linjc16/ctgov huggingface dataset:
Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine

Study Overview
=================
Brief Summary
-----------------
This is an open label, single-center study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.

Detailed Description
-----------------
To examine the safety and assess the absolute bioavailability and nasopharyngeal absorption of PMI-150 30mg.

Official Title
-----------------
A Randomized, Open Label, Single Center, Single-Dose, Cross-Over Study to Determine the Absolute Bioavailability and the Nasopharyngeal Absorption of PMI-150 (Intranasal Ketamine) in Healthy Adult Volunteers

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

Intervention / Treatment
-----------------
* Drug: intranasal ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults Exclusion Criteria: under 18 years

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>oral ketamine | Drug: intranasal ketamine<br>* A randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study.<br>|
| Experimental: B<br>intranasal ketamine | Drug: intranasal ketamine<br>* A randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study.<br>|
| Active Comparator: C<br>intravenous ketamine | Drug: intranasal ketamine<br>* A randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ketamine pharmacokinetics |  | multiple | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioavailability
Study of Micafungin in Patients With Invasive Candidiasis or Candidemia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.

Detailed Description
-----------------
The purpose of the study is to determine the efficacy and safety of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia. The maximum length of antifungal treatment is 4 weeks except in pre-defined patients where maximum length of therapy is 8 weeks. A post treatment assessment will be conducted at 2 weeks and 6 weeks after the last dose of all antifungal treatments.

Official Title
-----------------
A Phase 3, Randomized, Double-Blind, Comparative Study of Micafungin (FK463) Versus Caspofungin as Antifungal Treatment in Patients With Invasive Candidiasis or Candidemia

Conditions
-----------------
Candidiasis, Candidemia

Intervention / Treatment
-----------------
* Drug: Micafungin
* Drug: Caspofungin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have candidemia or invasive candidiasis. Exclusion Criteria: Patients who have received an echinocandin within one month prior to study entry. Patients who have received more than two days of prior systemic antifungal therapy for the current infection.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>lower dose | Drug: Micafungin<br>* IV<br>* Other names: FK463;|
| Experimental: 2<br>higher dose | Drug: Micafungin<br>* IV<br>* Other names: FK463;|
| Active Comparator: 3<br> | Drug: Caspofungin<br>* IV<br>* Other names: Cancidas;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall treatment success, based on the investigator's assessment of pre-defined clinical and mycological response at the End of intravenous (IV) Therapy |  | End of therapy and 6 weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall treatment success, based on the Data Review Panel's assessment of pre-defined clinical and mycological response at the End of IV Therapy |  | End of therapy and 6 weeks post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Effectiveness, Treatment Efficacy, Investigational, Therapies, Antifungal, Systemic, Antibiotics, Antifungal, Micafungin
Cardiovascular Effects of Carbetocin Given During Elective Cesarean

Study Overview
=================
Brief Summary
-----------------
The investigators are investigating whether slow administration of carbetocin is tolerated by patients better than if it is administered quickly, with respect to side effects such as headache, nausea, vomiting and facial flushing.

Detailed Description
-----------------
Patients undergoing elective cesarean under spinal are included in the study. These patients are treated with carbetocin to reduce blood loss from the lining of the womb after delivery of the baby. The study is a randomised double blind controlled trial with 2 groups. One group will receive carbetocin quickly, the second group will receive carbetocin slowly. The investigators will compare the difference between groups with respect to side effects and the effect of carbetocin on the cardiovascular system.

Official Title
-----------------
Cardiovascular Effects of Carbetocin During Elective Caesarean Delivery: A Randomized Controlled Trial Comparing Infusion Versus Bolus Administration Using Nexfin™

Conditions
-----------------
Pregnancy, Effect of Carbetocin on Cardiovascular System

Intervention / Treatment
-----------------
* Drug: carbetocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective cesarean delivery under spinal, low risk for post partum hemorrhage, able to understand english Exclusion Criteria: cesarean under general anesthesia, bleeding condition, placenta previa, unable to understand english

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infusion<br>carbetocin is given slowly | Drug: carbetocin<br>* drug used to increase the tone of uterine muscle to prevent post partum hemorrhage after cesarean delivery.<br>* Other names: Duratocin;|
| Active Comparator: Bolus<br>carbetocin is given quickly | Drug: carbetocin<br>* drug used to increase the tone of uterine muscle to prevent post partum hemorrhage after cesarean delivery.<br>* Other names: Duratocin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent change in cardiac output parameters as measured by non-invasive cardiac output monitor | the parameters will be presented as percentage change from the baseline, which is determined prior to the start of the study period | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of side effects occurring within timeframe below | headache, nausea, vomiting, facial flushing | 30 minutes |
Trends Over Time (1990-2010) of Diarrhoea-related Hospitalizations and Deaths in Children < 5 Years of Age in Brazil

Study Overview
=================
Brief Summary
-----------------
This study aims at collecting data to obtain baseline incidence and monitor trends over time in hospitalizations and deaths from all cause gastroenteritis in children <5 years of age, before and after implementation of Rotarix™ universal mass vaccination in Brazil.

Detailed Description
-----------------
In this study baseline gastroenteritis related hospital discharges and mortality data from the Ministry of Health databases (DATASUS) will be compared to the current data after introduction of Rotarix™.

Official Title
-----------------
Time Trend Analysis of Diarrhea-related Hospitalizations and Deaths in Children < 5 Years of Age in Brazil, 1990-2010

Conditions
-----------------
Diarrhoea, Gastroenteritis

Intervention / Treatment
-----------------
* Other: Database analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gastroenteritis associated hospital discharges and gastroenteritis related deaths occurring in children <5 years of age during the period analyzed and registered in the DATASUS databases will be collected for the study Exclusion Criteria: Not applicable

Ages Eligible for Study
-----------------
Maximum Age: 5 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 |
| --- | --- |
| Gastroenteritis Cohort<br>All children suffering with gastroenteritis | Other: Database analysis<br>* Review and collect data from database<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of all cause gastroenteritis related hospital discharges and deaths |  | In post vaccine introduction period compared to pre-vaccination period (gastroenteritis related hospital discharges from 1998 to 2010, gastroenteritis related deaths from 1990 to 2009) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of all cause gastroenteritis related hospital discharges and hospital deaths by year, region and age groups |  | From 1998 to 2010 | 
| Occurrence of all cause gastroenteritis related deaths by year, region and age groups |  | From 1990 to 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroenteritis
Comparison of the Effect Between Levofloxacin and Moxifloxacin Among MDR-TB Patients

Study Overview
=================
Brief Summary
-----------------
Fluoroquinolone is a one of the most important drugs for treatment of multidrug-resistant TB (MDR-TB). Among them, levofloxacin and moxifloxacin has been used most widely. However, there is no study to directly compare the efficacy of levofloxacin and moxifloxacin among MDR-TB patients. The investigators will compare the efficacy of levofloxacin and moxifloxacin through a prospective multicenter randomized open label phase III trial.

Official Title
-----------------
Comparison of the Effect Between Levofloxacin and Moxifloxacin on the Culture Conversion After 3 Months Treatment Among MDR-TB Patients; Prospective Multicenter Randomized Open Label Phase III Trial

Conditions
-----------------
TB

Intervention / Treatment
-----------------
* Drug: levofloxacin, moxifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with multidrug-resistant TB, but sensitive to levofloxacin and moxifloxacin Exclusion Criteria: Achieved negative conversion of M. TB culture before the enrollment Positive anti-HIV antibody Pregnant women or sexually active women without using proper birth control method Serum creatine grater than 2mg/dL, or urine protein greater than 2+ Serum total bilirubin greater than 2 mg/dL or AST and ALT greater than 1.5 times of normal upper limit History or current arrhythmia Hypersensitivity to levofloxacin, moxifloxacin,or rifabutin Should use drug containing metal-ion, warfarin, phenytoin, theophylline, probenecid regularly

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: levofloxacin<br>Levofloxacin 750mg po per day for 3 months | Drug: levofloxacin, moxifloxacin<br>* Levofloxacin 750mg po per day for 3 months vs. Moxifloxacin 400mg po per day for 3 months<br>|
| Active Comparator: moxifloxacin<br>Moxifloxacin 400mg po per day for 3 months | Drug: levofloxacin, moxifloxacin<br>* Levofloxacin 750mg po per day for 3 months vs. Moxifloxacin 400mg po per day for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative conversion of M. tuberculosis |  | 3 months after initiation of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multidrug-resistant TB, sensitive to levofloxacin and moxifloxacin
Risperidone for Treatment of Cocaine Dependence in Outpatients - 12

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate pharmacological efficacy and clinical safety of risperidone in the treatment of cocaine and amphetamine dependence.

Official Title
-----------------
Risperidone for Treatment of Cocaine Dependence in Outpatients

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F ages 21-50 . Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Risperidone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Linear Source Registry for Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Ongoing follow up for subjects implanted with the Linear Source String for prostate cancer.

Detailed Description
-----------------
This registry is being conducted to provide long term analysis on the use of the linear Civastring source for prostate cancer. Prospective data collection will record and demonstrate biochemical response rates. Long term side effects and adverse events will be monitored.

Official Title
-----------------
CivaString Registry for Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: Linear LDR Source


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old Plans to remain in care of enrolling physician for 5 years > 5 years life expectancy Signed informed consent Enrolled within 6 weeks of implant or within 365 days of prior implant Exclusion Criteria: Not willing or able to comply with protocol visit schedule

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Linear LDR Source|The Linear LDR source is a permanent interstitial brachytherapy implant containing palladium-103 sources for the treatment of prostate cancer.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical Response Rate (PSA) |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side Effects (IPSS, IIEF, RFAS score) |  | Up to 5 years | 
| Adverse Events |  | Up to 5 years |
Effect of Anesthetic Agents on Optic Nerve Sheath Diameter

Study Overview
=================
Brief Summary
-----------------
The present study is to evaluate the effect of anesthetic agents ( propofol , sevoflurane) on intracranial pressure of female patients undergoing laparoscopic-robotic surgery.

Detailed Description
-----------------
Anesthetic agents (propofol and sevoflurane)have different effect on intracranial pressure. Sevoflurane when used over 0.5 minimum alveolar concentration, dilates intracranial vasculature and increases intracranial pressure. On the other hand, propofol decreases intracranial blood pressure and intracranial pressure is maintained or decreases. Optic nerve sheath diameter is a feasible diagnostic tool in evaluating intracranial pressure. Female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy are evaluated.

Official Title
-----------------
Effect of Anesthetic Agents (Propofol, Sevoflurane) on Optic Nerve Sheath Diameter(ONSD) in Patients Undergoing Robot-assisted Laparoscopic Gynecology Surgery

Conditions
-----------------
Uterus Myoma, Uterine Cancer

Intervention / Treatment
-----------------
* Drug: Sevoflurane
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy Exclusion Criteria: history of brain hemorrhage or brain infarction liver disease or end stage renal disease glaucoma or any signs of increased intraocular pressure combined wtih other types of operation patient refusal weight less than 40 kg or over 100 kg

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sevoflurane<br>1.5-2.5 vol% of sevoflurane is used for maintenance of anesthesia. | Drug: Sevoflurane<br>* 1.5-2.5 vol % sevoflurane is used for maintenance of anesthesia.<br>* Other names: sevoflurane anesthesia;|
| Active Comparator: Propofol<br>2-5 mcg/ml of propofol is used continuously for maintenance of anesthesia using target-controlled infusion system. | Drug: Propofol<br>* 2-5 mcg/ml of propofol is used for maintenance of anesthesia.<br>* Other names: propofol anesthesia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference of optic nerve sheath diameter | optic nerve sheath diameter is measured using sonographic probe. (10 minutes after induction of anesthesia/ 5 minutes after pneumoperitoneum and trendelenburg position / 20 minutes after pneumoperitoneum and trendelenburg position / 40 minutes after pneumoperitoneum and trendelenburg position / skin closure) | During the operation. |