linjc16/ctgov huggingface dataset:
The Causative Insects in Severe Insect Sting Allergy

Study Overview
=================
Brief Summary
-----------------
Study the causative insect by skin prick test and sIgE to wasp, bee and fire ants are important but false positive by crossreactivity can occur. sIgE to recombinant venom allergen is proposed to help in finding the causative insect.

Detailed Description
-----------------
Insect sting allergy from insects in Hymenoptera is not uncommon. The reaction maybe very severe and life threatening. To find the cause of insect sting allergy is important in prevention and specific treatment such as immunotherapy. The skin prick test and sIgE of these insects may have cross reactions so it is difficult to be interpreted. The usage of sIgE recombinant venom allergen can benefit in separate cross reaction and dual allergy reaction.

Official Title
-----------------
Evaluating the Causative Insects in the Cases With Severe Insect Sting Allergy

Conditions
-----------------
Insect Sting Allergy

Intervention / Treatment
-----------------
* Other: Skin prick test
* Other: sIgE measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases with severe insect sting allergy reactions Exclusion Criteria: Without other severe systemic diseases Not pregnant or lactation
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: insect sting allergy<br>Skin prick tests to local and imported insect sting allergen with different concentration are performed. sIgE Measurement (to insect and the recombinant venom) | Other: Skin prick test<br>* Skin prick tests to local and imported insect sting allergen with different concentration are performed.<br>Other: sIgE measurement<br>* sIgE levels to stinging insect allergen and their recombinant venom allergen are measured<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean wheal diameters of skin prick test of local and imported insect allergens | Compare Mean wheal diameters of skin prick test of local and imported insect allergens at different concentrations | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| specific IgE level to stinging insect allergen and recombinant venom allergens | compare skin prick test result and levels of specific IgE level to stinging insect allergen and recombinant venom allergens | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insect sting allergy, recombinant venom allergen
Diagnostic Outcomes Of The Females Presenting With Breast Lump In Surgical Department Services Hospital Lahore

Study Overview
=================
Brief Summary
-----------------
It is a simple crossectional study in which we are trying to identify the outcomes of female breast lump presenting to surgical OPD of services hospital lahore.

Official Title
-----------------
Diagnostic Outcomes Of The Females Presenting With Breast Lump In Surgical

Conditions
-----------------
Breast Lump in Females Presenting to Surgical OPD

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasonsography, mammography, biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:female patients with breast lump aged from 20 to onwards - Exclusion Criteria: female patients with breast abscess

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Ultrasonsography, mammography, biopsy|Ultrasonsography of lump in breast Mammography of patents above 35 years Biopsy if indicated|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome of breast lump in female patients | Outcome will either benign disease like fibroadenoma or malignat like carcinoma | 4 weeks |
Mapping of Lymph Node Metastasis and Survival For pN+ Superficial Esophageal Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
With the deeper tumor invasion, the higher LNM rate beside the bilateral recurrent laryngeal nerves(RLN) was.

Official Title
-----------------
Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Conditions
-----------------
National Cancer Center/Cancer Hospital

Intervention / Treatment
-----------------
* Procedure: Esophagectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Our predefined search strategy identified pT1N+ ESCC cases without preoperative treatment, between February 2012 and April 2022. Exclusion Criteria: The patients were excluded because they were (1)less than 10 lymph nodes removed; (2) lacked specific sites of LNM; or (3) incomplete follow-up information.

Ages Eligible for Study
-----------------
Minimum Age: 44 Years
Maximum Age: 73 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Esophagectomy|McKeown, Ivor-Lewis, and Sweet procedure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LNM rates of the 207 thoracic T1N+ ESCC patients. |  | 2012.2-2022.4 |
Correlation of Trans Cranial Doppler Ultrasound and CT Scan in Monitoring of Posttraumatic Brain Edema

Study Overview
=================
Brief Summary
-----------------
The most common tool for diagnosis and follow up of cerebral edema in ICU is brain CT scan that necessitate patient transportation with risk of hemodynamic instability, and exposure to radiation. Transcranial Doppler (TCD) sonography allows true and rapid imaging of blood flow velocities of intracranial vessels. Transcranial Doppler sonography provides noninvasive evaluation of intracranial pressure by its characteristic wave patterns

Official Title
-----------------
Correlation of Trans Cranial Doppler Ultrasound and CT Scan in Monitoring of Posttraumatic Brain Edema

Conditions
-----------------
Brain Edema

Intervention / Treatment
-----------------
* Diagnostic Test: transcranial ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: isolated blunt Traumatic Brain Injury age 18-60 years Exclusion Criteria: Pregnancy Intracerebral hemorrhage Patients whose blood flow velocities could not be obtained from Trans temporal acoustic bone windows.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: transcranial ultrasound|- Transcranial Doppler sonography will be performed with the patients in the supine position., using low frequency probe of 2 MHz will be placed on temporal bone- will be performed daily|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the correlation between CCT scans score and Pulsatility Index of each patient |  | 7 days |
A Study to Evaluate Efficacy and Safety of VX-864 in Participants With the PiZZ Genotype

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of VX-864 in participants with the PiZZ genotype over 48 weeks.

Official Title
-----------------
A Phase 2, Open-label Study Evaluating Efficacy and Safety of VX-864 in Subjects With Alpha-1 Antitrypsin Deficiency Who Have the PiZZ Genotype, Over 48 Weeks

Conditions
-----------------
Alpha-1 Antitrypsin Deficiency

Intervention / Treatment
-----------------
* Drug: VX-864


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Participants must have a PiZZ genotype confirmed at screening Plasma AAT levels indicating severe deficiency at screening Key Exclusion Criteria: History of a medical condition that could negatively impact the ability to complete the study Solid organ, or hematological transplantation or is currently on a transplant list History of use of gene therapy or Ribonucleic acid interference (RNAi) therapy at any time previously Participants for whom discontinuation of augmentation therapy is not considered to be in their best interest, based on the clinical judgement of the treating physician Other protocol defined Inclusion/Exclusion criteria may apply.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Participants will receive VX-864 every 12 hours (q12h) for 48 weeks. | Drug: VX-864<br>* Tablets for oral administration.<br>|
| Experimental: Group B<br>Participants will undergo a liver biopsy done before receiving VX-864 q12h for 48 weeks, and will undergo a second liver biopsy at either Week 24 or Week 48. | Drug: VX-864<br>* Tablets for oral administration.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Functional Alpha-1 Antitrypsin (AAT) Levels |  | From Baseline at Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Functional AAT Levels |  | From Baseline up to Week 48 | 
| Change in Blood Antigenic AAT Levels |  | From Baseline up to Week 48 | 
| Change in Blood Z-polymer Levels |  | From Baseline up to Week 48 | 
| Part B: Change in Z-polymer Accumulation in the Liver |  | From Baseline up to Week 48 | 
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Day 1 up to Week 52 |
A Study to Determine the Long-Term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1B

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To evaluate the long-term safety and tolerability of SAR421869 in patients with Usher syndrome Type 1B Secondary Objective: To assess long-term safety and biological activity of SAR421869

Detailed Description
-----------------
The total duration of study period is up to 15 years.

Official Title
-----------------
An Open-label Study to Determine the Long-term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1B

Conditions
-----------------
Usher's Syndrome

Intervention / Treatment
-----------------
* Drug: Blood draw for the laboratory assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Provide signed and dated written informed consent (and if appropriate assent) and any locally required authorization eg, Health Insurance Portability and Accountability Act (HIPAA). Must have been enrolled in protocol TDU13600. Must have received a subretinal injection of SAR421869 Exclusion criteria: Did not receive SAR421869 as part of the TDU13600 protocol.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Long-term follow up<br>Long-term follow up of patients who received SAR421869 in a previous study TDU13600 | Drug: Blood draw for the laboratory assessment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events | The number and percentage of patients with treatment emergent adverse events | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically important changes in ocular safety assessments | From baseline in (TDU13600) study and from the last visit best-corrected visual acuity (BCVA), slit-lamp examination, fundososcopy, intraocular pressure, laboratory parameters, concomitant medications | baseline to 15 years | 
| Delay in retinal degeneration | Measured as change from baseline in function relative to untreated contralateral eye on: BCVA, static perimetry, autofluorescence, optical coherence tomography (OCT) | baseline to 15 years |
Vascular Closure Device in Transcatheter Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a single-center prospective study.

Official Title
-----------------
Plug-based Percutaneous Vascular Closure Device in Transcatheter Aortic Valve Replacement

Conditions
-----------------
Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Device: MANTA vascular closure device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing transfemoral TAVI at the Karolinska University Hospital Exclusion Criteria: Patients undergoing TAVI with access other than transfemoral Use of closure device other than MANTA
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing transfemoral TAVI with MANTA closure<br>Patients undergoing transfemoral transcatheter aortic valve replacement with femoral access site closure using the novel plug-based vascular closure device (MANTA, Teleflex/Essential Medical Inc., Malvern, Pennsylvania, USA). | Device: MANTA vascular closure device<br>* Femoral access site closure using the MANTA closure device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with major vascular complications | Major vascular access site complications according to the VARC-2 definitions | 6 week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with minor vascular complications | Minor vascular access site complications according to the VARC-2 definitions | 6 week follow up | 
| Number of patients with vascular closure device failure | Percutaneous vascular closure device failure according to the VARC-2 definitions | 6 week follow up | 
| Number of patients with life-threatening, disabling or major bleeding | Life-threatening, disabling or major bleeding complications according to the BARC definitions | 6 week follow up |
Epidemiological Study to Evaluate Personality Disorders in Prison Populations in Treatment for Hepatitis C

Study Overview
=================
Brief Summary
-----------------
Primary objective: Evaluate the prevalence of personality disorders in patients starting treatment for hepatitis C in the prison and determine their influence on the evolution of the disease.

Detailed Description
-----------------
Secondary objectives: Describe the management of patients with personality disorders on treatment for hepatitis C in the prison. Describe the characteristics of patients who discontinue the treatment and the reasons for stratifying by the presence of personality disorders.

Official Title
-----------------
Prospective Observational Study to Assess Personality Disorders in Prison Populations for Hepatitis C Treatment. 

Conditions
-----------------
Hepatitis C, Chronic, Personality Disorders in Prison

Intervention / Treatment
-----------------
* Other: Peginterferon alfa-2a
* Drug: Ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age. Patients with expected prison stay beyond the duration of follow-up period of the study. Patients with chronic HCV infection and detectable viral load to initiate treatment with standard therapy. Patients their written informed consent to participate in the study. Exclusion Criteria: Patients previously treated with Interferon (IFN) and Ribavirin (RBV). Patients can not read or understand a written questionnaire at the discretion of the investigator.

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 |
| --- | --- |
| Pegasys, injection subcutaneous<br>Hepatitis C Virus (HCV) patients monoinfected or coinfected, all genotypes, treatment naive to Peginterferon alfa-2a and Ribavirin (RBV) | Other: Peginterferon alfa-2a<br>* Treatment as usual clinical practice<br>* Other names: Pegasys;Drug: Ribavirin<br>* Treatment as usual clinical practice<br>* Other names: Copegus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Viral Response (SVR) |  | RNA-VHC at weeks 24 or 48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prison, disorder, hepatitis c
Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty

Study Overview
=================
Brief Summary
-----------------
To compare the early visual results and postoperative recovery between two groups of keratoconic patients - one group having undergone a traditional, mechanical vacuum trephine procedure while the second group underwent femtosecond-enabled penetrating keratoplasty.

Official Title
-----------------
Visual Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Procedure: Penetrating keratoplasty with IntraLase
* Procedure: Penetrating keratoplasty with vacuum trephine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years old, with keratoconus and corneal transplant indication Exclusion Criteria: Exclusion criteria included different ocular pathology and a potential visual acuity of less than 20/40

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br> | Procedure: Penetrating keratoplasty with IntraLase<br>* penetrating keratoplasty with femtosecond laser shaped incisions- IntraLase TM (IntraLase Enabled Keratoplasty [IEK])<br>|
| Active Comparator: Group 2<br> | Procedure: Penetrating keratoplasty with vacuum trephine<br>* Group 2 - penetrating keratoplasty with vacuum trephine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pachimetry, Microscopy, Corneal topography |  | 1 year |
Chorioamnionitis and Proinflammatory S100A12

Study Overview
=================
Brief Summary
-----------------
Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS) and increased levels of proinflammatory molecules.

Detailed Description
-----------------
Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS). The aim of this pilot study was to evaluate S100A12, a marker of innate immune activation, in mothers with or without HCA and in their infants. Concentrations of S100A12, Interleukin 6 (IL-6) and C-reactive protein (CRP) were evaluated in maternal, cord, and neonatal blood of very preterm infants. Histologic examinations of placentae and umbilical cords were performed.

Official Title
-----------------
Impact of Chorioamnionitis on Maternal and Fetal Levels of Proinflammatory S100A12

Conditions
-----------------
Chorioamnionitis Affecting Fetus or Newborn

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm Birth Exclusion Criteria: Congenital Abnormalities
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>maternal chorioamnionitis | |
| group 2<br>no maternal chorioamnionitis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| S100A12 in Presence of Maternal Chorioamnionitis | Levels of S100A12 in Maternal, Cord and Neonatal Blood in the Presence or Absence of HCA | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonate, Chorioamnionitis, S100A12