linjc16/ctgov huggingface dataset:
Bilateral Treatment of Medication Refractory Essential Tremor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if the MR-guided focused ultrasound (MRgFUS) thalamotomy procedure can be performed on both sides of the brain safely and effectively to reduce bilateral tremor.

Official Title
-----------------
A Pivotal Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor

Conditions
-----------------
Essential Tremor

Intervention / Treatment
-----------------
* Device: Exablate Model 4000 Type 1.0/1.1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women age 22 years or older Diagnosis of medication-refractory Essential Tremor Has previously underwent an Exablate index procedure in a clinical trial or in a commercial setting at least 9 months prior to enrolling in this trial Able to communicate sensations during the Exablate thalamotomy procedure Exclusion Criteria: Has experienced any non-transient neurological event or worsening following the Exablate index procedure Presence of unknown or MR unsafe devices anywhere in the body Non-transient hemiparesis as determined by physical examination Clinically significant abnormal speech function as determined by a speech pathologist Pregnant or breastfeeding Unstable cardiac status Behavior(s) consistent with ethanol or substance abuse History of bleeding disorder Has received anticoagulants within one month of Exablate procedure Cerebrovascular disease Intracranial tumor Active or suspected acute or chronic uncontrolled infection Has previously had deep brain stimulation or a prior stereotactic ablation of the basal ganglia or thalamus Implanted objects in the skull or the brain Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research Unable to communicate with the investigator and staff

Ages Eligible for Study
-----------------
Minimum Age: 22 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: Exablate Secondary Procedure<br>Thalamotomy | Device: Exablate Model 4000 Type 1.0/1.1<br>* Exablate thalamotomy of non tremor dominant side of the brain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device and procedure related adverse events | rate of adverse events following the Exablate secondary procedure | 3 months |
Olmesartan as an add-on to Amlodipine in Hypertension

Study Overview
=================
Brief Summary
-----------------
This study is to test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with amlodipine alone

Official Title
-----------------
Add-on Study of Olmesartan Medoxomil in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Amlodipine 5 mg Alone

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: olmesartan medoxomil
* Drug: amlodipine
* Drug: hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Without antihypertensive pre-treatment mean seated BP greater than 160/100 mmHg Pre-treatment with amlodipine 5 or 10 mg: mean seated BP greater than or equal to 140/90 mmHg Exclusion Criteria: Secondary hypertension Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs

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 |
| --- |
|Drug: olmesartan medoxomil|nan|
|Drug: amlodipine|nan|
|Drug: hydrochlorothiazide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in trough seated diastolic blood pressure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in trough seated systolic BP |  |  | 
| Mean change in daytime, nighttime and 24 hour ambulatory blood pressure |  |  | 
| Percent of patients achieving target blood pressure goal |  |  | 
| Safety and tolerability |  |  |
Dermacyd Infantile (Lactic Acid) - Photo Evaluation.

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To demonstrate the absence of photo irritation and photosensitization potential of the product Dermacyd Infantile (Lactic Acid).

Official Title
-----------------
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Infantile (Lactic Acid).

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: LACTIC ACID(ND)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Phototype Skin I, II, III and IV Integral skin test in the region Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion. Exclusion criteria: Use of Anti-inflammatory, immunosuppressant or anti-histaminic drugs Lactation or gestation Use of Anti-inflammatory drugs 30 days and/or immunosuppressant drugs during 3 months before the selection Diseases which can cause immunity decrease, such as HIV, diabetes Previous atopy History of sensitivity or irritation for topic products Active cutaneous diseases which can interfere in the study results Use of new drugs and/ or cosmetics during the study Cutaneous reactivity Previous participation in studies, which had used the product Volunteers who have immunodeficiency congenital or acquired. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermacyd infantile (Lactic Acid)<br>5 weeks treatment | Drug: LACTIC ACID(ND)<br>* Dermacyd infantile (Lactic Acid)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type. |  | During 5 weeks (i.e. treatment period) |
Non-Inferiority Trial Comparing Eurofarma's Experimental Product Saccharomyces Boulardii Versus Floratil® in the Prevention of Antibiotic-Associated Diarrhea

Study Overview
=================
Brief Summary
-----------------
The study's objective is to evaluate the efficacy and safety of two formulations for the prophylactic treatment of diarrhea in subjects using antibiotics.

Official Title
-----------------
An Open-Label, Non-Inferiority, Phase III Trial Comparing Eurofarma's Experimental Product Saccharomyces Boulardii Versus Floratil® (S. Boulardii - Merck) in the Prevention of Antibiotic-Associated Diarrhea.

Conditions
-----------------
Antibiotics

Intervention / Treatment
-----------------
* Other: Probiotic
* Other: Probiotic
* Other: Probiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICF signature; The subject must agree to follow the instructions and to perform study procedures and visits; Male and female subjects between 18 and 65 years old; Subjects who have scheduled a treatment or started the use of antibiotics over 24 hours ago: Exclusion Criteria: Generalized infection or bacteremia; Chronic gastrointestinal diseases (e.g., Crohn's Disease and Irritable Bowel Syndrome); Documented chronic diarrhea; Acute diarrhea episode within 24 hours prior to the start of antibiotic use. Use of tube feeding (nasogastric and nasoenteral); Immunodeficiency (radiotherapy or chemotherapy); Use of food with probiotic properties in the last 10 days;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saccharomyces boulardii capsules (200 mg).<br> | Other: Probiotic<br> <br> |
| Active Comparator: Floratil®<br> | Other: Probiotic<br> <br> |
| Experimental: Saccharomyces boulardii powder (200 mg).<br> | Other: Probiotic<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of diarrhea in subjects using antibiotics |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of diarrhea by severity |  |  |
Practical Pattern of Surgical Timing of Childhood Cataract in China

Study Overview
=================
Brief Summary
-----------------
In the current study, the investigators analyzed the surgical RWD of 2,421 children with childhood cataracts from the Childhood Cataract Program of the Chinese Ministry of Health (CCPMOH) at the Zhognshan Ophthalmic Center and proposed data-based clinical experience for the timings of cataract extraction and IOL implantation.

Official Title
-----------------
Practical Pattern of Surgical Timing of Childhood Cataract in China

Conditions
-----------------
Childhood Cataract

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: childhood cataracts present at the ZOC at the first time age: 0-18 years Exclusion Criteria: complicated with other type of cataracts

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| cataract extraction (CE)<br>Patients received CE without IOL implantation in the first surgical stage, and received IOL implantation at secondary surgical stage. | Other: observation<br>* The surgical ages and other information between two groups were compared.<br>|
| cataract extraction and IOL implantation<br>Patients received CE and IOL implantation in the first surgical stage. | Other: observation<br>* The surgical ages and other information between two groups were compared.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical age | the surgical ages of two groups | 2005-2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical timing, cataract extraction, IOL implantation, childhood cataract, real-world data
Glove Perforation When Using Blunt Verses Sharp Needles in Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
This study is assessing whether there is a decrease in surgical glove punctures using blunt tipped needles compared with sharp needles for suturing during Cesarean Delivery.

Official Title
-----------------
Glove Perforation When Using Blunt vs. Sharp Needles in Cesarean Delivery

Conditions
-----------------
Cesarean Delivery, Glove Perforation

Intervention / Treatment
-----------------
* Other: Blunt tipped needle
* Other: Sharp needles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at least 18 years of age undergoing Cesarean Delivery Exclusion Criteria: Patient less than 18 years of age. Patient not undergoing Cesarean Delivery.

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blunt Needles<br>Cesarean Delivery Performed with Blunt-tipped surgical Needles | Other: Blunt tipped needle<br>* The Cesarean delivery is performed using blunt tipped needles.<br>|
| Placebo Comparator: Sharp Needles<br>Cesarean delivery performed with sharp surgical needles. | Other: Sharp needles<br>* The cesarean is performed using standard sharp surgical suture needles.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Glove Perforation. | Direct measurement of the number of glove perforations listed by surgical case. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon Satisfaction by Likert Scale. |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarean delivery, Surgical Needles, blunt-tip needles, surgical glove perforation
Risk Factors for Acute Kidney Injury in Critically Ill Patients With Acute-on-Chronic Liver Failure

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury (AKI) is one of the most important factors associated with increased mortality in patients with acute-on-chronic liver failure (AoCLF). Early identification and treatment of this subgroup of patients may improve survival and decrease ICU length of stay. As kidney ischemia is one of the main mechanisms responsible for AKI in AoCLF, an increase in urinary to arterial partial pressure of oxygen may help in the early diagnosis of renal failure. For this arterial and urinary oxygen pressure will be measured at ICU admission, on day 1 and day 3 of ICU stay. Diagnosis of AKI within the first 28 days after ICU admission will be recorded

Official Title
-----------------
Risk Factors for Acute Kidney Injury in Critically Ill Patients With Acute-on-Chronic Liver Failure

Conditions
-----------------
Acute Kidney Injury, Acute-On-Chronic Liver Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patients admitted to the ICU for acute-on-chronic liver failure Exclusion Criteria: pre-existing renal disease urine output<200 mL/day death within the first 24 hours after ICU admission emergency liver transplantation within the follow-up period (28 days)

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 |
| --- | --- | --- |
| AKI | incidence (%) of AKI in patients with AoCLF as defined by Acute Kidney Injury Network guidelines | 28 days after ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial to urinary oxygen gradient | mathematical difference in oxygen partial pressure between arterial blood and urine (mmHg) in patients with AKI compared to patients without AKI | ICU admission, ICU day 1 and ICU dy 3 | 
| mortality | 28-day mortality | 28-days |
Safety of Cardioversion of Acute Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the complications of cardioversion of acute (<48 hours duration) atrial fibrillation (AF). Primary Outcome Measures: - Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF Secondary Outcome Measures: Number of therapy non-responder and early recurrence of AF Bleeding complications during the 31 days follow-up Hemodynamic complications of cardioversion Estimated Enrollment: 3000 cases Study Start Date: Jun 2011 Estimated Study Completion Date: December 2011

Detailed Description
-----------------
It has been a common practice to perform cardioversion of acute (<48 hour) AF without any anticoagulation. The new European guidelines recommend that anticoagulation should be started already before cardioversion in all patients with CHADS2VASC score indicating need for long-term oral anticoagulation. The evidence behind these guidelines is, however, scarce. In this retrospective study we collect data on the safety of acute AF cardioversion from emergency rooms of two university hospitals and one secondary referral center from the years 2003-2010. Inclusion criteria: All patients admitted to emergency room because of acute AF in whom electrical or pharmacological cardioversion was attempted <48 from the beginning of the symptoms.

Official Title
-----------------
Safety of Cardioversion of Acute Atrial Fibrillation

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted to emergency room because of acute AF in whom electrical or pharmacological cardioversion was attempted <48 from the beginning of the symptoms Exclusion Criteria: duration of the AF is unknown or >48 hours

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 |
| --- | --- | --- |
| Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF |  | 31 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of therapy non-responder and early recurrence of AF |  | 31 days | 
| Bleeding complications during the 31 days follow-up |  | 31 days | 
| Hemodynamic complications of cardioversion |  | 31 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, cardioversion, stroke, thromboembolism
Anticholinergic Burden - Treatment Optimization

Study Overview
=================
Brief Summary
-----------------
There is increasing evidence that medications with anticholinergic effects may adversely affect cognitive function. Older adults are particularly sensitive to anticholinergic effects because of changes in pharmacokinetics and pharmacodynamics. The cumulative effect of taking one or more medicines with anticholinergic properties is referred to as anticholinergic burden. To estimate the anticholinergic burden, Boustani et al. published the Anticholinergic Cognitive Burden scale (2008). The objective of this study is to measure the association between the use of medications with anticholinergic properties (identified by the ACB scale) and cognitive performance. Anticholinergic use and cognitive performance will be measured at baseline and 6-months follow-up.

Official Title
-----------------
Treatment Optimization Regarding Anticholinergic Medications Potential Impact on Cognitive Test Performance

Conditions
-----------------
Anticholinergics, Cognitive Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50 years and older

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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 |
| --- | --- | --- |
| Cognitive function | Cognitive function, measured by the Mini-Mental State Examination (MMSE) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticholinergic burden | Anticholinergic burden, determined according to the Anticholinergic Burden scale | 6 months | 
| Cognitive function | Cognitive function, measured by Montreal Cognitive Assessment (MOCA) | 6 months | 
| Cognitive function | Cognitive function, measured by the Trail Making Test A & B (TMT) | 6 months | 
| Cognitive function | Cognitive function, measured by The Alzheimer´s Disease Assessment Scale - Cognitive subscale (ADAS-Cog) | 6 months | 
| Cognitive function | Cognitive function, measured by the Symbol Digit Modalities Test (SDMT) | 6 months | 
| Cognitive function | Cognitive function, measured by A Quick Test of cognitive speed (AQT) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anticholinergic, alzheimer, cognition, MMSE, anticholinergic cognitive burden scale