linjc16/ctgov huggingface dataset:
Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Rhythm

Study Overview
=================
Brief Summary
-----------------
The primary objective is to demonstrate that a higher proportion of responders to deep brain stimulation (DBS) in the anterior nucleus (AN) of the thalamus in refractory epilepsy patients in the SANTE study exhibit a recruitment rhythm relative to non-responders.

Official Title
-----------------
Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Rhythm (SANTE RR)

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

Intervention / Treatment
-----------------
* Device: There was no intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in the SANTÉ study, have been implanted with a complete DBS system, and is currently receiving stimulation in the long-term follow-up phase (post Month 13) of the study Patient or legal representative is able to understand and provide signed consent for participating in the study Willing and available to attend the visit as scheduled and to comply with the study protocol Exclusion Criteria: Patients unable to tolerate stimulation turned OFF during the testing period Are pregnant or suspected of being pregnant
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Responder<br>A subject having at least a 50% reduction in total seizure frequency compared to the SANTE study 3-month Baseline Phase | Device: There was no intervention.<br>* There was no intervention. This study was designed as an in-clinic testing protocol to identify recruitment rhythms.<br>|
| Non-responder<br>A subject with a less than 50% reduction in total seizure frequency compared to the SANTE study 3-month Baseline Phase. | Device: There was no intervention.<br>* There was no intervention. This study was designed as an in-clinic testing protocol to identify recruitment rhythms.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that a higher proportion of DBS responders exhibit a RR relative to non-responders, using maximum tolerated voltage settings, at activated electrode contacts used for DBS stimulation in the SANTE study. |  | Study testing to occur during the long-term follow-up phase of the SANTE trial. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For patients without a RR at their activated DBS electrode contacts used in the SANTE study, demonstrate that activating other electrode contacts generates a RR. |  | Study testing to occur during the long-term follow-up phase of the SANTE trial. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DBS, Epilepsy, Recruitment rhythm
Dose Response Effect of Probiotics for the Prevention of Antibiotic-associated Diarrhea in Chinese Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the dose response effect of probiotic capsules for the prevention of antibiotic-associated diarrhea (AAD).

Official Title
-----------------
Dose Response Effect of a Proprietary Probiotic Formula for the Prevention of Antibiotic-associated Diarrhea in Chinese Adults

Conditions
-----------------
Antibiotic-associated Diarrhea

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic
* Dietary Supplement: Probiotic
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 30-70 years initiating antibiotic therapy informed consent Exclusion Criteria: current diarrhea life threatening illness habitual probiotic use

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br> | Dietary Supplement: Probiotic<br>* L. acidophilus, L. paracasei, B. lactis; 2.5 billion cfu capsule once per day<br>|
| Active Comparator: Probiotic-2<br> | Dietary Supplement: Probiotic<br>* L. acidophilus, L. paracasei, B. lactis; 10 billion cfu capsule once per day<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of antibiotic-associated diarrhea |  | 5 weeks after antibiotic discontinuation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antibiotic, diarrhea, probiotic
Respiratory Mechanics in Intensive Care Patients

Study Overview
=================
Brief Summary
-----------------
This study aims at assessing the respiratory mechanics of intubated patients in intensive care unit.

Official Title
-----------------
Study of the Respiratory Mechanics Characteristics With Esophageal PREssure Measurements in Mechanically Ventilated Patients in IntensivE caRe Unit

Conditions
-----------------
Intensive Care, Ventilator Lung

Intervention / Treatment
-----------------
* Device: Esophageal pressure measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > or = 18 years Invasive mechanical ventilation on tracheal tube Treatment with neuromuscular blocking agents Nasogastric tube needed for enteral nutrition Exclusion Criteria: Lack of free and informed consent Pregnant or breastfeeding woman Contra-indication to esophageal pressure measurement catheter

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assessement of respiratory mechanics<br>Measurement of respiratory mechanics characteristics | Device: Esophageal pressure measurement<br>* Use of a nasogastric tube equipped with esophageal balloon to assess respiratory mechanics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest wall compliance measurement (mL/cmH2O) |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung compliance measurement (mL/cmH2O) |  | 1 hour | 
| End expiratory lung volume (mL) |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mechanical ventilation
Evaluation of the GORE® C3 Delivery System Module

Study Overview
=================
Brief Summary
-----------------
This is an observational Registry designed to obtain early data on the use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System.

Detailed Description
-----------------
This is a retrospective and prospective observational cohort Registry designed to obtain data on the use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System. Patient and device performance outcomes will be collected during treatment and throughout all post-treatment visits, including follow-up extending up to 10 years.

Official Title
-----------------
Global Registry for Endovascular Aortic Treatment (GREAT)

Conditions
-----------------
Aortic Aneurysm, Abdominal

Intervention / Treatment
-----------------
* Device: Stent graft (EXCLUDER)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age required by local regulations (as applicable) Indication for aortic endovascular stent graft repair as determined by the treating physician (refer to current Instructions for Use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aortic pathologies<br>Indication for aortic endovascular stent graft repair | Device: Stent graft (EXCLUDER)<br>* Endovascular repair<br>* Other names: EXCLUDER;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate procedural outcomes for the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System when used in accordance with the standard medical practice at each participating hospital. |  | Up to 10 Years |
Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.

Study Overview
=================
Brief Summary
-----------------
This study is designed as an open label evaluation of the efficacy of latanoprost and timolol fixed combination (Xalacom) after 6 month of treatment. Eligible patients may be enrolled at the baseline visit. All current ocular hypotensive therapy must be discontinued at this time. On baseline day, patients eligible for the study will receive Xalacom which is to be instilled in the morning.

Official Title
-----------------
Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom (Fixed Combination Of Latanoprost And Timolol) In Patients With Poag Or Oh. A 6-Month, Open, Multi-Center Trial In Italy

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Xalacom


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of glaucoma (primary open angle, pigmentary, exfoliative) or ocular hypertension (IOP >= 21 mmHG). Visual acuity >= 20/200. Exclusion Criteria: Closed/barely open anterior chamber angle or history of acute angle closure glaucoma. Hystory of ALT within 3 months prior to the baseline visit. History of any ocular filtering surgical intervention. Ocular surgery or inflammation/infection within 3 months prior to the baseline visit.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Xalacom|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP change from baseline to the 6-month visit. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % reduction of IOP change from baseline to the 6-month visit. |  |  | 
| Proportion of pts achieving different levels of mean % of IOP reduction at the end of the treatment(eg:0%,10%,15%,20%,etc). |  |  | 
| Proportion of pts who reach specific IOP levels at the end of treatment(eg:16,17,18,19 mmHg,etc). |  |  |
Prevention of Amputation in Diabetic Foot Ulcers Using Amniotic Tissue

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see whether the use of AMNIOEXCEL® improves healing and reduces the need to cut off all or part of a leg (amputation) in high-risk patients who have diabetes and foot sores (also sometimes called ulcers or wounds).

Detailed Description
-----------------
The purpose of this study is to demonstrate the effectiveness of comprehensive, interdisciplinary approach (usual care) in combination with early application of advanced therapy; dehydrated human amniotic membrane allografts (AMNIOEXCEL®, Derma Science, Princeton, New Jersey) in healing and preventing amputation in high risk patients with diabetic foot ulcers.

Official Title
-----------------
Prevention of Amputation in a High Risk Population With Comprehensive Care and Amniotic Tissue

Conditions
-----------------
Diabetic Foot Ulcer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or 2 diabetes Ulcer anywhere on the foot Moderate to high risk for amputation according to Prevention of Amputation for Veterans Everywhere (PAVE) and the Society for Vascular Surgery Lower Extremity Threatened Limb (SVS WIfI) classification system (WIFi) criteria Exclusion Criteria: Inability or unwillingness to travel to Boise VA for clinic visits Enrolled in Hospice Have known or expected malignancy of foot ulcer Are or planning to become pregnant Signs of progressive gangrene, limb-threatening infection

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 |
| --- | --- |
| Diabetic Foot Ulcers at Amputation Risk<br>Patients at high risk for limb amputation from a diabetic foot ulcer will be treated with comprehensive, interdisciplinary approach (usual care) in combination with early application of advanced therapy; dehydrated human amniotic membrane allografts (AMNIOEXCEL®, Derma Science, Princeton, New Jersey). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limb salvage | All subjects will be seen weekly/biweekly by the study team until the point of definitive wound closure (epithelialization) and the subject has the ability to progress weight bearing and ambulation. | One month past wound healing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effective wound healing | Early application of amniotic tissue and multidisciplinary team comprehensive care on diabetic foot ulcers with a high risk for amputation | One month past wound healing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
foot ulcer, diabetic, wound healing, diabetic foot ulcer
Effect of Hyponatremia in Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
In this retrospective study, the investigators determined the frequency of hyponatremia in small cell lung cancer and the prognosis. 126 (27%) of 466 patients were hyponatremic. Hyponatremia could not be corrected in 50.8% (n=64) of hyponatremic patients. Survival was found to be better in the group of whom hyponatremia was corrected.

Official Title
-----------------
Frequency and Effect on the Prognosis of Hyponatremia During the diagnosıs in Small Cell Lung Cancer

Conditions
-----------------
Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with SCLC between January 2012 and January 2017 in our hospital were retrospectively screened Exclusion Criteria: Over 18 age If data doesn't exist

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 |
| --- | --- |
| Hyponatremia<br>Hyponatremic small cell cancer patients | |
| Normonatremia<br>Normonatremic small cell cancer patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Effect of hyponatremia according to mortality | Through study completion, an average of 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Small cell lung cancer, hyponatremia, prognosis, treatment, biochemistry
Efficacy and Safety of 400 μg Twice Daily of Aclidinium Bromide vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to observe the Efficacy and safety of 400 μg twice daily of aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Official Title
-----------------
Efficacy and Safety of 400 μg Twice Daily of Aclidinium Bromide vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Drug: aclidinium bromide 400 μg
* Drug: aclidinium bromide placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of stable moderate to severe COPD as defined by GOLD (the Global Initiative for Chronic Obstructive Lung Disease) guidelines(http://www.goldcopd.org); a postbronchodilator FEV1/forced vital capacity [FVC] ratio < 70% and FEV1 ≥ 30% to <80% of the predicted value. Current or former cigarette smokers with a smoking history of at least 10 pack-years. Exclusion Criteria: History or current diagnosis of asthma Patients who have been hospitalized for an acute COPD exacerbation within 3 months prior to Visit 1 Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit 1. Patients with any clinically significant respiratory conditions other than COPD

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Active Comparator: aclidinium bromide<br> | Drug: aclidinium bromide 400 μg<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: aclidinium bromide placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Week 12 in morning predose (trough) FEV1 |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Week 12 in peak FEV1 |  | Week 12 |
Genetic Variants and Oxidative Stress as Links Between Periodontitis and Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the systemic impact of periodontitis in patients with Metabolic Syndrome, by assessing measures of sub-clinical atherosclerosis and cardiovascular risk, microbial factors and host genetic variants, and to study the possible effect of mediators of inflammation and oxidative stress as links between the two conditions.

Detailed Description
-----------------
This is a cross-sectional study. 102 patients with metabolic syndrome will be recruited and will have periodontal and dental examination for diagnosis of caries and periodontal diseases. They will undergo blood, saliva, GCF and subgingival plaque sampling and a series of tests on cardiovascular disease, including measures of pulse-wave velocity,carotid intima-media thickness and echocardiography assessment. Statistical analysis will assess associations between dental diagnoses and metabolic, cardiovascular, inflammatory, genetic, microbial and cardiovascular risk outcomes.

Official Title
-----------------
Genetic Variants and Oxidative Stress as Links Between Periodontitis and Metabolic Syndrome

Conditions
-----------------
Periodontitis, Adult, Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: Observational study (no intervention)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian ethnicity Age 18- 75 Diagnosis of metabolic syndrome Presence of at least 12 teeth Exclusion Criteria: Pregnancy Presence of infectious diseases such as hepatitis and HIV Use of non-steroidal anti-inflammatory drugs (excluding low-dose aspirin) within one month prior to the baseline visit Use of systemic antibiotics within three months prior to the baseline visit Antibiotic pre-medication required for the performance of periodontal examination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational study (no intervention)|No interventions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulse wave velocity |  | baseline | 
| oxidative stress |  | baseline | 
| carotid intima-media thickness |  | baseline | 
| genetic variants |  | baseline | 
| left ventricular mass |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory markers |  | baseline | 
| subgingival microbes |  | baseline |