linjc16/ctgov huggingface dataset:
Trigeminus-evoked Somatosensory Potentials in Patients Undergoing Carotid Surgery

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Trigeminus-evoked somatosensory potentials (TRI-SEP) may be used as an alternative technique to medianus-evoked somatosensory potentials (MED-SEP) in patients undergoing elective carotid surgery.

Detailed Description
-----------------
For CNS-monitoring somatosensory-evoked responses ba electrical stimulation of the contralateral median nerve are established: A reduction of amplitude and a delay in latency may represent a sensible marker of imminent cerebral ischemia. This study will evaluate a new concept by using trigeminal nerve evoked somatosensory evoked potentials in comparison to the established MED-SEP. Beside the comparison of two methods of neuromonitoring, this study will investigate the neurological long-term outcome (90-day evaluation) with different neuropsychological tests for the detection of cognitive deficits.

Official Title
-----------------
Comparison of Trigeminus-evoked Somatosensory Potentials (TRI-SEP) and Medianus-evoked Somatosensory Potentials (MED-SEP) in Patients Undergoing Carotid Surgery

Conditions
-----------------
Carotid Surgery

Intervention / Treatment
-----------------
* Procedure: MED-SEP
* Procedure: TRI-SEP
* Procedure: neuropsychological tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years Agreement with study procedure Elective carotid surgery Exclusion Criteria: Inability to take somatosensory potentials Inability to respond to neuropsychological tests Severe preoperative neurological deficit

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 |
| --- | --- |
| 1<br>Patients undergoing carotid surgery | Procedure: MED-SEP<br>* intraoperative neurophysiological monitoring<br>Procedure: TRI-SEP<br>* intraoperative neurophysiologic monitoring<br>Procedure: neuropsychological tests<br>* neurological short- and longterm outcome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of episodes of cerebral ischemia during carotid surgery |  | intraoperative, 28 days, and 60 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carotid Surgery, Cerebral Ischemia, Cognitive Deficits, Somatosensory-evoked Potentials, Neuromonitoring
Anti-calculus Efficacy of a Dentrifice Containing Sodium Pyrophosphate and Potassium Pyrophosphate in Heavy Calculus Formers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine the anti-calculus effect of dentrifice containing 5% sodium pyrophosphate and potassium pyrophosphate in a triple-mask placebo controlled randomized clinical trial.

Official Title
-----------------
Evaluation of Anti-calculus Efficacy of a Dentrifice Containing Sodium Pyrophosphate and Potassium Pyrophosphate in Heavy Calculus Formers

Conditions
-----------------
ANTICALCULUS EFFICACY OF PYROPHOSPHATE IN HEAVY CALCULUS FORMERS

Intervention / Treatment
-----------------
* Drug: DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE
* Drug: PLACEBO DENTRIFICE WITHOUT PROPHOSPHATE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age group 15-30 years. Subjects who have not received periodontal therapy within preceding 1year. Heavy calculus formers with simplified calculus index score 1.5-3 . Exclusion Criteria: Age group 15-30 years. Subjects who have not received periodontal therapy within preceding 1year. Heavy calculus formers with simplified calculus index score 1.5-3 .

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 30 Years

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

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

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 |
| --- | --- |
| Active Comparator: Group 1<br>DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE WAS PRESCRIBED AND SUBJECTS WERE EVALUATED AT 3MONTH AND 6 MONTHS | Drug: DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE<br>* DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS<br>* Other names: XTAR;|
| Placebo Comparator: Group 2<br>PLACEBO DENTRIFICE WITHOUT PYROPHOSPATE WAS PRESCRIBED AND SUBJECTS WERE EVALUATED AT 3MONTH AND 6 MONTHS | Drug: PLACEBO DENTRIFICE WITHOUT PROPHOSPHATE<br>* PLACEBO DENTRIFICE WITHOUT PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| simplied calulus index. |  | Baseline to 6 months |
Alglucosidase Alfa Pompe Safety Sub-Registry

Study Overview
=================
Brief Summary
-----------------
To collect uniform and meaningful data on patients with Pompe disease who experience anaphylaxis, severe allergic reactions, and/or signals of severe cutaneous and/or systemic immune complex-mediated reactions following treatment with alglucosidase alfa.

Official Title
-----------------
A Prospective Safety Sub-Registry to Assess Anaphylaxis and Severe Allergic Reactions, and Severe Cutaneous and Systemic Immune Complex Mediated Reactions With Alglucosidase Alfa Treatment

Conditions
-----------------
Pompe Disease

Intervention / Treatment
-----------------
* Biological: alglucosidase alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must be enrolled in the Pompe Registry; Provide a signed patient information and authorization form; Have a confirmed diagnosis of Pompe disease (confirmation of diagnosis is defined as documented GAA enzyme deficiency from any tissue source and/or documentation of 2 GAA gene mutations); Be naïve to and plan to be treated with alglucosidase alfa at or prior to enrollment, or are being treated with alglucosidase alfa. Exclusion Criteria: Patients will be excluded if they have received an investigational drug (excluding alglucosidase alfa) within 30 days prior to signing a Safety Sub-Registry Patient Information and Authorization form, or if they are taking or plan to take any investigational product while enrolled in the Safety Sub-Registry.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pompe safety sub-registry<br>patients are selected from those who are enrolled in the Pompe Registry, and will be followed for safety evaluation in this sub-registry | Biological: alglucosidase alfa<br>* Alglucosidase alfa IV infusion of 20 mg/kg; qow<br>* Other names: Myozyme; Lumizyme;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients experience anaphylaxis, severe allergic reactions and/or signals of severe cutaneous and/or systematic immune complex-mediated reactions | collect meaningful data on patients with these outcomes following treatment with alglucosidase alfa | 4 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pompe disease, alglucosidase alfa, anaphylaxis, severe cutaneous, systemic immune complex-mediated reactions
Effect of Antiviral Therapy on Host Immune in Patients With Chronic Hepatitis B Virus(HBV) Infection

Study Overview
=================
Brief Summary
-----------------
During hepatitis B virus(HBV) infection host immune plays important role.Recently there are many different antiviral therapy methods.Different antiviral therapy methods showed different effector.In order to investigate whether these antiviral therapy methods especially methods directly inhibit viral replication have some effect on host immune the investigators designed these study. The investigators want to observe the change of host immune during antiviral therapy in patients with chronic HBV infection, and analyze the relationship between these changes and the antiviral effector of these drugs.

Official Title
-----------------
Study the Effect of Nucleoside on Host Immune in Patients With CHB

Conditions
-----------------
HBeAg Positive Chronic Hepatitis B Infection

Intervention / Treatment
-----------------
* Drug: Telbivudine


Participation Criteria
=================
Eligibility Criteria
-----------------
inclusion criteria: 18-65 years old chronic HBV infection HBeAg positive,HBV DNA more than 10E5 IU/mL ALT ≥2×UTL exclusion criteria: with liver cancer with liver failure pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 66 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 |
| --- | --- |
| No Intervention: therapy<br> | Drug: Telbivudine<br>* 600mg,1/d,one year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of programmed death-1(PD-1) level of patients with chronic HBV infection during therapy |  | base line-4 weeks-12 weeks-24 weeks-end of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decline of hepatitis B e antigen (HBeAg) level |  | base line-4weeks-12weeks-24weeks-end of therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HBV, Immune, antiviral therapy
Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary intervention.

Official Title
-----------------
Randomized Multicenter Comparison of Sirolimus Versus Bare Metal Stent Implantation in Complex Coronary Lesions. Acronym: Scand Stent

Conditions
-----------------
Ischaemic Heart Disease

Intervention / Treatment
-----------------
* Device: Coronary Drug Eluting Stents for PCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable, or unstable angina and/or objective signs of myocardial ischaemia Lesions should be de novo and located in native vessels with a diameter > 2.25 mm. Complex lesions to be included should have at least one of the following characteristics: Ostial in location (< 5 mm from ostium) Total occlusions with a length ≥ 15 mm Bifurcational (side branch > 1.75 mm in diameter) Angulated (> 45° within lesion) Exclusion Criteria: Patients: Other severe disease with an expected survival < 1 year Other significant cardiac disease Known allergy against paclitaxel, clopidogrel or stainless steel. Myocardial infarction within 3 days of the index procedure Linguistic difficulties needing an interpreter Renal insufficiency (p-creatinine > 200 micromol/l) Gastrointestinal bleeding within 1 month Childbearing potential or pregnancy Participation in another study Lesions: Unprotected left main disease Restenosis Lesions containing visible thrombus Treatment with other modality than balloon or stent (ablation, brachytherapy, ultrasound) in connection with the index procedure Diffuse coronary disease distal to the treated lesion Heavily calcification Lesion located in saphenous vein graft

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

| Intervention/Treatment |
| --- |
|Device: Coronary Drug Eluting Stents for PCI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal lumen diameter |  |  | 
| Frequency of restenosis (>50%) at 6 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diameter stenosis, late loss and loss index at 6 months MACE: death, myocardial infarction, target lesion revascularisation within 12 months and 24 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary complex lesions, Restenosis, Drug eluting stents
Extension Study of Long-term Safety and Efficacy of Myozyme for a Single Patient With Pompe Disease Who Were Previously Enrolled in Genzyme Sponsored ERT Studies.

Study Overview
=================
Brief Summary
-----------------
This extension study was to monitor the long-term safety and efficacy of rhGAA treatment in a single patient with infantile-onset Pompe disease who were previously treated with rhGAA in a Genzyme study.

Official Title
-----------------
An Open-Label Extension Study of the Long-Term Safety and Efficacy of Recombinant Human Acid α-Glucosidase (rhGAA) Given as Enyzme Replacement Therapy to a Single Patient With Pompe Disease (Glycogen Storage Disease Type II) Who Were Previously Enrolled in Genzyme-Sponsored Enzyme Replacement Therapy Studies

Conditions
-----------------
Pompe Disease Late-Onset, Glycogen Storage Disease Type II GSD II

Intervention / Treatment
-----------------
* Biological: Myozyme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written informed consent prior to participating in any study related procedures; Currently enrolled in Protocol AGLU01402 Have the ability to comply with the clinical protocol, which required extensive clinical evaluations for an extended period of time. Exclusion Criteria: Was pregnant or unwilling to use approved birth control during the course of the study; Had experienced any unmanageable AEs under Protocol AGLU01402 (as determined and agreed upon by the Principal Investigator and sponsor) due to rhGAA that would preclude continuing ERT; Was participating in any other investigational study.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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: 1<br> | Biological: Myozyme<br>* 30 mg/kg qow f and 40 mg/kg qow<br>* Other names: Alglucosidase alfa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of this extension study was to monitor the long-term safety and efficacy of a single patient |  | 3 years |
The Gut Microbiota and Delirium in the ICU

Study Overview
=================
Brief Summary
-----------------
To investigate whether the composition of the gut microbiota is different in patients that develop delirium during critical illness as compared to patients who do not.

Detailed Description
-----------------
We plan to include an equal number of patients admitted to the ICU, that either do or don't develop delirium during their course of critical illness. Samples of feces/rectal swaps will be taken at admission and again either when the patients become CAM-ICU positive, alternatively after 5 days admssion/at discharge in patients that remain CAM-ICU negative. Samples are then sent to analyses for purification of bacterial DNA and metagenomic analysis.

Official Title
-----------------
The Association Between the Gut Microbiota Composition and Development of Delirium in ICU Patients

Conditions
-----------------
Microbial Colonization, Delirium of Mixed Origin

Intervention / Treatment
-----------------
* Diagnostic Test: Metagenomic analysis of gut microbiota


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to the ICU, Disability to make informed consent due to critical illness - Exclusion Criteria: Dementia. Delirium diagnosed prior to the ICU admission on the non-ICU floors. Coma. Indication for deep sedation (-4/-5). -

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Metagenomic analysis of gut microbiota|All patients have rectal swaps/fecal samples subjected to metagenomic analysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut Microbiota composition | Metagenomic analysis of Gut Microbiota / composition by different bacterial families | May 2018 |
Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL

Study Overview
=================
Brief Summary
-----------------
Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL

Official Title
-----------------
Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL

Conditions
-----------------
Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Drug: Venetoclax
* Drug: Umbralisib
* Biological: Ublituximab
* Drug: Lenalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia, or Non-Hodgkin's Lymphoma Refractory to or relapsed after at least 1 prior treatment regimen Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion Criteria: Any major surgery, chemotherapy or immunotherapy within the last 21 days Known hepatitis B virus, hepatitis C virus or HIV infection Known histological transformation from CLL to an aggressive lymphoma (Richter's)

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ublituximab + Umbralisib + Venetoclax<br>Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose | Drug: Venetoclax<br>* BCL-2 Inhibitor<br>* Other names: Venclexta;Drug: Umbralisib<br>* PI3K-Delta Inhibitor<br>* Other names: TGR-1202;Biological: Ublituximab<br>* Glycoengineered Anti-CD20 mAb<br>* Other names: TG-1101;|
| Experimental: Ublituximab + Umbralisib + Lenalidomide<br>Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days | Drug: Umbralisib<br>* PI3K-Delta Inhibitor<br>* Other names: TGR-1202;Biological: Ublituximab<br>* Glycoengineered Anti-CD20 mAb<br>* Other names: TG-1101;Drug: Lenalidomide<br>* Thalidomide Analog, immunomodulatory agent with antiangiogenic and antineoplastic properties<br>* Other names: Revlimid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine Acceptable Adverse Events That Are Related to Treatment |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response and Complete Remission Rate |  | 12 months | 
| Minimum Residual Disease (MRD) |  | 12 months |
A Study of the Metabolic Syndrome in Patients With Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
An increased prevalence of the metabolic syndrome has been found in patients with systemic lupus erythematosus in recent years.

Detailed Description
-----------------
This study will investigate the prevalence of the metabolic syndrome in patients with SLE in Taiwan. We expect our study will provide further understanding of the association between SLE and metabolic syndrome, which may give direction to prevent late cardiovascular morbidity and mortality in SLE patients.

Official Title
-----------------
Association of the Metabolic Syndrome and Systemic Lupus Erythematosus in Taiwan

Conditions
-----------------
Metabolic Syndrome, Cardiovascular Risk Factors, Systemic Lupus Erythematosus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons aged 18 and above. Persons fulfill the diagnostic criteria of the 1997 American College of Rheumatology for systemic lupus erythematosus in the patient group. Exclusion Criteria: Exclude a history myocardial infarction, angina or stroke.

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

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 |
| --- | --- |
| Systemic lupus erythematosus<br>Patients should fulfill the diagnostic criteria of the 1997 American College of Rheumatology for systemic lupus erythematosus | |
| Normal control<br>Age- and sex-matched health volunteers will serve as controls. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of the metabolic syndrome in patients with systemic lupus erythematosus in Taiwan |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic syndrome, Systemic lupus erythematosus