linjc16/ctgov huggingface dataset:
MRSA Colonization in Peripartum Women and Their Offspring

Study Overview
=================
Brief Summary
-----------------
We hypothesize that pregnant women are at baseline risk for carrying community-acquired MRSA, but also have frequent contact with healthcare workers which may put them at risk for hospital-acquired MRSA carriage. Our study aimed to identify the colonization rate of women in active labor and whether transmission to infants may occur.

Detailed Description
-----------------
Mothers are at risk for carrying MRSA. What this risk is is not known. We have seen a dramatic increase in neonatal intensive care unit MRSA infections. Could mothers transmit MRSA to their newborns if they are asymptomatic carriers? Mothers come into close contact with health care providers, often have other children in daycare (known risk factor) and may have other exposures to MRSA. Our study was designed to sample 300 mother-infant pairs to determine whether MRSA carriage is present in asymptomatic women. The study consisted of obtaining informed consent, then performing a sterile swab of mothers' nares and vaginal area, then babies' nares and umbilicus once the baby was born.

Official Title
-----------------
A Prospective Study of MRSA Colonization in Peripartum Women and Their Offspring

Conditions
-----------------
Pregnancy, Bacterial Colonization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy expected to deliver next 24 hours Exclusion Criteria: Cesarean sections
Sexes Eligible for Study
-----------------
Female

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

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
-----------------
MRSA, Colonization, Pregnancy, Neonates
Slide Interpretation or Standard Surgical Pathology in Assessing Margin Status in Patients With Pancreatic Cancer Undergoing Surgery

Study Overview
=================
Brief Summary
-----------------
This study is being done to investigate another way of evaluating margin status after pancreatectomy by using cytopathology (slide interpretation) as compared to the traditional method of surgical pathology

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To compare margin status on final pathology with margin status from cytopathologic evaluation. OUTLINE: Patients undergo cytopathologic sample collection during pancreatic resection during which slides are gently pressed against the cut edge of the pancreas, the surgical bed, and along the superior mesenteric artery, and finally against the tumor itself.

Official Title
-----------------
Cytopathologic Margin Evaluation in Patients Undergoing Pancreatic Cancer Resection

Conditions
-----------------
Pancreatic Cancer, Adenocarcinoma

Intervention / Treatment
-----------------
* Other: cytology specimen collection procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing pancreatic resection for a presumed, although not necessarily biopsy-proven pancreatic malignancy, ages 18 years to 80 years old Exclusion Criteria: Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (cytopathologic evaluation)<br>Patients undergo cytopathologic sample collection during pancreatic resection during which slides are gently pressed against the cut edge of the pancreas, the surgical bed, and along the superior mesenteric artery, and finally against the tumor itself. | Other: cytology specimen collection procedure<br>* Undergo cytopathologic sample collection<br>* Other names: cytologic sampling;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence at the site of resection | Will be evaluated in a Cox proportion hazards regression model. The prognostic ability of the histological reporting of the specimen margin as well as the cytopathological reporting of the specimen and in situ margins will be evaluated. | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic cancer, adenocarcinoma, pancreatic resection
Radiolabel ADME (Absorption, Distribution, Metabolism, and Excretion) Study Of [14C] PF-00868554 In Healthy Adult Male Subjects

Study Overview
=================
Brief Summary
-----------------
This is a phase 1 study to assess the routes of elimination of a single oral dose of [14C] PF-00868554 and to characterize the metabolic profile following single dose administration.

Official Title
-----------------
A Phase 1 Study To Evaluate The Metabolism And Excretion Of [14C] PF-00868554 In Healthy Adult Male Subjects

Conditions
-----------------
HCV

Intervention / Treatment
-----------------
* Drug: [14C]-PF-00868554


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, healthy volunteers. Exclusion Criteria: Females.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>[14C]-PF-00868554 | Drug: [14C]-PF-00868554<br>* solution, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of radioactivity recovered in urine and feces, as a percent of the dose. |  | 7 weeks | 
| The amount of PF-00868554, expressed as a percent of total radioactivity, in plasma, urine, and feces. |  | 7 weeks | 
| Identification and determination of relative abundance of the metabolites of PF-00868554 in plasma, urine, and feces. |  | 7 weeks | 
| PK parameters: AUClast, AUCinf, maximum concentration (Cmax), time of maximum concentration (Tmax), and half-life (t1/2) to describe the single dose PK of a) total radioactivity in blood; b) total radioactivity in plasma; c) PF-00868554 in plasma. |  | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoints including adverse events, clinical laboratory tests, vital signs and ECGs. |  | 7 weeks |
Utility of Tracheal Ultrasonography for the Confirmation of the Endotracheal Tube Placement

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare tracheal ultrasound with direct visualization of tracheal rings for the confirmation of endotracheal tube placement in intubated patients. We hypothesize that this method is more reliable, cheap, and readily available for all emergency physicians.

Detailed Description
-----------------
Confirmation of the ETT placement has utmost importance in the management of airway in emergency medicine (EM). Visual examination of the tube (fogging), auscultation, chest x-ray, capnography, capnometry and fiberoptic bronchoscopy are the main tools used for confirmation with increasing diagnostic utilities. Recently, tracheal ultrasonography (US) was introduced as a reliable, cheap and readily available method of confirmation of ETT placement.

Official Title
-----------------
Utility of Tracheal Ultrasonography for the Confirmation of Endotracheal Tube Placement During Intubation: A Diagnostic Accuracy Study

Conditions
-----------------
Intubation Complication

Intervention / Treatment
-----------------
* Device: Tracheal ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults (>=18 years) intubated in the ED during the shifts of the researchers (TM, OFC). Exclusion Criteria: anatomical, traumatic or tumoral defect(s) at the site of sonographic imaging

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

| Intervention/Treatment |
| --- |
|Device: Tracheal ultrasonography|Tracheal ultrasonography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of endotracheal tube in trachea | Whether the endotracheal tube is in the trachea or not | Immediately after the intubation process | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endotracheal intubation, confirmation, ultrasonography
Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)

Study Overview
=================
Brief Summary
-----------------
In an observational multi-centre study (CHALLENGE), the effects were assessed of starting treatment with low doses of rosuvastatin in statin naive patients with a history of coronary heart disease (CHD), peripheral vascular disease (PVD), cerebrovascular accident (CVA), transient ischemic attack (TIA) or diabetes (DM), on low-density lipoprotein cholesterol (LDL-C) goal achievement. Also proportional changes in LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglycerides (TG) and the ratio TC/HDL-C were studied.

Official Title
-----------------
Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)

Conditions
-----------------
Hypercholesterolemia, Coronary Heart Disease, Peripheral Vascular Disease, CVA, Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible for the study were high-risk patients with a documented history of CHD, PVD, cerebrovascular atherosclerotic disease, DM II or DM I with microalbuminuria. LDL-C had to be > 2.5 mmol/l and the patient did not use any cholesterol lowering medication during the last 3 months preceding inclusion. The specialist made the decision to start treatment with rosuvastatin irrespective of study participation. Patient approved to place anonymous results at the disposal of AstraZeneca Exclusion Criteria: Exclusion criteria included patients familiar with muscular pain, myopathy or liver function disorders (inclusive elevation of serum transaminases), patients with familial dyslipideamia like familial hypercholesterolaemia and familial combined hyperlipid

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholesterol, coronary heart disease, rosuvastatin, LDL-C goal, hypercholesterolemia
A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia.

Official Title
-----------------
A Phase 3, Multicenter Study to Assess the Long Term Safety and Tolerability of ALKS 3831 in Subjects With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: ALKS 3831


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Agrees to use an acceptable method of contraception for the duration of the study Subject has completed the 24-week treatment period in the antecedent study, ALK3831-A303, within 7 days Additional criteria may apply Exclusion Criteria: Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine Subject has a positive test for drugs of abuse at study entry Subject is pregnant, planning to become pregnant, or breastfeeding during the study Additional criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: ALKS 3831<br>Oral tablet, daily dosing | Drug: ALKS 3831<br>* Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Adverse Events | Overall summary of treatment emergent adverse events during the treatment period | Up to 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alkermes, ALKS 3831, Samidorphan, Schizophrenia, Safety
Analysis of Emergency Department (ED) Volumes During Natural Disasters

Study Overview
=================
Brief Summary
-----------------
The 'Analysis of Emergency Department Volumes during Natural Disasters' retrospective study focuses on three specified populations including dialysis patients, trauma patients, and patients poisoned by carbon monoxide. These three populations have one commonality - hurricanes, ie. natural disasters, which is the exposure. Causal associations and significant correlations will be explored in all three subgroups.

Official Title
-----------------
Analysis of Emergency Department Volumes During Natural Disasters

Conditions
-----------------
Dialysis, Trauma Related Injuries, Carbon Monoxide Poisoning

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with carbon monoxide poisoning in addition to trauma and dialysis patients admitted to the Memorial Hermann Health System's (MHHS) Emergency Department (ED) 1 week pre- and post-Hurricane Ike's landfall to the City of Houston, which was September 12, 2008. Exclusion Criteria: Patients with the specified conditions that were not admitted during the time interval allotted.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Dialysis patients | |
| 2<br>Trauma patients | |
| 3<br>Patients with carbon monoxide poisoning | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy and Safety of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines

Study Overview
=================
Brief Summary
-----------------
This study will confirm the efficacy and safety of a single topical administration of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines

Conditions
-----------------
Skin Aging

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe crow's feet lines Female or male, 18 to 65 years of age and in good general health Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study Exclusion Criteria: Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A Muscle weakness or paralysis, particularly in the area receiving study treatment Active skin disease or irritation at the treatment area Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart Treatment with Botulinum Toxin Type A for crow's feet lines in the last 6 months or 3 months anywhere in the body

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Placebo Comparator: Dose B<br>Dose B: Placebo | Drug: Placebo<br>* Placebo, Dose B; dose applied to the lateral canthal lines<br>|
| Experimental: Dose A<br>Dose A: Botulinum Toxin Type A | Drug: Botulinum Toxin Type A<br>* Botulinum Toxin Type A, Dose A, dose applied to the lateral canthal lines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint | Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment with 2 points or greater improvement from baseline | Proportion of subjects with 2 point or greater improvement from baseline using the Investigator Global Assessment | Week 4 | 
| Investigator Global Assessment with 1 point or greater improvement from baseline | Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment | Week 4 | 
| Patient Severity Assessment with 2 points or greater improvement from baseline | Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment | Week 4 |
Scalp Sampling for Fetal Surveillance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare lactate and total acid-base status in fetal scalp blood with lactate and total acid-base status in maternal blood and amniotic fluids to provide information on how lactate and base deficit correlates with scalp samples. Furthermore, the investigators want to study whether angiogenic factors in fluids above may be a possible marker of asphyxia during labor.

Official Title
-----------------
Biosampling for Markers of Hypoxia in Fetal Blood Scalp Sampling During Labor

Conditions
-----------------
Fetal Hypoxia

Intervention / Treatment
-----------------
* Other: Fetal scalp blood scalp, amniotic fluid, maternal blood and umbilical cord sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All deliveries eligible for fetal blood sampling Exclusion Criteria: Non Swedish speaking Those who decline to participate in the study

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Fetal scalp blood scalp, amniotic fluid, maternal blood and umbilical cord sampling|Fetal blood sampling is conducted when a non reassuring cardiotocographic pattern occurs to detect fetal hypoxia during labor. Amniotic fluid, maternal blood is sampled in cases of fetal blood sampling. Umbilical cord blood sampling is conducted at delivery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxia | Fetal blood sampling is conducted when a non reassurring cardiotocographic pattern occurs to detect fetal hypoxia during labor | 120 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subacute hypoxia | Fetal blood sampling is conducted when a non reasurring cardiotocographic pattern occurs to detect fetal hypoxia during labor | 120 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fetal blood sampling, Lactate, pH, base deficit, angiogenic factors, suspected fetal hypoxia, Hypoxia