linjc16/ctgov huggingface dataset:
Single Ascending Dose Study of PRX002 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 40 healthy subjects.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX002 Administered by Intravenous Infusion in Healthy Subjects

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: PRX002
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Body mass index (BMI) between 18-32 kg/m2 with a minimum weight of 46 kg Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception Male subjects and their partners of childbearing potential must use contraception Exclusion Criteria: Positive test for drug of abuse Past or current history of alcohol abuse Positive for hepatitis B, hepatitis C or HIV infection

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRX002<br> | Drug: PRX002<br> <br> |
| Placebo Comparator: Placebo<br> | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as determined by number of subjects with adverse events |  | up to 3 months | 
| Determination of pharmacokinetics parameters | - maximum concentration (Cmax) | up to 3 months | 
| Determination of pharmacokinetics parameters | - time of the maximum measured concentration (Tmax) | up to 3 months | 
| Determination of pharmacokinetics parameters | - area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast) | up to 3 months | 
| Determination of pharmacokinetics parameters | - area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) | up to 3 months | 
| Determination of pharmacokinetics parameters | - elimination rate constant | up to 3 months | 
| Determination of pharmacokinetics parameters | - terminal elimination half life (t½) | up to 3 months | 
| Determination of pharmacokinetics parameters | - clearance (CL) | up to 3 months | 
| Determination of pharmacokinetics parameters | - apparent volume of distribution (Vd) | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity as determined by measurement of anti-PRX002 antibodies |  | up to 3 months |
Characteristics of Pneumothorax Associated With Transthoracic Percutaneous Lung Biopsy in Standard of Care

Study Overview
=================
Brief Summary
-----------------
The number of lung biopsies has increased steadily in recent years. Pneumothorax is the most common complication of a lung biopsy and can occur during the procedure, immediately after the procedure or within a few hours (delayed pneumothorax). The incidence of pneumothorax in the literature is very different from one study to another: it has been reported to be from 9 to 54% in patients undergoing percutaneous transthoracic needle biopsy. This difference of incidence could be explained by the absence of consensus for the definition of an iatrogenic pneumothorax. The characteristics of pneumothorax and the management of patients with iatrogenic pneumothorax will be evaluated in different centres in a retrospective manner. This study will contribute to refining the criteria for defining pneumothorax occurring during lung biopsy and will provide a better understanding of the condition and its management.

Official Title
-----------------
Characteristics of Pneumothorax Associated With Transthoracic Percutaneous Lung Biopsy in Standard of Care: a Retrospective Study in 6 Centers

Conditions
-----------------
Pneumothorax Iatrogenic Postprocedural

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years old and more at the time of the biopsy procedure in year 2020 Having had a pneumothorax following their transthoracic percutaneous lung biopsy in year 2020 Exclusion Criteria: Objection to the use of the data (French sites only)

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: No intervention - retrospective study|This is a retrospective study. No intervention.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual incidence rate of pneumothorax related to transthoracic lung biopsy on total number of lung biopsies |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual incidence rate of hospitalisation in patients with pneumothorax related to lung biopsies |  | 3 months | 
| Annual incidence rate of drainage in patients with pneumothorax related to lung biopsies |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
interventional radiology, iatrogenic pneumothorax, transthoracic lung biopsy, pneumothorax rate, pneumothorax characteristics, patient management
Long Term Results After Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
Today sleeve gastrectomy is the most performed bariatric procedure worldwide. Since 2005 it is gaining popularity as a single procedure. Long term data is scarce. In this retrospective study long term follow-up in relation to weight loss, comorbidities, re-do and revisional surgery is getting analyzed.

Detailed Description
-----------------
Today sleeve gastrectomy is the most performed bariatric procedure worldwide. Since 2005 it is gaining popularity as a single procedure. Long term data is scarce. Re-Do and revisional surgery in form of re-sleeve, gastric bypass (mini -gastric bypass, roux-en y gastric bypass) and biliopancreatic diversion (BPD) is described in the current literature due to weight regain and reflux. The investigators want to analyze the frequency of this re-do/revisional surgery and want to compare weight loss and improvement in comorbidities.

Official Title
-----------------
Long Term Results After Sleeve Gastrectomy as a Primary Procedure in Obesity Surgery

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: laparoscopic sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: s.a. sleeve gastrectomy since 2007 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| sleeve gastrectomy<br>laparoscopic sleeve gastrectomy | Other: laparoscopic sleeve gastrectomy<br>* laparoscopic sleeve gastrectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of revisional surgery |  | up to 9 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess weight loss in % |  | up to 9 years after surgery | 
| Incidence of Gastroesophageal Reflux Disease |  | up to 9 years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleeve gastrectomy, long-term follow-up, gastroesophageal reflux disease after sleeve, revisional surgery
Thyroid Cancer and Photoacoustic Imaging

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the usefulness of photoacoustic imaging in thyroid nodules. In addition, we would like to confirm the relationship between the results of photoacoustic imaging and histopathologic findings when thyroid nodules were diagnosed as thyroid cancer.

Official Title
-----------------
Diagnosis of Thyroid Cancer Using Photoacoustic Imaging

Conditions
-----------------
Thyroid Cancer, Thyroid Nodule

Intervention / Treatment
-----------------
* Device: Photoacoustic imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All thyroid nodule identified as benign or as thyroid cancer Exclusion Criteria: Patient refuses to participate in the study or withdraws consent

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

| Intervention/Treatment |
| --- |
|Device: Photoacoustic imaging|Photoacoustic image of thyroid nodule is obtained by using probe of photoacoustic imaging equipment and image data and data are stored in the device. The patient's examination is the same as the general ultrasound, and the patient is asked to hold his breath for about 3-4 seconds to get the photoacoustic image.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photoacoustic analysis of thyroid nodule and thyroid cancer | Photoacoustic intensity of each chromophore (deoxyhemoglobin, oxyhemoglobin, lipid, water) obtained from ROI (region of interest) of photoacoustic image | As soon as the photoacoustic test was performed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thyroid cancer, Photoacoustic imaging
TREM-1 Pathway Activation in COVID-19

Study Overview
=================
Brief Summary
-----------------
Severe Acute Respiratory Syndrome-Corona Virus-2 infection results in a mild infection in most of the patients. However, 15-20% require hospitalization, and among them, 15-20% will develop acute respiratory failure, leading to their admission in Intensive Care Unit. There are no accepted predictive criteria for aggravation. Severe forms of Coronavirus induced disease-19 (COVID-19) are the consequence of endotheliopathy, and hyperinflammatory and pro-coagulant state. The Triggering Receptor Expressed on Myeloid cells-1 (TREM-1) is an immunoreceptor that acts as an amplifier of the inflammatory response. TREM-1 is expressed on myeloid and endothelial cells. Its activation leads to endothelial activation and damage, hyperinflammatory, and pro-coagulant state. TREM-1 activation is associated with poor outcome during septic shock and myocardial infarction. We here aim at investigating the relationship between TREM-1 pathway activation and clinical degradation and outcome of COVID-19 hospitalized patients.

Official Title
-----------------
Prognostic Significance of the TREM-1 Pathway Activation in COVID-19

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Consecutive COVID-19 hospitalized patients for less than 3 days Exclusion Criteria: No consent Pregnancy protected populations

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: blood sampling|Blood will be collected every 3 days until Day 28, discharge, or death|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prognostic value of the TREM-1 pathway activation on clinical worsening |  | day 28 |
Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics

Study Overview
=================
Brief Summary
-----------------
The purpose is to compare the prevalence of dry eyes in diabetics and non diabetics. This might help identify a group of patients at greater risk for dry eye complications. Diabetics have been shown to have poor ocular surface healing and might benefit from dry eye therapy earlier if they are shown to be at greater risk for dry eyes.

Detailed Description
-----------------
Dry eye disease is one of the most common eye problems seen in ophthalmology. Diabetics are at high risk for multiple eye problems, including retinopathy and glaucoma. They also have been shown to have poor ocular surface healing. I would like to evaluate the prevalence of dry eye disease in diabetics to see if they are also at greater risk for the known complications of dry eye disease. If so, they might benefit from early intervention.

Official Title
-----------------
Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics

Conditions
-----------------
Dry Eyes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50 patients with diabetes, 25 without diabetes over the age of 40 Exclusion Criteria: current use of glaucoma drops or currently within the postoperative period from eye surgery

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

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 |
| --- | --- |
| diabetics<br>diabetics | |
| non diabetics<br>non diabetics | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival Staining Score | Conjunctival staining with lissamine green dye is measured at the time of the evaluation on a scale from 0 to 5 using the oxford scoring system, with 5 being the most severe staining. | at the time of the evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Film Osmolarity | The tear film osmolarity is measured at the time of the exam. | at the time of the exam | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dry eyes, diabetes
Sepse: Critical Analysis of New Sepse Definitions and Retrospective Evaluation of Sepse Protocol at a Tertiary Hospital in Brazil

Study Overview
=================
Brief Summary
-----------------
Research in the databases Lilacs, BIREME, SciELO by the terms: systemic inflammatory response syndrome (SIRS), sepsis, severe sepsis and septic shock and their equivalents in the English language. Selection of the main articles of the last five years to study and contextualize the reality presented since the implantation of the HUVR sepsis protocol. Statistical analysis of data since the implementation of the sepsis protocol in the HUVR, in July 2014 until June 2016.

Official Title
-----------------
Sepse: Critical Analysis of New Sepse Studies and Definitions and Retrospective Evaluation of Sepse Protocol Implementation at Hospital Unimed Volta Redonda

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Other: Sepsis protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All individuals who had a confirmed or suspected sepsis diagnosis and had a sepsis protocol completed during the study period. - Exclusion Criteria: Individuals with confirmed or suspected sepsis in the study period who did not complete the protocol. Individuals under the age of 18 -

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 |
| --- | --- |
| 2015<br>2015 - Individuals with a diagnosis of sepsis from June 2014 to May 2015 | Other: Sepsis protocol<br>* Adherence to the sepsis protocol<br>|
| 2016<br>2016 -Individuals with a diagnosis of sepsis from June 2015 to May 2016 | Other: Sepsis protocol<br>* Adherence to the sepsis protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the sepsis protocol | Implementation of the measures recommended in the sepsis protocol | From 2014 to 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sepsis mortality rate | Assessment of the evolution of the sepsis mortality rate | From 2014 to 2016 |
Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)

Study Overview
=================
Brief Summary
-----------------
This study is a local, prospective, open-label, company-sponsored, non interventional, multi-center study. Patients documented must suffer from a cIAI and take at least one dose of Moxifloxacin infusion.The primary objective is to define the types of cIAI infections that require Moxifloxacin i.v. therapy in China.

Official Title
-----------------
Clinical Effectiveness and Safety Study of Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)

Conditions
-----------------
Secondary Peritonitis, Abscess, Intra-Abdominal

Intervention / Treatment
-----------------
* Drug: Moxifloxacin (Avelox, BAY12-8039)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at least 18 years of age with a diagnosis of cIAI treated with Moxifloxacin infusion with/without sequential tablet treatment can be included into the study. The local Moxifloxacin product information must be considered. Exclusion Criteria: Contraindications stated in the local Moxifloxacin product information. Warnings and precautions, stated in the local Moxifloxacin product information must be considered as potential exclusion criteria.

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 |
| --- | --- |
| Group 1<br> | Drug: Moxifloxacin (Avelox, BAY12-8039)<br>* The treatment with Moxifloxacin 400 mg infusion should comply with the recommendations written in the local product information. The decision about the treatment with Moxifloxacin as well as the duration of treatment is solely up to the attending physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Types of cIAI infections |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate |  | 5-14 days | 
| Clinical signs and symptoms |  | 5-14 days | 
| Duration until improvement and cure |  | 5-14 days | 
| Adverse event collection |  | 5-14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Moxifloxacin,, cIAI, non-interventional
Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients

Study Overview
=================
Brief Summary
-----------------
Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.

Official Title
-----------------
Immunogenicity, Efficacy and Safety of Treatment With Human-cl-rhFVIII in Previously Untreated Patients With Severe Hemophilia A

Conditions
-----------------
Severe Hemophilia A

Intervention / Treatment
-----------------
* Biological: Human cl rhFVIII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients Severe Hemophilia A (FVIII:C <1%) No previous treatment with FVIII concentrates or other blood products containing FVIII Exclusion Criteria: Diagnosis with a coagulation disorder other than Hemophilia A Severe liver or kidney disease Concomitant treatment with any systemic immunosuppressive drug
Sexes Eligible for Study
-----------------
Male

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: Human cl rhFVIII<br> | Biological: Human cl rhFVIII<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors | The number of patients developing FVIII inhibitors was observed during the observation period by assessing inhibitor development using the modified Bethesda assay (Nijmegen modification). The definitions for thresholds were ≥0.6 to <5 BU/mL for a low titre inhibitor and ≥5 BU/mL for a high-titre inhibitor. | maximum 5 years (100 exposure days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Spontaneous Break-through Bleeds | The annualized bleeding rate (ABR) was calculated during inhibitor-free periods for spontaneous bleeding events (BEs) during prophylactic treatment with Human cl rhFVIII | Maximum 5 years (100 exposure days) | 
| Efficacy of Human-cl rhFVIII for the Treatment of Bleeds | A personal efficacy assessment to assess the efficacy of Human-cl rhFVIII for the on-demand treatment of bleeding episodes. Efficacy was assessed using a four-point scale (excellent, good, moderate, none). | Maximum 5 years (100 exposure days) | 
| Efficacy of Human-cl rhFVIII for Surgical Prophylaxis | An overall efficacy assessment to assess the efficacy of human-cl rhFVIII in surgical prophylaxis of minor and major surgeries. The efficacy assessment was analyzed using a four-point scale (excellent, good, moderate, none). | Maximum 5 years (100 exposure days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Previously untreated patients