linjc16/ctgov huggingface dataset:
Study of Pazopanib Monotherapy in Patients With Unresectable, Metastatic Neuroendocrine Tumor

Study Overview
=================
Brief Summary
-----------------
To determine the response rate of pazopanib when administered as monotherapy in patients with unresectable neuroendocrine tumor.

Official Title
-----------------
Phase II Study of Pazopanib Monotherapy in Patients With Unresectable, Metastatic Neuroendocrine Tumor

Conditions
-----------------
Neuroendocrine Tumor

Intervention / Treatment
-----------------
* Drug: Pazopanib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: low to intermediate grade neuroendocrine tumor not amenable to surgery or local therapy Exclusion Criteria: poorly differentiated (high grade or anaplastic)/small cell, pheochromocytoma

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pazopanib<br> | Drug: Pazopanib<br>* Pazopanib 800 mg qd daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | 1 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuroendocrine tumor
Evaluation of Different Continuous Positive Airway Pressure (CPAP) Systems in Patients With Acute Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the performance, the tolerability and the efficacy on gas-exchange of different CPAP (Continuous Positive Airway Pressure) systems.

Detailed Description
-----------------
Three CPAP systems are studied for each patient at the same level of PEEP: 1) continuous high-flow CPAP with fixed value PEEP valve; 2) continuous high-flow CPAP with Boussignac PEEP valve; 3) demand flow CPAP, supplied by a ventilator.

Official Title
-----------------
The CPAP in Patients Affected by Acute Respiratory Failure

Conditions
-----------------
Acute Respiratory Failure

Intervention / Treatment
-----------------
* Procedure: CPAP system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intubated-tracheostomized subjects receiving CPAP during the weaning from invasive mechanical ventilation Exclusion Criteria: Hemodynamic instability Barotrauma Severe myopathy

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>Acute Respiratory Failure patients | Procedure: CPAP system<br>* Evaluating the effects of different CPAP systems on respiratory mechanics, respiratory effort and gas-exchange CPAP systems: Continuous high-flow CPAP with fixed value PEEP valve Continuous high-flow CPAP with Boussignac valve Demand flow CPAP supplied by ventilator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory mechanics, work of breathing, end-expiratory lung volume (EELV) and gas exchange |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort of breathing |  | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CPAP, Acute Respiratory Failure
Inflammatory Markers in Exhaled Breath Condensates From Asthmatic Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the inflammatory mediators in exhaled breathe condensates from allergic and non-allergic asthmatic patients.

Official Title
-----------------
Inflammatory Markers in Exhaled Breath Condensates From Asthmatic Patients

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been diagnosed as asthma at least 6 months before enrolled to the study Known skin prick test results to aeroallergens ; either positive or negative 15-65 years of age Exclusion Criteria: On oral or inhaled corticosteroids within 1 month before the study Having asthma exacerbation Being pregnant Suffering from severe systemic disease/ in bad health

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 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 |
| --- | --- |
| Allergic asthma<br>Patients with allergic asthma | |
| Non-allergic asthma<br>Patients with non-allergic asthma | |
| Non-asthmatic controls<br>Non-asthmatic controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of inflammatory cytokines in exhaled breathe condensates |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Exhaled breath condensates, Cytokines
Extra-pulmonary Clinical Manifestations of Influenza Virus and Respiratory Syncitial Virus Infections

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe extra-pulmonary clinical manifestations of Influenza virus and Respiratory Syncitial Virus infections in hospitalized adults at a French university hospital.

Detailed Description
-----------------
Influenza virus and Respiratory Syncitial Virus (RSV) could be responsible for severe infections. Although flu was primarily considered as limited to the respiratory system, clinical reports suggest its association with organ involvement outside of the respiratory tract. The aim of the study is to describe extra-pulmonary complications due to influenza virus and RSV in hospitalized patients from November 2018 to April 2019 and November 2019 to April 2020 in a French university hospital.

Official Title
-----------------
Extra-pulmonary Clinical Manifestations of Influenza Virus and Respiratory Syncitial Virus Infections

Conditions
-----------------
Influenza, Respiratory Virus Syncitial, Extra-respiratory

Intervention / Treatment
-----------------
* Other: observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized adults ≥18 years old Flu or RSV infection confirmed by multiplex qPCR on nasal swab Oral non-opposition Exclusion Criteria: No health insurance Co-infection with viruses other than influenza or RSV

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: observational|The aim of the study is to describe extra-pulmonary complications due to influenza virus and RSV in hospitalized patients from November 2018 to April 2019 and November 2019 to April 2020 in a French university hospital.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation frequency of extra-respiratory manifestations with clinical, biological and radiological data | Clinical data (clinical examination) Biological Data (blood test) Radiological data | at 1 month |
Study of Dietary Intervention Under 100 MMOL in Heart Failure

Study Overview
=================
Brief Summary
-----------------
This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients.

Official Title
-----------------
The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure

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

Intervention / Treatment
-----------------
* Other: low-sodium diet (1500 mg daily)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be recruited from each research center if they are 18 years or older, with confirmed diagnosis of Heart Failure (including both those with a reduced and preserved systolic function), NYHA II-IV, and willing to sign informed consent. Exclusion Criteria: Subjects will be excluded if they have severe hyponatremia (serum sodium <130 mmol/L) Renal failure (a glomerular filtration rate < 30 mL/min) Uncontrolled thyroid disorders Hepatic failure Implantable cardiac device (ICD or CRT) or myocardial revascularization procedures (coronary angioplasty and/or surgical revascularization) in the previous 3 months Uncontrolled atrial fibrillation or recurrent ventricular arrhythmias Malignancy, or with moderate-severe dementia. Patients will be excluded if, in the opinion of the investigator, another condition exists that would preclude dietary compliance or compliance with the protocol.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low-sodium diet<br>(1500 mg daily) | Other: low-sodium diet (1500 mg daily)<br> <br> |
| No Intervention: moderate-sodium diet<br>sodium (100 mmol or 2300 mg daily; Usual Care) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite clinical outcomes | (cardiovascular hospitalizations, emergency department visits due acute decompensated HF, and all-cause mortality) in patients with stable HF | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms and quality of life | improves symptoms and quality of life for patients with stable HF | 12 months | 
| reduces natriuretic peptide levels | reduces natriuretic peptide levels | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with stable heart failure
Quality of Life and Sexuality in Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The trial is to describe quality of life in patients affected by prostate cancer treated with exclusive radiotherapy and submitted to psychological and andrologic evaluation.

Detailed Description
-----------------
This trial is to describe quality of life and sexuality in patients with prostate cancer treated with exclusive radiotherapy. Descriptive analysis of baseline characteristics will be performed by using appropriate summary measures for continous and categorical data. Analysis of variation over time of FACT scores will be conducted by means of ANOVA analysis for repeated measures.

Official Title
-----------------
Quality of Life and Sexuality in Patients Treated With Radical Radiotherapy for Prostate Cancer

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Radiation: Patients affected by prostate cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 years. Histologically-proven of prostate cancer Indication to radical radiotherapy on prostate/ prostate + seminal vesicles / prostate + seminal vesicles + pelvic lymph nodes Informed consent Exclusion Criteria: Other coexisting malignancies, uncontrolled intercurrent illness, active infectious processes, and exudative, bloody, or cytologically malignant effusions excluded patients from the trial. Previous surgery for prostate cancer, severe cardiac or vascular pathology Other major surgery in the preceding year or currently undergoing psychiatric care or psychological counseling.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with prostate cancer<br>Patients affected by prostate cancer and treated with a multidisciplinary approach that comprise exclusive radiotherapy, psychological and andrologic evaluation. | Radiation: Patients affected by prostate cancer<br>* Patients affected by prostate cancer and treated with a multidisciplinary approach: it includes exclusive radiotherapy, psychological and andrologic evaluation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measurement | Evaluation of the quality of life with FACT-P test in patient affected by prostate cancer treated with exclusive radiotherapy and submitted to psychological and andrologic evaluation | 2.5 years |
Specimens From Normal Controls

Study Overview
=================
Brief Summary
-----------------
The Viral Epidemiology Branch (VEB) of the National Cancer Institute (NCI) conducts research on viral infections and their associations with various diseases including AIDS and cancer. For some research questions, specimens are available from case subjects as part of ongoing protocols but are not available from normal control subjects (i.e., those without the infection or disease under study) to whom the case subjects can be compared. This protocol is to obtain routine specimens (usually peripheral venous blood, occasionally other body fluid such as saliva, urine, or tears) from healthy volunteers.

Detailed Description
-----------------
The Viral Epidemiology Branch (VEB) of the National Cancer Institute (NCI) conducts research on viral infections and their associations with various diseases including AIDS and cancer. For some research questions, specimens are available from case subjects as part of ongoing protocols but are not available from normal control subjects (i.e., those without the infection or disease under study) to whom the case subjects can be compared. This protocol is to obtain routine specimens (usually peripheral venous blood, occasionally other body fluid such as saliva, urine, or tears) from healthy volunteers.

Official Title
-----------------
Specimens From Normal Controls

Conditions
-----------------
Viral Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Subjects can be friends of VEB investigator or collaborator, hospital or office workers, repeat volunteer blood donors, etc. EXCLUSION CRITERIA: Must not be minors, prisoners, pregnant women or incapable of providing informed consent.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AIDS, Cancer, Epidemiology, Immunology, Virology
Moderate Sedation for Elective Upper Endoscopy With Balanced Propofol Versus Propofol Alone: a Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Since introduction in 1989, propofol has gained wide acceptance for sedation during endoscopic procedures. The optimal sedation drug during esophagogastroendoscopy (EGD) is not established. Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol. In this study, the investigators want to compare the patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone.

Conditions
-----------------
EGD Procedure

Intervention / Treatment
-----------------
* Drug: Midazolam + propofol
* Drug: propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 19 years old, male and female patients who have plan to get esophagogastroduodenoscopy (EGD) Exclusion Criteria: ASA class III or IV Allergies to propofol, sulfites or eggs patients who had surgery for esophagus, stomach or duodenum inpatients patients who had sleep apnea, gastroparesis or achalasia patients who are taking sedative drugs more than 6 months pregnancy hypotension (systolic pressure less than 90mmHg), bradycardia (pulse rates less than 50 times per minute) or hypoxia (SpO2 less than 90%) psychiatric or neurologic problems (ex. epilepsy or dementia)

Ages Eligible for Study
-----------------
Minimum Age: 19 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: balanced propofol group<br> | Drug: Midazolam + propofol<br>* Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol.<br>|
| Active Comparator: propofol alone group<br> | Drug: propofol<br>* propofol are used for sedation drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale | The patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone | Within the 24 hours after EGD | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications rates | The recovery time after EGD following balanced propofol sedation versus propofol sedation alone. The safety after EGD following balanced propofol sedation versus propofol sedation alone | Within the 1 hour after EGD | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sedation, propofol, midazolam
Bone Mineral Density (BMD) in Adolescents With Growth Hormone Deficiency (GHD)

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, open-label, postmarketing surveillance study. The substudy will collect information on BMD in adolescents and young adults with GHD or Turner syndrome who are completing GH treatment for statural indications.

Official Title
-----------------
Bone Mineral Density in Adolescent Subjects With Growth Hormone Deficiency Who Are Completing Treatment With Nutropin AQ, Nutropin, or Protropin in the National Cooperative Growth Study (NCGS)

Conditions
-----------------
Dwarfism, Pituitary, Turner Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bone age of at least 15 years for girls or at least 16 years for boys within 6 months of obtaining the DXA scan Previous enrollment in the NCGS core study, 85-036 Tanner Stage 4 or greater Either spontaneous or induced puberty Subjects who plan on terminating GH treatment for statural purposes for one or more of the following reasons: epiphyseal fusion, slowing growth rate indicates that near adult height has been reached, or satisfied with current height Exclusion Criteria: Current therapy with a non Genentech GH product Pregnancy (to avoid exposure to low levels of radiation from DXA scanners) Bilateral hip replacement Weight >130 kg (286 lb.)

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Growth Hormone Deficiency
Observational Study to Observe the Efficacy of Levemir® (Insulin Detemir) in Patients With Type 2 Diabetes.

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this observational study is to observe the efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin initiation is evaluated.

Official Title
-----------------
Evaluation of Glycaemic Control After Initiation of Levemir® in Patients With Type 2 Diabetes Mellitus and Time Period Between Diagnosis of Type 2 Diabetes Mellitus and Insulin Initiation.

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

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes mellitus Insulin-naive or currently treated with another basal insulin Inclusion of patients at the discretion of the treating physician after the decision to prescribe Levemir® Exclusion Criteria: Type 1 diabetes mellitus Patients treated with short acting or with premix insulin Women who are pregnant, breast feeding or have the intention to become pregnant Known or suspected allergy to the study product or related product Any exclusion criteria according to the Swiss Levemir® SPC (Summary of Product Characteristics)

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 |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* Effectiveness and safety data collection in connection with the use of the drug Levemir® in daily clinical practice<br>* Other names: NN304;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c of treatment |  | after 12 to 16 weeks | 
| Change in FPG (fasting plasma glucose) of treatment |  | after 12 to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events |  | after 12 to 16 weeks | 
| Insulin dose and concomitant oral antidiabetic medication time period between diagnosis of type 2 diabetes and insulin initiation |  | after 12 to 16 weeks |