linjc16/ctgov huggingface dataset:
Study on the Role of Gamma Delta T Cells in Sepsis Immunosuppression and Its Molecular Mechanism

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the status and function of gamma delta T cells in peripheral blood of sepsis patients.

Detailed Description
-----------------
Sepsis therapy is a prominent problem of the modern critical care medicine,and improving the level of sepsis treatment by immune intervention measures is a hot research topic with close attention.Gamma delta T cells is considered as one new T lymphocyte subset in recent years,which playing an important role in resistance to infection,anti-tumor and immune regulating function in the body.First,we played attention to the status and function of gamma delta T cells in peripheral blood of sepsis patients including differentiation marker,subtype and production of related cytokine,and then the molecular mechanism of insufficient gamma delta T cells.At the same time the responsibility of gamma delta T cells of sepsis patients to certain bacteria and viral antigen and the regulation of gamma delta T cells on other natural immune cells including NK cells and mononuclear cells were studied to identify the status and role gamma delta T cells in sepsis immunosuppression by culture in vitro.Further we studied the effect of specific stimulants on proliferation and activation of gamma delta T cells in patients with sepsis and also anti-infection acquired by gamma delta T cells,expecting as an entry point to explore new treatment strategy to sepsis.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical symptoms of severe sepsis and septic shock age over 18 years Exclusion Criteria: preexisting autoimmune disease patients received immuno-suppressive treatment in the previous 6 months patients with chronic infection,e.g.tuberculosis,hepatitis or HIV infection,etc. pregnancy

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 |
| --- | --- |
| severe sepsis and septic shock<br>patients were diagnosed severe sepsis or septic shock | |
| patient control<br>Patients after elective surgeries presented with SIRS but without sepsis | |
| volunteer<br>Health persons | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of activated gamma delta T cells |  | within 24h after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of apoptotic gamma delta T cells |  | within 24h after recruitment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, gamma delta T cells, immunosuppression
Retrospective Evaluation of Thrombo-embolic Complication in Pelvic Fracture Surgery

Study Overview
=================
Brief Summary
-----------------
Pelvic fracture are very often treated by surgery ; however there are a high level of thrombotic risk during the surgery (venous thrombo embolic events represent about 10% to 50%. The aim of our study is to report the number of these events and identify the risk factor associated to these events regarding Greenfield Risk Assessment Profile .

Official Title
-----------------
Retrospective Evaluation of Thrombo-embolic Complication in Pelvic Fracture Surgery

Conditions
-----------------
Venous Thromboembolism, Pelvic Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication to pelvic fracture surgery age above 18 years Exclusion Criteria: pelvic fracture without surgery indication.

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 |
| --- | --- | --- |
| number of venous thrombo-embolic events |  | Month 1 |
Multidrug Resistance After Trabeculectomy With Mitomycin C

Study Overview
=================
Brief Summary
-----------------
We investigate whether mitomycin C treatment during previous filtration surgery induces P-glycoprotein expression.

Detailed Description
-----------------
Despite the adjuvant use of mitomycin C during trabeculectomy, short-term and long-term failures still occur. We investigate whether mitomycin C treatment during previous trabeculectomy induces P-glycoprotein expression. Expression of P-glycoprotein is analysed in surgically removed Tenon tissue using immunohistochemistry.

Official Title
-----------------
Multidrug Resistance After Trabeculectomy With Mitomycin C

Conditions
-----------------
Glaucoma, Trabeculectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with planned trabeculectomy for elevated eye pressure one third of patients without previous trabeculectomy two thirds of patients with previous trabeculectomy (one third with and one third without the use of mitomycin C) Exclusion Criteria: patients not requiring surgery patients with planned surgery for elevated eye pressure other than trabeculectomy

Ages Eligible for Study
-----------------
Minimum Age: 8 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Drug Resistance, Multiple, Trabeculectomy
Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate non inferiority of Eurofarma budesonide nasal spray x referral Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients will receive Astrazeneca medication. There is no placebo group.

Detailed Description
-----------------
Budesonide is a medicine already very used and registered about 20 years. Eurofarma has the intention to collect more data about safety and efficacy and present them to local authority. This study was draw to treat patients with persistent rhinitis moderate to severe in sites located locally in Brazil.

Official Title
-----------------
Phase III, Multicenter, Randomized, Simple-blinded, Parallel Groups to Evaluate Non Inferiority of Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Persistent Rhinitis Moderate to Severe

Conditions
-----------------
Rhinitis, Allergic, Perennial

Intervention / Treatment
-----------------
* Drug: Budesonid 50mcg (Noex)
* Drug: Budesonid 50mcg (Busonid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 12 History of allergic persistent rhinitis moderate to severe at least 2 years Proved allergic using PRICK or RAST test Nasal symptoms (NIS) > 3 and nasal obstruction >1 Indication of nasal corticosteroids use Washout of nasal corticosteroids for 14 days ICF Exclusion Criteria: Other types of rhinitis Asthma non controlled Use of oral/injectable corticoids 30 days before screening patients not eligible to complete diaries patients with allergy to any substance of medicines non controlled disease

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonid 50mcg (Noex)<br>Budesonid 50mcg (Noex), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day. Treatment of 28 days. | Drug: Budesonid 50mcg (Noex)<br>* Suspention to nasal use, 2 atomization in each nostril during the morning and at night.<br>|
| Active Comparator: Budesonid 50mcg (Busonid)<br>Budesonid 50mcg (Busonid), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day. Treatment of 28 days. | Drug: Budesonid 50mcg (Busonid)<br>* Suspention to nasal use, 2 atomization in each nostril during the morning and at night.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate non inferiority of Noex using the questionnaire Nasal Index Score (NIS) | Using the questionnaire Nasal Index Score (NIS) | 28 days |
Coordinated Assessment of Notifications of Trials Containing Overt Published Errors

Study Overview
=================
Brief Summary
-----------------
Clinical research, like all science, is self-correcting, with errors detected by the scientific community and communicated to the publishing journals, which then relay the information (and its resolution) to its readers. If this relaying process fails, science grinds to a halt. In this study we are testing its integrity.

Detailed Description
-----------------
This prospective study documents the outcome of notification to journal editorial boards (or equivalent authorities) of factually incorrect or inconsistent claims, in reports they have published.

Official Title
-----------------
Phase II Study of Response of Medical Journal Editorial Boards to Notification of Serious Discrepancies in Published Clinical Trials in Human Patients.

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Behavioral: Reporting of discrepancy to journal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Report of a clinical trial in humans of treatment of heart disease with bone marrow derived stem cells Report containing discrepancy by reference to same report or another report Exclusion Criteria: Discrepancy has already been corrected by an erratum
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Provision of information<br>Reporting of discrepancy to journal | Behavioral: Reporting of discrepancy to journal<br> <br> * Other names: Negative NYHA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to correction, retraction, or other notification to the readership of discrepancy |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to initial response from journal |  | 0-4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Discrepancy, Committee on Publication Ethics, Correction, Erratum, Retraction
Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated Patients Using the AnapnoGuard System

Study Overview
=================
Brief Summary
-----------------
Ventilator Associated Pneumonia (VAP) is a common complication experienced by mechanically ventilated patients and within the framework of Respiratory Intensive Care Units. The AnapnoGuard system, developed by Hospitech Respiration Ltd. is a ventilation guard system that includes a number of unique characteristics. This study was designed to test the frequency VAP in mechanically ventilated ICU patients using the AnapnoGuard System.

Official Title
-----------------
Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated ICU Patients Using the AnapnoGuard System

Conditions
-----------------
Ventilator Associated Pneumonia

Intervention / Treatment
-----------------
* Device: AnapnoGuard 100,
* Device: routine mechanical ventilator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patients; Patient was connected to AnapnoGuard system up to six hours from intubation; Age - above 18. Exclusion Criteria: Pneumonia; Aspiration Pneumonia; Chronic or Severe Pneumonia; Chronic Obstructive Pulmonary Disease (COPD) requiring permanent home-based antibiotic treatment; Interstitial Lung Disease (ILD); Post Lung Transplant State; Immunosuppression. Patients ventilated in prone position Patient who was ventilated 3 months prior to being enrolled in the study Pregnant 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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AnapnoGuard 100<br>Respiratory guard system during mechanical ventilation | Device: AnapnoGuard 100,<br>* Respiratory guard system during mechanical ventilation with routine mechanical ventilator<br>|
| Active Comparator: Control<br>routine mechanical ventilator | Device: routine mechanical ventilator<br>* routine mechanical ventilation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAP occurence |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events occurence |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VAP
Evaluations of Optimizing Perioperative Fluid Management on Postoperative Pain Outcomes

Study Overview
=================
Brief Summary
-----------------
Patient characteristics, duration of surgery, and infusion volumes will be compared between the groups. Oxygen transport and organ function will be compared Length of hospital stay, morbidity, postoperative pain intensity were compared. Continuous variables will be analyzed using the student t-test and discrete variables will be analyzed using Chi-Square test. P-value <0.05 will be considered significant, where appropriate 95% confidence intervals will be calculated. Statistical analysis will be carried out using standardize statistical programs SPSS 12.0 for windows.

Conditions
-----------------
Patients Major Laminectomy Surgery

Intervention / Treatment
-----------------
* Procedure: SVV-guided fluid management
* Procedure: CVP-guided fluid management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients are undergoing elective spine laminectomy Exclusion Criteria: age <20 yr emergency surgery coagulopathy renal and hepatic dysfunction hyperthyroidism, and cardiac rhythm other than sinus rhythm

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SVV-guided fluid management<br>SVV : Stoke volume variation | Procedure: SVV-guided fluid management<br> <br> |
| Active Comparator: CVP-guided fluid management<br>CVP : Central venous pressure | Procedure: CVP-guided fluid management<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at rest and movement |  | Post-operation Day1 to Day4 |
A Study of CAT-1004 Biomarkers in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy humans.

Official Title
-----------------
A Phase 1, Single Center, Biomarker Study in Healthy Subjects Receiving Single Doses of CAT-1004

Conditions
-----------------
Assessment of Mechanistic Blood Biomarkers in Healthy Humans

Intervention / Treatment
-----------------
* Drug: CAT-1004
* Drug: Salsalate + DHA
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good health as determined by medical history, vital signs, EGC, physical exam and clinical lab results BMI between 18 and 30 kg/m2 inclusive Exclusion Criteria: Viral or bacterial infection within 21 days prior to randomization Use of prescription drugs, nonprescription drugs, herbals and dietary supplements within 7 days prior to randomization

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAT-1004 Dose #1<br>Single dose #1 | Drug: CAT-1004<br> <br> |
| Active Comparator: Salsalate + DHA<br>Single dose #2 | Drug: Salsalate + DHA<br> <br> |
| Placebo Comparator: Placebo<br>Single Dose #3 | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) activity p65 following ex vivo lipopolysaccharide stimulation |  | Pre/post each of 3 Single doses |
Adult Arm of DZL All Age Asthma Cohort (ALLIANCE)

Study Overview
=================
Brief Summary
-----------------
Deep Phenotyping of adult asthma patients: severity from mild to severe both atopic and non-atopic both childhood and adult onset both smokers and non-smokers corresponding pediatric cohort (Pediatric Arm of DZL All Age Asthma Cohort) with equivalent SOPs regarding collection of biomaterial and clinical data incl. lung function, further processing of biomaterial and further analyses

Detailed Description
-----------------
The clinical heterogeneity of asthma patients has been increasingly recognised within the last years. Recent studies and articles highlighted the idea of asthma not beeing a single disease but rather a unifying term for multiple phenotypes. Phenotype in this sense is defined as the combination of observable properties of an organism, that are produced by the interactions of a genotype and the environment. In contrast, endotype describes a specific underlying pathophysiological pathway. Linking asthma phenotypes and endotypes in a system biological approach is an important research goal in order to develop targeted therapy, especially for severe asthma. The advantage the investigators' cohort provides is the collaboration with an equivalent pediatric cohort. In this setting questions regarding disease onset, exacerbation and chronicity can be posed and worked with in a comprehensive manner.

Official Title
-----------------
The All Age Asthma Cohort (ALLIANCE) of the German Center for Lung Research (DZL), Adult Arm

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proven Diagnosis according to current GINA Guideline (2014) Ability to read and understand German Ability to understand and agree to informed consent Exclusion Criteria: History of respiratory tract infection within the last 4 weeks before inclusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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 |
| --- | --- | --- |
| Defining clinical asthma phenotypes by combining clinical, lung function and biomaterial data |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, phenotype, childhood, adulthood
Pre-Approval Access Program for Talquetamab in Relapsed or Refractory Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The purpose of this pre-approval access program is to give talquetamab monotherapy (treatment with single drug) to participants with relapsed or refractory multiple myeloma (a type of cancer that begins in plasma cells [white blood cells that produce antibodies] which has returned or difficult to treat) who have relapsed on or are refractory to all locally available and clinically appropriate treatment and who are not eligible for a clinical trial.

Detailed Description
-----------------
Talquetamab (JNJ-64407564) is a humanized immunoglobulin G4 proline, alanine, alanine (IgG4PAA) bispecific antibody designed to target G-Protein Coupled Receptor (5DGPRC5D) and cluster of differentiation 3 (CD3). Redirecting T-cells to a tumor surface antigen using bispecific antibody approaches may be an effective means to harness the immune system to destroy cancer cells expressing GPRC5D and create meaningful and long-lasting clinical responses. Talquetamab is supplied as single-dose Investigational Product (IP) vials for subcutaneous administration. Safety assessments will include adverse events, serious adverse events, adverse drug reactions, and special situations which will be reported during the duration of the pre-approval access program.

Official Title
-----------------
Pre-Approval Access Named Patient Program for Talquetamab (JNJ-64407564) for Treating Physician Use in Relapsed or Refractory Multiple Myeloma

Conditions
-----------------
Relapsed or Refractory Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Talquetamab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant diagnosed with relapsed or refractory multiple, myeloma Participant exhausted all commercially approved and clinically appropriate treatment options, and is ineligible for a clinical trial

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 |
| --- |
|Drug: Talquetamab|Talquetamab will be administered subcutaneously.|

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

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