linjc16/ctgov huggingface dataset:
TroponinT After Subcutaneous Cardioverter-Defibrillator Implantation

Study Overview
=================
Brief Summary
-----------------
Serum Troponin levels pre- and postoperatively will be compared in patients receiving an entirely subcutaneous cardioverter-defibrillator.

Detailed Description
-----------------
To analyze the periprocedural myocardial damage the pre- and postoperative assessment of serum levels of high sensitive TroponinT (hsTnT) is done. The main objectives of the TROPIC register are to evaluate the level of high sensitive TroponinT before and after S-ICD device implantation and to compare these changes in TroponinT-levels with those after standard transvenous ICD-implantation.

Official Title
-----------------
Register About Change of hsTROPoninT After Implantation of a Subcutaneous Implantable Cardioverter-Defibrillator

Conditions
-----------------
Sudden Cardiac Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for the implantation of an entirely subcutaneous cardioverter-defibrillator Exclusion Criteria: None

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 |
| --- | --- | --- |
| High sensitive TroponinT | Difference between pre- and postoperative high sensitive TroponinT serum levels | 24 hours |
Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.

Detailed Description
-----------------
Mullerian anomalies are rare, therefore they are not well known and not often considered as differential diagnosis. This causes a delay in the diagnosis with risk of long lasting symptoms and adverse effects on the reproductive function. However, the diagnosis can be made more accurately with improved diagnostic tools. Moreover, minimally invasive surgery allows for preservation and potential improvement of fertility in these women. The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.

Official Title
-----------------
Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies: a Prospective Cohort

Conditions
-----------------
Mullerian Anomaly of Uterus, Nec, Mullerian Anomaly of Vagina, Mullerian Anomaly of Cervix

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with a uterus presence of a mullerian variation Maximum age 45y Exclusion Criteria: women without a uterus aged >45y

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with a mullerian variation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertility | Time to clinical pregnancy | 10 years after trying to conceive | 
| Fertility | Early pregnancy loss | 18 weeks after conception | 
| Surgical approach | Different surgical approaches used | During surgery | 
| Surgical success | Relief of symptoms after surgery | 15 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | The ability of a test to detect a Mullerian variation when it is present and detect the absence of a Mullerian variation when it is absent | at the time of diagnostic workup | 
| Obstetric complications | Complications during pregnancy, labor, delivery, and the postpartum period | 1 year after conception | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mullerian anomaly, Diagnostic tools, Surgical treatment, Reproductive function, Obstetric complications
Opioid Receptors Influence Ischemia-Reperfusion Injury

Study Overview
=================
Brief Summary
-----------------
The most powerful protective mechanism against ischemia-reperfusion injury other than rapid reperfusion is ischemic preconditioning. Ischemic preconditioning is defined as the development of tolerance to ischemia-reperfusion injury by a previous short bout of ischemia resulting in a marked reduction in infarct size. This mechanism can be mimicked by several pharmacological substances such as adenosine and morphine. We, the researchers at Radboud University Nijmegen Medical Centre, have recently developed a method in which we can detect ischemia-reperfusion injury in the human forearm by using Annexin A5 scintigraphy (Rongen et al). With this method we will determine whether opioid receptors are involved in ischemic preconditioning. We expect to find that morphine can mimic ischemic preconditioning and that acute ischemic preconditioning can be blocked with the opioid receptor antagonist naloxon. This study will increase our knowledge about the mechanism of ischemic preconditioning and may also provide leads to exploit this endogenous protective mechanism in a clinical setting.

Official Title
-----------------
Opioid Induced Acute Preconditioning

Conditions
-----------------
Ischemia-Reperfusion Injury

Intervention / Treatment
-----------------
* Drug: morphine
* Drug: naloxone
* Drug: Technetium-TC99m-labeled Annexin A5
* Procedure: forearm ischemic exercise
* Procedure: ten minute forearm ischemia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers Exclusion Criteria: Exposition to radiation due to imaging techniques in the previous five years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: morphine|nan|
|Drug: naloxone|nan|
|Drug: Technetium-TC99m-labeled Annexin A5|nan|
|Procedure: forearm ischemic exercise|nan|
|Procedure: ten minute forearm ischemia|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentual difference in Annexin A5 targetting between the experimental and control arm 1 and 4 hours after intravenous injection |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioids, ischemic preconditioning, morphine
Observational of PNH Type Cells in Korean Patients With Bone Marrow Failure Syndrome and Having Hemolytic PNH

Study Overview
=================
Brief Summary
-----------------
Patients who are positive of PNH-type cells are followed up for the percentage of PNH-type cells regularly for examining how it change.

Official Title
-----------------
Observational of GPI-anchored Protein-deficient (PNH-Type) Cells in Korean Patients With Bone Marrow Failure Syndrome and Having Hemolytic Paroxymal Nocturnal Hemoglobinuria (OPENK)

Conditions
-----------------
PNH

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Commbs' test - negative Any patients meeting any of Idiopathic AA/MDS/Patients who had PNH clone size <10% Exclusion Criteria:

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

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 |
| --- | --- | --- |
| Time-course changes in the percentage of PNH-type cells in patients who are positive of PNH-type cells during period |  | 5 years |
Comparison of CLE in Vivo Diagnosis and ex Vivo Examination Against Surgical Histopathology of CPL

Study Overview
=================
Brief Summary
-----------------
Comparison of confocal laser endomicroscopic in vivo diagnosis and ex vivo examination against surgical histopathology of cystic pancreatic lesions.

Detailed Description
-----------------
The primary objective of the study is to assess the ability of nCLE (AQ-Flex) to accurately diagnose the type of CPL by comparing in vivo and ex vivo CLE patterns to final histopathology of surgically resected CPLs. The primary endpoints are whether or not the CLE diagnosis correlates with final diagnosis (yes vs. no).

Official Title
-----------------
Comparison of Confocal Laser Endomicroscopic IN Vivo Diagnosis and EX Vivo Examination (INDEX Study) Against Surgical Histopathology of Cystic Pancreatic Lesions

Conditions
-----------------
Cystic Pancreatic Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For in vivo nCLE (needle-based confocal laser endomicroscopy) (Part 1): Patient age 18 years and older All patients referred for EUS-FNA (endoscopic ultrasound - fine needle aspiration) of accessible CPL (cystic pancreatic lesion) The minimum size of the cyst should be ≥ 1.5 cm as determined by prior cross-sectional imaging studies. For ex vivo pCLE (probe-based confocal laser endomicroscopy) (Part 2): All patients must satisfy inclusive criteria for in vivo nCLE. All patients should have completed EUS-guided nCLE. All patients should have a CPL lesion referred for surgical removal based on recommended international consensus guidelines1 and inter-departmental consensus pancreatic tumor board meeting (departments of surgical oncology, radiology, pathology and gastroenterology). Patient participated and completed in vivo nCLE (Part 1) Exclusion Criteria: Unable to obtain informed consent Unable to tolerate the procedure Women with known pregnancy at time of procedure Patient age less than 18 years Bleeding diathesis Lesion not accessible by EUS guided FNA Allergy to fluorescein.

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 |
| --- | --- | --- |
| Diagnosis of cystic pancreatic lesion (CPL) using nCLE (confocal laser endomicroscopy) | Comparing the ability of nCLE to accurately diagnose the type of CPL by comparing in vivo and ex vivo CLE patterns to final histopathology of surgically resected CPLs. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of high-grade dysplasia and/or adenocarcinoma by CLE imaging |  | 12 months | 
| CLE imaging interpretation variation | Calculate inter-observer variation in CLE image interpretation | 12 months |
Concentrate of Autologous Rich Plasma in Growth Factors in the Treatment of the Thin Endometrium

Study Overview
=================
Brief Summary
-----------------
This study evaluate the percentage of women with thin endometrium who achieve an endometrial thickness equal to or greater than 7 mm after administration of PRGF (plasma rich in growth factors)

Official Title
-----------------
Efficacy and Safety of the Concentrate of Autologous Rich Plasma in Growth Factors in the Treatment of the Thin Endometrium in Patients Undergoing Transfer of Cryo-preserved Embryos: Clinical Trial II.

Conditions
-----------------
Infertility, Infertility, Female

Intervention / Treatment
-----------------
* Drug: Plasma rich in growth factors (PRGF-Endoret)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who signed informed consent. Women who understand the Spanish language. Women under 42 years Exclusion Criteria: Thrombopenia. Congenital or acquired uterine malformations that reduce embryo implantation or term gestation. Ovarian tumors. Benign uterine tumors require surgical treatment Local acute inflammatory diseases Patients with malignant tumors requiring chemotherapy. Patients with acute or chronic infectious or inflammatory diseases requiring active treatment with drugs that may interfere with implantation and gestation. Chronic treatment with NSAIDs (Nonsteroidal anti-inflammatory drugs)

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

Sexes Eligible for Study
-----------------
Female

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: PRGF<br>Plasma rich in growth factors (PRGF) administration | Drug: Plasma rich in growth factors (PRGF-Endoret)<br>* Intrauterine administration of PRGF<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of women who achieve an endometrial thickness equal to or greater than 7 mm | Measurement of the endometrial thickness by ultrasonography. | 3 days after administration of PRGF |
Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study

Study Overview
=================
Brief Summary
-----------------
Children with malnutrition are often low in some nutrients, like zinc or vitamin A, that could help them fight off infections like pneumonia. Our study was designed to see if children who got supplements of zinc or vitamin A had fewer infections.

Detailed Description
-----------------
The Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) study was a multi-year nutritionally-stratified, placebo-controlled, double-blind study of low-dose vitamin A and/or zinc in 2,582 normal and malnourished urban children aged 6 to 36 months in Quito, Ecuador. Four group of   645 children were enrolled in 2000, 2001, 2002, and 2003 with each child participating for up to 50 weeks. Children were visited 4 days each week. Outcome measures were pneumonia, other respiratory tract infections, diarrheal disease, and growth.

Official Title
-----------------
Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study

Conditions
-----------------
Pneumonia, Diarrhea, Acute Upper Respiratory Tract Infections

Intervention / Treatment
-----------------
* Drug: Zinc (12.5 mg/day)
* Drug: vitamin A 10,000 IU per week


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6 to 36 months at the time of enrollment No recent vitamin or micronutrient use Residence of 1 year or longer in the neighborhood Full and free written consent No clinical evidence of zinc or vitamin A deficiency Absence of severe malnutrition such as weight < or = to 60% of expected weight - Exclusion Criteria: Age less than 6 months or greater than 36 months at enrollment Recent vitamin or micronutrient use Residence for less than 1 year in neighborhood Lack of full and free consent Any evidence of zinc or vitamin A deficiency Severe malnutrition

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 36 Months

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: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zinc (12.5 mg/day)|nan|
|Drug: vitamin A 10,000 IU per week|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute lower respiratory infection (pneumonia) |  |  | 
| Growth |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additive or synergistic effects of zinc and vitamin A |  |  | 
| Incidence of diarrheal disease |  |  | 
| Incidence of other respiratory infections |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute respiratory infection, acute lower respiratory infection, diarrhea
Phase 3 Study to Evaluate IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertension C-01-69

Study Overview
=================
Brief Summary
-----------------
To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone.

Official Title
-----------------
Phase III Safety and Efficacy Study to Evaluate Combination IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertensive Patients C-01-69.

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

Intervention / Treatment
-----------------
* Drug: Alcon Investigational Agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; visual acuity of 20/80 to 20/400 or better (Snellen equivalent) or logMAR visual acuity not worse than 0.6. Clinically relevant ophthalmic or systemic conditions may be excluded.

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

| Intervention/Treatment |
| --- |
|Drug: Alcon Investigational Agent|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
open-angle, glaucoma, ocular, hypertension, POAG
CT Window Setting to Select Double-lumen Tube Size

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the appropriate window setting of chest computed tomography to select a correct size of double-lumen endobronchial tube.

Conditions
-----------------
Bronchial Cuff Volume at Air-tight Seal, Intracuff Cuff Pressure at Air-tighe Seal

Intervention / Treatment
-----------------
* Device: Width 1000 HU/Level -450 HU
* Device: Width 400 HU/Level 25 HU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes Exclusion Criteria: Abnoraml anatomy of tracheobronchail tree Intraluminal lesion in the left mainstem bronchus Anticipated difficult intubation

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Width 1000 HU/Level -450 HU<br> | Device: Width 1000 HU/Level -450 HU<br>* Double-lumen tube size is selected according to the internal diameter of the left mainstem bronchus measured in the chest computed tomography with width 1000 HU and level -450 HU.<br>|
| Active Comparator: Width 400 HU/Level 25 HU<br> | Device: Width 400 HU/Level 25 HU<br>* Double-lumen tube size is selected according to the internal diameter of the left mainstem bronchus measured in the chest computed tomography with width 400 HU and level 25 HU.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Air-leak at deflation of bronchial cuff |  | An expected average of 10 min after double lumen tube intubation | 
| Air-tight seal below resting volume of bronchial cuff |  | An expected average of 10 min after double lumen tube intubation |
Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position

Study Overview
=================
Brief Summary
-----------------
This study analyse the rise in Intraocular Pressure while patient is in surgery in head low position.

Detailed Description
-----------------
Patient undergoing robotic surgeries requires steep trendelenburg position (upto 60 degrees) along with pneumoperitoneum. These both can cause a significant rise in intraocular pressure. Significant rise of pressure for prolonged period can cause post operative visual disturbances, which can be of medicolegal importance. Thus studying the quantitative rise and thus trend of intraocular pressure is first step in managing ophthalmic changes during robotic surgeries.

Official Title
-----------------
Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position

Conditions
-----------------
Intraocular Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anaesthesiologists (ASA) status 1-3 without any ophthalmic complains or interventions Exclusion Criteria: lasix given during preoperative or intraoperative period cardiac patients who are on medications for stents or post Coronary Artery Bypass Graft (CABG) pre-existing glaucoma, eye surgeries, cataract or retinal vascular diseases, corneal diseases which may affect IOP measurement were excluded

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 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 |
| --- | --- |
| robotic surgery<br>all those patients aged 40 - 60 years undergoing robotic surgeries, who does not have any ophthalmic complains. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure | change in pressure with the position during surgery | 7-8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intraocular Pressure, Trendelenburg position