linjc16/ctgov huggingface dataset:
Efficacy and Safety Study of Abnoba Viscum F 20mg in Malignant Pleural Effusion Patients

Study Overview
=================
Brief Summary
-----------------
Phase 3, non-randomized, Multicenter, single arm study to assess efficacy and safety of Abnoba viscum F 20mg in patients with malignant pleural effusion

Official Title
-----------------
A Phase 3, Multi-Center, Single-Arm, Open-Label Study For The Safety And Efficacy Of Mistletoe Extract (AbnobaViscum® Injection) In Malignant Pleural Effusions

Conditions
-----------------
Malignant Pleural Effusion

Intervention / Treatment
-----------------
* Drug: Abnoba Viscum F 20mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject who need the pleurodesis among subjects diagnosed with a mlignant pleural effusion Full lung expansion must be achieved within 12 to 24 hours after drainage Expected survival time of at least 2 months Subject who score 50 or more on the Karnofsky Performance Scale Exclusion Criteria: Subjects with previous attempts at pleurodesis with sclerosing agent Subjects with trapped lung or bronchial obstruction Subjects with adverse drug response to mistletoe agents Subjects who have participated in another clinical study other than the present study Subjects who is taking immune-suppressive agents Subjects with medical and psychiatric contraindications for the study drug Subjects who are not allowed to participate in the study by legal requirement Subjects who are not allowed to participate in the study by the Investigator's discretion

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abnoba Viscum F 20mg<br> | Drug: Abnoba Viscum F 20mg<br>* intravesical instillation of five amples of AbnobaViscum® F20mg and 0.9% normal saline into the pleural space<br>* Other names: abnobaVISCUM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Efficacy assessment of pleural effusion with Chest X-ray after 4 weeks of final treatment | 4 weeks |
Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes in Pediatric Population

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness and safety of catheter ablation of frequent symptomatic PVCs in the pediatric population as first-line therapy compared with antiarrhythmic drugs.

Official Title
-----------------
Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes as a First-line Therapy in Pediatric Population Without Structural Heart Disease

Conditions
-----------------
Ventricular Arrhythmia

Intervention / Treatment
-----------------
* Procedure: Radiofrequency catheter ablation
* Drug: Metoprolol
* Drug: Verapamil
* Device: NAVI-STAR® RMT ThermoCool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic, frequent, premature ventricular complexes (more than 10,000 according to the 24 hour Holter ECG) Exclusion Criteria: Antiarrhythmic therapy before inclusion Structural heart pathology requiring surgical correction; Premature ventricular complexes associated with structural heart disease; Previously performed radiofrequency ablation due to premature ventricular complexes.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum 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 |
| --- | --- |
| Experimental: Ablation<br>Standard radiosurgery ablation of premature ventricular complexes using navigation system. | Procedure: Radiofrequency catheter ablation<br>* Biosense Webster: NAVI-STAR ThermoCool, NAVI-STAR® RMT ThermoCool<br>Device: NAVI-STAR® RMT ThermoCool<br> <br> |
| Active Comparator: Control<br>Antiarrhythmic therapy of premature ventricular complexes according to the guidlines | Drug: Metoprolol<br>* Antiarrhythmic therapy of premature ventricular complexes Metoprolol 12-50 mg<br>Drug: Verapamil<br>* Verapamil 20-240 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of premature ventricular complexes ≥ 300 according to the 24-hour Holter ECG monitoring |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications |  | 12 months | 
| Left ventricle diameter |  | 12 months | 
| Right ventricle diameter |  | 12 months | 
| Premature ventricular complexes burden according to the 24- hour Holter ECG |  | 12 months | 
| Ventricular tachycardia according to the 24- hour Holter ECG |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric population, ablation
Left Ventricular Diastolic Dysfunction in Kidney Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the relationship between pre-operative LV diastolic function and post-operative complications and kidney function in living-donor kidney transplantation patients.

Official Title
-----------------
Influence of Left Ventricular Diastolic Dysfunction on Graft Function and Postoperative Complication in Patients Undergoing Elective Kidney Transplantation

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Other: medical records


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective kidney transplantation patients Exclusion Criteria: No data of preoperative echocardiography

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 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 |
| --- | --- |
| LV diastolic dysfunction<br> | Other: medical records<br>* review of medical records<br>|
| No LV diastolic dysfunction<br> | Other: medical records<br>* review of medical records<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with postoperative cardiovascular complications | acute myocardial infarction, ventricular fibrillation/tachycardia, cardiogenic shock, newly-onset atrial fibrillation, clinical pulmonary edema requiring endotracheal intubation or dialysis | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with postoperative pulmonary edema | pulmonary edema by radiological evidence | 30 days |
A Study to Evaluate Food Effect on ONO-5920/YM529 Intermittent Formulation

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the effects of food intake on the plasma concentration profile of YNO-5920/YM529 in post menopausal women.

Official Title
-----------------
A Study to Evaluate Food Effect on Pharmacokinetics Parameters After Administration of ONO-5920/YM529 Intermittent Formulation

Conditions
-----------------
Osteoporosis, Osteoporosis, Postmenopausal, Bone Diseases

Intervention / Treatment
-----------------
* Drug: ONO-5920 / YM529


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post menopausal women (at least 2 years after menopause) Body weight: more than 40.0 Kg and less than 70.0 Kg BMI: more than 17.6 and less than 30.0 Exclusion Criteria: Receives investigational drug within 120 day before the study Blood donation before the study With abnormal laboratory values

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 81 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose group<br>Receives low dose of ONO-5920/YM529 with and without food | Drug: ONO-5920 / YM529<br>* oral<br>* Other names: Minodronic Acid;|
| Experimental: High dose group<br>Receives high dose of ONO-5920/YM529 with and without food | Drug: ONO-5920 / YM529<br>* oral<br>* Other names: Minodronic Acid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter of ONO-5920/YM529 |  | For 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-5920, YM529, Minodronic Acid, Food Effect
The Genetics of Chiari Type I Malformation

Study Overview
=================
Brief Summary
-----------------
Duke University Medical Center is investigating the hereditary basis of Chiari type I malformations with or without syringomyelia (CM1/S). Our research is aimed at learning if CM1/S is indeed caused by factors inherited through the family and, if so, which genes are involved.

Official Title
-----------------
The Genetics of Chiari Type I Malformation (CMI) With or Without Syringomyelia

Conditions
-----------------
Chiari Type I Malformation

Participation Criteria
=================
Eligibility Criteria
-----------------
The study is not currently enrolling new participants.
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 |
| --- | --- | --- |
| Genetic factors contributing to Chiari Type I malformation | This study aims to identify genetic factors that contribute to or cause Chiari Type I malformation. | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chiari, Chiari Type I, Chiari Type I Malformation, Familial Chiari
Geri-TBI: A Prospective Multi-center Evaluation of Geriatric Patients With Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
This multicenter prospective observational study is designed to prospectively record data on patients who are managed per institutional standard of care. The objectives of this study are to establish an aggregate database of information on baseline clinical and demographic characteristics, medication use, markers of frailty, injury characteristics, management strategies, and outcomes following TBI in geriatric patients, determine best practices for management of geriatric patients with TBI, and establish how markers of frailty correlate with outcome in geriatric patients with TBI.

Detailed Description
-----------------
This is a prospective multi-center observational study of geriatric patients with TBI. Data collected will be purely observational and involve no study-based therapeutic interventions or alterations in patient care. Due to the purpose of this study being the creation of a registry and the absence of demographic information being collected, all patients meeting the inclusion criteria will be enrolled without informed consent. We plan to complete the data collection and analysis by 12/31/2018.

Official Title
-----------------
Geri-TBI: A Prospective Multi-center Evaluation of Geriatric Patients With Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Other: no study-based therapeutic interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥40 CT-verified TBI Exclusion Criteria: Any other body region injury AIS >2 Presentation at enrolling center >24 hours after injury Pregnant women Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no study-based therapeutic interventions|no study-based therapeutic interventions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT scan | CT scan-verified traumatic brain injury in patients aged greater than or equal to 40 | through study completion, an average of 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comorbidities | history of any systemic diseases like diabetes, hypertension, blood pressure | through study completion, an average of 1 year. |
A Prospective Study of Hypothyroidism After Radiotherapy for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This study is to prospectively investigate the incidence of hypothyroidism after postoperative radiotherapy and identify risk factors for development of hypothyroidism. Patients with breast cancer treated with surgery followed by radiotherapy is enrolled. Thyroid function was assessed at baseline and different times after radiotherapy. The radiation technique, thyroid dose parameters and hypothyroidism are prospective evaluated, and the dose-effect relationship is analyzed.

Detailed Description
-----------------
Breast cancer patients treated with radiotherapy after surgery are prospectively enrolled. Thyroid function is evaluated mainly by the measurement of thyroid-stimulating hormone (TSH), free triiodo-thyronine (FT3) and free thyroxine (FT4). Thyroid function is regularly assessed before and after radiotherapy. The radiation technique and thyroid dose parameters are assessed. Development of subclinical or biochemical hypothyroidism is noted. The incidence and risk factors of hypothyroidism is analyzed. The dose-volume constraints that correlate with functional impairment of the thyroid in breast cancer patients treated with radiotherapy is discussed.

Official Title
-----------------
Hypothyroidism After Postoperative Radiation Therapy in Patients With Breast Cancer：a Prospective Clinical Study

Conditions
-----------------
Breast Neoplasms, Hypothyroidism, Radiation Toxicity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer patients at first diagnosis, patients who are treated with radiotherapy after breast conserving surgery or modified radical mastectomy, no medical history of hyperthyroidism, hypothyroidism or thyroiditis, have never taken thyroxine, no thyroid surgery. Exclusion Criteria: Absence or ectopic thyroid gland, previous radiotherapy of the neck, diseases of thalamus or pituitary, previous radiotherapy of thalamus or pituitary

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Number of participants with treatment-related hypothyroidism as assessed by CTCAE v4.0 | The subclinical and biochemical hypothyroidism are regularly assessed with the measurement of thyroid-stimulating hormone (TSH), free triiodo-thyronine (FT3) and free thyroxine (FT4). | up to 2 years |
A Pharmacokinetic Evaluation Study in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous, intranasal, and inhalation administration and to calculate the relative bioavailability of INS37217 when administered via oral or nasal inhalation.

Official Title
-----------------
A Single-Center, Randomized, Crossover Pharmacokinetic Evaluation of the Effect of Single Doses of Intravenous INS37217, Nasally Inhaled INS37217 and Orally Inhaled INS37217 Solution in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: denufosol tetrasodium (INS37217)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are current nonsmokers or previous smokers who have not smoked within 6 months and who do not have greater than or equal to a 10 pack-year history of tobacco use Are within 20% of their ideal body weight Are healthy on the basis of a pre-trial physical examination Exclusion Criteria: History or suspicion of recent alcohol, barbiturate, amphetamine or narcotic abuse or a positive urine drug test at study screening History of cardiac arrhythmias, any pathological abnormality on the ECG, bronchospasm, diabetes mellitus, thyrotoxicosis, Parkinsonism, asthma, COPD or cardiovascular disease significant drug allergy Subject with a physical obstruction in the nose Use of concomitant medication other than hormonal contraceptives and multi-vitamins Subjects with a current upper respiratory illness or infection for the 2 weeks prior to screening or any chronic respiratory illness

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: denufosol tetrasodium (INS37217)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma concentrations of INS37217 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pilot study - not specified |  |  |
Pathways to Fatherhood

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to better understand the decision-making process that gay couples go through in order to have children.

Detailed Description
-----------------
The purpose of this study is to better understand treatment considerations, obstacles, motivations, and outcomes for gay men through a survey based questionnaire study.

Official Title
-----------------
Family Building Decisions for Gay Men

Conditions
-----------------
Family Research

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men over age 18 who self-identify as gay Participants should be individuals who are seeking or have sought reproductive services at RMA New Jersey locations. Participants may be included if they have not yet gone through the assisted reproductive process but are considering fatherhood and identify as gay. Exclusion Criteria: Individuals who are not 18 years of age or older. Participants who do not self-identify as gay males. Female patients. Failure of the participant to agree to enrollment in the study with written consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Enrolled subjects will complete a questionnaire to ascertain information on treatment considerations, obstacles, motivations, and outcomes encountered on their pathway to fatherhood.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to survey questions | assess response to questions regarding quality of life, general health, demographic info as well as vies on sperm, egg donation, gestational carriers, legal and financial issues as well as adoption or foster care | 1 week |
Feasibility Study of Supine Breast MRI : Comparison With Prone MRI and Comfort Assessment

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to determine the prone-to-supine displacement of breast lesions using preoperative prone MRI and supine second-look ultrasound data

Official Title
-----------------
Feasibility Study of Supine Breast MRI : Comparison With Prone MRI and Comfort Assessment

Conditions
-----------------
Breast Diseases

Intervention / Treatment
-----------------
* Device: preoperative prone MRI and supine second-look ultrasound data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria were being a woman with breast lesions whose assessment involved breast MRI and ultrasound at our institution. There were no exclusion criteria. Exclusion Criteria: -

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: preoperative prone MRI and supine second-look ultrasound data|Patients were examined using a standard clinical MRI protocol in the prone position with both arms placed above the head. Second-look ultrasonographies were performed. Patients were instructed to lie supine, with their hands behind their heads.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distance to the nipple (mm) | the distance to the nipple for lesion was determined using prone MRI and supine ultrasound | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Breast