linjc16/ctgov huggingface dataset:
Nomograms for Optimization of Amikacin First Dose in Critically Ill Patients Using a Population Pharmacokinetics Model

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to elaborate nomograms to optimize amikacine first dosing in critically ill patients, using a population pharmacokinetics model elaborated with multicentric data.

Detailed Description
-----------------
French guidelines recommend for probabilistic therapy to reach an amikacin concentration 1 hour after beginning the infusion ≥ 60 mg/L. This target is rarely achieved in the ICU despite a 30 mg/kg recommended dosage. Using data collected prospectively in critically ill patients of Nîmes (France) (1) and Nantes (France), we will elaborate a population pharmacokinetic model on the non-parametric software Pmetrics and on the parametric software Monolix. We will calculate probability of target attainment of Monte-Carlo simulations, using the non-parametric model. Nomograms to determine optimal first dose of amikacin in critically ill patients, according to a few variables previously identified, will be produced.

Official Title
-----------------
Population Pharmacokinetics Modeling : a Priori Optimization of Amikacin First Dose in Critically Ill Patients Using a Nomogram

Conditions
-----------------
Pharmacokinetics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients treated with amikacin for sepsis in one of the participating ICU will be included. Exclusion Criteria: patients with aminoglycoside allergy, history of myasthenia, pregnancy, under guardianship.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| amikacin infusion | Target is defined as 8 times x Minimal Inhibatory Concentration for MIC = 4 mg/L and MIC = 8 mg/L. Those PTA will be calculated using the final pharmacokinetics model, according to the dependent variables. | one hour after beginning of infusion.ed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal dose of amikacin (in mg) allowed to have a probability of target attainment (PTA) of 50% or less for the trough concentration. | Target is 2.5 mg/L. Those PTA will be calculated using the final pharmacokinetics model, according to the dependent variables. | 24 hours after beginning of infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amikacin
Satraplatin for Patients With Metastatic Breast Cancer (MBC)

Study Overview
=================
Brief Summary
-----------------
To determine the objective response rate (ORR) of oral satraplatin in patients with Metastatic Breast Cancer.

Detailed Description
-----------------
This is a Phase II open label, nonrandomized study for patients with metastatic breast cancer. WHAT IS SATRAPLATIN: Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

Official Title
-----------------
Phase II of Oral Satraplatin in Patients With Metastatic Breast Cancer (MBC)

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: Satraplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Has cytologically or pathologically confirmed breast cancer that is metastatic Must have had prior HerceptinÒ therapy if patient has HER2+ (overexpressing) breast cancer. HER2 is considered overexpressed if it is 3+ by IHC or if the gene is amplified by Flourescence in situ hybridization (FISH) Has had no more than 1 prior chemotherapy regimen for MBC Has had no prior platinum-based therapy Has an ECOG Performance Status (PS) 0-2

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Satraplatin|Patients will receive 80mg/m2 Satraplatin on Days 1-5 of Cycles 1 and 2. A cycle consists of 21 days.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the objective response rate (ORR) of oral satraplatin in patients with metastatic breast cancer |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine duration of response |  | 6 weeks | 
| To determine progression-free survival (PFS) |  | 1 year | 
| To determine 1-year survival |  | 1 year | 
| To evaluate the toxicities of satraplatin in MBC patients |  | 6 weeks | 
| In patients with nonmeasurable MBC, to assess the clinical utility of serum CA27.29 (or CA15.3) and circulating tumor cells as predictors of time to disease progression |  | 6 weeks |
Dexamethasone on Fetal and Uteroplacental Doppler

Study Overview
=================
Brief Summary
-----------------
The current study aims to investigate the effects of dexamethasone exerted on fetal and uteroplacental circulation as measured by Doppler ultrasonography in pregnancies at risk for preterm birth after 24 hours of its administration.

Official Title
-----------------
Effects of Antenatal Dexamethasone Administration on Fetal and Uteroplacental Doppler Waveforms in Women at Risk for Preterm Birth

Conditions
-----------------
Preterm Birth

Intervention / Treatment
-----------------
* Other: Doppler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at risk of preterm labor to be included were those with preterm uterine contractions, placenta previa, and mild preeclampsia Exclusion Criteria: Patients who were actively in labor, presented with premature rupture of membranes, intrauterine growth restriction (IUGR), those who had received corticosteroids in their pregnancies and/or fetuses with suspected structural abnormalities
Sexes Eligible for Study
-----------------
Female

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: Preterm<br> | Other: Doppler<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean of Doppler Resistance index (RI) |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean of Doppler Pulsatility index (PI) |  | 24 hours |
Open-Label Treatment Extension of Protocol MNTX 302

Study Overview
=================
Brief Summary
-----------------
This is a 3 month open-label extension study that allows patients who completed Protocol MNTX 302 to receive SC MNTX.

Official Title
-----------------
A Three-Month Open-Label Treatment Extension of Protocol MNTX 302

Conditions
-----------------
Terminal Illness

Intervention / Treatment
-----------------
* Drug: SC Methylnaltrexone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be enrolled and consented within 28 days of the end of study visit of MNTX 302 and 14 or more days from first dose of study drug in MNTX 302. Negative pregnancy test Stable vital signs Exclusion Criteria: Women who are pregnant and/or nursing Received any investigational product, other than MNTX, in the past 30 days Evidence of fecal impaction Clinically significant active diverticular disease

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: SC Methylnaltrexone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events | To provide access to treatment with MNTX, administered SC, to patients who completed Progenics' Protocol MNTX 302 | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced medical illness
Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)

Study Overview
=================
Brief Summary
-----------------
CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy. Subjects meeting the entry criteria will be randomized in a 1:1 ratio either to placebo for three weeks followed by AXS-12 (up to 10 mg daily) for three weeks, or to AXS-12 (up to 10 mg daily) for three weeks followed by placebo for three weeks. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Placebo-controlled, 3-Week Crossover Study to Assess the Efficacy and Safety of AXS-12 in Subjects With Cataplexy and Excessive Daytime Sleepiness in Narcolepsy

Conditions
-----------------
Narcolepsy, Cataplexy Narcolepsy, Excessive Sleepiness

Intervention / Treatment
-----------------
* Drug: AXS-12 (Reboxetine)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Male or female subjects between 18 and 70 years of age, inclusive Primary diagnosis of narcolepsy with cataplexy Willing and able to comply with the study requirements Exclusion Criteria: Other clinically significant conditions potentially causing EDS Clinically significant psychiatric disorders

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXS-12 (reboxetine)<br> | Drug: AXS-12 (Reboxetine)<br>* Dosed orally, twice daily for up to 3 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Dosed orally, twice daily for up to 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks | Presented as LSmeans. A positive change is indicative of improvement. | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataplexy, EDS, CONCERT, AXS-12, Narcolepsy, Axsome, Reboxetine
Pulmonary Resistance in Fontan Who Have Undergone Heart Transplantation

Study Overview
=================
Brief Summary
-----------------
Clinical evidence reveals that some patients who undergo cardiac transplantation exhibit problems with pulmonary vascular resistance as well. In some studies, an increase in pulmonary vascular resistance has been used as an indicator for increased 3-day and 3-month mortality after heart transplantation2. In this study, the investigators would like to look at pulmonary vascular resistance in patients with a surgical history of the Fontan procedure followed by heart transplantation.

Detailed Description
-----------------
Children born with certain congenital heart diseases such as tricuspid atresia or single ventricle physiology normally undergo the Fontan procedure during their course of treatment. The Fontan procedure however is palliative and some of these children will eventually require heart transplantation. It has been shown in pre-clinical animal models that pulmonary vascular resistance actually increases after having the Fontan procedure however this has not been quantitated in the human population.1 This is a retrospective chart review with the primary objective of examining Fontan patients with pulmonary vascular resistance and who have undergone heart transplantation. We will review 50 charts at Children's Healthcare of Atlanta, Egleston Hospital. Three other United States' sites are participating. All de-identified data will be forwarded to the Great Ormond Street Hospital in London, England for study analysis. In order to ascertain this objective, the following data will be collected. Diagnosis Surgical History Information from Pre-transplant evaluation Post-transplant hemodynamics Post-transplant catheterization results

Official Title
-----------------
Retrospective Assessment of Pulmonary Vascular Resistance in Fontan Patients Who Have Undergone Orthotopic Heart Transplantation

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have undergone the Fontan procedure patients cared for at Children's Healthcare of Atlanta Patients who have undergone a heart transplantation at Children's Healthcare of Atlanta Exclusion Criteria: Those patients who do meet inclusion criteria

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, cardiac, surgery, transplantation, pulmonary vascular resistance in Fontan patients
Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a single dose of IL-10 compared to placebo is safe and effective in reducing the incidence of post-ERCP acute pancreatitis for subjects with increased risk.

Conditions
-----------------
Bile Duct Diseases, Biliary Tract Diseases, Gallbladder Diseases, Pancreatitis, Pancreatic Diseases

Intervention / Treatment
-----------------
* Drug: IL-10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adults weighing up to 125 kg who are undergoing ERCP for any of the following: Evaluate recurrent abdominal pain; Evaluate unexplained recurrent pancreatitis; Evaluate prior post-ERCP pancreatitis; Treatment of pancreatic disorders; Treatment of Common Bile Duct Stones (without jaundice) Exclusion criteria: Active (acute) pancreatitis; Chronic pancreatitis (moderate and severe cases); ERCP to perform a second procedure on biliary tract; Patients who previously had pancreatic sphincterotomy; Known or suspected pancreatic cancer or cancer of Papilla of Vater; Known or suspected other malignancy; History of, or current clotting or bleeding problems; Moderate and severe Anemia; Low platelet counts

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: IL-10|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Hysteroscopic Assessment of Fallopian Tubal Patency

Study Overview
=================
Brief Summary
-----------------
Disease of the fallopian tubes is one of the most common reasons for infertility. The most common test, a hysterosalpingogram, tends to be painful,inconvenient, and frequently misses concurrent uterine disease. We propose using a less painful technique (through modified office hysteroscopy) for tubal assessment that can be performed in the office rather than hospital radiology and that uses gold standard technology for identifying coexisting uterine conditions.

Official Title
-----------------
Hysteroscopic Assessment of Fallopian Tubal Patency

Conditions
-----------------
Infertility, Menorrhagia

Intervention / Treatment
-----------------
* Procedure: Salpingography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 50 years old Able to give consent Must have a uterus Must have documented negative testing for gonorrhea and chlamydia within the past year or previously negative when tested with a current partner in a monogamous relationship Negative test prior to procedure Exclusion Criteria: Pregnancy Active lower and upper genital tract infection Patients with allergies to hysterosalpingogram contrast will not be exposed to a contrast material to which they are allergic Premenarchal or postmenopausal Unable to read English at a 6th grade level or above History of endometrial Ablation Asherman's syndrome > Stage 1

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salpingography<br>Infusion of air bubbles through Fallopian tubes with hysteroscopic visualization; typically 1-2 mL is infused. This is less than that typically used in the established technique of sonosalpingography. | Procedure: Salpingography<br>* Infusion of typically 1-2 mL of air bubbles in to the uterine cavity to assess whether they disappear through the ostia in to the Fallopian tubes.<br>* Other names: Parryscope technique;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hysteroscopic assessment of tubal patency | Patients undergoing the procedure will be informed based on the findings as to whether or not it is believed that their Fallopian tubes are patent | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hysteroscopy
A Study to Observe the Onset of Immune-related Adverse Reactions in Patients With Non-surgical or Renal Cell Carcinoma (RCC) That Has Spread

Study Overview
=================
Brief Summary
-----------------
Patients with non-surgical or renal cell carcinoma that has spread who are starting treatment for the first time with Yervoy and Opdivo in the real world

Official Title
-----------------
Drug Use Investigation on Combination Therapy With Yervoy and Opdivo (Unresectable or Metastatic Renal Cell Carcinoma)

Conditions
-----------------
Renal Cell Carcinoma, Kidney Cancer

Intervention / Treatment
-----------------
* Other: Non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with unresectable or metastatic renal cell carcinoma who are initiating treatment for the first time with Yervoy and Opdivo in accordance with the Japanese package insert will be included in this PMS Exclusion Criteria: Patients receiving combination therapy with Yervoy and Opdivo for non RCC indication will be excluded from this PMS Other protocol defined inclusion/exclusion criteria could apply
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients taking combination therapy with Yervoy and Opdivo<br>Medical records will be reviewed for safety and treatments for specific ADR | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of immune-related AE's |  | Approximately 13 weeks | 
| Incidence of immune related SAE's |  | Approximately 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment for immune-related adverse reactions |  | Approximately 13 weeks | 
| Incidence of unknown AE's |  | Approximately 13 weeks | 
| Incidence of unknown SAE's |  | Approximately 13 weeks |
Fetal Heart Rate Variability and Fetal Growth Restriction

Study Overview
=================
Brief Summary
-----------------
There is growing evidence in the field of fetal heart rate variability revealing the fetal neurological state. Furthermore, fetal heart rate variability has shown potential as fetal surveillance in fetal growth restriction. This study aim to investigate the association between fetal heart rate variability and doppler flow changes in growth restricted fetuses.

Official Title
-----------------
Fetal Heart Rate Variability Compared to Doppler Flows in the Growth Restricted Fetus: a Cohort Study

Conditions
-----------------
Fetal Growth Retardation

Intervention / Treatment
-----------------
* Diagnostic Test: fetal heart rate variability


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnant women with estimated fetal weight below 2 standard deviations (2SD) of mean for gestational age corresponding to minus 22%. Fetal weight assessed by doppler ultrasound. Exclusion Criteria: Fetal malformations
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: fetal heart rate variability|observational study. no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Root mean square of successive inter beat interval differences RMSSD | Time domain analysis | 1/12-2020 | 
| Standard deviation of normal to normal inter beat interval (SDNN) | Time domain analysis | 1/12-2020 | 
| Low frequency power (LF-power) | Spectral analysis | 1/12-2020 | 
| High frequency power (HF-power) | Spectral analysis | 1/12-2020 | 
| Low frequency power/High frequency power (LF/HF) | Spectral analysis | 1/12-2020 |