linjc16/ctgov huggingface dataset:
To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.

Official Title
-----------------
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz GmbH and Bristol-Myers Squibb Company (Cefzil) 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose In Healthy Adults Volunteers Under Fasting Conditions.

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

Intervention / Treatment
-----------------
* Drug: Cefprozil 250 mg/5 ml Oral Suspension (Sandoz GmbH)
* Drug: Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cefprozil 250 mg/5 ml Oral Suspension (Sandoz GmbH) | Drug: Cefprozil 250 mg/5 ml Oral Suspension (Sandoz GmbH)<br> <br> |
| Active Comparator: 2<br>Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb) | Drug: Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic
Pilocarpine, Brimonidine, Oxymetazoline (PBO) Compound to Control Presbyopia Symptoms

Study Overview
=================
Brief Summary
-----------------
Safety and Efficacy of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) ophthalmic compound to improve uncorrected near vision in healthy presbyopic patients one hour after instillation.

Detailed Description
-----------------
To determine the safety and efficacy of a novel pharmacological compound of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) to improve uncorrected near vision in healthy presbyopic patients one hour after binocular instillation.

Official Title
-----------------
Pilocarpine, Brimonidine, Oxymetazoline Ophthalmic Compound Safety and Efficacy in Patients With Presbyopia

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Drug: Pilocarpine, brimonidine, oxymetazoline, hyaluronic acid, bromfenac (PBOHB) compound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Presbyopic 40 - 60 years Exclusion Criteria: Diabetics Previous eye surgery Previous eye disease > 0.50 myopia > 1.5 hyperopia or astigmatism

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: To determine safety and efficacy of a Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac compound to improve near uncorrected vision in healthy presbyopic patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBOHB<br>Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac to evaluate safety and efficacy to improve uncorrected near vision in healthy presbyopic patients | Drug: Pilocarpine, brimonidine, oxymetazoline, hyaluronic acid, bromfenac (PBOHB) compound<br>* To determine the safety and efficacy of a PBOHB compound in near vision of presbyopic patients.<br>* Other names: PBOHB;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jaeger near uncorrected visual acuity improvement | Measure uncorrected near vision change after binocular instillation of PBOHB compound | 1 hour |
HSPA12B as a Potential Biomarker for Sepsis and Severe Sepsis

Study Overview
=================
Brief Summary
-----------------
Molecules indicating endothelial injury may serve as biomarkers for severe sepsis because of the critical role of endothelial injury in organ dysfunction during severe sepsis. HSPA12B is primarily located in endothelial cells and detectable during sepsis. The investigators speculated that HSPA12B from endothelial cells might be correlated with severe sepsis.

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients Patients meet the diagnostic criteria according to the grouping Exclusion Criteria: patients without informed consent patients who were undergoing continuous renal replacement therapy before sampling patients with special infection induced by virus, tubercle bacillus, mycoplasma, Chlamydia, and so on

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sepsis<br>Patients with sepsis but not severe sepsis | |
| Severe sepsis<br>Patients with severe sepsis | |
| SIRS<br>Patients with SIRS after major orthopedics surgery | |
| Control<br>Healthy volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | mortality within 28 days after recruitment. | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, biomarker, HSPA12B
Effects of Magnesium Sulfate on Onset and Duration of Low Dose Rocuronium

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition.

Conditions
-----------------
Intubation Condition, Surgical Condition, Observation of Neuromuscular Block

Intervention / Treatment
-----------------
* Drug: magnesium sulfate 30 mg/kg
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-75 yr American Society of Anesthesiologists physical status 1 or 2, BMI of 20-24.9 kg/m2 scheduled for elective laryngeal microsurgery Exclusion Criteria: severe respiratory or cardiac disease hepatic or renal function impairment neuromuscular disease on medications affecting neuromuscular function with known allergy to the drugs

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: standard dose rocuronium group<br>pretreatment of saline 100ml and rocuronium 0.6 mg/kg | Drug: saline<br>* Patients in each group received 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia<br>|
| Active Comparator: low dose rocuronium group<br>pretreatment of saline 100ml and rocuronium 0.45 mg/kg | Drug: saline<br>* Patients in each group received 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia<br>|
| Active Comparator: low dose rocuronium plus magnesium group<br>pretreatment of magnesium sulfate 30 mg/kg and rocuronium 0.45 mg/kg | Drug: magnesium sulfate 30 mg/kg<br>* Patients in each group received the magnesium sulfate 30 mg/kg for 2 min in 0.9% normal saline (total volume 100 ml) intravenously for 5 min before induction of anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| onset time of rocuronium | from injection of rocuronium to T1 suppression more than 95% up to 10 minutes | from injection of rocuronium to T1 suppression more than 95% up to 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal suppression time and duration of rocuronium |  | time from the injection of rocuronium to T1 maximal suppression time and reversal of T1 25% up to 1 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
magnesium sulfate, rocuronium
Multicenter, Prospective Observational Study for Early Diagnosis, and Development of Follow-up Protocol and Hearing Rehabilitation Program for Ototoxic Hearing Loss After Chemotherapy for Pediatric Solid Cancer

Study Overview
=================
Brief Summary
-----------------
More than half of all pediatric cancer in Korea are solid cancer. For the treatment of solid cancer, multidisciplinary methods such as surgery, chemotherapy, and radiation therapy are applied, and with the development of the treatment method, the treatment performance has improved dramatically, and the 5-year survival rate of more than 80% is currently recorded. Due to the improvement in survival rate, interest in side effects caused by cancer treatment itself is gradually increasing, and efforts to reduce them are increasing. Accordingly, it aims to contribute to improving the quality of life of pediatric solid cancer survivors. by developing a Korean-type early diagnosis and follow-up protocol of ototoxic hearing loss, which commonly occurs in pediatric solid cancer who have undergone chemotherapy.

Official Title
-----------------
Multicenter, Prospective Observational Study for Early Diagnosis, and Development of Follow-up Protocol and Hearing Rehabilitation Program for Ototoxic Hearing Loss After Chemotherapy for Pediatric Solid Cancer

Conditions
-----------------
Solid Tumor, Childhood

Intervention / Treatment
-----------------
* Other: Chemotherapy involving cisplatin or carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ① Solid cancer patients under the age of 19 receiving Platinum chemotherapy ② Solid cancer patients under the age of 19 receiving 30 Gy or more head and neck radiation therapy Exclusion Criteria: ① Those who have received chemotherapy or radiation in the past Those who have difficulty understanding the clinical trial due to mental retardation or unable to read the consent form, such as illiteracy or foreigners ③ Those who have difficulty in hearing test due to neurological factors, etc. ④ Other cases judged to be inappropriate for this study by the judgment of the person in charge of the clinical trial

Ages Eligible for Study
-----------------
Maximum Age: 19 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 |
| --- | --- |
| Pediatric solid cancer<br> | Other: Chemotherapy involving cisplatin or carboplatin<br>* Chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with ototoxic hearing loss | Proportion of patients with ototoxic hearing loss in total patients | 1 year after the initiation of chemotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric solid tumor, Chemotherapy, Hearing loss
Virtual Reality Training Simulator for Cesarean Section

Study Overview
=================
Brief Summary
-----------------
The goal of this is to determine the effectiveness of virtual reality training simulator for cesarean section. Evaluate the effect of using VR surgery on the self-confidence and knowledge of cesarean section procedures.

Detailed Description
-----------------
A single center randomized controlled trial (RCT) was performed. The participants were obstetrics residents, fellows and residents in other majors with limited experience in performing cesarean section. The primary outcome measures were the self-assessment scores of trainee confidence using a virtual reality training and an objective assessment of the cognitive skills. The participants were randomly divided into a study group of VR training group and a control group. Participants in the study group used the VR application. The control group participants used similar content in a standard PowerPoint presentation on a laptop.

Official Title
-----------------
A Clinical Trial to Evaluate Effectiveness of Virtual Reality Training Simulator for Cesarean Section

Conditions
-----------------
Virtual Reality

Intervention / Treatment
-----------------
* Other: virtual reality training for cesarean section


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Residents and fellows receiving training at Seoul National University Bundang Hospital and who wish to participate in this study Exclusion Criteria: If trainee refuse to participate in this study
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants who received virtual reality training<br> | Other: virtual reality training for cesarean section<br>* Participants who received virtual reality training for cesarean section can learn the surgical procedures as if they were in a real field.<br>|
| Placebo Comparator: Participants who received similar contents in a standard PowerPoint presentation on a laptop<br> | Other: virtual reality training for cesarean section<br>* Participants who received virtual reality training for cesarean section can learn the surgical procedures as if they were in a real field.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement on the knowledge of cesarean section procedures. | After using VR training, the test scores cesarean section procedures. | 1 month after examination | 
| improvement on the self-confidence of cesarean section procedures. | After using VR training, the self-assessment scores of trainee confidence via questionnaire | 1 month after examination |
ST2, a Novel Biomarker for Cardiac Remodeling in Adults With Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
The remarkable improvement in survival of children with congenital disease has led to a continuously growing number of adults with congenital heart disease in the developed world. Many of these patients had had cardiac surgery at early age, the may live for many years with pressure overload, volume overload, systolic or diastolic dysfunction, cyanosis or any combination of the above. These past and ongoing cardiac insults often result in significant cardiac remodeling. A biomarker for fibrosis and remodeling may have enormous clinical and prognostic value for these patients. Serum biomarkers are now integrated in many fields in medicine. In cardiology, a number of biomarkers are used. In the last decade, our group has focused on the natriuretic peptides as markers for heart disease in infants and children. This resulted in many studies and more than 25 publications in the medical literature. We believe that the newly discovered cardiac marker, ST2, will emerge as an important addition to cardiac evaluation in the coming years.The aim of this study is to measure ST2 levels in patients with congenital right heart disease and correlate ST2 levels to clinical status, imaging and prognosis.

Conditions
-----------------
Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (age>18 y) congenital heart disease Exclusion Criteria: Additional lung diseases, renal disease or inflammatory disease. Patients who underwent therapeutic intervention between the MRI and the ST2 - measurements. Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| NYHA classification and/or 6 minute walk distance |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin level |  | six months |
Emotion Regulation and Cancer Caregiving

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine how the behaviors of cancer caregivers can impact patients.

Official Title
-----------------
Emotion Regulation and Cancer Caregiving

Conditions
-----------------
Breast Cancer, Cancer, Healthy, Emotions

Intervention / Treatment
-----------------
* Behavioral: Expressive Writing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants must: Be 21 years or older Have access to a computer with internet access Patients must: Be women Have a diagnosis of breast cancer (non-recurrent) Caregivers must be: -The patient's caregiver (providing support to the patient) Exclusion Criteria: Participants must not be: -Younger than 21 years Patients must not: Be men Have a diagnosis other than breast cancer (non-recurrent)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Caregivers<br>Control participants will write about their daily and future tasks three times. | Behavioral: Expressive Writing<br>* Caregivers complete three 20-min writing sessions in which they write about an assigned topic - emotional or non-emotional.<br>|
| Expressive Writing Caregivers<br>Experimental participants will write about their thoughts and feelings about an emotionally difficult event three times. | Behavioral: Expressive Writing<br>* Caregivers complete three 20-min writing sessions in which they write about an assigned topic - emotional or non-emotional.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion Regulation Questionnaire | Emotion regulation refers to the ways people influence which emotions they have, and how they experience and express these emotions. Participants will rate their habitual pursuit of pro-hedonic, contra-hedonic, pro-social, and impression management goals using the ERGS. The items will be rated on the same 7-point scale (1 = never; 7 = always). | Baseline through 3 months post-intervention |
Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy of a nasopore sponge dressing soaked in Bacitracin VS a sponge soaked in Saline / and the administration of oral antibiotics.

Detailed Description
-----------------
Same as above

Official Title
-----------------
Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge After Functional Endoscopic Sinus Surgery

Conditions
-----------------
Paranasal Sinus Disease

Intervention / Treatment
-----------------
* Drug: Bacitracin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient having primary or revision sinus surgery. Aged 18 years or older.Patients must have middle meatus easily identified. The type of surgery will not be influenced by the participation in this study. Exclusion Criteria: Age less then 18 Known sensitivity to Bacitracin Pregnancy

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bacitracin<br>Nasopore sponge soaked in Bacitracin, no oral antibiotics | Drug: Bacitracin<br>* Bacitracin soaked nasopore sponge<br>|
| No Intervention: Saline<br>Nasopore sponge soaked in saline, routine oral antibiotics | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Infection | Number of participants without infections on post-op visits 90 days. | 90 days |