linjc16/ctgov huggingface dataset:
Effect of Covid-19 Pandemic on Emergency Surgery Practice

Study Overview
=================
Brief Summary
-----------------
A retrospective study at a tertiary university hospital to determine the effect of the COVID-19 pandemic on the emergency surgery practice in the hospital.

Detailed Description
-----------------
The investigators conducted a retrospective review of all the patients who were admitted to the surgical wards through the emergency department at the Jordan University Hospital in the periods from March 2020 to May 2020. The records were compared to those of the patients who were admitted in the same period from the year 2019. Data collection includes the number of admissions, the reason for admission, the average of symptoms duration until admission, the age of the patients admitted, gender, type of management, and the average length of stay before discharging the patients.

Official Title
-----------------
The Impact Of The Covid-19 Pandamic On Emergency Surgery In A Tertiary Hospital In Jordan. A Cross Sectional Study

Conditions
-----------------
Emergencies

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who were admitted to the surgical wards via the emergency department during the study periods Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 2020 group (COVID19 group)<br>Patients who were admitted to the surgical ward via the emergency department during the lockdown period due to the COVID19 pandemic | Other: Observational study<br>* Observational study, the study did not involve any interventions<br>|
| 2019 group (pre COVID19 group)<br>Patients who were admitted to the surgical ward via the emergency department during the similar period in 2019 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average duration of sx prior to admission in hours |  | 1 year | 
| Type of management (surgical vs conservative) |  | 1 year | 
| Length of stays in Days |  | 1 year | 
| Level of care (ICU vs floor) |  | 1 year |
Safety And Anti-Inflammatory Effect Of SB681323 In Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
This is a 28-day, placebo controlled clinical study assessing the safety, tolerability anti-inflammatory effect and pharmacokinetics of SB681323 in patients with COPD (Chronic Obstructive Pulmonary Disease).

Official Title
-----------------
A 28-day, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Anti-inflammatory Effect and Steady-state Pharmacokinetics of SB-681323 7.5 mg Per Day in Patients With Chronic Obstructive Pulmonary Disease.

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive, Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Drug: SB681323


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Non-childbearing potential. Clinical diagnosis of COPD. Cigarette smoking history of greater than or equal to 10 pack years. Post-bronchodilator FEV1 to FVC ratio (FEV1:FVC) < 0.7 Post-bronchodilator FEV1 50% - 80% of predicted normal. Receiving inhaled corticosteroids for a minimum of 6 weeks prior to Screening. Serum CRP concentration greater than 3mg/L. Exclusion criteria: Current diagnosis of asthma. Active tuberculosis, sarcoidosis or bronchiectasis. History of any type of malignancy, rheumatoid arthritis or other conditions associated with chronic inflammation. Clinically significant renal or hepatic disease. History of increased liver function tests, or patients receiving hormone replacement therapy, statins or systemic or topical corticosteroids.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SB681323|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers in blood and sputum Spirometric lung function tests Dyspnoea measured by the TDI Safety assessments Population Pharmacokinetics |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
P38 map kinase, CRP, COPD, safety
Gemini Symbicort pMDI

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether treatment with Symbicort for 12 weeks will improve lung function and symptoms of adults and adolescents with asthma.

Official Title
-----------------
A Rand, Doubleblind, Activecontrolled, Parallel-grp,Singledummy, Multicenter,12 wk Study to Assess the Effic.&Safety of Symbicort pMDI 2x160/4.5mcg QD Compared to Symb. pMDI 2x80/4.5mcg QD, Symb. pMDI 2x80/4.5mcg Bid and to Budesonide pMDI 2x160 Mcg QD in Asthmatic Sub's12yrs and Over

Conditions
-----------------
Mild or Moderate Asthma

Intervention / Treatment
-----------------
* Drug: budesonide/formoterol (Symbicort)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma Baseline lung function tests as determined by protocol. Required and received treatment with inhaled corticosteroids and/or lung treatments specified in the protocol within timeframe and doses specified in protocol. Exclusion Criteria: Severe asthma Has required treatment with any non-inhaled corticosteroid within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 12 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> | Drug: budesonide/formoterol (Symbicort)<br> <br> * Other names: Symbicort;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from start of treatment in evening pre-dose FEV1 |  | 2, 6 and 12 weeks after starting treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from before treatment in lung function, symptoms, use of rescue medication and patient-physician reported outcomes |  | Daily | 
| Investigate safety profile of Symbicort and budesonide |  | Before and 2, 4, 12 weeks after start of treatment and 1 week after end of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, inhaled corticosteroids, Symbicort, budesonide/formoterol, budesonide
EC-MOTION : ExtraCorporeal Membrane Oxygenation and Therapeutic Drug Monitoring of Drugs of infectION

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to investigate the exposure difference between antibiotic studied patients in intensive care with Extracorporeal Membrane Oxygenation and patients without Extracorporeal Membrane Oxygenation. The exhibition is evaluated by population pharmacokinetic modeling.

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Other: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years Hospitalisation in intensive care Treatment with ECMO or without ECMO Introducing sepsis treated with an anti-infective molecule studied (piperacillin) for less than 48 hours With an arterial catheter Patient Information or their next of kin according to the patients status. Exclusion Criteria: Pregnancy Major person under legal protection (backup justice, trusteeship, quardianship), person deprived of liberty

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ECMO piperacillin<br>patients in intensive care treated with ECMO with antiinfective therapy : piperacillin | Other: blood sample<br> <br> |
| without ECMO piperacillin<br>patients in intensive care without ECMO with antiinfective therapy : piperacillin | Other: blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure exposure to piperacillin | evaluated by population pharmacokinetic modeling and is defined by the time during which the antibiotic concentration is greater than 4 times the critical concentration of the germ to treat | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ExtraCorporeal Membrane Oxygenation, patient in intensive care, pharmacokinetic modeling
Observational Study of Insulin Resistance and Muscle Wasting After Burn Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine important and significant problems, that of insulin resistance and muscle wasting after burn injury.

Detailed Description
-----------------
Burn injury induces insulin resistance and our investigators have previous shown the importance of insulin receptor substrate 1 (IRS-1)-mediated pathways. This project will establish the inhibitory effects of burn injury on IRS-1 mediated signaling in human skeletal muscle of burn patients.

Official Title
-----------------
Project 4: Molecular Mechanisms in Burn-induced Insulin Resistance in Humans

Conditions
-----------------
Burn

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Burn injury >=10% total body surface area involvement from any etiology that will require surgical treatment Age 18 years or older Admitted to the Massachusetts General Hospital within 30 days of burn injury Patient or guardian who is capable of giving full informed consent Exclusion Criteria: Decision not to treat due to severity of injury Presence of anoxic brain injury that is not expected to result in complete recovery Existence of co-morbid conditions of malignancy currently under treatment, medical condition requiring glucocorticoid treatment, insulin dependent diabetes mellitus, morbid obesity defined as body mass index >= 40

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 |
| --- | --- | --- |
| Determination of gene expression profile and protein expression | Determination of individual profiles and comparison with profiles from existing patients and healthy controls | Time of burn injury up to 24 months postinjury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital discharge status | Alive or dead | From hospital admission to discharge | 
| Presence of clinical complications | Analysis of incidence of clinical complications related to organ function/dysfunction | From hospital admission to discharge | 
| Intensive care unit (ICU) days | Total number of ICU days | From hospital admission to discharge | 
| Nutritional status at discharge | Analysis of change in total body weight, lean body mass, indirect calorimetry, and nitrogen balance | At hospital discharge | 
| Correlation between protein data and in vivo physiologic measurement data | Gene and and protein expression data will be correlated with the physiological and and in vivo physiologic measurements (lab values) and nutritional status data. | Hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burn
The Effect of a Short Educational Program on Young Women's Knowledge and Beliefs About Osteoporosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the effect of a short educational program on young women's knowledge and beliefs about osteoporosis. They hypothesis is that following the intervention women who receive the educational program will have greater knowledge and beliefs about osteoporosis.

Detailed Description
-----------------
Objective. To determine the effect of a short osteoporosis educational program on young women's knowledge and beliefs about osteoporosis. Methods. Ten college physical activity classes enrolling 133 predominantly Caucasian women (age range 18 to 21 years) were randomized to an osteoporosis educational program or control. Knowledge and beliefs about osteoporosis were assessed at baseline and at one week and three weeks following the intervention using the Multiple Osteoporosis Prevention Survey. Knowledge was defined as the ability to identify correctly osteoporosis risk factors. Beliefs were measured with the use of a five point Likert type scale. The educational program was comprised of a lecture and printed materials developed by the National Osteoporosis Foundation. Chi-square and analysis of variance evaluated for between group differences. Alpha was set at 0.05.

Official Title
-----------------
The Effect of a Short Educational Program on Young Women's Knowledge and Beliefs About Osteoporosis

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women enrolled in a mid-atlantic college physical activity course Exclusion Criteria: Unable to partake in three survey's and one educational lesson
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Education|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteoporosis Knowledge |  | 7 days and 21 days post educational intervention | 
| Osteoporosis Beliefs |  | 7 days and 21 days post educational intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, Knowledge, Beliefs, Education, Women
To Examine Smoking Behavior of Prisoners - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the smoking behavior of female incarcerated smokers and to determine how smokers differ from non-smokers on measures of substance abuse, personality, criminal history, and mental illness

Official Title
-----------------
Smoking Research With Incarcerated Females

Conditions
-----------------
Smoking Behavior

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all smokers, non-smokers, and ex-smokers Exclusion Criteria: inability to understand English and inability to be able to provide informed consent due to mental impairment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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 |
| --- | --- | --- |
Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure

Study Overview
=================
Brief Summary
-----------------
To further characterize the transfer potential of marketed testosterone gel and new 1.62% formulation.

Official Title
-----------------
An Open-label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62%

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: Testosterone gel 1.62%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female volunteers, with a BMI 20-35 kg/m2 (males) and 20-30 kg/m2 (females). Exclusion Criteria: Males: history, current or suspected prostate or breast cancer. Female: pregnant or lactating.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Testosterone gel 1.62%<br>* 5 grams applied topically to upper arms/shoulder and abdomen on Day 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Testosterone replacement therapy
Middle-ear Reflex Testing Using Wideband Acoustic Immittance

Study Overview
=================
Brief Summary
-----------------
This project will assess the middle-ear muscle reflex using wideband acoustic immittance which is a valuable method for evaluating infants, children, and adults. The developments will facilitate clinical applications that include hearing screening and diagnostic evaluation of persons of all ages with normal hearing and with hearing loss.

Detailed Description
-----------------
Measurement of middle-ear muscle reflexes (MEMR) constitutes an important component of the standard of care in auditory function assessment and diagnostic audiology. An important component of the middle-ear test battery involves characterizing neural function through the eighth nerve-brainstem pathway which is accomplished through measurement of the MEMR. The evaluation component of this project will involve testing of human subjects using wideband acoustic immittance in the evaluation of middle-ear muscle reflexes. Subjects in this project will be infants, children and adults with normal hearing as well as with conductive, sensory, and neural hearing loss. All subjects will receive wideband acoustic immittance (WAI) and middle-ear muscle reflex (MEMR) testing. Baseline testing includes pure tone audiometry and otoacoustic emissions.

Official Title
-----------------
Middle-ear Reflex Testing Using Wideband Acoustic Immittance

Conditions
-----------------
Hearing Disorders

Intervention / Treatment
-----------------
* Diagnostic Test: WAI-MEMR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal hearing or hearing loss Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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: MEMR Diagnostic Evaluation<br>Middle Ear Muscle Reflex using wideband acoustic reflectance to assess hearing status. | Diagnostic Test: WAI-MEMR<br>* Using wideband acoustic reflectance for middle-ear muscle reflex.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WAI-MEMR | MEMR threshold | Through study completion, an average of 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
middle ear muscle reflex, wideband acoustic immittance