linjc16/ctgov huggingface dataset:
Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.

Detailed Description
-----------------
This is a randomized, double-blind, controlled trial in which patients with long-standing clinically inactive UC receiving ASA for maintenance of remission will be randomized to either continue 5-ASA or to receive an equivalent placebo for 12 months. The primary endpoint is clinical relapse at 12 months.

Official Title
-----------------
Oral 5-aminosalicylic Acid Withdrawal in Long Standing Inactive Ulcerative Colitis: A Double-blind, Randomized, Placebo-controlled Trial

Conditions
-----------------
Colitis, Ulcerative, Aminosalicylic Acid

Intervention / Treatment
-----------------
* Drug: Mesalazine
* Drug: Placebo oral capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have a confirmed diagnosis of UC according to established clinical, endoscopic and histologic criteria in long-standing clinical remission written informed consent Exclusion Criteria: allergic to mesalazine prior bowel surgery except appendectomy hepatic or renal dysfunction malignant disease within 5 years pregnancy or breast feeding or women of child-bearing age without regular use of contraception on anti-tumor necrosis factor therapy terminal illness

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mesalazine<br>mesalazine 2g od po for 12 months | Drug: Mesalazine<br>* Patients will be prescribed Asacol 2g daily for 12 months<br>* Other names: Asacol;|
| Placebo Comparator: Placebo oral capsule<br>placebo 5 capsules od po for 12 months | Drug: Placebo oral capsule<br>* Patients will be prescribed placebo 5 capsules daily for 12 months<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The differences of relapse rates between the two arms | Relapse rate of patient in both arms will be calculated | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' drug compliance | Proportion of patients with good drug compliance, defined as more than 80% of drug taken will be evaluated. | 12 months |
Evaluation of Airtraq in Pediatric

Study Overview
=================
Brief Summary
-----------------
This study indented to evaluate the use of Optical laryngoscope in pediatric

Detailed Description
-----------------
The authors are welling to study how intubation will differ if Airtraq optical laryngoscope used in pediatrics

Official Title
-----------------
Evaluation of Airtraq in Pediatric Population: A Prospective Randomized Study

Conditions
-----------------
Intubation

Intervention / Treatment
-----------------
* Device: Airtraq
* Device: Macintoch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children undergoing general anesthesia required tracheal intubation. Exclusion Criteria: History of difficult intubation. Risk of aspiration. Children with cardiovascular disease. Children with respiratory disease.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 10 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 |
| --- | --- |
| Active Comparator: Airtraq group<br>Use Airtraq for intubation | Device: Airtraq<br>* intubation with airtraq<br>* Other names: Optical laryngoscope;|
| Active Comparator: Macintoch gorup<br>Use Macintoch laryngoscope for intubation | Device: Macintoch<br>* use Macintoch laryngoscope for intubation<br>* Other names: Standard laryngoscope;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of intubation |  | two minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Airtraq, Pediatric
Safety and Efficacy Study to Treat Bacterial Vaginosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.

Official Title
-----------------
A Phase 3, Multicenter, Randomized, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of Product 55394 in the Treatment of Bacterial Vaginosis

Conditions
-----------------
Bacterial Vaginosis

Intervention / Treatment
-----------------
* Drug: Product 55394
* Drug: Placebo Vehicle (non-treatment)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a clinical diagnosis of bacterial vaginosis as determined by the investigator. Other items as identified in the protocol. Exclusion Criteria: Have a known or suspected other infectious cause of vulvovaginitis. Other items as identified in the protocol.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br>Treatment with the vehicle (placebo) | Drug: Placebo Vehicle (non-treatment)<br>* The vehicle vaginal gel in an applicator (placebo).<br>|
| Experimental: Product 55394<br>Treatment with product 55394 | Drug: Product 55394<br>* Product 55394 vaginal gel in a prefilled applicator.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure | The proportion of subjects with a clinical cure at the Day 21 visit, as assessed by the investigator. | Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic Cure | The proportion of subjects with a therapeutic cure at the Day 21 visit. Therapeutic cure is defined as both a clinical cure and bacteriological cure as assessed by the investigator and the central laboratory, respectively. | Day 21 |
To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.

Study Overview
=================
Brief Summary
-----------------
To evaluate the long-term safety and tolerability of pregabalin in patients with partial seizures.

Official Title
-----------------
Pregabalin BID Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.

Conditions
-----------------
Seizure Disorder, Partial

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have met the inclusion criteria for preceding double-blind study Have received double-blind study medication and wish to receive open-label pregabalin. Exclusion Criteria: Cannot have absence seizures

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- |
|Drug: Pregabalin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Tolerability |  |  |
CT-angiographic Follow up of Patients That Underwent Coronary Bypass Surgery Between 1993-1997

Study Overview
=================
Brief Summary
-----------------
Coronary artery surgery (CABG) is necessary to improve blood circulation in many patients with coronary artery disease. This is done by using alternative blood vessels (grafts) to bypass the stenosed coronary arteries. In CABG, vein grafts are traditionally used where surrounding tissue is removed, this may damage the vessel and influence its patency. The no-touch technique was developed by Professor Domingos Souza at the Department of Cardiovascular and Thoracic Surgery, Örebro University Hospital. This technique includes taking out the vein with its surrounding tissue and by this way the vessel is less damaged. The first two follow ups have shown that no-touch grafts had better patency than conventionally extracted graft at 18 months and 8.5 years. This long term follow up is a continuation of the randomized trial started in 1993 where the patency and incidence of stenoses in the no touch and conventional vein grafts has been studied.

Official Title
-----------------
CT-angiographic Follow Upp of Patients That Underwent Coronary Bypass Surgery Between 1993-1997. A Randomized Longitudinal Trial.

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: No touch technique
* Procedure: Conventional technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First time coronary artery bypass grafting with either conventional or no touch vein grafts performed by Dr.Souza between 1993-1997. Included in the previous follow up studies Signed and dated consent. Exclusion Criteria: Allergy to contrast Renal failure Uncontrolled diabetes Unable to implement the study according to protocol -
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 |
| --- | --- |
| Active Comparator: No touch vein grafts<br>The grafts were harvested with there surrounding tissues. | Procedure: No touch technique<br>* The vein graft is harvested with its surronding tissues.<br>|
| Active Comparator: Conventional vein grafts.<br>The grafts were stripped from surrounding tissue. | Procedure: Conventional technique<br>* The vein graft is stripped from its surrounding tissues.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency of the grafts |  | Mean time of 15 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stenosis in the grafts. |  | Mean time of 15 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery bypass grafting, Saphenous vein grafts
Effect of Perioperative Sivelstat Administration for Liver Resection

Study Overview
=================
Brief Summary
-----------------
It is reported that sivelstat improved and preserved the postoperative renal function in the orthopedic management. Moreover because sivelstat reduced the migration of neutrophil, it improved acute lung injury. During liver resection, Pringle maneuver, clamping the hepatoduodenal ligament, was performed. Pringle maneuver causes reperfusion injury of the liver. We have a hypothesis that sivelstat prevent the warm shock of reperfusion injury of the liver by Pringle maneuver.

Detailed Description
-----------------
Whether the incidence of postoperative morbidities, such as liver failure, renal failure, or congestive heart failure, was reduced by administration of perioperative sivelstat.

Official Title
-----------------
Effect of Perioperative Sivelstat Administration for Liver Resection

Conditions
-----------------
Liver Diseases

Intervention / Treatment
-----------------
* Drug: sivelstat
* Drug: glucose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver disease which surgical management was indicated Exclusion Criteria: weight loss greater than 10 per cent during the previous 6 months, signs of distant metastasis, or of respiratory, renal or heart disease
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>250mL of 5% glucose plus 300mg of sivelstat was infected through the vein at 10mL per an hour | Drug: sivelstat<br>* sivelstat sodiumhydrate<br>* Other names: sivelstat sodiumhydrate, ONO PHARMACEUTICAL CO;|
| Placebo Comparator: 1<br>250mL of 5% glucose was injected though the vein at 10mL per an hour | Drug: glucose<br>* glucose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of liver damage due to reperfusion injury by Pringle maneuver was measured by several cytokines, including IL-8, IL-6, and HMGB-1. |  | during hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of ICU stay and hospital stay, postoperative complications, and the liver damage at 6 POD, measuring hepato-biliary enzyme |  | during hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery
Study to Evaluate Hemodynamic Response to to a Sublingual Dose of Glyceryl Trinitrate in Subjects Receiving TA-1790, Sildenafil Citrate, and Placebo

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the hemodynamic response to a sublingual dose of glyceryl trinitrate in subjects receiving oral TA-1790, sildenafil citrate, and placebo.

Official Title
-----------------
A Double-blind, Randomized, Crossover Evaluation of the Hemodynamic Response to Sublingual Glyceryl Trinitrate in Patients Receiving TA-1790, Sildenafil, and Placebo

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: TA-1790
* Drug: Sildenafil citrate
* Drug: Placebo
* Drug: Nitrostat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written informed consent Willing to comply with all study requirements and clinic schedules Male between 30 to 60 years of age Non-smoker No history of alcohol abuse Normal screening laboratory values Exclusion Criteria: Allergy or hypersensitive to PDE5 inhibitors Evidence of clinically significant disease Supine systolic/diastolic blood pressure level History of cardiovascular disease Previously participated in TA-1790 within the past 30 days

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>TA-1790 + glyceryl trinitrate | Drug: TA-1790<br>* 2 TA-1790 100 mg capsules<br>Drug: Nitrostat<br>* glyceryl trinitrate tablet, USP 0.4 mg<br>|
| Active Comparator: Treatment B<br>sildenafil citrate + glyceryl trinitrate | Drug: Sildenafil citrate<br>* 2 sildenafil citrate 50 mg capsules<br>Drug: Nitrostat<br>* glyceryl trinitrate tablet, USP 0.4 mg<br>|
| Placebo Comparator: Treatment C<br>placebo + glyceryl trinitrate | Drug: Placebo<br>* 2 placebo capsules for TA-1790 100 mg capsules<br>Drug: Nitrostat<br>* glyceryl trinitrate tablet, USP 0.4 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemodynamic measurements | Change in hemodynamic measurements consisted of blood pressure and pulse rate measurements. | Pre-dose, 5 min interval for first 45 minutes. 60, 90, and 120 minutes post-dose. |
Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether local infiltration analgesia (LIA) with Ropivacaine and adrenaline is effective in the treatment of postoperative pain after major spine surgery.

Official Title
-----------------
Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo Ved Rygkirurgi for Spinalstenose: et Prospektivt Randomiseret, Dobbeltblindet, Placebo-kontrolleret Studie

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Ropivacaine 0.5 %
* Drug: Isotonic NaCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients eligible for major spine surgery must speak and understand Danish must be able to give oral and written consent Exclusion Criteria: alcohol or medicine abuse treatment with opioids > 100 mg daily allergy to local anesthetics severe obesity

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine<br> | Drug: Ropivacaine 0.5 %<br>* Local infiltration analgesia<br>|
| Placebo Comparator: Placebo<br> | Drug: Isotonic NaCl<br>* Local infiltration analgesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain |  | 0-48 h postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia consumption |  | 0-48 h postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Local infiltration analgesia, postoperative pain, ropivacaine
The Degree, Duration and Frequency of Insulin Resistance in Non-operated Patients With Sepsis

Study Overview
=================
Brief Summary
-----------------
Surgery induces insulin resistance lasting for 2-3 weeks. We wanted to elucidate if stress-metabolic, medical conditions carry the same effect.

Detailed Description
-----------------
Background: Insulin resistance is well documented after surgery in a severity positively correlated to the degree of trauma (Thorell et al. 1999; Chambrier et al. 2000). Similar phenomena have been described in severely ill patients in ICU with consequences for the survival (Van den Berghe et al. 2001; The NICE-SUGAR Study Investigators 2009). The documentation, however, is scarce and the extent is unknown in acutely ill patients with sepsis. Method: Adult, consecutive, non-diabetic patients with elevated CRP, leukocyte counts, SOFA-score of ≥ 2 were monitored with fasting p-C-peptide, blood glucose, CRP, leukocyte count and HOMA-IR at admittance, discharge and at two follow-up visits 2 weeks and 4 weeks after admission. Blood glucose levels were measured continuously during the whole study period with a flash glucose monitor mounted on the patients' upper arm. The diagnosis was sepsis, urosepsis, pneumonia, erysipecosis, bacteremia, infection with unknow focus and covid-19.

Official Title
-----------------
Insulin Resistance in Septic Patients in the Acute Phase and After Discharge From Hospital

Conditions
-----------------
Sepsis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elevated CRP on acute asdmission elevated leukocyte count on admission SOFA-score ≥ 2 diagnosis: bacterial sepsis full age and authority Exclusion Criteria: not able to understand the protocol not able to co-operate diabetes mellitus of any kind

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 |
| --- |
|Other: no intervention|standard treatment in the clinical routine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| continous blood glucose | flash glucose monitor on the upper arm | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-peptide | plasma concentration | 4 weeks | 
| HOMA-IR | calculated glucose load test | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
septicaemia, insulin resitance, continous blood glucose