linjc16/ctgov huggingface dataset:
Advanced MR Techniques in Detection of Tumor Infiltration and Grading in Gliomas

Study Overview
=================
Brief Summary
-----------------
In this study, we evaluate the role of diffusion kurtosis imaging (DKI) and MR spectroscopy (MRS), two advanced imaging techniques in magnetic resonance (MR) in grading and detection of microscopic infiltrating tumour in gliomas. These parameters are of utmost importance in optimal choice and planning of treatment. Patients treated with gliomatous brain tumours are included voluntarily. They undergo one imaging session on a 3T MR scanner prior to treatment. DKI data are quantitively analyzed in order to estimate specific parameters in normal appearing white matter, grey matter, tumor and peritumoral edema. MRS data are analyzed quantitatively and qualitatively with peak integration, ratio calculation and classification algorithms. Histological confirmation is obtained at subsequent surgery. Information from this study can be of significant importance in avoiding brain biopsies. Furthermore, information on microscopic tumour spread can be used during neurosurgery or in radiotherapy planning. An important advantage of these advanced MR techniques is the non-invasivity and the lack of ionizing radiation, two important issues in this relatively young patient population.

Official Title
-----------------
Diffusion Kurtosis Imaging en MR Spectroscopy in Grading and the Characterization of Tumour Infiltration in Gliomas

Conditions
-----------------
Gliomas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of gliomatous brain tumour Exclusion Criteria: younger than 18 years of age prior treatment history of neurological or neurosurgical treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gliomas, magnetic resonance, diffusion kurtosis imaging, MR spectroscopy, grading
Tolerance to Light for Patients Suffering From Keratitis

Study Overview
=================
Brief Summary
-----------------
In order to develop an innovative device to study infectious keratitis, we need to illuminate the cornea of patients suffering from an infectious keratitis with red or near-infrared light. Because of technical reasons the shortest possible wavelength (red) presents advantages.

Detailed Description
-----------------
The aim of this preliminary study is to measure the maximal intensity tolerated during illumination with 6 wavelength corresponding : 2 red, 2 far red and 1 near infrared lights in order to determine the shortest wavelength well tolerated by patients, in comparison with the standard blue light illumination.

Official Title
-----------------
Tolerance to Light for Patients Suffering From Keratitis

Conditions
-----------------
Keratitis

Intervention / Treatment
-----------------
* Device: Light exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Social security insurance Suspected infectious keratitis (clinically defined. No lab testing required) Signed informed consent Exclusion Criteria: Major Blepharospasm Aphakia (absence of lens) Pregnant woman Nursing mother

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Each patient is its own control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Light exposure<br>The keratitis eye of the patient is exposed to 6 lights with increasing intensity according to a constant speed. The patients switch off the light when the discomfort is too elevated | Device: Light exposure<br>* The 6 lights used randomly are : 482nm =standard blue light illumination, 650nm, 675nm, 700nm, 750nm 800nm<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Light intensity | For each wavelength, the highest light intensity tolerated by the patient is measured (mWatts/cm² ) | At the inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of the keratitis | It is determined by slit lamp. The result is severe or not severe | At the inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keratitis, Eye Infection, Photophobia, Red light, Infrared light
Clozapine Therapy Sample Collection - Method Comparison Study

Study Overview
=================
Brief Summary
-----------------
The method comparison study involves capillary fingerstick blood, venous serum, and venous K2EDTA blood sample collection from human subjects receiving clozapine treatment and their clozapine concentration measurement using a validated mass spectrometry method, the automated immunoassay MyCare Psychiatry Clozapine Assay Kit manufactured by SBI, and the point of care MyCare Insite Clozapine Test manufactured by SBI. Clozapine measurements obtained using the MyCare Insite Clozapine Test are intended for investigational purposes only and shall not be used in the management of patients receiving clozapine therapy.

Official Title
-----------------
Collection of Capillary Fingerstick Blood, Venous Serum, and Venous K2EDTA Blood Samples From Subjects Receiving Clozapine Therapy

Conditions
-----------------
Patients Prescribed Clozapine

Intervention / Treatment
-----------------
* Device: MyCare Insite Clozapine Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study subjects must meet all the following criteria to be eligible for enrollment into the study: Female or male subjects 21 years of age or older; Current treatment with clozapine with documentation of diagnosed psychiatric condition requiring treatment; Capable of understanding and complying with parameters as outlined in the protocol; Capable of understanding and providing written informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any screening or study specific procedures. Exclusion Criteria: 1. Female or male subjects under the 21 years of age; 2. Unwilling or unable to follow protocol requirements or to give written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients Prescribed Clozapine<br> | Device: MyCare Insite Clozapine Test<br>* The MyCare Insite Clozapine Test is a 2 reagent system designed to evaluate the level of antipsychotic drug clozapine in a patients blood using the near patient device the MyCare Insite Analyser.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sample Analysis - Method Comparision | Determine if the MyCare Insite Clozapine Test returns blood level results which are equivalent to results obtained using the MyCare Pyschiatry Assay Kit and LC-MS | October, 2022 |
A Natural History Study of Molybdenum Cofactor and Isolated Sulfite Oxidase Deficiencies

Study Overview
=================
Brief Summary
-----------------
Primary objective: Characterize the natural history of MoCD type A in terms of survival Secondary objectives: Evaluate blood and urine for biochemical markers Evaluate head circumference, seizure activity and neurologic outcomes To evaluate brain MRI Compare blood and urine analysis, head circumference, seizure activity and neurologic outcomes to MRI findings

Official Title
-----------------
A Natural History Study Of Molybdenum Cofactor And Isolated Sulfite Oxidase Deficiencies

Conditions
-----------------
Molybdenum Cofactor Deficiency, Isolated Sulfite Oxidase Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both living and deceased patients of any age will be considered for study inclusion. Diagnosis of MoCD or isolated SOX deficiency Documented informed consent Exclusion Criteria: MoCD Type A patient who was in Study ALX-MCD-501 Deceased patients with unknown genotype (as of Amendment 4)
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Living<br> | |
| Deceased<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the natural history of molybdenum cofactor deficiency (MoCD) type A, the most common subtype of MoCD, in terms of survival |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate levels of the biochemical markers S-sulfocysteine (SSC), uric acid, and xanthine in blood, urine, and cerebral spinal fluid over time in patients with MoCD and isolated sulfite oxidase (SOX) deficiency. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Natural history study
MRI Study of the Structural and Functional Rehabilitation in the Cerebral Infarction Patients With Diabetes

Study Overview
=================
Brief Summary
-----------------
Diabetes mellitus (DM) plays an important role in the occurrence of the cerebral infarction (CI). Clinical studies have demonstrated that the CI patients with DM had a poor prognosis compared with those without DM. Previous magnetic resonance imaging (MRI) studies have shown that patients with DM had abnormalities in cerebral vessels, nerves and functions, similar with the findings in mice models. In this study, with multi-modal MRI technologies, investigators tend to observe structural and functional changes of the brain in both DM and non-DM CI patients and assess their neural rehabilitation using clinical scales in the following 6 months. Investigators also expect to find out dynamic changes of brain structure and function, to reveal the weights of factors including brain blood vessels, nerves and function remodeling related with stroke recovery, as well as the potential mechanism in CI patients with DM.

Official Title
-----------------
MRI Study of the Structural and Functional Rehabilitation in the Cerebral Infarction Patients With Diabetes

Conditions
-----------------
Cerebral Stroke, Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ﬁrst-ever ischemic stroke; single infarct in the distribution of the middle cerebral artery; no evidence of hemorrhagic infarction; age greater than 18 years; admission between 3 and 7 days after stroke onset; National Institute of Health Stroke Score (NIHSS) score of 4 to 21 on admission and no thrombolytic or recanalization therapies. Exclusion Criteria: atrial fibrillation; history of neurological or psychiatric disorders; pre-stroke modified Rankin scale (mRS) > 1; life expectancy < 1 year.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic stroke<br> | |
| Non-diabetic storke<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin scale (mRS) | scores range from 0 (no symptoms) to 6 (dead) | 6 months | 
| National Institute of Health Stroke Score | scores ranging from 0 to 42 (the higher the score, the greater the function deficits) | 6 months | 
| Barthel index | score ranging from 0 (totally dependent) to 100 (completely independent) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral infarction, diabetes, rehabilitation, MRI
Safety and Efficacy Registry of Yinyi Stent

Study Overview
=================
Brief Summary
-----------------
Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may prevent these complications.

Official Title
-----------------
Safety and Efficacy Registry of Yinyi Polymer-free Paclitaxel-eluting Stent

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Yinyi stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-80 years old both gender native coronary lesion narrowing > 70% vessel size 2.5-4.0 in diameter Exclusion Criteria: without informed consent, ST elevation myocardial infarction within 7 days, patient with ≤ 70% coronary narrowing at target lesion, left main lesion, multivessel narrowing need more than 3 stent implantations, by-pass graft, abnormal liver function before randomization, active hepatitis or muscular disease, impaired renal function with serum creatinine level > 3mg/dl, impaired left ventricular function with LVEF < 30%, Participate in other studies.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yinyi stent<br>subjects with Yinyi stent implantation | Device: Yinyi stent<br>* subjects with Yinyi stent implantation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiac events | including cardiac death, myocardial infarction and target vessel failure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stent thrombosis | according to ARC definition | 12 months |
Clinical Study Of Schizophrenia in Both Men and Women

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effectiveness of a marketed drug in the treatment of schizophrenia, as an add-on therapy to antipsychotics over a 12-week period. Subjects with schizophrenia who have been maintained on a stable dose of antipsychotics and who fulfill the screening entrance criteria will have an assessment 1-7 days after the first visit to confirm eligibility.

Official Title
-----------------
A Multi-Center, Double Blind, Placebo-controlled, Randomized, Parallel Group Evaluation of the Efficacy of a Flexible Dose of Lamotrigine Versus Placebo As Add-On Therapy In Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: lamotrigine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception. Diagnosis of Schizophrenia Patients must be taking clozapine monotherapy or other atypical antipsychotic at least 3 months prior to this study. Exclusion criteria: Patients who are currently taking or have taken antidepressant medication in the last month prior. Patients who are or have been suicidal or homicidal in the last 6 months. Patients with a history of autistic disorder or another pervasive developmental disorder Patients whose condition is due to the direct physiological effects of a substance (e.g. a drug of abuse, a medication) or a general medical condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lamotrigine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the total score of the 7 items of the Positive and Negative Symptom Scale (PANSS) positive symptom subscale for lamotrigine vs. placebo at Week 12. |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the PANSS total score at Week 12; Change from baseline in the Scale for the Assessment of Negative Symptoms (SANS) at Week 12; Change from baseline in the Clinical Global Impression-Severity of Illness (CGI-S) score at Week 12. |  | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, lamotrigine
Post Stroke Epileptic Seizures Risk Forecast

Study Overview
=================
Brief Summary
-----------------
Improve the effectiveness of treatment and prognosis in patients with cerebrovascular accident by early detection of the risk of developing epileptic seizures.

Official Title
-----------------
Clinical Diagnostic Criteria of Forecasting Epileptic Seizures in Stroke Patients

Conditions
-----------------
Stroke, Post Stroke Seizure, Post Stroke Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent to participate in the study signed by the patient / relative of the patient / the legal representative of the patient age over 18 years stroke, confirmed by neuroimaging light to moderate stroke (score on National Institutes of Health Stroke Scale). Exclusion Criteria: recanalization therapy previous epileptic seizures and history of epilepsy psychiatric diseases in history previous stroke traumatic brain injury brain tumors. inflammatory and infectious diseases decompensated physical illness. pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ischemic<br>questionnaire, physical-neurological examination, labor investigations, EEG | |
| Hemorrhagic<br>questionnaire, physical-neurological examination, labor investigations, EEG | |
| Control<br>questionnaire, physical-neurological examination, labor investigations, EEG | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First epileptic seizure | Patient's dairy will be used to assess this outcome measure. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longest seizure-free period | Patient's dairy will be used to assess this outcome measure. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, epilepsy, seizure, EEG
Thromboelastography-derived Functional Fibrinogen Levels

Study Overview
=================
Brief Summary
-----------------
This study hopes to determine if thromboelastography-derived functional fibrinogen (TEG-FF or FLEV) levels obtained during the rewarming phase of cardiopulmonary bypass can provide information on coagulation status sooner, allowing for anticipation of post-bypass bleeding and transfusion requirements

Official Title
-----------------
Comparison of Thromboelastography-derived Functional Fibrinogen Levels During and After Cardiopulmonary Bypass

Conditions
-----------------
Focus of Study, Coagulation Status of Cardiac Surgery Patient, Reducing Excess Blood Transfusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective cardiac surgery patients who are undergoing primary cardiac surgery Exclusion Criteria: Emergency surgery Re-operative cardiac surgery History of hypercoagulable state as defined in medical record Anticoagulated status at time of surgery Plasma requirement prior to discontinuation of bypass (alters fibrinogen level)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac surgery with cardiopulmary bypass<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV) | FLEV values obtained during rewarming while on cardiopulmonary bypass (CPB) were compared to FLEV values obtained immediately after CPB and protamine administration. For all patients included, the mean values for rewarming FLEV and mean values for post-CPB FLEV were obtained. If the mean difference for the two timepoints was not statistically different by t-test, then the primary outcome would demonstrate the value of obtaining a rewarming FLEV sample. | Change in FLEV from rewarming and after cardiopulmonary bypass | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Clauss Assay and FLEV | This secondary outcome aimed to determine if standard laboratory assays for fibrinogen (Clauss) provided values similar to TEG-based functional fibrinogen (FLEV). The difference between the means at various timepoints is calculated in mg/dL. | Clauss vs FLEV for rewarming and post-CPB | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
functional fibrinogen assay, cardiac surgery