linjc16/ctgov huggingface dataset:
MRI Exploration of Meningeal Inflammatory Disease

Study Overview
=================
Brief Summary
-----------------
Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which two additional sequences of 6 minutes duration will be added. The MRI of routine care includes at least the following sequences: 3D T1 TFE 1.0 isotropic (2 minutes) T2 TSE (2 minutes) 3D FLAIR pre-injection (opt) (3 minutes) 3D FLAIR post-injection (3 minutes) As part of the research, the following sequences will be acquired: FABIR pre-injection (3 minutes) FABIR post-injection (3 minutes) Patients hospitalized for a foreseeable duration of at least 24 hours will be offered participation in the longitudinal tab of the study, for which four non-injected MRI examinations will be performed. The examinations will be carried out remotely from the injected MRI (1h, 2h, 12h-15h, 24h-36h). These exams dedicated to research will include the following sequences for a maximum of 8 minutes: 3D T1 TFE 1.0 isotropic (2 minutes) 3D FLAIR (3 minutes) FABIR (3 minutes)

Official Title
-----------------
MRI Exploration of Meningeal Inflammatory Disease

Conditions
-----------------
MRI

Intervention / Treatment
-----------------
* Device: MRI with gadolinium injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years old To benefit as part of his treatment of an MRI with injection of gadolinium Express consent to participate in the study Affiliate or beneficiary of a social security scheme For the ancillary study to meet secondary endpoint number 5: Patient over 18 years old To benefit as part of his treatment of an MRI with injection of gadolinium Hospitalized for an expected period of at least 48 hours after the time of inclusion Express consent to participate in the study Affiliate or beneficiary of a social security scheme Exclusion Criteria: Patient benefiting from a legal protection measure Pregnant or breastfeeding woman

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

| Intervention/Treatment |
| --- |
|Device: MRI with gadolinium injection|Patients presenting for imaging for whom an MRI examination with gadolinium injection has been prescribed and who meet the inclusion and non-inclusion criteria will be offered to participate in the study. The patients included, hospitalized at the A. de Rothschild Foundation Hospital for at least 24 hours, may be included in the ancillary study to meet secondary objective number 5.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of meningeal contrast enhancement with the flair sequence |  | 1 DAY | 
| detection of meningeal contrast enhancement with the FABIR sequence |  | 1 day |
A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia

Study Overview
=================
Brief Summary
-----------------
Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH

Detailed Description
-----------------
This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia and nocturia. The following procedures are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, Pittsburgh Quality of Sleep Index, Nocturia Quality of Life

Official Title
-----------------
A Double-Blind, Placebo-Controlled Phase 2 Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia

Conditions
-----------------
Nocturia, Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: silodosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH and nocturia (>=2 episodes per night) Exclusion Criteria: Medical conditions that would confound the efficacy evaluation. Medical conditions in which it would be unsafe to use an alpha-blocker. The use of concomitant drugs that would confound the efficacy evaluation. The use of concomitant drugs that would be unsafe with this alpha-blocker.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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: 1 Silodosin<br> | Drug: silodosin<br>* α1-adrenergic antagonist<br>* Other names: Rapaflo;|
| Placebo Comparator: 2 Placebo<br> | Drug: silodosin<br>* α1-adrenergic antagonist<br>* Other names: Rapaflo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nocturia Episodes |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nocturia, BPH, benign prostate hyperplasia, nocturia in men with benign prostate hyperplasia
A Phase I Study to Determine the Effect of Food on Brivanib (BMS-582664)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine the effect of food versus a fasted state on single-dose pharmacokinetics of BMS-540215, the active metabolite of Brivanib alaninate

Official Title
-----------------
Phase I Study to Determine the Effect of a High Fat Meal on the Pharmacokinetics of BMS-540215, the Active Metabolite of Brivanib Alaninate in Subjects With Advanced or Metastatic Solid Tumors

Conditions
-----------------
Tumors

Intervention / Treatment
-----------------
* Drug: Brivanib


Participation Criteria
=================
Eligibility Criteria
-----------------
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation. Inclusion Criteria: Histologic/cytologic diagnosis of advanced or metastatic solid tumors ECOG 0-2 4/6 weeks since prior therapy Exclusion Criteria: Brain metastases Second primary malignancy Thromboembolic disease requiring full anticoagulation within 6 months Inability to swallow or absorb oral therapy

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> | Drug: Brivanib<br>* Tablet, Oral, Brivanib 800 mg, QD after single dose Pk comparison of food effect, until progression<br>* Other names: BMS-582664;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect on pharmacokinetics of BMS-540215, the active metabolite of brivanib alaninate, when administered following a high fat meal versus administration in a fasted state |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety and tolerability of Brivanib alaninate when administered in a fasted state, or following a high fat meal |  | throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced or metastatic solid tumors
Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in South America. This trial aims for a comparison of the safety and efficacy of insulin NPH and a new insulin formulation on blood glucose control.

Official Title
-----------------
Assessment of Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation on Glycaemic Control in Subjects With Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin NPH
* Drug: EX1000


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes for at least 12 months Current NPH treatment for at least 3 months - alone or as the only insulin in combination with OADs Body Mass Index (BMI) less than or equal to 40 kg/m2 HbA1c less than or equal to 9.5% FPG less than or equal to 12 mmol/L Exclusion Criteria: Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors Treatment with more than 1 IU/kg NPH insulin daily Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator Known or suspected allergy to trial products or related products Receipt of any investigational drug within one month prior to this trial Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: insulin NPH<br>* Soft-treat-to-target dose titration scheme, injection s.c.<br>* Other names: Insulatard® 100 IU/mL;|
| Experimental: B<br> | Drug: EX1000<br>* Soft-treat-to-target dose titration scheme, injection s.c.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | For the duration of the trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fructosamine |  | For the duration of the trial | 
| FPG |  | For the duration of the trial | 
| 4-point SMPG profiles |  | For the duration of the trial | 
| Incidence of hypoglycaemic episodes |  | For the duration of the trial | 
| Frequency and severity of adverse events (including injection site reactions) |  | For the duration of the trial | 
| Laboratory safety parameters (haematology, biochemistry and lipids) |  | For the duration of the trial | 
| Physical examination and vital signs |  | For the duration of the trial | 
| HbA1c |  | For the duration of the trial |
Neurophysiological Characteristics of Subthalamic Deep-brain Stimulation (STN-DBS)

Study Overview
=================
Brief Summary
-----------------
The intraoperative neuroelectrophysiological signals were collected from patients undergoing STN-DBS under general anesthesia in the Neurosurgery Department of Wuhan union Hospital, and their preoperative conditions and postoperative efficacy will be evaluated.

Detailed Description
-----------------
The intraoperative neuroelectrophysiological signals were collected from patients undergoing STN-DBS under general anesthesia in the Neurosurgery Department of Wuhan union Hospital, and their preoperative conditions and postoperative efficacy will be evaluated. The intraoperative neuroelectrophysiological signals would be analyzed.

Official Title
-----------------
Neurophysiological Characteristics of Subthalamic Deep-brain Stimulation (STN-DBS) Under General Anesthesia for Patients With Parkinson's Disease or Dystonia and Their Correlation With Prognosis

Conditions
-----------------
Parkinson Disease, Dystonia

Intervention / Treatment
-----------------
* Other: No intervention used


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients underwentSTN-DBS in neurosurgery department of Wuhan Union Hospital. Patients with Parkinson's disease or dystonia. Exclusion Criteria: 1.Patients without enough follow-up length.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson's disease or dystonia patients<br>Patients with Parkinson's disease or dystonia and underwent STN DBS under general anesthesia in neurosurgery department | Other: No intervention used<br>* No intervention used<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's Disease Rating Scale (UPDRS) | UPDRS has four parts: part I (nonmotor experiences of daily living, total score=16); part II (patient motor experience of daily living, total score=52); part III (clinician motor examination, total score=56); part IV (complications, total score=23). The total score of all the four parts is147. Higher scores means a worse outcome. | Two years postoperatively | 
| Burke Fahn Marsden's Dystonia Rating Scales(BFMDRS) | BFMDRS has two parts: BFMDRS movement part (BFMDRS-M) and BFMDRS disability part (BFMDRS-D). The total score of BFMDRS-M is 120 and the total score of BFMDRS-D is 30. Higher scores means a worse outcome. | Two years postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dystonia, Parkinson Disease, deep brain stimultation, neurophysiological characteristics
Personalizing Enzalutamide Therapy by Understanding the Relation Between Tumor mRNAs, miRNAs and Treatment Response

Study Overview
=================
Brief Summary
-----------------
The primary aim is to show whether a reduction in tumor related mRNAs and a panel of selected miRNAS can be used to personalize enzalutamide therapy. Furthermore the aim is to explore the relation between drug exposure and the decrease in the selected biomarkers and treatment response.

Official Title
-----------------
Personalizing Enzalutamide Therapy by Understanding the Relation Between the Decrease in the Expression Profile of a Panel of Preselected microRNAs, Tumor Related mRNAs and Treatment Response in Chemotherapy Naive Patients With mCRPC

Conditions
-----------------
Metastatic Castration Resistant Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Enzalutamide, 160mg, 40 mg soft capsules, once daily


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients with chemotherapy naive metastatic castration resistant prostate cancer* Age at least 18 years Patients from who it is possible to collect blood samples Patient who are able and willing to give written informed consent prior to screening and enrollment Life expectancy of > 6 months Measurable disease *definition of CRPC according to EAU guidelines 2014 Exclusion Criteria: None The study objective is to explore the effect of enzalutamide on biomarker exposure in a group of patients treated with enzalutamide in agreement with the drug label. Therefore no strict exclusion criteria will be used in this study

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 |
| --- |
|Drug: Enzalutamide, 160mg, 40 mg soft capsules, once daily|Exclusively determine pharmacokinetics and pharmacodynamics of enzalutamide for the indication according to the drug label|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation between biomarker response and therapeutic response |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation between drug exposure, biomarker and therapeutic response |  | 6 months |
Physiotherapy and Capsulitis

Study Overview
=================
Brief Summary
-----------------
Multicenter randomised study, on parallel groups to compare recovery of functional amplitude following shoulder dilatation with auto rehabilitation in one group and physiotherapy in the other group.

Official Title
-----------------
Physiotherapy Versus Self Rehabilitation After Shoulder Dilatation for Primary Idiopathic Capsulitis

Conditions
-----------------
Arthritis

Intervention / Treatment
-----------------
* Other: Self rehabilitation
* Other: Self rehabilitation plus physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary idiopathic phase 2 capsulitis Diagnosis of capsulitis confirmed by shoulder dilatation Patients between 18 and 70 years of age Exclusion Criteria: Secondary capsulitis Shoulder pain of other etiology Cognitive disorders Patients less than 18 years, and more than 70 years of age

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self rehabilitation<br>Self rehabilitation | Other: Self rehabilitation<br> <br> |
| Experimental: Self rehabilitation plus physiotherapy<br>Self rehabilitation plus physiotherapy | Other: Self rehabilitation plus physiotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function of the shoulder joint (Score de Constant) |  | 12 months post shoulder dilatation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Visual Analogue Scale (at evening, rest, and at movement) |  | 12 months post shoulder dilatation |
Decision Support AMPATH

Study Overview
=================
Brief Summary
-----------------
Computer-generated clinical reminders offered to providers will improve compliance with care guidelines and impact outcomes in resource-limited clinics.

Detailed Description
-----------------
The investigators will assess the effects of computer-generated reminders for the 3 cohorts of patients: (1) pregnant women; (2) HIV-exposed infants; and (3) adults and children co-infected with TB and HIV identified from the AMPATH clinics. Patients will be randomized to either receive the reminders as part of a paper summary, or to not have any of the reminders in their summary. Reminders implemented will vary by type of patient population. Comparisons will be made between the intervention and control groups.

Official Title
-----------------
Electronic Medical Records to Improve Patient & Public Health in Rural Kenya

Conditions
-----------------
Behavior

Intervention / Treatment
-----------------
* Behavioral: reminders vs. no reminders


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pregnant women, children born to HIV+ mothers, and TB/HIV co-infected patients visiting these clinics during the this study will be included. Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

Design Details

Primary Purpose: Health Services Research


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: reminders, no reminder<br> | Behavioral: reminders vs. no reminders<br>* Intervention providers will receive clinical reminders as part of patient care, and control group providers will not receive the reminders<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance rates with care guidelines |  | 12 months |
The Effect of Licorice Root Extract and Pomegranate Juice on Atherosclerotic Parameters in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The study will check whether taking 100 mg of licorice root extract or 250 cc of pomegranate juice daily by men with diabetes mellitus who are non-smokers and already treated with statins decreases the risk of developing atherosclerosis. The hypothesis of the study is that natural anti-oxidants (such as licorice root extract and pomegranate juice), by scavenging free radicals, retard and may even reverse atherosclerosis.

Conditions
-----------------
Diabetes Mellitus, Atherosclerosis

Intervention / Treatment
-----------------
* Drug: Licorice root extract or Pomegranate juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Diabetes Mellitus Exclusion Criteria: Younger than 18 Smoker Receiving Fibrates

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Licorice root extract or Pomegranate juice|nan|

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

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