linjc16/ctgov huggingface dataset:
Effect of Valproate on Propofol

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effect of valproate on the required dose of propofol for sedation in patients with mental retardation.

Detailed Description
-----------------
The intravenous sedation with propofol is very useful for patients with mental retardation and challenging behavior. However, it is very difficult to titrate the dose of propofol for maintaining the adequate sedation depth because of the difficulty of verbal communication with them. Most of them have a epilepsy and take antiepileptic drugs. Antiepileptic drugs are thought to influence on the effect of anesthetics. Valproate is reported to inhibit the metabolism of propofol. Therefore, we divide the patients into two groups : patients receiving valproate (valproate group), patients receiving no antiepileptic drugs (control group), and compare the required dose of propofol and the recovery time.

Official Title
-----------------
The Effect of Valproate on the Required Dose of Propofol for Sedation in Patients With Mental Retardation

Conditions
-----------------
Mental Retardation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 16 or over American Society of Anesthesiologists (ASA) physical status 1 or 2 The treatment of dental caries, endodontics, periodontics and prosthesis were planed Participants had moderate or severe Mental Retardation, and were not completely cooperated with dental treatment Exclusion Criteria: Patients could communicate and cooperate with dental treatment, but used dental sedation for decrease of the anxiety and the fear about dental treatment or another reasons Patients needed premedication and inhalational anesthetics Patients had uncontrolled or sever medical condition

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Mental Retardation<br>Patients receiving valproate or not | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dose of anesthesia agent |  | 1 day | 
| The recovery time of eyelash reflex |  | 1 day | 
| The recovery time of eye opening |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intravenous sedation, Dental treatment, Mental retardation, Antiepileptic drug, Valproate, Propofol
Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM)

Study Overview
=================
Brief Summary
-----------------
This study involved the medical record review of resuscitation records for all severely-injured trauma patients requiring emergent surgical intervention and significant acidosis from 2005 through 2009.

Detailed Description
-----------------
The study objective is to assess the efficacy of fluid resuscitation and treatment of acidosis in patients who were managed with use of amine buffer THAM (tris-hydroxymethlaminomethane) versus those who were resuscitated with crystalloids or colloids and may have have received sodium bicarbonate for the treatment of acidosis.

Official Title
-----------------
Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM) in Patients With Severe Traumatic Injury: A Retrospective Cohort Study

Conditions
-----------------
Resuscitation, Trauma Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of severe traumatic injury requiring emergent surgery Peri-operative development of severe acidosis (defined arterial ph less than or equal to 7.20 or base deficit greater than or equal to 10 mEq/dL) Acidosis was treated with either THAM or usual care (defined as crystalloid either or without sodium bicarbonate) Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 90 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 |
| --- | --- |
| THAM Patients<br>Patients who were managed with the use of THAM | |
| Non-THAM Patients<br>Patients who did not use THAM but were resuscitated with crystalloids and colloids and may have received sodium bicarbonate for the treatment of acidosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of fluids and blood products used during the operative and 72 hr post-operative period. | Total amount of fluids and blood products used during the operative and 72 hr post-operative period. | Operative period and ICU (72 hr) post-op period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative, intensive care unit and hospital mortality | Measure the the number of mortality during intra-operative and/or ICU period | From the operative procedure onset to discharge out of the ICU or expiration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
resuscitation, trauma, THAM, colloids, crystalloids
AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study)

Study Overview
=================
Brief Summary
-----------------
Assess the impact of lesion preparation using the AngioSculpt balloon in the treatment of bifurcation lesions in native coronary arteries.

Detailed Description
-----------------
The purpose of the AngioSculpt® Scoring Balloon Catheter For Bifurcation Coronary lesions (ABC registry) is to demonstrate the acute procedural success, device performance and long term outcome associated with use of the AngioSculpt Scoring Balloon Catheter (AngioScore, Inc., Fremont, CA) for lesion preparation in the treatment of bifurcation lesions in native coronary arteries

Official Title
-----------------
AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study) Prospective, Multi-center, Non-randomized, Single-arm Registry

Conditions
-----------------
Bifurcation Coronary Disease

Intervention / Treatment
-----------------
* Device: AngioSculpt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with significant (≥ 50% diameter stenosis) native coronary artery disease involving a bifurcation (Medina class (x,x,1)). Exclusion Criteria: Concomitant use of Rotablator, Cutting Balloon, or investigational coronary devices. Additional planned coronary interventions for a non-target lesion within 30 days of the study procedure.

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: 1<br>Single Arm - Interventional | Device: AngioSculpt<br>* The AngioSculpt Scoring Balloon Catheter is a standard balloon dilatation catheter with a scoring balloon near the distal tip<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success ≤ 50% diameter stenosis of the main and the side branch at the conclusion of the procedure in the absence of in-hospital MACE |  | 9 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of side branch stenting |  | 9 Months | 
| Angiographic dissection rate and grade |  | 9 months | 
| MACE rate at 30 days post-procedure |  | 9 months | 
| Cumulative stent thrombosis and TLR rates at 9 months |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Side branch, Angiosculpt, Bifurcation Lesion, IVUS
Search for Genetic Basis of Vulvodynia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).

Detailed Description
-----------------
The short-term goal proposed for the current study was to investigate the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF). Eight polymorphic SNPs in the three different genes suspected to be involved in LPV has been examined as follow: HSPE gene: Four polymorphic SNPs: rs4693608, rs11099592, rs6856901 and rs4364254 that were found to be informative in the Ashkenazi Jewish population TRPV1 gene: Two polymorphic SNPs: rs222747 and rs8065080. NGF gene: A novel T to C SNP in the promoter region at position -198 (rs11102930) and rs6330 which was found to be associated with anxiety-related personality traits and has been suggested to may affect intracellular processing and secretion of NGF.

Conditions
-----------------
Vulvodynia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:o meeting Friedrich's criteria [50] for vulva vestibulitis syndrome diagnosed by a gynecological examination with LPV diagnosed with a severe degree of the syndrome according to Marinoff [48] classified with the primary type of the syndrome according to an interview with both parents of Ashkenazi origin.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Women with severe Vulvodynia | |
| Healthy controls<br>Women without vulvodynia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic association of Vulvodynia | the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF). | four years |
Troponin T in Chronic Obstructive Pulmonary Disease (COPD) Patients After Physical Exercise

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to investigate if physical exercise is associated with myocardial damage, expressed by elevated troponin T, in patients with COPD.

Detailed Description
-----------------
Patients with COPD will perform a cardiopulmonary exercise test (CPET) on treadmill until exhaustion, 8-12 minutes. Venous blood will be drawn before exercise test and 15 minutes, 3 hours and 24 hours after test for analysis of high sensitive Cardiac troponin T (hs-cTnT). The investigators will also measure arterial bloodgas, oxygen uptake, carbon dioxide consumption, ventilation, blood pressure, ECG, heart rate and ask for dyspnea-score.

Official Title
-----------------
COPD, Physical Exercise and Troponin T

Conditions
-----------------
COPD, Myocardial Diseases

Intervention / Treatment
-----------------
* Device: Treadmill exercise test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD GOLD 2-4 BODE-index ≥ 2 Referred by physician to a CPET Exclusion Criteria: Other serious pulmonary diseases (e.g. cancer, sarcoidosis, restrictive pulmonary diseases) Chronic heart disease with unstable angina or myocardial infarction ≤ 3 months prior to inclusion Percutaneous coronary intervention (PCI) Hypertension that is not controlled

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treadmill exercise test<br>Patients are subjected to an incremental Cardiopulmonary Exercise Test to exhaustion | Device: Treadmill exercise test<br>* Patients are subjected to an incremental exercise test to exhaustion on a treadmill<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Troponin T concentration 3 h |  | 3 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Troponin, Exercise
An Observational Study of MabThera/Rituxan (Rituximab) Plus Chemotherapy As First-Line Treatment in Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) plus chemotherapy as first-line treatment in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). Data will be collected from each patient during the 6 months of induction treatment and for up to 3 years of follow-up.

Official Title
-----------------
A Multi Centre, Single Arm, Observational Study on Safety and Efficacy of MabThera Plus Chemotherapy as 1st Line Treatment in Patients With DLBCL or FL

Conditions
-----------------
Diffuse Large B-Cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed CD20+ diffuse large B-cell lymphoma or follicular lymphoma Treatment with MabThera/Rituxan as per locally approved China package insert Documented patient with medical records Exclusion Criteria: Previous treatment for diffuse large B-cell lymphoma or follicular lymphoma

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 4.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (complete response + partial response) |  | 4.5 years | 
| Progression-free survival, defined as time from first treatment to lymphoma progression or death |  | 4.5 years | 
| Overall Survival, defined as time from 1st treatment to death of any cause |  | 4.5 years |
Contrast Enhanced Ultrasonography (CEUS) of Patients With Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is investigate if high frequency sonography and contrast enhanced sonography can be used to predict remission in patients with deterioration of Crohn's disease treated with steroids or tumor necrosis factor (TNF) alfa inhibitors.

Official Title
-----------------
High Frequency Ultrasound and Contrast Enhanced Ultrasound of Patients Treated for Deterioration of Crohn's Disease

Conditions
-----------------
Crohn's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Deterioration of Crohn's disease CDAI>150 Treated with systemic steroids or TNF alfa inhibitors Lesion found on ultrasound Exclusion Criteria: Disease location not reachable with ileocolonoscopy Pregnancy Acute coronary disease Unstable coronary disease Previous allergic reaction to SonoVue or its components

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 |
| --- | --- |
| Deterioration, Crohn's disease<br>Patients > 18 years old with a deterioration of Crohn's disease defined by CDAI >150 and requiring treatment with systemic steroids or TNF alfa inhibitors | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission defined by Crohns disease activity index (CDAI)<150 |  | 52 weeks from inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical treatment for Crohn's disease during follow up. (Surgery for perianal disease not included.) |  | 52 weeks | 
| Mucosal healing on ileocolonoscopy. Defined by Simple Endoscopic Index for Crohn's disease (SES-CD) |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's disease, sonography, contrast enhanced ultrasound
The Human Blastocyst Secretome and Implantome

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify the protein secretion and consumption profile of the human blastocyst (secretome) and the implanted blastocyst (implantome) using the protein array technology.

Conditions
-----------------
Blastocyst

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Conditioned medium of blastocytes

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
ProMRI ICD/CRT-D Post Approval Study

Study Overview
=================
Brief Summary
-----------------
Following product approval, confirmation of appropriate VF episode detection after MRI exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold changes post-MRI.

Official Title
-----------------
ProMRI ICD/CRT-D Post Approval Study

Conditions
-----------------
Tachyarrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ProMRI ICD/CRT-D system enabled with BIOTRONIK Home Monitoring. Exclusion Criteria: None
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 |
| --- | --- | --- |
| Proportion of ICD/CRT-D subjects with a ≥ 5 second delay in post-MRI VF detection. | Primary objectives will be analyzed once 25 subjects implanted with the ProMRI ICD system have been identified with a documented true VF episode post-MRI. | Up to 5 years post-approval | 
| Proportion of LV pacing leads with a LV pacing threshold increase > 1V between pre-MRI and one-month post-MRI. |  | Up to 5 years post-approval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Workflow compliance following MR exposure | Proportion of subjects with appropriate restoration of tachycardia detection and ICD therapy post-MRI. | Up to 5 years post-approval | 
| Left ventricular sensing attenuation | Proportion of subjects who experience left ventricular sensing amplitude attenuation >50% between pre-MRI and 30 days post-MRI. | Up to 5 years post-approval |
Expand New Drugs for TB [endTB]

Study Overview
=================
Brief Summary
-----------------
This observational study will examine the safety and efficacy of bedaquiline and delamanid used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB. The information gathered in this study will inform doctors how best to use these TB drugs in the future.

Official Title
-----------------
endTB (Expand New Drugs for TB) Observational Study: Treatment of MDR-TB With Regimens Containing Bedaquiline or Delamanid

Conditions
-----------------
Tuberculosis, Multidrug-Resistant

Intervention / Treatment
-----------------
* Other: This is a non-intervention observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient who receives a treatment regimen containing bedaquiline or delamanid at an endTB site will be invited to participate in this observational study, regardless of age or gender. Any patient who signs the study informed consent form will be included in the study. Exclusion Criteria: Refusal to participate in the study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bedaquiline and companion WHO Group 5 drugs<br> | Other: This is a non-intervention observational study<br>* No applicable intervention; this is a secondary data analysis observational study.<br>|
| Delamanid and companion WHO Group 5 drugs<br> | Other: This is a non-intervention observational study<br>* No applicable intervention; this is a secondary data analysis observational study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End of treatment outcome | Final outcomes: cured, treatment completed, treatment failed, lost to follow-up, died, not evaluated | 20 - 24 months of treatment |