linjc16/ctgov huggingface dataset:
A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
For patients with relapsed and refractory aggressive non-Hodgkin's lymphoma

Official Title
-----------------
A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Patients With Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

Conditions
-----------------
Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: Filgrastim SD/01
* Drug: Paclitaxel
* Drug: Topotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION: Bidimensionally measurable current/refractory aggressive NHL (Diffuse lg cell, diffuse mixed cell, follicular lg non-cleaved, immunoblastic, Ki-1+ALCL, peripheral T-cell lymphoma, mantle cell lymphoma & transformed lymphoma.) No more than 3 prior treatment regimens. No anti-lymphoma therapy within the past 3 weeks. Not be eligible for treatment of a higher priority. Performance status <2 Zubrod, > 60 Karnofsky. Good marrow reserve: ANC>1.5 x 10(9)/L, platelets > 100 x 10(9)/L. Bilirubin <1.5mg/dL, SGOT, SGPT < 2 x normal values. Serum creatinine < 1.8 mg/dL. Age > 18 yrs. Signed informed consent. Life expectancy of > 12 weeks. No prior Taxane (paclitaxel or docetaxel), topotecan, or CPT-11. No prior stem cell or bone marrow transplantation. No prior second malignancies except for basal cell carcinoma of the skin. EXCLUSION: Active or prior history of CNS lymphoma. Serious intercurrent medical illnesses requiring hospitalization. History of primary/secondary immunodeficiency (other than related to the malignant lymphoma because treatment is dependent on a functional immune system) or patients taking immunosuppressive drugs (systemic corticosteroids). Prior exposure to Filgrastim-SD/01. Women who are pregnant or lactating. Participation in another clinical trial. Positive HIV antibody. History of prior sensitivity to E. coli derived products (such as filgrastim/neupogen).

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Filgrastim SD/01|nan|
|Drug: Paclitaxel|nan|
|Drug: Topotecan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LYMPHOMA, NON-HODGKINS, AGGRESSIVE, RELAPSED AND REFRACTORY
Effect of Stair Climbing and Descending on Postprandial Blood Glucose

Study Overview
=================
Brief Summary
-----------------
Determine effect of stair climbing and descending on postprandial blood glucose

Detailed Description
-----------------
Determine effect of 1, 3, and 10 minutes of stair climbing and descending on postprandial blood glucose compared to seated control following consumption of mixed meal

Official Title
-----------------
Effect of Stair Climbing and Descending on Postprandial Blood Glucose Following Mixed Meal

Conditions
-----------------
Postprandial Blood Glucose

Intervention / Treatment
-----------------
* Other: 1 minute of stair climbing and descending
* Other: 3 minute of stair climbing and descending
* Other: 10 minute of stair climbing and descending


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: within specified age limit, ability to climb and descend stairs determined by ACSM's PAR-Q Exclusion Criteria: diagnosis of diabetes or use of diabetic medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Seated control | |
| Experimental: 1 minute SCD<br>1 minute of stair climbing and descending | Other: 1 minute of stair climbing and descending<br>* 1 minute of stair climbing and descending<br>|
| Experimental: 3 minute SCD<br>3 minute of stair climbing and descending | Other: 3 minute of stair climbing and descending<br>* 3 minute of stair climbing and descending<br>|
| Experimental: 10 minute SCD<br>10 minute of stair climbing and descending | Other: 10 minute of stair climbing and descending<br>* 10 minute of stair climbing and descending<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial blood glucose |  | 15 minutes | 
| Postprandial blood glucose |  | 30 minutes | 
| Postprandial blood glucose |  | 45 minutes | 
| Postprandial blood glucose |  | 60 minutes | 
| Postprandial Insulin |  | 15 minutes | 
| Postprandial Insulin |  | 30 minutes | 
| Postprandial Insulin |  | 45 minutes | 
| Postprandial Insulin |  | 60 minutes |
Identification of Novel Inflammation-related Biomarkers for Early Detection of Anthracycline-induced Cardiotoxicity in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to identify possible set of inflammatory biomarkers before, during and after anthracycline-based chemotherapy in breast cancer patients to identify (sub)clinical chemotherapy-related cardiac dysfunctionCRCD to identify patients who would benefit from additional cardioprotective therapy.

Official Title
-----------------
Identification of Novel Inflammation-related Biomarkers for Early Detection of Anthracycline-induced Cardiotoxicity in Breast Cancer Patients

Conditions
-----------------
Cardiotoxicity, Breast Cancer, Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: initial diagnosis of breast cancer planned Anthracycline-based therapy first-line chemotherapy first visit before initiation of chemotherapy Exclusion Criteria: previous chemotherapy medical history of cardiac disease inflammation-modulating medication medication with RAS inhibitors pregnancy autoimmune disease drug addictions unwilling or unable to provide informed consent

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiotoxicity during observational period | Defined according to IC-OS 2021 Consensus Criteria | continuous evaluation during observational period of 12 months |
Comparison and Analysis of Blood Loss Formulas

Study Overview
=================
Brief Summary
-----------------
Although it has been pointed that estimates are significantly inexact and different from each other, the actual accuracy of them has not been properly investigated and compared.

Official Title
-----------------
Comparison and Analysis of Blood Loss Formulas

Conditions
-----------------
Blood Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Adults 18 - 90 yrs. Exclusion Criteria: Suspected or confirmed coagulopathy (including current treatment with anticoagulants or antiplatelet agents). Surgical blood loss volume < 200 ml. Requirement for surgical gauzes during surgery, including conversion to open surgical techniques. Transfusion of red blood cells (RBCs) during the perioperative period. Significant postoperative bleeding (> 50 ml in surgical drains) or any other type of significant blood loss. Fluid infusions or vasoactive drugs after the first 24 postoperative hours.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Hemoglobin content on blood loss<br>Hemoglobin content on blood loss, to assess ratio hemoglobin/volume. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences on blood loss estimation. |  | 72 hours. |
AMS Evaluation Study

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the operational and functional features of the Ambulatory Monitor Solution (AMS) as well as the ease of use of the system.

Detailed Description
-----------------
The study is going to be conducted to collect feedback from the users about operation of AMS collect parameter raw data from patients in hospital ward setting using the investigational system for use in current and future AMS engineering and regulatory purposes as deemed appropriate by the Sponsor.

Official Title
-----------------
Evaluation Clinical Study Of The Ambulatory Monitoring Solution (AMS)

Conditions
-----------------
Patient Monitoring

Intervention / Treatment
-----------------
* Device: Ambulatory monitoring solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 years or older (≥18 years); Able and willing to provide written informed consent independently. Exclusion Criteria: Have previously participated in this study (no subject may participate more than once); Have an implantable pacemaker; Diagnosed with infection requiring isolation; OR Known to be pregnant and/or breast feeding;

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambulatory Monitoring Solution<br>The evaluable device is a secondary monitoring device and no decisions/diagnosis will be made from these devices. | Device: Ambulatory monitoring solution<br>* Subjects participating in this study will be monitored with the site's standard of care primary monitor and the evaluable device as the secondary monitor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User feedback survey about the use of the Ambulatory Monitoring Solution | The feedback from the clinical users about operational features, alarms, user experience and ease of use of Ambulatory Monitoring Solution will be collected. | 5 days |
Quality of Vision in Implantable Collamer Lens (ICL)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to observe the influence of pupil size upon visual outcome in patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation.

Detailed Description
-----------------
The aim of this study is to observe the influence of pupil size upon the quality of vision outcome in patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation. Pre-operation and 3-month post-operation pupil size, visual acuity, quality of vision will be evaluated in patient that had ICL surgery.

Official Title
-----------------
Pupil Influence on the Quality of Vision in Implantable Collamer Lens (ICL)

Conditions
-----------------
Pupil Diameter

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myopic eyes Preoperative corneal endothelial cell count ≥2200/mm2 Preoperative central anterior chamber depth> 2.80mm Intraocular pressure within the normal range (10-21mmHg) Exclusion Criteria: Severe dry eye Cataract and glaucoma Patients with uveitis Retinal detachment Patients with autoimmune diseases Patients with systemic diseases such as diabetes and hypertension Patients with mental or cognitive abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Subjective Quality of vision | Change in QoV questionnaire score after ICL surgery at 3-month testing will be compare with baseline measurements | Baseline (before surgery) and 3 month after surgery | 
| Pupil diameter pre-operation and post-operation | Change in Pupil diameter after ICL surgery at 3-month testing will be compare with baseline measurements | Baseline (before surgery) and 3 month after surgery | 
| Wave front aberrometry | Change in Wave front aberrometry after ICL surgery at 3-month testing will be compare with baseline measurements | baseline and 3 month after surgery | 
| Point Spread Function (PSF) | Change in Point Spread Function (PSF) after ICL surgery at 3-month testing will be compare with baseline measurements | baseline and 3 month after surgery | 
| Strehl ratio | Change in Pupil diameter after ICL surgery at 3-month testing will be compare with baseline measurements | Baseline and 3 month after surgery | 
| Modulation transfer function (MTF) | Change in Modulation transfer function after ICL surgery at 3-month testing will be compare with baseline measurements | Baseline and 3 month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICL, QoV, Visual acuity
Study of the Prevalence of Cosavirus and Salivirus Infections, Two New Genera of Picornaviridae, In Infants

Study Overview
=================
Brief Summary
-----------------
Cosavirus and Salivirus are two new genera of Picornaviridae and are responsible for acute diarrhoea. They have been identified in the pathological stools of infants and immuno-compromised subjects on every continent with prevalences ranging from 2.8% to 8.8% depending on the virus, the cohort and the country studied. To date, no study on these two viruses has been conducted in France to evaluate the circulation and the pathogenicity of these viruses in subjects with diarrhoea. The aim of this study is thus to: show that these viruses are in circulation in France in infants younger than 5 years old and that the proportions are similar to those reported in the literature. confirm the relationship between the diarrhoea and the infection with these viruses.

Official Title
-----------------
Study of the Prevalence of Cosavirus and Salivirus Infections, Two New Genera of Picornaviridae, In Infants

Conditions
-----------------
Gastro entérite

Intervention / Treatment
-----------------
* Other: stool samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children younger than 5 years Children hospitalized or consulting at Dijon CHU during the 12 months of the study for acute gastroenteritis. Acute gastroenteritis is defined by at least 3 soft or liquid stools or at least 3 bouts of vomiting within 24 hours or signs (diarrhoea or vomiting) accompanied by at least 2 additional symptoms among diarrhoea or vomiting, abdominal pain, fever for controls Children younger than 5 years old Children hospitalized or consulting at Dijon CHU during the 12 months of the study for any illness without diarrhoea (other than exclusion criteria). Exclusion Criteria: Persons without national health insurance cover Children older than 5 years. Children presenting chronic diarrhoea (> 2 weeks) (e.g. Crohn and UC) Children with immune deficiency. Children with nosocomial gastroenteritis; the nosocomial aspect will be defined as the onset of acute diarrhoea occurring after the 48th hour after admission for controls Persons without national health insurance cover Children older than 5 years. Children with chronic diarrhoea (> 2 weeks) (e.g. Crohn and UC) Children with immune deficiency.

Ages Eligible for Study
-----------------
Maximum Age: 5 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 |
| --- | --- |
| gastroenteritis<br> | Other: stool samples<br> <br> |
| control<br> | Other: stool samples<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of viruses detected |  | Baseline |
Use of the Perinatal Database and Biologic Tissue Bank at The Perinatology Research Branch (PRB)

Study Overview
=================
Brief Summary
-----------------
The purpose of this application is to request permission to use a bank of biological specimens and clinical information collected by the investigators prior to their joining the intramural program. The samples have been gathered under the sponsorship and approval of the Human Investigations Committees at Yale University, Wayne State University and Pennsylvania Hospital in the United States, the Sotero del Rio Hospital, the Hospital of the Universidad de Chile and the Universidad Catolica de Chile , in Chile. The investigators have generated a bank of amniotic fluid, maternal blood and urine, and fetal blood obtained at the time of delivery (from the umbilical cord and by cordocentesis), neonate s urine and sonographic examinations of the fetus, including echocardiography, stored on videotapes. Clinical information with patient identifiers is available for these samples and sonographic examinations.

Detailed Description
-----------------
The purpose of this application is to request permission to use a bank of biological specimens and clinical information collected by the investigators prior to their joining the intramural program. The samples have been gathered under the sponsorship and approval of the Human Investigations Committees at Yale University, Wayne State University and Pennsylvania Hospital in the United States, the Sotero del Rio Hospital, the Hospital of the Universidad de Chile and the Universidad Catolica de Chile , in Chile. The investigators have generated a bank of amniotic fluid, maternal blood and urine, and fetal blood obtained at the time of delivery (from the umbilical cord and by cordocentesis), neonate s urine and sonographic examinations of the fetus, including echocardiography, stored on videotapes. Clinical information with patient identifiers is available for these samples and sonographic examinations.

Official Title
-----------------
Use of a Perinatal Database and Biologic Tissue Bank at the Perinatology Research Branch (PRB)

Conditions
-----------------
Pregnancy, Premature Birth, Prenatal Care, Preterm Delivery, Preterm Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Not listed in protocol - samples only.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 Years

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

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
-----------------
Pregnancy, Preterm Birth, Preterm Birth Prevention, Prematurity, Pregnancy Complications
Clinical Study of SARS in Children

Study Overview
=================
Brief Summary
-----------------
Severe acute Respiratory Syndrome (SARS) is an emerging infectious disease. It is caused by a novel SARS-associated coronavirus. According to the epidemiological data, it is highly infectious by intimate contact, respiratory secretion, or direct contact with infectious body fluid. By June 1, 2003, Center for Disease Control Taiwan, R.O.C reported 677 probable SARS cases. Among them, 93.2% (631/677) were more than 20 years old. Only 6.8% (46/677) were under 20 years old. Usually the major hosts of respiratory viruses are children, but evidence up to now shows that SARS is mainly a disease of adults. The data of clinical presentation and epidemiological prevalence in teenage group and children are lacking. Therefore, this project is aimed at the children and teenager among 1 month to eighteen years old. Seroepidemiology of SARS-CoV infection in children would be investigated. Patients who admitted to pediatric wards or visited ER and received blood sampling due to the need of clinical diagnosis/management would be enrolled. After the necessary laboratory examinations were done, the remaining serum would be collected and tested for anti-SARS-CoV IgG by ELISA.

Official Title
-----------------
Clinical Study of SARS in Children

Conditions
-----------------
Epidemiology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged from 1 month to 18 years old Received blood sampling during admission or at emergency department due to the need of clinical diagnosis/management Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
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 |
| --- | --- | --- |