linjc16/ctgov huggingface dataset:
Effect of Intraoperative Magnesium on Remifentanil-induced Postoperative Hyperalgesia After Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effect of intraoperative magnesium on remifentanil-induced postoperative hyperalgesia after thyroidectomy

Conditions
-----------------
Hyperalgesia

Intervention / Treatment
-----------------
* Drug: remifentanil, MgSO4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing thyroidectomy, Age 20-65, American Society of Anesthesiologists physical status classification I or II. Exclusion Criteria: History of chronic pain, Regular use of analgesic, antiepileptic or antidepressive drugs, History of drug & alcohol abuse, Psychiatric disorder, Use of opioids within 24hrs, Renal disease with decreased GFR, Neuromuscular disease, Severe cardiac disease.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: remifentanil, MgSO4<br>Experimental 1 : Intraoperative remifentanil infusion at 0.2 ㎍/㎏/min and MgSO4 30 mg/kg IV at the induction followed by intraoperative infusion at 10 mg/kg/hr Drug : remifentanil, MgSO4 Experimental 2 : Intraoperative remifentanil infusion at 0.2 ㎍/㎏/min and normal saline Drug : remifentanil Active comparator : Intraoperative remifentanil infusion at 0.05 ㎍/㎏/min and normal saline Drug : remifentanil | Drug: remifentanil, MgSO4<br>* Patients undergoing thyroidectomy will be randomly assigned to one of three groups. Remifentanil will be infused intraoperatively at 0.05 ㎍/㎏/min (group Ⅰ) or 0.2 ㎍/㎏/min (group Ⅱ & Ⅲ). Patients in group Ⅲ will be received 30 ㎎/㎏ MgSO4 at the induction of general anesthesia followed by a maintenance infusion of 10 ㎎/㎏/hr intraoperatively until skin closure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tactile pain thresholds adjacent to the surgical wound assessed by von Frey hair before the induction and at postoperative 24 & 48 hrs |  | postoperative 48 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Remifentanil induced postoperative hyperalgesia
Quality of Life in Children and Adolescents With Chronic Functional Constipation: Educational Action Effects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the quality of life in children and adolescents diagnosed with chronic functional constipation improves after educational activity in focus group composed by these patients' mothers.

Detailed Description
-----------------
The present research will be conducted on the specific constipation clinic in Hospital das Clínicas at Universidade Federal de Pernambuco.

Official Title
-----------------
Quality of Life in Children and Adolescents With Chronic Functional Constipation: Educational Action Effects

Conditions
-----------------
Chronic Functional Constipation

Intervention / Treatment
-----------------
* Behavioral: Educational action with focal group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children (6 to 9 years-old) and adolescents Diagnostic of chronic functional constipation Exclusion Criteria: Patients using calcium and/or heme Patients with organic diseases that causes constipation

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational action group<br> | Behavioral: Educational action with focal group<br> <br> |
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement in the quality of life on participants after the intervention | The quality of life outcomes will be assessed by using the Generic Core Questionnaires (Standard form) of Measurement Model for the Pediatric Quality of Life InventoryTM version (PedsQL) 4.0 Generic Core Scales (VARNI et al., 2001) was translated and validated in Brazil by Klatchoian et al. (2008). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement in clinical parameters of chronic functional constipation | The clinical parameters were assessed according to a specific questionnaire used on patient assistance at clinical hospital at UFPE. This questionnaire will be applied before and after the intervention. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of life, Constipation, Focus groups, Health education, Problem-based learning
Renal HYPODYSPLASIA : Genetic and Familial Assessment

Study Overview
=================
Brief Summary
-----------------
Evaluation of the frequency of familial cases of renal HYPODYSPLASIA

Detailed Description
-----------------
DNA collection from the propositus and its family. A questionnaire will be filled by the parents to seek other affected individual in the family.With another affected member, DNA collection will be collected from the whole family. A renal ultrasound will be prescribed for the parents, brothers and sisters.

Official Title
-----------------
Renal HYPODYSPLASIA;Study of Familial Cases and Search for Predisposing Genes

Conditions
-----------------
Renal HYPODYSPLASIA, Nonsyndromic, 1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : - Children aged more than 3 months and less than 18 years old with a renal bilateral HYPODYSPLASIA set by renal ultrasound examination : renal size < -2DS with/or hyperechogenicity or lack of cortical-medullary differentiation with/or renal cysts Exclusion criteria : Bladder uropathy or sus-bladder uropathy Recessive or dominant renal polycystic disease Bardet-Biedl syndrome and other malformative syndromes except renal coloboma syndrome, Renal cysts and diabetes syndrome RCAD Lack of written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum 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 |
| --- | --- | --- |
| Evaluation of the heritability of renal HYPODYSPLASIA (on the renal ultra sound) and DNA collection to make possible identification of predisposing genes |  | the same day |
Nitroglycerin as Spasmolytic Regimen for RAS Prevention in Radial Center

Study Overview
=================
Brief Summary
-----------------
The investigators will investigate whether administration of Nitroglycerin (NTG) as spasmolytic regimen reduces the incidence of moderate to severe radial artery spasm (RAS) in patients undergoing transradial catheterization in radial center.

Detailed Description
-----------------
Patients will be randomized to receive either 200 microgram NTG or placebo (saline) at the beginning of the procedure soon after radial sheath placement. The operators will be blinded to both assignment. The primary outcome is the incidence of moderate to severe RAS evaluated by the operators during the radial procedure. Both NTG and placebo will be administered using an identical syringe to keep the operators blinded to the treatment allocation. Radial angiogram is mandatory to measure the diameter of both radial and ulnar arteries. Doppler ultrasound of the radial artery will be examined at the day after the procedure.

Official Title
-----------------
A Randomized Comparison of Nitroglycerin Versus Placebo as Spasmolytic Regimen to Prevent Moderate to Severe Radial Artery Spasm in Radial Center

Conditions
-----------------
Radial Artery Injury

Intervention / Treatment
-----------------
* Drug: NTG 1 MG/ML Injectable Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing transradial catheterisation using proximal radial artery puncture technique Exclusion Criteria: Blood pressure <100 mmHg Refuse to participate
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
Interventional Model Description: NTG vs Placebo
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 200 microgram NTG<br>200 microgram NTG through the radial sheath | Drug: NTG 1 MG/ML Injectable Solution<br>* administered after sheath placement<br>* Other names: Nitroglycerin;|
| Placebo Comparator: Saline<br>Saline infusion through the radial sheath | Drug: NTG 1 MG/ML Injectable Solution<br>* administered after sheath placement<br>* Other names: Nitroglycerin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of Moderate to severe radial artery spasm | arm pain associated with catheter manipulation (RAS grade 2 to 4) | During the index procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transradial catheterisation, radial artery spasm
A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Bimatoprost 0.01%
* Drug: Bimatoprost 0.03%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of glaucoma or ocular hypertension Exclusion Criteria: Active ocular disease other than glaucoma or ocular hypertension Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)

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 |
| --- | --- |
| Experimental: Bimatoprost 0.01%<br>Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks. | Drug: Bimatoprost 0.01%<br>* Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.<br>* Other names: LUMIGAN® 0.01%;|
| Active Comparator: Bimatoprost 0.03%<br>Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks. | Drug: Bimatoprost 0.03%<br>* Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.<br>* Other names: LUMIGAN® 0.03%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye | Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye. | Baseline, 6 Weeks |
Inflammation and Postoperative Tramadol Analgesia

Study Overview
=================
Brief Summary
-----------------
Patients will be admitted in the intensive care unit after major abdominal surgery. All patients will receive 100 mg of tramadol intravenously every 6 hours. Pain will be assessed before and half an hour after tramadol administration by verbal Numeric Rating Scale.

Detailed Description
-----------------
To all patients included in the study from the blood sample taken prior to the operation the leukocytes counts, c-reactive protein (CRP), procalcitonin (PCT) and lactate level will be performed, as well as arterial blood gas analysis. After admission to the intensive care unit, all patients will receive 100 mg of tramadol intravenously every 6 hours. Pain will be assessed before and half an hour after tramadol administration by verbal Numeric Rating Scale (NRS). Pain score will be compared between patients with and without systemic inflammation. Systemic inflammation is defined as fulfilling at least two of the following major criteria: fever > 38 oC or hypothermia < 36 oC, tachycardia > 90 beats/minute, pCO2 in arterial blood < 4.3 kPa and leukocytes > 12.000/mm3 or < 4.000/mm3. Also, preoperative values of CRP > 50 mg/L and PCT > 0.5 ng/ml was also considered systemic inflammation.

Official Title
-----------------
The Influence of Systemic Inflammation on the Analgesic Effect of Tramadol After Major Abdominal Surgery

Conditions
-----------------
General Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective and emergency open abdominal surgery ICU admission Exclusion Criteria: tramadol allergy surgery performed laparoscopically age younger of 18 years and older the 90 years

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic Affect of Tramadol After Major Abdominal Surgery | Pain will be assessed before and half an hour after tramadol administration in awake patients by verbal Numeric Rating Scale. This scale has values from 0 to 10, where 0 means no pain and 10 means maximum pain. | NRS was assessed before and 30 minutes after each tramadol dose during first 24 postoperative hours | 
| Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | Differences in Numeric Rating Scale (NRS) in Patients with and without Systemic Inflammation. This scale has values from 0 to 10, where 0 means no pain and 10 means maximum pain. | NRS was assessed before and 30 minutes after each dose of tramadol in a first 24 postoperative hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative analgesia, tramadol, intensive care unit
Open Lung Approach During General Anaesthesia to Prevent Post-Operative Pulmonary Complications

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that the Open lung approach ( recruitment and PEEP) during general anaesthesia reduces atelectasis formation and improves respiratory function in the immediate post-operative period after major abdominal surgery. This is a prospective, randomized, controlled clinical-trial,performed in patients undergoing major abdominal surgery, to compare the effects on the post-operative pulmonary complications of two different intraoperative ventilatory strategies during general anaesthesia: 1- Control Group: PEEP 0 cmH2O without recruitment manoeuvre; 2- Treatment Group:recruitment manoeuvre (after intubation and before extubation) and PEEP 10 cmH2O In the post-operative period the following variables will be recorded at the first, third and fifth postoperative day: 1- Gas-exchange in air; 2- Chest X-ray for atelectasis evaluation; 3- signs of pulmonary complication (cough, secretions, dyspnea, thoracic pain)

Conditions
-----------------
Postoperative Complications

Intervention / Treatment
-----------------
* Procedure: Positive end-expiratory pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ASA 1, 2 and 3 Age higher than 18 years Major abdominal surgery General anesthesia Exclusion Criteria: COPD with FEV1 lower than 50% Ischemic cardiopathy Loco-regional anesthesia alone Minor abdominal surgery Laparoscopic surgery

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

| Intervention/Treatment |
| --- |
|Procedure: Positive end-expiratory pressure|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Genetic Determinants of the Bronchodilatation Effect of Albuterol ex-Vivo

Study Overview
=================
Brief Summary
-----------------
The role played by ß2AR polymorphisms in determining the bronchial response to ß2AR agonist drugs, has been confirmed by several studies. The purpose of the present study is to examine possible causal relationships between genetically based alteration in the structure of ß2AR and drug responsiveness. An ex-vivo model (organ bath technique) will be used to investigate association between polymorphisms in the coding region of ß2AR and the response of bronchial rings derived from human lung tissue to the respective agonists (i.e. salbutamol). In the second part of the study the same bronchial rings will be incubated for 24 hours in a solution containing fixed concentration of albuterol. A second dose response curve for rising concentrations of albuterol will be constructed and a relationship between β2 genetic polymorphisms and the extent of desensitization to albuterol will be investigated. In addition, through specifically designed receptor binding assay the bronchial tissue will be used to define the affinity (Kd) and expression (Vmax) of the ß2 receptor. These data will enable to enhance our understanding regarding the mechanism responsible for the association noted between ß2AR polymorphism and altered drug effect.

Official Title
-----------------
The Effect of β2 Genetic Polymorphisms on the Brochodilatation Effect of Albuterol ex-Vivo

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: albuterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macroscopically normal pulmonary tissue Exclusion Criteria: The presence of pathological finding in the pulmonary tissue

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The extent of bronchial dilatation ex-vivo |  |  | 
| The extent of decrease in brochial dilatation after prolonged incubation with albuterol |  |  |
Right Ventricular Dysfunction Incidence After Major Lung Resection

Study Overview
=================
Brief Summary
-----------------
This study aims to describe incidence of right ventricular dysfunction after major lung resection with echocardiography criteria.

Detailed Description
-----------------
Few clinical trial studied the incidence of right ventricular dysfunction after major lung resection and time frame of occurrence. In this prospective observational study the right ventricular function will be mesure with echocardiographic criteria. Echocardiographic exam will be standardised and be realised day before surgery (at the same time that inclusion), day 1, day 2 and day 3 after surgery. In order to assess prognostic value of right dysfunction after lung resection, data as hospitalization stay, complications and survival will be collected at 6 months. Cardiac cycles will be recorded and be analysed by a single observer blind to the clinical finding and other echocardiographic measurements.

Official Title
-----------------
Right Ventricular Dysfunction Incidence After Major Lung Resection, a Prospective Study.

Conditions
-----------------
Right Ventricular Dysfunction, Major Lung Resection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written consent Patient older than 18 years Major lung surgery (pneumonectomy, lobectomy) Exclusion Criteria: Pre-existing pulmonary arteria hypertension Post-operative surgical complication on day 1 to 3 (bleeding, revision surgery) Technical difficulty preventing adequate echocardiographic assessment Patient refusal

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 |
| --- | --- | --- |
| Right ventricular dysfunction | Without pre-existing pulmonary arteria hypertension, it will be assess with echocardiography criteria : PAPS > 35mmHg or right ventricular dilatation or right systolic markers abnormalities. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors | Determining risk factors for developing right ventricular failure after pulmonary resection | 5 days | 
| Time frame to right ventricular dysfunction | Time frame to right ventricular dysfunction | 5 days | 
| Assessment of 2D strain for right ventricular dysfunctio | Assessment of 2D strain for right ventricular dysfunction | 5 days | 
| Estimate impact of right ventricular dysfunction on patient prognosis. | Estimate impact of right ventricular dysfunction on patient prognosis. | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major lung resection, Right Ventricular Dysfunction, 2D Strain