linjc16/ctgov huggingface dataset:
International Multicentre Prevalence Study on Sepsis

Study Overview
=================
Brief Summary
-----------------
To mark 10 years of the Surviving Sepsis Campaign (SSC), and timed to coincide with World Sepsis Day, on September 13, 2013, the SSC, ESICM and SCCM will be conducting an international point prevalence study of severe sepsis and septic shock. The goal of this project is to determine the world wide burden of severe sepsis and define current practices of sepsis care internationally. The study is a simple data collection exercise for patients presenting with either severe sepsis or septic shock on World Sepsis Day.

Detailed Description
-----------------
De---identified patient---level data will be collected on patients presenting to a participating intensive care unit or emergency department with severe sepsis or septic shock over a 24 hour period from 00:00 to 24:00 November 07, 2013. De---identified data that is already collected as part of routine clinical care will be collected for this study. Data to be collected includes hospital and ICU characteristics, patient characteristics, severity of illness, and adherence to SSC bundle elements and mortality. It will take between 30---60 minutes to collect and enter data for each patient admitted with severe sepsis or septic shock over the 24 hours study period.

Official Title
-----------------
Surviving Sepsis Campaign. International Multicentre Prevalence Study on Sepsis.

Conditions
-----------------
Septic Shock, Severe Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be eligible patients must have all of the following: Must be admitted or transferred to either the ED or an Intensive Care Unit. Have a high clinical suspicion of an infection Have sepsis as defined by an infection together with two or more SIRS criteria Evidence of acute organ dysfunction and/or Shock. Exclusion Criteria: Patients less than 18 years of age Patients in whom the sepsis has been present from before the beginning of the study period Any patients previously included in the study during the same study period

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 |
| --- | --- | --- |
| 28-Day Mortality |  | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organ Failure |  | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, severe sepsis, septic shock, infection, organ dysfunction, quality improvement
A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Open-label Study of the Effect of Maintenance Mircera Administered With Pre-filled Syringes on Hemoglobin Levels in Anemic Dialysis Patients With Chronic Kidney Disease

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: epoetin alfa or beta
* Drug: methoxy polyethylene glycol-epoetin beta [Mircera]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients >=18 years of age; chronic renal anemia; on dialysis therapy for at least 12 weeks before screening; receiving iv or sc epoetin for at least 8 weeks before screening. Exclusion Criteria: women who are pregnant, breastfeeding or using unreliable birth control methods; administration of another investigational drug within 4 weeks before screening, or during the study period.

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: 1<br> | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* 30, 50 or 90 micrograms iv or sc (starting dose) every 2 weeks<br>|
| Active Comparator: 2<br> | Drug: epoetin alfa or beta<br>* iv or sc, as prescribed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin concentration |  | Weeks 1-36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration |  | Weeks 29-36 | 
| RBC transfusions |  | Weeks 1-36 | 
| AEs, laboratory parameters, vital signs |  | Throughout study |
Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm.

Study Overview
=================
Brief Summary
-----------------
Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization. In this study, our hypothesis are as following: As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.

Detailed Description
-----------------
Indocyanine green, ICG (ICG-fluorescence) ICG is the most commonly used fluorophore which approve by FDA. NIR-F imaging with ICG could be used in various surgeries. For example, SLN mapping in breast cancer and localization of liver metastasis, especially superficial lesion Contains sodium iodide, patients who have history of allergy to iodides should be used as caution. Nonpalpable benign brest lesion localization New method for the localization and resection of non-palpable breast lesions. The breast lesion was correctly localized, and the area of ICG corresponded well to the site of the lesions.

Official Title
-----------------
Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm ; Observational Pilot Study for 20 Patients.

Conditions
-----------------
Benign Breast Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nonpalpable benign breast lesion ≤ 2cm in patients with breast cancer. patients who need breast biopsy as treatment for breast cancer. Eastern Cooperative Oncology Group Performance status 0 or 1 consented patients with more than 20 years, less than 70 years Exclusion Criteria: nonpalpable benign breast lesion ≥ 2cm in patients with breast cancer. pregnancy history of severe allergy to ICG(Indocyanine Green) iode hypersensitiveness

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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 |
| --- | --- | --- |
| non-palpable lesion localization rate | non-palpable lesion localization rate = number of patients complete excision of lesion / 20 enrolled patients | up to 6month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lesion of resection size, completeness of resection | actual lesion of width*height*length / resection lesion of width*height*length | up to 6month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Near-infrared fluorescence, Indocyanine green, ICG, Radio-guided surgery, breast cancer
Prednisone for Decompensated Congestive Heart Failure

Study Overview
=================
Brief Summary
-----------------
We designed this, randomized, double-blind, placebo-controlled trial to determine the clinical efficacy of chronic administration of prednisone on renal function and clinical status when added to standard care.

Detailed Description
-----------------
Studies showed that glucocorticoids could specifically dilate renal vessel, increase in GFR, and regulate synthesis and release of atrial natriuretic peptide (ANP), upregulate ANP receptors on vascular endothelial cells, leading to significant diuresis and natriuresis. Adding glucocorticoids to standard care may potentiate the diuretic and natriuretic effects of diuretics and improve renal function, thus improve the clinical outcomes.

Official Title
-----------------
Chronic Administration of Prednisone in Management of Patients With Decompensated Congestive Heart Failure

Conditions
-----------------
Heart Failure, Congestive

Intervention / Treatment
-----------------
* Drug: prednisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized with primary diagnosis of CHF Patients with normal cortical function LVEF <40% Significant fluid overload, defined as ≥ 2 of the following Enlarged liver or ascites Peripheral or sacral edema ( ≥ 2+) Jugular venous distention ≥ 10 cm Pulmonary rales, pleural effusion on chest x-ray or orthopnea Exclusion Criteria: Severe stenotic valvular disease Serum creatinine > 4 mg/dl Patient refusal Any signs of infection or any condition that would contraindicate an glucocorticoids use Poor controlled hypertension Poor controlled diabetes mellitus Active myocarditis Malignancy or other terminal illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: prednisone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in serum creatinine level, Patient and physician-assessed symptom scales at day 1, day 3, the end of week 1 and week 2 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily urine volume, changes in body weight, serum electrolyte levels at the end of week 1, week 2, respectively, and overall safety profile |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
decompensated heart failure, prednisone, diuretics, diuresis
Awake Prone Position in Patients With COVID-19

Study Overview
=================
Brief Summary
-----------------
Although prone position is widely used in awake patients with COVID-19 associated with supplemental oxygenation, high flow nasal catheter, or noninvasive ventilation, few studies are attesting to its real benefits on physiological variables or intubation rate. Awake patients dependent on supplemental oxygen may have different responses to PP about peripheral oxygen saturation, heart rate, and respiratory rate. Such responses may be permanent, transient, or even absent. We believe that the response to PP can be a predictor of the need for admission to the ICU. This study aimed to evaluate the acute effects of different types of response to the prone position in patients awake with COVID-19.

Official Title
-----------------
Evaluation of the Response to the Awake Prone Position in Patients With COVID-19

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Procedure: Awake prone position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a confirmed diagnosis of COVID-19, through tests based on PCR and chest tomography with suggestive findings, spontaneously ventilating, dependent on supplemental oxygen. The study included patients with: (1) age ≥ 18 years, (2) peripheral oxygen saturation less than 92% under supplemental oxygen administration equal to or greater than 6 L / min through a nasal catheter or reservoir mask; (3) no use of NIV or high-flow nasal catheter; (4) continuous monitoring with pulse oximeter; (5) mental status that allowed to follow the instructions; and (6) able to tolerate PP with minimal assistance. - Exclusion Criteria: hemodynamic instability, severe obesity, or who were unable to tolerate and cooperate with the performance of PP

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Awake prone position|The prone position in awake patients consists of asking the patient to voluntarily change to prone position, in a swimmer's posture|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU admission rate | The criteria defined for admission to the ICU included maintenance of SpO2 below 90% with oxygen flow at 15 L / min, RF greater than 30 incursions per minute, reduced level of consciousness, or clinical signs of persistent increase in respiratory work, such as paradoxical ventilatory pattern. | Patients were followed up for up to 15 days of hospitalization. |
To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Clarithromycin 250 mg tablets under fasting conditions.

Official Title
-----------------
A Relative Bioavailability of Clarithromycin 250 mg Tablets Under Fasting Conditions

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Clarithromycin 250 mg Tablets (Geneva, USA)
* Drug: Biaxin 250 mg Tablets (Abbott Laboratories, Inc, USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 54 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: 1<br>Clarithromycin 250 mg Tablets (Geneva, USA) | Drug: Clarithromycin 250 mg Tablets (Geneva, USA)<br> <br> |
| Active Comparator: 2<br>Biaxin 250 mg Tablets (Abbott Laboratories, Inc, USA) | Drug: Biaxin 250 mg Tablets (Abbott Laboratories, Inc, USA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 9 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic
PRISM Registry: Pseudobulbar Affect Registry Series

Study Overview
=================
Brief Summary
-----------------
PBA is a neurologic condition that is estimated to impact over a million patients and their families in the United States. PBA occurs secondary to an otherwise unrelated neurologic disease or injury, and manifests as involuntary, frequent, and disruptive outbursts of crying and/or laughing. Progress has been made in better understanding this debilitating condition, but much more needs to be done. That's why a new PBA patient registry, PRISM (Pseudobulbar Affect RegIstry Series), has been initiated. The goal of PRISM is to establish the prevalence and quality of life (QOL) impact of PBA in patients with underlying neurologic conditions including Alzheimer's disease Amyotrophic lateral sclerosis Multiple sclerosis Parkinson's disease Stroke Traumatic brain injury Because this is an observational registry, it doesn't require you to intervene with any specific treatment or procedure. Your participation allows the PRISM registry to collect and analyze data from your site and also compare it to national numbers captured in the PRISM registry about PBA across all of the major at-risk neurologic populations.

Official Title
-----------------
PRISM Registry: Pseudobulbar Affect Registry Series

Conditions
-----------------
Alzheimer's Disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease, Stroke, Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants must have underlying neurologic conditions known to be risk factors of PBA: Alzheimer's Disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's Disease, Stroke, and Traumatic Brain Injury. The population for this study will be 18 years and over

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 |
| --- | --- | --- |
| Prevalence of PBA (using CNS-LS) | The objective of the registry is to determine the prevalence of pseudobulbar affect (PBA) in patients with certain underlying neurologic conditions: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD), Stroke (STR), and Traumatic Brain Injury (TBI). Presence of PBA symptoms was defined as CNS-LS score >=13. | Upon Study Enrollment/Entry | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pseudobulbar affect
Pressure Ulcers in Knee Replacement Surgery

Study Overview
=================
Brief Summary
-----------------
From the point of view of nursing to know exactly the different risk factors for the onset of pressure ulcers is very important as it allows to accurately orient preventive care interventions. All the variable that could influence the development of pressure ulcer in patients undergoing knee replacement surgery are identified and collected: age, sex, body max index, risk to develop Pressure Ulcer (braden score), treatment to prevent pressure ulcers (typology of the devices used, such as air mattresses with alternating or static pressure, heel drains, frequency of mobilization carried out by both the patient care), management of eventual incontinence (use of diapers, urinary catheter), type of anesthesia, type of analgesia, length of stay, the ASA physical status classification system (ASA score), comorbidity, cancer, use of devices for controlling the position of the operated limb (foam valve), the number of physical therapy sessions actually carried out.

Official Title
-----------------
The Peripheral Nerve Blocks Analgesia in Patients Undergoing Knee Replacement Surgery is a Risk Factor for the Development of Pressure Sores at the Heel? Retrospective Cohort Study

Conditions
-----------------
Knee Osteoarthritis, Pressure Ulcer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary knee joint replacement Secondary knee joint replacement Exclusion Criteria: Cancer patients Adult or Senior with pressure ulcer at the heel

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Heel Pressure Sores | Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P. | every day until discharge (expected average of 6 days). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heel Pressure Sores of grade ≥2 | Numbers of Participants With Heel Pressure Sores of grade ≥2 Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P. | every day until discharge (expected average of 6 days). | 
| Pressure Sores in any other site | Numbers of Participants With Pressure Sores in any other site Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P. | every day until discharge (expected average of 6 days). | 
| Pain | Pain Score on the Numeric Rating Scale (NRS). The NRS scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain | up to the first 3 days post intervention |