linjc16/ctgov huggingface dataset:
The Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery

Study Overview
=================
Brief Summary
-----------------
Multimodal analgesia may be important for optimal postoperative pain treatment and facilitation of early mobilization and recovery. This study investigated the analgesic effect of pregabalin and dexamethasone in patients undergoing lumbar spinal surgery.

Official Title
-----------------
The Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery

Conditions
-----------------
Pain

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for lumbar spinal surgery, aged 20 to 70 years, with a body mass index (BMI) from 18 to 32 and an American Society of Anesthesiologists (ASA)physical status classification of I-II were eligible for the study. Exclusion Criteria: allergy to any drugs in the study alcohol and/or drug abuse treatment with antacids or antidepressants a history of diabetes or epilepsy a daily intake of analgesics or an intake of any analgesic within 24 h before surgery treatment with systemic glucocorticoids within 4 weeks before surgery known impaired hepatic and renal function.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo arm<br> | Drug: placebo<br>* vitamin B complex formula<br>|
| Active Comparator: pregabalin arm<br> | Drug: Pregabalin<br>* pregabalin: 300 mg/day, po, from operative day until third postoperative day.<br>|
| Experimental: dexamethasone with pregabalin arm<br> | Drug: dexamethasone<br>* Dexamethasone 16 mg, intravenous, before induction of anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the multimodal analgesic effect of pregabalin, and of pregabalin with dexamethasone | Primary Outcome is to investigate the multimodal analgesic effect of pregabalin, and of pregabalin with dexamethasone, in patients receiving a patient-controlled analgeisa with fentanyl, on fentanyl consumption (primary end point), pain scores and side effects in patients scheduled for lumbar spinal surgery. | Assessment was performed during the first 72 hour following emergence from general anesthesia, subdivided into 5 time periods; on arrival of patient to the PACU, 1-6 hour, 6-24 hour, 24-48 hour and 48-72 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients undergoing lumbar spinal surgery
Ibuprofen and Renal Function in Premature Infants

Study Overview
=================
Brief Summary
-----------------
Purpose of the study: To evaluate renal function maturation within the first month of life in very premature infants. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life.

Detailed Description
-----------------
Ibuprofen has improved the prognosis of infants with Patent Ductus Arteriosus. Several studies showed that Ibuprofen has significantly less side effects than Indomethacin that was used for this indication. However, experimental studies and few clinical observations suggested that side effects on renal function could occur in very premature infants. Purpose of the study: To evaluate renal function maturation within the first month of life in very premature infants. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life. Population: At least 120 infants 27 to 31 weeks gestation will be studied. That number will allow to demonstrate a 30% difference in creatinine clearance on day 7 postnatally. Careful recording of mother and child history, and associated therapies prone to alter renal function should allow to improve the use of this treatment.

Official Title
-----------------
Ibuprofen and Renal Function in Premature Infants

Conditions
-----------------
Premature Infants, Patent Ductus Arteriosus

Intervention / Treatment
-----------------
* Drug: Ibuprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational Age = 27 to 31 weeks Postnatal age < 48 hours Parental Consent Obtained Exclusion Criteria: Renal malformation Urinary tract infection Renal Failure Pulmonary Hypertension at echocardiography

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 28 Days

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ibuprofen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine Clearance on day seven postnatally |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ductus closure after treatment |  |  | 
| Mortality |  |  | 
| Rate of necrotizing enterocolitis |  |  | 
| Rate and severity of Intraventricular Hemorrhage |  |  | 
| Renal function maturation over 28 days |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature Infants, Patent ductus arteriosus, Renal function, Ibuprofen
Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with type 2 diabetes.

Official Title
-----------------
A Multi-National, Multi-Centre, Randomised, Open-Labelled, Parallel Trial Comparing Efficacy and Safety of NovoMix® 30 FlexPen® and Mixtard® 30 Twice Daily Injections in Subjects With Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart
* Drug: biphasic human insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes for at least 24 months Insulin treatment for the pase 3 months HbA1c (glycosylated haemoglobin) below 13% BMI (Body Mass Index) below 40 kg/m^2 Ability and willingness to perform self-blood glucose monitoring Exclusion Criteria: Receipt of any investigational drug within 4 weeks prior to this trial Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial Total daily insulin dosage less than or equal to 1.8 IU/kg

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: biphasic insulin aspart<br>* Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily<br>|
| Active Comparator: B<br> | Drug: biphasic human insulin<br>* Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycolated haemoglobin) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prandial increment in blood glucose |  |  | 
| 7-point blood glucose profile |  |  | 
| Number and severity of adverse events |  |  | 
| Number and severity of local tolerability issues at the injection site |  |  | 
| Number and severity of hypoglycaemic episodes |  |  |
Atherosclerosis in Juvenile Mixed Connective Tissue Disease (ACTID)

Study Overview
=================
Brief Summary
-----------------
This Study investigates presence of preclinical atherosclerosis in patients with Juvenile Mixed Connective Tissue Disease in Norway.

Detailed Description
-----------------
Patients and controls are examined with carotid ultrasound, venous blood is drawn, and they undergo a clinical examination.

Official Title
-----------------
Atherosclerosis in Juvenile Mixed Connective Tissue Disease

Conditions
-----------------
Carotid Atherosclerosis

Intervention / Treatment
-----------------
* Diagnostic Test: Carotid Ultrasound and venous blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of MIxed Connective Tissue Disease Exclusion Criteria: -
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 |
| --- | --- |
| Patients<br>Patients with diagnosis of Juvenile Mixed Connective Tissue Disease | Diagnostic Test: Carotid Ultrasound and venous blood sampling<br>* Carotid ultrasound and blood sampling<br>|
| Controls<br>Healthy, age-and sex-matched controls | Diagnostic Test: Carotid Ultrasound and venous blood sampling<br>* Carotid ultrasound and blood sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of carotid atherosclerosis | measuring intima-media thickness | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood markers of endothelial dysfunction |  | 20 minutes |
EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, observational study of the use of EmboCube Embolization Gelatin to control hemorrhaging and bleeding. The study is designed to enable the collection, analysis, and reporting of data from real-world use of EmboCube used in accordance with the Instructions for Use (IFU) associated with the product's CE Mark approval. Data collection will include that relating to safety and effectiveness and the period of observation during which data will be collected will extend from the index procedure through 28 days post procedure.

Official Title
-----------------
A Multicenter Observational Study to Evaluate Outcomes of EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging

Conditions
-----------------
Hemorrhage, Bleeding Hemorrhage

Intervention / Treatment
-----------------
* Device: EmboCube Embolization Gelatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Subject requires embolization and is suitable for treatment with EmboCube in accordance with device Instructions For Use for the treatment of bleeding or hemorrhage. Subject provides written informed consent to study data collection. Exclusion Criteria: Bleeding site in the neck, head, or brain. Subject has co-morbidity with survival prognosis of less than 30 days, in the opinion of the treating physician In the investigator's opinion, participation in the study may not be in the subject's best interest.

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 |
| --- |
|Device: EmboCube Embolization Gelatin|EmboCube is a uniformly cut gelatin foam pre-loaded into a syringe, indicated for use in embolization of blood vessels to occlude blood flow to control bleeding/hemorrhaging in the peripheral vasculature|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success: Cessation of Bleeding up to 24 hours | The primary performance endpoint will be clinical success defined as cessation of bleeding post-embolization and absence of rebleeding at the treated site requiring reintervention (repeat embolization or additional surgery), within 24 hours. | 24 hours | 
| Incidence of device and procedure-related AEs | Absence of unanticipated serious adverse device effects within 24 hours. | 24 hours |
AVERT™ Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN

Study Overview
=================
Brief Summary
-----------------
The Osprey Medical AVERT System is indicated to reduce contrast media (CM) exposure to the kidneys during percutaneous coronary procedures thereby reducing the risk of contrast induced nephropathy (CIN).

Detailed Description
-----------------
The purpose of this trial is to assess the AVERT System device, which is designed to limit the volume of CM (Contrast Media) utilized, during a staged therapeutic coronary PCI (Percutaneous Coronary Intervention) or a coronary diagnostic procedure that is anticipated to become a PCI (i.e. ad hoc PCI) for the reduction of CIN (Contrast Induced Nephropathy).

Official Title
-----------------
AVERT™ Clinical Trial

Conditions
-----------------
Contrast Induced Nephropathy (CIN)

Intervention / Treatment
-----------------
* Device: AVERT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is a candidate for a therapeutic percutaneous coronary intervention (PCI) procedure. The subject has documented chronic kidney disease (CKD) Exclusion Criteria: Subject is in acute renal failure Assessment of ventricular function that cannot be accomplished without the use of the CM. Subject has acute STEMI within 72 hours prior to planned PCI procedure, or is currently having an acute STEMI. Subject is unable to undergo peri-procedural hydration.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment<br>Standard of Care with the AVERT system | Device: AVERT<br> <br> |
| No Intervention: Standard of Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint | Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days. | 3-5 days | 
| Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event | Analyze the incidence of device related serious adverse events within the treatment arm. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoint 1- | Comparison in contrast media volume required between active treament and standard of care. | 30 Days | 
| Secondary Endpoint 2- Comparison of Serious Adverse Events. | Comparing event rates of serious adverse events 30 days following the index procedure. | 30 Days | 
| Secondary Endpoint 3- Change in Kidney Function. | Change in kidney function by analyzing eGFR 3 to 5 days post procedure. | 3-5 days |
Sensitivity and Specificity of the Roth Test in Patients With COVID-19 Positive

Study Overview
=================
Brief Summary
-----------------
The presence of the described silent hypoxia in subjects diagnosed with COVID19 highlights the need for valid tools to assess respiratory capacity. The Roth test has been associated with acceptable sensitivity and specificity criteria in patients with previous respiratory pathology; however, its validity in this type of patient has not been proven.

Official Title
-----------------
Sensitivity and Specificity of the Roth Test in Patients With COVID-19 Positive

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

Intervention / Treatment
-----------------
* Diagnostic Test: Roth´s Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having been diagnosed as COVID-19 positive and with symptoms compatible with Sars-Cov-2 infection in the last 7 days prior to assessment, having an understanding of Spanish, and having no history of respiratory pathology prior to the current infection.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 99 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 |
| --- | --- |
| COVID+ Group<br>Patients diagnosed with Covid19 positive in last 7 days | Diagnostic Test: Roth´s Test<br>* Subjets must count from 1 to 30 in their languages, and health professional will count seconds that last in take breath during the count.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Saturation | The pulseoximeter percentage value | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roth´s test | The level described in the test | 12 weeks |
Revision Total Hip Replacement Arthroplasty and Hematologic Variables

Study Overview
=================
Brief Summary
-----------------
Revision total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. The investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume.

Official Title
-----------------
Relations Between Hematologic Variables and Postoperative Bleeding and Transfusion in Revision Total Hip Replacement Arthroplasty

Conditions
-----------------
Avascular Necrosis of Hip, Degenerative Hip Joint Disease

Intervention / Treatment
-----------------
* Other: RTHRA group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: revision total hip replacement Exclusion Criteria: hematologic disease anticoagulant medication American Society of Anesthesiologists physical status 4 and 5

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- |
| RTHRA group<br>patients undergoing revision total hip replacement | Other: RTHRA group<br>* hematologic variables measurement in patients undergoing revision total hip replacement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of FIBTEM | FIBTEM: one of the measurements of the rotational thromboelastometry | 5 minutes before initiation of anesthesia and 5 minutes after finishing operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume of infused fluid during operation | Infused total crystalloid and colloid volume during the operation will be recorded | Period from starting to finishing the operation (During operation, an expected average of 3 hours) | 
| intraoperative urine output |  | Period from starting to finishing the operation (During operation, an expected average of 3 hours) | 
| transfusion units | Red blood cell | Period from starting to finishing the operation (During operation, an expected average of 3 hours) and postoperative first day | 
| postoperative bleeding volume |  | postoperative 72 hours | 
| Hemoglobin |  | preoperative day 1 | 
| Hemoglobin |  | postoperative day 4 | 
| Hematocrit |  | preoperative day 1 | 
| Hematocrit |  | postoperative day 4 | 
| Platelet count |  | preoperative day 1 | 
| Platelet count |  | postoperative day 4 | 
| prothrombin time_international normalized ratio |  | preoperative day 1 | 
| prothrombin time_international normalized ratio |  | postoperative day 1 | 
| activated partial prothrombin time |  | preoperative day 1 | 
| activated partial prothrombin time |  | postoperative day 1 | 
| fibrinogen concentration |  | preoperative day 1 | 
| fibrinogen concentration |  | postoperative day 1 |
IOP Lowering Effect of PLT Versus SLT in Naiv OAG Patients

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of patterned laser trabeculoplasty (PLT) compared to selective laser trabeculoplasty (SLT) on intraocular pressure (IOP) in treatment naiv patients suffering from open-angle glaucoma or ocular hypertension. Values for IOP will be measured at baseline, 1 day and 1 month post-interventional as well as 2, 3, 6, 9, 12, 18 and 24 months after treatment. Trial with medical device

Official Title
-----------------
Effect of Patterned Laser Trabeculoplasty on Intraocular Pressure Compared to Selective Laser Trabeculoplasty in Treatment Naiv Patients Suffering From Open-angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Open Angle Glaucoma,, Ocular Hypertension

Intervention / Treatment
-----------------
* Device: Laser trabeculoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Intraocular pressure (treatment naiv or after 4 weeks wash-out phase) > 21 mm Hg visible angle structures over 360° on gonioscopy age = 18 years Exclusion criteria: Intraocular Inflammation patients who underwent refractive corneal surgery for any reason or who underwent ocular surgery to reduce intraocular pressure (e.g. trabeculectomy) monocle situation anterior chamber lenses (incl. iris claw) secondary glaucoma (with the exception of pseudoexfoliation and pigment dispersion)

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLT<br>patients treated with patterned laser trabeculoplasty | Device: Laser trabeculoplasty<br> <br> |
| Active Comparator: SLT<br>patients treated with selective laser trabeculoplasty | Device: Laser trabeculoplasty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure 6 months after Intervention |  | 6 months |