linjc16/ctgov huggingface dataset:
Outcome of Patients Treated With IABP

Study Overview
=================
Brief Summary
-----------------
Intra-Aortic Balloon Pumps (IABP) is a widely used and effective left ventricular adjuvant therapy. IABP is an inflatable device placed in the aorta that inflates with diastole and deflates with systole. The aim of this study is to investigate the outcome of patients treated With IABP, and to evaluate the short-term and long-term outcomes of patients with IABP.

Official Title
-----------------
Outcome of Patients Treated With Intra Aortic Balloon Pump

Conditions
-----------------
Coronary Artery Disease, Heart Failure, Left Ventricular Dysfunction, Low Cardiac Output Syndrome, Post-cardiac Surgery, Acute Coronary Syndrome, Cardiogenic Shock

Intervention / Treatment
-----------------
* Device: Intra Aortic Balloon Pump


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving IABP for circulatory support Exclusion Criteria: Refusal of consent

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 100 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Intra Aortic Balloon Pump|Intra Aortic Balloon Pump (IABP) is a circulatory mechanical support device, placed in descending aorta, distally from left subclavian artery and proximally from renal artery. IABP works with counterpulsation concept, synchronized with heart cycle.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 30 days after IABP implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 3 months after IABP implantation |
Structure and Function of Salivary Proteins

Study Overview
=================
Brief Summary
-----------------
This study seeks to provide point-of-care clinical diagnostic systems for the diagnosis of current disease status using saliva as a sample specimen.

Detailed Description
-----------------
The overall hypothesis of this study is that whole saliva and its components, due to its direct anatomic relation to the airways, provides a window on the composition and nature of the disease-specific response in the bronchial, sinus, and nasal airways. By examining proteins created in saliva, we hope to validate that saliva is an important diagnostic tool for for rapid analysis of respiratory status. We further propose that rapid salivary diagnostics will improve patient care in prevalent respiratory diseases with frequent health care utilization and high morbidity, such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis (CF).

Official Title
-----------------
Structure and Function of Salivary Proteins

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6 or more years of age confirmed Cystic Fibrosis Exclusion Criteria: Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Cystic Fibrosis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
HBP Device EGM Data Collection

Study Overview
=================
Brief Summary
-----------------
This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac resynchronization device. Prospective data collection includes surface electrocardiograms, intracardiac electrograms, and pacing parameters, recorded during a patient visit. Additional retrospective data collection includes procedural data during the HB pacing lead and device implant. Up to 200 subjects will participate in this clinical investigation. The clinical investigation will be conducted at up to 8 centers worldwide. The total duration of the clinical investigation is expected to be 1 year, including enrollment and data collection from all subjects.

Official Title
-----------------
His Bundle Pacing Device Electrogram Data Collection

Conditions
-----------------
Sick Sinus Syndrome, AV Block, Heart Failure

Intervention / Treatment
-----------------
* Procedure: Device data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has previously implanted with Abbott device and any pacing lead at HB Age ≥ 18 years Ability to provide informed consent for study participation Willing to comply with study evaluation requirements Exclusion Criteria: Suspected pacing system failure Lead impedance out of range Ventricular sensing amplitude lower than 0.5 mV

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 |
| --- | --- |
| HBP device data collection group<br>Device electrograms and 12-lead ECG will be collected from patients over the age of 18 years who have been previously implanted with a permanent His Bundle pacing lead and an Abbott pacemaker, defibrillator, or cardiac resynchronization therapy device during a standard-of-care device follow-up visit. | Procedure: Device data collection<br>* Collection of device electrograms and 12-lead ECG during a device follow-up visit<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude of device electrogram | Mean amplitude of device electrogram during His bundle pacing | through study completion, an average of 1 year | 
| Duration of device electrogram | Mean duration of device electrogram during His bundle pacing | through study completion, an average of 1 year |
Cost of Cancer Diagnosis Using Next-generation Sequencing Targeted Gene Panels in Routine Practice

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to measure the total cost of performing next-generation sequencing (NGS) in clinical practice in France, in both germline and somatic cancer genetics. The study was performed on 15 French representative cancer molecular genetics laboratories performing NGS panels' tests. The production cost was estimated using a micro-costing method with resources consumed collected in situ in each laboratory from a healthcare provider perspective. A top-down methodology for specific post-sequencing steps was used. Additional non-specific costs were also included and costs were detailed per step of the process.

Official Title
-----------------
Cost of Cancer Diagnosis Using Next-generation Sequencing Targeted Gene Panels in Routine Practice: a Nationwide French Study

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: Measure of the total cost of performing next-generation sequencing (NGS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: French genetics laboratories performing somatic and germline clinical NGS tests. Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Measure of the total cost of performing next-generation sequencing (NGS)|Resources consumed were collected for each laboratory using a standardized questionnaire. The production costs were calculated for the overall process and resources consumed for each step were identified.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall production cost | The study is performed on 15 French representative cancer molecular genetics laboratories performing NGS panels' tests. The production cost is estimated using a micro-costing method with resources consumed collected in situ in each laboratory from a healthcare provider perspective. A top-down methodology for specific post-sequencing steps is used. | through study completion, an average of 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Next-generation sequencing (NGS), Cost, Cancer diagnosis
Prospective Study of HIV Infection in Hemophiliacs

Study Overview
=================
Brief Summary
-----------------
To examine mechanisms of individual differences in the progression of HIV infection in hemophiliacs.

Detailed Description
-----------------
BACKGROUND: In the late 1980s, hemophiliacs were transfused with a variety of blood products, including large amounts of cryoprecipitate. In comparison to other cohorts, hemophiliacs are CMV(-), resulting in a comparison group for the study of this virus as a potential cofactor. In contrast, non A, non-B hepatitis is common in comparison to other cohorts, and preliminary data prior to 1990 suggested that this chronic disease predisposes to more rapid progression of HIV infection. DESIGN NARRATIVE: Disease-free survival rates were determined in HIV-infected hemophiliacs. The effects of co-factors such as intensive transfusion, concomitant cytomegalovirus or chronic NANB hepatitis infection were ascertained. Host-virus interaction was assessed through the use of plasma cultures, specific antibody titers, and markers of immune changes detected by flow cytometry and immune function assays. The immunology of asymptomatic stable infection was investigated. The safety of volunteer donor blood products was determined in seronegative patients exposed to over 50,000 donors yearly and the risk of sexual transmission of HIV to spouses of seropositive patients was monitored.

Conditions
-----------------
Acquired Immunodeficiency Syndrome, HIV Infections, Blood Disease, Hemophilia A, Hepatitis, Viral, Human, Blood Transfusion, Cytomegalovirus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Ultrasound-guided Percutaneous Electrolysis in Female Soccer With Soleus Injury

Study Overview
=================
Brief Summary
-----------------
This study evaluates if the physiotherapy treatment based on combination of therapeutic exercise program and ultrasound-guided PNE on chronic soleous injuries may cause changes in pain, dorsal flexion of the ankle and muscle fatigue in female dance

Official Title
-----------------
Clinical Application of Percutaneous Electrolysis in Female Soccer

Conditions
-----------------
Injury;Sports

Intervention / Treatment
-----------------
* Other: Invasive treatment and exercise therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years having a soleus muscle injury chronic injury (> 3 meses) pain at stretch > 3 points measured by NRS Exclusion Criteria: belenophobia other accuse injury lumbar back pathology

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Participants will receive EPM and they will perform exercise program during 1 month. | Other: Invasive treatment and exercise therapy<br>* The subjects of experimental group will perform therapeutic exercise program and they will be receive Percutaneous Electrolysis therapy and the subjects of experimental group will perform the same exercise program and they will be receive only needling puncture<br>|
| Experimental: Control group<br>Participants will receive needling puncture and they will perform exercise program during 1 month. | Other: Invasive treatment and exercise therapy<br>* The subjects of experimental group will perform therapeutic exercise program and they will be receive Percutaneous Electrolysis therapy and the subjects of experimental group will perform the same exercise program and they will be receive only needling puncture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at palpation | measured by numeric rate scale (0 no pain; 10 worst pain) | From baseline measurement up to one month | 
| Pain at stretch | measured by numeric rate scale (0 no pain; 10 worst pain) | From baseline measurement up to one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ankle dorsiflexion | range of motion measured by goniometer (grade) | From baseline measurement up to one month | 
| muscle fatigue | measured by heel test: raise until muscle fatigue (repetitions) | From baseline measurement up to one month |
Laparoscopic Ultrasound Guided Tissue Sampling in Patients With Cancer of the Upper Gastrointestinal Tract

Study Overview
=================
Brief Summary
-----------------
Laparoscopic Ultrasound (LUS) is an important part of the pre-treatment evaluation of patients with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver cancer). When a suspect lesion is visualized during LUS a biopsy should be provided in order to differentiate between benign and malignant lesions. A new system for LUS guided biopsy has been developed, but how often these biopsies are clinically relevant (i.e. changing patient management)and how reliable are these biopsies are unknown. The study hypothesis is that LUS guided biopsies are accurate and clinically relevant in the pre-treatment evaluation of patients with upper gastrointestinal tract cancer.

Official Title
-----------------
Prospective Evaluation of the Impact of Laparoscopic Ultrasound (LUS) Guided Fine-Needle Aspiration or Tru-Cut Biopsy in Patients With Upper GI Tract Cancer

Conditions
-----------------
Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Liver Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven upper GI tract cancer Laparoscopic Ultrasound indicated during pre-treatment evaluation Exclusion Criteria: Patients unfit for surgery

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopy, Ultrasound, Cancer, Biopsy
Genotype and Phenotype Registry: Enrollment of Normal Control Subjects for Current and Future Research

Study Overview
=================
Brief Summary
-----------------
Registry program for volunteers who are willing to serve as control subjects in future research studies.

Detailed Description
-----------------
The registry is a collection of volunteers willing to participate as control subjects in research studies. Control subjects are people who do not have a specific disease; therefore they can serve a critical role as a comparison with people who have the disease or other characteristic being studied. Once registered, participants will be notified about studies they may be able to participate in as a control. Participation requires: signing a consent form answering a short health survey providing a DNA sample via a mouthwash kit The registry allows scientists to select study participants based on whether or not they have a specific genetic change that may be relevant to a disease under investigation. Having the ability to access controls when needed is an extremely valuable resource that will speed up scientific discoveries.

Official Title
-----------------
TAP0307: Enrollment of Normal Control Subjects for Current and Future Research

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy over age 18 Exclusion Criteria: under age 18

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 |
| --- | --- |
| Healthy Control<br>Healthy control group for research on autoimmune diseases | |

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
-----------------
Healthy, volunteer, Healthy controls, Normal controls
Clinical Evaluation of the Xpert® HIV-1 VL

Study Overview
=================
Brief Summary
-----------------
Compare the clinical performance of the Xpert® HIV-1 VL to another FDA approved HIV-1 RNA quantitative assay using frozen and fresh specimens from known HIV-1 positive individuals.

Official Title
-----------------
Clinical Evaluation of the Xpert® HIV-1 VL: A Method Comparison Study

Conditions
-----------------
Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Device: Xpert HIV-1 VL Assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 seropositive adults using an FDA approved method At least 18 years of age or older Informed consent, if applicable Exclusion Criteria: Subject is less than 18 years of age Previously enrolled in this study Samples not collected according to the procedure

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 |
| --- | --- |
| HIV-1 infected<br>this is a study comparing Xpert HIV-1 VL assay quantitation to an already FDA approved HIV-1 quantitative HIV-1 RNA assay in known HIV-1 infected individuals | Device: Xpert HIV-1 VL Assay<br>* in vitro diagnostic test to quantify HIV-1 RNA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of HIV-1 RNA in copies/mL in known HIV-1 positive subjects | This study is a comparative analysis of HIV-1 RNA quantitation between Xpert HIV-1 VL to another FDA approved test. A single time point (cross-sectional) from each of at least 300 subjects with HIV-1 RNA quantitation within the dynamic range of both assays will be used in regression models to assess performance of the Xpert HIV-1 VL in comparison to the other FDA approved test. | 1 day (A single time point) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1
Risk Factors and Biomarkers Associated With Recurrence After Excision of Primary Pterygium

Study Overview
=================
Brief Summary
-----------------
This study looks at global gene expression in pterygium and found the derangement of matrix genes in particular to be a feature of pterygium. In the investigators opinion, it would be more beneficial to elicit changes in gene expression before the recurrence of pterygium and by developing a panel of biomarkers that are associated with pterygium recurrence; one would be able to predict the post surgical prognosis of patients after resection.Biomarker levels will be compared to discover a biomarker panel for prediction of recurrence.

Detailed Description
-----------------
A comprehensive questionnaire will be used to evaluate the environmental, biological, physical and behavioral risk factors of associated with the recurrence after pterygium excision. Slit lamp digital color photographs will be taken on primary and recurrent pterygium and pterygium will be graded in three levels of severity, based on relative transparency of pterygium tissue; grade 1 (transparent), grade 2 (intermediate), and grade 3 (opaque) to see whether the risk factors correlate to the morphology of the pterygium. Tear samples will be collected before surgery using schirmers strip.Proteins in tear samples will be analyzed using the iTRAQ method. The transcriptional differences in pterygium and conjunctival tissue samples will be analyzed using western blot, qPCR and immunohistochemistry assays.

Official Title
-----------------
Risk Factors and Biomarkers Associated With Recurrence After Excision of Primary Pterygium

Conditions
-----------------
Pterygium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of primary and recurrence pterygium Must agree to participate in this study Must sign informed consent form Exclusion Criteria: Hepatitis HIV/AIDS

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| biomarkers | Elevation of biomarkers in pterygium tissue and tears (transcripts, proteins, or tear proteins) at the time of initial presentation of primary pterygium may predict the post-surgical recurrence within one year. visits: 2 further visits at 6 months and 12 months after surgery | 12 months |