linjc16/ctgov huggingface dataset:
Vaasa Childhood Obesity Primary Prevention Study

Study Overview
=================
Brief Summary
-----------------
This study aims to prevent childhood obesity with early life (pregnancy) intensified counselling. The recruited intervention group is pregnant mothers who are at risk to get gestational diabetes. Lifestyle intervention (nutritional and physical activity) begins during pregnancy in maternity clinics and continues in child wellfare clinics until the child is 5 years of age.

Official Title
-----------------
Vaasa Childhood Obesity Primary Prevention Study

Conditions
-----------------
Childhood Obesity Pevention

Intervention / Treatment
-----------------
* Behavioral: Vaasa Childhood Obesity Primary Prevention Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women who are at risk to get gestational diabetes. Exclusion Criteria: Foreigner with language problems Major psychosocial problems Diabetes mellitus type I or II Physical disability, Major medical problems in pregnancy

Ages Eligible for Study
-----------------
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Pragmatic controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br>VACOPP (Vaasa Childhood Obesity Primary Prevention Study): Intensified lifestyle counseling including physical activity and nutritional information beginning during maternity health care and continuing during child health care clinic visits. | Behavioral: Vaasa Childhood Obesity Primary Prevention Study<br>* Intensified counselling concerning healthy diet and suitable physical activity during pregnancy to mothers in the intervention group continuing in child health care clinic visits with the offspring until child's age of 5 year.<br>* Other names: VACOPP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preventing childhood obesity | Difference in offspring weight gain compared to control group | Offspring age until six years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lower cholesterol values |  | up to six years | 
| lower HOMA-index |  | up to six years |
Renal Functional Magnetic Resonance Imaging in Healthy Persons - Reproducibility and Impact of Stress

Study Overview
=================
Brief Summary
-----------------
The main purpose of the study is to describe the applicability and reproducibility of functional MRI scans of the kidneys in healthy participants. Furthermore, the study examines to what extent physiological stress caused by lying in a scanner affects the renal perfusion and thus the reproducibility

Detailed Description
-----------------
2 groups of 10 healthy participants each are included. 1 group aged 18 to 40 and a group of participants above 60 years of age. The functional MRI sequences are performed consecutively in a protocol set up on a 1,5 T MRI scanner. In totl, 3 identical scans are being performed. 2 scans on day 1 followed by another scan 1-2 weeks later. Before and after each scan, cortisol and copeptin is controlled in a blood sample to quantify the level of physiological stress.

Official Title
-----------------
Renal Functional Magnetic Resonance Imaging in Healthy Persons - Reproducibility and Impact of Stress

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

Intervention / Treatment
-----------------
* Diagnostic Test: Functional MRI scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 40 Age of 60 or above Exclusion Criteria: Known kidney or cardiovascular disease Medicine of any kind, that must be taken on days of scanning MRi incompatible implants or other contraindications to MRi Claustrophobia Not being able to lie still in an hour Body weight above 110 kg or waist circumference above 95 cm Pregnancy

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 |
| --- | --- |
| Healthy participants aged 18 to 40<br>3 identical functional MRI scans. Blood samples to quantify level of physiological stress are taken before and after each scan. | Diagnostic Test: Functional MRI scan<br>* Functional MRI scan: Phase contrast, BOLD, Arterial Spin Labeling, Diffusion weighted MRI, T1 mapping, T1rho mapping<br>|
| Healthy participants aged 60 and above<br>3 identical functional MRI scans. Blood samples to quantify level of physiological stress are taken before and after each scan. | Diagnostic Test: Functional MRI scan<br>* Functional MRI scan: Phase contrast, BOLD, Arterial Spin Labeling, Diffusion weighted MRI, T1 mapping, T1rho mapping<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility | Reproducibility as a coefficient of variation | Results from scans performed with an interval of 1 to 2 weeks are compared | 
| Physiological stress | Quantified by level of cortisol and copeptin in blood samples. | Results from scans performed with an interval of 1 to 2 weeks are compared |
Management of Noninvasive Ventilation in Hypoxemic Patients

Study Overview
=================
Brief Summary
-----------------
The investigator aimed to manage noninvasive ventilation in patients with hypoxemic respiratory failure.

Detailed Description
-----------------
Patients with hypoxemic respiratory failure were enrolled in this study. The investigator collected the data at beginning and first stage of noninvasive ventilation to analyze the efficacy of noninvasive ventilation. To manage the noninvasive ventilation easily, the investigator also aimed to develop a scale to predict the efficacy of noninvasive ventilation, and used this scale to guide clinicians how to use noninvasive ventilation.

Official Title
-----------------
The First Affiliated Hospital of Chongqing Medical University

Conditions
-----------------
Noninvasive Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PaO2/FiO2 less than 300; PaCO2 less than 50 mmHg; Respiratory rate more than 25 breaths/min or presence of labored breath. Exclusion Criteria: Requirement of emergency intubation; Sequential use of noninvasive ventilation after extubation;Use of noninvasive ventilation after accident extubation.

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 |
| --- | --- | --- |
| Noninvasive ventilation failure | Noninvasive ventilation failure was defined as requirement of intubation. | From participation to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality in ICU and hospital | From participation to 30 days | 
| ICU stay | Length of ICU stay | From participation to 30 days |
Machine Learning to Predict Acute Care During Cancer Therapy

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to apply a validated machine-learning based model (SHIELD-RT, NCT04277650) to a cohort of patients undergoing systemic therapy as outpatient cancer treatment to generate an automatic system for the prediction of unplanned hospital admission rates and emergency department encounters.

Detailed Description
-----------------
A previously described machine learning (ML)-based model accurately predicted ED visits or hospitalizations for cancer patients undergoing radiation therapy or chemoradiation. An IRB approved prospective randomized trial, SHIELD-RT (NCT04277650) found that preemptive intervention for patients undergoing radiation and chemoradiation based on the ML model's risk stratification decreased the relative risk of acute care visits by 50%, showing that ML-guided escalation of care improved personalized supportive care and treatment compliance while decreasing healthcare costs. The objective of this study is to apply this validated ML based model to a cohort of patients undergoing systemic therapy as outpatient cancer treatment to generate an automatic system for the prediction of unplanned hospital admission rates and emergency department encounters. Once validated, this study will add to the previously published body of evidence supporting a randomized trial evaluating the ML algorithm's ability to assign intervention for patients receiving systemic therapy at highest risk for acute care encounters.

Official Title
-----------------
Generalizable Machine Learning to Predict Acute Care During Outpatient Systemic Cancer

Conditions
-----------------
Chemotherapeutic Toxicity

Intervention / Treatment
-----------------
* Other: Machine learning algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: had treatment encounter in the Duke Medical Oncology department from January 7th, 2019 to June 30th, 2019 DUHS medical record available Exclusion Criteria: -

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 |
| --- |
|Other: Machine learning algorithm|machine learning directed identification of chemotherapy patients at high-risk for emergency department acute care and/or hospitalization|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of unplanned of hospital admission or emergency department visits during systemic therapy |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
machine learning, algorithm, outpatient
Cardiac Rehabilitation of Heart Failure Patients by Telemedicine

Study Overview
=================
Brief Summary
-----------------
The purpose of the READ study is to compare the continuation of the cardiac rehabilitation at home with clinical follow-up, therapeutic education, and advice on the training at the stamina, via telemedicine with the classic strategy in day hospital.

Official Title
-----------------
Cardiac Rehabilitation of Heart Failure Patients by Telemedicine: a Randomized Multicenter Study.

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: SCAD information system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a dysfunction of left ventricle with ejection fraction of left ventricle < 40 % appreciated by echocardiogram at hospital discharge for cardiac rehabilitation. Exclusion Criteria: Patient non authorized to follow an effort training Therapeutic education impossible Pregnant woman or breast-feeding No assent Incapacity to use the terminal Minor patient or under supervision

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Program of cardiac rehabilitation introduced in complete hospitalization pursued in day hospital during 3 months | |
| Experimental: telemedicine<br>Program of cardiac rehabilitation introduced in complete hospitalization pursued at home via a terminal during 3 months | Device: SCAD information system<br>* Cardiac rehabilitation at home by telemedicine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of VO2 peak at 3 months in comparison to VO2 peak at hospital discharge |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2 peak at 3 months compared with VO2 peak at the beginning of the hospitalization |  | 3 months | 
| BNP |  | 3 months | 
| % patient with a BNP < 300 pg/ml |  | 3 months | 
| Medical treatment by ACE inhibitor (in % of target dose) |  | 3 months | 
| Ejection fraction of left ventricle |  | 3 months | 
| Disease knowledge questionnaire |  | 3 months | 
| Life quality questionnaire (Minnesota) |  | 3 months | 
| Beck questionnaire |  | 3 months | 
| Day number at hospital |  | 3 months | 
| Number of medical consultation |  | 3 months | 
| Pharmaco-economic analysis |  | 3 months | 
| Total mortality |  | 3 months | 
| Cardiovascular mortality |  | 3 months |
Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To characterize the steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects

Official Title
-----------------
A Study to Characterize the Steady-State Pharmacokinetics and Pharmacodynamics of 2.5 mg Saxagliptin Administered Twice Daily With Meals to Healthy Subjects

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Saxagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women ages 18 to 45 inclusive Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ [height (m)]² Exclusion Criteria: WOCBP who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product Any significant acute or chronic medical illness Current or recent (within 3 months) gastrointestinal disease Any major surgery within 4 weeks of study drug administration History of allergy to DPP4 inhibitor or related compounds Prior exposure to saxagliptin

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Saxagliptin<br> | Drug: Saxagliptin<br>* Tablets, oral, 2.5 mg, twice daily, 7 days<br>* Other names: Onglyza™;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects |  | Within the first 24 hours of dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the steady-state pharmacodynamics of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects |  | 18 time points up to 14 hours on two separate study days | 
| To assess the PK of the pharmacologically active major metabolite of saxagliptin, BMS-510849, following administration of 2.5 mg saxagliptin twice daily with meals to healthy subjects |  | 21 time points up to 23 hours after first dosing | 
| To assess the safety and tolerability of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects |  | Day 1 to Day 7 |
Quality of Life in Lung Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out about the quality of life of individuals who have been diagnosed and treated for lung cancer (lung cancer survivors). By quality of life, we mean how you are feeling about different aspects of your life, including your physical health, your emotional health, and your ability to carry out daily activities. We are interested in people's opinions about their quality of life, as well as the factors that affect their quality of life. Learning about quality of life will help us to develop new services for lung cancer survivors.

Official Title
-----------------
Quality of Life in Lung Cancer Survivors

Conditions
-----------------
Lung Cancer Survivors

Intervention / Treatment
-----------------
* Behavioral: questionnaires or telephone interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary Stage IA or IB NSCLC; Underwent surgical resection for NSCLC at MSKCC; From 1 to 5 years and 11 months post-treatment for NSCLC prior to study recruitment; No evidence of disease (NED) at the time of recruitment; Can be reached by telephone; Able to provide informed consent. Exclusion Criteria: Undergoing active antineoplastic treatment; Major psychopathology or cognitive impairment likely in the judgment of the investigator to interfere with participation and compliance with the protocol.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Lung Cancer Survivors | Behavioral: questionnaires or telephone interview<br>* In the first phase, a random sample of lung cancer survivors will complete a comprehensive telephone interview or questionnaire by self-report focusing on assessment of quality of life and related covariates. We estimate the total time for completion of the survey by telephone interview or self-report to be 45-60 minutes. second phase of the study, a subset of telephone survey participants will take part in a focus group discussion that will explore their perceptions of barriers for delivery of post-treatment medical and psychosocial follow-up care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the health-related quality of life (HQOL) of lung cancer survivors and compare their HQOL with age- and gender-appropriate, population-based normative data. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe and identify covariates of HQOL in lung cancer survivors. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Cancer Survivors
Sputum Validation for the Molecular Diagnosis of Respiratory Viral Infections in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The aim of this pilot study is to demonstrate the feasibility of viral biomolecular diagnosis in sputum compared to nasopharyngeal swab in cystic fibrosis acute respiratory infection.

Detailed Description
-----------------
In cystic fibrosis (CF), patients face polymicrobial airway infections. Besides bacteria, viruses are now also considered as important agents in lung function deterioration. No strategy has been established on the optimal sampling for respiratory viral molecular diagnostic in CF. Nasopharyngeal swabs (NP) are recommended for respiratory viral screening in non-CF patients but are invasive and sometimes painful for patients. As sputa are non invasive and collected for bacterial monitoring in CF patients they could represent a convenient alternative to NP swabs. This study's aim is to define whether viral screening give concordant results between sputa and NP swabs.

Official Title
-----------------
Pilot Feasibility Study for Cystic Fibrosis Sputum Validation for the Molecular Diagnosis of Respiratory Viral Infections

Conditions
-----------------
Cystic Fibrosis, Respiratory Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant with Cystic Fibrosis Participant able to expectorate Participant with sign of acute respiratory infection Exclusion Criteria: participant not able to expectorate patient refusing to participate
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 |
| --- | --- | --- |
| Concordance of viral type detected in both samples for each participant: sputum and nasopharyngeal swab | Comparison of per participant results of viral molecular detection in sputum and nasopharyngeal swab. Concordance=same virus(es) or no virus detected in both sample. no concordance=different viruses detected in each sample or virus(es) detected in only one sample and not in the other | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Expectoration, Cystic Fibrosis, Nasopharyngeal, Viral molecular diagnosis