linjc16/ctgov huggingface dataset:
Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in Healthy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerbility of ascending multiple oral doses of AGG-523 in healthy subjects and in subjects with osteoarthritis.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Test Article or Placebo Administered Orally to Healthy and Osteoarthritis Subjects.

Conditions
-----------------
Healthy Subjects, Osteoarthritis

Intervention / Treatment
-----------------
* Drug: AGG-523


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men or women, aged 18 to 40 years and subjects with osteoarthritis of the knee, aged 40 to 75 years. Women must be of non-childbearing potential, defined as surgically sterile with documentation of ultrasound. Must be nonsmoker or smoke less than 10 cigarettes per day.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AGG-523|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety of multiple doses of AGG-523 administered to subjects. |  |  |
Prevention of CF Exacerbation in Childhood: PREVEC Study

Study Overview
=================
Brief Summary
-----------------
Pulmonary exacerbations of CF are an important cause for the experienced disability of patients, respiratory symptoms, and decreases in lungfunction, which require antibiotic therapy at home or in the hospital. Therefore, prevention of exacerbations in CF is important. The aim of this study was to assess the predictive properties of inflammatory markers in exhaled breath for pulmonary exacerbations in children with CF. In addition the reliability of home monitor assessments of symptoms and lungfunction was investigated.

Official Title
-----------------
Prevention of CF Exacerbation in Childhood (PREVEC): Early Recognition of Inflammation by Non-invasive Biomarkers in Exhaled Breath (Condensate)

Conditions
-----------------
Cystic Fibrosis, Children, Exhaled Breath Condensate, Non-invasive Inflammatory Markers, Volatile Organic Compounds, Home Monitoring, Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CF disease is defined as the combination of: characteristic clinical features (persistent pulmonary symptoms, meconium ileus, failure to thrive, steatorrhoea); and/or abnormal sweat test (Chloride > 60mM); and/or two CF mutations. Exclusion Criteria: cardiac abnormalities; mental retardation; no technical satisfactory performance of measurements; on the waiting list for lung transplantation; non-compliance with the home-assessments; patients with Burkholderia Cepacia; participation in another intervention trial.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
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 |
| --- | --- |
| Children with Cystic Fibrosis, care as usual<br>Treatment according to the Dutch Central Guidance Committee (CBO) guidelines for CF. Assessments: home monitoring, symptoms, lung function, quality of life and diagnostic assessments of non-invasive inflammatory markers in exhaled air and exhaled breath condensate. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of exacerbations | Definition of an exacerbation according to Treggiari MM et al. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life questionnaire | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic Fibrosis, Children, Exhaled Breath Condensate, Non-invasive Inflammatory Markers, Volatile Organic Compounds, Home monitoring, Quality of life
Evaluation of Placenta Maturity by the Sonographic Textures

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate placenta maturity by the sonographic textures.The evaluation of placenta maturity by the sonographic textures is related to anticipative pregnancy and actual pregnancy . By analyzing this theory, the investigators want to bring up another objective and accurate analysis method in order to provide information for the evaluation of clinical trials.

Official Title
-----------------
Evaluation of Placenta Maturity by the Sonographic Textures

Conditions
-----------------
Pregnant Women

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women Placenta Maturity by the Sonographic Textures Exclusion Criteria: intrauterine-growth retardation(IUGR) Pre-eclampsia Higher Blood Pressure Fetal Distress during a labor

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnant Women, Sonographic Textures
Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of ID1201 in patients with mild Alzheimer's disease

Detailed Description
-----------------
ID1201 is a fruit extract of Melia toosendan. ID1201 alleviates Alzheimer's disease-type pathologies and cognitive deficit through the various actions of its effective components such as α-secretase activation followed to Aβ reduction, RAGE inhibition, neuro-protection, and anti-inflammatory activities.

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: ID1201


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient diagnosed with dementia of Alzheimer's type according to DSM-IV criteria and probable Alzheimer's disease according to the NINCDS-ADRDA modified Hachinski Ischemia Scale score of less than or equal to 4 Mini-Mental State Examination score 16 to 26 and Clinical Dementia Rating-Global Scale score 0.5 to 1 Amyloid postivie PET image (BAPL score 2 or 3) Patients who have not received AChE inhibitors or NMDA antagonist at least for 3 months prior to the screening visit Exclusion Criteria: Patients diagnosed or accompanied with Dementia due to other Neurodegenerative disorders other than Alzheimer's disease Chronic alcohol and/or drug abuse within the past 5 years Subjects who have medical history of significant renal disease (ccr<30ml/min) or hepatic disease( 3*ULN <= ALT or AST) Has received choline agonists, anticholinergics, anticonvulsants, antidepressants, antipsychotic drugs, Ginko biloba extract, Vitamin E, hormone replacement therapy etc. in the previous 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ID1201 100mg<br> | Drug: ID1201<br> <br> |
| Experimental: ID1201 200mg<br> | Drug: ID1201<br> <br> |
| Experimental: ID1201 400mg<br> | Drug: ID1201<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: ID1201<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at 12 Weeks |  | Baseline, 12 weeks |
Malaria in Strasbourg University Hospital

Study Overview
=================
Brief Summary
-----------------
The primary purpose is to describe the anamnestic, clinical, biological, and therapeutic characteristics of imported malaria in people originated from endemic areas. Indeed, clinicians have observed that people from such areas start malaria just after their arrival in France. Such observation needed to be confirmed. In addition, The investigators observed a variation in the laboratory diagnostic performance of malaria between hospital and private laboratories. Such observation also needed to be analyzed objectively

Official Title
-----------------
Retrospective Clinical Study of Malaria in Strasbourg University

Conditions
-----------------
Malaria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Patient over 18 years Patients from birth to 18 years Patient submitted to guardianship Patient submitted to trusteeship Diagnosis patients with malaria from 01/01/2017 to 01/01/2018 Patient or legal representative agree to use medical data for this research Exclusion Criteria: Lack of confirmation malaria diagnosis Impossibility to inform patients Patient who does not wish to participate in the study Patient submitted to justice safeguarding

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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 |
| --- | --- | --- |
| Study of clinical characteristics of imported malaria in people originated from endemic areas hospitalized at Strasbourg University Hospital from 2017 to 2018. |  | The period from January 1st, 2017 to January 1st, 2018 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malaria, Malaria imported cases, Recurrent malaria, Endemic malaria areas, Biological diagnosis, Hospital vs private laboratory diagnosis
Does COVID-19 Pandemic Reduce In-hospital Mortality?

Study Overview
=================
Brief Summary
-----------------
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Although it is suggested that hospital admissions are reduced due to some reasons such as trauma, during COVID-19 pandemic, it is controversial whether in-hospital mortality rates changed. Therefore this multi-centered study aimed to determine how in-hospital mortality effected during the pandemic period according to the specific patient groups.

Detailed Description
-----------------
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Although it is suggested that hospital admissions are reduced due to some reasons such as trauma, during COVID-19 pandemic, it is controversial whether in-hospital mortality rates changed. Therefore this multi-centered study aimed to determine how in-hospital mortality effected during the pandemic period according to the specific patient groups. Thus, in case of a pandemic, it will be a guide in which patient groups healthcare providers should be more careful about.

Official Title
-----------------
Does COVID-19 Pandemic Reduce In-hospital Mortality?

Conditions
-----------------
Covid19, In-hospital Cardiac Arrest

Intervention / Treatment
-----------------
* Other: in-hospital mortality rate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Deaths, with all required data available, occurred within the study hospitals centers Accepted to participate with an informed consent Exclusion Criteria: lack of consent lack of data deaths occurred outside the study hospitals

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

| Intervention/Treatment |
| --- |
|Other: in-hospital mortality rate|In-hospital mortality rate during pandemic of 2020 will be compared with the in-hospital mortality rate of the last year's same time period|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality | During the pandemic (March-July), deaths occurred in hospital will be evaluated. | 4 months |
Registry for Severe ROP and Treatment on Visual Outcomes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine what factors influence the visual outcomes of infants with severe retinopathy of prematurity (ROP) and to monitor the outcomes.

Official Title
-----------------
Study Registry for Severe Retinopathy and Treatment on Visual Outcomes of Premature Neonates

Conditions
-----------------
Retinopathy of Prematurity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documentation of informed consent and authorization Inborn and those admitted within 7 days of birth Infant with a diagnosis of stage 2 ROP or higher Site ability to plan close ophthalmological follow-up due to significant and persistent ROP Parents must agree to report outcomes following each ophthalmological visit and overall outcomes for up to five (5) years of age Ability to obtain follow-up data on outcomes if the child is transferred to another facility No known major congenital anomalies Exclusion Criteria: ROP stage 1 or less Parents unwilling to participate in follow-up Major congenital anomalies

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of visual acuity in subjects who were treated for ROP |  | Five year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of stage 3+ retinopathy of prematurity in one or both eyes in zone I or posterior zone II Recurrence of stage 3+ retinopathy of prematurity in one or both eyes in zone I or posterior zone II |  | Five year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinopathy of Prematurity
Establishment of a LVAD Destination Program in a Swiss Non Cardiac Transplant University Hospital

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to demonstrate the challenges and the effort to set up an artificial heart program as well as to report about the follow-up treatment and the mortality rate

Official Title
-----------------
Establishment of a LVAD Destination Program in a Swiss Non Cardiac Transplant University Hospital: 5 Year Experience

Conditions
-----------------
Heart Implant Complication

Intervention / Treatment
-----------------
* Other: collection of patient data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received an LVAD implant Exclusion Criteria: not enough data collected stated will of the Patient, that his data can not be used
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with an implanted LVAD<br>Patients which received an implantation of a left ventricular assist device (LVAD) at the University Hospital Basel since 2014 | Other: collection of patient data<br>* assess mortality rate, rehospitalization and survival rate of patients after receiving an artificial heart implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 days mortality | mortality rate 30 days after receiving the LVAD implant | 30 days after surgery | 
| rehospitalization rate | rehospitalization rate of patients after receiving the LVAD implant | between day of surgery and 31.12.2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate | survival rate of patients after receiving the LVAD implant (Kaplan-Meier curve) | between day of surgery and 31.12.2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
left ventricular assist device (LVAD), heart, implant, artificial
Impact of Using a Cuffed Endotracheal Tube on Limiting the Risk of Airway Fire

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of using a cuffed endotracheal tube (ETT) on the oxygen concentration in the oropharynx during adenoidectomy, tonsillectomy, or adenotonsillectomy. The study hypothesis is that inflation of the cuff on the ETT will eliminate contamination of the oropharynx with the inspired anesthetic gases and decrease the oxygen concentration in the oropharynx.

Conditions
-----------------
Adenoidectomy, Tonsillectomy, Adenotonsillectomy

Intervention / Treatment
-----------------
* Other: Cuffed ETT
* Other: Uncuffed ETT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing adenoidectomy, tonsillectomy, or adenotonsillectomy. Exclusion Criteria: Airway anomalies or cardiac conditions that have the potential for a complicated anesthesia induction.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cuffed ETT<br> | Other: Cuffed ETT<br>* Kimberly Clark<br>|
| Active Comparator: Uncuffed ETT<br> | Other: Uncuffed ETT<br>* Kimberly Clark<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in oxygen concentration in the oropharynx between cuffed and uncuffed ETT. | The oxygen and sevoflurane (anesthetic agent) concentration of the oropharynx would be measured during positive pressure ventilation immediately after intubation and then 4-5 mins. after anesthetic induction when the patient resumes spontaneous ventilation. | 4-5 minutes after induction |
Unicirc vs Open Surgical Circumcision

Study Overview
=================
Brief Summary
-----------------
RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.

Official Title
-----------------
Adult Male Circumcision With Unicirc Under Topical Anesthetic vs Open Surgical Circumcision: a Randomized Controlled Trial

Conditions
-----------------
Circumcision, Male

Intervention / Treatment
-----------------
* Procedure: Unicirc with tissue adhesive
* Procedure: Open Surgical


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male Uncircumcised With normal penile anatomy Exclusion Criteria: Concurrent illness History of bleeding disorder Past reaction to local anesthetic Infection Penile abnormality which could complicate circumcision

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unicirc with tissue adhesive<br>Unicirc under topical anesthetic w/ cyanoacrylate wound sealing | Procedure: Unicirc with tissue adhesive<br>* As above<br>|
| Active Comparator: Open Surgical<br>Open surgical circumcision under local anesthetic with suturing | Procedure: Open Surgical<br>* As above<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing | Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing | Up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Pain 0=no Pain; 10=Worst Pain Ever | Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever | Up to 30 minutes | 
| Completely Healed at 4 Weeks | Number of participants who were completely healed at 4 weeks | At the 4-week followup visit | 
| Wound Dehiscence | Proportion experiencing wound dehiscence (< 2 cm vs > 2 cm) | Up to 4 weeks | 
| Infection | Proportion experiencing post-op infection, determined clinically (treated with antibiotics) | Up to 4 weeks |