linjc16/ctgov huggingface dataset:
Effects of Postoperative Pain Management on Immune Function After Laparoscopic Resection of Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare postoperative immune function (e.g. NK cell activity) of fentanyl-based analgesic regimen versus local anesthetic wound infiltration-based anlagesic regimen after laparoscopic colorectal surgery

Conditions
-----------------
Colorectal Surgery

Intervention / Treatment
-----------------
* Drug: fentanyl-based analgesia
* Drug: local anesthetic wound infiltration-based anlagesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class I-III 20-80 years old elective laparoscopic colorectal surgery for cancer Exclusion Criteria: drug allergy significant renal or hepatic impairment sign of infection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fentanyl-based analgesia<br>fentanyl intravenous patient-controlled analgesia + additional pethidine | Drug: fentanyl-based analgesia<br>* fentanyl based patient-controlled analgesia + additional pethidine for postoperative 48 hour<br>|
| Experimental: local anesthetic wound infiltration-based anlagesia<br>continuous wound inflitration with ropivacaine + tramadol intravenous patient-controlled analgesia + additional ketorolac or propacetamol | Drug: local anesthetic wound infiltration-based anlagesia<br>* continuous wound inflitration with ropivacaine + tramadol patient-controlled analgesia + additional ketorolac or propacetamol for postoperative 48 hour<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NK cell activity | NK cell activity : preoperation, POD 1, POD 2 | 48 hours | 
| IL-2 | IL-2 level : preoperation, POD 1, POD 2 | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication and recurrence | Postoperative complication, recurrence | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
analgesia; colorectal surgery; immunity; local anesthetics; opioids
Effectiveness and Safety of Early Treatment With Infliximab for Hip Arthritis Associated With Ankylosing Spondylitis (AS) (P06451)

Study Overview
=================
Brief Summary
-----------------
This trial is designed to measure improvement of hip involvement in patients with ankylosing spondylitis (AS) after receiving 4 doses of infliximab. Participants will receive infliximab 5 mg/kg (as an intravenous perfusion over a period of 2 hours) at Weeks 0, 2, 6, and 14, consistent with the approved dosing regimen described in the label. Participants will be evaluated for hip pain, functional capacity and stiffness before and after 14 weeks (4 doses) of treatment. Further treatment after 4 doses is based on standard clinical practice as determined by the trial site.

Official Title
-----------------
Hip Arthritis Associated With AS Efficacy and Safety of Early Treatment With Infliximab (Remicade®)

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Drug: Infliximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Ankylosing spondylitis (AS) diagnosis Have all 3 of the following: Presence of hip pain (nocturnal inflammatory pain) Limitation of hip mobility Patient's Global Assessment Visual Analog Scale (0-10 cm) ≥4 cm. Inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) Eligible to be treated with Infliximab (Remicade®) Exclusion Criteria: Causes of coaxalgia other than coxitis of AS, demonstrated by images or laboratory tests Women who are pregnant or nursing or plan to nurse or become pregnant Serious infections like sepsis, abscesses. History of or current certain infections History of or current certain medical conditions

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remicade<br>Infliximab 5 mg/kg was administered as specified in the Summary of Product Characteristics for patients with ankylosing spondylitis | Drug: Infliximab<br>* Infliximab 5 mg/kg administered as an intravenous perfusion over a period of 2 hours at Weeks 0, 2, 6, and 14, as indicated in the Summary of Product Characteristics<br>* Other names: Remicade, SCH 215596;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with clinical improvement assessed by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire |  | Baseline and Week 15 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankylosing spondylitis, Hip arthritis, Infliximab
Hypophosphatemia as a Predictive Marker of Mortality During Sepsis in ICU

Study Overview
=================
Brief Summary
-----------------
Retrospective study in the 3 intensive care units of the Brest Teaching Hospital (France) during a 18-months period (June 2014 -December 2015) to study the independent association between hypophosphatemia and 90-day mortality.

Official Title
-----------------
Evaluation of Hypophosphatemia as a Predictive Marker of Mortality During Sepsis in ICU

Conditions
-----------------
Hypophosphatemia, Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blood stream infection Exclusion Criteria: Less than 18 years old

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 |
| --- | --- | --- |
| 90-day mortality |  | 90 days since the first blood stream infection in ICU |
PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Whether the perceived changes in management of Acute Severe Ulcerative Colitis during the COVID pandemic are widespread, and whether they have any impact on patient outcomes

Detailed Description
-----------------
The study aims to evaluate the process, evaluation and therapy variation in management of ASUC with reference to 2019 British Society of Gastroenterology guidelines and see whether there are any differences between ambulatory and hospital management in ASUC. Also to evaluate the outcomes in ASUC patients managed during the COVID-19 pandemic

Official Title
-----------------
PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis: A Multi-centre Observational Case- Control Study

Conditions
-----------------
Inflammatory Bowel Diseases, COVID

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 16 -100 inclusive Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period Exclusion Criteria: Patients aged 16 -100 inclusive Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period Admission for elective colectomy Pouch or stoma

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main group<br>Patient with Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period | |
| Control Group<br>Patients with ASUC managed in the unit from 1st Jan to 31st June 2019 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome measure: The need for in-hospital colectomy or rescue therapy | The need for in-hospital colectomy or rescue therapy | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2.1: Duration and type/route of steroid use | Duration and type/route of steroid use | 3 months | 
| 2.2: 30 day colectomy free survival rates | 30 day colectomy free survival rates | 3 months | 
| 2.3: Covid-19 infection rates | Covid-19 infection rates | 3 months | 
| 2.4: Rate of Rescue therapy use | Rate of Rescue therapy use | 3 months | 
| 2.5: Duration of hospital stay | Duration of hospital stay | 3 months | 
| 2.6: Admission severity scoring | Admission severity scoring | 3 months | 
| 2.7: Readmission rates | Readmission rates | 3 months |
An Observational Study of Statin Treatment Induced HDL Changes

Study Overview
=================
Brief Summary
-----------------
The aim with this study is to investigate the effect of statin induced changes in HDL-C on all cause mortality and CVD with adjustment for changes in other blood lipids and clinical parameters in Sweden, UK and the Netherlands.

Detailed Description
-----------------
An observational study of statin treatment induced HDL changes - effect on cardiovascular disease

Official Title
-----------------
An Observational Study of Statin Treatment Induced HDL Changes - Effect on Cardiovascular Disease

Conditions
-----------------
Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Started treatment with statins within the observation period (2004-2010) The patient must have valid baseline and follow-up measurements for HDL-C and LDL-C. Exclusion Criteria: Malignancy Alcohol abuse/alcohol dependence

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 86 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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first occurrence of hospitalization for acute myocardial infarction, unstable angina pectoris or ischemic stroke related to changes in HDL-C |  | 1st of January 2004 to 31st December 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of statin induced changes in HDL-C (per mmol/L) on a composite endpoint including unstable angina pectoris, myocardial infarction, ischemic stroke and all cause mortality. |  | 1st of January 2004 to 31st December 2010 | 
| Time to first occurence of hospitalization for acute myocardial infarction, unstable angina pectoris or ischemic stroke and ischemic heart disease mortality related to changes in HDL-C. |  | 1st of January 2004 to 31st December 2010 | 
| The relationships between acquired HDL levels after statin treatment on the primary endpoint and the effect of HDL increase on the primary endpoint for different levels of baseline HDL |  | 1st of January 2004 to 31st December 2010 | 
| Potential interactions between baseline HDL and HDL increase and other factors like age, gender, treatment and co-morbidity on the primary endpoint |  | 1st of January 2004 to 31st December 2010 | 
| The health economic consequences of increasing HDL-C with statin treatment |  | 1st of January 2004 to 31st December 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular disease, Statin treatment induced HDL changes and the effect on cardiovascular disease, Statin treatment
Traditional Thai Massage and Brain Electrical Activity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the immediate effect of traditional Thai massage on brain electrical activity in the patients with scapulocostal syndrome

Official Title
-----------------
The Immediate Effect of Traditional Thai Massage on Brain Electrical Activity in Patients With Scapulocostal Syndrome

Conditions
-----------------
Scapulocostal Syndrome

Intervention / Treatment
-----------------
* Other: Traditional Thai massage
* Other: Ultrasound therapy and hot pack


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 - 50 years old The participants have experienced spontaneous scapular pain (VAS ≥ 3) for longer than 12 weeks (chronic) and that at least one trigger point will be present in the scapular region (serratus posterior superior, rhomboid groups, levator scapulae and trapezius muscles). Trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition. The participants will be able to follow instructions. Good communication and cooperation. Exclusion Criteria: A history of the following diseases or disorders: Rotator cuff disease Cervical radiculopathy Degenerative shoulder joint disease Shoulder stiffness Contraindications of traditional Thai massage Contagious skin disease Injury or inflammation of muscle Bone fracture and/or joint dislocation Open wound Uncontrolled hypertension Drug and/or alcohol intoxication

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional Thai massage<br>The participants will receive a thirty minutes session of traditional Thai massage onto the scapular region | Other: Traditional Thai massage<br>* The participants will receive a thirty minutes session of traditional Thai massage onto the scapular region<br>|
| Active Comparator: Ultrasound therapy and hot pack<br>The participants will receive a thirty minutes session of Ultrasound therapy and hot pack | Other: Ultrasound therapy and hot pack<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroencephalography (EEG):the absolute band power in every frequency band | Electroencephalography (EEG) will be assessed through the gamma,delta,theta,alpha and beta bands | 1 Day |
Endoscopic Management of Esophageal Wall Defects

Study Overview
=================
Brief Summary
-----------------
The study aim at comparing outcomes from the implementation of various endoscopic closure techniques including stenting and suturing on the healing and resolution of esophageal wall defects.

Detailed Description
-----------------
Esophageal wall defects are a rare but potentially life-threatening subset of luminal pathology which usually require timely intervention in order to reduce the known associated high morbidity and mortality. These defects can be due to surgical and endoscopic procedures, such as post-operative leaks and fistulas and perforations complicating endoscopic dilation. In addition, defects can occur spontaneously due to Boerhaave's syndrome or following chemoradiation treatments of esophageal or other chest malignancies. Surgical management was historically the mainstay of therapy for these defects with conservative management remaining an alternative in poor surgical candidates. Over the last several years however, interventional endoscopy has played an increasing role in treatment of esophageal wall defects, with endoscopic stenting quickly becoming a viable alternative. Temporary stents including the fully covered self-expandable metal stents (FC-SEMS), partially covered self-expandable metal stents (P-SEMS) and self-expandable plastic stents (SEPS) have all been successfully used and have become increasingly regarded as the new standard of care. Indiana University is a tertiary referral center is a destination for complex thoracic surgery, oncology and esophageal disease referrals. The innovative luminal endoscopy team started employing a several modalities including flexible endoscopic suturing and stenting to close esophageal defects. To our knowledge, there is a dearth of data on outcomes associated with multi-modality esophageal defect closure techniques and little to no data comparing this approach to the current standard of care of stenting alone or surgery.

Official Title
-----------------
Outcomes of Endoscopic Management of Esophageal Wall Defects at a Large Referral Center

Conditions
-----------------
Esophageal Fistula, Esophageal Perforation

Intervention / Treatment
-----------------
* Device: Stenting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient with spontaneous or iatrogenic esophageal wall defect Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Stenting|Effect of endoscopic stenting on healing of esophageal wall defects|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of esophageal wall defect | Resolution of esophageal wall defect | 7/1/2014 to 7/1/2022 |
Relative Potency of Inhaled Corticosteroids

Study Overview
=================
Brief Summary
-----------------
To investigate the validity of a clinical model to determine the relative potency of different preparations of inhaled corticosteroids used for the treatment of asthma or of eosinophilic bronchitis without asthma.

Official Title
-----------------
Relative Potency of Inhaled Corticosteroids: Validation of a Clinical Model

Conditions
-----------------
Asthma, Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Drug: fluticasone 25, 50, 100, 200 mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sputum eosinophilia >3% Adults age 18-70 years History of episodic wheeze, chest tightness, dyspnea or cough within the last 12 months. FEV1 ≥ 60% predicted Steroid naive or on not more than 500 µg a day of beclomethasone or equivalent. Able to give written informed consent Exclusion Criteria: Recent asthma or COPD exacerbation (as judged by the clinician) due to respiratory infection within the last month Relevant seasonal allergen exposure within 4 weeks or within the course of the study Treatment with prednisone or antibiotics or hospitalisation within the past 6 weeks Other respiratory diseases Women who are pregnant or unwilling to use appropriate contraception during the study Unable to withhold short-acting ß-agonist treatment for 6 hours before visit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluticasone 25, 50, 100, 200 mcg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum eosinophils |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled nitric oxide, FEV1, FEF25-75% |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eosinophilic bronchitis with asthma, Eosinophilic bronchitis without asthma