linjc16/ctgov huggingface dataset:
Urine Chloride/Creatinine Ratio for Estimation of Urine Sodium

Study Overview
=================
Brief Summary
-----------------
We plan to assess the accuracy of a new means of estimating urine sodium excretion. We will compare the chloride to creatinine ratio obtained by titrator sticks with urine sodium measured by a standard laboratory. If found to approximate sodium excretion, the titrator sticks could provide a convenient means for doctors and patients to monitor their salt intake.

Detailed Description
-----------------
Level of salt intake has an important impact in patients with high blood pressure or congestive heart failure. Despite this there is no convenient way for doctors or patients to assess their salt intake other than diet recall, which is unreliable, or measurement of sodium excretion in a 24 hour collection of urine, which is very inconvenient. As a result, salt intake is not monitored in most patients. 2 innovations might enable a more convenient assessment of salt intake. A titrator stick that measures chloride ion concentration (chloride and sodium concentrations correlate strongly with each other), and a titrator stick that measures urine creatinine. The latter enables estimation of 24 hour excretion from a single sample of urine. In assessing sodium intake, a measurement that provides an approximation of urine sodium intake would be of considerable clinical value In this study, we shall compare the estimation of urine sodium excretion measured by a laboratory with estimation of sodium excretion from measurement of chloride/creatinine ration in a random urine sample. We will compare the estimate obtained by titrator stick with the sodium concentration from the same urine sample, and from measurements obtained from a 24 hour urine collection. In the next phase we will also compare the average estimate from titrator stick obtained on 3 different days with the measurement obtained from 3 24 hour urine collections. We will assess the accuracy with which the titrator stick estimate approximates the measured urine sodium. As of March 2007, we have recruited 50 subjects, and continue to study the predictive value of spot urine chloride/creatinine ratio, as described.

Official Title
-----------------
Urine Chloride/Creatinine Ratio for Estimation of Urine Sodium

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 21 years of age. Exclusion Criteria: No exclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| urine sodium excretion |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sodium intake, sodium excretion, chloride excretion, creatinine, hypertension
Evaluation of Subjective Ratings on a New Sound Processor and Compatible Products

Study Overview
=================
Brief Summary
-----------------
Clinical study designed to collect user feedback from Cochlear Implant recipients on a new Sound Processor System

Official Title
-----------------
Evaluation of Subjective Ratings on a New Sound Processor and Compatible Products

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Device: A New Sound Processor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12 months old or older Implanted with a CI24RE (Freedom implant) or later implant in at least one implanted ear Use of the CP810, CP920 or CP910 sound processor Willingness to participate in and to comply with all requirements of the protocol Exclusion Criteria: Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device Additional disabilities or illnesses that would prevent participation in evaluations or compromise the integrity of the investigation or quality of data collected Nucleus 22 or Nucleus 24 Implant in ear to be fitted with the investigational device

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 100 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A New Sound Processor<br>Sound Processor is the next generation sound processor. | Device: A New Sound Processor<br> <br> |
| No Intervention: Subject's own sound processor<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective rating with a new sound processor compared to ratings with each subjects own processor |  | 3 months |
Endostar and/or Cisplatin for Treatment of Malignant Pleural Effusion or Ascites

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the efficacy of Endostar/cisplatin with cisplatin alone or Endostar alone in patients with malignant pleural effusion or ascites.

Official Title
-----------------
A Randomized Controlled Multicenter Trial of Endostar and/or Cisplatin in Patients With Malignant Pleural Effusion or Ascites

Conditions
-----------------
Malignant Pleural Effusion, Malignant Ascites

Intervention / Treatment
-----------------
* Drug: Endostar
* Drug: Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological diagnosis of thoracic or abdominal tumor At least medium amount of malignant pleural effusion or ascites ECOG Performance Status 0-2 Life expectancy ≥ 2 months Adequate hematologic, cardiac, renal, and hepatic function No major surgery within 4 weeks prior to this study Written informed consent Exclusion Criteria: Patients with central nervous system (CNS) metastases Evidence of bleeding diathesis, serious infection Evidence of myocardial infarction, unstable angina or cardiac insufficiency Presence of serious COPD and/or respiratory failure Allergic to study drug Pregnant or lactating women Participation in other clinical trials within 30 days prior to this study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endostar<br> | Drug: Endostar<br>* intrapleural injection 45 mg; intraperitoneal injection 60 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles<br>|
| Active Comparator: Cisplatin<br> | Drug: Cisplatin<br>* cisplatin 40 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles<br>|
| Experimental: Endostar and Cisplatin<br> | Drug: Endostar<br>* intrapleural injection 45 mg; intraperitoneal injection 60 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles<br>Drug: Cisplatin<br>* cisplatin 40 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | WHO criteria | baseline to measured progressive disease, every three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression |  | baseline to every three weeks until disease progression | 
| Quality of Life |  | baseline to every three weeks | 
| Incidence of Adverse Events |  | Up to 1 month after the last treatment |
A Pilot Study to Explore the Role of Gut Flora in Chronic Constipation

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding chronic constipation

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding chronic constipation.

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Chronic Constipation

Conditions
-----------------
Constipation, Constipation Chronic Idiopathic, Constipation - Functional, Constipation (Excl Faecal Impaction)

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study Male or female patients of any age (interest is given to children to compare with mothers) Diagnosis of chronic constipation Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with a diagnosis of chronic constipation | Other: No intervention<br>* There is no intervention for this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Sequencing Methods | To validate the methods used to sequence samples | One year |
Regional Anesthesia / Peripheral Nerve Block and General Anesthesia on Preoperative Anxiety

Study Overview
=================
Brief Summary
-----------------
The researchers aimed to investigate that preoperative anxiety scores of patients who are informed about the anesthesia before surgery with using State-Trait Anxiety Inventory and Amsterdam preoperative anxiety and information scale tests together.

Detailed Description
-----------------
Patients will be informed about the anesthesia procedure in service ad then It will be held anxiety questionnaires one day before surgery and operation rooms.

Official Title
-----------------
Comparison of the Effects of Regional Anesthesia / Peripheral Nerve Block and General Anesthesia on Preoperative Anxiety

Conditions
-----------------
Anxiety Disorders

Intervention / Treatment
-----------------
* Behavioral: regional anesthesia
* Behavioral: general anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 18 and 80, both women and men, Patients will be operated Exclusion Criteria: psychiatric and neurologic diseases, hearing and speech disorders, Psychiatric drug and chronic alcohol use

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: regional anesthesia<br>spinal anesthesia or peripheral nerve block | Behavioral: regional anesthesia<br>* preoperative anxiety<br>|
| Active Comparator: general anesthesia<br>intubated patients | Behavioral: general anesthesia<br>* preoperative anxiety<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-Trait Anxiety Inventory scores in patients undergoing regional anesthesia |  | two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-Trait Anxiety Inventory scores in operating rooms |  | two months | 
| Amsterdam Preoperative Anxiety and Information Scale scores in operating rooms |  | two months | 
| Amsterdam Preoperative Anxiety and Information Scale scores in patients undergoing regional anesthesia |  | two months |
Hsv 1 and 2 Gowey Protocol Versus Placebo

Study Overview
=================
Brief Summary
-----------------
This study will compare efficacy of versabase gel with 20% sarracenia purpurea versus placebo applied every 3-4 hours to herpes lesions.

Detailed Description
-----------------
Patients screened for hsv one or two. Patients with herpes given a 1/8 oz of gel. Researcher does not know which is active and which is placebo (placebo is actually just versabase gel). Patent applies gel to lesions every 3-4 hours. Returns to clinic on days 3, 5, and 14 for evaluation. Up to 50 patients may be enrolled.

Official Title
-----------------
Phase II Clinical Trial of Versabase/Sarracenia Purpurea Versus Placebo

Conditions
-----------------
Herpes

Intervention / Treatment
-----------------
* Other: Versabase gel with sarracenia purpurea 20% liquid extract
* Other: placebo (versabase gel only)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Hsv 1&2 Exclusion Criteria: No active lesions

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Versabase/20% S. purpurea extract<br> | Other: Versabase gel with sarracenia purpurea 20% liquid extract<br>* Topical application of gel/plant mix to lesions<br>|
| Placebo Comparator: placebo (versabase gel only)<br>placebo used will be versabase gel alone | Other: placebo (versabase gel only)<br>* versabase gel only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain scale-- subjective | 2 weeks | 
| Size | Measure lesion size over 2 weeks | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance | Photo taken of lesion w patient informed consent | 2 weeks |
The Visual Performances of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational, non-controlled, multicenter trial with a retrospective design is to evaluate the visual performance of one cohort of patients who received the EDOF MINI WELL® intraocular lenses following refractive lens exchange (RLE) or cataract surgery.

Detailed Description
-----------------
The study aims at evaluating the visual performance of the EDOF MINI WELL® in qualitative and quantitative terms of the progressive vision. The cohort of subjects includes all patients submitted in the six involved Centers. for the surgical procedure for cataract extraction or Refractive Lens Exchange (RLE) using the MINI WELL® with a pre-operative visit (from the day - 60 to day -1 before surgery) and a post-operative follow-up visit performed 30-60 days after implant.

Official Title
-----------------
Retrospective Observational Trial on the Visual Performances of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus

Conditions
-----------------
Cataract, Presbyopia

Intervention / Treatment
-----------------
* Device: EDOF Mini WELL Ready IOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any gender and age above 18 years Refractive lens exchange (RLE) or cataract surgery Symmetrical preoperative keratometric astigmatism < 0.75 D Healthy corneas, not treated surgically Exclusion Criteria: Previous corneal surgery (i.e. pterygium, refractive surgery) Eye diseases with visual acuity < 20/32 Pseudoexfoliation Abnormal pupil size and position. Use of contact lens 30 days before the preoperative visit. Corneal warpage

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

| Intervention/Treatment |
| --- |
|Device: EDOF Mini WELL Ready IOL|implant|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refraction; UDVA (Uncorrected Distance Visual Acuity); CDVA (Corrected Distance Visual Acuity); DCNVA (Distance Corrected Near Visual Acuity); Defocus curve; Reading speed; Halometry. |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE). |  | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
extended depth of focus, cataract surgery, presbyopia correction
PET Imaging Study on Occupancy of Dopamine D2 Receptors and Genotypes After Bupropion Administration

Study Overview
=================
Brief Summary
-----------------
Bupropion has different effects on D2 dopamine receptors according to genotype.

Detailed Description
-----------------
Open, one arm, single sequence, 2-period, study stratified into 2 DRD2 genotype groups For subjects who volunteer to cease smoking, genotypes are investigated. Twelve subjects are enrolled (6 - DRD2 Taq1A1 allele, 6 - DRD2 Taq1A2 homozygotes). Subjects receive baseline raclopride PET (High Specific Activity, Low Specific Activity). Period 1 Subjects receive 150 mg of bupropion SR every day. After 1 week of medication, pharmacokinetic and PET studies are performed. Period 2 Subjects receive 150 mg of bupropion SR twice a day. After 1 week of medication, pharmacokinetic and PET studies are performed.

Official Title
-----------------
[11C] Raclopride PET Imaging Study That Investigates Relation Between Occupancy of Dopamine D2 Receptors and Genotypes of DRD2 After Bupropion Administration

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

Intervention / Treatment
-----------------
* Drug: Bupropion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active smoker (more than 10 cigarettes per day for the past 2 years) Exclusion Criteria: Medical or psychiatric co-morbidity Hypersensitive to bupropion

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>DRD2 Taq1A1 allele | Drug: Bupropion<br>* bupropion<br>|
| Experimental: 2<br>DRD Taq1 A2 homozygote2 | Drug: Bupropion<br>* bupropion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dopamine receptor occupancy |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters of bupropion and hydroxybupropion |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking cessation, Bupropion