linjc16/ctgov huggingface dataset:
A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and Intraocular pressure lowering effectiveness of the Streamline™ Surgical System.

Detailed Description
-----------------
This is a prospective, nonrandomized, open-label study evaluating the safety and IOP-lowering effectiveness of CPI Visco-Surgical System (STREAMLINE™ SURGICAL SYSTEM) in patients with open-angle glaucoma undergoing cataract surgery.

Official Title
-----------------
A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE™ SURGICAL SYSTEM in Patients With Open-Angle Glaucoma

Conditions
-----------------
Intraocular Pressure, Open Angle Glaucoma

Intervention / Treatment
-----------------
* Device: ab interno canaloplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must meet all the following criteria in order to be eligible for participation in this study: Subjects qualifying for cataract surgery Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 21-36 mmHg. Exclusion Criteria: Subjects are ineligible for participation in this study if s/he meets any of the following criteria: Patients who could not be washed-out of IOP-lowering medications. .

Ages Eligible for Study
-----------------
Minimum Age: 22 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: Treatment with Streamline following cataract surgery<br>Treatment with Streamline System following phacoemulsification | Device: ab interno canaloplasty<br>* A modification of traditional canaloplasty procedure. Can be combined with or done without cataract surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20% | Descriptive | From Baseline at Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in intraocular pressure (IOP) | Exploratory analysis | From Baseline at Month 12 | 
| Changes from baseline in number of IOP lowering medications | Exploratory analysis | From Baseline at Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intraocular Pressure, Glaucoma, Glaucoma Surgery, Ab interno
Study of ONO-1078 in Patients With Chronic Sinusitis

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy and safety of ONO-1078 in patients with chronic sinusitis in a double-blind, randomized, placebo-controlled, parallel group, multi-center study

Official Title
-----------------
Study of ONO-1078 in Patients With Chronic Sinusitis, a Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study

Conditions
-----------------
Chronic Sinusitis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Pranlukast hydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic sinusitis Exclusion Criteria: acute sinusitis chronic sinusitis with acute exacerbation

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 74 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: P<br> | Drug: Placebo<br>* 0 mg BID for 12 weeks<br>|
| Experimental: E<br> | Drug: Pranlukast hydrate<br>* 225 mg BID for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nasal congestion |  | 12 weeks | 
| rhinorrhea |  | 12 weeks | 
| postnasal drip |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| easiness of blowing nose |  | 12 weeks | 
| easiness of removing postnasal drip |  | 12 weeks | 
| dull headache |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-1078, chronic sinusitis
Lamictal in the Treatment of Post-Herpetic Neuralgia

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of Lamictal for the treatment of pain and reduction of allodynia in patients with post herpetic neuralgia.

Official Title
-----------------
Lamictal in the Treatment of Post-Herpetic Neuralgia-A Safety, Efficacy,Randomized, Double Blind, Placebo Controlled, Cross-Over Study

Conditions
-----------------
Neuralgia, Postherpetic

Intervention / Treatment
-----------------
* Drug: Lamictal in the treatment of Post-Herpetic Neuralgia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients will be over the age of 18, Need to have a diagnosis of Post-Herpetic Neuralgia, Minimum of 4 on the Likert Pain Scale, If currently taking TCA and/or Gabapentin, need to have been on stable dose for minimum of 4 weeks Exclusion Criteria: Currently on any antiepileptic drugs (AED), except for Gabapentin. Currently taking opioid or unwilling to washout prior to the study, Pregnant and lactating, Have active severe systemic disease, History of Stevens-Johnson syndrome or TEN, Clinically significant abnormal lab values, Known drug allergy to Lamictal, Patients on Fibrates (Tricor and Lopid), History of major psychiatric disturbance and substance abuse. Valproate due to increase chances of severe rash, Lidocaine Patch, Use of hormonal contraceptives (birth control pills, patch, ring, injection)

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lamictal in the treatment of Post-Herpetic Neuralgia|nan|

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
-----------------
Inclusion Criteria:Minimum of 4 on the Likert Pain Scale.If currently taking TCA and/or Gabapentin, need to have been on stable dose for minimum of 4 weeks., Exclusion Criteria:, Currently on any antiepilepic drugs (AED), except for Gabapentin., Currently taking opioid or unwilling to washout prior to the study,, Pregnant and lactating,, Have active severe systemic disease,, History of Stevens-Johnson syndrome or TEN,
Study of ZIO-101 in Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma

Official Title
-----------------
A Phase I/II Trial of ZIO-101 in Advanced Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: ZIO-101 (Darinaparsin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects with multiple myeloma who have received at least two prior therapies and currently require therapy.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: ZIO-101 (Darinaparsin)<br>* IV zio-101 (Darinaparsin) give for 5 consecutive days to be repeated every 28 days for up to 6 months<br>* Other names: ZIO-101;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I: toxicity defined in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) 12/12/03 |  | 6 months | 
| Phase II efficacy using EMBT criteria. |  | 6 months | 
| Safety |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of ZIO-101 |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma, Arsenic, Cancer study, Failed treatment
Different Hemostasis According to the Anesthetic Agents

Study Overview
=================
Brief Summary
-----------------
We investigated the hemostatic differences according to the main anesthetic agents by analyzing rotational thromboelastometry (ROTEM) under the hypothesis that propofol-based anesthesia would impair postoperative coagulability more than the sevoflurane-based anesthesia.

Official Title
-----------------
The Influence of Propofol and Sevoflurane on Hemostasis During Ophthalmic Surgery: Rotational Thromboelastographic Study.

Conditions
-----------------
Cataract, Retina Detachment, Pterygium, Keratitis, Vitreous Hemorrhage

Intervention / Treatment
-----------------
* Drug: Propofol, remifentanil
* Drug: Sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patient scheduled for ophthalmic surgery under general anesthesia American Society of Anesthesiologist physical status I or II Exclusion Criteria: hematologic disorder severe anemia liver disease kidney disease taking a medication interfering with hemostasis

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total intravenous anesthesia group<br>This group received propofol and remifentanil for the maintenance of general anesthesia. | Drug: Propofol, remifentanil<br> <br> |
| Experimental: Inhalation anesthesia group<br>This group received sevoflurane for the maintenance of general anesthesia. | Drug: Sevoflurane<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clotting time of ROTEM |  | 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia | 
| Clot firmness time of ROTEM |  | 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia | 
| Alpha angle of ROTEM |  | 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia | 
| Maximum clot firmness of ROTEM |  | 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin |  | 10 minutes before the induction of anesthesia | 
| Hematocrit |  | 10 minutes before the induction of anesthesia | 
| Platelet count |  | 10 minutes before the induction of anesthesia | 
| International normalized ratio of prothrombin time |  | 10 minutes before the induction of anesthesia | 
| Activated partial thromboplastin time |  | 10 minutes before the induction of anesthesia | 
| Fibrinogen |  | 10 minutes before the induction of anesthesia |
Optimal Sensing in Atrial Tachyarrhythmia's Study

Study Overview
=================
Brief Summary
-----------------
The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal atrial fibrillation (AF) and atrial tachyarrhythmia (AT), and the rejection of far field sensing of the far field R-wave (FFRW).

Detailed Description
-----------------
The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal AF and AT and the rejection of far field sensing of the far field R-wave (FFRW). The study aims to evaluate the accuracy of the detection of atrial tachyarrhythmias (ATAs). An improved detection can potentially increase the accuracy of clinical treatment decisions, based on device derived data.

Official Title
-----------------
OSAT: Optimal Sensing in Atrial Tachyarrhythmia's Study

Conditions
-----------------
Sick Sinus Syndrome, Paroxysmal Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Accent Pacemaker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with class I or II pacing indications for Sick Sinus Syndrome with suspected paroxysmal atrial tachyarrhythmias over the last 6 months Signed informed consent Age >18 yrs Exclusion Criteria: Severe valvular heart disease (echocardiogram less than 6 months old) Angina Pectoris class ≥ III Congestive heart failure - NYHA class ≥ III Left Ventricular Ejection Fraction < 35% (less than 6 months old) Hypertrophic Cardiomyopathy

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: Optisense lead<br>Patients with an Accent pacemaker and an OptiSense atrial lead | Device: Accent Pacemaker<br>* Implantation of pacemaker<br>* Other names: OptiSense 1999 atrial lead;|
| Active Comparator: Tendril lead<br>Patients with an Accent pacemaker and a Tendril atrial lead | Device: Accent Pacemaker<br>* Implantation of pacemaker<br>* Other names: OptiSense 1999 atrial lead;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of undersensing of paroxysmal AF and AT from Holter recording. |  | 1-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and duration of inappropriate mode switches due to FFRW sensing during sinus rhythm. |  | 1-3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AF, Automatic Mode Switch, FFRW, paroxysmal AF
Volume of Perirenal Fat and Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The perirenal fat may alter renal function by secreting fibrotic inflammatory agents when accumulates during obesity. Nephrectomy for renal tumor is a model that would provide tissue samples to test this hypothesis. Renal tumor could itself be responsible for inflammation and fibrosis in its environment. This study aims to measure the influence of the tumor on his kidney Environment and fat and define molecular markers not influenced by renal tumor. The main objective is to compare the inflammation of the perirenal fat taken in two locations in the same patient, in contact and 4 cm from the outer edge of the tumor, each patient as his own control. The secondary objective is to compare the degree of interstitial fibrosis of the renal cortex in the same sampling methods.

Conditions
-----------------
Nephrectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or more Indication nephrectomy for kidney tumor Stadium T1a, T1b or T2 and M0 according to the TNM (Tumor Nodes Metastasis) classification of tumors Exclusion Criteria: Nephrectomy indication for chronic pyelonephritis Asian topic because of the difference threshold values used to characterize the metabolic syndrome in this population Diabetes type I or II due to a high score of renal interstitial fibrosis Infection with HIV (Human immunodeficiency virus) Partial nephrectomy (a part of the kidney on the side of the tumor is left in place)

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 |
| --- | --- | --- |
| Numbers of renal interstitial fibrosis |  | 1 day |
The Study of Polycystic Ovary Syndrome(PCOS) With Gene and Questionnaire

Study Overview
=================
Brief Summary
-----------------
Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous as the syndrome. This first part of study is determine whether genetic polymorphisms influence hormonal and metabolic characteristics in Taiwanese patients with PCOS and controls. Furthermore, women with PCOS were reported with high risk of cardiovascular disease, the investigators planned to calculate the difference of carotid intima-media thickness (IMT) and B-type natriuretic peptide (BNP) between women with PCOS and normal control to determine the premature atherosclerosis of women with PCOS.

Official Title
-----------------
The Study of Metabolic and Cardiac Vascular Risk in Patients With Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women at reproductive age women with PCOS and women without PCOS. Exclusion Criteria: young women who had their menarche less than 3 years women older than 45 years old, Amenorrhea of menopause, hyperglycemia, hyperthyroidism, hypothyroidism, heart failure, lung failure, renal failure, anemia, dystrophy, gonitis.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with PCOS<br> | |
| Normal Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation of PCOS betwwen metabolic and cardiovascular disease. |  | Participant were followed for 1 month in study period. |
University Hospital Cardiac Device MR Registry: The Safety of MR Imaging in Patients With Implanted Cardiac Devices

Study Overview
=================
Brief Summary
-----------------
A single-center registry to prospectively evaluate the safety of non-cardiac/non-thoracic magnetic resonance imaging (MRI) in patients with implanted cardiac devices (pacemakers and implantable cardioverter defibrillators).

Detailed Description
-----------------
Evaluation of safety of MR scanning of patients with implanted cardiac devices. Device parameters pre and post MR imaging will be assessed.

Official Title
-----------------
University Hospital Cardiac Device MR Registry: The Safety of MR Imaging in Patients With Implanted Cardiac Devices

Conditions
-----------------
MRI, Pacemaker, Defibrillator

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years or older Informed consent can be provided by patient or medical power of attorney Presence of implanted pacemaker or ICD MRI is the diagnostic modality of choice for a specific clinical scenario without acceptable alternative imaging technology as determined by ordering physician Non-cardiac/non-thoracic MRI ordered Exclusion Criteria: Presence of metallic objects that represent a contraindication to MR imaging Morbid obesity which results in body contact with the magnet façade Pacemaker or ICD generator implanted prior to 2002 ICD patients who are pacing dependent Pregnancy Device generator at ERI (elective replacement interval) Presence of other active implanted medical device Presence of abandoned leads (with the exception of post CABG temporary epicardial pacing wires) Presence of implanted cardiac device in the abdominal position Pacemaker or ICD that is labeled as MRI-Conditional by the FDA Pacemaker or ICD implanted less than 6 weeks prior to MRI scan

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

| Intervention/Treatment |
| --- |
|Other: MRI|MR imaging of patients with implanted cardiac devices|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Battery voltage | Change in voltage > 0.04 V | Immediate | 
| Pacing lead impedance | Change in impedance > 50 Ohms | Immediate | 
| Shock impedance | Change in impedance > 3 Ohms | Immediate | 
| P wave amplitude | Decrease in amplitude > 50% | Immediate | 
| R wave amplitude | Decrease in amplitude > 25% | Immediate | 
| Pacing lead threshold | Threshold increase > 0.5 V at a fixed pulse width of 0.4ms | Immediate | 
| Adverse event | An adverse clinical event | Immediate |