linjc16/ctgov huggingface dataset:
DSP-3025 Study of Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season

Study Overview
=================
Brief Summary
-----------------
Investigate safety/tolerability after a single dose intranasal administration of DSP-3025 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season.

Official Title
-----------------
A Double-blind, Placebo-controlled, Randomised Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of DSP-3025 Administered Intranasally to Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season

Conditions
-----------------
Allergic Rhinitis, Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: DSP-3025
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) between 18.5 and 25 kg/ m2 and a weight between 50 and 80 kg No clinically relevant abnormal findings History of cedar and/or Japanese cypress pollen induced seasonal allergic rhinitis for at least the previous 2 years (only Allergic rhinitis) Exclusion Criteria: Acute illness which requires medical intervention Definite or suspected personal history of adverse drug reactions or drug hypersensitivity Clinical relevant disease or disorder (past or present) A history of asthma

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 Years

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

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

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

Design Details

Allocation: Randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: DSP-3025<br> <br> |
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical chemistry, haematology, urinalysis |  |  | 
| Nasal symptoms and peak nasal inspiratory flow |  |  | 
| Pharmacokinetics |  |  | 
| Biomarkers nasal lavage and blood |  |  |
Metabolic and Endocrine Status in Women With Prior Preterm Birth

Study Overview
=================
Brief Summary
-----------------
The prevalence of preterm birth is rising in most western countries. The causes of preterm birth is not fully understood and seem to be multifactorial. The endocrine and metabolic aspects are scarcely investigated.The main purpose of this study is to test the hypothesis that endocrine and metabolic factors associate to preterm births.

Official Title
-----------------
Metabolic and Endocrine Status in Women With Prior Preterm Birth. A Cross Sectional, Case- Control Study

Conditions
-----------------
Polycystic Ovary Syndrome, Preterm Birth, Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One or more preterm birth in the given period of time Having Namsos Hospital as their local Hospital during pregnancy Exclusion Criteria: Moved from the region of Mid- Norway at the time of the study Lack of communication skills in Norwegian or English Ongoing pregnancy Ongoing breastfeeding
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm birth group<br>Women with prior preterm birth | |
| Term birth group<br>Women with prior term birth | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of PCOS | The prevalence of PCOS will be assessed in both study groups and the difference between the groups will be reported. | one week after enrollment. | 
| The prevalence of Diabetes Mellitus | The prevalence of Diabetes Mellitus will be assessed in both study groups and the difference between the groups will be reported. | one week after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian antral follicle count | Difference between study groups. | three years. | 
| Difference in quality of life between study groups. | Quality of life will be assessed by using Short form 36 Health Survey Questionnaire (SF- 36) | four years | 
| Serum levels of androgens | Difference between study groups | one year | 
| Difference in anxiety between study groups. | Anxiety will be assessed by using Spielberger State Anxiety Inventory Y1 and Y2 (STAI Y1 and Y2). | four years | 
| Serum levels of AMH | Difference between study groups | One year | 
| Serum levels of glucose | Difference between study groups | One year | 
| Serum levels of insulin | Difference between study groups | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preterm birth, Preterm labour, Polycystic Ovary Syndrome, PCOS, Diabetes Mellitus, Hyperandrogenism, Hirsutism, Ovarian cysts, Anti Muller Hormone, Hypertension
Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study

Study Overview
=================
Brief Summary
-----------------
The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study period of 12 months in 30 patients.

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

Intervention / Treatment
-----------------
* Drug: Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of a pigment epithelial tear secondary to age-related macular degeneration Written informed consent Exclusion Criteria: Time of diagnosis more than 6 months before study recruitment Ocular surgery of the study eye within 1 month before study recruitment Extensive subretinal fibrosis or retinal atrophy of the study eye Significant opacification of optical media of the study eye Uncontrolled glaucoma of the study eye Active ocular inflammation of the study eye Best-corrected visual acuity of the contralateral eye below 20/200 Concurrent ocular or systemic therapy with other vascular endothelial growth factor (VEGF)-inhibitory drugs

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 |
| --- | --- |
| Experimental: Ranibizumab<br> | Drug: Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)<br>* Monthly intravitreal injections<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected Visual Acuity | Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal Morphology | Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness | 12 months | 
| Vision-related Quality of Life | National Eye Institute Visual Function Questionaire 25-item version (NEI VFQ-25) 0 to 100 scale, where 100 represents the best possible score and 0 represents the worst Reference: Mangione CM et al. Arch Ophthalmol 2001 Jul;119(7):1050-8. | 12 months |
A Clinical Follow-up Study of Heart Failure Patients.

Study Overview
=================
Brief Summary
-----------------
Heart failure (HF), a current worldwide pandemic with an unacceptable high level of morbidity and mortality, brings an enormous medical and societal burden. Chronic HF is characterized by progressive alteration of cardiac structure and function. But the molecular mechanism of these alterations is still not well-established and needs to be discussed further. HF is a highly heterogeneous disease that can be caused by a multiple of diseases. Dilated cardiomyopathy (DCM) and ischemic cardiomyopathy (ICM) are the main causes of this syndrome. Although HF is the common manifestation of DCM and ICM, the etiology and pathogenesis are different. Understanding the different pathophysiological mechanisms will contribute to the prevention and individualized therapy of heart failure. Therefore, this study aims to observation the different characteristics of the molecular biology and clinical courses in DCM and ICM patients.

Official Title
-----------------
A Clinical Follow-up Study of Heart Failure Patients.

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LVEF≤ 55% enlarged left ventricular end-diastolic dimension ICM group: with history of MI or revascularization; ≥ 75% stenosis of LM or proximal LAD; ≥ 75% stenosis of two or more epicardial vessels. symptomatic heart failure Exclusion Criteria: Known malignant tumour diseases Pregnancy or lactation period； Investigators think not suitable to participate in this trial.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 80 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 |
| --- | --- |
| NC<br>Patients without heart failure. | |
| DCM<br>Dilated cardiomyopathy patients. | |
| ICM<br>Ischemic cardiomyopathy patients. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NYHA functional class | NYHA cardiac functional class | one year after enrolled | 
| All-cause mortality | All-cause mortality during follow-up | one year after enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospitalization for cardiac causes | hospitalization for cardiac causes during follow-up | one year after enrolled | 
| left ventricular end-diastolic dimension(LVEDD) dilates. | left ventricular structure changes:left ventricular end-diastolic dimension(LVEDD) dilates. | one year after enrolled | 
| left ventricular ejection fraction reduces | left ventricular function changes:left ventricular ejection fraction reduces | one year after enrolled |
Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.

Study Overview
=================
Brief Summary
-----------------
The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This is a prospective observational study of infants born at < 30 weeks of gestation. The primary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in premature infants with PDA in comparison to infants without PDA. The secondary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in infant who develop serious adverse events.

Official Title
-----------------
Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.

Conditions
-----------------
Premature Infant, Patent Ductus Arteriosus, Hemodynamic Instability

Intervention / Treatment
-----------------
* Device: Resonance Raman Spectroscopy (RRS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants < 30 weeks estimated gestational age Exclusion Criteria: Infants with major congenital anomalies Infants >34 weeks post-menstrual age
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group -Patent Ductus Arteriosus Absent<br> | Device: Resonance Raman Spectroscopy (RRS)<br>* Pre and post-ductal RRS measurements will be obtained daily for a maximum of 14 data collection times in infants with and without PDAs.<br>|
| Study Group - Patent Ductus Arteriosus Present<br> | Device: Resonance Raman Spectroscopy (RRS)<br>* Pre and post-ductal RRS measurements will be obtained daily for a maximum of 14 data collection times in infants with and without PDAs.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences and pre- and post-ductal RRS measurements of tissue oxygenation. | Pre- and post-ductal tissues oxygenation as measured by RRS may be more significant in infants with PDA. | Up to a maximum of 14 data collection times | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Are differences in pre- and post-ductal StO2 as detected by RRS more significant in infants with serious adverse events. | RRS measurements and the difference between pre- and post-ductal tissue oxygenation will be evaluated in infants with serious adverse events to determine if the measurements could have predicted the serious adverse event. | Up to a maximum of 14 data collection times | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature infant, Tissue Oxygenation, Patent Ductus Arteriosus
The Utility of Cell-free Methylation Markers in Blood for Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Patients with liver cancer expected to undergo radiofrequency ablation or transvascular embolization. Relevant tumor markers (AFP and methylation analysis) were performed. The two data are then counted and compared.

Detailed Description
-----------------
The subjects of this study were patients who were diagnosed with liver cancer by physicians based on AASLD clinical criteria or pathological biopsy. Patients are those who received radiofrequency ablation or transvascular embolization in National Taiwan University Hospital. Which excludes weakness and inability to cooperate Patients with blood test, under the condition of fully informed consent, complete blood test related tumor indicators (AFP and methylation analysis). The two data are then counted Compare.

Official Title
-----------------
The Utility of Cell-free Methylation Markers in Blood for the Prognosis Prediction of Locoregional Treatment for Hepatocellular Carcinoma

Conditions
-----------------
Serum Tumor Markers

Intervention / Treatment
-----------------
* Diagnostic Test: Met-score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with liver cancer by AASLD clinical criteria or pathological sections are planned to receive treatment at National Taiwan University Hospital Liver local treatment such as radiofrequency ablation or transvascular embolization. Be over 20 years old. Under the condition of informed consent, willing to sign the consent form of the subjects. Exclusion Criteria: Patients who are weak and unable to cooperate with blood test. Kidney dysfunction, serum creatinine greater than 1.5mg/dl, it is judged that computer tomography or MRI cannot be performed Vibrate the injector.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCC case<br>Patients are those who received radiofrequency ablation or transvascular embolization in National Taiwan University Hospital. Which excludes weakness and inability to cooperate Patients with blood test, under the condition of fully informed consent, complete blood test related tumor indicators (AFP and methylation analysis). The two data are then counted Compare. | Diagnostic Test: Met-score<br>* methylation analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate efficacy (methylation profiling results) | Correlation of methylation profiling results with AFP and tumor treatment response. | 3 month after treatment |
Efficacy and Safety of Titrated Oral Misoprostol Solution for Labor Induction at Term

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a titrated solution of oral Misoprostol is safe and effective at inducing labor at term, regardless of Bishop Score.

Official Title
-----------------
Efficacy and Safety of Titrated Oral Misoprostol Solution for Labor Induction at Term

Conditions
-----------------
Labor Induction at Term

Intervention / Treatment
-----------------
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: term, singleton no contraindication to prostaglandins vertex no exposure to vaginal prostaglandins in the index pregnancy Exclusion Criteria: parity > 3 severe PIH: BP> 160/100, abnormal LFT's, proteinuria >1g/day previous uterine surgery regular uterine contractions maternal age > 45 twins

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: Misoprostol|titrated oral misoprostol solution|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of vaginal delivery within 24 hours |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine hyperstimulation rate |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor induction at term using a titrated oral misoprostol solution
Effect of LY333531 on Vascular and Neural Functions

Study Overview
=================
Brief Summary
-----------------
To determine if protein kinase C beta plays a significant role in vascular endothelial dysfunction, small fiber neural dysfunction, and oxidative stress associated with diabetes mellitus.

Detailed Description
-----------------
32mg Ruboxistaurin; 4 week cross-over treatment.

Official Title
-----------------
The Effects of a Protein Kinase C Beta Inhibitor, LY333531, on Vascular and Neural Functions in Type 2 Diabetes Mellitus - Study B7A-MC-MBDM

Conditions
-----------------
Diabetes Mellitus

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes diagnosed for at least 1 mo and less than 10 yrs prior to visit 1 HbA1c less than 9% and fasting plasma glucose less than 260mg/dl Blood pressure less than 160/100 mmHg Total cholesterol less than 300 mg/dl and/or triglycerides less than 600 mg/dl Exclusion Criteria: Subjects treated with a thiazolidinedione (TZD) in 12 weeks prior to visit 1. History of heart disease (MI, unstable angina, CVA, TIA, CABG, or percutaneous transluminal coronary angioplasty) w/in 6 months of visit 1 or subjects with BYHA class III or IV congestive heart failure. Female subjects of child-bearing potential that are pregnant or intend to become pregnant (i.e. not practicing an acceptable method of birth control) TSH greater than 1.5 times upper limit of normal at V1 or other endocrine disease. ALT greater than 1.5 times upper limit of normal at V1; Serum creatinine greater than 2.0mg/dl at V1; micro-albumin greater than 300.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ruboxistaurin|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in endothelium-dependent vasodilation of the microcirculation of the skin and nerve axon-related reflex vasodilation. |  | 4 weeks | 
| Improvement in endothelium-dependent vasodilation of the brachial artery (flow mediated dilation) |  | 4 weeks | 
| Improvement in selective measurements of oxidative stress, endothelial activity and vascular abnormalities which will correlate with PKC activity in the peripheral monocytes. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of ruboxistaurin |  | 4 weeks |