linjc16/ctgov huggingface dataset:
Preventing Myocardial Ischemia by Preconditioning in Elective Operation for Abdominal Aortic Aneurysm

Study Overview
=================
Brief Summary
-----------------
Primary To investigate whether peripheral predonditioning induced by brief, intermittent constriction of blood supply to an arm can reduce the incidence of perioperative myocardial ischemia in patients operated electively for infrarenal aortic aneurysm. Secondary To investigate the impact of peripheral preconditioning on perioperative inflammatory response. To investigate whether peripheral preconditoning can protect against perioperative myocardial infarction and reduced cardiac pump function.

Official Title
-----------------
The Effect of Preconditioning to Prevent Perioperative Myocardial Ischemia in Elective Operation of Abdominal Aortic Aneurysm

Conditions
-----------------
Aortic Aneurysm

Intervention / Treatment
-----------------
* Procedure: preconditioning
* Procedure: Normal surgery, with sham intervention without inflating arm cuff


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients older than 18 years, hospitalized for elective surgery of abdominal aortic aneurysm Exclusion Criteria: Lack of informed consent. Hemiparetic patient. Pregnancy or nursing patient.

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

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

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

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: Preconditioning and normal treatment<br> | Procedure: preconditioning<br>* peripheral preconditioning induced by brief, intermittent constriction of blood supply to an arm<br>|
| Placebo Comparator: normal treatment<br>Standard treatment | Procedure: Normal surgery, with sham intervention without inflating arm cuff<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurements of CKMB and Troponin T |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preconditioning, aortic aneurysm
Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fasted conditions.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 5 mg Chewable Tablets Under Fasted Conditions

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

Intervention / Treatment
-----------------
* Drug: Montelukast
* Drug: Singulair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to montelukast or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Montelukast<br>5 mg Chewable Tablet | Drug: Montelukast<br>* Chewable Tablet<br>* Other names: Singulair;|
| Active Comparator: Singulair<br>5 mg Chewable Tablet | Drug: Singulair<br>* 5 mg Chewable Tablet<br>* Other names: Montelukast;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 9 days |
Incisional Hernia in Infants and Children

Study Overview
=================
Brief Summary
-----------------
the study of development of incisional hernia in infants and children at a tertiary level experience.

Detailed Description
-----------------
Background: incisional hernia in children and infants (IHCI) represents a major complication following exploration. The condition is associated with prolonged hospital stay, readmission and the need for another operation to treat the resulting incisional hernia. The incidence is variable worldwide. The leading causes are still indeterminate as well as the management strategy. We aimed at studying IHCI at a tertiary level hospital as regard presenting symptoms, methods of management and its impact on the quality of life of patients. Methods: a retrospective study included all infants and children presented with incisional hernia. Patients were categorized in to two groups according to the age of presentation, group A patients younger than two years of age and group B patients older than two years. All data related to the first operation in addition to data related to repair of the incisional hernia were collected in special charts.

Official Title
-----------------
Incisional Hernia in Children and and Infants : a Tertiary Center Experience

Conditions
-----------------
Incisional Hernia

Intervention / Treatment
-----------------
* Other: surgical management of incisional hernia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all infants and children with incisional hernia Exclusion Criteria: congenital abdominal wall defects

Ages Eligible for Study
-----------------
Minimum Age: 8 Months
Maximum 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br>patients younger than 2 years | Other: surgical management of incisional hernia<br>* surgical repair of the incisional hernia<br>|
| Active Comparator: group B<br>patients older than 2 years | Other: surgical management of incisional hernia<br>* surgical repair of the incisional hernia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| repair of incisional hernia | surgical repair | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
incisional hernia, infants, children, tissue repair, wound healing
Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to measure the variations of serum and urinary hepcidin levels following a single intravenous injection of erythropoietin in healthy volunteers. Hepcidin is a major regulator of iron homeostasis. It acts by binding on ferroportin, and limits cellular efflux of iron through enterocytes and macrophages. Anemia and hypoxia are known to modulate hepcidin synthesis. In these situations, erythropoietin synthesis is increased, so it can be postulated that erythropoietin could modulate hepcidin synthesis.

Official Title
-----------------
Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers

Conditions
-----------------
Iron Metabolism Disorders

Intervention / Treatment
-----------------
* Drug: Erythropoietin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers male aged 18 - 30 normal routine laboratory values normal ECG normal iron status Exclusion Criteria: C282Y mutation of the HFE gene alcohol or tobacco consumption

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>erythropoietin | Drug: Erythropoietin<br>* Intravenous injection of 50 U/kg of erythropoietin<br>* Other names: Neorecormon®;|
| Placebo Comparator: 2<br>Saline serum | Drug: Placebo<br>* Intravenous injection of equivalent volume of saline serum<br>* Other names: NaCl 0,9%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum hepcidin levels |  | over 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary hepcidin levels |  | over 24 hours | 
| serum iron and ferritin levels |  | over 24 hours |
Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose

Study Overview
=================
Brief Summary
-----------------
Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose

Detailed Description
-----------------
A Phase I, Double blind, Placebo-controlled, safety and tolerability study of ZP1848 administered as Ascending single Dose, SUBCUTANEOUS bolus injections in healthy SUBJECTS followed by a Multiple Dose cohort of patients with stable Crohn's disease in remission

Official Title
-----------------
A Phase I, Double Blind, Placebo-Controlled Study of ZP1848 Administered as Subcutaneous Bolus Injections in Healthy Subjects Followed by Multiple Doses in Patients With Crohn's Disease in Remission

Conditions
-----------------
Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Drug: ZP1848


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult male and/or females, 18 to 50 years of age Body mass index (BMI)18-30. Chrons Inclusion Adult male and/or females, 18 to 60 years of age (inclusive). Body mass index (BMI) ≥ 18 and ≤ 30 (kg/m2). Crohn's Disease Activity Index (CDAI) score < 150. In a stable state of Crohn's disease as per the Investigator's opinion. Free of steroid treatment (therapy targeted for the GI tract only) within the 3 months prior to Day 1. Exclusion Criteria: History or presence of dysplasia, cancer, chronic hepatitis, HIV, tuberculosis (TB), or histoplasmosis. Fistula within the 3 months prior to dosing. 3. Ostomy (having ostomy now or at any time in the past). 4. Any surgery for the treatment of inflammatory bowel disease (IBD) within the 3 months prior to Day 1. 5. Short Bowel Syndrome (SBS). 6. Any other condition, chronic disease, or prior therapy, which in the opinion of the Investigator/Investigator's designee would put the patient at undue risk or would make the patient unsuitable for the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZP1848<br>Healthy Subjects or Crohn's Disease patients | Drug: ZP1848<br>* sc. bolus<br>|
| Placebo Comparator: Placebo<br>Healthy subjects or Crohn's Disease patients | Drug: ZP1848<br>* sc. bolus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability |  | January2009-January2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | Jan 2009 - Jan 2010 |
External Micropulse Diode Laser Transscleral Trabeculoplasty (EMDLT) for Severe Open Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
To prove that external contact micropulse diode laser trabeculoplasty (EMDLT) can significantly lower intraocular pressure in cases of advanced open angle glaucoma.

Detailed Description
-----------------
Micropulse diode laser trabeculoplasty applied through a gonioscopy len has been shown to be effective in lower the pressure for patients with primary open angle glaucoma (POAG). We believe that applied externally, the contact diode micropulse laser will be effective in lowering intraocular pressure for patients with advance open angle glaucoma with minimal side effects

Official Title
-----------------
External Micropulse Diode Laser Transscleral Trabeculoplasty(EMDLT) For Severe Open Angle Glaucoma

Conditions
-----------------
Primary Open Angle Glaucoma

Intervention / Treatment
-----------------
* Device: EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Diagnosis of Primary Open Angle Glaucoma Advanced glaucoma with intraocular pressure higher than 21mmHg on one or more topical medications (for at least 2 months) Visual acuity worse than 6/6 Age more than 21 years Poor candidate for additional filtration surgery Exclusion Criteria: • Age less than 21 years Any eye surgery within 2 months of enrolment Any patient with rubeosis Unable to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- |
|Device: EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of pressure lowering after EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY (EMDLT) treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of safety of EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY (EMDLT) treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Open Angle Glaucoma
Pediatric Spinal Muscular Atrophy (SMA) China Registry

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to describe the natural history and utilization of disease modifying therapy (DMT) treatments among pediatric Chinese participants with spinal muscular atrophy linked to chromosome 5q (5q-SMA).

Official Title
-----------------
Pediatric Patients With Spinal Muscular Atrophy in China: A Nationwide Registry

Conditions
-----------------
Muscular Atrophy, Spinal

Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Ability of the participant and/or his/her legally authorized representative (e.g., parent or legal guardian), as appropriate and applicable, to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations. Genetically confirmed 5q-SMA. Age < 18 years at enrollment. Key Exclusion Criteria: Unable or unwilling to provide informed consent. Other types of SMA (non 5q-SMA). NOTE: Other protocol defined inclusion/ exclusion criteria may apply.

Ages Eligible for Study
-----------------
Maximum Age: 18 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 |
| --- | --- |
| DMT Treated Participants<br>Participants with SMA who received prior treatment with DMTs including nusinersen will be followed prospectively for up to 60 months and the available data is collected retrospectively. | |
| Untreated Participants<br>Participants with SMA who received no treatment will be followed prospectively for up to 60 months. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural History and Utilization of Disease Modifying Therapy (DMT) Treatments Among Pediatric Chinese Participants With Spinal Muscular Atrophy Linked to Chromosome 5q (5q-SMA) |  | Up to 60 months |
Lactacyd Radiance (Lactic Acid) Prophetic Patch Test

Study Overview
=================
Brief Summary
-----------------
Primay objective: To evaluate the potential of the products in eliciting adverse skin reaction.

Official Title
-----------------
Skin Irritation : Prophetic Patch Test of Lactacyd Radiance

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Lactic Acid
* Other: Distilled water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Test area should have a healthy or normal skin Individuals free of any systemic or dermatological disorder which, in the opinion of the investigative personnel would interfere with the study results or increase the risk of adverse reaction Not currently use of steroid or any medication during the test Exclusion Criteria: History of Allergy or Allergic Reaction to: Hey Fever Asthma Poison Ivy Food Cosmetics Soap Detergent Metal Jewelry Lather Fabric Medication The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Lactic Acid<br>* Application of occlusive patches containing test product. For 24 hours and repeat 2 weeks later for participants with no reaction to Lactacyd Radiance<br>* Other names: Lactacyd Radiance;|
| Placebo Comparator: 2<br> | Other: Distilled water<br>* Application of patches containing distilled water for 24 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction after patch removal. |  | at 15-30 minutes and day 3 |
Comparison of Palonosetron Versus Combination of Palonosetron and Dexamethasone for Preventing Postoperative Vomiting in Patients Receiving Fentanyl by Patient-controlled Analgesia After Minor Orthopedic Surgery

Study Overview
=================
Brief Summary
-----------------
Postoperative nausea and vomiting (PONV) is related with extended hospital day and risk factor of aspiration pneumonia. Postoperative patient controlled intravenous analgesia is related with postoperative nausea and vomiting. Selective 5-HT3 antagonist, Palonosetron, is the most recent medication for prevention of PONV. Purpose of our study is comparison of PONV preventive effect of palonosetron and combination of palonosetron and dexamethasone.

Conditions
-----------------
Orthopedic Surgery

Intervention / Treatment
-----------------
* Drug: palonosetron
* Drug: palonosetron with dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who are undergoing minor orthopedic surgery. IV patient controlled analgesia Exclusion Criteria: 1. minority (0 19 year) patients who are belongs to ASA class 3 or more, and have underlying complicated cardiovascular or psychological disease. Steroid medication Diabetes Mellitus medication

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: P group<br>Palonosetron group | Drug: palonosetron<br> <br> |
| Experimental: PD group<br>Palonosetron and dexamethasone group | Drug: palonosetron with dexamethasone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of clinically significant PONV with PONV impact scale |  | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
palonosetron, dexamethasone, PONV (postoperative nausea and vomiting)