linjc16/ctgov huggingface dataset:
A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
The objective of this sample collection study is to collect blood and urine samples. This study is observational and will have no impact on the medical management of the subject.

Official Title
-----------------
A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 21 years of age or older Subjects must be enrolled (first study-specific sample collection) within 24 hours of ICU admission Subjects enrolled from ED or Floor must be admitted to the ICU within 24 hours of enrollment Subjects enrolled in the ICU must have been admitted to the ICU or transferred into the study ICU from another ICU no more than 24 hours prior to enrollment Expected to remain in the ICU for at least 48 hours after enrollment Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment At least one of the following acute conditions documented within 24 hours prior to enrollment Respiratory SOFA score of ≥ 2 (PaO2/FiO2 <300) Cardiovascular SOFA score of ≥ 1 (MAP < 70 mm Hg and/or any vasopressor required Subject (or authorized representative) able and willing to provide written informed consent for study participation. Exclusion Criteria: Special populations including women with known pregnancy, prisoners or institutionalized individuals Previous renal transplantation Known moderate to severe AKI prior to enrollment (e.g., RIFLE-I or RIFLE-F/ AKIN 2 or AKIN 3 Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic) Subjects with a history of Chronic Kidney Disease (CKD) without a baseline serum creatinine value (baseline within 6 months of enrollment)

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury |  | 04/1/2012 to 3/29/13 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Renal
Objective Sleep Disturbances in Orthostatic Intolerance

Study Overview
=================
Brief Summary
-----------------
We wish to study sleep architecture in patients with chronic orthostatic intolerance. We will test the null hypothesis that there is no difference in time during the various phases of sleep between patients and healthy control subjects.

Official Title
-----------------
Assessment of Objective Sleep Disturbances in Orthostatic Intolerance

Conditions
-----------------
Postural Tachycardia Syndrome, Chronic Orthostatic Intolerance

Intervention / Treatment
-----------------
* Procedure: Polysomnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with chronic orthostatic intolerance (or healthy subject) Exclusion Criteria: overt cause or acute orthostatic intolerance pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| 1<br>Patients with Chronic Orthostatic Intolerance | Procedure: Polysomnography<br>* Overnight Sleep Study<br>* Other names: Sleep Study;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of sleep |  | 1 night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in individual phases of sleep |  | 1 night | 
| sleep latency |  | 1 might | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postural tachycardia syndrome, sleep, insomnia
Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The incidence of efficacy failure at 12 months between two regimens.

Official Title
-----------------
An Open-label, Concentration Controlled, Randomized, 12 Month Study of Prograf + Rapamune + Cor

Conditions
-----------------
Chronic Kidney Failure, Graft vs Host Disease, Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Rapamune


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age: 13 years or older, 40 kgs or more End-stage renal disease African-American/Black transplant recipient and/or repeat renal transplant recipient who lost a previous allograft Exclusion Criteria Evidence of active infection Evidence abnormal chest x-ray Patients with HIV.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

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

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
-----------------
Kidney Transplant
Vitamin D and HbA1c Levels in Diabetic Patients With CKD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the association between serum 25-hydroxyvitamin D and HbA1c levels in diabetic patients with chronic kidney disease. The investigators hypothesized that serum 25-hydroxyvitamin D levels were negatively correlated with HbA1c levels.

Detailed Description
-----------------
This was a cross sectional study using consecutive sampling methodology for participant recruitment. It was carried out at the specialized diabetic, renal, and general outpatient clinics in the University of Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia. Serum 25(OH)D levels were determined by using direct chemiluminesent immunoassay (ADVIA Centaur XP; Siemens Healthcare Diagnostics, Tarrytown, New York, USA). Serum HbA1c levels were determined using high-pressure liquid chromatography (Variant™ II Turbo; Bio-Rad, Hercules, California, USA). Data collected will be analyzed using Statistical Package for Social Sciences SPSS version 23.0 for Windows, version 23.0 (IBM Corp., Armonk, New York, USA).

Official Title
-----------------
Association Between Serum 25-hydroxyvitamin D Levels and Glycated Haemoglobin in Diabetic Patients With Chronic Kidney Disease

Conditions
-----------------
Vitamin D Deficiency, Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: eGFR 15-59 ml/min/1.73m2 age ≥ 18 years old able to provide informed consent Exclusion Criteria: active infections autoimmune diseases malignancies on immunosuppressive therapy on vitamin D supplements

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 |
| --- | --- | --- |
| 25-hydroxyvitamin D levels | The unit of measure was nmol/L. The detection limit of the device was <10 nmol/L. A mean value of 5 nmol/L were taken for results reported as <10nmol/L. | Within 2 weeks from enrolment | 
| HbA1c levels | The unit of measure was percentage (using NGSP standarization). | Within 2 weeks from enrolment |
Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions

Study Overview
=================
Brief Summary
-----------------
The goal of this investigation is to obtain clinical data to show the Health Beacons Radiofrequency Identification (RFID) Localization System is safe and performs as intended as a localization device for marking and retrieving a non-palpable surgical target from the breast.

Official Title
-----------------
A Prospective, Single-Arm, Multicenter Clinical Study to Evaluate the Safety and Performance of the Health Beacons Radiofrequency Identification (RFID) Localization System for Marking and Retrieving Non-Palpable Breast Lesions

Conditions
-----------------
Non-palpable Breast Lesions

Intervention / Treatment
-----------------
* Device: RFID Tag (Health Beacon)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have had stereotactic or ultrasound-guided biopsy with marker placement Have a lesion or biopsy marker that is visible under ultrasound Have surgical target < 6 cm from the skin when lying supine Have a discreet surgical target Have a lesion in which the center/focal area is defined Be at least 18 years of age or older Exclusion Criteria: Have a palpable lesion that does not require localization Require more than one localization needle for localization of the surgical target Have undergone previous open surgical biopsy or lumpectomy in the operative breast Have an implant in the operative breast Have a cardiac pacemaker or defibrillator device

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects scheduled to undergo lumpectomy<br> | Device: RFID Tag (Health Beacon)<br>* The radiologist or surgeon will place the Health Beacons RFID Tag under ultrasonic or stereotactic guidance. The surgeon will use the Tagfinder to locate the lesion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The surgical target is visualized in the removed specimen AND the RFID Tag was removed from the patient's breast. | The study endpoints are known soon after the lumpectomy procedure by 1) confirmation of the pathology lab examination; and 2) retrieval of the implanted RFID tag. | Within 96 hours after lumpectomy |
Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients

Study Overview
=================
Brief Summary
-----------------
A randomized clinical trial to evaluate the effect of using pulmonary ultrasound to guide fluid therapy on distinct variables.

Detailed Description
-----------------
In this randomized clinical trial, the investigators will evaluate the effect of guiding fluid therapy by pulmonary ultrasound on the following variables: Length of stay in the pediatric ICU Duration of mechanical ventilation Oxygenation index PaO2/FiO2

Official Title
-----------------
Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients

Conditions
-----------------
Fluid Overload Pulmonary Edema, Fluid Overload, Pneumonia, Ventilator-Associated, Fluid Overload Without Edema

Intervention / Treatment
-----------------
* Diagnostic Test: Pulmonary ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pediatric inpatient intensive care unit admissions Signed Informed Consent Form Exclusion Criteria: Cyanotic congenital heart disease Not requiring mechanical ventilation

Ages Eligible for Study
-----------------
Minimum Age: 1 Week
Maximum Age: 14 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound Guided Fluid Therapy<br> | Diagnostic Test: Pulmonary ultrasound<br>* Pulmonary ultrasound is a basic application of critical ultrasound, defined as a loop associating urgent diagnoses with immediate therapeutic decisions.<br>|
| No Intervention: Conventional Fluid Therapy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Number of days that the patient requires care in the ICU | through study completion, an average of 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation Index | Measure of the fraction of inspired oxygen (FiO2) and its usage within the body. | Daily through study completion, an average of 14 days | 
| PaO2/FIO2 | Ratio of arterial oxygen partial pressure to fractional inspired oxygen | Daily through study completion, an average of 14 days | 
| Duration of mechanical ventilation | Days that a patient remains under mechanical ventilation | through study completion, an average of 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric intensive care, lenght of stay
Measurement of Blood Perfusion in Response to Loading in Patients With Wounds

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the skin blood flow in the lower leg, with different levels and types of applied loads. These loads will not be placed over the patient's wound nor will they be higher than loads the skin normally experiences in daily activities. The results of this research will help investigators understand the development of pressure ulcers, commonly known as bedsores and stasis ulcers.

Conditions
-----------------
Wound Formation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are eligible if he/she has a wound on one or both legs. Exclusion Criteria: under the age of 18 individuals with mental illness individuals who are unable to sit for an hour individuals whose wound care method prohibits testing

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Wounds on leg<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in perfusion | Skin perfusion will be measured as different loads are applied to the leg. | Cross-sectional, evaluation time frame is approximately 2 hours occuring at the time of enrollment |
Healing Touch During Chemotherapy Infusions for Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To study if Healing Touch is effective during chemotherapy treatment for breast cancer

Detailed Description
-----------------
To study the effectiveness of Healing Touch provided during chemotherapy infusions on the experience of women undergoing treatment for breast cancer. Healing Touch (HT) is a gentle, non-invasive form of energy-balancing work that promotes relaxation and can help manage the side effects of chemotherapy.

Official Title
-----------------
Healing Touch During Chemotherapy Infusions for Women With Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Healing Touch
* Other: Standard care
* Procedure: guided relaxation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Stage I or II breast cancer Post-operative Concurrent enrollment on a treatment protocol of 8 weeks of adriamycin + cyclophosphamide given every other week followed by 8 weeks of paclitaxel given every other week ECOG Performance Status: 0 to 2 Speak and read English Exclusion Criteria:- Previous chemotherapy exposure - Concomitant energy-work interventions (HT, Reiki, QiGong, acupuncture).

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Care + Healing Touch (HT)<br>A a gentle, non-invasive form of energy-balancing work that promotes relaxation and can help manage the side effects of chemotherapy. It occurs every other week (during their infusion). | Procedure: Healing Touch<br>* every other week (during their infusion)<br>Other: Standard care<br>* Adriamycin, cyclophosphamide, and paclitaxel administered as standard of care<br>|
| Active Comparator: Standard Care + Guided relaxation<br>Guided relaxation every other week (during their infusion). | Other: Standard care<br>* Adriamycin, cyclophosphamide, and paclitaxel administered as standard of care<br>Procedure: guided relaxation<br> <br> |
| Active Comparator: standard care only<br>Standard care | Other: Standard care<br>* Adriamycin, cyclophosphamide, and paclitaxel administered as standard of care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FACT-B summary score |  | Baseline, 6 wks, 14 wks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Domain scores for FACT-B; BSI-18; FACIT-Fatigue; nausea measured on a Likert scale |  | Baseline, 6 wks, 14 wks |
Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy and safety of Botulax® in treatment of crow's feet line

Detailed Description
-----------------
Allocation: Randomized Masking: Double Blind

Official Title
-----------------
Randomized, Double-blind, Active-controlled, Multicenter, Phase I/III Clinical Trial to Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines

Conditions
-----------------
Crow's Feet Lines

Intervention / Treatment
-----------------
* Drug: Botulinum toxin type A
* Drug: Botulinum toxin type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of at least 19 to 65 years old Bilaterally symmetrical moderator-to-severe CFL at maximum smile on the FWS as rated by the investigator Exclusion Criteria: Subject with hypersensitivity to the investigational products or their components Female subject who are pregnant or lactating Subject who are unable to communicate or follow the instructions Subject who are not eligible for this study based on the judgment of an investigator

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulax<br>Single dose | Drug: Botulinum toxin type A<br>* Experimental<br>* Other names: Botulax;|
| Active Comparator: Botox<br>Single dose | Drug: Botulinum toxin type A<br>* Active Comparator<br>* Other names: Botox;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial Wrinkle Scale(FWS) severity of crow's feet lines(CFL) at maxium smile as assessed by investigators | The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported as assessed by investigators | 4weeks |