linjc16/ctgov huggingface dataset:
The Emerging Role of Resolvins in the Prevention of Chronic Pain After Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate whether pre-operative dysregulated systemic lipid mediator pathways are associated with increased risk for the development of persistent post surgical pain. In addition we will investigate whether treatment with an over the counter dietary supplement containing a fractionated marine lipid derivative from anchovy and sardine oil prevents the development of chronic pain after surgery.

Official Title
-----------------
The Emerging Role of Resolvins in the Prevention of Chronic Pain After Thoracic Surgery

Conditions
-----------------
Patients Scheduled for Thoracic Surgery/Esophagectomy Will be Enrolled, Persistent Post Surgical Pain

Intervention / Treatment
-----------------
* Dietary Supplement: fractionated marine lipid concentrate derived from anchovy and sardine oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled to undergo esophagectomy at BWH 18-80 years old Exclusion Criteria: pre-existing chronic pain current opioid use current treatment with corticosteroids evidence of active infection chronic liver disease end-stage renal disease (CKD-5) chronic inflammatory disorders recent major surgery or illness within 30 days use of immunosuppressive medication history of organ transplant pregnancy or plans to become pregnant lactating allergies to fish or fish oil

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: fractionated marine lipid concentrate derived from anchovy and sardine oil<br>* Patients will be randomized to receive perioperative treatment versus placebo<br>|
| Experimental: Treatment<br> | Dietary Supplement: fractionated marine lipid concentrate derived from anchovy and sardine oil<br>* Patients will be randomized to receive perioperative treatment versus placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale (0=no pain; 10=worst imaginable pain) at 3 months after surgery | Persistent pain after thoracic surgery | 3 months |
Difficult Airway and Ultrasonographic Evaluation

Study Overview
=================
Brief Summary
-----------------
In this study, it was planned to evaluate the preoperative neck ultrasonography measurements as a predictor of difficult airway in adult patients who will undergo elective surgery under general anesthesia.

Official Title
-----------------
Evaluation of Neck Ultrasound Measurements as a Difficult Airway Signification

Conditions
-----------------
Difficult Airway

Intervention / Treatment
-----------------
* Diagnostic Test: difficult airway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical condition I-II-III Exclusion Criteria: . Uncooperative patients, pregnant women, patients who have had head and neck trauma/surgery, patients with a known history of difficult airway

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| difficult airway<br> | Diagnostic Test: difficult airway<br>* ultrasonography of airway<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| epiglottis-skin thickness | epiglottis-skin thickness is a marker of difficult airway | one month |
Is Oxytocin Given During Surgical Procedure for Abortion Before 12 Weeks of Pregnancy Useful?

Study Overview
=================
Brief Summary
-----------------
This is a randomized, single-blind study using oxytocin 5U i.v. during surgical abortion in one arm of the study, and no medication in the other arm of the study. Comparison is done between the two groups measuring the following outcomes: pain, nausea and blood loss. The investigators' hypothesis is that there will be no significant differences between the two groups.

Detailed Description
-----------------
All women seeking surgical abortion before 12 weeks of pregnancy will be invited to participate in the study. We will include 400 patients. Written consent is given. Pain is measured on a VAS-scale (1-10) 2 hours post operatively and repeated 2 days postoperatively. Nausea is categorized in 4 groups, from 1 (no nausea) to 4 (pronounced nausea with vomiting)and is registered together with bloodloss also during the hospital stay (2 hours) and 2 days postoperatively. The two groups will be compared.

Official Title
-----------------
Is Oxytocin Given During Surgical Procedure for Abortion Before 12 Weeks of Pregnancy Useful ?

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

Intervention / Treatment
-----------------
* Drug: oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: seeking legal abortion first trimester surgical intervention no current medication fluent in norwegian language Exclusion Criteria: current medication medical condition with coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br> | Drug: oxytocin<br>* 5 U i.v. during surgical abortion<br>|
| No Intervention: A2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss, pain, nausea |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
first trimester abortion, oxytocin
Embryo Transfer: Direct Versus Afterloading Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate two types of embryo transfer procedure. The investigators will compare direct embryo transfer against afterloading embryo transfer.

Official Title
-----------------
Direct Transfer vs Previous Cervical Canalization Transfer (Afterloading): Randomized Clinical Trial.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: Afterloading embryo transfer procedure
* Procedure: Direct embryo transfer procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in IVF/CICSI program Transfer day:2 or 3 after ovum pick-up Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Afterloading embryo transfer procedure | Procedure: Afterloading embryo transfer procedure<br>* Afterloading embryo transfer procedure<br>|
| Active Comparator: 2<br>Direct embryo transfer procedure | Procedure: Direct embryo transfer procedure<br>* Direct embryo transfer procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy |  | 8 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficulty of embryo transfer |  | During embryo transfer procedure | 
| Duration of embryo transfer |  | During embryo transfer procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Embryo transfer, IVF, Ultrasound embryo transfer
Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Naprosyn E

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body's uptake of naproxen given as PN400 is comparable to that of currently marketed naproxen tablets.

Official Title
-----------------
Phase I, Open-label, Randomized, 2-way Crossover Study to Assess Relative Bioavailability of Single Oral Dose of Naproxen as PN400 Compared to Naproxen as Naprosyn E Under Fasting and Fed Conditions in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: PN400
* Drug: Naproxen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects 18-55 yrs. of age (inclusive) at Screening Visit Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg Clinically normal physical exams and laboratory measurements Exclusion Criteria: Subject has received another investigational drug within 4 weeks preceding this study or planning to participate in another study at any time during the period of this study Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PN400 | Drug: PN400<br>* oral tablet<br>* Other names: VIMOVO™;|
| Active Comparator: 2<br>Naprosyn E | Drug: Naproxen<br>* oral tablet<br>* Other names: Naprosyn E;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | pre-dose and multiple times post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | Throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase 1, Healthy Volunteer, Healthy Volunteer Study
Evaluating Potential Risk of Choking by Laryngeal Ultrasound in Patients With Acute Stroke

Study Overview
=================
Brief Summary
-----------------
The investigators evaluate the vocal cord movement in patients with acute stroke by ultrasound. The occurrence of choking or aspiration pneumonia will be collected in one year after the index stroke.

Detailed Description
-----------------
Post-stroke dysphagia is a common complication for the stroke patient. It may cause aspiration, poor nutrition or even pneumonia; thus, it is crucial for the physicians to evaluate the swallowing function of the stroke patients. However, the evaluation methods nowadays still have some limitations. Water swallowing test is one of the well-known methods, but the test itself would put the patients at risk of aspiration. Furthermore, in order to increase the sensitivity of the water swallowing test, the amount of the water should also be increased; as a consequence, the risk of aspiration will also increase. Fiberoptic endoscopic evaluation of the swallowing and videofluoroscopy have limitations of invasiveness. The laryngeal ultrasound to evaluate the vocal cord movement can be an alternative method, having the characteristics of non-invasiveness and repeat evaluation. The investigators aim to evaluate the vocal cord movement in patients with acute stroke by ultrasound. The occurrence of choking or aspiration pneumonia will be collected in one year after the index stroke.

Official Title
-----------------
Evaluating Potential Risk of Choking by Laryngeal Ultrasound in Patients With Acute Stroke

Conditions
-----------------
Acute Stroke

Intervention / Treatment
-----------------
* Diagnostic Test: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute stroke (in one month) patients Exclusion Criteria: patients with stroke occurring more than one month ago

Ages Eligible for Study
-----------------
Minimum Age: 20 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: vocal cord movement among the stroke patients<br> | Diagnostic Test: ultrasound<br>* evaluate the vocal cord movement among the stroke patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of aspiration pneumonia |  | one year |
Sustained Immunity to COVID-19 as Measured by SARS-CoV-2 Serology Assays

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess the ability of COVID-19 IgG and IgM assays to detect an immune response in COVID-19 patients in the Henry Ford Health System (HFHS), both during hospitalization and over the following 12 months.

Detailed Description
-----------------
The design strategy for this study is to validate the detection of COVID-19 antibodies in subjects at HFHS who test positive with RT-PCR for SARS-CoV-2 using fully automated test systems already in the core automated laboratory at HFH. This is a study of the immune response and kidney health of subjects who have recovered from COVID-19 infection. There are 4 aims: Aim 1. Assess detection of COVID-19 antibodies in subjects before discharge from HFHS who tested positive with RT-PCR for SARS-CoV-2 using fully automated immunoassays. Aim 2. Evaluate emergence of immunity over a one-year period in subjects who tested positive with RT-PCR for SARS-CoV-2 using a fully-automated immunoassays. Aim 3. Monitor renal function and kidney health at 6 and 12- months post diagnosis with COVID-19. Aim 4. Determine if SAR-COV-2 can be detected in the saliva of patients over a one year period after a positive PCR test.

Official Title
-----------------
Initial and Sustained Immunity to SARS-CoV-2 Measured by Serologic Assays on an Automated Immunoassay System

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Serologic immunoassays to SARS-CoV-2 antibodies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥18 years of age Positive COVID-19 by RT-PCR SARS-CoV-2 assay Patients must have a serum sample stored by pathology or within the TCRC biorepository around the date of their COVID-19 RT-PCR positive test Exclusion Criteria: < 18 years of age negative for RT-PCR no serum sample

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Serologic immunoassays to SARS-CoV-2 antibodies|Detect and characterize antibodies to SARS-CoV-2|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of antibodies to SARS-CoV-2 in human serum and plasma | The study will assess the ability of COVID-19 IgG and IgM assays to detect an immune response in COVID-19 patients in the Henry Ford Health System (HFHS), both during hospitalization and over the following 12 months. The study will use Beckman Coulter anti-Spike IgG assay and Roche anti-Nucleocapsid assay. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, Antibodies, Seroprevalence
Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.

Detailed Description
-----------------
This is a multicenter, randomized, double-blinded study. The efficacy with E3810 20 mg once daily is compared with E3810 20 mg twice daily and 10 mg twice daily using endoscopic recovery. The frequency of adverse event, etc., will be compared among 3 groups for safety assessment.

Official Title
-----------------
Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis

Conditions
-----------------
Refractory Reflux Esophagitis

Intervention / Treatment
-----------------
* Drug: E3810
* Drug: E3810
* Drug: E3810


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have mucosal breaks (erosions, ulcers) on endoscopy and are diagnosed with reflux esophagitis. Proton Pump Inhibitor standard dose-resistant reflux esophagitis. Patients who are 20 years and older when informed consent is obtained. Exclusion Criteria: Patients with a concurrent severe illness, serious heart disease, comorbid severe disease such as hematology, kidney disease, or liver disease. Patients with malignancy. Patients who are taking another trial drug or the interval between the end of treatment and screening is less than 12 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: E3810<br>* 20 mg taken orally, once a day for 8 weeks.<br>* Other names: Aciphex;|
| Experimental: 2<br> | Drug: E3810<br>* 10 mg, taken orally, twice a day for 8 weeks.<br>* Other names: Aciphex;|
| Experimental: 3<br> | Drug: E3810<br>* 20 mg taken orally, twice a day for 8 weeks.<br>* Other names: Aciphex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) | Grade N indicates a normal appearance of lower esophageal mucosa | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
reflux esophagitis, rabeprazole, GERD, Japan
Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs

Study Overview
=================
Brief Summary
-----------------
This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.

Detailed Description
-----------------
After obtaining consent patients who sustained third or fourth degree perineal laceration after vaginal delivery were randomly assigned to a single dose of antibiotic (cefotetan or cefoxitin, 1 g intravenously or clindamycin, 900 mg intravenously, if allergic to penicillin), or placebo (100ml normal saline) intravenously.

Official Title
-----------------
A Randomized Controlled Trial of the Effect of Prophylactic Antibiotics on the Infection Rate in Postpartum Third and Fourth Degree Perineal Tear Repairs

Conditions
-----------------
Pregnancy Complications, Infectious

Intervention / Treatment
-----------------
* Drug: Cefotetan or Cefoxitin vs placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - third and fourth degree perineal laceration Exclusion Criteria: - chorioamnionitis, HIV positive, inflammatory bowel disease

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cefotetan, Cefoxitin or Clindamycin<br> | Drug: Cefotetan or Cefoxitin vs placebo<br>* Cefotetan or Cefoxitin, 1 g intravenously, or Clindamycin, 900 mg intravenously. Normal Saline, 100 ml intravenously for placebo arm.<br>|
| Placebo Comparator: Normal Saline<br> | Drug: Cefotetan or Cefoxitin vs placebo<br>* Cefotetan or Cefoxitin, 1 g intravenously, or Clindamycin, 900 mg intravenously. Normal Saline, 100 ml intravenously for placebo arm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No perineal breakdown or infection |  | Six weeks post partum |