linjc16/ctgov huggingface dataset:
Is There an Association Between Chronic Pancreatitis and Pulmonary Function

Study Overview
=================
Brief Summary
-----------------
To evaluate pulmonary function in chronic pancreatitis compared with healthy volunteers and patients with cirrhosis.

Official Title
-----------------
Association Between Chronic Pancreatitis and Respiratory Dysfunction: A Prospective Cohort Study?

Conditions
-----------------
Chronic Pancreatitis, Respiratory Insufficiency, Cirrhosis, Liver, Lung Function Decreased, Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic pancreatitis or cirrhosis Healthy controls Exclusion Criteria: Lack of informed consent Known chronic lung disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Patients and controls<br>Patients diagnosed with chronic pancreatitis or cirrhosis and healthy controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diffusion capacity of the lung for carbon monoxide | Lung diffusion capacity | Three years | 
| Alveolar volume | Alveolar volume | Three years |
Vashe Wound Therapy Study

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy, safety, and tolerability of topical Vashe™ Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist versus 5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.

Official Title
-----------------
Pilot Study to Evaluate Effectiveness of Vashe™ Wound Therapy as an Antimicrobial Irrigant in Burn Wound Management

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Device: Vashe
* Drug: Mafenide acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged 18 years and over requiring hospitalization for burn injury Burn injury requiring wound excision and auto-grafting Less than or equal to 20% Total Body Surface Area burns Exclusion Criteria: Pregnant or lactating females Individuals with chlorine sensitivity Electrical, chemical and cold injury Burns to the face, hands, feet and or perineum area Steroid therapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vashe<br>Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days. | Device: Vashe<br>* Antimicrobial irrigant<br>|
| Active Comparator: 5% Mafenide Acetate<br>5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days. | Drug: Mafenide acetate<br>* Antimicrobial solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Grafted Area That is Viable at Day 14 | Percentage area of graft viability at 14 days as determined by clinical assessment of revascularization, adherence of the graft to the wound bed and color | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | Average hospital length of stay in days | 0 days, 3 days, 5 days and 14 days post-operation | 
| Hospital Cost Per Patient | Average hospital irrigant cost per patient | Volume used from admission to discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burn, Burn wound management, Burn graft
Analysis on the Infection Risk, Prognosis, and Drug Sensitivity of Klebsiella Pneumoniae.

Study Overview
=================
Brief Summary
-----------------
Nosocomial infections are increasing rapidly both internationally and domestically, especially carbapenem-resistant Klebsiella pneumoniae infections. However, there were still lack of evidence about the risk and prognosis in Taiwan. The choice of drug and related sensitivity test was also limited. We would analyze the infection risk, prognosis, and drug sensitivity of Klebsiella pneumoniae and focus on strategy to manage carbapenem-resistant Klebsiella pneumoniae infections.

Official Title
-----------------
Analysis on the Infection Risk, Prognosis, and Drug Sensitivity of Klebsiella Pneumoniae.

Conditions
-----------------
Klebsiella Pneumoniae Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
All adult patients (≥18 years) with K. pneumoniae bloodstream infection were included. Patients were excluded if there was other recognized bacteremia within two weeks before or after the first episode of K. pneumoniae bloodstream infection.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| All-cause 28-day mortality |  | 2017-2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
risk factors ,outcomes,Drug Susceptibility,Klebsiella pneumoniae
Monitoring of Vital Signs During Skin-to-skin Holding by Mothers of Their Preterm Babies

Study Overview
=================
Brief Summary
-----------------
This observational study aims to monitor the vital sign changes in both mother and baby that occur during kangaroo care in preterm infants and to investigate any potential correlations between maternal measurement values and those of the infant. The purpose of this observational study is to look for a method to track the earliest responses that could, theoretically, be considered as 'social responses' in hopes of providing developmental interventions earlier to at-risk infants.

Detailed Description
-----------------
The goal of this observational study is to identify any signs of early social response in order to be able to assist infants that lack this response with early neurobehavioral modifications.

Official Title
-----------------
Vital Sign Monitoring of Mother-Infant Dyads During Kangaroo Care in Preterm Infants

Conditions
-----------------
Other Preterm Infants

Intervention / Treatment
-----------------
* Behavioral: Mother-Infant Dyad


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inborn at Mount Sinai gestational age between 30 0/7 weeks and 34 6/7 weeks gestation only one infant of a multiple gestation plan by family to do kangaroo care during NICU stay Exclusion Criteria: outborn infants gestational age less that 29 6/7 weeks or greater than 35 0/7 weeks other infants of multiple gestation (see inclusion criteria) any major congenital anomalies sepsis and/or any other serious clinical complication precluding kangaroo care

Ages Eligible for Study
-----------------
Minimum Age: 30 Weeks
Maximum Age: 35 Weeks

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mother-Infant Dyad<br>Skin-to-skin holding of preterm infants by their mothers | Behavioral: Mother-Infant Dyad<br>* Skin-to-skin holding of preterm infants by their mothers<br>* Other names: Kangaroo Care;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate |  | up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Rate |  | up to 30 minutes | 
| Oxygen Saturation |  | up to 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preterm, Kangaroo Care, Skin-to-Skin, Vital Sign, Heart Rate, Respiratory Rate, Oxygen Saturation
Far Forward Battlefield Telemedicine: Evaluation of Handheld Ultrasound

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to improve survival of battlefield trauma through ultrasound telemedicine and remotely guided therapeutics.

Detailed Description
-----------------
Specific aims to meet to improve the survival of battlefield trauma are 1)validation of portable ultrasound for diagnosis of various medical and surgical emergencies, ie cardiac tamponade, intraabdominal hemorrhage, 2)Extension of our expertise in digital echocardiography and local telemedicine to support other centers in such procedures as TEE 3)development of wireless telemedicine systems for rapid relay of ultrasonic images from portable ultrasound system to a remote review station. 4)development of a precision guide for diagnostic and therapeutic percutaneous procedures using ultrasound guidance 5)combining wireless telemetry with the guided percutaneous access tool to permit remotely guided emergency procedures 6)augmenting this work(2D/echo) with 3D/echo.

Official Title
-----------------
Far Forward Battlefield Telemedicine:Ultrasound Guidance System (UGS)

Conditions
-----------------
Thoracic Injuries

Intervention / Treatment
-----------------
* Device: Miniature echo machine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-80 yrs old Scheduled for clinical echocardiogram Exclusion Criteria: None

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Miniature echo machine<br>Diagnostic capabilities Wireless transfer | Device: Miniature echo machine<br>* Images captured and real-time and store-and-forward file transfers performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of small portable ultrasound units | paired t-testing and linear regression will be used to test the hypothesis that the small system is equivalent to the full-featured one (mean difference in values not different from 0 and slope of the regression line not different | single time point | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trauma, portable ultrasound, telemedicine, Department of Defense
Safety and Efficacy of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia, Europe and Oceania. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects)

Detailed Description
-----------------
The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Official Title
-----------------
Safety and Efficacy of Inhaled Pre-prandial Human Insulin Plus Glimepiride Versus Rosiglitazone Plus Glimepiride in Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: rosiglitazone
* Drug: inhaled human insulin
* Drug: glimepiride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Treated with OAD(s) for more than or equal to 2 months Body mass index (BMI) less than or equal to 40.0 kg/m2 HbA1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in OAD monotherapy HbA1c greater than or equal to 7.5 % and less than or equal to 10.0 % for subjects on OAD combination therapy Exclusion Criteria: Recurrent major hypoglycaemia Current smoking or smoking within the last 6 months Impaired hepatic or renal function Cardiac problems Uncontrolled hypertension Proliferative retinopathy or maculopathy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: inhaled human insulin<br>* Treat-to-target dose titration scheme, pre-prandial, inhalation.<br>* Other names: NN1998;Drug: glimepiride<br>* Tablets, 4 mg/day.<br>|
| Active Comparator: B<br> | Drug: rosiglitazone<br>* Tablets, 4 mg once or twice a day.<br>Drug: glimepiride<br>* Tablets, 4 mg/day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment difference in HbA1c |  | After 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | For the duration of the trial | 
| Body weight |  | during treatment | 
| Lung function |  | after 26 weeks of treatment | 
| Blood glucose |  | after 26 weeks of treatment | 
| Hypoglycaemia |  | from 12-26 weeks of treatment |
Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of diclofenac 1.16% gel compared with placebo applied four times a day in subjects with acute neck pain.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Multi-center Parallel Group Phase IV Study to Evaluate the Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain

Conditions
-----------------
Neck Pain

Intervention / Treatment
-----------------
* Drug: Diclofenac diethylamine 1.16% gel
* Drug: Placebo gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects, age range 18 and over. Patient with acute neck pain meeting baseline pain intensity level and duration Exclusion Criteria: Pain medication was taken within the 6 hours that precede randomization. Patient with chronic neck pain as defined as pain for 3 months or longer Any neck pain that is attributable to any organic disease, such as prolapsed disc, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumors. Any recent strains of the neck muscles documented by the clinical evaluation and anamnesis

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac diethylamine 1.16% gel<br> | Drug: Diclofenac diethylamine 1.16% gel<br>* Diclofenac diethylamine 1.16% gel<br>|
| Placebo Comparator: placebo gel<br> | Drug: Placebo gel<br>* Placebo gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on Movement | Pain on movement on a 100 mm visual analog scale. Minimum score =0 mm no pain. Maximum score =100 mm extreme pain. | 48 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at Rest | Pain at Rest on a 100 mm visual analog scale. Minimum score =0 mm no pain. Maximum score =100 mm extreme pain. | 96h | 
| Neck Disability Index | Neck Disability Index total score. Minimum = 0 Best. Maximum = 50 Worst | 96h |
Effect of the Genotype on Postoperative DVT

Study Overview
=================
Brief Summary
-----------------
Postoperative Venous Thromboembolism Events (VTE) constitute a major source of morbidity and mortality after surgery. The aim of this study was to investigate whether commonly occurring Single Nucleotide Polymorphisms (SNPs) are associated with VTE in the surgical setting.

Detailed Description
-----------------
Data extracted from the participants in the UK Biobank collaborative study. Two cohorts will be examined: Surgical cohort, consisting of all patients with a registered surgical procedure in the UK biobank repository Validation cohort, consisting of all non-surgical patients in the UK biobank repository. A GWAS approach will be used to associated commonly occurring single nucleotide polymorphisms (SNPs) with a postoperative venous thromboembolic event (VTE) within 30 days of a surgical procedure in the surgical cohort. Findings from the surgical GWAS step will be replicated in the Validation cohort in order to assess whether the same SNPs drive both surgical and non-surgical VTE risk. A final GWAS model will be fielded, correction for confounders including sex, age, smoking, obesity and open/minimal invasive surgery (surgical discovery GWAS only).

Official Title
-----------------
Postoperative Venous Thromboembolism Risk in 140,831 Surgical Patients - a Genetic Association Cohort Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All patients included in the UK biobank repository Exclusion criteria: - None
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 |
| --- | --- | --- |
| Postoperative VTE event |  | 30 days of a surgical procedure |
Current Situation of Natural History, Diagnosis and Treatment in Inpatients With Embolism Stroke of Unknown Cause (ESUS)

Study Overview
=================
Brief Summary
-----------------
Evaluate the epidemiological characteristics, risk factors, clinical characteristics in patients with ESUS and their medication compliance and relapse within 1 year.

Detailed Description
-----------------
The purpose of this study is to evaluate the epidemiological characteristics, risk factors (such as hypertension, diabetes, hyperlipidemia, coronary heart disease, history of previous stroke, smoking, and alcohol consumption), clinical characteristics in patients with ESUS and their medication compliance and relapse within 1 year.

Official Title
-----------------
A Research of Current Situation of Natural History, Diagnosis and Treatment in Inpatients With Embolism Stroke of Unknown Cause (ESUS)

Conditions
-----------------
Embolic Stroke of Undetermined Source

Intervention / Treatment
-----------------
* Other: ESUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients diagnosed with acute cerebral infarction and treated in Peking University Third Hospital Neurology Department from January 2010 to June 2016. Exclusion Criteria: Lacunar infarction Aortic atherosclerotic cerebral infarction Clear cardiogenic cerebral infarction Other related system diseases (arteritis, vascular dissection, migraine and vasospasm, etc.)

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 |
| --- | --- |
| ESUS<br>Embolic stroke of undetermined source (ESUS) designates patients with nonlacunar cryptogenic ischemic strokes in whom embolism is the likely stroke mechanism. | Other: ESUS<br>* Embolic stroke of undetermined source (ESUS) designates patients with nonlacunar cryptogenic ischemic strokes in whom embolism is the likely stroke mechanism.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | Medication adherence usually refers to whether patients take their medications as prescribed (eg, twice daily), as well as whether they continue to take a prescribed medication. The Morisky scale, a validated, 4-item self-reported adherence measure that has been shown to be predictive of adherence to cardiovascular medications and blood pressure control. If a patient scores higher on the scale, they are evaluated as more adherent. If they score lower on the scale, they are presumed to be struggling with nonadherence. | 1 year after recruitment | 
| Recurrence rate | Recurrence rate of stroke | 1 year after recruitment |