linjc16/ctgov huggingface dataset:
Exploratory Study, Prospective, of Volume, Composition and Bacteriology of the Recovered Blood of Multi-perforated Catheter Inserted in the Drapes Thickness of Incisional Sternal Area During Heart Surgery

Study Overview
=================
Brief Summary
-----------------
The recovered blood into the surgical site at the border of the fields, is very rich in red blood cells, due to the adjacency of the bone marrow and the sternum. The blood recovered from the surgical site at the border of the fields, is richer in red blood cells than the bloodstream of the patient. The recovered blood into the surgical site at the border of the fields, is not contaminated and bacteriological cultures are negative. Consequences: The recovered blood in the surgical site at the edge of fields, can be recovered in the Saver® Cell for reprocessing and re-injected into the patient. There isn't in our knowledge of published clinical data on the volume and composition of the recovered blood in the surgical site after cardiac surgery. The analysis of the available literature does not allow to estimate the expected outcomes us. Therefore, this study will be exploratory in nature and will aim to estimate the volume and the content of red blood cells from blood recovered, and generate clinical data to be used in subsequent confirmatory tests.

Official Title
-----------------
Exploratory Study, Prospective, of Volume, Composition and Bacteriology of the Recovered Blood of Multi-perforated Catheter Inserted in the Drapes Thickness of Incisional Sternal Area During Heart Surgery

Conditions
-----------------
Heart Surgery

Intervention / Treatment
-----------------
* Procedure: heart surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years; Any open heart surgery with or without extracorporeal circulation Signature of informed consent Affiliation to social security Exclusion Criteria: Subjects legally protected or unable to consent Persons deprived of liberty Cardiac Surgery extreme emergency (due to difficulties obtaining informed consent) Pregnant or breastfeeding women

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Patients undergoing heart surgery | Procedure: heart surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of red blood cell numeration from blood collected. |  | Between the incision and the closure. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart surgery blood
Post-transplant Cyclophosphamide in Wiskott-Aldrich Syndrome

Study Overview
=================
Brief Summary
-----------------
A protocol named as CIP-2015 for patients with Wiskott-Aldrich Syndrome may reduce the rate of GvHD. The details of the protocal followed with: Conditioning regimen Busulfan 16 mg/kg in total, Fludarabine 160 mg/m2 in total. GvHD Prophylaxis: Rabbit antihuman thymocyte globulin 7.5 mg/kg post-transplant cyclophosphamide (CY) (50 mg/kg.d on days +3 and +4) Cyclosporine or tacrolimus, mycophenolate mofetil, on days +5

Detailed Description
-----------------
Patients were enrolled in CIP-2015 Protocol at the Capital Institute of Pediatrics (Beijing). The conditioning regimen consisted of fludarabine (40 mg/m2) from days -6 to -3, and Busulfan was administered intravenously for 4 days, from days -5 to -2，using dose targeting based on therapeutic drug monitoring. Thymoglobulin (Sanoﬁ, Cambridge, MA) 7.5 to 10 mg/kg (cumulative dose over 4 days) was administered over 4 days, from days -5 to -2. Bone marrow (BM) and PBSC were infused on day 0, followed by post-transplant CY (50 mg/kg/day, on days +3 and +4). To protect against hemorrhagic cystitis, MESNA (2-mercaptoethane sodium sulfonate) was administered at 150% of the CY dose. Post grafting immunosuppression with mycophenolate mofetil and tacrolimus commenced on day +5 and extended until days +28 and +84, respectively. Tacrolimus was tapered off by day +90 if there was no GVHD.

Official Title
-----------------
Post-transplant Cyclophosphamide for HLA-haploidentical Transplantation in Wiskott-Aldrich Syndrome

Conditions
-----------------
Wiskott-Aldrich Syndrome

Intervention / Treatment
-----------------
* Procedure: cyclophosphamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients diagnosed with Wiskott-Aldrich Syndrome with indication of Hematopoietic stem cell transplantation Exclusion Criteria: without indication of Hematopoietic stem cell transplantation

Ages Eligible for Study
-----------------
Minimum Age: 5 Months
Maximum Age: 10 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cyclophosphamide|on days +3，+4,using cyclophosphamide 50mg/kg|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of aGvHD | after post transplant cyclophospamide | 3month |
Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate whether the volume of water administered with NN9924 affects the anatomical location (stomach or proximal small bowel) of tablet erosion.

Official Title
-----------------
Pharmacoscintigraphic Investigation NN9924 in Healthy Male Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: semaglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good general health Body mass index (BMI) of 18.5-30.0 kg/m^2 (both inclusive) Exclusion Criteria: Males who are not willing to use two acceptable forms of highly effective contraception Participation in another clinical trial within 90 days Any chronic disorder or severe disease Use of GLP-1 (glucagon-like peptide-1) agonists within 3 months preceding dosing Subjects who are smokers Subjects who have donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period 1: NN9924 with 50 mL water<br> | Drug: semaglutide<br>* Subjects will be treated with two single doses of 10 mg semaglutide in a tablet. Dosing will be done on 2 dosing visits separated by 4 to 6 weeks.<br>* Other names: NN9924;|
| Experimental: Period 2: NN9924 with 240 mL water<br> | Drug: semaglutide<br>* Subjects will be treated with two single doses of 10 mg semaglutide in a tablet. Dosing will be done on 2 dosing visits separated by 4 to 6 weeks.<br>* Other names: NN9924;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE) |  | Assessed 0-4 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the NN9924 concentration curve |  | From time 0-24 hours | 
| Anatomical location of initial tablet erosion (ITE) |  | Assessed 0-4 hours post dose | 
| Time to ITE |  | Assessed 0-4 hours post dose | 
| Time to CTE |  | Assessed 0-4 hours post dose |
Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to determine how safe and effective Gabitril is for outpatients with Social Anxiety Disorder (SAD).

Detailed Description
-----------------
This study is being conducted at two sites in the United States. Approximately 50 patients, who are between the ages of 18 and 65 years old will be enrolled at Emory. This study consists of two parts. The first part consists of 12 weeks of open-label treatment with Gabitril. If the study doctor determines that the patients condition has improved and they have completed the initial 12 weeks of treatment they may be eligible for the second part of the study. This part is a 24-week double-blind treatment period with either Gabitril or placebo (inactive medication). There will also be a follow-up visit about 1 to 3 weeks after they have completed taking the study medication. Altogether study participation is expected to last approximately 37 weeks.

Official Title
-----------------
A 12-Week Open-Label Study Followed By A 24-Week Double-Blind Discontinuation Exploratory Study To Evaluate The Effects Of Gabitril™ (Tiagabine Hydrochloride) In Patients With Social Anxiety Disorder (SAD)

Conditions
-----------------
Social Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: Gabitril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of SAD CGI (S) ≥ 4 at screen LSAS ≥ 50 at baseline Covi Anxiety Scale score greater than the Raskin depression Scale total score at screen Exclusion Criteria: Non-responsive to adequate trials of two or more treatment medications, if previously treated for SAD. HAM-D ≥15 or a score of >2 on Item 1 at baseline Serious or unstable medical condition Alcohol or substance use disorder within 6 months prior to study

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gabitril|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liebowitz Social Anxiety Scale (LSAS) |  |  | 
| Clinical Global Impression-Change (CGI-C) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Anxiety Scale (HAM-A) |  |  | 
| Social Phobia Inventory (SPIN) |  |  | 
| Pittsburgh Sleep Quality Index (PSQI) |  |  | 
| 36-Item Short-Form Health Survey (SF-36) |  |  | 
| Clinical Global Impression-S (CGI-S). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Social Anxiety Disorder, Mental Health
Cost-effectiveness Study of Symbicort as Maintenance and Reliever Therapy (SMART)

Study Overview
=================
Brief Summary
-----------------
This study is an economic evaluation of Symbicort (Budesonide/formoterol) as maintenance and reliever therapy (SMART) versus its competitive alternatives. The aims of this study are: To estimate the relative effectiveness of each one of the alternatives in the management of patients with moderate to severe asthma through a systematic review for the following outcomes: Cumulative incidence of asthma severe exacerbations symptoms Safety of each alternative (frequency of adverse events and complications due to the medications) To estimate the direct medical costs of treating with each pharmacologic alternative: Symbicort as SMART versus increased use of inhaled corticosteroids or Adding long-acting inhaled beta 2 agonist plus inhaled corticosteroids. To create a decision analysis model (decision tree) that allows comparisons between the alternatives on expected values and costs. To calculate the average and incremental cost-effectiveness ratios. To carry out a sensitivity analysis to test de robustness of the cost-effectiveness results allowing for reasonable changes in expected values and costs.

Official Title
-----------------
Management of Patients With Moderate to Severe Asthma Uncontrolled When Treated With Low Dose Inhaled Corticosteroids: Cost-effectiveness of Three Therapeutics Alternatives

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe asthma.

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 |
| --- | --- |
| 1<br>Adult patients 18-65 years with moderate to severe uncontrolled asthma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate incremental cost-effectiveness ratio using Symbicort as Maintenance and Reliever Therapy in the pharmacologic management of patients when compared with competitive alternatives |  | 12 months | 
| Incremental cost-effectiveness ratio from using Symbicort as symbicort as Maintenance and Reliever Therapy when compared with its competitive alternatives |  | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cost-effectiveness analysis, Symbicort
Resuscitation Decisions in the Emergency Department (ED)

Study Overview
=================
Brief Summary
-----------------
The investigators will retrospectively examine the connection between resuscitation decisions of admitted patients at the ED of the University Hospital of Basel and several demographic and health related measures. Additionally there will be an examination, which patient characterestics may have lead to patients not having been asked about resuscitation decisions.

Official Title
-----------------
Influencing Factors on Resuscitation Decisions in the ED

Conditions
-----------------
Resuscitation

Intervention / Treatment
-----------------
* Other: Factors influencing resuscitation decisions of patients
* Other: Factors leading to not asking patients about resuscitation preference


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the emergency department (duration of hospitalisation more than 24 h). Patients with a research consent yes. Exclusion Criteria: Patients being discharged within less than 24 hours. Patients with a research consent no.

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 |
| --- | --- |
| Admitted patients at the ED<br> | Other: Factors influencing resuscitation decisions of patients<br> <br> Other: Factors leading to not asking patients about resuscitation preference<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resuscitation decision of the patient | Answer to the question Do you want life prolonging treatment if necessary? | During stay at ED (range: <1 hour until 31 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient characterestics, which may have lead to patients not having been asked about resuscitation decisions | Age, gender, resuscitation decision, ICD codes | During stay at ED (range: <1 hour until 31 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
resuscitation decision
The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns

Study Overview
=================
Brief Summary
-----------------
The goal of this research study is to compare the levels of free fatty acids and free bilirubin between two intravenous lipid emulsion products in premature newborns.

Official Title
-----------------
The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns

Conditions
-----------------
Prematurity

Intervention / Treatment
-----------------
* Drug: Intralipid, 20% Intravenous Emulsion
* Drug: SMOF lipid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: premature newborns (<32 weeks gestation, stratified <28 weeks versus >28 weeks) <8 days of age receiving lipid infusions <1 g/kg/day at enrollment anticipated to be treated with 3 g/kg/day for a minimum of 48 hours. Exclusion Criteria: patients with direct hyperbilirubinemia >1.5 mg/dl with suspected sepsis meeting Systemic inflammatory response syndrome (SIRS) criteria undergoing treatment with a continuous infusion of morphine with a continuous infusion of pressors (dopamine, dobutamine, epinephrine, etc.) positive blood cultures

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 8 Days

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intralipid<br> | Drug: Intralipid, 20% Intravenous Emulsion<br>* Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.<br>|
| Other: SMOF lipid<br> | Drug: SMOF lipid<br>* Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| free bilirubin serum levels |  | first day of infusion at 3 g/kg/day | 
| free bilirubin serum levels |  | second day of infusion at 3 g/kg/day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| unbound free fatty acid serum level |  | first day of infusion at 3 g/kg/day | 
| unbound free fatty acid serum level |  | second day of infusion at 3 g/kg/day | 
| free fatty acid (total) serum level |  | second day of infusion at 3 g/kg/day of infusion at 3 g/kg/day | 
| number of participants with peak serum triglyceride level >350 mg/dl |  | first and second days of infusion at 3 g/kg/day | 
| mean serum triglyceride level |  | first and second days of infusion at 3 g/kg/day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
parenteral nutrition, lipid emulsion, free bilirubin, free fatty acids
Multispectral Imaging to Characterize Patterns of Vascular Supply Within Lymphoepithelial Mucosa in Oropharyngeal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the blood supply at the base of the tongue and within the tonsil region. We hypothesize that high-resolution Narrow Band Imaging (NBI) will improve the diagnosis of oropharyngeal carcinoma (OPC). The goal is to provide the better assessment of tumor and thus providing better preoperative expectations to patients with OPC or tumor extent prior to radiation therapy.

Official Title
-----------------
Multispectral Imaging to Characterize Patterns of Vascular Supply Within the Lymphoepithelial Mucosa of Patients With Known or Suspected Oropharyngeal Carcinoma (OPC)

Conditions
-----------------
Oropharyngeal Carcinoma, Oropharynx Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years or older Written informed consent Patients with oropharyngeal carcinoma Exclusion Criteria: Tumors of the oral cavity or nasopharynx

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 |
| --- | --- | --- |
| assessment of differential vascularity between normal and clinically apparent tumor with in the specified sites of oropharynx, using standard white-light endoscopy and narrow-band imaging | endoscopy of the oropharynx using white-light and narrow-Band imaging | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Narrow Band Imaging, oropharyngeal carcinoma
Study of Ezetimibe and Fenofibrate in Patients With Mixed Hyperlipidemia (0653-036)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the cholesterol lowering safety and effectiveness of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

Detailed Description
-----------------
The duration of treatment is 48 weeks.

Official Title
-----------------
Evaluation of the Efficacy and Safety of Fenofibrate and Ezetimibe Coadministration in Patients With Mixed Hyperlipidemia

Conditions
-----------------
Hypercholesterolemia, Hypertriglyceridemia

Intervention / Treatment
-----------------
* Drug: MK0653, ezetimibe
* Drug: Comparator: fenofibrate monotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High cholesterol and high triglycerides Exclusion Criteria: Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study

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: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0653, ezetimibe|nan|
|Drug: Comparator: fenofibrate monotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma LDL-C, HDL-C and triglycerides after 12 weeks. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mixed hyperlipidemia (high cholesterol and high triglycerides)