linjc16/ctgov huggingface dataset:
Measurement of Natriuretic Hormone Peptides in Exacerbation of Asthma

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that there is a statistically significant decrease of Natriuretic Hormone Peptides (NHPs) in subjects with asthma exacerbation compared to levels following treatment of an exacerbation of asthma.

Detailed Description
-----------------
Overall Study Design Measurement of Natriuretic Hormone Peptides in individuals suffering from exacerbation of asthma. Measurement of Natriuretic Hormone Peptides 5-7 days after initiation of treatment of exacerbation of asthma. Measurement of Natriuretic Hormone Peptides 10-14 days after initiation of treatment of exacerbation of asthma. 3 comparisons of Natriuretic Hormone Peptides levels will be made: Exacerbation compared to 5-7 days after initiation of treatment Exacerbation compared to 10-14 days after initiation of treatment 5-7 days after initiation of treatment compared to 10-14 days after initiation of treatment. Samples of blood will be secured in the Division of Allergy/Immunology at the University of South Florida, Joy McCann Culverhouse Airways Disease Center. All samples will be appropriately coded to maintain confidentiality. Blood specimens will be held at minus 20 degrees Celsius.

Official Title
-----------------
Measurement of Natriuretic Hormone Peptides in Exacerbation of Asthma

Conditions
-----------------
ASTHMA

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both genders, age 18-85. Females who are pregnant or lactating are not eligible. Read and comprehend English. Ability to give informed consent. Seen in the outpatient setting at one of the clinic. The subject must have a history of physician diagnosed asthma for at least 1 year and must have an exacerbation of asthma for entry into the study.

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 |
| --- | --- | --- |
| The measurement of NHPs after treatment of an exacerbation of asthma |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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ASTHMA, ACUTE EXACERBATION OF ASTHMA
A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting

Study Overview
=================
Brief Summary
-----------------
A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.

Official Title
-----------------
A Clinical Study to Evaluate the Steady State Pharmacokinetics of Baraclude in Participants With Hepatitis B Virus Infection

Conditions
-----------------
Hepatitis B Virus

Intervention / Treatment
-----------------
* Drug: Baraclude


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Participants with chronic hepatitis B (CHB) (excluding participants with a superinfection) who have been confirmed to have CHB. Participants who are being treated with 0.5 mg daily Baraclude for a minimum of 10 consecutive days prior to the study enrollment. Body mass index (BMI) of 18.5 to 30 kg/m2 (BMI = body weight [kg]/height [m]2) Exclusion Criteria: Current or recent (within 3 months of Baraclude administration) gastrointestinal disease that could impact upon the absorption of study drug. Any gastrointestinal surgery that could impact upon the absorption of study drug. Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only). Other protocol defined inclusion/exclusion criteria could apply.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: Arm A<br> | Drug: Baraclude<br>* Specified dose on specified day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) | Cmax is defined as the peak plasma concentration | Up to 24 hours | 
| Time of Maximum Observed Plasma Concentration (Tmax) | Tmax is defined as the time of maximum observed plasma concentration, measured in hours | Up to 24 hours | 
| Trough Observed Plasma (Predose) Concentration (Ctrough) | Ctrough is defined as the trough in observed plasma (predose) concentrations | prior to administration of drug (predose) | 
| Observed Plasma Concentration at 24 Hours Postdose (C24) | C24 is defined as the observed plasma concentration at 24 hours post-dose | 24 hours post-dose | 
| Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] | AUC(TAU) is defined as the area under the concentration-time curve in one dosing interval | Up to 24 hours | 
| Apparent Total Body Clearance (CLT/F) | CLT/F is defined as the apparent total body clearance | Up to 24 hours |
Acute Ventilatory Response to Hypoxia During Sedation With Dexmedetomidine Compared to Propofol in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The overall aim with this project is to investigate the effect of dexmedetomidine on control of breathing in healthy volunteers and to compare it with propofol at the same degree of sedation.

Detailed Description
-----------------
15 volunteers will be investigated for their hypoxic and hypercapnic ventilatory response during sedation with dexmedetomidine and propofol in a randomized cross-over study. 6 volunteers will be investigated for their repeated response to hypoxia and hypercapnia in order to validate the method.

Conditions
-----------------
Hypoxia, Anesthetics, Conscious Sedation, Hypercapnia

Intervention / Treatment
-----------------
* Procedure: Hypoxic ventilatory response
* Procedure: Hypercapnic ventilatory response


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Age 18-40 American Society of Anesthesiologist´s classification (ASA) 1, i.e. healthy No medication No allergies Non-smoker/no snuff, i.e. no nicotine intake Normal weight, BMI <26 Exclusion Criteria: Snoring

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sedation with dexmedetomidine<br>Sedation with dexmedetomidine | Procedure: Hypoxic ventilatory response<br> <br> * Other names: HVR;Procedure: Hypercapnic ventilatory response<br> <br> * Other names: HCVR;|
| Experimental: Sedation with propofol<br>Sedation with propofol | Procedure: Hypoxic ventilatory response<br> <br> * Other names: HVR;Procedure: Hypercapnic ventilatory response<br> <br> * Other names: HCVR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxic ventilatory response | Acute hypoxic ventilatory response,i.e. the ventilatory response to acute hypoxia measured as change in minute ventilation over change in peripheral oxygen saturation | One day for each drug; before,during and after sedation with dexmeditomidine or propofol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypercapnic ventilatory response | The acute ventilatory response to hypercapnia, i.e. change in minute ventilation over change in end-tidal carbon dioxide | One day for each drug; Before, during and after sedation with dexmedetomidine or propofol | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexmedetomidine, Propofol, Hypoxic ventilatory response, Hypercapnic ventilatory response
Prehospital Recognition and Identification of Unspecific Symptoms

Study Overview
=================
Brief Summary
-----------------
This study evaluates the predictive value of soluvent urokinase plasminogen activator receptor (suPAR) and lactate with respect to serious conditions among patients presenting to the EMS with unspecific symptoms.

Official Title
-----------------
Prehospital Recognition and Identification of Unspecific Symptoms

Conditions
-----------------
Serious Condition, Morality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unspecific symptoms (not feeling well, decreased general health condition, unable to cope with usual daily activities, feeling weak) Normal vital signs Transported to ED Able to give informed consent/ Next of kin gives informed consent Exclusion Criteria: Specific symptoms under 18 years of age Stays home / other caregiver than ED Referral from caregiver No personal numer (social security number)

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious condition | Predefined serious condition | During medical care event | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | 24h and 30 day mortality | 24hours and 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Unspecific symptoms, Soluvent urokinase plasminogen activator receptor, Lactate, Emergency Medical Services
Discard:Characterisation of Colonic Polyps in Vivo

Study Overview
=================
Brief Summary
-----------------
Prospective study of accuracy of colonic polyp characterisation in vivo using high resolution white light endoscopy, narrow band imaging and chromoendoscopy.

Official Title
-----------------
Characterisation of Small Colonic Polyps in Vivo

Conditions
-----------------
Colorectal Polyps

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age, assessed as fit for routine colonoscopy Patients attending for screening or surveillance colonoscopy meeting the following criteria: Polyp surveillance with at least 3 adenomas or 1 adenoma>10mm at previous colonoscopy Surveillance post colorectal cancer resection Screening with positive faecal occult blood test Exclusion Criteria: Patients with known colitis or polyposis syndromes Unable or unwilling to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| 1<br> | |
| 2<br> | |
| 3<br> | |
| 4<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of polyp characterisation |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in surveillance interval after formal histopathology |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal cancer, polyps, colonoscopy, advanced imaging
Polypropylene Meshes in Hernia Repair

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to analyze the shrinkage of two different screens in the repair of inguinal hernias in men . 32 patients with unilateral inguinal hernia were assigned randomly. A Lichtenstein tension-free hernia repair was accomplished by emplacing heavy weight versus ultralight weight polypropylene meshes for repair of incisional hernia, marked next to the lips with six titanium clips (LT200).

Detailed Description
-----------------
eligibility criteria : Elective Surgery, men with unilateral inguinal hernia, 20 - 50 years Exclusion criteria: BMI> 30, recurrent inguinal hernia, strangulated inguinal hernia, anesthetic risk ASA III and IV, Diabetics, COPD, benign prostatic hypertrophy,cancer disease outcome: Percentage of contraction of the different meshes by digital radiography in post-surgical days: 1, 30, 60 and 90 Independent variables: age, BMI, smoking, ethnicity, profession

Official Title
-----------------
Morphofunctional Evaluations of Heavyweight and Ultralightweight Polypropylene Meshes in Men Inguinal Hernia Repair

Conditions
-----------------
Inguinal Hernias

Intervention / Treatment
-----------------
* Procedure: two different meshes in the repair of inguinal hernias


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective Surgery Men with unilateral inguinal hernia Age 20 - 50 years Exclusion Criteria: BMI> 30 Recurrent inguinal hernia Strangulated inguinal hernia Anesthetic risk ASA III and IV Diabetics COPD Benign prostatic hypertrophy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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: two differents meshes<br>Heavy-weight versus low-weight polypropylene meshes | Procedure: two different meshes in the repair of inguinal hernias<br>* A Lichtenstein tension-free hernia repair was accomplished by emplacing Heavy-weight versus low-weight polypropylene meshes for repair of incisional hernia, marked next to the lips with six titanium clips (LT200)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| contraction of two different meshes in the repair of inguinal hernias in men |  | digital radiography in post-surgical days: 1, 30, 60 and 90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inguinal Hernia, contraction of two different meshes in the repair of inguinal hernias in men
Follow-up Study for Participants of Jointstem Phase 3 Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this follow-up study is to investigate the efficacy and safety of autologous Adipose Tissue derived Mesenchymal stem cells (JOINTSTEM®) in patient with severe Knee Osteoarthritis.

Official Title
-----------------
Long-Term Safety and Efficacy Extension Study Of Autologous Adipose-Derived Mesenchymal Stem Cells 『JOINTSTEM』 in Patients With Knee Osteoarthiritis: A Phase III Extension Study

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Biological: JOINTSTEM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants of Jointstem Phase 3 Clinical Trial Participates who signed informed consent document of this study Exclusion Criteria: No applicable

Ages Eligible for Study
-----------------
Minimum Age: 20 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: JOINTSTEM<br>Long Term Follow-up after Jointstem Transplantation | Biological: JOINTSTEM<br>* Autologous Adipose Tissue derived MSCs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Incidence of adverse events from baseline to 5 Years | 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline | Pain, stiffness, and physical function of the knee will be measured by the WOMAC score | 5 Years | 
| WOMAC 3 subscale score | Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC) | 5 Years | 
| SF-36 | The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health. | 5 Years | 
| Measuring of Kellgren-Lawrence grade | Measuring of Kellgren-Lawrence grade through X-ray | 1, 2, 3, 4, 5 Years | 
| Measuring of Femoro-tibial anatomical angle(FTA) | Measuring of FTA through X-ray | 1, 2, 3, 4, 5 Years | 
| Measuring of Hip-Knee-Ankle angle(HKA) | Measureing of HKA through X-ray | 1, 2, 3, 4, 5 Years | 
| Measuring of Joint Space Width | measuring Joint Space Width through X-ray | 1, 2, 3, 4, 5 Years | 
| MRI scan | The cartilage defect area is measured using MRI | 1, 2, 3, 4, 5 Years |
IDH1/2 Mutational Analysis in AML Patients: Diagnosis and Follow-up

Study Overview
=================
Brief Summary
-----------------
In a spanish series of AML patients it is intended to perform, at the moment of diagnosis, pyrosequencing of IDH1 and IDH2 genes. Taking into account the incidence of AML in the area, it is planed to study 100 patients per year. Among the cases with IDH1/2 mutations, targeted deep sequencing (TDS) of a panel covering coding regions of 40 myeloid related genes will be applied. With TDS, pyrosequencing results will be validated at the same time that prognosis value of co-mutated genes could be studied. Furthermore, with TDS, molecular architecture of IDH1 and IDH2 mutated cases might be better understood.

Official Title
-----------------
IDH1/2 Mutational Analysis in AML Patients: Diagnosis and Follow-up

Conditions
-----------------
Acute Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >18 years old with de novo acute myeloid leukemia will be included. All patients will be treated according to clinical routine. Exclusion Criteria: Patients not following the above criteria.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IDH1/2 mutated patients<br>Patients harboring mutations in IDH1 or IDH2 genes | |
| Patients without IDH1/2 mutations<br>Patients that don´t present any mutation in IDH1/2 genes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of IDH1/2 mutation | Detection of mutations in IDH1 and IDH2 genes | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of co-mutations | Screening of aditional mutations in those cases with IDH1/2 mutation | 1 day |
MSSA and MRSA Screening in Patients Undergoing Elective TJA: the Benefits of Next-generation Sequencing

Study Overview
=================
Brief Summary
-----------------
The aims of this study were to evaluate the diagnostic performance of molecular and culture techniques in S. aureus screening using paired nasal and groin swabs, to determine, if any, discrepancy between the diagnostic techniques and to model the potential effect of different diagnostic techniques on S. aureus detection in orthopaedic patients

Official Title
-----------------
MSSA and MRSA Screening in Patients Undergoing Elective TJA: the Benefits of Next-generation Sequencing

Conditions
-----------------
Staphylococcus Aureus, Next Generation Sequencing, Total Joint Arthroplasty

Intervention / Treatment
-----------------
* Diagnostic Test: next generation sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing primary total knee or total hip arthroplasty at our institution will be eligible. Exclusion Criteria: Patients included in other prospective studies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: next generation sequencing|diagnostic performance of molecular and culture techniques in S. aureus screening using paired nasal and groin swabs, to determine, if any, discrepancy between the diagnostic techniques on S. aureus detection in orthopaedic patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic techniques to identify S. aureus in total joint replacement patients | to model the potential effect of different diagnostic techniques on S. aureus detection in orthopaedic patients. | 1 day |