linjc16/ctgov huggingface dataset:
Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Serum and cerebrospinal fluid will be obtained from 20 patients with relapsing-remitting multiple sclerosis treated with teriflunomide tablets 14 mg daily

Detailed Description
-----------------
Teriflunomide concentration in cerebrospinal fluid and serum will be determined in 12 patients with multiple sclerosis. They have been treated for at least 6 months and the sampling from blood and by spinal tap is done before dose at 8 am in 10 patients and at 12 am in 10 patients. The dependence from age, sex, and blood-brain barrier (BBB) integrity will be evaluated.The ratio between serum and cerebrospinal fluid will determine the passage over the BBB.

Official Title
-----------------
Determination of Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis Treated With Teriflunomide 14 mg Daily.

Conditions
-----------------
Multiple Sclerosis, Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: Teriflunomide 14 MG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with multiple sclerosis treated with teriflunomide 14 mg for at least 6 months Exclusion Criteria: other immunosuppressive or immunomodulating drugs, other CNS diseases

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
Intervention Model: Single Group Assignment
Interventional Model Description: Pharmacokinetic
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Teriflunomide 14 mg tablets<br>Single arm | Drug: Teriflunomide 14 MG<br>* Blood and cerebrospinal fluid is obtained from teriflunomide treated patients with multiple sclerosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of teriflunomide in cerebrospinal fluid |  | one year |
VP3: Vancouver Primary Prevention Program (Anxiety Disorders Prevention in School Children)

Study Overview
=================
Brief Summary
-----------------
Objective: To evaluate the efficacy of a school-based cognitive behavior therapy (CBT) program in reducing anxiety disorder symptoms in at-risk public school children. To determine whether parent education and involvement improves outcome in anxious children treated with CBT. To determine the ability of school personnel in a) recognizing classroom behaviors as anxiety disordered after targeting training of observable child behaviors e.g., avoidance, over-worry, etc.), and b) delivering a cognitive behavior intervention and To evaluate a new measure of teacher-rated anxiety disorder symptoms in children. Hypothesis: A CBT oriented intervention as delivered by school personnel will be superior to an attention control procedure in reducing anxiety symptoms in at-risk children. Children who have parental involvement will post stronger and more enduring treatment gains.

Official Title
-----------------
VP3: Vancouver Primary Prevention Program (Anxiety Disorders Prevention in School Children)

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behaviour Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children enrolled in school between the ages of 7 and 13 who display anxiety symptoms. Anxiety disorder symptoms (identified by a score of 56 or higher on the MASC; and teacher report, and /or parent recommendation) as the primary presenting problem. An enrolled child must have at least 2 of these criterions. Fluency in English. Parent willingness to sign consent form and to complete required assessments. Student willingness to participate (child assent) in 10-week affective education program and completion of required assessments. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cognitive Behaviour Treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety, Therapy, Behaviour
A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer.

Official Title
-----------------
A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer

Conditions
-----------------
Advanced Cancer

Intervention / Treatment
-----------------
* Drug: ANX-514
* Drug: docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old. Advanced cancer potentially sensitive to single agent docetaxel; ie.. locally advanced or metastatic breast cancer, locally advanced non-small cell lung cancer, hormone refractory metastatic prostate cancer, other tumor type with no standard treatment. ECOG performance status of 0-2 and Karnofsky Score of 100-70. Exclusion Criteria: Patients who have more effective therapy available than single agent docetaxel for the malignancy. Pregnancy or lactation. Intolerance to any antineoplastic agents belonging to the taxoid family. Hypersensitivity to drugs formulated with polysorbate 80. Active infection. Prior anticancer therapy within 30 days prior to the first day of study treatment. Participation in another experimental drug study within 30 days prior to the first day of study 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ANX-514 | Drug: ANX-514<br>* 75 mg/m^2<br>* Other names: Docetaxel for Injectable Emulsion;|
| Active Comparator: 2<br>Taxotere | Drug: docetaxel<br>* 75 mg/m^2<br>* Other names: Taxotere;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic equivalence of ANX-514 and Taxotere |  |  |
Perception of Female Hormonal Contraception by the Main Prescribers

Study Overview
=================
Brief Summary
-----------------
The recommendations for contraception, after researching contraindications to certain methods, are to offer clear and honest information to allow the patient to make an informed choice, adapted to her lifestyle. The best contraception is the one chosen by the patient. The choice of contraception illustrates the difficulty of assessing the benefit-risk balance in the context of functional and preventive treatment. Taking into account this imbalance between patient beliefs and medical advice is an essential step in improving the provision of gynecological care.

Official Title
-----------------
Perception of Female Hormonal Contraception by the Main Prescribers

Conditions
-----------------
Female Hormonal Contraception

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Any health care professional in general medicine, gynecology and midwifery graduate or in progress in practice (any practice modality in metropolitan France) agreeing to participate in the survey by completing the questionnaire anonymously, after having read the information and non-objection notice attached to the questionnaire. Exclusion criteria: - Any other health profession Inclusion criteria: - Any health care professional in general medicine, gynecology and midwifery

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 |
| --- | --- | --- |
| Study of the perception of risks and management of adverse effects of hormonal contraception among prescribers |  | 5 months after interviews with prescribers | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Female Hormonal Contraception
Vasoreactivity in Carriers of Genetic Polymorphisms

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess the impact of genetic variation (especially polymorphisms of the gene coding endothelial nitric oxide synthase (eNOS) and the bradykinin B2 receptor gene) on venous and arterial responsiveness to vasodilators in healthy individuals without cardiovascular risk factors.

Detailed Description
-----------------
Study I: Using the dorsal hand vein compliance technique dose-response curves to bradykinin and sodium nitroprusside will be obtained in healthy volunteers during preconstriction with phenylephrine and after pretreatment with a single dose of 500 mg i.v. acetylsalicylic acid. Study II: Using venous occlusion plethysmography dose-response curves to acetylcholine, sodium nitroprusside and L-NG-monomethyl-arginine (L-NMMA) will be obtained in healthy volunteers pretreated with a single dose of 500mg i.v. acetylsalicylic acid.

Official Title
-----------------
Endothelium-Dependent Vasoreactivity in Nitric Oxide Synthase Gene (Glu298Asp) Polymorphism: Studies in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: sodium nitroprusside, bradykinin, acetylcholine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 18 - 70 gender: male good state of health Exclusion Criteria: known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, smoking, homocysteinemia) regular medication and/or treatment with drugs within the last 4-6 weeks (exclusion has to be decided in each case) acute or chronic illness methylxanthines and alcohol during 12 hours before the study nicotine during 1 year before the study drug and/or alcohol abuse pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sodium nitroprusside, bradykinin, acetylcholine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study I: Venous responsiveness assessed by dorsal hand vein compliance technique |  |  | 
| Study II: Forearm blood flow assessed by venous occlusion plethysmography |  |  |
Placenta and Cord Blood Analyses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to standardize methods in collecting and processing placenta, umbilical cord and cord blood samples. Samples will be used to determine potential differences between normal weight, overweight and obese individuals.

Official Title
-----------------
Placenta and Cord Blood Analyses

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 7 months pregnant 18 years of age or older Exclusion Criteria: underweight (BMI<18.5)

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

Sexes Eligible for Study
-----------------
Female

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placenta, cord blood and umbilical analyses |  | at delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy pregnant women
The Roles of Exosomal Circ-LRBA and 451/CRTC2 Signaling Axis in Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Colorectal cancer (CRC) is one of the most common malignant tumors in the world. Most of the patients with colorectal cancer were diagnosed in poor stage. Although 40% to 50% patients of colorectal cancer can be cured by surgery, but most patients have undergent metastasis or recurrence, and eventually death. In recent years, molecular targeted therapy has shown significant efficacy in specific patients. It was necessary to detect the corresponding molecular targets of tumors before selecting appropriate targeted drugs in clinic. The changing state of related gene molecules in colorectal cancer played a key role in drug selection, there were few effective targets so far. At present, metastasis and recurrence still be the most difficult problems in treatment. Therefore, investigators should deeply study the occurrence and development of colorectal cancer at the gene level and look for new biomarkers to predict the prognosis. Furthermore, the study can clarify the exact molecular mechanism of colorectal cancer. These will be important clinical significance for targeted therapy of colorectal cancer.

Official Title
-----------------
The Roles and Molecular Mechanism of Exosomal Circ-LRBA That Regulates miR-451/CRTC2 Signaling Axis in Colorectal Cancer Progression

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Other: nothing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.18-80 years old. 2.18.5 < BMI < 27.9. 3. The surgical methods are radical resection of rectal cancer, resection of right colon cancer, resection of left colon cancer and radical resection of sigmoid colon cancer. Exclusion Criteria: Those who refuse to collect samples. Patients with severe dysfunction of coagulation, hepatorenal dysfunction or severe cardiopulmonary diseases. Patients who has a history of neoadjuvant radiotherapy or chemotherapy. Combining with distant multiple metastases of tumor

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 |
| --- | --- |
| cancer group<br> | Other: nothing<br>* nothing<br>|
| control group<br> | Other: nothing<br>* nothing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expressional quantity | Expression of CRTC2 in patient samples | Through study completion, an average of 2 year |
Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients (CLAMP)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the effect of DMMET-01 on insulin sensitivity by Glucose CLAMP technique in Mexican type 2 diabetes patients, after 2 months of treatment.

Official Title
-----------------
Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients by Glucose CLAMP Technique

Conditions
-----------------
Diabetes Type 2

Intervention / Treatment
-----------------
* Drug: DMMET-01
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages eligible for study: 40 to 60 years With type 2 diabetes evolution < 5 years without pharmacological treatment 1 month prior to the screening Fasting glucose = 130-200 mg/dL AIc of 7% to 9% Blood pressure < 140/80 mmHg Ability to communicate and meet the requirements of the study Signed Written Informed Consent before to conducting any study Body mass index (BMI) of 25 kg/m2 to 35 Kg/m2 Exclusion Criteria: Suspected or confirmed pregnancy Nursing Inability to secure the non-pregnant during the study duration Hypersensitivity to any biguanides Use of an investigational drug within 30 days prior to the screening Liver failure, heart failure, kidney failure or thyroid disease Periods of acute or chronic diarrhea or vomiting Chronic hepatic disease Total Cholesterol > 300 mg/dL Triglycerides > 400 mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DMMET-01<br> | Drug: DMMET-01<br>* 60 days: 30 days; dose 1050.6 mg per day (before dinner)+ 30 days; dose 1050.6 mg twice a day 30 more days (before breakfast ando before dinner)<br>|
| Placebo Comparator: Control<br> | Drug: Placebo<br>* 60 days: 30 days placebo once a day (before dinner) + 30 days twice a day (before breakfast and before dinner)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin, fasting glucose, HbA1c |  | 2 months | 
| Adverse Events |  | 3 months | 
| Creatinine, Total Cholesterol, HDL, Triglycerides, Uric acid, AST, ALT, FA, DHL |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, Type 2, monotherapy, antidiabetics, metformin
CombIning advaNces in imagiNg With biOmarkers for improVed Diagnosis of Aggressive prosTate cancEr

Study Overview
=================
Brief Summary
-----------------
To enable the paradigm of mp-MRI before biopsy in all patients with suspected prostate cancer by better selecting patients who will benefit from diagnostic MRI and by improving the performance of the mp-MRI itself

Detailed Description
-----------------
Patients will undergo an advanced diffusion-weighted MRI sequence called VERDICT with the intention of better characterising prostate cancer. A panel of serum and urine biomarkers will also be analysed, which we hope will predict those patients who go on have a positive MRI. OBJECTIVES: To establish a fluidic marker - prostate MRI paradigm which: (i) utilises fluidic markers to rationalise selection of patients with significant prostate cancer; and (ii) improves the diagnostic accuracy of imaging over and above standard multiparametric (mp) MRI Enable a pathway for rapid clinical evaluation of emerging fluidic markers and exosomes Assess the repeatability of VERDICT MRI Ascertain whether VERDICT derived quantitative parameters correlate with quantitative histological parameters Develop a database of fluidic marker and VERDICT characterised, mp-MRI, histologically validated patients for subsequent exploratory and longitudinal outcome analysis

Official Title
-----------------
CombIning advaNces in imagiNg With biOmarkers for improVed Diagnosis of Aggressive prosTate cancEr

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men referred to University College London Hospital (UCLH) for prostate mp-MRI following biopsy elsewhere and biopsy naive men presenting to UCLH with a clinical suspicion of prostate cancer. Exclusion Criteria: Men unable to have a MRI scan, or in whom artefact would reduce quality of MRI Men unable to given informed consent Previous treatment (prostatectomy, radiotherapy, brachytherapy) of prostate cancer On-going hormonal treatment for prostate cancer Previous biopsy within 6 months of scheduled mp-MRI

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: MRI|VERDICT diffusion-weighted microstructure imaging sequence|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of VERDICT MRI | Radiological assessment with added VERDICT MRI improves the specificity of mp-MRI for detection of significant prostate cancer by >10% above standard multi-parametric MRI alone. | 3 - 6 months (after targeted biopsy or follow up MRI) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Magnetic resonance imaging, Biomarkers, Fluidics, Diffusion MRI