linjc16/ctgov huggingface dataset:
How Our Immune System Can Help Fight Cancer

Study Overview
=================
Brief Summary
-----------------
There is growing evidence that our immune system can help fight cancer. This has stimulated interest in the development and application of tumor vaccines for several human solid tumors, including epithelial ovarian cancer (EOC). A major obstacle to the development of these vaccines is that there are specialty cells called regulatory T cells that prevent the immune system from attacking all of our organs. These regulatory T cells also prevent our immune system for attacking cancer cells. Indoleamine 2,3-dioxygenase (IDO), an enzyme that degrades an essential amino acid tryptophan that is necessary for T cells to multiply, however regulatory T cells are less susceptible to low levels of tryptophan, and can still multiply. This allows cancer growth and progression. This may be explained by genetic polymorphisms (changes) in the IDO gene, which may alter its function. Five of these changes in the IDO gene have been described. In this research project, we are asking if you would donate a small piece of your tumor and ascites to see if we can examine your IDO gene in the tumor cells and see if any of these gene changes are present. We hope that this will help us understand how the immune system works in EOC. We hypothesize that genetic polymorphisms within the IDO gene alter its enzymatic activity and affect the outcome of ovarian cancer patients. These findings have the potential to translate into a method for predicting successful immunotherapy.

Official Title
-----------------
The Effect of Genetic Polymorphisms in Indoleamine 2, 3-Dioxygenase in Epithelial Ovarian Cancer

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females aged 20-90 who are having surgery to confirm epithelial ovarian cancer. Exclusion Criteria: patients who have a diagnosis of non-epithelial histology.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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 |
| --- | --- | --- |
| To examine the association of indoleamine 2,3-dioxygenase (IDO) genetic polymorphisms with clinical outcomes of ovarian cancer. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate IDO activity with gene polymorphisms by measuring tryptophan/kynurenine ratios in the ascites of epithelial ovarian cancer patients. |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian
A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to give indinavir sulfate plus stavudine to HIV-infected patients who have already been treated with zidovudine.

Official Title
-----------------
One Year Study in HIV-1 Seropositive, AZT-Experienced Patients to Evaluate the Safety and Efficacy of MK-639 Administered Concomitantly With Stavudine (d4T)

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Indinavir sulfate
* Drug: Stavudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Prophylaxis with aerosolized pentamidine, topical antifungals, TMP / SMX, dapsone, or isoniazid. Patients must have: HIV infection. CD4 count 50 - 500 cells/mm3. Prior AZT use for more than 6 months OR documented intolerance to AZT with more than 6 months use of another anti-HIV therapy other than d4T or any protease inhibitor. No active opportunistic infection or visceral Kaposi's sarcoma. NOTE: Patients with hemophilia may be enrolled at discretion of investigator. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Symptomatic neuropathy. Acute hepatitis. Concurrent Medication: Excluded: Antiretrovirals other than specified in protocol. Chronic therapy for an active opportunistic infection. Immunosuppressive therapy. Prior Medication: Excluded: Any prior protease inhibitor or d4T. Any nucleoside analogs within 2 weeks prior to study entry. Investigational agents or immunomodulators within 30 days prior to study entry. Required: More than 6 months of prior AZT unless intolerant, in which case more than 6 months of another anti-HIV therapy (other than protease inhibitors or d4T).

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Stavudine|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
-----------------
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Stavudine, HIV Protease Inhibitors, Indinavir
Brain Fuel - Morning Nutrition and Cognitive Function

Study Overview
=================
Brief Summary
-----------------
This study will help us learn more about how what a child eats can affect how their brain works.

Detailed Description
-----------------
Following a high protein/low carbohydrate meal brain activation and performance measurements will differ from those following a high carbohydrate/low protein meal and executive functioning will be affected.

Official Title
-----------------
Morning Nutrition and Cognitive Function in Preadolescents

Conditions
-----------------
Obese, Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: High protein/low carbohydrate
* Dietary Supplement: High carbohydrate/low protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 9-10 yr, 3rd to 5th grade Obese Right hand dominance Report eating breakfast at least 4 days/week Able to hear at least 20dB stimulus Visual acuity must be at least 20/40 Biological mother available to attend visit Exclusion Criteria: Full scale IQ <80 Children taking medications or having chronic illness/disorders

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group will be given a high protein/low carbohydrate shake and one group will be given a high carbohydrate/low protein shake
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High protein/low carbohydrate<br>A breakfast shake will be made with high protein/low carbohydrate mixture. | Dietary Supplement: High protein/low carbohydrate<br>* A high protein/low carbohydrate shake will be given to the child.<br>|
| Experimental: High carbohydrate/low protein<br>A breakfast shake will be made with high carbohydrate/low protein mixture. | Dietary Supplement: High carbohydrate/low protein<br>* A high carbohydrate/low protein shake will be given to the child<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological assessments | Standardized testing | 9-10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive measures | Brain Lab recordings and fMRI readings | 9-10 years |
Treatment of Post Traumatic Stress Disorder in Patients With Other Mental Illnesses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop an effective treatment for people with Post Traumatic Stress Disorder (PTSD) along with other mental illnesses.

Detailed Description
-----------------
Despite the progress in treating PTSD in the general population and the elevated prevalence of PTSD in people with severe mental illness (SMI), there are no empirically validated treatments designed for patients with comorbid PTSD. The cognitive behavioral treatment provided in this study may improve knowledge of PTSD, decrease distorted beliefs, reduce PTSD symptoms, and improve quality of life. Participants are randomly assigned to receive either a cognitive behavioral treatment plus standard care for SMI or standard care alone. The cognitive behavioral treatment incorporates several common features, including psychoeducation, relaxation training, and cognitive restructuring. Standard care for SMI includes medication, case management, and psychosocial treatment. PTSD, psychiatric symptoms, health, quality of life, and substance abuse outcomes are measured. Participants' knowledge of PTSD and beliefs about the world are also measured. Participants are assessed at baseline, post-treatment (16 weeks), and at 3- and 6-month follow-ups. For information on a related study, please follow this link: http://clinicaltrials.gov/show/NCT00494650

Official Title
-----------------
Cognitive-Behavioral Treatment of PTSD in SMI Clients

Conditions
-----------------
Stress Disorders, Post-Traumatic

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post Traumatic Stress Disorder New Hampshire definition of SMI plus DSM-IV Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression Case management services and contact with a case manager at least twice a week Exclusion Criteria: Alcohol or drug dependence Hospitalization or suicide attempt in the past 2 months

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cognitive Behavior Treatment|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
-----------------
Comorbidity, Schizophrenia, Bipolar Disorder, Depression
Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise (0431-158)

Study Overview
=================
Brief Summary
-----------------
After 24 weeks of treatment evaluate the efficacy and security.

Official Title
-----------------
Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: sitagliptin phosphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Being Treated With Metformin Patients With Hba1c Between 6.5 % And 12.0%. Type 2 DM

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 78 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 |
| --- | --- |
| Experimental: 1<br>sitagliptin | Drug: sitagliptin phosphate<br>* Patients will receive sitagliptin with metformin for 24 weeks, given as oral tablets<br>* Other names: MK0431;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in A1C at Week 24 | Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is percent. Thus, this measure represents a difference of percent values. | Baseline and 24 Weeks |
ICP Versus Intracranial Compliance Guided Management in SAH

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether treatment guided also by ICP mean wave amplitude improves outcome compared to international standard care in patients with SAH.

Detailed Description
-----------------
In this study SAH-patients are randomized to treatment based on international standard care (ICP/CPP guided therapy) or intracranial compliance (ICP mean wave amplitude) guided therapy in addition to ICP/CPP guided therapy. Main outcome variables are survival and neurological outcome after 3 and 12 months.

Official Title
-----------------
Intracranial Pressure (ICP) Versus Intracranial Compliance (ICC) Guided Management in Subarachnoid Hemorrhage; - a Prospective, Randomized Trial.

Conditions
-----------------
Subarachnoid Hemorrhage (SAH)

Intervention / Treatment
-----------------
* Device: ICP mean wave amplitude


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subarachnoid hemorrhage, acute Intracerebral pressure monitoring device inserted Exclusion criteria: No intracranial pressure monitoring Age < 18 years

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ICP mean wave amplitude|Appropriate measures when ICP mean wave amplitude is to high, e.g. CSF drainage|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality and neurological outcome |  | 3 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay (ICU, hospital); complications; effect of treatment modalities on mean ICP, CPP, ICP mean wave amplitude. |  | Hospital stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subarachnoid hemorrhage, Intracranial hypertension, Intracranial pressure, Diagnostic techniques and procedures, Compliance, Treatment outcome, Intensive care, surgical
Prospective Assessment in Newborns for Diabetes Autoimmunity

Study Overview
=================
Brief Summary
-----------------
This is an observational study designed to help researchers understand the genetics and pathogenesis of type 1 diabetes, and to identify biomarkers for disease and disease complication prediction.

Detailed Description
-----------------
This study is designed to identify people who are at risk for developing type 1 diabetes, based on their genetics, family history and autoimmunity status, and to understand the role genetics plays in the development of the complications associated with type 1 diabetes in patients already affected by type 1 diabetes.

Official Title
-----------------
1. Prospective Studies in Infants of the Immunopathogenesis of Type 1 Diabetes 2. Consortium for Identification of Environmental Triggers of Type 1 Diabetes: MCG/UF Clinical Center 3. Identification of Serum Protein Markers for Type 1 Diabetes Using Mass-Spectrometry Techniques 4. Validation of Microarray-Based Biomarkers for Type 1 Diabetes 5. Development of Microarray-Based Biomarkers for Type 1 Diabetes 6. Proteomic Changes/Progression of Human Type 1 Diabetes 7. Identification and Validation of Serum Biomarkers for T1D

Conditions
-----------------
Type 1 Diabetes, Autoimmunity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all are welcome - Exclusion Criteria: -
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 |
| --- | --- |
| 1<br>controls: healthy individuals with no family history of type 1 diabetes | |
| 2<br>high-risk: Subjects with islet autoantibodies or high-risk diabetes genes | |
| 3<br>type 1 diabetes: subjects with type 1 diabetes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| autoantibodies against the pancreas and type 1 diabetes |  | 50 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for type 1 diabetes |  | 50 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
genetics, type 1 diabetes, biomarkers, autoimmunity
A Powered Ankle Foot Rehabilitation Orthosis

Study Overview
=================
Brief Summary
-----------------
Ankle rehabilitation training becomes a tough question for the patients with ankle joint injuries especially with the hemiplegia after stroke. Here a novel powered ankle foot orthoses which can provide ankle dorsiflexion and plantar flexion assistant using electric motor is proposed in this paper. The mechanical structure of the orthoses includes wearing parts, ankle joint hinged part, driving unit, transmission mechanism and sensing units. This study provides a new method for ankle foot orthoses design and has great significance for ankle rehabilitation.

Official Title
-----------------
Design of A Powered Ankle Foot Orthoses for Ankle Rehabilitation

Conditions
-----------------
Stroke, Ankle Injuries

Intervention / Treatment
-----------------
* Device: Ankle-Foot Orthosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ankle joint injuries about dorsiflexion and plantar flexion Ability to keep balance independently Exclusion Criteria: ankle joint injuries about varus and valgus rehabilitation two assistants needed while walking

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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: experimental test of healthy subjects<br>wearing experiment，motion experiment | Device: Ankle-Foot Orthosis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| good performance of the ankle foot orthosis | Two researchers wore the ankle foot orthosis without any motion to test the rationality of design size and wearing coordination；motion experiment without load was carried out to test the stability of transmission structure and effectiveness of motor control. The ankle foot orthosis was fixed on a table. | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
powered ankle-foot orthosis, mechanical structure, optimization, dorsiflexion, plantar flexion, gait, servomotor, ankle rehabilitation
Transcranial Doppler Ultrasound Monitoring During Flow-Diverter Embolization

Study Overview
=================
Brief Summary
-----------------
Flow diverters have been approved since 2012 for the treatment of large, wide neck intracranial aneurysms. These devices have been associated with embolic events which cause blockage in a blood vessel and can result in long term complications. One possible cause of these events is the formation of small emboli during placement of the device.

Detailed Description
-----------------
Flow diverters have been developed to treat intracranial aneurysms. Embolisms have occurred in a small percentage of patients which can result in long term complications including stroke, hemorrhage, and even death. The formation of microemboli during the insertion of the device has not been evaluated. During insertion, there is significant disruption of blood flow and this may be a source of intracranial microemboli. This study will use transcranial doppler ultrasound (TCD) to evaluate the blood flow during the placement of flow diverters to try to determine why these embolic events occur.

Official Title
-----------------
A Prospective Study of the Treatment of Intracranial Aneurysms Using Pipeline Flow-Diverter Embolization in Conjunction With Transcranial Dopplers (TCD)

Conditions
-----------------
Intracranial Aneurysm, Aneurysm, Intracranial, Giant Intracranial Aneurysm

Intervention / Treatment
-----------------
* Device: TCD Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects 18 years of age and older Non-pregnant Diagnosis of intracranial aneurysm that will be clinically treated with a flow diverter Exclusion Criteria: Pregnant

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 |
| --- | --- |
| TCD Ultrasound<br>Transcranial doppler ultrasound monitoring during flow diverter placement. | Device: TCD Ultrasound<br>* Transcranial doppler ultrasound monitoring will occur during flow diverter placement.<br>* Other names: TCD;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of microemboli | The number of subjects who experience microemboli during device placement. | 1 day |