linjc16/ctgov huggingface dataset:
The Effect of Aerobic Exercise on Learning After Stroke

Study Overview
=================
Brief Summary
-----------------
Determine if attaining aerobic fitness is beneficial in producing cortical neuroplasticity in individuals with chronic stroke.

Detailed Description
-----------------
Crossover clinical trial. Experimental group undergoes 3x/wk/6 months of aerobic conditioning. Control group performs usual daily activities. All participants will be assessed with cognitive and motor behavioral testing at baseline, 3, 6, 9 and 12 months.

Official Title
-----------------
Effect of Cardiovascular Fitness on Motor Learning and Executive Function in Individuals After Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: Rehabilitation exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single ischemic stroke occuring 6-72 months prior Fugl-Meyer score (upper + lower extremity) 45 or greater Mini mental status score of >23 approval of the subject's medical doctor Exclusion Criteria: already performing >20 min of cardiovascular exercise 3x/wk or more alcohol consumption of >2 oz. liquor, 8 oz. wine or 24 oz beer/day cardiac history of unstable angina, recent myocardia infarction within the last 3 months, congestive heart failure, significant valve dysfunction medical history of recent hospitalization (> 3 months) for medical illness symptomatic peripheral arterial occlusive disease orthopedic or chronic pain conditions restricting exercise pulmonary or renal failure active cancer unstable hypertension (>160/100 mmHg) diabetes mellitus (fasting glucose > 180 NG./dk, HgA1C > 10%) that is unable to be controlled < month receptive or expressive aphasia as indicated on MMSE multiple strokes or other neuromuscular conditions major depression that is untreated using the Beck depression inventory

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Rehabilitation exercise<br>* Rehab therapy is delivered for 8 weeks.<br>|
| No Intervention: 2<br>Control Group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor learning behavioral measures; executive function behavioral measures. |  | Baseline, 8 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak V02 and other aerobic capacity measures. Physical disability measures. |  | Baseline, 8 weeks, 12 weeks |
Intervention With Black Currant Seed Press Residues in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The study was performed to investigate the effects of the consumption of black currant seed press residues, which were baked into bread.

Detailed Description
-----------------
Berry seeds are a by-product of berry fabrication (e. g. to juices or jam). In order to maintain their functionality and long life span, berry seeds need to contain cell stabilizing ingredients such as vitamins and polyphenols. Since it seems to be a valuable source of health beneficial substances in human nutrition, commercial use should be found. Therefore, seeds were pressed (seed press residue), ground and baked into bread for consumption. Black currant seed press residues are rich in tocopherols and also contain anthocyanins; both act as antioxidants. Additionally there is 50% fibre in the residue, soluble and insoluble fibre in equal shares.

Official Title
-----------------
Intervention Study on the Health Beneficial Effects of Bread Enriched With Black Currant Seed Press Residues in Healthy Subjects

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Dietary Supplement: black currant seed press residue
* Dietary Supplement: Bread without black currant seed press residues
* Dietary Supplement: Baseline data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: discrimination between smoker (> 5 cigarets/d) or non-smoker Exclusion Criteria: diet during the study serious sport diagnosed diseases use of nutritional supplements

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: black currant seed press residue|Black currant seed press residue, baked into bread|
|Dietary Supplement: Bread without black currant seed press residues|Same bread but without seeds|
|Dietary Supplement: Baseline data|No supplement was administered.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxidant/antioxidant status of the test person |  | after 1, 5, and 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tocopherol intake, tocopherol faecal excretion and serum tocopherol concentration |  | after 1, 5, and 9 weeks | 
| fiber intake and excretion |  | after 1, 5, and 9 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Black currant, Berry seed, Press residue, Tocopherol, Fatty acids, Fiber, Total phenols, TEAC, Comet assay, Dihydroxybenzoic acid
Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 160/4.5

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare Symbicort with budesonide alone and with formoterol alone in the treatment of asthma in adolescents and adults

Official Title
-----------------
A 12 Week, Randomized, Double-blind, Double-dummy, Placebo-controlled Trial of Symbicort TM (160/4.5mcg) Versus Its Mono-products (Budesonide and Formoterol) in Adolescents (at Least 12 Years of Age) and Adults With Asthma - SPRUCE 160/4.5

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

Intervention / Treatment
-----------------
* Drug: budesonide/formoterol
* Drug: budesonide
* Drug: formoterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 12 years of age Diagnosis of asthma Baseline lung function test results as determined by protocol and required and received treatment with inhaled corticosteroids and/or lung treatments specified in protocol within the timeframe and doses specified in the protocol Exclusion Criteria: Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 12 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<br> | Drug: budesonide/formoterol<br> <br> * Other names: Symbicort;|
| Active Comparator: 2<br>budesonide | Drug: budesonide<br> <br> |
| Active Comparator: 3<br>formoterol | Drug: formoterol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation |  | FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments |  | Throughout the treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Symbicort, budesonide/formoterol, budesonide, formoterol
Doppler Ultrasonographic Assessment of Fetal Internal Thoracic Artery Indexes

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the feasibility of visualizing the internal thoracic artery (ITA), establishing the normogram for ITA pulsatility index (PI), resistance index (RI) and acceleration/ejection time (AT/ET) at 24-32 weeks.

Detailed Description
-----------------
Background: The internal thoracic artery arises from the subclavian artery as the first branch. It travels downward on the inside of the rib cage and then gives off six main branches; mediastinal, thymic, pericardiacophrenic, sternal, perforating and intercostal branches. In literature, there are so many articles that have been focused on thymus size in pregnancies complicated with diabetes mellitus, fetal growth restriction, preterm rupture of membranes and so on. To the best of our knowledge, there is no paper about fetal ITA whose branch are feeding vessel of thymus and ITA Doppler velocity. The arteries supplying the thymus are branches of the internal thoracic, and inferior thyroid arteries. As far as it has been known, growing of a tissue depends on increased blood flow. Before detecting possible blood-flow changes in fetuses complicated with great obstetrics patologies, the investigators should obtain normal values of ITA Doppler velocity.

Official Title
-----------------
Doppler Ultrasonographic Assessment of Fetal Internal Thoracic Artery Indexes

Conditions
-----------------
Pregnancy Related, Fetal; Circulation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy having no fetal anomalies healthy pregnant women age >17 and <45 years between 24th-32nd gestational weeks Exclusion Criteria: fetuses with congenital aneuploidy or structural malformation underlying chronic diseases pregnant women complicated with gestational diabetes, Type 1-2 DM, hypertension (pregnancy-induced; chronic; preeclampsia), malignancy pregnancy complicated with preterm premature rupture of membranes, preterm labour, fetal growth restriction and another obstetric complication

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 45 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 |
| --- | --- | --- |
| Doppler indices for internal thoracic artery | Doppler indices (pulsatility index, resistance index, acceleration and ejection time) | Between 24th and 32nd gestational weeks | 
| assessment of fetal thymus size | volume and perimeter and transvers diameter | Between 24th and 32nd gestational weeks |
Rollover Protocol for Subjects Who Have Responded on Study 4218s - A Phase 2 Study

Study Overview
=================
Brief Summary
-----------------
Subjects achieving a clinical response in study OX4218s with a biomarker reduction or symptom response are eligible to enroll in this rollover study to continue once every three weeks fosbretabulin infusions for up to one year.

Detailed Description
-----------------
Subjects enrolled in the PNET/GI-NET study OX4218s received weekly dosing with fosbretabulin for up to 3 cycles or approximately 9 weeks. Subjects achieving a clinical response with a biomarker reduction or symptom response based on investigator assessment are eligible to enroll in this rollover study (protocol OX4219s). Subjects will receive fosbretabulin every three weeks for a maximum of approximately one year or until disease progression, unacceptable toxicity, consent withdrawal, protocol-noncompliance, or the investigator feels that it is no longer in the subject's best interest to continue therapy.

Official Title
-----------------
Rollover for Study OX4218s, A P2 Study to Investigate Safety and Activity of Fosbretabulin Tromethamine in the Treatment of Well-Differentiated, Low-to-Intermediate-Grade Unresectable, Recurrent or Metastatic PNET or GI-NET With Elevated Biomarkers

Conditions
-----------------
Neuroendocrine Tumors

Intervention / Treatment
-----------------
* Drug: fosbretabulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has been treated in the OXiGENE-sponsored Phase 2 study OX4218s Exclusion Criteria: Subject has not received fosbretabulin treatment in the study OX4218s

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Subjects will receive fosbretabulin at the same dose and frequency as in study OX4218s | Drug: fosbretabulin<br>* fosbretabullin, 60 mg/m2 weekly for up to 1 year<br>* Other names: CA4P, combretastatin A-4 phosphate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biomarkers from baseline |  | 48 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic, Gastrointestional
THERMOCOOL® SMARTTOUCH™ Registry

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this registry is to obtain real world clinical use of contact force measurements during ablation procedures.

Official Title
-----------------
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Atrial Fibrillation- Registry

Conditions
-----------------
Symptomatic Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with symptomatic atrial fibrillation (AF) who, in the opinion of the investigator, are candidates for ablation for atrial fibrillation. Candidates who have had previous ablation procedures may be included in the registry Subjects who have failed at least one antiarrhythmic drug (AAD)(class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic atrial fibrillation, or intolerable to the AAD. Subjects must be 18 years of age or older Subjects must be able and willing to comply with all pre-, post and follow-up testing and requirements Subjects must provide written informed consent to participate in the registry Exclusion Criteria: Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this registry History of blood clotting or bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran) History of a documented thromboembolic event within the past year Significant pulmonary disease (eg, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease)or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms Previous cardiac surgery (eg, CABG) or valvular cardiac surgical procedure (eg, ventriculotomy, atriotomy, valve repair or replacement, presence of a prosthetic valve) Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months) Diagnosed atrial myxoma Unstable angina Uncontrolled heart failure Uncontrolled heart Failure or NYHA Class III or IV heart failure Acute illness, active systemic infection, or sepsis Any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator

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 |
| --- | --- | --- |
| Acute Success | Confirmation of entrance block in the pulmonary veins (acute success) | 1 year | 
| Contact Force | Contact force during ablation procedures | 1 year | 
| Adverse Events | Procedural complications and adverse events throughout the registry | 1 year |
Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the efficacy and safety of pemetrexed monotherapy as salvage treatment in patients with relapsed or metastatic squamous cell carcinoma of head and neck.

Detailed Description
-----------------
The treatment option in patients with platinum-resistant relapsed or metastatic squamous cell carcinoma of head and neck is limited. Previous randomized phase III study showed a borderline benefit of pemetrexed added to cisplatin. Therefore, we aim to evaluate the efficacy of pemetrexed in salvage setting.

Official Title
-----------------
Phase II Study of Pemetrexed Monotherapy in Patients With Platinum-resistant Squamous Cell Carcinoma of Head and Neck

Conditions
-----------------
Squamous Cell Carcinoma of Head and Neck

Intervention / Treatment
-----------------
* Drug: Pemetrexed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range: 18-65 years old Histological confirmed incurable relapsed or metastatic squamous cell carcinoma of head and neck Prior exposure of at least one line of platinum-containing regimen At least one site of measurable disease according to RECIST criteria ECOG performance status 0-1 Life expectancy of more than 3 months Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L Liver function: total bilirubin, ALT and AST <1.5×UNL Renal function: Cr<1.5×UNL, CCR≧45ml/min Exclusion Criteria: With curable treatment option Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Significant active infection Pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Pemetrexed<br>500 mg/m2, repeated every 3 weeks until disease progression or intolerable toxicity | Drug: Pemetrexed<br>* Pemetrexed 500 mg/m2 at day 1. Frequence of cycles: every 3 weeks<br>* Other names: Alimta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median progression-free survival |  | 1 year | 
| Median overall survival |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Squamous cell carcinoma of head and neck, Pemetrexed
Preoperative Prediction of of Thymic Epithelial Tumors by Diffusion-Weighted MR Imaging

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyze aquaporins expression of thymic epithelial tumors and to compare them with apparent diffusion coefficient(ADC) from ultra-high b-values, and to test a possibility of use of ADCuh to identify the pathological type of tumor.

Detailed Description
-----------------
Magnetic resonance (MR) diffusion-weighted imaging (DWI) measures water diffusion in biological tissue. The quantification of diffusion is described by the apparent diffusion coefficient (ADC),which largely depends on the number and separation of barriers.Thus, ADC can provide information regarding tissue microstructure. According to the literature, ADC is also related to cell membrane permeability for water molecules.It is well known that cellular water transport depends on aquaporins (AQPs).In general,the expression of aquaporins might differ in several pathologic disorders. With reference to this fact,we hypothesize that AQPs expression may influence ADC in thymic epithelial tumors(TETs).Therefore,the aim of the present study is to analyze possible associations between ADC from ultra-high b-values and AQPs expression(ADCuh) in TETs and to use ADCuh to identify the pathological type of tumor.

Official Title
-----------------
Preoperative Prediction of the Pathological Classification of Thymic Epithelial Tumors by Apparent Diffusion Coefficient Using Ultra-high B-values

Conditions
-----------------
Thymic Epithelial Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no use of corticosteroid drugs; no MRI contraindication; no infection or fever; tumor diameter is greater than 2cm. Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with low-risk thymomas<br>low-risk thymomas include types A, AB, and B1 thymomas | |
| Patients with high-risk thymomas<br>high-risk thymomas include types B2 and B3 thymomas | |
| Patients with thymic carcinomas<br>thymic carcinomas also called types C thymomas | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Different DWI parameters in thymic epithelial tumors |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To acquire aquaporins expression level of thymic epithelial tumors |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
apparent diffusion coefficient, aquaporins