linjc16/ctgov huggingface dataset:
EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to identify the patients suffering from a mitral valve condition who benefit from the implantation of a Profile 3D annuloplasty ring in terms of acute and long-term relief of mitral valve regurgitation.

Official Title
-----------------
EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty

Conditions
-----------------
Mitral Valve Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indicated for a surgical repair for moderate to severe mitral valve regurgitation at rest (level 2 or higher); Willing to return to the hospital where the implantation originally occurred as part of the standard practice of care Exclusion Criteria: Heavily calcified valves Valvular retraction with severely reduced mobility Active bacterial endocarditis Already participating in another investigational device study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints; Life expectancy of less than one year; Pregnant or desire to be pregnant within 12 months of the study treatment; Under 18 years or over 85 years of age.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Identify the patient population for which a Profile 3D Annuloplasty Ring is chosen to repair the mitral valve insufficiency. |  | screening | 
| Assess the percentage of patients that are chronically relieved from mitral valve dysfunction |  | 6-12 months follow up | 
| Determine the level of mitral valve regurgitation in patients |  | 6-12 months post-surgery |
A Study to Compare Two Paracetamol Tablets

Study Overview
=================
Brief Summary
-----------------
This is a single dose pharmacoscintigraphic study investigating the differences in paracetamol absorption between two formulations.

Official Title
-----------------
A Single Dose Pharmacoscintigraphic Study Investigating the Differences in Gastrointestinal Behavior and Paracetamol Absorption Between Sustained Release Formula and Standard Release Formula

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Marketed paracetamol
* Drug: Experimental paracetamol formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects who are in good general health Have not exceeded the limits of total radiation exposure (5mSv) allowed in any 12 month period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Marketed paracetamol<br>Marketed formulation | Drug: Marketed paracetamol<br>* marketed formulation<br>|
| Experimental: Experimental paracetamol formulation<br>Experimental formulation | Drug: Experimental paracetamol formulation<br>* Experimental formulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition |  | Baseline to 12 hours post dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the gastrointestinal transit by qualitative scintigraphic analysis |  | Baseline to 12 hours post dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
paracetamol, healthy volunteer, pharmacoscintography
Obstructive Sleep Apnea Syndrome in Glaucoma

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine if plasma matrix-metalloproteinase activity can predict glaucoma in patients with OSAS and if the level of plasma matrix-metalloproteinase activity will decrease after one month of nCPAP-treatment.

Detailed Description
-----------------
Glaucoma is a leading cause of blindness world-wide. Chronic primary open-angle glaucoma is the most common form among Caucasian patients. The key feature of glaucoma is damage to the optic nerve head, which is not necessarily related to an increased intraocular pressure. The prevalence of glaucoma among the patients with sleep apnoea was 7,2%: normal-tension glaucoma 2,9%, primary open-angle glaucoma 4,3%. The prevalence of obstructive sleep apnoea syndrome (OSAS) is around 4-10% for men and 2-4% for women. Matrix metalloproteinases (MMPs) substrates include essentially all extracellular matrix components as well as a wide array of molecules involved in intracellular adhesion, cell-matrix interaction, and cell signalling. However, MMPs effects are not restricted to extracellular matrix degradation. The prevalence of increased MMP in patients with OSAS and its predicting value for an additional glaucoma are not known. Further, we do not know if treatment of OSAS with nasal continuous positive air pressure(nCPAP) can decrease the MMP activity. With this study, we want to determine the prevalence of MMP activity and the prevalence of glaucoma in patients with OSAS. Further, we want to investigate if a nCPAP treatment period of four weeks decreases the MMP activity.

Official Title
-----------------
Does Plasma Matrix-metalloproteinase Activity Predict Glaucomas in Patients With OSAS (Obstructive Sleep Apnea Syndrome) and Does the Level of Plasma Matrix-metalloproteinase Activity Decrease After One Month of nCPAP-treatment

Conditions
-----------------
Obstructive Sleep Apnea Syndrome, Glaucoma

Intervention / Treatment
-----------------
* Device: nCPAP treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OSAS planned begin of a nCPAP treatment Exclusion Criteria: Current malignancy Oral steroids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: nCPAP treatment|treatment with positive air pressure during night|

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
-----------------
OSAS, glaucoma, MMP
Strength-enhancing Effect of Whey Protein Supplementation Following Resistance Exercise in Adolescent Males

Study Overview
=================
Brief Summary
-----------------
This study investigates the strength gains associated with resistance training in a group of 18 male high school athletes consuming either a whey protein supplement or chocolate milk following their exercise.

Official Title
-----------------
Strength-enhancing Effect of Whey Protein Supplementation Following Resistance Exercise in Adolescent Males

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: member of Bellarmine Preparatory School boys sports team Must be willing to consume a post-exercise beverage Exclusion Criteria: allergy to either beverage

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 19 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| whey beverage<br>consumption of 52 grams of whey protein supplement following resistance exercise | |
| chocolate milk beverage<br>consumption of chocolate flavored milk following resistance exercise | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bench press strength | Calculated 1-repetition maximum bench press strength | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| squat strength | calculated 1-repetition squat strength | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent, supplements, strength, whey protein, bench press strength, squat strength
Pregnancy Subsequent to Ventral Hernia Repair

Study Overview
=================
Brief Summary
-----------------
We will examine the outcome of ventral hernia repair with subsequent pregnancy

Official Title
-----------------
Pregnancy Subsequent to Ventral Hernia Repair: a Nationwide Cohort Study

Conditions
-----------------
Hernia, Ventral, Pregnancy

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of ventral hernia repair with subsequent pregnancy Born between January 1 1955 and January 1 1995 Exclusion Criteria: Registered in the Danish Hernia Database with a non-valid ID-number, i.e. non-Danish resident.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Cohort<br>Patients with a history of ventral hernia repair (umbilical/epigastric and incisional) with subsequent pregnancy Ventral hernia repair - perioperative factors of interest: - mesh vs sutured repair, age, planned vs emergency repair, open vs laparoscopic approach, Pregnancy and delivery - factors of interest: - vaginal vs caesearan section, single vs multiple pregnancy Subgroup of patients with mesh repair: - subanalysis on main attributes Subgroup of patients with sutured repair: - mono- vs multifilament, slowly vs rapidly absorbable | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of ventral hernia |  | 7 years |
Quality of Life After Permanent Interstitial Iodine Seed Prostate Brachytherapy

Study Overview
=================
Brief Summary
-----------------
Retrospective study to analyze Quality of life in men after iodine seed brachytherapy for localized prostate cancer

Detailed Description
-----------------
Retrospective Evaluation of Quality of life data collected on men who underwent iodine seed brachytherapy at the University Hospital Zurich

Official Title
-----------------
Retrospective Analysis of Quality of Life After Permanent Interstitial Iodine Seed Brachytherapy for Prostate Cancer

Conditions
-----------------
Neoplasms, Prostate

Intervention / Treatment
-----------------
* Other: No intervention in this retrospective study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male > 18 years of age iodine seed brachytherapy for localized prostate cancer at the University Hospital Zurich Exclusion Criteria: No iodine seed brachytherapy for localized prostate cancer at the University Hospital Zurich

Ages Eligible for Study
-----------------
Minimum Age: 48 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention in this retrospective study|No Intervention in this retrospective Analysis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTCAE v4.03ff Grade 1-4 Sexual/Reproductive Function | Scale | 5 years (2009-2014) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTCAE v4.03ff Grade 1-4 Gastrointestinal | Scale | 5 years (2009-2014) | 
| CTCAE v4.03ff Grade 1-4 Renal/Genitourinary | Scale | 5 years (2009-2014) | 
| International Prostate Symptom Score (IPSS) | Scale | 5 years (2009-2014) | 
| International Index of erectile function, five items (IIEF-5) | Scale | 5 years (2009-2014) |
Long-Term Safety Study of CTX0E03 in Subjects Who Completed PISCES III Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this long-term safety study is to follow up subjects treated with CTX0E03 DP to monitor for delayed oncological, neurological, and CTX0E03 DP-related adverse events and to monitor survival

Detailed Description
-----------------
The goal of this study is to assess the long-term safety of subjects treated with intracerebral CTX0E03 DP as measured by the onset of delayed adverse events of special interest (AESIs). AESIs are defined as adverse events leading to death, new oncological adverse events, new neurological adverse events and any other adverse event, which in the opinion of the Safety/Project Physician is related to CTX0E03 DP.

Official Title
-----------------
Long-Term Safety Study of CTX0E03 in Subjects Who Completed PISCES III Study

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Other: Non Interventional long term safety follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have received CTX0E03 DP as part of the active arm in the PISCES III study Have provided appropriate written informed consent Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non Interventional long term safety follow up|Non Interventional long term safety follow up|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety study is to follow up subjects treated with CTX0E03 DP | Identify delayed oncological, neurological, and CTX0E03 DP-related adverse events and to monitor survival. | 4 Years |
The Effects of Z-338 in Subjects With and Without Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
To assess in subjects with and without functional dyspepsia the effects of Z-338 on: Type and severity of symptoms a standardized nutrient challenge The gastric nutrient distribution and gastric emptying of a standardized nutrient challenge The association of the above with the manifestations of symptoms and symptom pattern

Official Title
-----------------
The Effects of Z-338 on the Symptomatic Response to a Nutrient Challenge and Gastric Nutrient Distribution and Emptying in Subjects With and Without Functional Dyspepsia

Conditions
-----------------
Dyspepsia

Intervention / Treatment
-----------------
* Drug: Z-338


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with functional dyspepsia Positive documented diagnosis of FD via RomeII criteria and three or more moderate symptoms of Gastrointestinal Score Subjects with no history of functional dyspepsia Clinical assessment, physical examination and laboratory testing without evidence for relevant abnormality. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Z-338|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Determination of Pneumothorax Post Lung Biopsy

Study Overview
=================
Brief Summary
-----------------
Bedside ultrasonography for detection of pneumothorax after transbronchial lung biopsies in lung transplant patients

Detailed Description
-----------------
The patients who undergo transbronchial forceps lung biopsies get a routine CXR after the biopsies are performed. The reason for CXR is to find out if pneumothorax occurred or not. CXR is required patient transportation and interpretation by the radiologist as well as time consuming. Instead, we are planning to perform bedside ultrasound to determine if pneumothorax occurred or not

Official Title
-----------------
Role of Ultrasonography in the Diagnosis of Pneumothorax Following Transbronchial Biopsy in LungTransplant Patients.

Conditions
-----------------
Pneumothorax

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any lung transplant patient who undergoes to bronchoscopic lung biopsy Exclusion Criteria: Patients develop respiratory failure during the procedure

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Determination of pneumothorax after transbronchial lung biopsy |  | 2 hours |
Comparison of Time Taken for Intubation and Cormack Lehane View Between C-Mac With Glidescope Video Laryngoscopy in Paediatric Patients

Study Overview
=================
Brief Summary
-----------------
This study compares the time taken to intubate between Cmac video laryngoscopy with Glidescope video laryngoscopy in paediatric patients aged 3-12 years old.

Detailed Description
-----------------
This study aims to determine whether are both devices comparable to each other in terms of intubation time and Cormack Lehane view in paediatric patients with normal airway undergoing elective surgery.

Official Title
-----------------
Comparative Study of Time Taken for Intubation and Cormack Lehane View Between C-Mac Video Laryngoscopy With Glidescope Video Laryngoscopy in Paediatric Patients Undergoing Elective Surgery

Conditions
-----------------
Paediatric Airway

Intervention / Treatment
-----------------
* Device: Glidescope video laryngoscopy/ C-MAC video laryngoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Paediatric patients 3-12 years old undergoing elective surgery American Society of Anesthesiology (ASA) 1-2 No difficult airway features/history of difficult intubation Not obese Exclusion Criteria: Any difficult intubation features/history of difficult intubation Obese child

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: GlideScope intubation Vs Cmac intubation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: C-Mac intubation<br>Intubation with C-MAC video laryngoscopy | Device: Glidescope video laryngoscopy/ C-MAC video laryngoscopy<br>* usage of said devices according to manual<br>|
| Active Comparator: Glidescope intubation<br>Intubation with Glidescope video laryngoscopy | Device: Glidescope video laryngoscopy/ C-MAC video laryngoscopy<br>* usage of said devices according to manual<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | Time taken from insertion of specified laryngoscope blade to lip until presence of capnography tracing | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cormack Lehane view | grade from 1-4 by operator's assesment | 5 minutes |