linjc16/ctgov huggingface dataset:
Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the effect of deferasirox on renal hemodynamics by determining glomerular filtration rate (GFR), renal plasma flow (RPF) and filtration fraction (FF).

Official Title
-----------------
Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload

Conditions
-----------------
β-thalassemia, Transfusional Iron Overload

Intervention / Treatment
-----------------
* Drug: Deferasirox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male or female patients ≥ 18 years of age without prior history of deferasirox treatment β-thalassemia patients receiving regular transfusions every 2-5 weeks Transfusion history of ≥ 20 units of packed red blood cells Exclusion criteria: Abnormal renal function at baseline ALT greater than 5 x ULN at screening Patients with underlying cardiac disease requiring continuous iron chelation therapy Other protocol-defined inclusion/exclusion criteria may apply.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deferasirox<br>30 mg/kg/day | Drug: Deferasirox<br>* 30 mg/kg/day<br>* Other names: ICL670;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of deferasirox on renal hemodynamics in patients with β-thalassemia and transfusional iron overload. |  | Once a month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of deferasirox on standard markers of renal function |  | Once a month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
β-thalassemia, transfusional iron overload, renal function, renal biomarkers, deferasirox
Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as shown below through the Post Marketing Surveillance (PMS) study upon approval. Unexpected adverse events (especially, serious adverse events (SAEs)) To find out the status of incidence of adverse events under actual practice Factors on the safety profile Factors on the efficacy profile

Official Title
-----------------
Mirapex PMS Study Final Report

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: Pramipexole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Among the patients with idiopathic Parkinson's disease, from those receiving MIRAPEX Tablets first after a contract of the study to the requested number of cases will be consecutively enrolled without skipping Exclusion Criteria: Following patients are contraindicated. Patients who are hypersensitive to MIRAPEX or its ingredients Refer to the insert paper for other contraindication. Following patients should be carefully administered. Patient with renal impairment Refer to the insert paper for other precaution.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Idiopathic Parkinson's disease patients<br> | Drug: Pramipexole<br> <br> * Other names: Mirapex®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Unified Parkinson's disease Rating Scale (UPDRS) | Tremor at rest, Rigidity, Body bradykinesia and hypokinesia | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | up to 4 weeks | 
| Global Assessment of efficacy by investigator on 3-point scale |  | after 4 weeks |
Video-assisted Thoracic Surgery (VATS) Versus Axillary Mini-thoracotomy for the Treatment of Recurrent Spontaneous Pneumothorax

Study Overview
=================
Brief Summary
-----------------
The investigators conducted a prospective randomized study to compare axillary minithoracotomy versus a modified two-port thoracoscopic technique for surgical pleurodesis in patients with recurrent spontaneous pneumothorax operated in a single institution. The main objective of the study was to investigate possible differences regarding short- and long-term clinical outcome between the two different techniques.

Official Title
-----------------
A Prospective Randomized Study of a Modified Two-port Thoracoscopic Technique Versus Axillary Minithoracotomy for the Treatment of Recurrent Spontaneous Pneumothorax.

Conditions
-----------------
Pneumothorax

Intervention / Treatment
-----------------
* Procedure: Modified thoracoscopic technique
* Procedure: Axillary mini-thoracotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ipsilateral recurrent spontaneous pneumothorax first episode of contralateral pneumothorax Exclusion Criteria: None
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: VATS group<br> | Procedure: Modified thoracoscopic technique<br>* Two-port thoracoscopic technique<br>* Other names: VATS;|
| Active Comparator: Mini-thoracotomy group<br> | Procedure: Axillary mini-thoracotomy<br>* Axillary mini-thoracotomy<br>* Other names: Thoracotomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pneumothorax recurrence rate | Recurrence rate |  | 
| Postoperative complication rate | Postoperative complications |  | 
| Patient satisfaction with treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of one-lung ventilation |  |  | 
| Total operative time |  |  | 
| Duration of chest tube drainage |  |  | 
| Length of postoperative hospital stay |  |  | 
| Incidence of chronic pain |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
video-assisted thoracic surgery, axillary mini-thoracotomy, bullectomy
Distal Protection Combined With PTCA in AMI Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate if use of the AngioGuard™ XP improves myocardial reperfusion after PTCA as assessed by ST segment resolution at the end of PTCA.

Detailed Description
-----------------
This is a prospective, randomized, multicenter trial. Patients will be randomized either to be treated by PTCA only or in combination with the An-gioGuard™ XP device. The patients will be followed for six-months post-procedure.

Official Title
-----------------
Distal Protection Combined With PTCA in AMI Patients -- The DIPLOMAT Study.

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Angioguard distal protection device
* Other: PTCA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute myocardial infarction < 12 hours with ST segment elevation > 2 mm in at least 2 contiguous leads; Clinical indication of primary PTCA; De novo or restenotic lesions in native coronary vessel, single vessel treatment only; Target lesion stenosis is > 80% (by visual estimation). Exclusion Criteria: Patient has unprotected left main coronary disease with > 50% stenosis in case left coronary artery is treated; Patient has an ostial target lesion; Killip class > 3.

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 |
| --- | --- |
| Other: 1<br>PTCA | Other: PTCA<br>* PTCA<br>|
| Other: 2<br>PTCA with angioguard | Device: Angioguard distal protection device<br>* PTCA with the Angioguard distal protection device.<br>* Other names: Cordis AngioGuard™ XP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute ST segment resolution. |  | post-PTCA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ST segment resolution (> 50% decrease). |  | pre- and post-PTCA | 
| TIMI Frame Count |  | post PTCA | 
| Composite endpoint of slow flow, no reflow or distal embolization. |  | at anytime | 
| Regional wall motion index by echocardiography. |  | discharge and 6 month follow-up | 
| Clinical success evaluation; qualitative evaluation of device and delivery system characteristics. |  | post-procedure | 
| Cardiac function assessed by echocardiography. |  | before discharge and at 6 month follow-up |
Incidence of Retained Surgical Devices and Treatment

Study Overview
=================
Brief Summary
-----------------
It has been estimated that in the United States alone 48 million operations are performed annually and most involve the use of multiple surgical items, including needles and other sharp objects, surgical sponges, and surgical instruments1. Textile material and instruments forgotten in a patient undergoing an invasive procedure is a negligence of an entire team responsible for maintaining patient safety. A retained surgical foreign body (RSFB) usually requires at least a second surgery for retrieval of the object, and also carries a risk for major complications including morbidity and death2. Retained foreign bodies are underreported to minimize exposure to possible litigation3. Therefore, the real occurrence of RSFB is underestimated, recently there has reported an incidence of 0.356 / 1,000 patients whereas others reported a rate of 1/5000 with an associated mortality ranging from 11 to 35% 4-5. Therefore, there is a need for improved systems and methods for identifying and tracking surgical items, including needles and other sharp objects, surgical sponges, and surgical instruments during a surgical procedure.

Detailed Description
-----------------
All cases investigated due to retained material during hospital surgical treatment will be included. Incidence, type of procedure performed, the prevalence and guilty of the personal actuating will be considered.

Official Title
-----------------
Incidence of a Retained Surgical Device in Patients That Underwent Surgery

Conditions
-----------------
Postoperative Complications, Surgical Sponges, Surgical Instruments, Retained Surgical Tools

Intervention / Treatment
-----------------
* Other: Cases study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient who during internment for surgery had an accident of forgetfulness in the material used for their treatment. Exclusion Criteria: No exclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Cases study|Patients with a retained device or almost|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of retained devices | Cases with retained devices or almost accident will be considered | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of devices | Sponge , instruments and others devices | 3 years |
A Retrospective, Observational, Noninterventional Data Collection Study for Patients With Molybdenum Cofactor Deficiency Who Have Been Previously Treated With Cyclic Pyranopterin Monophosphate (cPMP)

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess safety and efficacy data of Escherichia coli-derived cPMP in patients with molybdenum cofactor deficiency (MoCD).

Official Title
-----------------
A Retrospective, Observational, Noninterventional Data Collection Study for Patients With Molybdenum Cofactor Deficiency Who Have Been Previously Treated With Cyclic Pyranopterin Monophosphate (cPMP)

Conditions
-----------------
Molybdenum Cofactor Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of any age. Patient with MoCD type A, suspected type A, or type B. Patient previously received cPMP only by intravenous route of administration. Parent(s) or legal guardian(s), depending on local regulations, has voluntarily provided written informed consent for the Investigator, Investigator's designee, or Sponsor designee to review, collect, transmit, and analyze data extracted from the medical record. In the case of a deceased patient for whom the parents or legal guardians could not be located, the appropriate ethical review committee may assign another person as legal representative to provide consent, where applicable per local and country regulations. Exclusion Criteria: Patient's parent(s) or legal guardian(s) are unable to understand the nature and scope of the study.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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 |
| --- | --- | --- |
| Safety and Efficacy | This is a noninterventional, observational, retrospective study to collect data on pediatric patients with MoCD who have received E. coli derived cPMP by intravenous only administration. The study will neither provide treatment with cPMP nor alter any ongoing treatment schedules; rather, its objective is to retrospectively collect data on MoCD history and previous treatment with intravenous E. coli derived cPMP, which is documented in the medical records of patients who have received treatment according to a named patient treatment plan. | For up to 60 months from the initial date of treatment with cPMP |
Study of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to assess the safety and effectiveness of entecavir, when being added to lamivudine, in the treatment of adults with chronic hepatitis B infection who are co-infected with HIV.

Official Title
-----------------
A Phase II Study of the Safety and Efficacy of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients Who Have Hepatitis B Viremia While Being Treated With Lamivudine

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

Intervention / Treatment
-----------------
* Drug: Entecavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Documented history of co-infection with HIV and HBV Stable Anti Retroviral Therapy regimen containing lamivudine 150 mg BID for at least 24 weeks prior to enrollment; Documented HBV viremia on screening and at least at 4 weeks prior to screening HBe Ag-positive or HBe Ag-negative / anti-HBe-positive HIV viral load below 400 copies/mL by the Roche Amplicor(TM) 1.5 HIV PCR assay at screening and equally low at least 12 weeks prior to screening Absence of Co-Infection with hepatitis C virus (HCV) or hepatitis D virus (HDV) Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease Less that 1/2 weeks of prior therapy with nucleoside/nucleotide analogue (excluding lamivudine) with activity against HBV (including e.g. famciclovir, tenofovir, ganciclovir, adefovir). No receipt of any of these therapies within 24 weeks prior to randomization into this study.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Entecavir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ramanspectroscopy in Barrett's Esophagus

Study Overview
=================
Brief Summary
-----------------
This study is being done to see if a new device, called near-infrared Raman spectroscopy, can provide similar information as that obtained from taking biopsies of the lining of your Barrett's esophagus

Detailed Description
-----------------
In the search for means to enhance the surveillance of BE, optical spectroscopy is emerging as a candidate with high potential. Optical spectroscopic techniques measure specific light-tissue interactions, such as fluorescence, elastic scattering, and Raman (inelastic) scattering, which provide objective and quantitative diagnostic information about the molecular and/or structural status of tissue. Moreover, optical spectroscopy has the capacity to identify tissue pathology in situ in a rapid and non-destructive fashion. Among the optical spectroscopic techniques, near-infrared Raman spectroscopy (NIRS) is particularly promising because of the wealth of molecular-specific information contained in its spectra

Official Title
-----------------
In-Vivo Raman Spectroscopy of Barrett's Esophagus

Conditions
-----------------
Barrett's Esophagus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Closed to further enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrett's Esophagus
Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine if a novel lead-based arm board is effective at reducing radiation dose to the operator during invasive cardiac procedures. Secondary objectives are to measure effect on radiation dose to patient and total fluoroscopy (x-ray) time.

Official Title
-----------------
Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures With a Novel Lead-Based Arm-Board

Conditions
-----------------
Patients Undergoing Invasive Cardiac Procedures, Radiation Exposure

Intervention / Treatment
-----------------
* Device: Novel Lead Based Armboard
* Device: Standard Armboard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Planned invasive cardiology procedure, cardiac catheterization with or without percutaneous coronary intervention (PCI), or PCI alone. Exclusion Criteria: Inability to provide consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Novel Lead Based Armboard<br> | Device: Novel Lead Based Armboard<br>* Novel Lead Based Armboard<br>|
| Placebo Comparator: Standard Armboard<br> | Device: Standard Armboard<br>* Standard Armboard (without lead)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation dose (μSv) to the operator at the chest | Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level. | At procedure completion | 
| Radiation dose (μSv) to the operator at the forearm level | Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level. | At procedure completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Air kerma |  | At procedure completion | 
| Dose area product |  | At procedure completion | 
| Radiation dose to the patient |  | At procedure completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Catheterization, Percutaneous Coronary Intervention, Radiation, Lead Shielding