linjc16/ctgov huggingface dataset:
Prediction for Bronchopulmonary Dysplasia

Study Overview
=================
Brief Summary
-----------------
In this Multi-center study performed from January 2018, we reviewed data on infants whose gestational ages were below 36 weeks. we collected data containing maternal diseases and neonatal clinical features. LASSO regression was used to select variables for the risk model. Then, we used multivariable logistic regression to build the prediction model incorporating these selected features. Discrimination was assessed by the C-index, and and calibration of the model was assessed by and calibration curve and the Hosmer-Lemeshow test.

Official Title
-----------------
Development of a Nomogram for Predicting Bronchopulmonary Dysplasia in Infants

Conditions
-----------------
Bronchopulmonary Dysplasia

Intervention / Treatment
-----------------
* Other: occurrence of bronchopulmonary dysplasia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were recruited from Multi-center Collaborative Group Hospital Neonatal Intensive Care Unit (NICU) Department. Patients with gestational age <36 weeks admitted to the NICU within 24 h after birth the length of stay was more than 1 week Exclusion Criteria: patients with inherited disease, metabolic disorders and multiple malformations.

Ages Eligible for Study
-----------------
Maximum Age: 1 Day

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bronchopulmonary dysplasia group<br>infants diagnosed with bronchopulmonary dysplasia | Other: occurrence of bronchopulmonary dysplasia<br>* We observe the incidence of bronchopulmonary dysplasia<br>|
| no bronchopulmonary dysplasia<br>infants not diagnosed with bronchopulmonary dysplasia | Other: occurrence of bronchopulmonary dysplasia<br>* We observe the incidence of bronchopulmonary dysplasia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bronchopulmonary dysplasia occurs | Number of cases of bronchopulmonary dysplasia | 2 weeks after admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchopulmonary Dysplasia; Infants；Nomogram
Non Invasive and Non-Contact Imaging Of Tissue Oxygenation and Vascular Reactivity

Study Overview
=================
Brief Summary
-----------------
Quantitative validation of non-contact oxygenation imaging by the CWC imaging system Quantitative validation of non-contact vascular function imaging by the CWC imaging system Evaluation of the clinical usability of the CWC imaging system for further technology development and engineering improvement

Detailed Description
-----------------
The hyperspectral imaging technique estimates cutaneous tissue oxygenation by illuminating tissue and detecting tissue reflectance at different wavelengths. One major advantage of hyperspectral imaging is non-invasive and non-contact detection of tissue functional properties. The dual-mode imaging system integrates hyperspectral and thermal imaging modalities for simultaneous assessment of cutaneous tissue oxygenation and vascular function. This clinical protocol is defined to validate the CWC system on healthy human subjects

Official Title
-----------------
Non Invasive and Non-Contact Dual-modal Imaging Of Tissue Oxygenation and Vascular Reactivity Dynamic Imaging Of Tissue Metabolism and Vascular Function.

Conditions
-----------------
Quantitative Validation of Imaging System

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult 18 years and older No history of diabetes. No history of vascular disease Exclusion Criteria: Under 18 years of age Unable to provide informed consent Prisoners Current smoker

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Healthy participants. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-Contact Oxygenation Imagiing | Quantitative validation of non-contact oxygenation imaging by the CWC imaging system | 1 year | 
| Non-Contact Vascular Function Imaging | Quantitative validation of non-contact vascular function imaging by the CWC imaging system | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical usability for Comprehensive Wound Centers | Evaluation of the clinical usability of the CWC imaging system for further technology development and engineering improvement. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-invasive, tissue-oxygenation, hyperspectral, CWC imaging system
Association Between Treatment Adherence and Treatment Adherence in Sleep Apnea (SEMSAS)

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to define an optimal threshold of the SEMSA-15 scale for obstructive sleep apnea (OSA) perception in patients with OSA to predict 3-month and 1-year continuous positive airway pressure adherence.

Official Title
-----------------
Association Between Treatment Perception and Treatment Adherence in Obstructive Sleep Apnea Patients Treated by Continuous Positive Airway Pressure (SEMSAS Study)

Conditions
-----------------
Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obstructive Sleep apnea diagnosed, whatever the initial severity and treated with CPAP Voluntary patient patient in the national healthcare insurance system Exclusion Criteria: Patient with central sleep apnea Treatment other than CPAP Person with liberty privation or under legal protection

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 |
| --- | --- | --- |
| Continuous positive airway pressure adherence | To define an optimal threshold for the Self-efficacy Measure for Sleep Apnea (SEMSA-15) scale to predict 3-month CPAP adherence | 3-month | 
| Continuous positive airway pressure adherence | To define an optimal threshold for the Self-efficacy Measure for Sleep Apnea (SEMSA-15) scale to predict 1-year CPAP adherence | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compute an overall score to predict CPAP adherence | Use Self-efficacy Measure for Sleep Apnea (SEMSA-15) scale and socio-economics parameter from patients to improve CPAP adherence prediction | 3-month and 1-year | 
| To study the impact of health litteracy on CPAP adherence | Use of Health Litteracy Questionnaire HLQ | 3-month and 1-year | 
| To study the impact of precariousness on CPAP adherence | Use of Deprivation in Primary Care (DIPCARE-Q) questionnaire | 3-month and 1-year | 
| To study the impact of patient quality of life on CPAP adherence | Use of simplified Short-Form (SF-36) questionnaire for quality of life (SF-12 questionnaire) | 3-month and 1-year | 
| To construct an overall predictive model of CPAP adherence | CPAP Adherence | 3-month and 1-year | 
| To assess the interactions between CPAP adherence trajectories and patients parameters | CPAP adherence trajectories | 3-month and 1-year | 
| to assess the improvement of quality of life according to health litteracy and precariousness | Quality of life | 1-year | 
| Define patient phenotype according all collected variables | Clinical and socio-demographic phenotype at CPAP initiation | At inclusion |
The Use of Mole Mapping Diagrams to Increase Skin Self Examination Accuracy

Study Overview
=================
Brief Summary
-----------------
This study aims to improve Skin Self-Examination accuracy by a simple cost effective intervention requiring participants to complete a mole-mapping diagram.

Official Title
-----------------
The Use of Mole Mapping Diagrams to Increase Skin Self Examination Accuracy

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Behavioral: Mole Mapping Diagram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects above age 18 of any ethnicity will be enrolled in this study. Exclusion Criteria: Subjects will be excluded from the study if they have significant skin disease which would not allow manipulation of their photographs consistent with the rest of the subjects. Since the study instructions are in English, Non-English speakers will be excluded. Those with co-morbidity sufficiently severe to prevent them from being able to perform a SSE will be excluded. In addition, those with cognitive impairment who are unable to give informed consent, or to understand the study instructions given to them, will be excluded.

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Mole Mapping Diagram|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
-----------------
Skin Self Examination, Mole Mapping Diagram, Melanoma
Validation of a Seizure Monitoring System

Study Overview
=================
Brief Summary
-----------------
The investigators aim to determine the feasibility of using the Medtronic LINQ device for epilepsy diagnosis, monitoring and management. The feasibility will be determined by comparing EEG signals from the LINQ system to the gold standard clinical recordings. If seizures can be identified using the LINQ device with the same level of accuracy as adjacent scalp EEG recording electrodes, then the LINQ will be deemed feasible.

Official Title
-----------------
Validation of a Seizure Monitoring System

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Device: Medtronic LINQ Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with epilepsy Exclusion Criteria: Women that are pregnant Patients that are highly dependant on medical care Patients that cannot give informed consent for themselves

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: Medtronic LINQ Device|Using two LINQ devices that are fixed to scalp to record EEG (in addition to the standard scalp EEG).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verify feasibility of using the LINQ device for epilepsy diagnosis, monitoring and management | Compare EEG from traditional scalp EEG to the LINQ recordings to determine if seizure activity can be accurately identified | one week |
A Phase 1/2 Study of Epofolate (BMS-753493) in Subjects With Advanced Cancer (Schedule 2)

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to study the safety of Epofolate (BMS-753493) in patients with advanced cancers (in Phase 1 portion) and to determine whether Epofolate (BMS-753493) can shrink or slow the growth of the cancer in patients with advanced ovarian, renal or breast cancer (in Phase 2 portion)

Official Title
-----------------
A Phase 1/2, Ascending Multiple-Dose Study to Evaluate the Safety, Efficacy and Pharmacokinetics of BMS-753493 in Subjects With Advanced Cancer (Schedule 2)

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: Epofolate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced cancer, excluding cancer in the blood Availability of 10 tumor tissue slides Exclusion Criteria: Known brain metastases Severe nerve damage Significant cardiovascular disease Inadequate blood counts Inadequate liver or kidney function Inadequate thyroid function or uncontrolled thyroid disease

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: 1<br> | Drug: Epofolate<br>* Intravenous solution, intravenous, initially 3 patients will be treated and if there is a DLT then additional 3 patients will be treated in that dose level. 3-5 minute IV bolus on Days 1 through 4 of a 21-day cycle, until the disease progresses<br>* Other names: BMS-753493;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity and the recommended dose of Epofolate (BMS-753493) |  | at the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and exposure levels of Epofolate (BMS-753493) in the body and the anticancer activity of Epofolate (BMS-753493) |  | every 21 days |
Subjective and Objective Changes in Muscle-stiffness

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate muscle stiffness in relation to delayed on-set muscle soreness following exercise and to investigate how well the change in muscle stiffness correlates with the subjective experienced degree of stiffness.

Official Title
-----------------
The Relationship Between Subjective and Objective Changes in Muscle-stiffness

Conditions
-----------------
Healthy, Muscle Soreness

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy participants aged 18-80 Able to speak, read and understand Danish and/or English Exclusion Criteria: Have performed resistance training on a regular basis during the past month Experience of delayed onset muscle soreness (DOMS) during the last two weeks leading up to the first test session Current use of analgesics Any current neurological, musculoskeletal or mental illnesses that could interfere with the results. Pregnancy Lack of ability to cooperate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants will not perform any exercise | |
| Experimental: Exercise<br>Participants will perform an exercise recommended for preventing neck and shoulder pain | Other: Exercise<br>* Upper limb exercises using an elastic band.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle stiffness (change) - Shear wave | Muscle stiffness measured by ultrasound using shear wave elastography | Day1,Day 2 and Day7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle stiffness (change) - Self-reported | Self-reported muscle stiffness: Measured on a NRS scale (0-10), where 0 = not stiff at all, 10 is maximal stiffness | Day1,Day 2 and Day7 | 
| Muscle stiffness (change) - Myotonometry | Muscle stiffness measured by Myotonometry | Day1,Day 2 and Day7 | 
| Muscle stiffness (change)- Palpation | Muscle palpation: Reported using a 5-point Likert: 1 = very low muscle stiffness and 5 = very high muscle stiffness | Day1,Day 2 and Day7 |
Analysis of Percutaneous Ablations for Cancer Treatment

Study Overview
=================
Brief Summary
-----------------
This is a study involving patients with cancer who are referred by their treating physician for percutaneous locoregional therapies. Patient's clinical and radiology findings, pathology findings, survival, treatment responses, and complications after their locoregional therapy will be studied.

Detailed Description
-----------------
The efficacy of the percutaneous and transarterial treatments for solid tumors will be studied. Prospective study on patients who receive percutaneous locoregional therapies, including radiofrequency ablation (RFA), cryoablation, microwave ablation, IRE and chemical ablation for treatment of cancer will be performed. Preoperative clinic chart, procedure note, postoperative chart, pre- and post-operative CT, MRI or Ultrasound, angiographic findings, biopsy results and pathologic findings, will be reviewed. Patient survival, treatment responses, complications after the therapy will be collected from clinic visits and clinical encounters. Patient overall performance status before and after procedures will be assessed using the Quality of Life questionnaire (SF-36™ Health Survey).

Official Title
-----------------
Prospective Analysis of Percutaneous Ablations for Cancer Treatment

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18yrs of age Cancer diagnosis Candidate for Locoregional therapy Willingness to sign informed consent Exclusion Criteria: Unable to sign informed consent Patients not eligible for locoregional therapies

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 |
| --- | --- | --- |
| Effect of percutaneous and transarterial treatments for cancer in quality of life | Patients will complete the QOL questionnare during their follow up visits after procedure. 1 month, 3 months, 6 months and 1 year. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate to percutaneous and transarterial treatment for cancer | Patients will be followed up 1, 3, 6 and 1year intervals after procedure. | 1 month, 3 months, 6 months, 1 year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, locoregional therapies, RFA, Cryoablation, Microwave ablation, chemical ablation, Irreversible electroporation
Drug Interaction Study Between AZD3355 and Nexium

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate if AZD3355 and Nexium interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.

Official Title
-----------------
An Open, Randomised, Three Period Cross, Single Centre, Phase 1 Pharmacokinetic Interaction Study of the Reflux Inhibitor AZD3355 150 mg Bid and Esomeprazole 40 mg od After 7 Days of Treatment in Healthy Volunteers

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: AZD3355
* Drug: Esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Females no childbearing potential Clinically normal physical findings Exclusion Criteria: Clinically significant illness within 2 weeks prior to the first dose of investigational product History of clinically significant disease Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD3355 150 mg | Drug: AZD3355<br>* 150 mg bid, oral, 7 days<br>* Other names: Lesogaberan;|
| Experimental: 2<br>Esomeprazole 40mg | Drug: Esomeprazole<br>* 40 mg od, oral, 7 days<br>* Other names: Nexium;|
| Experimental: 3<br>AZD3355 150mg/Esomeprazole 40mg | Drug: AZD3355<br>* 150 mg bid, oral, 7 days<br>* Other names: Lesogaberan;Drug: Esomeprazole<br>* 40 mg od, oral, 7 days<br>* Other names: Nexium;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | Frequent sampling occasions during day 7 each treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-BOH cholesterol |  | Sampling occasions during day 7 one treatment period (AZD3355 alone) | 
| Safety variables (adverse events, blood pressure, pulse, safety lab) |  | During the whole treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reflux Inhibitor, GERD, PPI Interaction