linjc16/ctgov huggingface dataset:
A Phase 1, Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of E10030 intravitreous injection when administered as monotherapy or in combination with Lucentis® 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Official Title
-----------------
A Phase 1, Single Ascending Dose Trial to Establish the Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) Monotherapy and of E10030 Given in Combination With Lucentis®0.5 Mg/Eye in Subjects With Neovascular Age-Related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: E10030


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subfoveal choroidal neovascularization (CNV) due to AMD Exclusion Criteria: Any of the following underlying diseases including: Diabetic retinopathy. History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 19.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months, ventricular tachyarrythmias requiring ongoing treatment. History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation. Clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function. Stroke (within 12 months of trial entry). Any major surgical procedure within one month of trial entry. Previous therapeutic radiation in the region of the study eye. Any treatment with an investigational agent in the past 60 days for any condition. Known serious allergies to the fluorescein dye used in angiography, to the components of the ranibizumab formulation, or to the components of the E10030 formulation.

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| No Intervention: 1<br>E10030 | Drug: E10030<br>* Intravitreal injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ophthalmic DLTs |  | immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  | immendiate |
Inactive FSH in Galactosemia

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate whether inactive FSH plays a role in the development of Premature Ovarian Failure in women with Classic Galactosemia

Official Title
-----------------
The Role of Inactive Follicle Stimulating Hormone in Ovarian Dysfunction in Galactosemia

Conditions
-----------------
Galactosemia, Premature Ovarian Failure

Intervention / Treatment
-----------------
* Drug: follitropin and lutropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of galactosemia through GALT-activity analysis and/or mutation analysis Premature Ovarian Failure with FSH > 30 U/l Exclusion Criteria: Gynecological cancers and/or unexplained vaginal bleeding

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: follitropin and lutropin<br>* follitropin and lutropin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estradiol response |  | 3 days |
Double Blind Comparative Study of TAK-875

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in diabetic patients.

Conditions
-----------------
Diabetic Patients

Intervention / Treatment
-----------------
* Drug: TAK-875
* Drug: TAK-875
* Drug: Glimepiride
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant is an outpatient. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. Exclusion Criteria: The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease. The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAK-875 25 mg<br> | Drug: TAK-875<br> <br> |
| Experimental: TAK-875 50 mg<br> | Drug: TAK-875<br> <br> |
| Active Comparator: Glimepiride<br> | Drug: Glimepiride<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose | Blood glucose | 4 weeks |
Scleroderma Treatment With Celution Processed ADRCs Registry

Study Overview
=================
Brief Summary
-----------------
This registry study will assess the safety and performance of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand scleroderma.

Detailed Description
-----------------
This registry study will assess the safety and performance of the Celution System in preparation of adipose derived regenerative cells in the treatment of scleroderma affecting the hands. This will be a multi-center, multi-national study.

Official Title
-----------------
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (ADRCs) Registry

Conditions
-----------------
Scleroderma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of scleroderma and presence of hand scleroderma Cochin score ≥ 20 units Exclusion Criteria: Body Mass Index < 17 kg/m2 Infection in any finger Stable medications for the treatment of scleroderma for ≥ 1 month Pregnant or lactating status.

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 |
| --- | --- | --- |
| Change in Cochin score |  | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cochin score |  | Days 30 and 180 | 
| Scleroderma Health Assessment Questionnaire (SHAQ) |  | Days 7, 30, 90 and 180 | 
| Physician and Patient Global Assessment |  | Days 7, 30, 90 and 180 | 
| Raynaud's Condition Score |  | Days 7, 30, 90 and 180 | 
| EQ-5D |  | Days 7, 30, 90 and 180 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scleroderma, Device, ADRCs, adipose derived regenerative cells, hand
Accuracy of the RIVA Digital Blood Pressure Measurement App - a Pilot Study

Study Overview
=================
Brief Summary
-----------------
The aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure Measurement App with and without initial calibration. Additionally, accuracy of the Blood Pressure Measurement 24 hours after calibration will also be tested.

Detailed Description
-----------------
Conventional blood pressure measurements (BPM) using a cuff-based device are actually gold standard of BPM in clinical practice. Due to availability and patient comfort, the number of such BPM is limited. Considering the large number of people using smartphones, app-based measurements and screening procedures have the potential to increase the availability of BPM and improve blood pressure control, but a prerequisite of the use of these alternative BPM methods is accuracy. The aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure Measurement App with and without initial calibration. Additionally, accuracy of the BPM 24 hours after calibration will also be tested. Before mounting the 24h-Blood Pressure (BP) monitor, a set of 11 BPM will be taken, starting with a conventional BPM using a Welch Allyn Connex® Spot Monitor, then alternating to the app, leading to 6 possible pairs of comparison. The next day, without another calibration of the app, we will take another 3 pairs of comparison (7 alternating measurements, starting with a conventional measurement). Examinators are blinded for the results of the app measurements. The app automatically sends the data of the BPM to RIVA Digital, where the results measured by the app will be processed. The staff of RIVA Digital are blinded to the conventional BPM results. Number of Participants: 50 consecutive patients will be included in the study. Statistical analyses: Both BPM procedures are analyzed for correlation and accuracy.

Official Title
-----------------
Accuracy of the RIVA Digital Blood Pressure Measurement App After Initial Calibration and After 24 Hours in a General Population - a Pilot Study

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing a 24h-ambulatory blood pressure measurement Exclusion Criteria: age < 18 years impossibility to sign informed consent physical restrictions to Blood Pressure Measurement

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 |
| --- | --- | --- |
| Data statistical analysis | Both Blood Pressure Measurement procedures are analysed for correlation and accuracy | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Pressure, RIVA
Adverse Events With Magnesium Sulfate

Study Overview
=================
Brief Summary
-----------------
To investigate in pregnant women the adverse pulmonary effects of magnesium sulfate (MgSO4), a commonly used drug for tocolysis or arrest of labor.

Detailed Description
-----------------
BACKGROUND: Preterm labor is a major public health concern in the United States. The delay of labor, particularly for idiopathic preterm labor, is important because it allows further fetal development and the opportunity to administer steroids which improve fetal lung maturity. It is now common for MgSO4 to be administered to delay labor. The most dangerous adverse event with MgSO4 treatment is the development of pulmonary edema which may lead to maternal adult respiratory distress syndrome and death with associated fetal morbidity and mortality. The estimates of the frequency of this complication vary from 0 to 8 percent. Therefore, improved understanding of the pulmonary toxicity of this therapeutic agent is clinically important. DESIGN NARRATIVE: There were three phases in the study. The first, a retrospective cohort study, examined the incidence rate of pulmonary edema when MgSO4 was administered as a tocolytic agent. The second, a case-control study nested within the cohort, examined the relationship between the patient and other clinical factors and the incidence of pulmonary edema in patients treated with MgSO4. The third phase used the results of the case-control study to develop and validate a predictive index to define a group of patients at increased risk of developing pulmonary edema associated with MgSO4. Patients were identified using ICD-9-CM codes for preterm labor and delivery. The medical record was reviewed to determine exposure to MgSO4 as a tocolytic agent, excluding patients who received MgSO4 for other indications. Cases were defined as probable when patients met the clinical definition for pulmonary edema, including chest X-ray findings. The medical charts of both cases and a random sample of non cases were then reviewed in detail and the data from these groups were compared. The primary analysis of these case-control data included unadjusted analysis and multivariable explanatory models to provide insight into the risk factors for pulmonary edema associated with MgSO4. The data from the case-control study were used to develop a clinical predictive index. The predictive rule was then validated in a separate patient population.

Conditions
-----------------
Lung Diseases

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

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

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

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 |
| --- | --- | --- |
Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation

Study Overview
=================
Brief Summary
-----------------
The chronic success rate, defined as freedom from any atrial tachyarrhythmias will increase from 35% to 60% by ablation of complex fragmented atrial electrograms potentials in addition to pulmonary vein isolation (PVI) as compared to PVI alone in patients with long-standing persistent AF.

Official Title
-----------------
Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation - Pulmonary Vein Isolation With or Without Ablation of Complex Fragmented Atrial Potentials

Conditions
-----------------
Atrial Fibrillation, Tachycardia

Intervention / Treatment
-----------------
* Procedure: pulmonary vein isolation
* Procedure: pulmonary vein isolation with additional ablation of fragmented potentials


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: long standing persistent atrial fibrillation > 6 months and < 5 years Exclusion Criteria: renal failure left atrial size >55 mm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: 1<br>ablation: pulmonary vein isolation | Procedure: pulmonary vein isolation<br>* common pulmonary vein isolation procedure<br>|
| Active Comparator: 2<br>ablation: pulmonary vein isolation with additional ablation of fragmented potentials | Procedure: pulmonary vein isolation with additional ablation of fragmented potentials<br>* common pulmonary vein isolation with additional but also common ablation of fragmented potentials<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| data collection in view of acute and chronic success rate |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| data collection of complications in both groups and also procedure parameters |  | 12 months |
Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether tranilast at two different dosages compared to placebo is effective in patients with active RA when added to continuing methotrexate (MTX) therapy.

Detailed Description
-----------------
The primary objective of this study is to assess the efficacy and safety of two different doses of tranilast as determined by ACR20 response at 12 weeks.

Official Title
-----------------
A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast With Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients With Active Rheumatoid Arthritis (RA)

Conditions
-----------------
Active Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Tranilast
* Drug: Tranilast
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving methotrexate Have at least 8 painful/tender and 6 swollen joints May be receiving oral steroids, chronic NSAIDs and/or hydroxychloroquine. Exclusion Criteria: Use of any anti-arthritic treatments except those allowed in inclusion criteria Pregnant or nursing females Abnormal laboratory values History of clinically significant renal, hepatic dysfunction, psychiatric disorder, or alcohol/drug dependence Clinically significant systemic infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Tranilast<br>Tranilast, 300 mg/day | Drug: Tranilast<br>* 150 mg tranilast tablets, bid, 12 weeks<br>|
| Experimental: 2 Tranilast<br>Tranilast, 150 mg/day | Drug: Tranilast<br>* 75 mg tablets, bid, 12 weeks<br>|
| Placebo Comparator: 3<br>Placebo | Drug: Placebo<br>* Placebo tablets, bid, 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieve of ACR20 response |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving ACR 50 and 70 response |  | Week 12 | 
| EULAR responders (e.g. DAS28 good or moderate responders) |  | week 12 | 
| Mean change from baseline of each ACR component |  | weeks 2, 4, 8, 12 and 16 | 
| Assess the safety and tolerability of both doses of tranilast |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid arthritis
Evaluation of Clinical Significance and Feasibility of CT Guided Biopsy of Double Site Lesions：A Preliminary Lung Centered Study

Study Overview
=================
Brief Summary
-----------------
This study aims to explore the clinical significance and feasibility of double site biopsy by analyzing the pathological characteristics and the incidence of main complications of CT guided puncture biopsy of lung and other parts coexisting lesions.

Detailed Description
-----------------
CT guided biopsy is minimally invasive, accurate and low cost. It is often used as an important diagnostic method when the clinical suspect of malignant disease or the treatment effect of the disease is not good. In patients with suspected malignant lung disease, metastasis of other parts of lung, pulmonary door, mediastinum, bone, and distant soft tissue may be combined at the same time. It is the key link of clinical work to evaluate the nature of these coexisting lesions accurately and choose appropriate treatment methods. At present, there is little clinical study on lung centered double site biopsy. This study aims to explore the clinical significance and feasibility of double site biopsy by analyzing the pathological characteristics and the incidence of main complications of CT guided puncture biopsy of lung and other parts coexisting lesions.

Official Title
-----------------
Evaluation of Clinical Significance and Feasibility of CT Guided Biopsy of Double Site Lesions：A Preliminary Lung Centered Study

Conditions
-----------------
Carcinoma of the Lungs

Intervention / Treatment
-----------------
* Diagnostic Test: Double site CT guided needle biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with suspected malignancy underwent dual site CT guided biopsy in the Third Hospital of Peking University Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinical diagnosis of suspected malignant tumor by dual site CT guided needle biopsy<br> | Diagnostic Test: Double site CT guided needle biopsy<br>* Double site CT guided needle biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| for the combination of two site biopsies | The incidence of 4 kinds of combined pathological results in different lesion location groups was analyzed. | up to 2weeks | 
| for the combination of two site biopsy approaches 1 | The incidence of pneumothorax on the surgical side after unilateral lung biopsy | up to 2weeks | 
| for the combination of two site biopsy approaches 2 | the incidence of pneumothorax on the surgical side after bilateral lung biopsy | up to 2weeks | 
| for the combination of two site biopsy approaches 3 | the incidence of intra tissue hemorrhage after biopsy were statistically analyzed. | up to 2weeks |