linjc16/ctgov huggingface dataset:
Evaluation of Functional MRI and DTI (Imaging Techniques) in Children With Epilepsy and Focal Brain Lesions

Study Overview
=================
Brief Summary
-----------------
This study is being done to look at the relationship between brain structure and brain function in patients with epilepsy or focal brain lesions (abnormal areas) that require surgery. This study will look at an imaging technique called magnetic resonance imaging (MRI) for looking at the brain. Specifically, the study will look at functional MRI, which is an imaging technique that can map brain function by taking pictures of the brain as it performs different tasks such as reading, thinking, or moving a body part and diffusion tensor imaging (DTI), which will look at brain structure. These types of imaging may help us learn more about different areas of the brain and how those areas of the brain are used in children with epilepsy. We plan to study 30 children with epilepsy.

Official Title
-----------------
Advanced MR Imaging Evaluation Of Neurosurgical Candidates With Focal Abnormalities

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Procedure: Functional MRI, Diffusion Tensor Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with intractable epilepsy Exclusion Criteria: children requiring sedation for scanning

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Functional MRI, Diffusion Tensor Imaging|nan|

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
-----------------
MRI, fMRI, Epilepsy, Pediatric
Evaluation of MRI for Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate imaging quality and correlation with histopathology in prostate cancer.

Detailed Description
-----------------
The objective of this study is to evaluate of the potential of endorectal 3T MRI for the staging of prostate cancer before prostatectomy or recurrence of prostate cancer after prostatectomy

Official Title
-----------------
Evaluation of the Potential of Endorectal MRI for the Staging and Recurrence of Prostate Cancer

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Device: MR imaging with endorectal coil
* Device: MRI with endo-rectal coil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of patients: up to 80 years. Men scheduled for radical prostatectomy due to prostate cancer or men post radical prostatectomy with suspicion of recurrence. Patients who are able and willing to give consent and able to have an MRI examination. Exclusion Criteria: Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast agent (e.g. Gadolinium or Dotarem) Individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hr.) Any rectal pathology preventing probe insertion, (as active proctitis, active ulcerative colitis, fissure ani) Any spinal pathology that prohibits maintaining supine position for an hour Patients with documented myocardial infarction within one month of protocol entry, and patients with cardiac pacemakers Severe cerebrovascular disease (multiple CVA or CVA within 6 months)

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MR imaging with endorectal coil|MR imaging with endorectal coil|
|Device: MRI with endo-rectal coil|MRI with endo-rectal coil|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • MRI and pathology correlation |  | 2 years |
Renin and Prorenin in Pregnancy

Study Overview
=================
Brief Summary
-----------------
To determine the role of the prorenin-renin-angiotensin-aldosterone system (RAAS) in normal and hypertensive pregnancy.

Detailed Description
-----------------
BACKGROUND: The renin-angiotensin system is involved in the physiology of pregnancy in two ways. Circulating angiotensin II affects blood pressure, renal hemodynamics, and uteroplacental blood flow. Abnormalities in angiotensin II production rates in hypertensive pregnancy contribute to the hemodynamic changes seen in the disease. Additionally, there is a form of the renin-angiotensin system in kidney, ovary, and placenta whose function is regulated by prorenin. Prorenin, activated by a specific receptor, is involved in the regulation of steroid hormone biosynthesis and renal and uteroplacental blood flow. The study was conducted in response to a Request for Applications on Research on Hypertension in Pregnancy jointly released in 1986 by the National Heart, Lung, and Blood Institute and the National Institute of Child Health and Human Development. DESIGN NARRATIVE: The study was longitudinal in design. Measurements were made of glomerular filtration rate, renal plasma flow or uterine blood flow. To define first trimester changes, studies were conducted on in vitro fertilization and ovarian failure patients who had a broad spectrum of plasma prorenins. Since interrelated changes in renin and prostaglandins may participate in the pathogenesis of hypertensive pregnancy, RAAS, prostaglandins, and uteroplacental flow velocity profiles were monitored during a placebo-controlled trial of low-dose aspirin in chronic hypertensives. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension, Pregnancy Toxemias, Pre-Eclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Outcomes of Cutaneous T-Cell Lymphoma and Graft-Versus-Host Disease With Extracorporeal Photopheresis Treatment

Study Overview
=================
Brief Summary
-----------------
Extracorporeal Photopheresis (ECP) is a form of apheresis and photodynamic therapy in which the peripheral blood is treated with 8-methoxypsoralen, which is then activated with UV light. ECP is currently a standard therapy for cutaneous T-cell lymphoma (CTCL) and is also effective for graft-versus-host disease (GVHD). The investigators would like to study the outcomes (response rates) of patients receiving ECP treatment and other factors relating to their disease and treatment, as well as procedural events, such as complications.

Detailed Description
-----------------
The investigators intend to report outcomes from the inception of this procedure at Dartmouth-Hitchcock Medical Center (DHMC) in May 2008 through 9/30/11. Additionally, the investigators would like to maintain a prospective database of these patients so that new patient data can be collected for updating of outcomes.

Official Title
-----------------
Outcomes of Cutaneous T-Cell Lymphoma and Chronic Graft-Versus-Host Disease in Patients Treated With Extracorporeal Photopheresis

Conditions
-----------------
Cutaneous T Cell Lymphoma, Graft Versus Host Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who receive Extracorporeal Photopheresis treatment Treated at Dartmouth-Hitchcock Medical Center Must be 18 years or older Exclusion Criteria: - None specified

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 |
| --- | --- | --- |
| Response rates | Response rates to ECP treatment | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Complications to ECP procedures | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ECP, CTCL, Extracorporeal photopheresis, Cutaneous T Cell Lymphoma, GVHD, Graft versus host disease
Prospective Study in Pregnant Women With Hypercoagulopathy

Study Overview
=================
Brief Summary
-----------------
Pre-eclampsia is one of the most common causes of maternal and fetal morbidity and mortality. The aim of this study is to identify pregnant women at risk for pre-eclampsia or other cardiovascular complications at a very early state of the disease, and thereby improve the current method of screening.

Detailed Description
-----------------
600 pregnant women will be included in the project and followed in a standardized manner during their pregnancy. On a regular basis blood- and urine samples will be taken throughout their pregnancy and until 1 month after delivery and analyzed for a large variety of coagulation factors in order to identify factors that might predict an increased risk of developing pre-eclampsia and/or cardiovascular events. In addition a DNA-sample is taken if consented in order to evaluate genetic factors.

Official Title
-----------------
Prospective Study of Hypercoagulation in Pregnant Women

Conditions
-----------------
Pre-Eclampsia, Eclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women attending the midwife at Hilleroed Hospital, Frederiksborg County, Denmark. Exclusion Criteria: Mental disease. Problems understanding or reading Danish.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre-eclampsia, Pregnancy, Hypercoagulation, Screening, Cardiovascular complications
Functional Neuroimage in Assessment of Post-stroke Aphasia

Study Overview
=================
Brief Summary
-----------------
The substantial efficacy and the possible mechanism of repetitive transcranial magnetic stimulation (rTMS) improving language recovery remained unclear. It is hypothesized that the rTMS was associated with increased synaptic connection and neural regeneration which can be evaluated via functional neuroimage and neurofiber imaging analysis. The effect of rTMS intervention was monitored by clinical testing and neuroimaging study.

Detailed Description
-----------------
2-week rTMS modulation has been proved to produce substantial clinical benefit with sham-controlled study. This trial aimed to investigate the possible mechanism and make clinical correlation.

Official Title
-----------------
Phase 2 Study of rTMS Application in Aphasic Patients Evaluated With fMRI

Conditions
-----------------
Stroke, Aphasia

Intervention / Treatment
-----------------
* Device: rTMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aphasic stroke in chronic stage (over 3 months) Exclusion Criteria: No seizure history, no brain surgery history, no electronic device in brain or chest, no dementia

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Hz rTMS, real<br>1 Hz rTMS over unaffected hemisphere for 15 minutes | Device: rTMS<br>* To test the efficacy of this specific setting.<br>* Other names: Magstim, Rapid2;|
| Sham Comparator: 1Hz rTMS, sham<br>1Hz sham rTMS, over unaffected hemisphere for 15 minutes | Device: rTMS<br>* To test the efficacy of this specific setting.<br>* Other names: Magstim, Rapid2;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concise Chinese Aphasia Test | Assess the linguistic skills such as conversation, expression, description, comprehension... | Before the rTMS intervention, at 2nd week, and 3rd month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional MRI |  | Before rTMS intervention, and at the day completing the rTMS treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, aphasia, rTMS, Functional MRI, Speech training
Budesonide/Formoterol for Maintenance and Reliever Therapy Among Asthma Patients in Thailand

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the incidence of misuse, i.e., over-use and under-use, of Budesonide/formoterol for maintenance and reliever therapy in usual-care setting.

Official Title
-----------------
Budesonide/Formoterol for Maintenance and Reliever Therapy: A Medication Use Evaluation Among Persistent Asthma Patients in General Practice in Thailand

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established persistent asthma Currently treated with Symbicort SMART for 3 months or longer Exclusion Criteria: currently participating or have participated in a study with an investigational compound within the last 30 days current diagnosis of chronic obstructive pulmonary disease (COPD) smoked more than 10 pack-year

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- | --- |
| Number of budesonide/formoterol use per patient |  | On the survey date | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Symbicort SMART, Thai patient eligibility, Persistent asthma
Human Phototoxicity Test

Study Overview
=================
Brief Summary
-----------------
To determine the phototoxic potential of a topically applied article in human subjects

Official Title
-----------------
Human Phototoxicity Test

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Other: Bain De Soliel - Solid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be male or female between the ages of 18 and 60 inclusive; Be lightly pigmented (Fitzpatrick Skin Type I, II, III); Have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164; Be in general good health as determined by the subject's medical history and in the discretion of the investigator; Exclusion Criteria: Have a visible sunburn; Have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses; Must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product. Have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bain De Soliel - Solid<br>All subjects are patched with the same product | Other: Bain De Soliel - Solid<br>* 0.05 gm/cm2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back. After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of skin reactions is evaluated by 5 point scale |  | Up to 48 hours |
Bacteriotherapy in Pediatric Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators want to see if Bacteriotherapy (also referred to as stool transplantation) improves the symptoms and decreases inflammation in children with Inflammatory Bowel Disease (IBD). Examples of IBD are Crohn's Disease and Ulcerative Colitis. Additionally, researchers want to learn whether this experimental therapy delays the need for starting additional medications to treat pediatric IBD.

Official Title
-----------------
Bacteriotherapy in Pediatric Inflammatory Bowel Disease

Conditions
-----------------
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, CD

Intervention / Treatment
-----------------
* Biological: Bacteriotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children ages 12-21 years old with a diagnosis of mild to moderate Ulcerative Colitis or Crohn's Disease Willing parent to donate stool for the transplant Exclusion Criteria: Severe Disease History of intra-abdominal abscess, intra-abdominal fistula or stricturing History of other systemic diseases The patient has received TNF inhibitors to treat their IBD within two months of transplant

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 21 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bacteriotherapy<br>Study stool recipient's will receive approximately 30 grams of processed donor stool through a tube into their stomach for the transplant. | Biological: Bacteriotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Responded to Stool Translplantation By 2 Weeks as Determined by Pediatric Ulcerative Colitis Activity Index (PUCAI)/Pediatric Crohn's Disease Activity Index (PCDAI) Scoring | The primary outcome measure is based on estimating the responder rate. This is defined as the proportion of patients with response to therapy by a drop of 10 or more points in PUCAI/PCDAI scoring. PUCAI/PCDAI are validated activity indexes for pediatric Ulcerative colitis and Crohn's disease, respectively. PUCAI scoring ranges from 0 to 85, with disease remission less than 10, mild disease activity between 10 - 35, moderate disease activity from 35 - 65, and severe disease activity above 65. PCDAI scoring ranges from 0 to 100; with remission being less than 10, mild disease from 10 to 30, and moderate to severe disease greater than 30. | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohns Disease, Ulcerative Colitis, Inflammatory Bowel Disease, IBD