linjc16/ctgov huggingface dataset:
Indirect Calorimetry: SensorMedics Vmax vs GE Carescape - a Method Comparison Study

Study Overview
=================
Brief Summary
-----------------
Dosing of nutrition in PICUs is mainly based on patient weight and assumptions on clinical status. There is however poor correlation between these calculations and actual energy consumption measured with indirect calorimetry (IC). Available equipment for IC has however been too cumbersome to use in daily clinical practice. Of relative new date is IC integrated in modern ventilators. This functionality is easy to use, but we do not know if the results are reliable for children. This study is a method comparison study comparing measurements done with SensorMedics Vmax (gold standard) vs GE Carescape (modern ventilator with Integrated IC) in children undergoing intensive care treatment.

Official Title
-----------------
Indirect Calorimetry: SensorMedics Vmax vs GE Carescape - a Method Comparison Study

Conditions
-----------------
Nutrition Assessment, Critical Illness, Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: < 18 years of age, endotracheally intubated. FiO2 < 0,6, tube leak < 10%, tidal volume > 50 ml. Exclusion Criteria: Ventilatory and hemodynamically unstable during 2 hours prior to inclusion.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| MEE (measured energy expenditure) kcal/kg/day, RQ (respiratory quotient) | Comparison of measurements made by two different instruments | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
indirect calorimetry, method comparison
Primovist Post-marketing Surveillance in Japan

Study Overview
=================
Brief Summary
-----------------
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Primovist for contrast enhancement in MRI of liver. The objective of this study is to assess safety, especially in relation to renal dysfunction, and efficacy of using Primovist in clinical practice. A total 2,000 patients for diagnosis on detection and identify hepatic tumor will be recruited and followed 7 days after the injection.

Official Title
-----------------
Drug Use Investigation of EOB-Primovist Inj. Syringe

Conditions
-----------------
Diagnostic Imaging

Intervention / Treatment
-----------------
* Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received Primovist for liver MRI Exclusion Criteria: Patients who are contraindicated based on the product label
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873)<br>* Patients who will need to undergo contrast enhanced MRI with Primovist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist |  | After Primovist injection, up to 7 days | 
| Incidence of adverse drug reactions in patients with renal impairment |  | After Primovist injection, up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease and dose of Primovist] |  | After Primovist injection, up to 7 days | 
| MRI image evaluation assessment by the five rank scales of 1 to 5: 1) much improved; 2) improved; 3) slightly improved; 4) not improved; and 5) impaired |  | After Primovist injection, up to 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primovist, MRI agent
Evaluating Treatment of Anemia in Subjects With Non-Myeloid MalignanciesReceiving Multicycle Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of darbepoetin alfa administered in a weight based versus fixed dosing for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Official Title
-----------------
A Randomized, Open-Label Study of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) Using Fixed and Weight-Based Dosing for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy

Conditions
-----------------
Anemia, Non-Myeloid Malignancies, Cancer

Intervention / Treatment
-----------------
* Drug: Darbepoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Planned chemotherapy treatment - Anemia (hemoglobin concentration less than or equal to 11.0 g/dL) - Adequate renal and liver function - Eastern Cooperative Oncology Group (ECOG) 0 to 2 - Subjects must provide written informed consent Exclusion Criteria: - Known history of seizure disorder - Known primary hematologic disorder causing anemia other than non-myeloid malignancies - Unstable/uncontrolled cardiac condition - Clinically significant inflammatory disease - Known positive test for HIV infection - Transfusion within 4 weeks of randomization - Neutralizing antibodies to any erythropoietic agent - Treatment with erythropoietic therapy within 4 weeks before randomization - Received any investigational drug or device within 30 days before randomization - Pregnant or breast feeding - Not using adequate contraceptive precautions - Previously randomized into this study - Known hypersensitivity to any products to be administered - Concerns for subject's compliance

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Darbepoetin alfa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieving a hemoglobin concentration greater than or equal to 12.0 g/dL or a greater than or equal to 2.0-g/dL increase in hemoglobin concentration compared to baseline |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to and percentage of subjects with a hemoglobin response |  |  | 
| Time to and percentage of subjects with hemoglobin correction |  |  | 
| Hemoglobin concentration and change in hemoglobin concentration from baseline |  |  | 
| Time to first RBC transfusion and percentage of subjects receiving a RBC transfusion |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-myeloid malignancy, chemotherapy-induced anemia
Investigation of Female Reproductive Hormone Dynamics During Adolescence

Study Overview
=================
Brief Summary
-----------------
Irregular menstrual cycles are common in girls for several years after their first menstrual period. The cause of abnormal menstrual cycles during this time is not well-understood. The purpose of this study is to: 1) monitor girls during a menstrual cycle (with blood and urine sampling and serial pelvic ultrasounds) to identify those girls who do not ovulate (release of an egg from the ovary), and 2) determine whether cycles can be corrected by treating girls with a short course of low-dose estrogen and progesterone.

Official Title
-----------------
Investigation of Female Reproductive Hormone Dynamics During Adolescence

Conditions
-----------------
Menstruation Disturbances

Intervention / Treatment
-----------------
* Drug: micronized progesterone
* Drug: transdermal estradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no more than 3 ½ years postmenarchal Exclusion Criteria: Subjects currently on or previously treated with medications that may affect reproductive hormones (eg birth control pills). Subjects with severe acne or hirsutism Subjects who exercise excessively (running > 20 miles/week or its equivalent) Subjects with any of the following medical conditions: diabetes, hypertension, hyperlipidemia, valvular heart disease, lupus, rheumatoid arthritis, migraine headaches with aura, undiagnosed breast mass, inflammatory bowel disease, gallbladder disease, sickle cell disease, or thrombophilia. Current smoker History of deep venous thrombosis or pulmonary embolism in subject or first-degree relative

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
Female

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: Interventional<br>estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days | Drug: micronized progesterone<br> <br> Drug: transdermal estradiol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation in Cycle 2 | serum progesterone > 3 ng/ml or presence of corpus luteum on pelvic ultrasound | 20-40 days |
Systematic Follow up of Second Line Treatments for Parkinson's Disease (Deep Brain Stimulation, Apomorphin Pump, Duodopa Pump)

Study Overview
=================
Brief Summary
-----------------
Primary purpose: Fluctuations and dyskinesia evolution in Parkinson's disease patients, one year after initiation of deep brain stimulation, apomorphin pump or duodopa pump Secundary purposes: Motor complications evolution at 6 months, 2 and 3 years MDS UPDRS III score at 6 months, 1, 2 and 3 years non motor complications evolution at 6 months, 1, 2 and 3 years cognition and psychiatric complications evolution at 6 months, 1, 2 and 3 years cutaneous and digestive complications at 6 months, 1, 2 and 3 years neuropathy occurrence at 6 months, 1, 2 and 3 years medical treatment and Levodopa equivalent dose modifications at 6 months, 1, 2 and 3 years

Official Title
-----------------
Systematic Follow up of Second Line Treatments for Parkinson's Disease (Deep Brain Stimulation, Apomorphin Pump, Duodopa Pump)

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Parkinson disease (UKPDSSB criteria) Patient with fluctuations and/or dyskinesia , who need treatment with deep brain stimulation, apomorphin pump or duodopa pump MOCA >20 patient >21 years of age patient who has signed protocol acceptation Exclusion criteria: patient who did not give his acceptation for the protocol patient with another parkinsonian syndrome than Parkinson' s disease MOCA<20 Patient who does not need second line treatment

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| MDS UPDRS IV (Movement Disorder Society - Unified Parkin-son Disease Rating Scale) score improvement | Evaluate the evolution of motor fluctuations and dyskinesias at one year in patients. treated with one of the 3 TSLs (bilateral stimulation of the subthalamic nucleus, apomorphine pump and duodopa pump. the higher the score, the more the disease is installed | 1 year |
Non-invasive Positive Pressure (NPPV ) for Severe Stable Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Assessment of the effect and safety of noninvasive positive pressure ventilation for severe stable chronic obstructive pulmonary disease

Official Title
-----------------
Non-invasive Positive Pressure Ventilation for the Treatment of Severe Stable Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure

Intervention / Treatment
-----------------
* Device: BiPAP mode


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically stable, hypercapnic GOLD stage IV COPD, aged 18 years or older, baseline arterial carbon dioxide pressure (PaCO2) of 6.7 kPa (50 mmHg) or higher and a pH higher than 7·35, measured after at least 1 h rest in a sitting position. Exclusion Criteria: thorax or the lung other than COPD No smoking or Cigarette≤10/day obesity with a bodymass index (BMI) ≥40 kg/m² malignant co-morbidities,severe heart failure (New York Heart Association stage IV),unstable angina, and severe arrhythmias.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noninvasive ventilator<br>noninvasive positive pressure ventilation combined with long-term oxygen therapy for severe stable chronic obstructive pulmonary disease | Device: BiPAP mode<br>* Noninvasive ventilator<br>|
| No Intervention: LTOT<br>long-term oxygen therapy for severe stable chronic obstructive pulmonary disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe Respiratory Insufficiency (SRI) Questionnaire |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood gas analysis |  | 1 year | 
| Pulmanory function |  | 1 year | 
| Baseline Dyspnea Index/Transition Dyspnea Index |  | 1 year | 
| Chromic Respiratory Questionnaire |  | 1 year | 
| Chronic Obstructive Pulmonary Disease (COPD) Assessment Test |  | 1 year | 
| 6 Minute-Walking Distance and Borg Score |  | 1 year | 
| The frequency of exacerbation |  | 1 year | 
| The frequency of readmission |  | 1 year | 
| The frequency of ICU readmission |  | 1 year | 
| survival rate |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Obstructive Pulmonary Disease, Non-invasive positive pressure ventilation, quality of life, long-term oxygen therapy
Observational Study on Efficacy of Alvesco(Ciclesonide) in Asthma Children and Adolescent in Real Practice

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-comparative, open, observational study.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who is prescribed with ciclesonide for asthma Exclusion Criteria: Subjects with contraindications to ciclesonide use Subjects with clinically relevant concomitant disease that could compromise the patient's safety should not be included in this study.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- |
| Alvesco<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control day |  | 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morning peak expiratory flow |  | 12weeks | 
| asthma exacerbation |  | 12weeks | 
| The number of Reliever use |  | 12weeks | 
| Asthma symptom score |  | 12weeks | 
| Number of Participants with Adverse Events |  | 12weeks |
Safety and Efficacy of Sofosbuvir Based Antiviral Regimen for Treating Hepatitis C in Patients With Moderate to Advanced Chronic Kidney Disease and Patients Receiving Renal Replacement Therapy

Study Overview
=================
Brief Summary
-----------------
All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with HCV infection attending nephrology and Hepatology OPD or getting outpatient dialysis at the dialysis unit of ILBS.

Official Title
-----------------
A Prospective Study on Safety and Efficacy of Sofosbuvir Based Antiviral Regimen for Treating Hepatitis C in Patients With Moderate to Advanced Chronic Kidney Disease and Patients Receiving Renal Replacement Therapy

Conditions
-----------------
CKD With Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with moderate to severe renal dysfunction (CKD stage 3, 4, 5) and chronic dialysis patients Patients consented for the study protocol by signing the informed consent. Exclusion Criteria: Age less than 18 years Confirmed pregnancy HCV-HIV Co infection HBV-HCV co infection

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 |
| --- | --- |
| advanced chronic kidney disease<br>Subjects on dialysis with GFR (Glomerular Filtration Rate) > 30 | |
| Renal replacement therapy.<br>Subjects who are not on dialysis with GFR (Glomerular Filtration Rate) < 15 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virologic Response 24 defined as HCV RNA <Lower Level of Qunatification 24 weeks after discontinuation of therapy. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of adverse Events in both groups |  | 2 years |
Combining Intratumoral Metabolic Heterogeneity and Dissemination Feature (Dmax) on 18F-FDG PET/CT Improves Prognosis Prediction in DLBCL

Study Overview
=================
Brief Summary
-----------------
This retrospective study aimed to investigate the combined prognostic values of intratumoral metabolic heterogeneity (MH), disseminate feature (Dmax) and total metabolic tumor volume (TMTV) by 2-deoxy-2-[18F]fluoro-D-glucose positron emission tomography/computed tomography ([18F]FDG PET/CT), and establish novel nomograms to improve prognosis prediction in diffuse large B-cell lymphoma (DLBCL)

Detailed Description
-----------------
This retrospective study aimed to investigate the combined prognostic values of intratumoral metabolic heterogeneity (MH), disseminate feature (Dmax) and total metabolic tumor volume (TMTV) by 2-deoxy-2-[18F]fluoro-D-glucose positron emission tomography/computed tomography ([18F]FDG PET/CT), and establish novel nomograms to improve prognosis prediction in diffuse large B-cell lymphoma (DLBCL) Patients would be retrospectively includedin this study.The inclusion criteria included (1) pathologically proven DLBCL; (2) first-line treatment with R-CHOP or R-CHOP-like chemotherapy including R-miniCHOP and R-ECHOP (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin); (3) at least 2 evaluable hypermetabolic lesions on PET/CT;(4) underwent pre-treatment [18F]FDG PET/CT.

Official Title
-----------------
Combining Intratumoral Metabolic Heterogeneity and Dissemination Feature (Dmax) on 18F-FDG PET/CT Improves Prognosis Prediction in Diffuse Large B-Cell Lymphoma

Conditions
-----------------
Diffuse Large B-cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) pathologically proven DLBCL, (2) first-line treatment with R-CHOP or R-CHOP-like chemotherapy including R-miniCHOP and R-ECHOP (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin),(3) at least 2 evaluable hypermetabolic lesions on PET/CT, (4) underwent pre-treatment [18F]FDG PET/CT Exclusion Criteria: (1) patients who had received surgical resection or other treatments before chemotherapy, (2) patients who had coexistent central system lymphoma or other types of malignancies
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patient<br>patients with DLBCL | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the accuracy of prognosis prediction | The accuracy of clinical model, PET models and combined model for prediction | Through study completion, about 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metabolic heterogeneity, diffuse large B-cell lymphoma, Positron emission tomography (PET), dissemination, metabolic tumor volume