linjc16/ctgov huggingface dataset:
Renal Effects of Levosimendan in Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
Recent experimental and clinical data suggest a benefit of levosimendan on the kidney function. Therefore, this retrospective, single center, matched-pairs analysis aimed to investigate whether administration of levosimendan was associated with improved renal function in cardiac surgery patients.

Conditions
-----------------
Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing cardiac surgery (OPS 5-35 bis 5-37) between 2007 and 2011 followed by postoperative observation on an ICU of the anaesthesiology department of the Charité hospital Exclusion Criteria: Patients younger 18 Preexisting renal insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Levosimendan<br>study group | |
| No Levosimendan<br>Control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of plasma creatinine (Difference in renal function) | Only in patients not requiring renal replacement therapy | last available value pre-op (baseline), first available value on post-op day 1, 2, 3 and 4 | 
| Change of urine output after surgery (difference in renal function) | Only in patients not requiring renal replacement therapy | post-op day 1, 2, 3, 4 | 
| Cumulative incidence and duration of hemodialysis (Difference in renal function) |  | last day of hospital stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Length of stay (hospital and ICU) |  | last day of hospital stay | 
| In-hospital mortality |  | last day of hospital stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
levosimendan, renal effects, cardiac surgery, left heart insufficiency
Special Drug Use Investigation for Botox® (Botulinum) Spasticity (BOTOX is a Registered Trademark of Allergan, Inc.)

Study Overview
=================
Brief Summary
-----------------
The objective of this post-marketing surveillance study is to collect safety, efficacy and usage data on botulinum injection in subjects with upper or lower limb spasticity on the long-term use in clinical practice and to identify the factors affecting the safety or efficacy.

Official Title
-----------------
Special Drug Use Investigation for Botox® (Botulinum) Spasticity

Conditions
-----------------
Mumps

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with upper or lower limb spasticity Subjects must use botulinum injection for the first time Exclusion Criteria: Not applicable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects prescribed botulinum injection<br>Subjects prescribed botulinum injection | Drug: Botulinum Toxin Type A<br>* Botulinum Toxin Type A<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events in Japanese subjects with spasticity treated with botulinum injection |  | 1 year | 
| Occurence of adverse events at remote sites |  | 1 year | 
| Occurence of adverse events associated with pulmonary function |  | 1 year | 
| Onset status of adverse events associated with convulsion |  | 1 year | 
| Onset status of adverse events associated with accidents such as fall |  | 1 year |
Bioactive Glass in the Treatment of Enamel White Spot Lesions

Study Overview
=================
Brief Summary
-----------------
the aim of this study is to evaluate the effectiveness of BiominF® and Novamin® in comparison to Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in the treatment of enamel white spot lesions

Official Title
-----------------
Effectiveness of Novel Bioactive Glass in the Treatment of Enamel White Spot Lesions : A Randomized Controlled Trial

Conditions
-----------------
White Spot Lesion of Tooth

Intervention / Treatment
-----------------
* Drug: BiominF
* Drug: Novamin
* Drug: CPP-ACP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not less than 1 white spot lesion on the labial surface of teeth in the anterior region with code 2 International Caries Detection and Assessment System II (ICDAS-II) or less Absence of any active periodontal disease. Written informed consent Exclusion Criteria: Known hypersensitivity/allergy to study products and/or materials used teeth having deep carious lesions or extensive restorations Unwillingness to be randomly assigned to 1 of the 3 treatment groups Advanced periodontal disease.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 26 Years

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

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

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 |
| --- | --- |
| Active Comparator: BiominF®<br>Test group | Drug: BiominF<br>* in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached<br>|
| Active Comparator: Novamin®<br>Test group | Drug: Novamin<br>* in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached<br>|
| Active Comparator: CPP-ACP<br>Control group | Drug: CPP-ACP<br>* applied in accordance with the manufacturer's specifications<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in White spot lesions dimension | Quantified using computer-assisted analysis based on digital intraoral photographs | 6 months: (Baseline, 1 week, 1 month, 3 months, 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in lesion fluorescence | evaluated using diode laser fluorescence device (Diagnodent) | 6 months: (Baseline, 1 week, 1 month, 3 months, 6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioactive glass, CPP-ACP, Remineralization, White spot lesions
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-063)

Study Overview
=================
Brief Summary
-----------------
A clinical study to determine the efficacy and safety of MK0869 in the treatment of depression.

Detailed Description
-----------------
The duration of treatment is 8 weeks.

Official Title
-----------------
A Double-Blind, Multicenter, Placebo Controlled, Acute and Extension Study of 2 Doses of MK0869 in the Treatment of Patients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: MK0869, aprepitant
* Drug: Comparator: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Major depressive disorder

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0869, aprepitant|nan|
|Drug: Comparator: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMD-17 total score at week 8. Tolerability. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-I Scale score at week 8 and at least a 50% reduction in the HAMD-17 total score. |  |  |
Pentoxifylline and Endometriosis

Study Overview
=================
Brief Summary
-----------------
To prove efficacy of an immunomodulator called pentoxifylline in the treatment of endometriosis in infertile patients undergoing laparoscopy surgery

Official Title
-----------------
Combined Laparoscopic Surgery and Pentoxifylline Therapy for Treatment of Endometriosis-Associated Infertility: A Preliminary Study

Conditions
-----------------
Endometriosis-Associated Infertility

Intervention / Treatment
-----------------
* Drug: pentoxifylline
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile patients having early endometriosis as the only factor of their infertility Exclusion Criteria: Previous treatment for endometriosis or patients having pelvic disorders in addition to endometriosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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> | Drug: pentoxifylline<br>* 800 mg daily for six months<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate |  | 6 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometriosis, immunomodulation, infertility, laparoscopic surgery, pentoxifylline
Myocardial Protection With Adenosine Preconditioning

Study Overview
=================
Brief Summary
-----------------
Adenosine has been proved to be an important mediator of myocardial protection induced by ischemic preconditioning. The hypothesis of this study is that adenosine preconditioning can provide additional myocardial protection in the setting of pediatric open heart surgery with cardioplegia and cardiopulmonary bypass.

Detailed Description
-----------------
Adenosine has been used for diagnosis and treatment of cardiovascular diseases for many years. New progresses in myocardial protection in the settings of acute myocardial infarction treatment put forward the its clinical use to a broader field. But the safety and effectiveness of its use in myocardial protection in the setting of open heart surgery has not been investigated intensively. Our primary results suggested that adenosine preconditioning could decrease the release of myocardial serum markers, such as cTnI. This study will focus on the safety and effectiveness of adenosine in the field of pediatric myocardial protection during surgery repair of congenital heart defects with CPB and cardioplegia.

Official Title
-----------------
Study of Myocardial Protection in Pediatric Cardiac Surgery With Adenosine Preconditioning

Conditions
-----------------
Heart Defects, Congenital, Cardiac Surgical Procedures, Myocardial Reperfusion Injury, Adenosine

Intervention / Treatment
-----------------
* Drug: adenosine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of congenital heart defects eligible for surgery treatment under cardiopulmonary bypass and cardioplegia Body weight less than or equals to 10kg Exclusion Criteria: Cardiac surgery is performed without cardiopulmonary or cardioplegia Body weight more than 10Kg

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 24 Months

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: adenosine<br>Adenosine will be administered intravenously before surgery | Drug: adenosine<br>* 1.5mg/Kg adenosine will be administered intravenously before surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome Measure: all cause mortality |  | within the first 30 days (plus or minus 3 days) after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time of ICU stay |  | within the first 30 days (plus or minus 3 days) after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ischemic Preconditioning, Myocardial, Adenosine
Vision-based Ultrasonic Robot Autonomous Scanning Research

Study Overview
=================
Brief Summary
-----------------
MGIR3-US is a remote scanning robot which can perform ultrasound exam. The aim of the study is to evaluate the feasibility and the application of MGIR3-US.

Official Title
-----------------
Vision-based Ultrasonic Robot Autonomous Scanning Research

Conditions
-----------------
Ultrasound Therapy; Complications

Intervention / Treatment
-----------------
* Device: MGIR3-US


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who agree using MGIR3 to do ultrasonic examinations age from 18 to 65 Exclusion Criteria: Patients who has trauma on the inspection site or on the body surface Pregnant patients. Patients who are afraid of MGIR3-US

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MGIR3-US group<br>using MGIR3-US to do ultrasonic examinations. | Device: MGIR3-US<br>* MGIR3-US is an remote scanning robot which can do ultrasonic examinations.<br>|
| control group<br>using conventional B-mode ultrasound to do ultrasonic examinations. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of satisfaction in participants | The degree of satisfaction in participants | from 2021.08 to 2024.08 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of satisfaction in doctors | The degree of satisfaction in doctors | from 2021.08 to 2024.08 | 
| the lesion inspection rate | the lesion inspection rate | from 2021.08 to 2024.08 |
Inhalation of 20,000 Endotoxin Units(EU) of Clinical Center Reference Endotoxin in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the inflammatory response to 20,000 endotoxin units (EU) of CCRE (Clinical Center Reference Endotoxin) inhalation in a cohort of healthy volunteers. Preferably these subjects will have participated in ozone exposure studies, allowing a direct comparison of their responses to both endotoxin and ozone. Additionally, cardiovascular endpoints will be investigated with the CCRE exposure.

Official Title
-----------------
Inhalation of 20,000 EU of Clinical Center Reference Endotoxin in Healthy Volunteers

Conditions
-----------------
Healthy Adults

Intervention / Treatment
-----------------
* Biological: Clinical Center Reference Endotoxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior participation in Ozone Study Healthy adults Nonsmokers No chronic illness No active allergies Exclusion Criteria: Reduced Lung function Asthma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Clinical Center Reference Endotoxin|20,000 EU inhaled|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the inflammatory response to 20,000 endotoxin units (EU) of CCRE (Clinical Center Reference Endotoxin) inhalation in a cohort of healthy volunteers. |  | 6 hours post challenge |
Maternal Non-Stress Testing

Study Overview
=================
Brief Summary
-----------------
Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring

Official Title
-----------------
Wireless Wearable Maternal Fetal Sensors for Non-Stress Testing

Conditions
-----------------
Pregnant Women

Intervention / Treatment
-----------------
* Device: wearable vital signs sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Maternal age >18 years old Pregnant mothers >26 weeks undergoing nonstress testing or delivering Singleton pregnancy No fetal abnormality or chromosomal abnormality Subjects willing and able to comply with requirements of the protocol Nurses and clinicians who will be administering the non-stress test to the pregnant subject Exclusion Criteria: Women who refuse to signed the informed consent form Maternal age under 18 years old Multiple pregnancy Known major fetal malformation or chromosomal abnormality Medical or obstetric problem that would preclude the use of abdominal electrodes Inability to consent to this study due to medical illness, diminished intellectual capacity, or language barrier Women using pacemakers

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: wearable vital signs sensor|vital signs monitoring during maternal non-stress testing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device comparison to standard monitoring | The primary outcome measure is concordance of FHR tracing assessments from Rogers sensor recordings with those obtained from the current standard of care electronic fetal monitoring systems. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative analyses of sensor output | Qualitative analyses of FHR, MHR, BP, pulse oximetry, and UC data capture from the sensors will be performed for the purpose of optimizing signal-to-noise filtering of raw data collected during the study. Any adverse events will be recorded such as skin irritation (expected to be negligible). | 3 years |
A Comparison of Propofol Based Total Intravenous Anesthesia and Sevoflurane Based Balanced Anesthesia on Renal Protection During Lung Transplantation Under Extracorporeal Membrane Oxygenation - A Prospective, Randomized Trial

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate whether propofol based total intravenous anesthesia reduces incidence of acute kidney injury following the lung transplantation under extracorporeal membrane oxygenation

Conditions
-----------------
Patients Undergoing Lung Transplantation Under Extracorporeal Membrane Oxygenation

Intervention / Treatment
-----------------
* Drug: Administration of anesthesia: Propofol
* Drug: Administration of anesthesia: Sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sixty adults undergoing lung transplantation under extracorporeal membrane oxygenation Exclusion Criteria: Patient having propofol allergy, BMI > 30 kg/m2

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol group<br>Propofol group | Drug: Administration of anesthesia: Propofol<br>* Maintenance of anesthesia with the propofol<br>|
| Active Comparator: Sevoflurane group<br>Sevoflurane group | Drug: Administration of anesthesia: Sevoflurane<br>* Maintenance of anesthesia with the sevoflurane<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the incidence of acute kidney injury between the lung transplantation recipients under propofol based anesthesia and inhalation based anesthesia | Developement of the acute kidney injury is determined by Plasma neutrophil gelatinase-associated lipocalin (NGAL), Cystatin C, and Creatinine | Postoperative 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Propofol, Lung transplantation, Extracorporeal membrane oxygenation, Acute kidney injury