linjc16/ctgov huggingface dataset:
Endothelial Function, Arterial Stiffness and Components

Study Overview
=================
Brief Summary
-----------------
Specific Aim: Compare the endothelial function, arterial stiffness and components of metabolic syndrome of childhood Acute Lymphoblastic Leukemia (ALL) survivors to healthy sibling controls. Plan: A cross sectional study comparing ALL survivors to sibling controls including measures of endothelial function and arterial stiffness obtained form a peripheral artery tonometry device, height, weight, waist circumference, fasting lipid, glucose and insulin.

Official Title
-----------------
Endothelial Function, Arterial Stiffness and Components of Metabolic Syndrome in Acute Lymphoblastic Leukemia (ALL) Survivors

Conditions
-----------------
Acute Lymphoblastic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Survivor: Inclusion Ages 8-28 (8 is chosen as lower age limit because developmental understanding will allow survivor to follow instructions for procedures, 28 is chosen as upper limit to include age ranges seen for treatment in the pediatric program) Off therapy for at least 6 months and not more than 10 years (6 months Inclusion Biological sibling Ages 8-28 (when more than one sibling is available the one closest in age will be chosen.)) Exclusion Criteria: Uncontrolled medical conditions that could interfere with participation or interpretation of results History of relapsed ALL or history of bone marrow transplantation

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 28 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure of endothelial |  | at enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute lymphoblastic leukemia, Survivor, Sibling control
Joint Coordination to Facilitate the Transition From Sick Leave to Employment

Study Overview
=================
Brief Summary
-----------------
GESAM is a randomized controlled intervention study that addressed women and men on long-term sick leave in Uppsala County. Participants which are on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance will be offered to participate in an intervention. Those how give informed consent will be randomly assigned one of the following groups: 1) informing and motivating intervention with insurance officer 2) control group. The main purpose of the study is to facilitate the return to work (preventing a return to the public health insurance) during the project period.

Official Title
-----------------
Joint Coordination (GESAM) - Collaboration Project to Facilitate the Transition From Sick Leave to Employment

Conditions
-----------------
Long Term Sick Leave, Absent-mindedness

Intervention / Treatment
-----------------
* Behavioral: Motivational interviewing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: On sick leave Risk of losing sick leave compensation Exclusion Criteria: Major mental illness (schizophrenia, bipolar disorder type I, severe social dysfunction/personality disorder) Cancer disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Motivational interviewing | Behavioral: Motivational interviewing<br>* Motivational interviewing with insurance officer<br>|
| No Intervention: Control<br>Control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to work (RTW) | Return to work measured as time to participation in the labor force | One year |
Natural History of Asphyxiating Thoracic Dystrophy (DTJ)

Study Overview
=================
Brief Summary
-----------------
The aim of the project is to prospectively analyze at a clinical and molecular level a series of 50 asphyxiating thoracic dysplasia (ATD) patients and 20 fetuses to further define the natural history of the disorder and to contribute to the identification of its molecular basis.

Detailed Description
-----------------
Asphyxiating thoracic dysplasia (ATD, MIM 208500) belongs to the short rib polydactyly group and is characterized by short ribs often responsible for an early death due to respiratory distress, trident acetabular roof and short long bones. In the course of the disease, renal, liver and eye complications may occur. However, their frequencies are unknown. ATD is transmitted with an autosomal mode of inheritance and up till now only one gene has been identified, namely IFT80, which accounts only for a small part of ATD. The aim of our project is to prospectively analyze at a clinical and molecular level a series of 50 ATD patients and 20 fetuses to further define the natural history of the disorder and to contribute to the identification of its molecular basis.

Official Title
-----------------
Clinical and Molecular Study, Natural History of Asphyxiating Thoracic Dystrophy (DTJ)

Conditions
-----------------
Asphyxiating Thoracic Dystrophy

Intervention / Treatment
-----------------
* Genetic: IFT80 screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Short ribs with narrow thorax Trident acetabular roof Short hands All ages Informed consent signed Exclusion Criteria: Other disease Ellis van creveld syndrome No social security
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>All ages | Genetic: IFT80 screening<br>* Natural History<br>* Other names: Natural History;|
| Fetuses<br> | Genetic: IFT80 screening<br>* Natural History<br>* Other names: Natural History;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural history of asphyxiating thoracic dystrophy (ATD) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Phenotype-Genotype |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Natural history, IFT80, short ribs, multivisceral involvement
SEP-SEQ Trial - Determining the Etiology of Sepsis Using an Infectious Disease Diagnostic Sequencing Assay

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the performance of the Karius Infectious Diseases Plasma Sequencing Assay in patients who present to the emergency room with sepsis.

Official Title
-----------------
SEP-SEQ Trial - Determining the Etiology of Sepsis Using an Infectious Disease Diagnostic Sequencing Assay

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Meet 2 of 4 sepsis criteria Temperature > 38C or < 36C Heart rate > 90 bpm Respiratory rate >20 or PaCO2 <32mmHg WBC >12000/µL or < 4000/µL or > 10% bands Exclusion Criteria: Inability to understand instructions and comply with study-related procedures Any condition that in the opinion of the treating physician will prevent the subject from completing the study.

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 |
| --- | --- | --- |
| Accuracy of sequencing assay in diagnosing etiology of sepsis |  | 7 days |
Noninvasive Ultrasound Assessment of Detrusor Dysfunction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test a new ultrasound method called Quantitative Ultrasound Bladder Vibrometry to detect abnormal bladder function.

Detailed Description
-----------------
The purpose of this study is to evaluate the effectiveness of quantitative ultrasound bladder vibrometry (QUBV) as a noninvasive tool for detrusor overactivity assessment and for benign prostatic hyperplasia (BPH) treatment selection. Participants in this study will have a QUBV ultrasound performed at the same time as a urodynamic study that had been ordered as part of their regular clinical care.

Official Title
-----------------
Noninvasive Ultrasound Assessment of Detrusor Dysfunction

Conditions
-----------------
Bladder Dysfunction, Overactive Bladder, BPH With Urinary Obstruction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aim1: Age >18 scheduled to undergo UDS for their clinical care for one of the included diagnoses. -Aim2: Inclusions: Age >45 scheduled to undergo selective photovaporization of the prostate. Exclusion Criteria: Aim1:Obesity (BMI >35kg/m2), known neurologic disease impacting bladder function (e.g. spinal cord injury, multiple sclerosis, Parkinson's, prior cerebrovascular accident), previous pelvic radiation therapy, previous radical pelvic surgery (such as for uterine or colorectal cancer), prior bladder surgery (including prostate resection), and pregnant or breast-feeding women. Aim2:Obesity (BMI >35kg/m2), known neurologic disease impacting bladder function (e.g. spinal cord injury, multiple sclerosis, Parkinson's, prior cerebrovascular accident), previous pelvic radiation therapy, previous radical pelvic surgery (such as colorectal cancer).

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of quantitative ultrasound vibrometry for measuring detrusor pressure | Will be reported including 95% confidence intervals derived from the cross-validation procedure. | time Frame: Up to study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of quantitative ultrasound vibrometry for selecting BPH patients for de-obstructive surgery | Will be reported including 95% confidence intervals derived from the cross-validation | time Frame: Up to study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Detrusor Pressure, Bladder Compliance, Ultrasound, Ultrasound Vibrometery
Detection of Bacterial and Viral Pathogens Infection Among Hospitalized Patients Feasibility Study

Study Overview
=================
Brief Summary
-----------------
Detection of bacterial and viral pathogens infection among hospitalized patients using breath analysis - feasibility study.

Detailed Description
-----------------
A diagnostic prospective single-site study, with no anticipated risks or constraints. Primary objective: To identify a set of breath Volatile Organic Compound biomarkers that enable the detection of pathogens infection and inflammatory response to pathogens infection among hospitalized patients.

Official Title
-----------------
Detection of Bacterial and Viral Pathogens Infection Among Hospitalized Patients Feasibility Study

Conditions
-----------------
Infectious Disease

Intervention / Treatment
-----------------
* Diagnostic Test: VOX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 80 years at the time of consent Capable of understanding written and/or spoken language Able to provide informed consent Negative results for SARS-CoV-2 Diagnosed with suspected respiratory infection Exclusion Criteria: Under guardianship or deprived of liberty Pregnant or lactating woman Not able to breathe through mask for 8 minutes Intubated patients Patients in critical condition Diagnosed with hospital-acquired infection Medical history of malignancies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hospitalized Patients<br>Patients hospitalized in internal ward at Poriya Medical Center | Diagnostic Test: VOX<br>* Breath biopsy<br>|
| Experimental: Controls<br>Healthy volunteers | Diagnostic Test: VOX<br>* Breath biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discovery of exhaled breath biomarkers | To evaluate the sensitivity, specificity, positive and negative predictive value of metabolomic biomarkers in exhaled breath samples as compared with pathogens biomarkers found in participants' blood and sputum samples. | Through the study completion, up to 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association of exhaled biomarkers with inflammatory known biomarkers. | To measure the association between exhaled biomarkers and inflammatory known biomarkers that are found in participants' blood and sputum samples. | Through the study completion, up to 3 months. |
Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

Study Overview
=================
Brief Summary
-----------------
This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.

Official Title
-----------------
A Phase 1b, Open-Label Study of Sorafenib With BIIB022 in Subjects With Advanced Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: BIIB022
* Drug: Sorafenib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Histologically-confirmed advanced HCC with at least 1 target lesion measurable by modified RECIST. Child-Pugh score A5 or A6. ECOG Performance Status of ≤2. Exclusion Criteria: Known central nervous system or brain metastases. Prior anti-IGF-1R therapy. Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if subjects have documented disease progression according to modified RECIST. Concurrent anticancer therapy. History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure. Acute hepatitis Fibrolamellar HCC Other protocol-defined inclusion/exclusion criteria may apply

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sorafenib Monotherapy<br>Sorafenib Monotherapy | Drug: Sorafenib<br>* Standard dosing of Sorafenib<br>* Other names: Nexavar;|
| Experimental: Sorafenib with BIIB022<br>Sorafenib with BIIB022 | Drug: BIIB022<br>* IV Q3W<br>* Other names: Nexavar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the PK profile of BIIB022 and sorafenib in this study population |  | 6 months | 
| To assess the anti-tumor response in this study population |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nexavar, Liver Cancer, Hepatocellular Carcinoma, Sorafenib, HCC, BIIB022, Open-Label, IGF-1R
Sentinel Lymph Node Biopsy Versus Lymphadenectomy in Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
To compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage endometrial cancer.

Detailed Description
-----------------
This retrospective study aims to compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage endometrial cancer by reviewing the medical records.

Official Title
-----------------
Sentinel Lymph Node Biopsy Versus Pelvic Lymphadenectomy in Early Stage Endometrial Cancer

Conditions
-----------------
Early Stage Endometrial Cancer, Sentinel Lymph Nodes, Lymphadenectomy

Intervention / Treatment
-----------------
* Procedure: Sentinel lymph node mapping and biopsy
* Procedure: Lymphadenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≧ 20 years early stage endometrial cancer (FIGO stage I) Exclusion Criteria: Did not receive a complete course of treatment in this hospital, interrupted the treatment halfway (except if the disease continued to deteriorate or caused death during treatment), and did not follow up in this hospital after the course of treatment.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Sentinel lymph node group<br>woman who had sentinel lymph node mapping and biopsy | Procedure: Sentinel lymph node mapping and biopsy<br>* Sentinel lymph node mapping with indocyanine green dye followed by biopsy if positive<br>|
| Lymphadenectomy group<br>woman who underwent traditional pelvic lymphadenectomy without sentinel lymph node mapping | Procedure: Lymphadenectomy<br>* Conventional lymphadenectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | The length of time from the day of operation till recurrence or last follow up | 4 years | 
| overall survival | The length of time from the day of operation till death (of any cause) or last follow up | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical complications related to lymph node biopsy or lymphadenectomy | asymptomatic lymphocele, lymphedema, infected lymphocele | from the day of operation till post-operative 6 months |
Efects of Noninvasive Mechanical Ventilation and Conventional Mechanical Ventilation in Patients With Severe Comunity Pneumonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the noninvasive ventilation is more effective in the treatment of severe comunity acquired pneumonia in comparison with the conventional mechanical ventilation with orotracheal intubation.

Official Title
-----------------
Noninvasive Mechanical Ventilation in Severe Community-Acquired Pneumonia and Acute Hypoxemic Respiratory Failure. A Prospective, Randomized and Controlled Study

Conditions
-----------------
Community Acquired Pneumonia., Acute Hypoxemic Respiratory Failure

Intervention / Treatment
-----------------
* Device: Non invasive mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The criteria for the diagnosis of SCAP included: Blood systolic pressure lower than 90 mmHg or blood diastolic pressure lower than 60 mmHg RR higher than 30 breaths per minute PaO2/FiO2 lower than 250 while breathing through a Venturi mask with a 50% inspired oxygen fraction (FiO2) Bilateral or multiple lobar infiltrations evidenced by thorax X-ray, and Use of vasopressor drugs Exclusion Criteria: Exclusion criteria included: COPD Asthma Acute cardiogenic pulmonary edema Severe haemodynamic instability (arterial systolic pressure lower than 70 mmHg) or requirements of vasoactive drugs Glasgow score equal to or lower than 9 or requiring OTI for airway protection or for recent pulmonary resucitation Antecedents of respiratory failure resulting from neuromuscular pathology Failure of two or more organs Facial deformities; and Recent facial, aesophagic and gastric surgeries

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Non invasive mechanical ventilation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary aim of this study was to compare the effects of NIMV on mortality rate and length of stay at the ICU with the effects of CMV |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary aims were to evaluate the incidence and the complications of OTI as well as to compare the improvements in the gas exchange. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Severe community-acquired pneumonia, Noninvasive mechanical ventilation, Acute hypoxemic respiratory failure.