linjc16/ctgov huggingface dataset:
Rad-67 Repeatability and Reproducibility

Study Overview
=================
Brief Summary
-----------------
The primary objective of this clinical investigation is to evaluate the repeatability and reproducibility of using Rad-67 Pulse CO-Oximeter

Official Title
-----------------
Noninvasive Hemoglobin Spot Check Repeatability and Reproducibility in a Blood Donation Setting

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

Intervention / Treatment
-----------------
* Device: Rad-67 Pulse CO-Oximeter and DCI Mini sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Weight at least 110 pounds Subjects with the intention of being screened for eligibility to donate blood The subject has given written informed consent to participate in the study Exclusion Criteria: Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc. Subjects unwilling to remove nail polish or acrylic nails Subjects with blood cancers such as leukemia Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia or with known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc. Subjects with self-disclosed/known pregnancy at the time of enrollment Subjects deemed not suitable for the study at the discretion of the investigator Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.

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

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

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

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 |
| --- | --- |
| Experimental: Test subjects<br>All subjects are enrolled and receive Rad-67 Pulse Oximeter and DCI Mini sensor for measurement of hemoglobin. | Device: Rad-67 Pulse CO-Oximeter and DCI Mini sensor<br>* Noninvasive Pulse CO-Oximeter device and sensor are used to measure hemoglobin.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation Ratio of Total Repeatability and Reproducibility Hemoglobin Measurements Using Rad-67. | Quality of hemoglobin measurements is defined as a variance ratio of total Gage repeatability and reproducibility variance to total variance. Subject, operator and device were considered as components to calculate this ratio. | 1 hour |
Prognostic Value of Lactates in ICU

Study Overview
=================
Brief Summary
-----------------
he aim of this prospective, analytic trial was to evaluate the accuracy of blood lactates levels in predicting mortality in ICU patients.

Detailed Description
-----------------
In this study, conducted over o 12 months period, arterial blood lactates levels were measured in ICU patients at admission (H0), every 6 hours during the first day and and H48. This trial included traumatic, medical and surgical patients requiring ICU stay for a predictive period > to 24 hours. Blood lactates were evaluated as a prognostic parameter in predicting ICU mortality and compared to classic prognostic scores such as: SOFA score, IGS II and APACHE II. The primary end point was ICU mortality.

Official Title
-----------------
Prognostic Value of Lactates in Predicting Intensive Care Unit Mortality

Conditions
-----------------
Mortality

Intervention / Treatment
-----------------
* Diagnostic Test: Blood lactate level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults admissions in ICU with a predicted length of stay > 24 hours Exclusion Criteria: Patients who died during the first 24 hours after ICU admission

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 |
| --- | --- |
| Survivors<br>Patients discharged alive from intensive care unit | Diagnostic Test: Blood lactate level<br>* Blood lactate level measured at admission H0, every 6 hours during the first 24 h and at H48<br>|
| non survivors<br>Patients who succumbed during their ICU stay | Diagnostic Test: Blood lactate level<br>* Blood lactate level measured at admission H0, every 6 hours during the first 24 h and at H48<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Mortality | Mortality at Day 28 | 28 days after ICU admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lactates, Prognosis, intensive care units
AIDS and Cancer Specimen Bank (ACSB)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain clinical specimens from pathologists and physicians involved in the diagnosis and care of patients with AIDS and non-AIDS associated malignancies. The National Cancer Institute has set up a Bank for tissues and biological fluids from HIVpositive and HIV-negative individuals in order to have specimens available for scientists studying malignancies associated with HIV disease.

Detailed Description
-----------------
The overall goal of the AIDS and Cancer Specimen Bank is to obtain clinical specimens from pathologists and physicians involved in the diagnosis and care of patients with AIDS and non- AIDS associated malignancies. These specimens will be banked and linked to a clinical data set so that experimental results obtained by analysis of specific specimens can be linked to relevant clinical data. Contents of the ACSB will be made available to researchers through an application to the National Cancer Institute. Strict patient confidentiality protection guidelines are in place for all specimens in the ACSB. The objective of this protocol is to obtain clinical specimens from potential participants in clinical trials conducted by the AIDS Malignancies Consortium, and from other patients with and without HIV infection, who have AIDS-Associated malignancies.

Official Title
-----------------
AIDS and Cancer Specimen Bank (ACSB)

Conditions
-----------------
Kaposi's Sarcoma AIDS Related, Kaposi's Sarcoma Classical, Non-Hodgkin's Lymphoma, HEMATOPOIETIC SYSTEM, Cancer, AIDS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient > 18 years of age Suspected or confirmed AIDS-Associated malignancy with or without HIV infection Will obtain fresh tissue and/or biological fluids Patient signed the correct version of the informed consent Exclusion Criteria: N/A

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 |
| --- | --- | --- |
| Identify and improve access to tumor tissue, biological specimens, and associated clinical outcome data that could be utilized for research by the research community at-large on the pathogenesis of HIV and non-HIV associated malignancies. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kaposi's Sarcoma AIDS Related, Kaposi's Sarcoma Classical, Non-Hodgkin's Lymphoma, HEMATOPOIETIC SYSTEM, Cancer, AIDS
Use of Perforated Barrier Membranes and IPRF Nano- Micro Sticky Bone

Study Overview
=================
Brief Summary
-----------------
Comparing amount of horizontal bone gain 4 months after alveolar ridge augmentation using IPRF Nano- micro Sticky Bone with perforated collagen membrane versus occlusive barrier membrane by : clinical and Radiographic analysis . Histomorphometric analysis .

Official Title
-----------------
The Use of Perforated Barrier Membranes and IPRF Nano- Micro Sticky Bone in Horizontal Alveolar Ridge Augmentation - Controlled Clinical and Histomorphometric Study

Conditions
-----------------
Bone Augmentation

Intervention / Treatment
-----------------
* Procedure: Perforated collagen membrane
* Procedure: Occlusive collagen membrane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult patients. Both sex, males and females. 3-Age from 20 - 40 years old. 4-All patients will be free from any systemic diseases as evidenced by Burkett's oral medicine health history questionnaire. 5-Remaining alveolar bone ≥ 8mm vertically and ≤ 4 mm horizontally. 6-Gingival biotype 1-2mm thickness. Exclusion Criteria: Smokers. Pregnant and breast feeding females. Mentally retarded Patients. Presence of hematologic disease. Previous radiation, chemotherapy, or immunosuppressive treatments. Diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy. Anticoagulant drugs, Endocarditis risk factors, renal and hepatic failure

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: Perforated collagen membrane<br> | Procedure: Perforated collagen membrane<br>* Horizontal Bone Augmentation using Perforated Collagen Membrane<br>|
| Active Comparator: Occlusive collagen membrane<br> | Procedure: Occlusive collagen membrane<br>* Occlusive collagen membrane<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Horizontal alveolar bone width in mm | Measured By Bone caliber and Cone Beam Computed Tomography (CBCT) | 6 months |
Evaluation of Patients With Rapid Cycling Bipolar Disorder (RCBD)

Study Overview
=================
Brief Summary
-----------------
Bipolar disorder is a mood (affective) disorder characterized by the occurrence of alternating feelings of excitement (mania) and depression. It is a common, but serious condition, and potentially life-threatening. Patients are considered to have a rapid cycling form of bipolar disorder if they experience four or more episodes of hypomania (mild degree of mania), mania, and/or depression. Approximately 20% of the patients in bipolar clinics have the rapid cycling form of the disorder. Therefore it can be said that RCBD is not a rare condition and that it can severely impair a patient. These reasons alone justify studying RCBD. However, researchers also believe that information gathered by studying patients with RCBD can be used while studying other patients with different forms of bipolar disorder. The purpose of this study is to screen patients diagnosed as having rapid cycling bipolar disorder to see if they fit the criteria for the diagnosis and to see if they would be interested in participating in other research studies. Patients will undergo diagnostic interviews, physical examination, routine blood tests, EKG (electrocardiogram), and complete self-rating forms as part of the screening process.

Detailed Description
-----------------
The purpose of this protocol is to allow for the medical and psychiatric screening of patients with rapid cycling bipolar disorder in order to ascertain (1) that they fit the criteria for the diagnosis; and (2) that they are interested in participating in one of our research projects. Patients will undergo diagnostic interviews, complete self-rating forms, and have a physical examination, routine blood tests, and an electrocardiogram.

Official Title
-----------------
Evaluation of Patients With Rapid Cycling Bipolar Disorder

Conditions
-----------------
Bipolar Disorder, Rapid Cycling Bipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Must be currently in treatment with a psychiatrist. Subjects must not have borderline or antisocial personality disorders, must not meet criteria for substance abuse or dependence within the past six months. Subjects must not have significant hepatic, renal, endocrine, or cardiovascular disease. Subjects must not be pregnant.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Disorder, Rapid Cycling, Screening
A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS

Study Overview
=================
Brief Summary
-----------------
Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA

Detailed Description
-----------------
A repeat-dose open label randomized incomplete block design in pediatric subjects with asthma, ages 4-11 years, to compare systemic exposure and pharmacodynamics of fluticasone propionate and salmeterol following ADVAIR HFA 45/21mcg(2 inhalations), ADVAIR HFA 45/21mcg(2 inhalations) with Aerochamber Plus Spacer and ADVAIR DISKUS 100/50 twice daily

Official Title
-----------------
A Repeat-dose, Open-label, Randomized, Incomplete Block Design in Pediatric Subjects With Asthma, Ages 4 - 11 Years, to Compare Systemic Exposure and Pharmacodynamics of Fluticasone Propionate and Salmeterol Following Advair HFA 45/21mcg (2 Inhalations), ADVAIR® HFA 45/21mcg (2 Inhalations) With Aerochamber Plus Spacer and Advair Diskus 100/50 Twice Daily

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: ADVAIR HFA
* Drug: ADVAIR DISKUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subjects with mild asthma No significant medical conditions at screen Weigh at least 20 kg Exclusion criteria: No clinical abnormalities at screen visit Asthma control at least 3 months prior with anti-steroidal medication only

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 11 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ADVAIR HFA|nan|
|Drug: ADVAIR DISKUS|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD of Fluticasone as measured by serum cortisol followed by doses of ADVAIR HFA and ADVAIR DISKUS |  | 3 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the exposure of FP and Salmeterol following the doses of ADVAIR HFA and ADVAIR DISKUS as well as assessing safety measurements based on adverse event reporting |  | 3 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatrics, ADVAIR Inhaler, Asthma, ADVAIR DISKUS
Early Weight Bearing for Ankle Fractures

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to assess the rate of return to work, rate of return to activities, functional outcome measures and pain scores in operatively repaired rotational Bimalleolar and Trimalleolar (AO/OTA Classification of 44A and 44B) ankle fractures not requiring fixation of the syndesmosis and allowed early weight bearing on or before the first post-operative visit.

Official Title
-----------------
Early Weight Bearing for Bimalleolar and Trimalleolar Ankle Fractures Without Syndesmotic Disruption

Conditions
-----------------
Broken Ankle

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women ages of 18 and up Closed, low-energy Bimalleolar and Trimalleolar rotational ankle fractures Orthopaedic Trauma Association (OTA) classification of 44A and 44B English speaking Able and willing to consent Exclusion Criteria: Open fractures OTA classification of 43 and 44C Patients with diabetes mellitus No other lower extremity injuries that would affect functional outcomes Previous use of walking aides Patients with paralysis or hemiplegia Ankle fractures requiring syndesmotic repair Ankle fractures requiring fixation of the posterior malleolar Associated neurovascular injury Problems maintaining follow up (homeless or not willing to return for follow up) Pathological fractures Prisoners Patients not allowed to bear weight before the 6 week post-operative follow up visit

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 |
| --- | --- | --- |
| Functional Outcome Scores | During follow up visits functional outcomes scores will be assess using the Foot and Ankle Score and the PROMIS (Patient Reported Outcomes Measurement Information System) Mobility Measure questionnaires. These forms will be analyzed together to determine the patients functional outcomes. | 12 months post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to work | During follow up visits the patients return to work status will be assessed. | up to 12 months | 
| Fracture Healing | During follow up visits fractures healing will be assessed by physician review of x-rays. | up to 12 months | 
| Pain Scores | Pain Scores and PROMIS Pain Intensity and Interference questionnaires will be assessed during follow up. These forms will be analyzed together to determine the patients overall pain. | 12 months post operatively | 
| Post operative complications | Post operative complications will be assessed during follow up visits. | up to 12 months |
Limb Girdle Muscular Dystrophy (LGMD) Natural History

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand more about limb-girdle muscular dystrophy. Therefore, the investigators would like to track the following information collected once a year from patients with GENETICALLY CONFIRMED LGMD: quality of life questionnaires, muscle strength, motor function, routine examination, assessment of patient (or parent) understanding of LGMD, and serum (blood) for growth factors, cytokines, and biomarkers (all parts of your blood). By tracking this information, we hope to be able to understand more about the diagnosis, progression and natural history of this disorder.

Official Title
-----------------
Longitudinal Assessment and Genetic Understanding of Limb-Girdle Muscular Dystrophy

Conditions
-----------------
Muscular Dystrophies, Limb-Girdle (GENETICALLY CONFIRMED)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You have a GENETICALLY CONFIRMED diagnosis of Limb Girdle Muscular Dystrophy You must be at least 6 years of age or older (if under 18 you will need Parental consent) You must be able to travel to the study site You must be able to provide a DNA/Gene testing report that confirms a diagnosis of LGMD Exclusion Criteria: You or your child do not have a diagnosis of LGMD Your child is under age 6 You or your child are not able to travel to the study site

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| LGMD<br>Patients with GENETICALLY CONFIRMED limb girdle muscular dystrophy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive clinical evaluation of individuals with GENETICALLY CONFIRMED LGMD, according to the study protocol, in order to evaluate disease progression |  | yearly up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GENETICALLY CONFIRMED limb girdle muscular dystrophy
Latent TGF-β-binding Proteins Affect the Fibrotic Process in Renal Impairment and Cardiac Dysfunction

Study Overview
=================
Brief Summary
-----------------
The project is planed to explore the impact of LTBP4 and other matrix protein and potentially related biomarkers on renal outcomes, cardiac outcomes and all-cause mortality in patients with suspected acute coronary syndrome (ACS).

Detailed Description
-----------------
The investigators will collect the blood samples from patients with suspect ACS. LTBP4 will be the first matrix protein that are going to understand. Upon hospital arrival, blood samples around 8 ml will be collected and the 2nd collection will be two weeks to one month after the event. The third collection will be one year later. In the between, if any ACS event develop, blood samples will be collected as protocols.

Official Title
-----------------
Latent TGF-β-binding Proteins Affect the Fibrotic Process in Renal Impairment and Cardiac Dysfunction

Conditions
-----------------
Acute Coronary Syndrome, Acute Coronary Syndrome With Renal Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - acute coronary syndrome patients Exclusion Criteria: - cardiogenic shock, pregnancy, end-stage renal disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| suspect acute coronary syndrome<br>Subjects with the diagnosis of suspected acute coronary syndrome (ACS), age between 20 to 80. Exclusion criteria: pregnant women, patients with end-stage renal disease (eGFR <15 mL/min/1.73 m2), cardiogenic shock. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of renal functions | The investigators will follow up Cr and eGFR levels correlate with LTBP4 levels | One month, Six month and one year | 
| All cause mortality |  | 3 years | 
| Incidence of hospitalization |  | 3 years | 
| Incidence of required myocardial revascularization |  | 3 years |