linjc16/ctgov huggingface dataset:
Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo

Study Overview
=================
Brief Summary
-----------------
The rationale of this study is to conduct a summative (i.e., validation) usability test of Ciprofloxacin Dry Powder for Inhalation (DPI) and the associated Instructions for Use.

Official Title
-----------------
Multicenter Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation in Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB) or Chronic Obstructive Pulmonary Disease (COPD) Using Matching Placebo

Conditions
-----------------
Bronchiectasis, Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Placebo to Ciprofloxacin DPI (BAYQ3939)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Subjects (male and female) with non-cystic fibrosis bronchiectasis (NCFB) or chronic obstructive pulmonary disease (COPD) Subjects must be aged ≥40 Subject must be able to independently manage and administer their NCFB/COPD medications Exclusion Criteria: Subjects with recent exacerbation Subjects with recent significant hemoptysis in the four weeks before screening (and/or during the screening period) Subjects allergic to quinine Known chronic bronchial asthma

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Placebo to Ciprofloxacin DPI<br>Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training | Drug: Placebo to Ciprofloxacin DPI (BAYQ3939)<br>* Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The user performed the inhalation task based on the given instructions properly (Yes/No). | The performance was assessed by a test administrator. | 1 Day | 
| The user performed the inhalation task safely (Yes/No). | The user safety was assessed by a test administrator. | 1 Day | 
| DPI (Dry powder for inhalation) device malfunction (Yes/No). | The function was assessed by a test administrator. | 1 Day | 
| Subject's subjective feedback (paraphrased) on use-safety and usability |  | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhalation time | Inhalation time is assessed with a stop watch. | 1 Day | 
| User friendliness | User friendliness is assessd by a questionnaire. | 1 Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Usability Test
BM Collection From NICU Infants for Composition

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to collect feces from premature infants over a five weeks period to characterize its composition. Metabolomics, Proteomics, Genomics and Microbiome analyses and cell-based assays will be performed to identify individual components present in feces, which may contribute to the onset of irritation in the diapered area of premature infants.

Official Title
-----------------
Collection and Characterization of Premature Infants Feces for Identification of Factors Contributing to Skin Irritation

Conditions
-----------------
Diaper Dermatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant's parent(s)/legal guardian(s) must be fluent in English or Spanish, willing and able to read, understand, and sign the informed consent form (ICF). Infants (male or female) who are equal or less than a gestational age of 30 weeks + 4 days. Exclusion Criteria: Any medical condition which, in the opinion of the principal investigator, may compromise infant's safety. Any underlying chronic skin conditions. However, infants may participate in the study with a rash in the diapered area if, in the opinion of the principal investigator, this does not compromise infant's safety.

Ages Eligible for Study
-----------------
Maximum Age: 30 Weeks

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

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 |
| --- | --- | --- |
| Composition of proteins (ug/uL) in premature infant feces | This is an observational study where fecal samples will be collected twice each week for 5 weeks from enrolled patients. Primary analysis will consist of identification and quantification proteins present in samples. | 0 to 5 weeks |
A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension

Study Overview
=================
Brief Summary
-----------------
There is statistically significant correlation between invasive measures of intracranial pressure (ICP) and non-invasive, real-time, continuous physiologic waveform data algorithms to predict ICP. Furthermore, characteristics within this physiologic waveform data will allow modeling for trend prediction of derived ICP information. Specific aims: Develop models to estimate ICP and cerebral perfusion pressure (CPP) after traumatic brain injury in humans. Predict and anticipate changes in ICP for preemptive management purposes. Analyze characteristics of changes in ICP after treatment failure. Analyze data to predict/anticipate confounding physiologic factors that affect ICP and its treatment. Test the resulting models in real time.

Official Title
-----------------
A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension

Conditions
-----------------
Intracranial Hypertension, Elevated ICP (Intracranial Pressure)

Intervention / Treatment
-----------------
* Other: No Interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with severe traumatic brain injury resulting in motor Glasgow Coma Score (GCS) score < 5 age 18-89 years health care provider indicating the need for hyperosmolar therapy for elevated ICP Exclusion Criteria: pregnancy incarceration brain death (GCS 3 with fixed, dilated pupils) life-threatening systemic injuries (Abbreviated Injury Scale (AIS) >4 in an organ system other than CNS)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| SICU patients with ICP<br>Surgical intensive care unit patients with elevated intracranial pressure | Other: No Interventions<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Algorithm development | Developing algorithms relating data to intracranial pressure. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intracranial Hypertension, Elevated ICP (Intracranial Pressure)
Effect of Interscalene Block on Heart Rate Variability (HRV)

Study Overview
=================
Brief Summary
-----------------
The Left interscalene block has a different effect on heart's autonomic nervous system, as measured with Heart Rate Variability, compared to Right interscalene block

Official Title
-----------------
Effect of Interscalene Block on Heart's Autonomic Nervous System With Heart Rate Variability Measurement

Conditions
-----------------
Shoulder Surgery, Beach Chair Position, Interscalene Block, HRV, Autonomic Nervous System

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective shoulder surgery Age 20- 45 years old ASA I - II Exclusion Criteria: Coagulopathy disorders Infection at the puncture site for the interscalene block Neurologic deficit in the arm that is going to be operated Allergy to local anesthetics BMI > 35 Psychiatric disorders Patient's refusal Problems with patient communication Arrythmia Ischaemic heart disease Diabetes mellitus Thyroid function disorders Patients with conduction disorders on the ECG Electrolyte disorders (K+, Na+, Ca++) Patients on medication that affect the ECG

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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 |
| --- | --- |
| Left interscalene block<br>Left shoulder surgery under left interscalene block and HRV | |
| Right interscalene block<br>Right shoulder surgery under right interscalene block and HRV | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of interscalene block on Heart Rate Variability (HRV) | The Left interscalene block has different effect on heart's autonomic nervous system, as measured with HRV, than the Right. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interscalene block and beach chair positioning | Effect of interscalene block on hypotension during beach chair positioning | 2 years | 
| Interscalene block and beach chair positioning | Effect of interscalene block on bradycardia during beach chair positioning | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shoulder surgery, Beach chair position, Interscalene block, HRV, Autonomic nervous system
Porphyromonas Gingivalis and Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
With this study the investigators would like to analyze the the role of periodontal disease and especially the role of Porphyromonas gingivalis in initiation and progression of Alzheimer's Disease.

Official Title
-----------------
Porphyromonas Gingivalis - a Responsible Pathogen in Alzheimer's Disease?

Conditions
-----------------
Alzheimer's Disease, Dementia, Periodontitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 40-70 caucasian origin dementia (Alzheimer's or other dementia) cognitive healthy (need for spinal anesthesia) Exclusion Criteria: use of antibiotics within las 6 months pregnancy another illness explaining the symptoms in a better way smoking (>10 cigarettes) patients who have a legal custodian

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alzheimer's Disease<br> | |
| other Dementia<br> | |
| cognitive healthy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax Antibody Levels against Gingipains | laboratory analysis | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax Beta-Amyloid | laboratory analysis | Baseline |
Doripenem in the Treatment of Ventilator-Associated Pneumonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical response rate of doripenem versus comparator in patients with ventilator-associated pneumonia (VAP).

Detailed Description
-----------------
Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, open-label study of doripenem versus comparator to assess the effectiveness and safety of doripenem in the treatment of VAP in adult patients. The study consists of screening phase, open-label treatment phase, and follow-up. The treatment duration is from 7 to 14 days. The primary endpoint is the clinical response rate of doripenem at the early follow-up visit. The patients will receive either doripenem or comparator for 7 to 14 days.

Official Title
-----------------
A Multicenter, Randomized, Open-Label, Phase 3 Study of Doripenem Versus a Comparator Antibiotic in the Treatment of Ventilator-Associated Pneumonia

Conditions
-----------------
Pneumonia, Ventilators, Mechanical

Intervention / Treatment
-----------------
* Drug: doripenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has received mechanical ventilation for > 24 hours Presence of a new or progressive infiltrate on chest x-ray Exclusion Criteria: Believed at study entry to have ventilator-associated pneumonia caused solely by pathogen(s) resistant to certain antibiotics History of moderate or severe hypersensitivity reactions to certain antibiotics

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response rate at the early follow-up visit. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response rate at the late follow-up visit. Microbiological response at both early and late follow-up visits. Safety assessment (adverse events, vital signs, laboratory test results) conducted throughout the study.. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventilator-Associated Pneumonia
Yoga for Solid Tumor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to ascertain the effect of yoga interventions on radiation-related fatigue, and stress in cancer patients with stage I and II solid tumors.

Official Title
-----------------
A Pilot Study On The Effect Of Yoga On Fatigue, And Stress Levels In Solid Tumor Cancer Patients Undergoing Active Radiation Therapy

Conditions
-----------------
Solid Tumor, Adult

Intervention / Treatment
-----------------
* Behavioral: Yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage I and II Cancer patients with solid tumors undergoing RT for 4-8 weeks (external beam radiation). Patients of age >18, and all races will be included in the study. All patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Pennsylvania. Patients must be English speaking. Patients must be able to attend the schedule classes. Exclusion Criteria: Patients with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions per their physician orders. Patients with metastatic disease. Active smokers. Smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Self-reporting smokers that have been smoke free for 6 months may be included) Patients who currently practice or have recently practiced yoga (had not taken a yoga class on a regular bases in the last 6 months).

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Observational<br>All 10 pilot subjects will be taking yoga | Behavioral: Yoga<br>* Twice weekly yoga sessions for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The feasibility of implementing Eischens yoga interventions for solid tumor cancer patients undergoing radiation therapy. This will be measured by the success rate of recruitment and retention for 10 subjects. | Feasibility | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on fatigue | Examine the effect of yoga on cancer and radiation related fatigue during radiation therapy. We will use the BFI results both before, during and after radiation therapy. | 12 months | 
| Effects on Stress Level | Examine the effect of yoga on cancer and radiation related fatigue during radiation therapy. We will use the NCCN Distress thermometer results both before, during and after radiation therapy. | 12 Months |
Iron Overload in Stem Cell Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to examine the impact of iron overload in patients undergoing a bone marrow transplant. We believe that the iron status in these patients is associated with complications for transplant survivors. We will examine the iron status in these patients by MRI and by screening for mutations in genes known to cause iron overload. We will also determine the levels of hepcidin (a hormone produced in the liver that appears to regulate iron homeostasis) from blood and urine.

Official Title
-----------------
Impact of Iron Overload in Pediatric Patients Undergoing Stem Cell Transplantation

Conditions
-----------------
Iron Overload

Participation Criteria
=================
Eligibility Criteria
-----------------
Undergoing allogeneic HSCT for malignant or non-malignant conditions Age greater than or equal to 5 years Able to undergo MRI without a need for general anesthesia No metal implants Signed informed consent (by parent if patient is less than 18 years old, or by patient, if he or she is greater than 18 years old).

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- | --- |
| Hepatic iron content as measured by R2 MRI. |  | Pre-HSCT and Day 100 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic determinants of iron overload- HFE status. |  | Pre-HSCT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemochromatosis, Iron overload, Stem cell transplant, Pediatrics, Pediatric Stem cell transplant
The Efficacy of Pain Management With Self-reporting Pain Monitoring System in Cancer Patient

Study Overview
=================
Brief Summary
-----------------
To compare the pain scales between clinician evaluated and reported with wearable device by patients.

Detailed Description
-----------------
To compare the pain scales between clinician evaluated and reported with wearable device by patients with cancer of advanced stage.

Official Title
-----------------
The Efficacy of Pain Management With Self-reporting Pain Monitoring

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Device: using device for scoring pain scale, named ANAPA®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 20 year old cancer pain with visual analog scale or numeric rating scale score >/- 4 opioids candidates with informed consent form Exclusion Criteria: life expectancy within 3 months

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>using device for scoring pain scale, named ANAPA® | Device: using device for scoring pain scale, named ANAPA®<br>* wearable device for scoring pain scale<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actual difference of pain scales | comparing the pain scale assessed by wearable device and that assessed by physician when out patient clinic. | 1 week after using wearable pain scale device - baseline and 1 week. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer pain, wearable device
PACE30: 30 Years in Cardiac Pacing

Study Overview
=================
Brief Summary
-----------------
Limited data exist regarding temporal trends in permanent pacemaker (PPM) implantation. To describe trends in incidence and comorbidities of PPM recipients, the investigators aim to conduct a retrospective population-based cohort study using record linkage, over a 32 year period.

Official Title
-----------------
Trends in Cardiac Pacing - 30 Years of Implants

Conditions
-----------------
Pacemakers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with pacemakers
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All paced patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Mortality | We will examine time to cardiovascular death from pacemaker implant and relate to the differing indications for pacing | 30 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalisation for heart failure | We will examine the frequency of hospitalisations after device implantation | 30 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pacemakers, Survival