretrovirals, including efavirenz (EFV), are associated with increases in serum lipids. The investigators investigated whether stopping EFV and replace EFV by nevirapine can reduce significantly Low-Density Lipoprotein cholesterol, while keeping virologic control of HIV.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected adults, who were receiving antiretroviral therapy including efavirenz for at least 6 months
* plasma HIV RNA\<400 cp/ml during the previous 4 months on 2 occasions 14 days apart
* Severe dyslipidemia with Low-Density Lipoprotein cholesterol (LDL-c) \>3.4 mmol/L in the presence of at least one of the 3 following coronary heart disease (CHD) risk factors: age\>45 among males or age\>55 among females, hypertension, current smoking, family history of CHD
* Low-Density Lipoprotein cholesterol (LDL-c)\>4.1 mmol/L regardless of CHD risk factors.

Exclusion Criteria:

* Protease inhibitors use within the previous 6 months,
* Prior exposure to nevirapine
* Asparate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5N if hepatitis virus B or C were negative
* AST or ALT\>1.25N if hepatitis virus B or C were positive
* Fasting glycemia\>1.26g/L,
* Current CHD
* Triglycerides\>4.6 mmol/L
* Introduction of lipid lowering drugs, corticoïds, retinoïds and betablockers within the previous 3 months.
NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts

This study will explore the ability of patients on first line combination immunotherapy to sample cytokines at home. The data from this study will be used to evaluate the feasibility of in-home testing and the ability to analyse patients cytokine profiles retrospectively to help feed the development of further studies.

Patients will be informed of the study and given a minimum of 24 hours to consider. Once consented patients will enter the study where they will take cytokine samples at home over a 12 week period.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary informed consent.
* Aged at least 18 years.
* Diagnosis of locally advanced or metastatic RCC, Melanoma or NSCLC
* In the opinion of the investigator deemed suitable to receive first-line combination immunotherapy (RCC and MM) or combination immunotherapy and chemotherapy (NSCLC).
* Willingness to comply with scheduled trial procedures.
* Capable of performing own dry blood sampling procedure, or a carer who is willing and able to perform them.

Exclusion Criteria:

* Previous immunotherapy (including any CPI either as single agent on in combination, or high dose interleukin-2).
* Judgement by the investigator that the individual should not participate if they are unlikely to comply with study procedures and requirements.
* Patients receiving long term oral anticoagulation deemed by the clinician to be at risk from daily finger pricking.
Whole-Body Diffusion-Weighted Magnetic Resonance Imaging (MRI) as a Response Biomarker for Metastatic Prostate Cancer

The skeleton is the most frequent organ of distal metastases in prostate cancer, often representing the only site of metastatic disease. Still, assessment of response and progression to therapies in bone metastases remains a major unmet need, to aid treatment switch decisions, detecting primary/secondary resistance and to optimize drug development. The currently used standard imaging techniques, computed tomography (CT) and bone scintigraphy (BS), do not depict the true extent of bone metastases and are suboptimal in capturing biological changes occurring in response to treatment.

This results in treatment switch decisions too often being based on PSA changes, which is neither a surrogate of survival, nor an optimal response biomarker.Diffusion-weighted imaging (DWI) is a functional magnetic resonance imaging (MRI) technique that studies the movement of water molecules within a tissue and provides valuable information about the tissue microstructure and cellularity. Whole body MRI with DWI is highly accurate for bone metastases detection, outperforming the standard CT and BS and other imaging techniques when assessing bone metastases.

The investigators hypothesise that DWI changes are a response biomarker in bone metastases from metastatic castration resistant prostate cancer (mCRPC); these DWI changes can be detected as early as after 4 weeks of systemic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Men 18 or over years old.
* Patients with castration resistant prostate cancer.
* Evidence of bone metastases by any imaging technique.
* Patients due to start treatment with abiraterone or enzalutamide. In the exploratory cohorts, we will include patients due to start treatment with other systemic therapies for advanced prostate cancer (A-taxanes, B-radiopharmaceuticals, C-other therapies).
* Written (signed and dated) informed consent.

Exclusion Criteria:

* Contraindications to MRI.
* Inability of patient to tolerate whole body MRI (e.g. claustrophobia).
* Patients who have received radiotherapy within the last three months and with no bone metastases outside the radiotherapy field.
A Study of Ibandronate (Boniva) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia

This study will investigate participant satisfaction (including compliance, preference, tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or risedronate. The anticipated time on study treatment is 6 months, and the target sample size is 1776 individuals.


Eligibility Criteria:
Inclusion Criteria:

- Women who had been receiving once-weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis for greater than or equal to (\>=) 3 months

Exclusion Criteria:

* Inability to stand or sit upright for \>=60 minutes
* Hypersensitivity to bisphosphonates
* Inability to swallow a tablet whole
* Malignant disease diagnosed within previous 10 years (except resected basal cell cancer).
Re-evaluating Triglycerides in Coronary Heart Disease

To conduct a comprehensive epidemiologic investigation into the relationship between serum triglyceride (TG) levels and coronary heart disease (CHD).

BACKGROUND:

The results of this investigation helped to shed substantial light on the controversial relationship between triglycerides and coronary heart disease, a topic of great importance to preventive cardiology. Additionally, important methodological information was obtained in the study of interactions and precision of variables in epidemiologic analysis.

DESIGN NARRATIVE:

There were three components to the study: 1) an analysis of several existing cardiovascular databases for evidence of a significant association between coronary heart disease and specific lipid interactions involving triglycerides; 2) an analysis of these databases to investigate the role of measurement precision on the association between elevated triglyceride levels and coronary heart disease; and 3) a survey of both expert lipidologists and community clinicians to examine current practices related to screening for and treatment of elevated triglyceride levels for the purpose of reducing coronary heart disease risk. Five databases were used in the first two components of this study. These data sets included those of the Lipid Research Clinics Prevalence and Mortality Follow-up Studies; the Lipid Research Clinics Coronary Primary Prevention Trial; the Multiple Risk Factor Intervention Trial; the National Heart, Lung, and Blood Type II Coronary Intervention Study; and the Coronary Drug Project. For the first component, detailed statistical analyses of all databases were performed, specifically examining the role of lipid interactions involving triglycerides and their association with coronary heart disease. For the second component, more precise estimates of each subject's lipid levels were recalculated using the multiple lipid measurements already available in each database. Each dataset was then analyzed for evidence of an independent relationship between triglycerides and coronary heart disease and to validate the theoretical findings suggesting that measurement imprecision may explain the difficulty of detecting an independent triglyceride-coronary heart disease association. The public health implications of the current state of knowledge surrounding triglycerides were assessed with survey research techniques in the third component.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Identification and Treatment of Alcohol Problems in Primary Care

The Identification and Treatment of Alcohol Problems in Primary Care (iTAPP) Study is a pragmatic cluster randomized controlled intervention trial evaluating the effectiveness of the 15-Method as an identification and treatment tool for alcohol-related problems in Danish general practice. The 15-Method combines evidence-based approaches from specialized addiction treatment with screening and readily available treatment options in general practice to help identify and treat alcohol problems in a primary care setting. The method has shown promising results as a treatment tool in Sweden. A feasibility study of the 15-Method in Denmark suggested that the method can be implemented in Danish general practice.

The trial is led by the Unit for Clinical Alcohol Research at The University of Southern Denmark in collaboration with The Research Unit of General Practice Odense at The University of Southern Denmark.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Affiliated with the participating general practices

Exclusion Criteria:

- None
Effectiveness of a Knowledge-based Intervention for Patients With Cutaneous Lupus Erythematosus

Studies have shown that there are significant differences in severity and outcome of lupus in patients of colored skin compared with Caucasians. There are many factors that lead to this discrepancy: genetics, poverty, education level, as well as behavioral and cultural factors. Cutaneous Lupus Erythematosus (CLE) is a disease of flares and remissions with identifiable triggers. One of the most aggravating triggers in CLE is sun exposure. The investigators hypothesize that there are disparities in knowledge about photoprotection, leading to poorer outcomes in minority ethnic groups. This study aims to assess knowledge of risk factors and triggers, especially sun exposure, and the effects on quality of life of Caucasian and minority populations, by conducting an assessment survey and subsequent teaching intervention on appropriate skin protection techniques including appropriate sun screen application, and use of sun-protective clothing. After three months a survey to evaluate knowledge retention about and the application of the educational intervention will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of cutaneous lupus erythematous
* Subjects ages 18 years of age and older and able to give consent

Exclusion Criteria:

* That which does not fit the inclusion criteria
Subclavian Vein Ultrasound Guided Cannulation in Adult

There is actually two techniques of subclavian vein ultrasonography-guided venous catheterization : the axial and longitudinal approach. Currently, nothing makes it possible to privilege one technique compared to the other. This study aims to determine the best ultrasonography-guided method.

This prospective randomized study will concern 100 adult patients operated of cardiac surgery under general anesthesia and requiring a central venous catheter. Patients will be randomized by an operator experienced in echoguided venous catheterization to be included in the axial (50 patients) or the longitudinal (50 patients) approach group. The device used will be a vascular probe of 7.5 MHz (Sonosite I Look®). The principal outcome measure will be the time from percutaneous puncture to the rise of the metallic guide (seldinger technique). The secondary criteria will be the rate of complication and failure. A series of echographic (size and depth of the subclavian vein and biometric (BMI, theoretical distance not from puncture (way of Aubaniac)/réel) measurements will be done to identify predictive conditions of success or failure depending of the echographic approach.

Eligibility Criteria:
Inclusion Criteria:

* Patient requiring the installation of a central venous catheter in subclavian site
* Installation of catheter under general anaesthesia
* Oral consent of the patient

Exclusion Criteria:

* Thrombosis in subclavian vein
* Urgency of central venous catheterization.
* Insertion of central vein catheter other than subclavian
* Insertion of subclavian catheter under loco-regional anaesthesia
TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)

The purpose of this study is to determine whether TRI102 is effective in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6-12.

A Phase 3, randomized, double-blind, placebo-controlled, parallel group, multicenter, laboratory classroom study. After Screening and Baseline evaluations, eligible subjects are enrolled in the study and entered the open-label phase, dose-optimization phase. TRI102 is taken once daily and subjects undergo dose optimization activities for 5 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition

Exclusion Criteria:

* Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD