linjc16/ctgov huggingface dataset:
Study of PGA Suture in Ophthalmology

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of polyglycolic acid suture in ophthalmic surgical procedures

Detailed Description
-----------------
The sutures are classified into non-absorbable and absorbable sutures. Violet braided polyglycolic acid suture is the synthetic absorbable suture used in wound closure in ophthalmology, cardiology, neurology and plastic & reconstructive surgeries. In ophthalmology, PGA sutures are used in Trabeculectomy (Glaucoma), Orbit and Oculoplasty, Lid and Socket Reconstruction, Squint, ptosis and retinal detachment surgeries. Glaucoma patients who met the inclusion criteria were recruited for this study. Uniform surgery and suturing technique was performed in all patients (Trabeculectomy with IOL implantation). Surgeon assessed suture characteristics during surgery and wound integrity at the end of surgery. Patients were followed up during 1 day, 1 month and 3 months post operatively. Visual acuity, Intraocular Pressure (IOP), suture characteristics, wound integrity, inflammation and conjunctival status were examined during each follow up visit.

Official Title
-----------------
Evaluating the Safety and Efficacy of Polyglycolic Acid Suture in Ophthalmic Surgical Procedures

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: Polyglycolic acid suture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing Trabeculectomy with IOL implantation Current residence within 60 kms of madurai Exclusion Criteria: Life threatening illness Immunosuppressive disorders Chronic infection
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> | Device: Polyglycolic acid suture<br>* PGA suture used in Trabeculectomy surgery<br>* Other names: Aurocryl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suture characteristics |  | 1 month, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleb characteristics |  | 1 month, 3 months | 
| Conjunctival status |  | 1 month, 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Trabeculectomy, Sutures
A Pilot Study to Explore the Role of Gut Flora in Fatty Liver

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

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 Fatty Liver.

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

Conditions
-----------------
Fatty Liver

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 fatty liver 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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients who have been diagnosed with Fatty Liver. | 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 | The identification of bacterial species residing the gut flora will be processed by next generation sequencing followed by metagenomic analysis. Bacterial diversity will then be evaluated in parallel with relative abundance of targeted species within and among individual microbes. | One year |
Evaluating Erythropoietin as an Indicator for Possible Kidney Injury After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate kidney biomarkers and determine if there is a correlation between Erythropoietin (EPO) levels and acute kidney injury after cardiac surgery. An early biomarker for kidney injury may be helpful in identifying, monitoring and managing patients at risk for kidney failure after cardiac surgery. To evaluate Erythropoietin's role as a predictor of poor renal function in the immediate post-bypass period we plan to compare EPO levels to Neutrophil gelatinase-associated lipocalin (NGAL).

Detailed Description
-----------------
Acute kidney injury (AKI) is a serious complication after cardiac surgery and cardio-pulmonary bypass. AKI is associated with high mortality. Erythropoietin, a hormone produced by the kidneys, will be evaluated as a potential biomarker of kidney injury. Neutrophil gelatinase-associated lipocalin (NGAL) has been studied as a biomarker of kidney injury. Early kidney injury detection has been long sought and NGAL has been shown to be a promising biomarker. A troponinlike biomarker of AKI that is easily measured and capable of both early detection and risk stratification would represent an advancement in our ability to differentiate acute kidney injury from failure. Investigating EPO as a biomarker may prove to have increased predictive value in the clinical care of cardiac surgery patients.

Official Title
-----------------
EPO: A Renal Biomarker After Cardiac Surgery

Conditions
-----------------
Erythropoietin, Acute Kidney Injury, Renal Biomarker

Intervention / Treatment
-----------------
* Other: Cardiac Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac surgery with cardiopulmonary bypass with DHCA Normal renal function or renal insufficiency-serum creatinine less than 2.5 mg/dL Adult male and female patients 18 years and older Exclusion Criteria: VADS Emergent cases Prolonged hypoxemia before, during or after bypass End stage renal disease Patients receive erythropoietin receptor agonists

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 |
| --- | --- |
| Subjects undergoing cardiac surgery<br> | Other: Cardiac Surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal injury/Failure |  | 18 Hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erythropoietin, Cardiac Surgery, Renal Biomarker, Acute Kidney Injury, Hypothermic Circulatory Arrest
Effects of Multiple Nasal Exposures to House Dust Mite Allergen on Nasal and Body Inflammation and Airway Sensitivity

Study Overview
=================
Brief Summary
-----------------
This study will evaluate whether multiple nasal antigen challenges with dust mite allergen produces increases in nasal symptoms and local allergic inflammatory cells in the nose and the blood.

Official Title
-----------------
Assessment of the Effects of Multiple Nasal Antigen Challenges With Dust Mite Allergen on Local and Systemic Allergic Inflammation and Bronchoreactivity in Subjects With Allergic Rhinitis Sensitive to House Dust Mite - a Feasibility and Site Evaluation Study

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: Dust mite extract, Fluticasone, Methacholine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-smoking subjects with a history of allergic rhinitis consistent with dust mite allergy showing A positive skin prick test to dust mite at or within the 12 months before study start Demonstrate symptomatic worsening after graded nasal allergen challenge Exclusion Criteria: Subjects found to be very sensitive to house dust mites (if the skin prick test produces a wheal of mean with a diameter greater than 11 mm). Presence of any respiratory disease other than a history of mild stable asthma not requiring regular treatment. Any known contraindications for methacholine challenge testing Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dust mite extract, Fluticasone, Methacholine|Dust mite extract, Fluticasone, Methacholine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total nasal symptom score recorded at baseline, and at pre-challenge,15 mins, 30 mins,and at 1,2,3,4,8 hours |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak nasal inspiratory flow at time points of total nasal symptom score. Mechanistic markers during challenge days. Exhaled nitric oxide,forced expiratory vol in 1 second & airway resistance at baseline, first & last day |  | throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic Rhinitis, dust mites, IgE, IL-13, nasal, inflammation
Diastolic Dysfunction PPCM in Patients With Documented Left Ventricular Systolic Function Recovery

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to evaluate parameters of diastolic dysfunction assessed by clinical echocardiogram in patients who have had recovery of systolic function.

Official Title
-----------------
Diastolic Dysfunction PPCM in Patients With Documented Left Ventricular Systolic Function Recovery

Conditions
-----------------
Peripartum Cardiomyopathy, Diastolic Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: A clinical Transthoracic echocardiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female. Greater than age 18 years at the time of peripartum cardiomyopathy diagnosis. Adults with a current or prior diagnosis of peripartum cardiomyopathy and documented recovered of left ventricular systolic function. Documented recovered of LV systolic performance defined as LVEF > 50%. Exclusion Criteria: No pregnancy history. No diagnosis of peripartum cardiomyopathy. Non-recovery of LV systolic function.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PPCM with Diastolic Dysfunction & Normal Systolic Function<br>The patient population examined will include patients diagnosed with peripartum cardiomyopathy who have diastolic dysfunction and normal systolic function. | Diagnostic Test: A clinical Transthoracic echocardiogram<br>* A previously clinically completed transthoracic echocardiogram will be utilized to assess for diastolic dysfunction in the presence of normal systolic function for patients with previously diagnosed peripartum cardiomyopathy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Report the incidence of diastolic dysfunction in peripartum cardiomyopathy patients with full systolic function recovery | Investigators will review and report incidence of remaining diastolic dysfunction for local patient population which have recovered systolic function. | January 1, 2014 through September 1, 2019 |
Warm Water for Unsedated Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of drug-related side effects, although it may be painful for the patient. Based on recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation.

Official Title
-----------------
Warm Water Irrigation Versus Standard Air Insufflation for Unsedated Colonoscopy: a Randomized Controlled Trial

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Procedure: warm water irrigation
* Procedure: air insufflation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult outpatients willing to undergo colonoscopy without routine initial sedation Exclusion Criteria: refuse to initiate colonoscopy without routine sedation inadequate bowel preparation incapacity to give informed consent

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: warm water<br>warm water irrigation during the insertion phase of colonoscopy | Procedure: warm water irrigation<br>* warm water irrigation during insertion phase of colonoscopy<br>|
| Active Comparator: air<br>air insufflation during the insertion phase of colonoscopy | Procedure: air insufflation<br>* air insufflation during the insertion phase of colonoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Undergoing Complete Unsedated Colonoscopy |  | 6-9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Pain and Tolerability Scores | Entity of pain and tolerability level on a visual analogic scale (ranging from 0 - no pain, optimal tolerability - to 100 mm - worst pain ever, unbearable) | 6-9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sedation, warm water
Comparison of Tramadol vs Remifentanyl Patient Controlled Analgesia for Second Trimester Abortions

Study Overview
=================
Brief Summary
-----------------
Patients undergoing second trimester abortions will recieve either patient controlled analgesia with either remifentanyl or tramadol for pain alleviation. We beleive both to be equally effective for pain alleviation.

Detailed Description
-----------------
Women undergoing second trimester abortions will recieve patient controlled analgesia eith either tramadol or remifentanyl. Patients will not know what they are recieving. Patients in the tramadol goup will get a loading dose of tramadol and metocloparamide while the women in the remifentanyl group will be given a loading placebo. Women will then be attached to one of the two patinet controlled analgesia protocols. Throughout their laboring process they will be monitored for blood pressure, pulse, breathing rate, sedation score and nausea. Additional medicatyion will be given for nausea. If woman are still in pain the patient controlled analgesia settings will be set to deliver a higher dose. If the woman remains in pain, she will be given an additional per os medication.If this still does not alleviate pain, the option of epidural analgesia will be offered.

Official Title
-----------------
Randomized Double Blind Study Comparing Patient Controlled Analgesia With Tramadol vs. Remifentanyl for Women Undergoing 2nd Trimester Abortions

Conditions
-----------------
Abortion,Induced

Intervention / Treatment
-----------------
* Drug: tramadol
* Drug: remifentanyl
* Device: patient contolled analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman undergoing 2nd trimester abortion - Exclusion Criteria: Seizure disorder - * Psychiatric disorder Inability to recieve patient controlled analgesia Allergy to tramadol or remifentanyl

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: tramadol|nan|
|Drug: remifentanyl|nan|
|Device: patient contolled analgesia|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction |  |  | 
| VAS scores |  |  | 
| Nausea |  |  | 
| Sedation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tramadol, remifentanyl, patient controlled analgesia, abortion
Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.

Detailed Description
-----------------
Schizophrenia is a severe mental illness affecting an estimated 1% of the world's population. Patients with schizophrenia suffer from productive symptoms (e.g., hallucinations and delusions), and deficit symptoms (e.g., a reduction or absence of normal behaviors or emotions). Other symptoms include a reduced ability to recall and learn new information. Iloperidone is being development as a treatment for symptoms of schizophrenia. This trial will test the safety and efficacy of iloperidone in patients with an acute exacerbation of the disease.

Official Title
-----------------
A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Iloperidone in Schizophrenic Patients in Acute Exacerbation Followed by a Long-term Treatment Phase.

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: iloperidone
* Drug: active comparator
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject with schizophrenia. Subject must sign a written consent form. Exclusion Criteria: Clinically significant disease of the heart, kidneys, liver or gastrointestinal system Psychiatric disorder other than schizophrenia

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: iloperidone|nan|
|Drug: active comparator|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Symptom Scale (PANSS) - Total Score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacogenetic analysis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Atypical antipsychotic, psychosis
Combined Behavioral and Pharmacologic Treatment of Polydrug Abuse

Study Overview
=================
Brief Summary
-----------------
The primary goal of this study is to determine how contingency management can best be combined with standard or high doses of methadone to increase simultaneous abstinence from heroin and cocaine.

Detailed Description
-----------------
A study of people pmaintained on Methadone using contingency management

Conditions
-----------------
Opioid Dependence, Cocaine Abuse

Intervention / Treatment
-----------------
* Drug: Methadone
* Behavioral: Contingency Management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Opioid dependence; cocaine use Exclusion Criteria: Medical or psychiatric conditions that would contraindicate participation in a methadone maintenance study; inability to give informed consent; inability to attend clinic seven days a week

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Methadone|nan|
|Behavioral: Contingency Management|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |