linjc16/ctgov huggingface dataset:
Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis

Study Overview
=================
Brief Summary
-----------------
To determine whether an average population of males and females who smoke 10 pack years or more of cigarettes in a primary care setting with chronic bronchitis has already developed significant changes on pulmonary function testing.

Detailed Description
-----------------
The incident of COPD is dramatically increasing while other chronic disease states are decreasing in the US population. Smoking cigarettes is the leading risk factor for COPD. Smokers with chronic bronchitis may show early or late changes of COPD on pulmonary function tests. It is imperative that we define this patient population to determine whether early intervention will alter pulmonary function over the years.

Official Title
-----------------
Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis

Conditions
-----------------
Chronic Bronchitis, COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must sign a written informed consent. Enrollment population would include males and females 40 years of age to 80 years of age. Current history or past history of smoking at least 10 pack years of cigarettes. Patients to satisfy the diagnosis of chronic bronchitis. Non-smokers will be allowed in the control group Exclusion Criteria: Chronic infections such as TB or other infections of the lungs. Collagen diseases such as rheumatoid arthritis or lupus which affect the lungs. Any previous lung diseases such as pneumoconiosis. Previous accidents or surgery which would involve the lungs or the ribcage. Maintenance medications used for asthma or COPD such as long acting bronchodilators or inhaled corticosteroids. Asthma patients or other patients with allergies that may affect pulmonary function test will be excluded. Any medical condition in the opinion of the investigator that would make the subject unsuitable for enrollment. Pregnant woman will not be allowed Current participation in a research study or within the last 30 days.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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
-----------------
COPD, Smokers, Chronic Bronchitis, Pulmonary Function Test Abnormalities
PENG and LFCN Block Versus Lumbar Plexus Block for Postoperative Analgesia After Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Regional anesthesia for postoperative analgesia in THA includes epidural anesthesia and peripheral nerve blocks. However epidural anesthesia has a great role in THA, it has become restricted as perioperative antithrombotic drugs are generally used for orthopedic patients. the study aim to evaluate and compare efficacy and safety of pericapsular nerve group block (PENG) block and lateral femoral cutaneous nerve versus Lumbar plexus block on postoperative analgesia in hip surgery.

Official Title
-----------------
Efficacy and Safety of Ultrasound Guided Combined Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Versus Lumbar Plexus Block for Postoperative Analgesia After Total Hip Arthroplasty: Randomized Clinical Study.

Conditions
-----------------
Post Operative Pain, Regional Block

Intervention / Treatment
-----------------
* Procedure: pericapsular nerve group and lateral femoral cutaneous nerve block
* Procedure: lumbar plexus block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (ASA) physical status I to III scheduled for hip surgery aged (30-70) years Exclusion Criteria: Drug allergy, Morbid obesity (BMI >40 kg/m2), Coagulopathy, Psychiatric disorder, Opioid dependence, Patient refusal to give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PENG and LFCN<br> | Procedure: pericapsular nerve group and lateral femoral cutaneous nerve block<br>* Will undergo pericapsular nerve group block (PENG) combined with lateral femoral cutaneous nerve under ultrasound guided block with 20 mL of 0.25% bupivacaine.<br>|
| Experimental: lumbar plexus<br> | Procedure: lumbar plexus block<br>* Will undergo Lumbar plexus block (LPB) under ultrasound guided block with 20 mL of 0.25 % bupivacaine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale pain scores | pain score from 0-10 which 0 mean no pain and 10 the worst pain | 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first analgesic request | time to demand nalbuphine | 24 hour | 
| total analgesic consumption | total nalbuphine in mg consumed in the first day | 24 hour | 
| First time to ambulate | first time to move | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PENG, lumber plexus, hip surgery
Study of Accuracy of New Diagnostic Technology to Guide Rapid Antibiotic Treatment for Serious Infections

Study Overview
=================
Brief Summary
-----------------
This research will test a new ultra-rapid technology (called ID/AST Accelerate system) that uses a digital microscope to identify bacteria based on their growth patterns. This method does not have to wait for bacteria to grow in a lab. The new method can identify the type of bacteria within 2 hours of receiving a specimen. The new method also shows the effect of selected antibiotics on the bacteria including multidrug resistant bacteria so that doctors know within 6 hours from specimen collection which antibiotic kills the bacteria. To check the accuracy, speed and impact of the new method on antibiotic prescribing, investigators are proposing a study with two parts; The first part will test the accuracy and speed of the results obtained by the new method. The second part will test if having the results from the new method early would change the antibiotics prescribed to a patient in a simulation experiment. An independent infectious disease physician will be shown the results from the new method and asked if the results were accurate, would it change the antibiotic treatment for the patient.

Official Title
-----------------
Rapid Microbiological Diagnostics for MDRO Quantitative Identification and Resistance Phenotyping to Guide Antibiotic Selection in Wounded Warriors and Veterans - Task 3

Conditions
-----------------
INFECTIONS, Skin and Subcutaneous Tissue Bacterial Infections, Healthcare-associated Infection, Infection Due to Resistant Bacteria

Intervention / Treatment
-----------------
* Device: Testing on new technology called Accelerate ID/AST system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old Remnant sample from available from microbiology culture (respiratory, blood or tissue/skin) ordered as part of usual clinical care. Exclusion Criteria: Insufficient sample volume available after sufficient aliquot removed for usual care.

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: Testing on new technology called Accelerate ID/AST system|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in empiric antimicrobial use | Antibiotic use from the time of specimen collection until antibiotic susceptibility testing results are available to treating clinicians. Antibiotic use will be measured in days of therapy (DOT). DOT in usual care and simulated ID/AST Accelerate system will be compared | 1.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wounded warriors, Battlefield infection, ESBL, MRSA, KPC
PEEP Setting in COVID19-related ARDS

Study Overview
=================
Brief Summary
-----------------
The best way to titrate positive end-expiratory pressure (PEEP) in patients suffering from acute respiratory distress syndrome is still matter of debate. Electrical impedance tomography (EIT) in a non-invasive technique that could guide PEEP setting based on an optimized ventilation homogeneity.

Detailed Description
-----------------
COVID-19 related ARDS patients admitted to the ICU in March 2021 requiring mechanical ventilation were enrolled. Patients were monitored by an esophageal catheter and a 32-electrode EIT device. Within 48 hours after the start of mechanical ventilation, different levels of PEEP were applied based upon PEEP/ Fraction of inspired oxygen tables, positive end-expiratory transpulmonary (PL)/ FiO2 table, and EIT. Respiratory mechanics variables were recorded.

Official Title
-----------------
Positive End-expiratory Pressure Setting in COVID-19 Related ARDS : Comparison Between Electrical Impedance Tomography, PEEP/ Fraction of Inspired Oxygen Tables, and Transpulmonary Pressure.

Conditions
-----------------
ARDS Due to Severe Acute Respiratory Syndrome Coronavirus 2

Intervention / Treatment
-----------------
* Other: PEEP setting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID19-related ARDS under invasive mechanical ventilation Exclusion Criteria: none

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: PEEP setting|PEEP setting according to various methods|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of PEEP | different PEEP values obtained through using different methods | a single determination, within 24-48 hours after mechanical ventilation initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory mechanics | Respiratory mechanics (plateau pressure, driving pressure, compliance, mechanical power) following different PEEP settings | a single determination, within 24-48 hours after mechanical ventilation initiation |
Phase I Pharmacokinetic Study (BF-BLOCK)

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess if charcoal prevents the absorption of budesonide and formoterol via GI track. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve.

Official Title
-----------------
Effect of Charcoal on Gastrointestinal Absorption of Budesonide and Formoterol

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Budesonide/formoterol capsule.
* Drug: Budesonide/formoterol capsule for oral adm.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males and females aged 18-60 years. Normal weight at least 50 kg. Exclusion Criteria: Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease. Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study. Any condition requiring concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. Known hypersensitivity to the active substance(s) or the excipients of the drug. Pregnant or lactating females.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Budesonide/formoterol capsule (Orion Pharma) for oral administration. | Drug: Budesonide/formoterol capsule.<br>* Oral administration with concomitant charcoal.<br>|
| Experimental: Treatment B<br>Budesonide/formoterol capsule (Orion Pharma) for oral administration. | Drug: Budesonide/formoterol capsule for oral adm.<br>* Oral administration without concomitant charcoal.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of primary pharmacokinetic variable AUCt | The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover design. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables | Cmax | 4 weeks | 
| Pharmacokinetic variable | tmax | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma
Sputum Purulence as a Predictor of Cystic Fibrosis Exacerbations: a Prospective Cohort Trial.

Study Overview
=================
Brief Summary
-----------------
To use the sputum colour chart as a predictor for cystic fibrosis exaerbations

Detailed Description
-----------------
Patients will score their sputum purulence daily using three colour charts. They will also score for respiratory and other symptoms. Primary analysis will focus on the predicting value of sputum purulence on exacerbations. Secondary analysis will evaluate symptoms on exacerbation prediction. A third subanalysis will focus on correlation of daily pollution fluctuations and sputum purulence or symptoms.

Official Title
-----------------
Sputum Purulence as a Predictor of Cystic Fibrosis Exacerbations: a Prospective Cohort Trial.

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a diagnosis of cystic fibrosis Pseudomonas aeruginosa colonization at least 2 exacerbations in the previous year at least 18 years of age Exclusion Criteria: colour blindness

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 |
| --- | --- |
| Cystic fibrosis patients<br>patients with cystic fibrosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sputum colour evoluation as a predictor for exacerbation |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms as a predictor for exacerbations |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sputum colour, cystic fibrosis, pollution
FIRAZYR General Drug Use-Results Survey (Japan)

Study Overview
=================
Brief Summary
-----------------
The objectives of this survey are to collect data to report the safety and efficacy of Firazyr (Icatibant acetate) in the post-marketing phase in participants diagnosed with Hereditary Angioedema (HAE).

Official Title
-----------------
FIRAZYR General Drug Use-Results Survey (Japan)

Conditions
-----------------
Hereditary Angioedema (HAE)

Intervention / Treatment
-----------------
* Drug: Firazyr


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hereditary angioedema (HAE) participants in Japan who receive FIRAZYR for first time in the real world clinical setting. 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 |
| --- | --- |
| Firazyr<br>Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information. | Drug: Firazyr<br>* Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information.<br>* Other names: Icatibant acetate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Drug Reactions | Number of participants with adverse drug reactions will be assessed. | 4 Years | 
| Time to Treatment for Attack | Time to treatment for attack defined as the time between the onset of the attack and the first injection of treatment. Time to treatment for attack will be assessed. | 3 Months | 
| Time to First Symptom Relief | Time to first symptom relief will be assessed. | 3 Months | 
| Time to Complete Resolution of Attack | Time to complete resolution of attack defined as the time between the first injection of treatment and the complete resolution of all symptoms. Time to complete resolution of attack will be assessed. | 3 Months | 
| Total Duration of Attack | Total duration of attack defined as the time between the onset of the attack and the complete resolution of all symptoms. Total duration of attack will be assessed. | 3 Months |
Measurement of Body Weight Using Shoe Insole Pressure Sensors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a dataset to help accelerate machine learning (ML) based solutions for applications such as activity recognition, detect changes in weight and predict weight of carried load. The research will further help in the development of novel machine learning-based algorithm for accurately predicting the body weight of an individual in real-time and within few ounces error margin, using sampled data from smart insole sensors.

Official Title
-----------------
Measurement of Body Weight Using Smart Shoe Insole Pressure Sensors

Conditions
-----------------
Effect of Different Weights

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range of 18-70 years Exclusion Criteria: Refusal to adhere to covid19 safety guidelines

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure readings |  | 1hr |
Efficacy Evaluation of Products Against Long Wavelength Ultraviolet A1 and Visible Light Induced Biological Effects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of topical products in providing protection against the visible light and ultraviolet A1 (UVA1) part of sunlight. Ultraviolet radiation and visible light are both components of sunlight that reach the earth. It is important to test these topical products against visible light and UVA1 because our current sunscreens may not protect against these very well.

Official Title
-----------------
Efficacy Evaluation of Products Against Long Wavelength Ultraviolet A1 and Visible Light Induced Biological Effects

Conditions
-----------------
Sun Damaged Skin

Intervention / Treatment
-----------------
* Drug: Sunscreening Agents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age 18 and older Patients Fitzpatrick skin phototype (SPT) III-IV with normal skin health Patient able to understand requirements of the study and risks involved Exclusion Criteria: A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation A history of a relevant skin condition on any part of the patient's body (e.g. atopic dermatitis, eczema, vitiligo, sun burn, etc. A known history of photodermatoses A known history of photosensitivity disorders A known history of melanoma or non-melanoma skin cancers

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Topical products and Untreated areas<br>The subject will serve as their own control. Four different products will be tested. | Drug: Sunscreening Agents<br>* Four different sunscreens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Investigator's Global Assessment (IGA) | Assesses erythema and pigmentation | through study completion, an average of 1 week | 
| Change in Colorimetry | Measures erythema and pigmentation | through study completion, an average of 1 week | 
| Change in Diffuse Reflectance Spectroscopy | Measures erythema and pigmentation | through study completion, an average of 1 week |