linjc16/ctgov huggingface dataset:
Efficacy of I/v Nalbuphine v/s Iv Lignocain in Attanuation of Pressor Responseduring Laryngeoscopy and Intubation in Middle Age Patient Planned for Thyroid Surgery

Study Overview
=================
Brief Summary
-----------------
Comparison of I/V nalbuphine versus I/V xylocain in attanuation of pressor response during intubation and laryngeoscopy in patients undergoing for thyroid surgery,selection of better supressor agent minimises the drug repated side effects like hypertention tachycardia but also helps in heamodynamically stability at induction.

Official Title
-----------------
Efficacy of IV Lignocaine Versus IV Nalbuphine for Attenuation of Pressor Response Diring Laryngoscopy and Intubation in Patients Planned for Thyroid Surgery

Conditions
-----------------
Hemodynamic Stability

Intervention / Treatment
-----------------
* Drug: Lignocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: middle age(18_40) Asa 1 and 2 Non hypertensive Thyroid patients patient who gives consent Exclusion Criteria: hypertensive Asa 3 and 4 Patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lignocain<br>I/V lignocain 1.5mg per kg given to participants in state dose | Drug: Lignocaine<br>* Inj lignocain and inj nalbuphine given to two groups of participants and effects of both drugs<br>* Other names: Nalbuphine;|
| Experimental: nalbuphine<br>I/v nalbuphine 0.1mg per kg given to participants in stat dose | Drug: Lignocaine<br>* Inj lignocain and inj nalbuphine given to two groups of participants and effects of both drugs<br>* Other names: Nalbuphine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce stress response during intubation and hemodynamic stabilty | Assesment of Hemodynamic stability by observing vital signs | 10 minutes | 
| Achieve hemodynamic stabilty and smooth intubation | Assesment of hemodynamic stability by clinical examination of vital signs | 10 minutes |
Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

Study Overview
=================
Brief Summary
-----------------
Sepsis is a clinical syndrome which infection trigger systemic inflammatory response. Uncontrolled inflammatory process leads to multiple organ dysfunction and cause early mortality in severe sepsis. Unfractionated heparin is an anticoagulant that widely used either for DVT prophylaxis or treatment of disseminated intravascular coagulation. Heparin also have an anti-inflammatory effect through downregulates nuclear factor kappa B and tumor necrosis factor alpha. Aim of this study is to determine effects of low dose unfractionated heparin treatment on inflammation in severe sepsis patient.

Official Title
-----------------
Randomized Control Trial to Assessed the Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Severe Sepsis

Conditions
-----------------
Severe Sepsis With Septic Shock, Severe Sepsis Without Septic Shock

Intervention / Treatment
-----------------
* Drug: Unfractionated heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with severe sepsis and septic shock define by revised Sepsis Criteria (2001) Within 48 hour diagnose sepsis Agree to participate Exclusion Criteria: Pregnancy and lactation Severe thrombocytopenia, platelet less than 30.000/mm3 Bleeding or high risk of major bleeding During anticoagulant treatment After thrombolytic treatment Decompensated chronic liver diseases Chronic kidney diseases on dialysis treatment During high dose corticosteroid treatment HIV with CD4 count below 50/mm3 Indication for high dose heparin treatment

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unfractionated Heparin<br>Low dose unfractionated Heparin 10 unit/kgBW/hour continuous infusion | Drug: Unfractionated heparin<br>* 10 unit/kgBW/hour continuous infusion for 72 hours<br>|
| Placebo Comparator: Placebo<br>Normal saline packed in same form with trial drugs. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammation | determine effects of low dose unfractionated heparin treatment on nuclear factor kappa B, inhibitor kappa B kinase and tumor necrosis factor-alpha. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical outcome | determine impact of low dose unfractionated heparin on mortality and improvement APACHE II score | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heparin, sepsis, inflammation
Impact of EUS Guided Treatment of Gastric Varices

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the clinical impact of cyanoacrylate tissue adhesive treatment for Gastric Varices performed by Indiana University EUS physicians.

Detailed Description
-----------------
Using an IRB approved database (IU IRB#1209009522; NCT02037659), data collected from the database will be evaluated to identify complications, risk of rebleeding, death within 1 year of treatment, varices eradication and need for re-intervention associated with cyanoacrylate tissue adhesive (Dermabond) treatment performed by Indiana University Endoscopic Ultrasound (EUS) physicians.

Official Title
-----------------
Impact of EUS Guided Treatment of Gastric Varices

Conditions
-----------------
Gastric Varices Bleeding

Intervention / Treatment
-----------------
* Procedure: Endoscopic Ultrasound (EUS) administration of cyanoacrylate tissue adhesive to control bleeding gastric varices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any subject enrolled into the existing database (IU IRB#1209009522; NCT02037659). Exclusion Criteria: Not enrolled into the database.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic Ultrasound (EUS) administration of cyanoacrylate tissue adhesive to control bleeding gastric varices|Subjects will have undergone treatment and been enrolled into the existing registry.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of EUS guided treatment of Gastric varices post procedure complications and adverse events | Retrospective data review to Determine post procedure complications and adverse events at 24h, between 2 and 7 days and between 8 and 30 days after the procedure. Additionally, tracking rebleeding after first and second EUS. Moreover, looking at eradication of GV rate on second endoscopy (considered eradicated if absent or if residual varices have no or minimal flow on doppler)eradication, and need for re-intervention following cyanoacrylate tissue adhesive treatment for Gastric Varices performed by IU EUS physicians. | Complications reviewed at time of retrospective study. EUS-guided sclerotherapy done between November 2012 and December 2021 |
Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.

Official Title
-----------------
A Single-Center, Masked, Randomized Study Comparing Two Marketed Ocular Anti-Allergy Medications in the Cat Room Model

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: Elestat
* Drug: Pataday


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented history of ocular allergy to cats. Positive skin prick allergen reaction to cat dander. Exclusion Criteria: Use of any topical or systemic corticosteroids, immunosuppressive agents, antihistamines, decongestants, NSAIDs, or asprin during the two weeks prior to enrollment into the study. History of severe asthma, reactive airway disease or bronchial obstruction. Ocular surgery or trauma in the last year.

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: Elestat<br> | Drug: Elestat<br>* Elestat BID for 2 days<br>|
| Active Comparator: Pataday<br> | Drug: Pataday<br>* Pataday QD for 2 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ocular Itch Score From Baseline | Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes. | 0 hours, 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Comfort Score at 12 Hours | Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale. | 12 hours |
Tumor Microenvironment in Patients With Localized Osteosarcoma Treated With Mifamurtide: a Translational Study

Study Overview
=================
Brief Summary
-----------------
International, multicenter retrospecitve biological study

Detailed Description
-----------------
International, multicenter retrospecitve biological study that will analyze the tumor micro environment in biological archival samples of patients, who were treated with mifamurtide according the protocols for primary localized osteosarcoma (ISG-OS2 and GEIS-33)

Official Title
-----------------
Tumor Microenvironment in Patients With Localized Osteosarcoma Treated With Mifamurtide: a Translational Study

Conditions
-----------------
Localized Osteosarcoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with primary localized osteosarcoma who received mifamurtide according to ISG-OS2/GEIS-33 trials, Paraffin-embedded tissue tumor (FFPE) blocks from archive available to perform the biological analysis Written informed consent prior to any study-specific analysis and/or data collection Exclusion Criteria: 1) Patients with diagnosis different from osteosarcoma 2) Patient not treated with mifamurtide -
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate the level of the PDL-1 checkpoint with event-free survival and overall-survival | correlation by pSTAT1 and CMAF staining, respectively, for the characterization of M1 and M2 subpopulations. Osteoclastic cells will be evaluated independently as giant multinucleated cells by CD68 staining | at baseline (Day0) |
Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity- Pilot Study

Study Overview
=================
Brief Summary
-----------------
Evaluate the feasibility and effectiveness of a multi-component school-based intervention to promote healthy eating and physical activity with school children ages 9 to 11 years in Lebanon.

Official Title
-----------------
Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity-Pilot Study

Conditions
-----------------
Childhood Obesity

Intervention / Treatment
-----------------
* Other: Health-E-PALS-Pilot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schoolchildren Aged 9 to 11 years Exclusion Criteria: - no exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 11 Years

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group- Health-E-PALS-Pilot<br>Group of students receiving the school-based intervention: Health-E-PALS (pilot), it consists of in class activities and lessons. | Other: Health-E-PALS-Pilot<br>* Intervention to promote Healthy Eating and Physical Activity in Lebanese School-Children It comprises in class-activities, meetings with parents, improvement of school food service<br>|
| No Intervention: Control group<br>Group of students not receiving any intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in knowledge score | Change in the knowledge scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and -post assessment phases | One school year | 
| Change in dietary habits | Change in the percentage of children consuming sugary drinks, unhealthy and healthy snacks, fruits and vegetables/change in the percentage of children's physical activity frequency (self-reported in the questionnaires during pre- and -post assessment phases) | One school year | 
| Change in self-efficacy score | Change in the self-efficacy scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and -post assessment phases | One school year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight status | Change in Body Mass Index - BMI (in kg/m^2) at pre- and post-assesment. | One school year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
School-based intervention
Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients

Study Overview
=================
Brief Summary
-----------------
Idiopathic Thrombocytopenic Purpura (ITP) is an autoimmune bleeding disorder characterised by isolated low platelet counts. The aim of treating patients with ITP is to increase the platelet concentration and reduce the risk of bleeding. A number of controlled multi-centre studies have demonstrated that Intravenous Immunoglobulin (IVIg) therapy produces a rapid rise in platelet counts within a 24 to 72 hour period. This study will evaluate the efficacy and safety of Ig NextGen 10% in adult patients with ITP.

Official Title
-----------------
A Single-arm, Open Label, Multi-centre Study Evaluating the Efficacy and Safety of Ig NexGen 10% in Patients With Idiopathic Thrombocytopenic Purpura (ITP)

Conditions
-----------------
Idiopathic Thrombocytopenic Purpura (ITP)

Intervention / Treatment
-----------------
* Drug: IgNextGen 10%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of ITP platelet count of <50 X 10^9 Exclusion Criteria: planned splenectomy previous non-responders to IVIg treatment known or suspected hypersensitivity or previous evidence of severe side effects to immunoglobulin therapy patients who have received treatment with: IVIg or anti-D immunoglobulin immunosuppressive, any other immunomodulatory drug(s) or other active treatment(s)for ITP within three weeks prior to first day of study drug administration patients who have received IV administration of steroids OR have had a change of oral corticosteroid treatment OR danazol within 15 days prior to first day of study drug administration.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>IVIg | Drug: IgNextGen 10%<br>* Ig NextGen 10% is a liquid formulation and is to be administered intravenously. At the discretion of the Investigator, patients could be administered Ig NextGen 10% in accordance with either of two dosage regimens: Regimen One: 1 g/kg body weight of Ig NextGen 10% administered daily for two days. Regimen Two: 0.4 g/kg body weight of Ig NextGen 10% administered daily for five days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 97 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ITP, IVIg, Platelet count, Bleeding
2-Hour Dispensing Evaluation of Samfilcon A Lenses With EPG01 Packaging Solution Compared to Commercially Available B+L Ultra Lenses

Study Overview
=================
Brief Summary
-----------------
The objective of this 2 hour study is to evaluate the clinical performance of samfilcon A lenses with an alternate packaging solution (EPG01) compared to commercially available B+L Ultra lenses.

Official Title
-----------------
2-Hour Dispensing Evaluation of Samfilcon A Lenses With EPG01 Packaging Solution Compared to Commercially Available B+L Ultra Lenses

Conditions
-----------------
Contact Lens Wearer

Intervention / Treatment
-----------------
* Device: samfilcon A Lenses with EPG01 Packaging Solution
* Device: B+L Ultra Lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. Have no active ocular disease or allergic conjunctivitis. Not be using any topical ocular medications. Be willing and able to follow instructions. Have signed a statement of informed consent. Exclusion Criteria: Participating in a conflicting study in the opinion of the Investigator. Considered by the Investigator to not be a suitable candidate for participation.

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: samfilcon A Lenses with EPG01 Packaging Solution<br> | Device: samfilcon A Lenses with EPG01 Packaging Solution<br>* samfilcon A Lenses with EPG01 Packaging Solution<br>|
| Active Comparator: B+L Ultra Lenses<br> | Device: B+L Ultra Lenses<br>* Commercially available Biotrue ONEday lenses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalized logMAR Visual Acuity |  | 2 hours |
Platelet Hyperreactivity Project

Study Overview
=================
Brief Summary
-----------------
The PHP study aims to delineate gene products involved in high on-treatment platelet reactivity in aspirin-treated cardiovascular patients.

Detailed Description
-----------------
The PHP study aims to delineate gene products involved in high on-treatment platelet reactivity in aspirin-treated cardiovascular patients using a system biology approach that include proteomics analysis of selected platelet sub-fractions in patients displaying extreme phenotype. Main objective: to characterize the proteome profile of platelet hyperreactivity in aspirin-treated cardiovascular patients Secondary objectives: to characterize the platelet hyperreactivity phenotype in cardiovascular patients treated with aspirin to determine genetic polymorphisms associated with platelet hyperreactivity

Official Title
-----------------
Platelet Hyperreactivity Project: A System Biology Approach of High On-treatment Platelet Reactivity in Aspirin-treated Cardiovascular Patients

Conditions
-----------------
Platelet Reactivity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented symptomatic ischemic atherothrombotic disease treated by aspirin. Exclusion Criteria: Known platelet disorder Chronic treatment by antiplatelet drugs other than aspirin Chronic anticoagulant treatment Chronic non steroidal anti-inflammatory drug treatment Active cancer Treatment with serotonin reuptake inhibitors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| proteome profile of platelet hyperreactivity | to characterize the proteome profile of platelet hyperreactivity in aspirin-treated cardiovascular patients | cross sectional | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| platelet hyperreactivity phenotype in cardiovascular patients treated with aspirin |  | cross sectional | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aspirin, Blood platelets, proteomics, Platelet reactivity