linjc16/ctgov huggingface dataset:
Comparative Noninvasive Continuous Cardiac Output by the Clearsight® With Invasive Monitoring by PICCO® in Abdominal Major Surgery

Study Overview
=================
Brief Summary
-----------------
In high-risk patients, it is now recommended to guide the intraoperative volume replacement via the stroke volume. Today, the most commonly used technique for estimating the stroke volume is the transpulmonary thermodilution and the arterial waveform analysis in the radial artery by PICCO®. This technique has the disadvantage of being invasive and increasing the time dedicated to anesthesia during the surgery. The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has developed a continuous monitoring technology and non-invasive arterial pressure, cardiac output and stroke volume using a digital sensor (ClearSight®). This continuous monitoring of blood pressure was validated in cardiothoracic surgery but studies about monitoring cardiac output or stroke volume are inconclusive and contradictory. The objective of this study is to compare the use of non-invasive monitoring of stroke volume by ClearSight® with the transpulmonary thermodilution and the arterial waveform analysis in radial artery by PICCO® in abdominal major surgery.

Conditions
-----------------
Cardiac Output Measurement

Intervention / Treatment
-----------------
* Device: Cardiac output and stroke ejection volume monitoring with both ClearSight® and PICCO® in major abdominal surgery.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled to undergo major abdominal surgery Patients monitored by a PICCO® device Exclusion Criteria: Patients with heart rhythm disorder Patients with Raynaud's disease or vasculitis Emergency surgery Significant edema fingers

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

| Intervention/Treatment |
| --- |
|Device: Cardiac output and stroke ejection volume monitoring with both ClearSight® and PICCO® in major abdominal surgery.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke ejection volume (SEV) measure by ClearSight® |  | 24 hours | 
| Stroke ejection volume measure by PICCO® |  | 24 hours |
Validation of Existing Diabetes Risk Models in a Swedish Population

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to validate existing non-invasive diabetes clinical prediction models in a Swedish population. The main question it aims to answer is: how well 11 existing models will perform in predicting incident type 2 diabetes in participants from the Västerbotten Intervention programme (VIP). Participants in VIP are residents of Västerbotten that are invited for a comprehensive health screening at 30- (until 1995), 40-, 50-, and 60-years of age.

Detailed Description
-----------------
Several type 2 diabetes risk prediction models have been developed but how it will perform in a Swedish population is not known. No diabetes risk prediction model is routinely used in Sweden. The aim of this study is therefore, to validate 11 non-invasive models and to evaluate the performance to predict incident type 2 diabetes in a Swedish population. A population-based cohort from the Västerbotten Intervention programme (VIP) from 1990 to 2020 will be the validation sample. Incident type 2 diabetes within 10-years of follow-up, will be determined by oral glucose tolerance test or through self-reports. A self-administered questionnaire is completed, and anthropometric, clinical, and biochemical measures are obtained at each of the health screening visits. In the statistical analysis the overall performance of the models will be compared using the Brier score. In addition. discrimination and calibration of all the models will be evaluated. Recalibration of models will be done.

Official Title
-----------------
Validation of Non-invasive Risk Models for Prediction of Incident Type 2 Diabetes in a Swedish Population

Conditions
-----------------
Type2diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • At least one visit within the Västerbotten Intervention program Exclusion Criteria: • Prevalent diabetes at first visit defined by a fasting capillary plasma glucose >7mmol/L, a 2-hour capillary plasma glucose of ≥12.2 mmol/L or self-reported history of diabetes

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 62 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 |
| --- | --- | --- |
| Incident type 2 diabetes | Determined by a fasting capillary plasma glucose of ≥7 mmol/L or a 2-hour capillary plasma glucose of ≥12.2 mmol/L, or self-reported | 10-years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-invasive prediction model, Incident diabetes, Validation
Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. All patients self-administer daily subcutaneous injections of human parathyroid hormone (1-34) or placebo for a period of 2.5 years. Patients are followed regularly for unacceptable toxicities. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: human parathyroid hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Osteoporosis as defined by: Bone mineral density at the lumbar spine or femoral neck that is 2.5 standard deviations below peak bone mass reference value (T score less than -2.5) No family history of male osteoporosis No other metabolic bone disease --Prior/Concurrent Therapy-- Endocrine therapy: No concurrent glucocorticoid therapy No prior steroid use Surgery: No prior gastrointestinal tract surgery Other: No prior or concurrent anticonvulsant therapy --Patient Characteristics-- Hematopoietic: Normal CBC Hepatic: Normal liver function Renal: Normal renal function Other: Normal thyroid function Normal adrenal function Normal gonadal status No myeloma or other malignancy No alcoholism, hypercortisolism or diabetes mellitus No gastrointestinal tract disease or disorder associated with malabsorption

Ages Eligible for Study
-----------------
Minimum Age: 29 Years
Maximum Age: 67 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: human parathyroid hormone|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
-----------------
disease-related problem/condition, osteoporosis, rare disease
MammaPrint Value for Pre-menopausal Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Nearly 200 cases are to be enrolled. The information of patient age, histologic grade, tumor size, ER and PR status, Ki-67 index, surgery mode should be provided. The adjuvant therapy regime (chemotherapy: none, TC*4, TC*6 or EC-T; endocrine therapy: TAM, OFS+TAM, OFS+AI) will be compared before and after MammaPrint testing. About 20 clinical staffs are enrolled to participate in this survey for the clinical decision making. Each case could be chosen five times at random.

Official Title
-----------------
The Value of MammaPrint in Adjuvant Therapy Decision Among Pre-menopausal Breast Cancer Patients: a Survey Based on Clinical Staff

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pre-menopausal breast cancer patients aged less than 50 years old. Pathology confirmed invasive dutal carcinoma or invasive lobular carcinoma. receiving breast conserving surgery or mastectomy with/without reconstruction; sentinel lymph node biopsy or axillary lymph node dissection. TNM staging: T1b-T2N0-1M0. molecular subtype: ER positive/HER2 negative. MammaPrint testing before initiation of adjuvant therapy. Exclusion Criteria: Incomplete medical history. Pregnancy or lactation. Contradiction of chemotherapy or ovarian function suppression.

Ages Eligible for Study
-----------------
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 |
| --- | --- |
| MammaPrint group<br>Pre-menopausal breast cancer patients received MammaPrint test. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment decision survey | Treatment decision change after MammaPrint testing | 6 weeks |
Elevated Stearoyl-CoA Desaturase-1 Expression Predicts the Disease Severity of Severe Acute Pancreatitis

Study Overview
=================
Brief Summary
-----------------
In this study, the investgatiors aimed to investigate the associations between serum levels of stearoyl-CoA desaturase-1（SCD-1） and the disease severity as well as the presence of adverse clinical events, such as local complications, organ failure, mortality and so on.In this prospective study, participants were divided into two groups based on serum SCD-1 concentration on admission and prospectively observe the disease severity and clinical outcomes of them.

Official Title
-----------------
Elevated Stearoyl-CoA Desaturase-1 Expression Predicts the Disease Severity and Clinical Outcomes of Severe Acute Pancreatitis

Conditions
-----------------
Organ Failure, Multiple, Acute Pancreatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of acute pancreatitis (Atlanta standard), abdominal pain occurred within one week of admission; APACHEII score is more than 8 and Ranson score is greater than 3; Age 18-75; Obtaining informed consent. Exclusion Criteria: Pregnancy pancreatitis; Patients with the following disease history: severe cardiac, pulmonary, renal, liver function insufficiency or immunodeficiency disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| the incidence rate of infected pancreatic necrosis |  | 2-4 week after disease onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence rate of organ failure | the incidence rate of organ failure (transient or persistent) | 1-2 week after disease onset | 
| the incidence rate of local complications | acute peripancreatic fluid collections, pancreatic pseudocycts, acute necrotic collections and walled-off necrosis | 1-2 week after disease onset |
Quality Control of Home Mechanical Ventilators

Study Overview
=================
Brief Summary
-----------------
A multicentre quality control survey of home mechanical ventilation in patients. The prescribed ventilation settings, the settings of the ventilator control panel and the actual performance of the ventilator will be tested.

Official Title
-----------------
Quality Control Of Home Mechanical Ventilated Patient Mechanical Ventilators. A Multicenter Study

Conditions
-----------------
Mechanical Ventilation

Intervention / Treatment
-----------------
* Other: Quality control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Home mechanically ventilated >18 years Exclusion Criteria: Pacients with servoventilation

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quality control<br>The participants home mechanical ventilator will be tested in order to performe a quality control | Other: Quality control<br>* The performance of the home mechanical ventilator of all patients in the study will be evaluated with a portable device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure | ventilator pressures | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mechanical ventilation, Performance
Lynparza Breast Cancer Clinical Experience Investigation

Study Overview
=================
Brief Summary
-----------------
To characterise the development of ADRs of bone marrow depression in patients under actual post-marketing use

Detailed Description
-----------------
To characterise the development of adverse drug reactions (ADRs) of bone marrow depression in patients with unresectable or recurrent BRCA mutated HER2 negative breast cancer who have previously received anticancer chemotherapy under actual post-marketing use.

Official Title
-----------------
Lynparza Tablets 100mg, 150mg CEI, Investigation on Development of Bone Marrow Depression in Patients With Unresectable or Recurrent BRCA Mutated HER2 Negative Breast Cancer Who Have Previously Received Anticancer Chemotherapy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unresectable or recurrent BRCA mutated HER2 negative breast cancer with prior anticancer chemotherapy Exclusion Criteria: The patients who are not started on Lymparza for the first time
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 |
| --- | --- | --- |
| Adverse drug reactions of bone marrow depression | Bone marrow depression will be investigated as safety specification topics | One year period |
Clinical Interest of the TcPO2 Technique

Study Overview
=================
Brief Summary
-----------------
The measurement of the transcutaneous oxygen pressure records simultaneously the tcpO2 at the buttocks and chest level during walking. Before and after exercise the diagnosis, investigations and treatments ongoing or to be performed are recorded. The present study focuses on the clinical interest of the transcutaneous oxygen pressure during exercise in the diagnosis of claudication in patient referred for an oximetry exercise test.

Detailed Description
-----------------
Pre-test diagnostic hypothesis with probability will be completed by the physician. Pre-test and post test ongoing or scheduled treatments will be completed by the physician.After the test, the same post test items will be evaluated. Analysis will be done on differences of pre and post test results.

Official Title
-----------------
Multicentric Study of the Clinical Interest of the TcPO2 Technique

Conditions
-----------------
Claudication

Intervention / Treatment
-----------------
* Other: Exercise oxymetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: referred for an oximetry exercise test Patient able to walk on a treadmill Patient covered by the French health insurance Patient able to understand the protocol Patient agrees to be involve in the protocol and sign the consent form Exclusion Criteria: any heart issues during the last 3 months pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Exercise oxymetry|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients for whom results tcpO2 effort led to changes in diagnosis measured by the questionnaire filled by the doctor in charge of the patient before and after the test | during a walk on a treadmill, there is a DROP of tcpo2<-15 | up to 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peripheral artery disease, tcpo2, treadmill walking test, intermittent claudication
Development of a New Method for Steady-State Measurement of NO Lung Diffusing Capacity in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Using a rapidly responding nitric oxide analyzer in a new developed modular lung-function-setup we are going to measure steady-state NO diffusing capacity in 107 healthy subjects (age 6-45 years). The results will be compared to those measured by using carbon monoxide single-breath estimates. We like to show that the new method is sufficient to measure exactly lung diffusion capacity in this collective.

Official Title
-----------------
Development of a New Method for Steady-State Measurement of NO Lung Diffusing Capacity in Healthy Subjects

Conditions
-----------------
Pulmonary Diffusing Capacity

Intervention / Treatment
-----------------
* Drug: Nitric oxide, Carbon monoxide, Helium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Lung function testing possible Written consent Exclusion Criteria: Pulmonary, neuromuscular, cardiovascular, endocrinological illness Pregnancy Abuse of nicotine, alcohol, drugs during the last two years

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 45 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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nitric oxide, Carbon monoxide, Helium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TLNOss |  |  | 
| TLCOsb |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathing frequency |  |  | 
| tidal volume |  |  | 
| functional residual capacity |  |  | 
| airway resistance |  |  | 
| lung clearance index |  |  | 
| forced expiratory volume in one second |  |  | 
| vital capacity |  |  | 
| total lung capacity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diffusion, Membrane diffusing capacity, Alveolar capillary gas diffusion, Transfer factor, Nitric oxide diffusion
Clinical Evaluation of Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and stability of AT TORBI 709M 4-haptic toric IOL in cataract surgery.

Detailed Description
-----------------
Inclusion criteria senile cataract patients' age of 21 years or older preoperative regular corneal astigmatism between 1.00 D and 6.00 D Exclusion criteria pregnant, lactating women presence of other ocular diseases which affect stability of lens capsule Primary outcome : efficacy index (visual acuity, refractive results Secondary outcome : rotational stability, endothelial cell count, cornea thickness

Official Title
-----------------
An Investigator-Initiated Trials on the Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery

Conditions
-----------------
Iol, Astigmatism

Intervention / Treatment
-----------------
* Procedure: AT TORBI 709M


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: senile cataract patients' age of 21 years or older preoperative regular corneal astigmatism between 1.00 D and 6.00 D Exclusion Criteria: pregnant, lactating women presence of other ocular diseases which affect stability of lens capsule

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intraocular lens<br>AT TORBI 709M toric intraocular lens | Procedure: AT TORBI 709M<br>* Cataract surgery with AT TORBI 709M 4-haptic toric IOL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity, refractive results | uncorrected distance visual acuity (UCDVA) and best corrected distance visual acuity (BCDVA) measured using logarithm of the minimum angle of resolution (logMAR) refractive results measured by keratometry | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotational stability | Photographic evaluation of IOL rotation using slit-lamp digital photographs at each postoperative visit, and determine changes in the lens axis between visits. | 3 months | 
| Endothelial cell count | measured by specular microscopy | 3 months | 
| Cornea thickness | measured by ultrasound pachymetry | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
astigmatism, toric intraocular lens