linjc16/ctgov huggingface dataset:
Labor Analgesia With Ropivacaine and Clonidine

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to examine, for pain relief during labor, the efficacy of two pharmacological approaches - the 0.125% ropivacaine alone and the 0.0625% ropivacaine added to 75 ug clonidine, both by epidural administration. The effect of the drugs on mother and newborn was also determined.

Official Title
-----------------
Labor Analgesia With Ropivacaine Added to Clonidine. A Randomized Clinical Trial

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Drug: ropivacaine
* Drug: ropivacaine and clonidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton healthy Full-term pregnancy American Society of Anesthesiologists physical status I or II Exclusion Criteria: Patients who had received opioids History of hypersensitivity to local anesthetic or to clonidine Fetus showed signs of possible intrauterine suffering Fetus showed signs of possible neurological deficit
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 |
| --- | --- |
| R<br>R group:15 mL of 0.125% ropivacaine (18.75 mg) | Drug: ropivacaine<br>* 15 ml of ropivacaine 0.125% peridural once<br>|
| RC<br>RC group:0.0625% ropivacaine (9.375 mg) plus 75 ug clonidine | Drug: ropivacaine and clonidine<br>* 15 ml of ropivacaine 0.0625% plus 75 mcg clonidine<br>|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Analgesia, Obstetrical, Anesthesia, Epidural, Newborn, Anesthetics, local, Clonidine, Pregnant women, Infant, newborn
Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis

Official Title
-----------------
A Phase 3, Randomized, Double-Blind, Comparative Trial of Micafungin Versus Fluconazole for the Treatment of Esophageal Candidiasis

Conditions
-----------------
Candidiasis, Oral

Intervention / Treatment
-----------------
* Drug: Micafungin
* Drug: Fluconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of esophageal candidiasis confirmed by endoscopy Negative pregnancy test in females of childbearing potential Exclusion Criteria: Pregnant or nursing Evidence of liver disease Presence of another active opportunistic fungal infection and/or receiving acute systemic therapy for an opportunistic fungal infection Concomitant esophagitis caused by herpes simplex virus or cytomegalovirus Receipt of an oral or topical antifungal agent within 48 hours or a systemic agent within 72 hours of first dose of study drug Non-responsive to therapy in any prior systemic antifungal clinical trail History of > 2 episodes of esophageal candidiasis requiring systemic antifungal therapy History of anaphylaxis attributed to azole compounds or echinocandin class of antifungals

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Micafungin<br>* IV<br>* Other names: FK463;|
| Active Comparator: 2<br> | Drug: Fluconazole<br>* IV<br>* Other names: Diflucan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy |  | End of Therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response at end of therapy of cleared or improved |  | End of Therapy | 
| Mucosal response at end of therapy of cleared or improved |  | End of Therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Micafungin, Esophageal Candidiasis, Fluconazole
Predicting Cell Death by Radiation Therapy in Early Stage Non-small Cell Lung Cancer: a Prospective Translational Trial

Study Overview
=================
Brief Summary
-----------------
Surgical resection with mediastinal lymph node sampling is currently the therapy of choice for early stage (I-II) non-small cell lung cancer (NSCLC). Selected patients unwilling or unable to tolerate surgery are referred for so-called 'curative' high dose radiotherapy. This has shown to result in a long term local disease control rate and a high cancer specific survival. The current trial addresses the relationship between blood and tissue biomarkers, bio-imaging and pathology in patients with early stage NSCLC treated with hypofractionated radiation therapy and surgery.

Official Title
-----------------
Pathologic Effects of Neoadjuvant Radiation Therapy in Operable Early Stage Lung Cancer

Conditions
-----------------
Early Stage Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Radiation: hypofractionated radiation therapy followed by surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proof of cT1a/b - 2a/b N0M0 NSCLC Informed Consent signed Resectable tumour Operable patient > 18 years old men and women

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

| Intervention/Treatment |
| --- |
|Radiation: hypofractionated radiation therapy followed by surgery|hypofractionated radiation therapy followed by surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological effects of hypofractionated radiation therapy | To describe the pathological effects of hypofractionated radioation therapy (RT) and to address the relationship with blood and tissue biomarkers and bio-imaging. | at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical response rate |  | from 2 to 5 years | 
| the accuracy of clinical mediastinal staging |  | from 2 to 5 years | 
| the complication rate |  | from 2 to 5 years | 
| local, regional or distant failure |  | from 2 to 5 years | 
| progression free survival |  | from 2 to 5 years | 
| disease specific overall survival |  | from 2 to 5 years | 
| overall survival |  | from 2 to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early stage non-small cell lung cancer, hypofractionated radiation therapy
Detection of Influenza A, Influenza B, and RSV Using the Liat™ Assays on the Liat™ Analyzer

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the clinical sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay when used on the Liat Analyzer to detect the presence or absence of Influenza A, Influenza B, and RSV in a nasopharyngeal swab specimen as compared to an FDA approved NAAT and culture.

Official Title
-----------------
Multi-Center Study of In Vitro Diagnostic Devices for the Detection of Influenza A, Influenza B, and RSV

Conditions
-----------------
Influenza A, Influenza B, Respiratory Syncytial Virus (RSV)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients exhibiting 2 or more symptom groups characteristic of influenza and/or RSV at the time of visit or within the past 48 hours: fever of at least 37.8 C (100F) runny or stuffy nose coughing, wheezing or difficulty breathing sore throat, headache, extreme tiredness, or muscle aches infants: decreased activity, irritability, poor feeding Subject who are able to understand and consent to participation; for minors under the age of 18, this includes a parent or legal guardian Exclusion Criteria: Patients who are under-going anti-viral medication now or within the last 7 days. Patients who received Nasal Spray Flu Vaccine within the last 6 weeks
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 |
| --- | --- | --- |
| Evaluate the sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay as compared to an FDA-cleared nucleic acid amplification test |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay as compared to culture |  | 1 day |
Stavanger IBD Study - Cross Sectional

Study Overview
=================
Brief Summary
-----------------
In this cross sectional and longitudinal study, patients with inflammatory bowel disease on biological treatment with infliximab or adalimumab will be included. After inclusion, the dosage of their existing biological therapy will be adjusted following regular trough-level and antibody-level monitoring, according to a treatment algorithm. Disease activity markers, fatigue and QoL will be assessed during the study. The hypothesis is that therapeutic drug monitoring may improve clinical disease outcome after one year of follow-up.

Official Title
-----------------
Stavanger University Hospital IBD Study - a Cross Sectional Longitudinal Study on Patients Treated With Biologics

Conditions
-----------------
Inflammatory Bowel Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with inflammatory bowel disease on treatment with infliximab or adalimumab of any duration (at least 3 doses) Exclusion Criteria: Inability to consent Inability to adhere to treatment protocol.

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 |
| --- | --- |
| Biologic<br>Patients on treatment with biologics (infliximab or adalimumab) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission rate | Harvey Bradshaw Index <5 Partial Mayo score <=2 | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom scoring | Harvey Bradshaw Index, Partial Mayo Score. Change after therapeutic drug monitoring. | One Year | 
| Inflammatory markers | C reactive protein, Fecal Calprotectin. Change after therapeutic drug monitoring. | One year | 
| Fatigue scoring | Assessed by Fatigue severity scale and Visual analogue scale. Change after therapeutic drug monitoring. | One Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Therapeutic drug monitoring, Biological treatment, IBD
Retrospective Study of Implants With Peri-implantitis Surgically Treated Using Enamel Matrix Derivative (EMD)

Study Overview
=================
Brief Summary
-----------------
The existing records of a private practice limited to the practice of periodontology were reviewed to locate patients who had been diagnosed with peri-implantitis (failing dental implant) and had been surgically treated utilizing enamel matrix derivative (Commercially available FDA product Emdogain sold by Straumann USA). Various clinical factors were gathered from the existing records. Some of the factors recorded were: retention of the implant, presence of bleeding, presence of further damage, and presence of inflammation. All patients had signed an informed consent for treatment and the anonymous use of their data for research purposes. All HIPA requirements were followed.

Detailed Description
-----------------
See brief summary.

Official Title
-----------------
Retrospective Study of Implants With Peri-implantitis Surgically Treated Using Enamel Matrix Derivative (EMD)

Conditions
-----------------
Determination of Beneficial Effect of Using Enamel Matrix Derivative During Implant Treatment

Intervention / Treatment
-----------------
* Procedure: peri-implantitis surgery with enamel matrix derivative


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all adult patients of record who presented with existing peri-implantitis that was clinically deemed treatable (the implant was not considered hopeless.) Exclusion Criteria: none except for routine medical contraindications for periodontal surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: peri-implantitis surgery with enamel matrix derivative|surgical procedures around dental implants with peri-implantits to remove infectious material and apply enamel matrix derivative to the implant.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retention of the implant | Determine if the implant was still present at the time of reevaluation | 0.71 to 6.4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| record the clinical condition of the implant at the time of reevaluation | Multiple standard measurements of the clinical condition of the implant were recorded at the time of reevaluation | 0.71 to 6.4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental implant, peri-implantitis, enamel matrix derivative
The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions

Study Overview
=================
Brief Summary
-----------------
It exists a learning curve in using NBI with magnification to differentiating colorectal lesions.

Detailed Description
-----------------
It is very useful to use narrow-band imaging and Sano CP analysis in the differential diagnosis of colorectal lesions. The endoscopists who had never used NBI or no knowledge of NBI can have effective and stable diagnostic accuracy after using NBI with magnification to diagnose 15 target and non-target lesions respectively.

Official Title
-----------------
The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions

Conditions
-----------------
Colorectal Lesion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 16 to 85 Any patient undergoing NBI with magnification colonoscopy exam and found with colorectal lesions Exclusion Criteria: Unwilling to consent Had surgery of colorectal tumors Using NSAIDS Diagnosed or suspected IBD Familial adenomatous polyposis(FAP) or hereditary non-polyposis colorectal(HNPCC) or other hereditary disease

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Accuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic Lesions |  | For this training, patients were consecutively enrolled until a total of 45 target and non-target lesions were obtained. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
narrow band imaging, learning curve, colorectal, differential diagnosis, with colorectal lesion, NBI with magnification
The Influence of Corticosteroid Treatment on Heart Function

Study Overview
=================
Brief Summary
-----------------
Patients hospitalized in internal medicine departments are given corticosteroid treatment according clinical indications. Patients receive treatment at different dosage levels and in different preparations according to clinical indications. This study will investigate how corticosteroids effect the heart and specifically, longitudinal strain.

Conditions
-----------------
Myocardial Function

Intervention / Treatment
-----------------
* Other: Transthoracic Echocardiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable patients able to undergo Transthoracic Echocardiogram Patients beginning treatment with corticosteroids Exclusion Criteria: Pregnant Patients recently or chronically treated with corticosteroids

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 |
| --- | --- |
| Corticosteroid Treatment<br>Patients in the internal medicine department who are being treated with corticosteroids will undergo Transthoracic Echocardiogram to determine change in heart function. | Other: Transthoracic Echocardiogram<br> <br> * Other names: Transthoracic Echocardiogram using a VIVID 6 device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Heart Function | Heart contraction and specifically its longitudinal strain will be examined using Transthoracic Echocardiogram (TTE) before, during and after corticosteroid treatment. TTE reveals changes in contraction in the right and left ventricle and septum. | Two years |
Comparison of Obesity Alleles Among Diverse Demographic Patients

Study Overview
=================
Brief Summary
-----------------
This proposal is designed to (1) establish the feasibility of a research strategy for discovering ethnic differences in the frequency of genotypes in patients after bariatric surgery and (2) perform a preliminary evaluation of this research strategy. Our goal is to identify genetic factors that may influence the success of various surgical weight loss interventions and determine whether these factors are associated with specific patient populations.

Detailed Description
-----------------
Goals: Establish feasibility of obtaining research consent on patients to collect clinical data, family history, and blood samples. Complete comprehensive genetic analyses on a diverse group of severely obese patients who have undergone bariatric surgery, specifically the primarily non-Caucasian Bellevue population and the Caucasian population of Geisinger Health Systems and NYU Langone Weight Management Program, to help define genetic factors that influence which surgical interventions work best for which patients. The ultimate aim is to rapidly translate these discoveries into practical solutions. Methods and Procedures: The participants of this study are all patients who have undergone bariatric surgery at Bellevue Hospital, NYU Langone Weight Management Program, and Geisinger Health System. The investigators have already completed this in 200 patients and plan to increase enrollment for a total of 2500 patients. The investigators will collect blood samples on bariatric surgery patients and send the blood to Geisinger for genotyping and analysis. An extra sample of venous blood (about 4 tablespoons or 40ml) will be collected at the time of routine postoperative visits. In addition, the investigators will use information that has routinely been and will be collected during postoperative visits as part of the care that bariatric patients receive. The investigators will look at the electronic medical record to obtain the preoperative weights. This includes questionnaires patients complete and the results of the laboratory tests and other studies.

Official Title
-----------------
Comparison of Obesity Alleles Among Diverse Demographic Patient Populations Undergoing Bariatric Surgery

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who have undergone any type of bariatric surgery Exclusion Criteria: Patients who have not had bariatric surgery
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 |
| --- | --- | --- |
| Complete comprehensive genetic analyses |  | 01/01/2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric Surgery