linjc16/ctgov huggingface dataset:
Comparison of Blood Pressure Measurements Between Transdermal Optical Imaging and Standard of Care

Study Overview
=================
Brief Summary
-----------------
Participants (patients and volunteers) will be recruited to have their blood pressure measured by standard blood pressure assessment methods while having their face video recorded. The data collected will help improve the blood pressure measurement accuracy of Transdermal Optical Imaging, which relies on machine learning to extract physiological information from videos recorded.

Detailed Description
-----------------
There are many ways to measure blood pressure (monitors, mercury sphygmomanometer, aneroid devices), with most relying on a cuff-inflation. Transdermal Optical Imaging measures blood pressure using a video captured by any conventional camera (e.g., those on a phone, tablet, laptop) and advanced machine learning algorithms. The current study aims to improve the accuracy of Transdermal Optical Imaging algorithms for measuring blood pressure. The investigators will recruit participants (patients with medical problems and healthy volunteers) to have their blood pressure measured in various ways (e.g.,by registered nurses with sphygmomanometer and stethoscope, continuous blood pressure monitor, etc.). Further, participants will have their faces video-recorded intermittently between standard measurements or at the same time as standard measures.

Official Title
-----------------
Comparison of Blood Pressure Measurements Between Transdermal Optical Imaging and Standard of Care

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: Transdermal Optical Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able and willing to provide written informed consent to participate (including by parent or legal guardian if under 16 years old). Exclusion Criteria: No exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 100 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 |
| --- | --- |
| Healthy Controls<br>Blood pressure measurements by standard assessment methods and Transdermal Optical Imaging | Device: Transdermal Optical Imaging<br>* Blood pressure measurements completed by standard assessment methods and Transdermal Optical Imaging<br>|
| Patients<br>Blood pressure measurements by standard assessment methods and Transdermal Optical Imaging | Device: Transdermal Optical Imaging<br>* Blood pressure measurements completed by standard assessment methods and Transdermal Optical Imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Results | Comparison of Transdermal Optical Imaging data and Standard assessment data | Single visit; up to one day |
Pressure Support Ventilation During CF Exacerbations

Study Overview
=================
Brief Summary
-----------------
Chest physiotherapy is recognized as a mainstay of cystic fibrosis therapy, and is particularly important during treatment of pulmonary exacerbations. For some patients, especially those with moderate to severe compromise of lung function, this therapy may impose a high demand in the work of breathing and energy expenditure. The goal of this study is to evaluate the effectiveness of adding pressure support ventilation (PSV) during chest physiotherapy sessions in patients with cystic fibrosis with moderate to severe lung function compromise being treated for a pulmonary exacerbation.

Detailed Description
-----------------
The proposed study will be conducted over three years. Cystic fibrosis patients with moderate to severe pulmonary disease who are experiencing an acute exacerbation that requires hospitalization will be admitted to the GCRC. Subject participation in the study will be for the first 10 days of hospitalization. Subjects will be randomized into one of two treatment groups: usual care or usual care plus non-invasive pressure support ventilation (PSV).

Official Title
-----------------
Pressure Support Ventilation During CF Exacerbations: A Randomized, Controlled Trial

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

Intervention / Treatment
-----------------
* Device: Pressure support ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
cystic fibrosis subjects with pulmonary exacerbation

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pressure support ventilation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ritonavir and Agenerase Treatment for Patients Who Have Failed Previous Anti-HIV Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if treatment with an anti-HIV drug containing ritonavir and Agenerase is safe and can lower the level of HIV in the blood in patients who have failed an anti-HIV drug treatment containing nelfinavir.

Detailed Description
-----------------
HIV-infected patients will be treated with a ritonavir-enhanced Agenerase regimen.

Official Title
-----------------
The Safety and Efficacy of a Ritonavir-Enhanced Agenerase Regimen as Salvage Therapy in HIV-Infected Individuals

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Ritonavir
* Drug: Amprenavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients may be eligible for this study if they: Are 18 years of age or older. Are HIV-positive. Have a viral load (level of HIV in the body) of more than 1,000 copies/ml. Have had more than 12 weeks of prior anti-HIV drug treatment. Have failed a previous anti-HIV treatment containing nelfinavir as the only protease inhibitor. Are responsive to Agenerase. Are able to follow study requirements. Exclusion Criteria Patients will not be eligible for this study if they: Are intolerant to ritonavir (an anti-HIV drug). Have or have had problems with absorption. Have liver disease or damage. Have pancreatic disease or damage. Have taken any protease inhibitor other than nelfinavir. Are receiving investigational drugs or devices from another study. Are pregnant or breast-feeding. Currently use triazolam, astemizole, ergot medications, cisapride, midazolam, bepridil, rifampin, terfenadine, or pimozide. Have a bleeding disorder. Have previously been treated with Agenerase. Are receiving nonnucleosides.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ritonavir|nan|
|Drug: Amprenavir|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
-----------------
Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, VX 478, Salvage Therapy, Anti-HIV Agents, Drug Monitoring, Nelfinavir, Treatment Experienced
The Global Prevalence of Infections in Urology Study

Study Overview
=================
Brief Summary
-----------------
Urology departments from all over the world are invited to join the Global Prevalence Study on Infections in Urology (GPIU-study) and the GPIU Prostate Biopsy Side Study. The GPIU study is taking part annually in November since 2003. European urologists were the first group of specialist to register hospital acquired infections on an international level. More than 20.000 patients have been screened and more than 2000 patients are currently listed in this database. Why? Infectious complications after urological procedures, such as prostate biopsy and increasing antimicrobial resistance are posing significant threats to modern urology The GPIU-study is a combined quality improvement initiative and a scientific study. Once the participating departments have filled in the report forms they will get access to statistics showing the accumulated results for all participating hospitals. The participants can anonymously compare their own results with hospitals from all over the World. The GPIU-study application has been designed as an instrument to ongoing follow-up of the development of important factors related to infection on international, national and local levels. Take responsibility for the future of urology - join the GPIU-studies! http://gpiu.esiu.org Prof. Dr. Florian M.E. Wagenlehner, MD, PhD Clinic for Urology, Pediatric Urology and Andrology University Clinic Giessen, Germany GPIU study coordinator Prof. Truls E. Bjerklund Johansen, MD, PhD Urology Department, Oslo University Hospital, Chairman ESIU Oslo, NO GPIU Study coordinator Zafer Tandogdu University College London (UCL), UK Dominic Althaus Software engineer Giessen, Ger

Official Title
-----------------
The Global Prevalence of Infections in Urology Study

Conditions
-----------------
Hospital Infection, Urinary Tract Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
On the chosen single study day at 08:00 AM local time all patients present on the ward of the participating institution are included The presence of urinary tract infections (UTI) according to the CDC definitions during their entire hospital stay are documented and audited and the patients are categorized as having or not having a UTI and/or The presence of surgical site infection (SSI) according to the CDC definitions during their entire hospital stay are documented and audited and the patients are categorized as having or not having a SSI
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 |
| --- | --- | --- |
| Health care associated infection episode | Health Care Associated Infections per definition of the Center for Disease Control | an infection onset 48 hours after admission to hospital or after an intervention |
Sensitivity to Change of the Lower Extremity Functional Scale in Patients With Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the reliability, construct validity, and sensitivity to change of the Lower Extremity Functional Scale (LEFS) in individuals affected by stroke.

Detailed Description
-----------------
The purpose of this study was to investigate the reliability, construct validity, and sensitivity to change of the Lower Extremity Functional Scale (LEFS) in individuals affected by stroke. Patients were measured with the LEFS at the beginning and end of physical therapy treatment, or at 8 weeks of physical therapy treatment.

Official Title
-----------------
Sensitivity to Change of the Lower Extremity Functional Scale and a Single-Item Functional Assessment Tool in Patients With Neurological Impairments Secondary to Stroke

Conditions
-----------------
Lower Extremity Dysfunction, Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically stable patients receiving inpatient or outpatient physical therapy care for lower extremity dysfunction due to stroke Exclusion Criteria: Unable to understand English More than moderate assist for bed mobility and coming to sitting from the supine position Lower extremity amputation Unable to reach overhead, grasp an object, or feed self with an upper extremity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Stroke<br>Medically stable patients receiving inpatient or outpatient physical therapy care for lower extremity dysfunction secondary to stroke. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LEFS | Lower Extremity Function Scale | 36 days average (range 4-76 days) |
Premolar Autotransplantation in Juvenile Dentition: Quantitative Assessment of Vertical Bone and Soft Tissue Growth

Study Overview
=================
Brief Summary
-----------------
Objective: Premolar autotransplantation represents an effective therapeutic option for the treatment of juvenile dentition in traumatic dental injury with tooth loss. Numerous studies report on the osteoinductive potency of the method, however, to date no quantitative data has been provided. The objective of this prospective clinical study was to quantitatively assess the bone and soft tissue levels after autogenous premolar transplantation by clinical and radiographic parameters. Materials/Methods: In the study 26 premolars were transplanted in 20 patients after traumatic dental injury (n=10) or tooth aplasia (n=16) in the upper front. Standard clinical parameters were evaluated. Based on a standardized photo documentation, the relative soft tissue level was measured in comparison to the healthy adjacent teeth. Radiographic findings involved the evaluation of root resorption, pulp canal obliterations and the relative bone height. Patient satisfaction was determined using a standardized questionnaire.

Official Title
-----------------
Premolar Autotransplantation in Juvenile Dentition: Quantitative Assessment of Vertical Bone and Soft Tissue Growth

Conditions
-----------------
Traumatic Dental Injury, Tooth Aplasia

Intervention / Treatment
-----------------
* Procedure: premolar autotransplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: premolar transplantation after tooth loss in the anterior maxilla (13-23) by aplasia or trauma

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: premolar autotransplantation|Autogenous tooth transplantation of premolars to the anterior maxilla to stimulate bone and soft tissue growth.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplant survival | Evaluation by Kaplan-Meier-Estimator. | 2006-2014 | 
| Soft tissue development | Measurement by standardized clinical documentation. | 2006-2014 | 
| Bone development | Measurement by radiographic evaluation. | 2006-2014 | 
| Sensibility | Assessment of clinical sensibility. | 2006-2014 | 
| Root resorptions | Radiographic evaluation. | 2006-2014 | 
| Pulp obliteration | Radiographic evaluation. | 2006-2014 |
The Utility of Thromboelastography in Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
Hemocoagulation disorder is recognized to have crucial effects on hemorrhagic or ischemic diseases. Coagulation-related damages secondary to traumatic brain injury are common and severe secondary insults of head trauma and often leads to a poor prognosis. In this study, we sought to assess if posttraumatic hemocoagulation disorders determined using thromboelastography are associated with coagulation-related damages secondary to traumatic brain injury, and evaluate their influence on outcome among patients with head trauma. Based on above results, prediction models or risk scoring systems will be further developed and validated to predict coagulation-related damages secondary to traumatic brain injury.

Official Title
-----------------
The Utility of Thromboelastography for Predicting the Risk of Coagulation-Related Damages Secondary to Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury, Coagulation Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are delivered to hospital within 24 hours after head trauma Patients whose abbreviated injury score (AIS) for other body regions is 3 or less are considered to be isolated traumatic brain injury Exclusion Criteria: Patients with existing prior neurological disease Patients with known coagulation disorders Patients on anticoagulants and medications known to affect coagulation function within 30 days before trauma Patients receiving blood components prior to blood draw Patients who deteriorate and die before determining whether coagulation- related damage exists

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Traumatic brain injury<br>Patients who are delivered within 24 hours after head trauma and sustain isolated traumatic brain injury are included in this study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Outcome Scale scores | Glasgow Outcome Scale 1 = death; Glasgow Outcome Scale 2 = vegetative state; Glasgow Outcome Scale 3 = severe neurological deficit; Glasgow Outcome Scale 4 = mild neurological deficit and Glasgow Outcome Scale 5 = premorbid level of functioning or completely recovery. Unfavorable outcome is defined as a Glasgow Outcome Scale score of ≤ 3, and favorable outcome is defined as a Glasgow Outcome Scale score of > 3. | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thrombelastography, Coagulation Disorder, Traumatic Brain Injury, Coagulation-related damages
Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose comparison with a open-label, crossover, formulation comparison.

Official Title
-----------------
COMPARISON OF THE PHARMACOKINETICS AND SAFETY OF LIQUID (30 µg) AND LYOPHILIZED TETRODOTOXIN (15 µg AND 30 µg) FOLLOWING SINGLE AND TWICE DAILY SUBCUTANEOUS DOSE ADMINISTRATION TO HEALTHY VOLUNTEERS-DETERMINATIONS IN BLOOD AND URINE

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

Intervention / Treatment
-----------------
* Drug: Tetrodotoxin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal renal function Exclusion Criteria: History of multiple clinically significant drug allergies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* 1ml once or twice a day for 1 or 2 days.<br>|
| Experimental: Tetrodotoxin, TTX<br> | Drug: Tetrodotoxin<br>* 15ug and 30ug once or twice a day for 1 or 2 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare plasma and urine PK profiles of TTX following doses of Lyophilized and Injectable Liquid TTX | PK timepoints occurred at 0,0.33,0.67,1, 1.5,2,4,6,8,10,12,14 and 24 hours after first dose on Days 1 & 2. Liquid and Lyophilized formulations will be assessed using ANOVA of the T-R ratio based on log-transformed AUC and Cmax values. | 26 timepoints over 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety and tolerability of TTX following the administration of Lyophilized and Liquid TTX | Safety was assessed through the collection of AE's, concomitant medications, clinical laboratory assessments, neurological assessments and vital signs. Where summary statistics are presented, these will include n, mean, standard deviation, median, minimum, and maximum. | signage of the ICF to Day 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Comparison study
Pharmacokinetic and Exploratory Biomarker Study of ABT-126 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to determine the cerebrospinal fluid (CSF) levels of ABT-126 and to examine the effects of ABT-126 on exploratory biomarkers after administration of a single does of ABT-126 in healthy volunteers.

Official Title
-----------------
A Pharmacokinetic and Exploratory Biomarker Study of ABT-126 in the Cerebrospinal Fluid (CSF) of Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: ABT-126
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects between 18 and 50 years of age Exclusion Criteria: History of bleeding disorders or Deep Vein Thrombosis History of spinal surgery History of migraine headaches, or other types of headaches occuring more than 2 times per month, or history of spinal disc disease, or chronic, significant low back pain

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ABT-126<br>* ABT-126 administered on Day 1 of Period 1<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo for ABT-126 administered on Day 1 of Period 2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical examination and neurological examination) |  | Day 1 thru Day 4 in Periods 1 and 2 | 
| Pharmacokinetic samples |  | Day 1 (up to 24-hour post dose) in Periods 1 and 2 | 
| Cerebrospinal Fluid samples |  | Day 1 (up to 24-hour post dose) in Periods 1 and 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers