linjc16/ctgov huggingface dataset:
Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body that may protect against the subjects catching a pandemic strain of flu

Detailed Description
-----------------
Pandemic influenza occurs when a strain of influenza to which the human population has not been exposed develops the ability to infect man and spread from person to person. Some pandemics can have very severe health impacts and be widespread. This study will evaluate PowderMed's Particle Mediated Epidermal Delivery (PMED) DNA vaccine for pandemic influenza as a potential alternative to other vaccine technologies. This study represents the first study with this vaccine and will provisionally assess its safety and immunogenicity (ability to generate an immune response) at four different dose combinations. The vaccine will be given as a prime-boost regimen with vaccination on Days 0 and 28

Official Title
-----------------
A Randomised Double Blind Dose-Ranging Study to Assess the Safety, Tolerability and Immunogenicity of a Monovalent H5 DNA Influenza Vaccine (A Vietnam/1194/2004) Administered by Particle Mediated Epidermal Delivery (PMED) to Healthy Adults

Conditions
-----------------
Influenza (Pandemic)

Intervention / Treatment
-----------------
* Biological: pPML7789 with and without pPJV2012 administered by PMED


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults volunteers (women must be of nonchild-bearing potential) Provided written informed consent - Exclusion Criteria: No significant concomitant illness No allergy to gold No immunosuppression due to disease or treatment

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: pPML7789 with and without pPJV2012 administered by PMED|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability and local reactogenicity-AEs and laboratory parameters. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of the vaccine |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNA vaccine, influenza, immunogenicity, tolerability, PMED, pandemic
Symptoms and Quality of Life of Patients With Suspected Endometriosis

Study Overview
=================
Brief Summary
-----------------
All patients undergoing surgery due to suspected endometriosis in a previously selected 3-month period within the study period (between 12/2022 and 12/24) (each participating center will define the particular 3 months in question) will be asked to participate in this study. Upon inclusion, patients will be asked to fill out questionnaires regarding endometriosis-associated symptoms as well as a detailed patient history. Furthermore, patients will be asked to fill out 2 standardized questionnaires, one regarding quality of life (Endometriosis-Health Profile-30) and one regarding sexual function (Female Sexual Function Index). Six and 12 months after surgery, patients will again be asked to fill out these two standardized questionnaires as well as a questionnaire regarding postsurgical therapy and endometriosis-associated symptoms. The surgeon will be asked to fill out a form regarding the surgical procedure and possible surgical complications. The primary endpoints of this multicenter observational study are to prospectively examine: if the individual symptoms correlate with the individual compartments of the surgical #ENZIAN Endometriosis classification if the surgical intervention has an effect on the quality of life in relation to the individual #ENZIAN compartments.

Official Title
-----------------
Symptoms and Quality of Life of Patients With Suspected Endometriosis - a Prospective Multi-center Observational Study

Conditions
-----------------
Endometriosis, Surgery, Pain, Dysmenorrhea, Dyspareunia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned surgery for suspected endometriosis Age between 18 and 50 signed informed consent Exclusion Criteria: menopause current malignant disease

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom correlation with #ENZIAN | Do the individual symptoms correlate with the individual compartments of the surgical #ENZIAN Endometriosis classification | 12/2022-12/2024 | 
| Endometriosis surgery and #ENZIAN - Correlation with quality of life? | Does the surgical intervention have an effect on the quality of life in relation to the individual #ENZIAN compartments. | 12/2022-12/2024 |
The Relationship Between Dietary Habit and Gastroesophageal Flap Valve Abnormality

Study Overview
=================
Brief Summary
-----------------
Gastroesophageal reflux disease (GERD) is commonly seen in Western countries; however, it is gaining prevalence in Asia countries recently. In addition to the lower esophageal sphincter and the crural fibers of the diaphragm, the flap valve at the gastroesophageal junction is also responsible for maintaining an antireflux barrier. Hill et al developed a grading system of gastroesophageal flap valve (GEFV) and concluded that this flap valve system is simple, reproducible, and offers diagnostic aid in the evaluation of patients with suspicious reflux disease undergoing esophagogastroduodenoscopy (EGD). It is a common belief that large meals provoke considerable postprandial reflux and it results from an increase in the rate of transient lower esophageal sphincter relaxations. One study also revealed that rapid food intake produces more gastroesophageal reflux in healthy volunteers. So this study attempted to evaluate the relationship between dietary habit and GEFV abnormality. The investigators used a questionnaire regarding the dietary habit to the population undergoing EGD in a self-paid health examination.

Official Title
-----------------
The Relationship Between Dietary Habit and Gastroesophageal Flap Valve Abnormality

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The healthy subjects undergo EGD in a self-paid health examination in WanFang Hospital. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| population undergoing EGD in health examination.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grading of Gastroesophageal Flap Valve by Esophagoduodenoscopy |  | 1 year | 
| Dietary habit questionnaire |  | 1 year |
An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation

Study Overview
=================
Brief Summary
-----------------
Tegaserod is an aminoguanidine indole compound and a member of a new class of 5-hydroxytryptamine (5-HT) agonists. Activation of 5-HT4 receptors triggers the release of neurotransmitters from the enteric nerves which in turn stimulate contractility and peristalsis. This study will investigate the efficacy and safety of tegaserod against chronic constipation in a Chinese population of adult men and women

Official Title
-----------------
An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Drug: Tegaserod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women at least 18 years of age History of constipation for at least 6 months prior to screening Normal bowel evaluation performed within the past 5 years Exclusion Criteria: Most bothersome symptom in last 6 months is abdominal pain/discomfort Whose chronic constipation is thought to be a result of bowel surgery, gynecological surgery, neurologic disorder, systemic sclerosis, amyloidosis, scleroderma, myotonic dystrophy Insulin dependent diabetes Evidence of cathartic colon or laxative abuse Other inclusion/exclusion criteria may apply.

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: Tegaserod|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in number of complete spontaneous bowel movements (CSBM) per week |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate for CSBM during the first 4 weeks of treatment |  |  | 
| Patients' daily assessment of bowel habits |  |  | 
| Patients' weekly assessment of constipation symptoms |  |  | 
| Satisfactory relief of CC symptoms |  |  | 
| PAC-QoL questionnaire |  |  | 
| PPSM questionnaire |  |  | 
| Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
China, Chronic constipation, 5-HT,5-HT4,, functional GI, tegaserod
Examination of ADMA Serum Level and DDAH II

Study Overview
=================
Brief Summary
-----------------
Examination of ADMA (Asymmetric-Dimethylarginine)-serum level and DDAH II (Dimethylarginine Dimethylaminohydrolase)- Polymorphism in patients with severe Sepsis and septic shock as prognostic value. This study looks into ADMA as a good prognostic factor for sepsis. Further more the dependency of the ADMA level to the DDAH II polymorphisms is reviewed this study.

Detailed Description
-----------------
Secondary targets are the mortality (28 days ICU), the length of hospitalisation in ICU and peripheral station, the severity of the illness (SAPS II score), the SOFA-score values in the progress and the procalcitonin values in the progress

Official Title
-----------------
Examination of ADMA (Asymmetric-dimethylarginine)-Serum Level and DDAH II (Dimethylarginine Dimethylaminohydrolase)- Polymorphism in Patients With Severe Sepsis and Septic Shock as Prognostic Value

Conditions
-----------------
Septic Shock, Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 y/o sepsis septical shock Exclusion Criteria: primary cardiogenic shock pregnancy breastfeeding non compliance moribund status

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| septical patients<br>inclusion criteria are severe sepsis and septical shock and must be > 18 y/o | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADMA serum levels | measuring of ADMA serum levels on day 1, 3, 7 | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 day mortality |  | 28 day | 
| hospitalisation (ICU and peripheral) |  | 28 days | 
| severity of illness |  | 28 days | 
| DDAH Ii polymorphism |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADMA, DDAH II, SAPS, SOFA, Sepsis, Procalcitonin, mortality, length of stay, ICU
Enbrel Liquid Immunogenicity Protocol

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects with Rheumatoid Arthritis

Detailed Description
-----------------
The purpose of this study is to assess the rate of anti-etanercept antibody formation in a larger sample of subjects on liquid etanercept than the previous study, 20020378, in a minimum of 400 subjects receiving etanercept liquid for the first time, with and without concomitant MTX therapy. The rate of neutralizing antibodies to liquid etanercept will also be assessed.

Official Title
-----------------
Open-label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA)

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: 50 mg Etanercept
* Drug: Enbrel liquid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Must be able to self-inject or have someone who can do so for them Should have Rheumatoid Arthritis per ARA criteria and screening lab results per predefined value Exclusion Criteria: Any prior biologic therapy for inflammatory disease Any prior cyclophosphamide therapy Not using adequate contraception Pregnant or breast-feeding or any significant concurrent medical condition

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: Etanercept liquid<br> | Drug: 50 mg Etanercept<br>* 50 mg Etanercept liquid injected SC once weekly using prefilled syringes<br>Drug: Enbrel liquid<br>* 50 mg Etanercept liquid injected SC once weekly using prefilled syringes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24 |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of anti-etanercept antibody formation to etanercept liquid at week 12, and the rates of neutralizing antibodies at Weeks 12 and 24. Safety of etanercept liquid in RA subjects receiving 50 mg once weekly up to 24 weeks. |  | 12 weeks and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis, Enbrel liquid, antibodies
The Predictive Value of CT-PET in Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
A major focus of research in oncology is to identify patients who, following induction therapy, have a complete pathologic response, presenting opportunities for novel trials, including extended therapy or non-operative approaches, in addition to identifying cohorts who are resistant to the neoadjuvant therapy. The current gold standard for determining response to CRT is pathological evaluation following surgical resection, in particular the Mandard Tumour Regression Grade (TRG) or some modification thereof. At this time, however, there is no preclinical early response or post-treatment biomarker, nor endoscopic or radiologic assessment that predicts pathologic response prior to surgical resection.The aim of this study is to determine the accuracy of CT-PET for prediction of histopathologic response and/or oncologic outcome for patients with esophageal cancer.

Official Title
-----------------
CT-PET for Prediction of Histopathologic Response, Nodal Status and Oncologic Outcome Following Neoadjuvant Chemoradiation for Esophageal Cancer

Conditions
-----------------
Esophageal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Locally advanced esophageal or junctional neoplasm Histologically confirmed adenocarcinoma or squamous cell carcinoma Scheduled to undergo nCRT followed by surgery as per multidisciplinary Tumor Board CT-PET at diagnosis of malignancy (within 2 weeks from diagnosis), performed at study Center CT-PET 4-6 weeks after completion of nCRT, prior to surgical resection Exclusion Criteria: Incomplete data, patient lost to follow-up Scans performed at alternate Center

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 |
| --- | --- | --- |
| Overall survival |  | Undetermined | 
| Disease-free survival |  | Undetermined | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histopathologic response | Mandard tumor regression grade, ypT, ypN stage | Undetermined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chemoradiotherapy, Esophagectomy, Response Evaluation Criteria in Solid Tumors, Treatment Outcome, Survival, Recurrence, Disease-Free Survival, Progression-Free Survival, Prognosis, Neoplasm Grading, Adenocarcinoma, Squamous Cell Carcinoma, Neoplasm Metastasis, Positron-Emission Tomography, Neoadjuvant Therapy
Expanded Access to Bimatoprost (Durysta)

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Durysta (Bimatoprost) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Official Title
-----------------
Expanded Access to Bimatoprost

Conditions
-----------------
Open-angle Glaucoma

Intervention / Treatment
-----------------
* Drug: Bimatoprost Sustained Release Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant must not be eligible for bimatoprost implant (Durysta) clinical trial. Eligibility for this program is limited to patients with moderate or worse glaucoma who are at risk of severe visual impairment based on physician assessment of risk factors associated with visual field progression as defined by the respective country/regional glaucoma clinical practice guidelines (eg, Canadian Ophthalmological Society guidelines, European Glaucoma Society guidelines, etc.), and who have exhausted all the appropriate pharmaceutical treatment options and are contraindicated for surgery, which may include: Patients with ocular comorbidities such as severely scarred conjunctiva (eg, chemical burns, Stevens-Johnson Syndrome), scleral thinning. Patients who are intolerant to any pre- , intra-, or post-op treatments (e.g allergy/intolerance to medical treatments or to anesthesia). Patients with systemic comorbidities (e.g cardiovascular conditions) in which any surgery is not recommended
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bimatoprost Sustained Release Implant|Intraocular Implant|

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
-----------------
Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
Dipole Density Mapping of Typical Atrial Flutter

Study Overview
=================
Brief Summary
-----------------
Study to determine the feasibility of the Acutus Medical System in obtaining data to create Dipole Density Maps of electrical activation in the right atrium in patients with typical atrial flutter.

Official Title
-----------------
Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter

Conditions
-----------------
Atrial Flutter

Intervention / Treatment
-----------------
* Device: Acutus Medical System Mapping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be aged 18 to 75 years Be scheduled for ablation of typical atrial flutter (cavotricuspid isthmus dependent) Be able and willing to give informed consent Exclusion Criteria: Have any of the following: 1.1 Patients with implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped. 1.2 Patients with permanent pacemaker or ICD leads in the chamber being mapped. 1.3Patients with hypercoagulopathy or an inability to tolerate anticoagulation therapy during an electrophysiology procedure. Require treatment in the left atrium and/or a require a transseptal puncture to access the left atrium during the index procedure Have had a myocardial infarction within the prior two months Have had cardiac surgery within the prior three months Have an intracardiac thrombus Have clinically significant tricuspid valve regurgitation or stenosis Have had any cerebral ischemic event (including transient ischemic attacks) in the prior six months Be pregnant or nursing Be currently enrolled in any other clinical investigation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acutus Medical System<br>Proprietary software algorithms will be used generate electrical activation maps based dipole density data acquired by the Acutus Medical Catheter during the procedures. These activation maps will then be applied to a 3D model of the endocardial surface to create a 3D activation map. | Device: Acutus Medical System Mapping<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of device-and procedure-related adverse events |  | 7 days | 
| The number of patients in which offline construction of pre- and post-treatment activation maps can be completed |  | 7 days |