linjc16/ctgov huggingface dataset:
Delta qSOFA for Risk Stratification in Emergency Infected Patients

Study Overview
=================
Brief Summary
-----------------
The study will investigate the prognostic value of qSOFA (quick Sequential Organ Failure Assessment) kinetics between H0 and H1, and between H0 and H3 in patients with suspicion of Sepsis, i.e. an initial qSOFA of at least of 2.

Detailed Description
-----------------
qSOFA has been reported as a good tool for risk stratification in the ED for patients with infection. However, it is not clear whether qSOFA remains stable during the ED stay, nor whether its kinetics can have prognostic added value. Patients with a qSOFA of at least 2 in the ED, and suspicion of infection will be included. After treatment is initiated and fluids challenge performed, we will collect qSOFA value at 1 hour and 3 hours. Our hypothesis is that a decrease in qSOFA between H0 and H3 is associated with better outcome. We assume that 50% of patients will have a deltaqSOFA >0, with an overall mortality of 23% (according to previous cohort). Under the hypothesis of difference of at least 15% in mortality between the two groups (DeltaqSOFA > 0 and Delta qSOFA<=0), with a power of 90% and an alpha of 0.05, we need to recruit 322 patients.

Official Title
-----------------
Prognostic Value of Quick Sequential Organ Failure Assessment Kinetics After Fluids Challenge in the Emergency Department

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

Intervention / Treatment
-----------------
* Other: measurement of qSOFA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspicion of infection by the emergency physicians at least two of the following criteria : respiratory rate <= 22, systolic blood pressure <= 100 mmHg and altered mental status Exclusion Criteria: Infection ruled out by the expert after chart review patient who refuse to participate

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: measurement of qSOFA|qSOFA will be measured at H0, H1 and H3|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU admission more than 72 hours |  | 60 days | 
| ICU admission |  | 60 days |
Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the hypoallergenicity of an extensively hydrolyzed formula with an added probiotic in children with documented milk allergy.

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Other: Extensively Hydrolyzed Formula with a Probiotic
* Other: Extensively Hydrolyzed Formula without a Probiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≤14 years of age Essentially asymptomatic for a minimum of 7 days pre-challenge. Successful previous consumption of Extensively Hydrolyzed Formula within 1 week of study enrollment Medically documented allergy to cow's milk Exclusion Criteria: Presence of underlying systemic disease or other illness Used Beta-blockers within 12-24 hours of challenges Use of short-acting antihistamines within 3 days Use of medium-acting antihistamines within 7 days Use of long-acting antihistamines within 6 weeks Use of oral steroid medication within 3 weeks

Ages Eligible for Study
-----------------
Maximum Age: 14 Years


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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extensively Hydrolyzed Formula with a Probiotic<br>Extensively Hydrolyzed Formula with a Probiotic | Other: Extensively Hydrolyzed Formula with a Probiotic<br> <br> |
| Placebo Comparator: Extensively Hydrolyzed Formula without a Probiotic<br> | Other: Extensively Hydrolyzed Formula without a Probiotic<br> <br> |

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
-----------------
Confirmed milk allergy
Sodium Nitrate to Improve Blood Flow

Study Overview
=================
Brief Summary
-----------------
Investigators recently showed that tadalafil restores functional sympatholysis in patients with Becker muscular dystrophy (BMD). If tadalafil restores functional sympatholysis in BMD via the NO-cyclic guanosine monophosphate pathway, then functional sympatholysis should also be restored by sodium nitrite- which is an indirect nitric oxide donor.

Official Title
-----------------
Sodium Nitrate to Improve Blood Flow

Conditions
-----------------
Becker Muscular Dystrophy

Intervention / Treatment
-----------------
* Dietary Supplement: Sodium nitrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Becker muscular dystrophy age 15-55 years of age ambulatory Exclusion Criteria: hypertension, diabetes, or heart failure by standard clinical criteria elevated brain natriuretic peptide level (>100 pg/ml) Left ventricular ejection fraction < 50% cardiac rhythm disorder, specifically: rhythm other than sinus, supraventricular tachycardia, atrial fibrillation, ventricular tachycardia, heart block continuous ventilatory support liver disease renal impairment history of asthma or bronchospasm use of any medications other than common supplements unable to perform handgrip exercise

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium nitrate<br>Sodium nitrate will be administered orally and functional sympatholysis assessed before and after treatment | Dietary Supplement: Sodium nitrate<br>* Sodium nitrate will be ingested orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in muscle tissue oxygenation | The pre-specified primary outcome is the pre vs. post treatment change in functional sympatholysis measured by muscle oxygenation. | change from baseline to post treatment (3-4 hours) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Becker, dystrophy, sympatholysis
A Phase I, Dose-Escalation Study to Assess the Safety and Drug Levels in Blood of AZD4877 in Japanese Adult Patients

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies

Official Title
-----------------
A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Weekly in Japanese Adult Patients With Advanced Solid Malignancies

Conditions
-----------------
Cancer, Tumors, Carcinoma

Intervention / Treatment
-----------------
* Drug: AZD4877


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with solid tumour but which have no standard treatment or did not respond to previous treatments. Patients who usually have mild symptoms capable of walking and light and sedentary work. Patients who can stay in hospital at least during 4 weeks. Exclusion Criteria: Patients who have received treatment with anti-cancer agent within 4 weeks prior to first dose of study treatment; 6 weeks if the anti-cancer agent is mitomycin. Patients with abnormally low levels of neutrophil count, platelet count, or haemoglobin, indicators of bone marrow function. Patients who received therapeutic radiotherapy at central nervous system within 3 months prior to first dose of study treatment; the other sites within 4 weeks; or local site within 2 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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

| Intervention/Treatment |
| --- |
|Drug: AZD4877|10 mg IV (3 weeks treatment 1 week rest)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies |  | weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the PK profile of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies |  | weekly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
solid tumors, solid malignancies
Outcomes of Biological Therapy on Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Evaluate effect of biological therapy on activity of RA compared to usual DMARDs

Detailed Description
-----------------
Comparison between RA activity in both groups who recieved biological and DMARDS therapy

Official Title
-----------------
Outcomes of Different Biological Therapy on Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Biological Drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RA patients Exclusion Criteria: any other connective tissue 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RA patients recieved biological therapy<br>RA patients recieved different biological therapy | |
| RA patients recieved different DMARDS<br>RA patients recieved different DMARDS | Drug: Biological Drug<br>* Different biological drugs<br>* Other names: DMARDS as hydroquinone and methotrexate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in activity of rheumatoid arthritis | By DAS 28; it include 28 tender and swollen joints, laboratory test (ESR) and visual analogue score, if it higher than 5.1 it mean high disease activity and if lower than 3.2 it mean low activity and consider remission if lower than 2.6 | After 3 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity of RA | MHAQ.scores include questionnaire from eight activities of daily living and range from 0 to 3 and lower scores mean better function state and high scores mean worse function state | 3 months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RA
Brown Adipose Tissue in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Brown adipose tissue has the capacity to consume large amounts of energy and has insulin-independent glucose uptake. The investigators have recently observed an inverse correlation between irisin levels and insulin needs of type 1 diabetes patients. Transplantation of brown adipose tissue to insulin-deficient rats normalized their blood glucose levels. In this study 12 patients with long-standing type 1 diabetes (>10 years) and with variable exogenous insulin needs will be investigated for amount of brown adipose tissue with positron emission tomography using the tracer 18F-deoxy glucose.

Official Title
-----------------
Studies of Activity of Brown Adipose Tissue With Positron Emission Tomography Using the Tracer 18F-deoxy Glucose in Patients With Type 1 Diabetes

Conditions
-----------------
Type1diabetes

Intervention / Treatment
-----------------
* Radiation: Positron emission tomography with tracer 18F-deoxy glucose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (18 years of age or more) Type 1 diabetes diagnose for more than 10 years Exclusion Criteria: Ongoing pregnancy Ongoing breast-feeding BMI<19 BMI >30 P-creatinine <110 µmol/l

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Type 1 diabetes<br>Positron emission tomography with tracer 18F-deoxy glucose | Radiation: Positron emission tomography with tracer 18F-deoxy glucose<br>* Assessment of activity of brown adipose tissue with positron emission tomography using the tracer 18F-deoxy glucose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity of brown adipose tissue in correlation to exogenous insulin needs using the tracer 18F-deoxy glucose in positron emission tomography measurements |  | Assessment performed after more than 10 years of diagnosed type 1 diabetes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose uptake in muscle in correlation to exogenous insulin needs; assessment using the tracer 18F deoxy glucose in positron emission tomography measurements. |  | Assessment performed after more than 10 years of diagnosed type 1 diabetes |
Effect of Exercise on Prevention of Weight Gain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the dose-response of exercise on prevention of weight gain in overweight adults.

Official Title
-----------------
Effect of Exercise on Prevention of Weight Gain

Conditions
-----------------
Weight Loss

Intervention / Treatment
-----------------
* Behavioral: behavioral exercise intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female or Male 18-55 years of age BMI = 25-29.9 kg/m2 Ability to provide informed consent. Ability to provide consent from their personal physician to participate in this study. Exclusion Criteria: Reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (This study is designed to recruit relatively sedentary adults.) Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism. Women who are currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 12 months. (Pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects. However, this will be confirmed with the urine pregnancy test that will be conducted prior to the baseline DEXA.) Non-medicated resting systolic blood pressure >160 mmHg or non-medicated resting diastolic blood pressure >100 mmHg, or taking medication that would affect blood pressure. Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade). Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated. History of myocardial infarction or valvular disease. History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: behavioral exercise intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fitness |  |  | 
| physical activity |  |  | 
| dietary intake |  |  | 
| mediators |  |  |
Patient Expectations After Implantable-cardioverter Defibrillator (ICD) Implantation

Study Overview
=================
Brief Summary
-----------------
This study will be a qualitative survey to understand the expectations of defibrillator patients with regards to their device. It is unknown what ICD (implantable-cardioverter defibrillator) patients understand about their device and its purpose, thus we will be talking to them about their device. Also, we will be interested in studying their beliefs on how the ICD impacts their life expectancy and quality of life.

Official Title
-----------------
Patient Expectations After ICD Implantation

Conditions
-----------------
Defibrillators, Implantable

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients are eligible for inclusion. We hope to acquire a wide range of ages but are not limited to a specific set. Exclusion Criteria: Non-English speakers will be excluded.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICD Patients<br>ICD patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Why did you have an ICD implanted? |  | after ICD implantation |
The Point of View of Hematological Cancer Patients and Their Loved Ones Regarding Spirituality

Study Overview
=================
Brief Summary
-----------------
The management of patients with malignant hemopathy is based on comprehensive management. In this context and faced with the various difficulties encountered by cancer patients, the question of spirituality and its experience is central. Spirituality refers to the person's attachment to what inspires and gives him foundation, as well as the beliefs, values, and existential experiences associated with it, whether these are religious in nature or not. Although the concept has been identified as a resource in the literature and widely treated in an end-of-life context, assessing the needs of patients with hematological cancer and their loved ones in terms of spirituality from the initiation of treatment does not has not been developed

Official Title
-----------------
The Point of View of Hematological Cancer Patients and Their Loved Ones Regarding Spirituality During the Initial Healing Phase

Conditions
-----------------
Hematologic Cancer

Intervention / Treatment
-----------------
* Other: spirituality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥ 18 years with a recent diagnosis of hematological cancer (lymphoma or leukemia) and in treatment; Patients who speak and read French; Patients in general condition (physical and mental) judged emotionally and physically fit by the referring nurse to answer the questionnaires; Patients benefiting from a social security scheme, Patients who signed the non-objection form after being informed of the study, family person: Have been designated by the patient as being the loved one they wish to include with them; Aged ≥ 18 years; Fluent in and reading French; Having signed the non-objection form after being informed of the study. Exclusion Criteria: Patients in recurrence / progress or in remission of cancer; Patients in the terminal phase of the disease. Family person: person in the curative phase of cancer

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: spirituality|Patients will take three questionnaires (FACIT-Sp, Euroqol 5 dimensions and ESAS)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FACIT-Sp questionnaire |  | 15 minutes |
Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to explore the biomarker Fast Troponins response to exercise in patients with Becker muscular dystrophy, Limb-girdle muscular dystrophy and McArdle disease

Official Title
-----------------
Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases

Conditions
-----------------
Becker Muscular Dystrophy, McArdle Disease, Limb-Girdle Muscular Dystrophy Type 2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The ability to cycle No concurrent medical condition that could interfere with interpretation of the results Molecular diagnosis of the specific condition in specified patient groups or healthy control No active muscle injury on the test day (caused by recent exercise, seizures, trauma, etc.) Exclusion Criteria: Competing conditions at risk of compromising the results of the study Cardiac or pulmonary disease contraindicating peak exercise testing or strenuous exercise Veins that are too difficult to puncture for blood sampling, evaluated by the investigator Severe muscle weakness, that prevents the subject completing the exercise test, evaluated by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| Change in biomarkers | Change in Fast and slow Troponin I after muscle damage | 24 hours |