linjc16/ctgov huggingface dataset:
Audit of Bronchoscopy Practice in Egypt: Adherence to Safety and Infection Control Guidelines

Study Overview
=================
Brief Summary
-----------------
Both patient and staff safety are of major importance during the procedure of fibreoptic bronchoscopy. Patient safety depends partly on adequate disinfection of instruments and accessories used as well as careful monitoring during the procedure.

Detailed Description
-----------------
Adequate facilities, manpower and training are also essential. Staff safety depends partly on adequate procedures to minimise any risks of sensitisation to agents such as glutaraldehyde. An audit well be carried out of bronchoscopy procedures in hospitals in the Egypt and the findings well be compared with published guidelines on good practice and clinical consensus

Official Title
-----------------
Adherence to Safety and Infection Control Guideline in Bronchoscopy Units

Conditions
-----------------
Infection Control

Intervention / Treatment
-----------------
* Other: audit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bronchoscopy Units personnel Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: audit|Practice adherence to guidelines|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adherence to guidelines on disinfection procedures and patient monitoring |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self- administered questionnaire |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
audit, infection control, bronchoscopy unit, Egypt
Implementation of a Return Home With a Hospitalization at Home or With a Home Health Care Provider From the Services of Oncopneumology, Oncology and Hematology of University Hospital of Strasbourg

Study Overview
=================
Brief Summary
-----------------
Hospitalization at home is booming. It is designed to meet the demands of patients and their families to continue care at home. It partially solves the problem of the lack of places in the long-term care structures and allows to respond to a desire of the health policy to reduce the lengths of stay in the hospital. Hospitalization at home is also an alternative in the management of chronic patients. Nevertheless, at the moment a certain number of requests for hospitalization at home remain unsuccessful or their implementation is complicated. In addition, the number of home health care provider has increased significantly in recent years. According to the federation of home health care provider, the number of beneficiaries increased by 1.7% in 4 years. The home health care provider would support 1,200,000 patients per year. The objective of the study is to analyze the factors participating in Implementation of a return home with a Hospitalization at home or a home health care provider during a return home project constructed with the patient and his / her relatives from the services of Oncology, oncology, hematology of the University Hospital of Strasbourg.

Official Title
-----------------
Implementation of a Return Home With a Hospitalization at Home or With a Home Health Care Provider From the Services of Oncopneumology, Oncology and Hematology of University Hospital of Strasbourg: Observational, Prospective, Monocentric, Non-interventional Study. Advantages, Disadvantages, Limitations

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years old Patient for whom an application for Hospitalization at home or with a home health provider is initiated by the Oncology, Oncology or Hematology Department of the University Hospital of Strasbourg. Exclusion Criteria: Refusal to participate in the study

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 |
| --- | --- | --- |
| Analysis of factors participating in Implementation of a return home with a Hospitalization at home or a home health care provider |  | 15 days after patient discharge from hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, palliative care, hospitalization at home, home health care provider
Ultrasonography of Chest Versus Pulmonary Artery CT Angiography in Patients With Symptoms and Signs in Favor of PTE

Study Overview
=================
Brief Summary
-----------------
In this study the investigators compare the diagnostic validity of Bedside Ultrasonography of chest and Pulmonary artery CT Angiography in the patients who came to Emergency Department of Alzahra General Hospital from 1 may 2012 to 1 October 2012 with respiratory symptoms and signs in favor of Pulmonary Thromboemboli (PTE).

Official Title
-----------------
Bedside Ultrasonography of Chest Versus Pulmonary Artery CT Angiography in the Patients Who Came to Emergency Department of Alzahra General Hospital With Respiratory Symptoms and Signs in Favor of Pulmonary Thromboemboli.

Conditions
-----------------
Pulmonary Thromboembolism

Intervention / Treatment
-----------------
* Other: Pulmonary artery CT Angiography
* Other: Emergency Bedside Ultrasonography of chest


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with signs or symptoms in favor of PTE who come to Emergency department of Alzahra General Hospital. Exclusion Criteria: previous history of Allergy to IV contrast Serum creatinin more than 1.8 patients that will not agree to participate in the study. pregnancy Body weight more than 120 kg
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 with impression of PTE<br>Those with signs and symptoms in favor of pulmonary thromboembolism. | Other: Pulmonary artery CT Angiography<br>* Performing Pulmonary artery CT Angiography for patients with signs and symptoms in favor of PTE.<br>Other: Emergency Bedside Ultrasonography of chest<br>* Performing Emergency Bedside Ultrasonography of chest at the time of presentation for patients with signs and symptoms in favor of PTE.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency Ultrasonography findings in patients with signs and symptoms in favor of PTE. | Comparing the Emergency Bedside Ultrasonography findings in PTE with pulmonary CT Angiography findings. | Within 1 hour of admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary CT Angiography findings in patients with signs and symptoms in favor of PTE. |  | Within 24 hours of admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTE, Emergency bedside ultrasonography, pulmonary CT Angiography, Pulmonary Wedge infarction, Pulmonary Thromboembolism
Arrhythmias in Patients With COVID-19

Study Overview
=================
Brief Summary
-----------------
The study is a prospective clinical cohort study of consecutive patients hospitalized at all hospitals of greater Copenhagen with a laboratory confirmed diagnosis of COVID-19. The investigators aim to examine if continuous ECG monitoring can be used to understand the contribution of COVID-19 infection in the acute phase to the development of cardiac arrhythmias, especially focusing on cardiovascular outcomes. In all patients included, the investigators aim to examine if continuous ECG monitoring - alone and in combination with biomarkers - can be used to detect early signs of cardiac complications and predict long-term risk of cardiovascular morbidity and mortality following COVID-19 infection.

Official Title
-----------------
The ACOVID-19 Study - A Prospective Cohort Study Investigating the Acute Effect of COVID-19 on the Heart by Continuous ECG Monitoring

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Device: C3+ Holter Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients hospitalized at hospitals of greater Copenhagen area and Zealand with a laboratory confirmed diagnosis of COVID-19 > 18 years of age. Exclusion Criteria: Persons not able to cooperate Persons unable to understand and sign informed consent

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: C3+ Holter Monitor|ECG monitoring|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality during hospitalization and a confirmed COVID-19 diagnosis |  | 4 months | 
| Incident intensive care unit admission during hospitalization and a confirmed COVID-19 diagnosis |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident pulmonary embolism during hospitalization and a confirmed COVID-19 diagnosis |  | 4 months | 
| Incident cardiac arrest during hospitalization and a confirmed COVID-19 diagnosis |  | 4 months | 
| Incident hypoxic respiratory failure during hospitalization and a confirmed COVID-19 diagnosis |  | 4 months |
Premedication Gastric Ultrasound

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess gastric volume in fasted children using ultrasound before and after drinking premedication. The hypothesis is that the qualitative and quantitative assessment by gastric ultrasound in the stomach before and after drinking premedication will be the same as premedication has a small volume.

Official Title
-----------------
Ultrasound Assessment of Gastric Volume After Drinking Premedication: A Prospective Descriptive Study

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Device: Point-of-Care Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1-2 patients aged 0-18 years of scheduled for elective surgery under general anesthesia. Exclusion Criteria: Patients who are not adhere to institutional fasting guidelines.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 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 |
| --- | --- |
| Other: Fasted Children<br> | Device: Point-of-Care Ultrasound<br>* Portable ultrasonography done at the bedside.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Qualitative and Quantitative Gastric Assessment After Premedication | Gastric volume in fasted children before and after drinking premedication. Gastric volume in pediatric patients is estimated by the model: GV= -7.8 + (3.5× RLD CSA) + (0.127) × age (months). | Ultrasound scan performed at baseline (before surgery) to measure gastric volume and 3 minutes after taking premedication to assess change. |
Influenza Vaccine in Pregnancy Part 2

Study Overview
=================
Brief Summary
-----------------
Pregnant women have limited knowledge regarding influenza, its implications during pregnancy, and recommendations for vaccination during pregnancy. The researchers plan to distribute an information pamphlet to women in a prenatal clinic, offer the vaccine during prenatal visits, and then give a questionnaire on the postpartum floor assessing knowledge. The researchers hypothesize that with education intervention, knowledge scores on the questionnaire will be higher than those from last year, when no education was provided.

Official Title
-----------------
Knowledge Possessed by Pregnant Women Regarding Influenza Vaccination During Pregnancy

Conditions
-----------------
Influenza, Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all pregnant women Exclusion Criteria: known hypersensitivity to influenza vaccine

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 46 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>All women presenting to our prenatal clinic and postpartum floor during the study period. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge scores on our questionnaire |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza, vaccine, pregnancy
Pharmacokinetic (PK) Assessment of BIBR 1048 in Patients After Primary Elective Total Hip Replacement Surgery

Study Overview
=================
Brief Summary
-----------------
To determine the PK profile of a single dose 150 mg BIBR 1048, oral capsule, administered 1-3 hours post surgery in hip replacement patients.

Official Title
-----------------
Multicenter, Open-label-study to Assess PK Profile of a Single Oral Dose of 150 mg BIBR 1048 (Capsule) in Patients Shortly After Primary Elective Total Hip Replacement Surgery.

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: BIBR 1048 capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled to undergo a primary elective total hip replacement Male or female being 18 years or older (women of child bearing potential may not be included) Patients weighing at least 40 kg Written informed consent for participation Exclusion Criteria: Bleeding disorders, e.g. history of intracranial, intraocular, gastrointestinal or pulmonary bleeding, known thrombocytopenia, history of haemorrhagic stroke Known renal disease Known liver disease, alcohol or drug misuse Known malignancy Treatment with another study drug in the past month

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIBR 1048 capsule<br> | Drug: BIBR 1048 capsule<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum plasma concentration (Cmax) |  | pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose | 
| time to maximum plasma concentration (Tmax) |  | pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose | 
| total clearance of drug from plasma |  | pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose | 
| terminal elimination constant |  | pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose | 
| time of last measureable BIBR 953 ZW plasma concentration (Tf) |  | pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose | 
| area under the plasma concentration time curve until Tf (AUC0-Tf) |  | pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose | 
| area under the plasma concentration time extrapolated to infinity (AUC0-infinity) |  | pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events |  | up to 24 hours after drug administration |
An Evaluation of a Novel Food Product in Adults Residing in an Area Endemic for Helminths

Study Overview
=================
Brief Summary
-----------------
The prevalence of intestinal helminths is worldwide. This study will evaluate the tolerability of a novel food product consumed by adults residing in an area endemic for helminths.

Official Title
-----------------
A Double-blind, Randomized, Controlled Evaluation of the Tolerability of a Proprietary Oil Blend in Adults Residing in Areas Endemic for Helminth Infections.

Conditions
-----------------
Helminthiasis

Intervention / Treatment
-----------------
* Other: Novel Food Product
* Other: Control Food Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Male or Female adults, age 18-45 years old inclusive on date of screening Showing presence of no or mild-moderate helminths Exclusion Criteria: Presence of heavy helminth load Pregnant or lactating Hepatosplenomegaly or clinically significant abnormal hemoglobin, LAT or creatinine

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Food Product<br>Consumption of placebo food product | Other: Control Food Product<br>* Control food product<br>|
| Experimental: Novel Food Product<br>Consumption of novel food product | Other: Novel Food Product<br>* Novel food product containing essential oil blend<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Safety and Tolerability using the Reactogenicity Questionairre | Reactogenicity will be assessed using a structured questionnaire on days 2, 14, 28, and 42 of the study. In addition, blood will be collected on study days 14 and 42 for assessment of basic hematologic and clinical chemistry parameters. | 43 days |
A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and sertraline Tablet in Japanese healthy male subjects.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: ASC-01


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers aged 20 to 40 years. Have a body mass index (BMI) between 18.5 and 25.0 kg/m2 and a weight of at least 50 kg. Exclusion Criteria: History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study. History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. Any clinically significant abnormalities in the physical examination, clinical laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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 |
| --- | --- |
| Experimental: ASC-01 placebo<br>A single oral dose of ASC-01 Placebo (sertraline 100 mg) | Drug: Placebo<br> <br> |
| Active Comparator: Sertraline tablet<br>A single oral dose of sertraline tablets (sertraline 100 mg) | Drug: ASC-01<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) of Sertraline |  | predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration-time Curve From Time 0 to the Last Observable Concentration at Time t (AUCt) for Sertraline |  | predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose |