linjc16/ctgov huggingface dataset:
A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13

Study Overview
=================
Brief Summary
-----------------
This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL. Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.

Official Title
-----------------
A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-cell Lymphoma: NHL-13

Conditions
-----------------
Diffuse Large B-Cell Lymphoma (DLBCL), Follicular NHL Grade 3b

Intervention / Treatment
-----------------
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 4 to 8 cycles R-CHOP/like, total of 8x Rituximab CR, CRu ECOG/ 0.1 or 2 Known IPI at time of diagnosis Age > 18 years Negative pregnancy test Men must agree not to father a child during the therapy Exclusion Criteria: Transformed lymphoma Secondary malignancy Evidence of CNS - involvement Significant cardiac disease Creatinine > 2.0 mg/dl HIV, Hepatitis positive

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Treatment | Drug: Rituximab<br>* Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)<br>|
| No Intervention: B<br>Observation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| event free survival |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival, overall survival and safety |  | four years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DLBCL, NHL 13, Rituximab, maintenance
Preliminary Evaluation of CASTLE Barrier North American Prototype

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if an ostomy barrier that promotes a healthy skin environment will result in reduced peristomal skin irritation.

Official Title
-----------------
Peristomal Skin Irritation: A Preliminary Evaluation of CASTLE Barrier North American Prototype

Conditions
-----------------
Peristomal Skin Complication

Intervention / Treatment
-----------------
* Device: Use of CASTLE barrier


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years of age has colostomy or ileostomy current user of two-piece, flat, tape bordered barrier mild to moderate skin peristomal skin irritation community dwelling and cares for stoma independently at least 3 months post-operative provides informed consent Exclusion Criteria: presence of fistula on or near stoma prior participation in stoma care study within past 30 days pregnant or lactating (interview only) uses convex product, paste and/or rings known allergy to test barrier composition existing medical condition or therapy that might affect ability to participate or interpretation of study results

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 |
| --- | --- |
| person with ostomy<br>Community dwelling subject with either colostomy or ileostomy and at least 3 months post-surgery. | Device: Use of CASTLE barrier<br>* Test barrier to be used in place of normal barrier. Otherwise normal routine is followed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peristomal skin irritation |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Security | wear time, lifting of barrier from skin, leakage | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ostomy, colostomy, ileostomy, barrier, irritation
The Ability of NIRS to Predict Brain Injury in Hypoxic Ischemic Encephalopathy

Study Overview
=================
Brief Summary
-----------------
A longitudinal study evaluating the predictive ability of near infrared spectroscopy to predict brain injury in infants with hypoxic ischemic encephalopathy. Data will be analyzed at two different time periods, at discharge and again at 2 years of age.

Official Title
-----------------
The Ability of Near Infrared Spectroscopy Monitoring During Hypothermia Treatment to Predict Brain Injury in Infants With Hypoxic Ischemic Encephalopathy

Conditions
-----------------
HIE - Perinatal Hypoxic - Ischemic Encephalopathy

Intervention / Treatment
-----------------
* Device: NIRS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants with diagnosis at birth of HIE Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 2 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 |
| --- | --- |
| HIE<br>Infants with a diagnosis of HIE | Device: NIRS<br>* Monitoring cerebral and perirenal perfusion using NIRS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI findings of encephalopathy | MRI studies will be reviewed and assessed for markers of HIE including damage to deep grey matter structures. | 6 days | 
| Neurodevelopment at 2 years of age | Bayleys developmental test will be used to categorize the infants' neurodevelopment at 2 years of age. | 2 years |
Study on Early Lyme Neuroborreliosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine clinical course and the sequelae of early Lyme neuroborreliosis after treatment with ceftriaxone.

Official Title
-----------------
Clinical and Microbiological Parameters in Patients With Early Lyme Neuroborreliosis

Conditions
-----------------
Nervous System Lyme Borreliosis

Intervention / Treatment
-----------------
* Drug: ceftriaxone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: erythema migrans within 4 months before neurologic involvement and pleocytosis in patients >15 years old Exclusion Criteria: pregnancy lactation history of adverse reaction to a beta-lactam antibiotic

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early Lyme neuroborreliosis patients<br> | Drug: ceftriaxone<br>* ceftriaxone 2 g od i.v. for 14 days<br>|
| No Intervention: control subjects<br>Control subjects without a history of Lyme borreliosis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective sequelae and post-treatment subjective symptoms in patients treated with ceftriaxone for early Lyme neuroborreliosis |  | 1 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of subjective symptoms between patients treated with ceftriaxone for early Lyme neuroborreliosis and control subjects without a history of Lyme borreliosis |  | 1 year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lyme neuroborreliosis
A Study to Evaluate the Efficacy and Safety of AD-218

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of AD-218

Detailed Description
-----------------
Condition or disease : Mixed Dyslipidemia Treatment Drug : AD-218, AD-218A, Placebo of AD-218, Placebo of AD-218A

Official Title
-----------------
A Randomized, Double-blinded, Active-controlled, Multicenter Phase 3 Clinical Trial and Open-label, Extension Study to Evaluate the Efficacy and Safety of AD-218 in Patients With Mixed Dyslipidemia

Conditions
-----------------
Mixed Dyslipidemia

Intervention / Treatment
-----------------
* Drug: AD-218
* Drug: AD-218A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A man or woman over 19 years old. Sign on ICF prior to study participation Exclusion Criteria: History of Fibromyalgia, Myopathy etc (CK ≥ 2 X ULN) Other exclusions applied

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Active Comparator : Test group<br>AD-218 | Drug: AD-218<br>* PO, Once daily(QD), 12weeks<br>|
| Active Comparator: Active Comparator : Control group<br>AD-218A | Drug: AD-218A<br>* PO, Once daily(QD), 12weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change (%) of non-HDL-C from baseline at week 12 | non-HDL-C at week 12 compared AD-218 with AD-218A | from baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change (%) of non-HDL-C from baseline at week 4, 8 | non-HDL-C at week 4,8 compared AD-218 with AD-218A | from baseline at week 4,8 | 
| Percent change (%) of Lipid panel from baseline at week 4, 8, 12 | Lipid panel at week 4, 8, 12 compared AD-218 with AD-218A | from baseline at week 4, 8, 12 |
Effects of Massage Therapy and Kinesthetic Stimulation on Pre-Term Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine whether massage with or without physical exercise impacted weight gain or length of hospital stay for premature infants.

Detailed Description
-----------------
Premature infants are often cared for in a fashion that minimizes physical activity in order to reduce stress and stress-related complications. Previous studies have indicated that massage therapy may increase weight gain and enabled earlier discharge of premature infants. In this study, premature infants were randomly assigned to one of three groups: A: Control Group B: Massage Group, 15 minutes twice a day; C: Massage and physical exercise group 15 minutes each, twice a day.

Official Title
-----------------
Effects of Massage Therapy and Kinesthetic Stimulation on Pre-Term Infants

Conditions
-----------------
Prematurity

Intervention / Treatment
-----------------
* Behavioral: Massage therapy without exercise
* Behavioral: Massage therapy with exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: low birth weight, less than 1500 grams weight of at least 1000 grams at time of entry into study must be at least one week of age must have relative medical stability gestational age between 28-32 weeks Exclusion Criteria: infants with major congenital anomaly those that require mechanical ventilatory support those that are restricted in their movement or ability to undergo the intervention

Ages Eligible for Study
-----------------
Minimum Age: 28 Weeks
Maximum Age: 32 Weeks

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 |
| --- | --- |
| No Intervention: A<br>Control Group receives routine care. | |
| Experimental: B.<br>massage group, receives massage only. | Behavioral: Massage therapy without exercise<br>* Infants will receive massage twice a day; 15 minutes each.<br>|
| Experimental: C.<br>Massage and Exercise group, receives both massage and exercise. | Behavioral: Massage therapy with exercise<br>* Infants will receive massage with exercise twice a day; 15 minutes each.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily weight gain. Length of hospital stay |  | From birth until time of hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on heart rate and respirations |  | Birth until time of hospital discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preterm infants, massage, physical activity, weight gain, length of hospital stay, NICU
A Phase I Study of Lintuzumab Combined With Lenalidomide in Patients With Myelodysplastic Syndromes (MDS)

Study Overview
=================
Brief Summary
-----------------
This study is a phase I, open-label, single-arm, dose escalation trial to determine the safety and activity of lenalidomide combined with lintuzumab in patients with MDS. Small groups of 3-6 patients will be treated with pre-specified doses of lenalidomide and lintuzumab and will receive 3-week cycles of combination therapy.

Official Title
-----------------
A Phase I Combination Trial of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) and Lenalidomide (Revlimid®) in Patients With Myelodysplastic Syndromes (MDS)

Conditions
-----------------
Myelodysplastic Syndrome (MDS)

Intervention / Treatment
-----------------
* Drug: lintuzumab
* Drug: lenalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Disease confirmation of MDS. Between 5% and 30% blasts in the bone marrow. Received treatment for cytopenias within 2-months ECOG ≤ 2. Exclusion Criteria: Received prior therapy with lenalidomide, gemtuzumab ozogamicin (Mylotarg®). Received chemotherapy/radiotherapy within 4 weeks of study registration. Received prior bone marrow transplant. 5q- chromosomal deletion in malignant cells.

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: 1<br>lintuzumab and lenalidomide | Drug: lintuzumab<br>* 4 or 8 mg/kg IV (in the vein) on Days 1, 8 and 15 for the first 21-day cycle; 4 or 8 mg/kg IV (in the vein) on Days 1 and 8 for the second through the eighth 21-day cycle<br>* Other names: SGN-33;Drug: lenalidomide<br>* 10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle<br>* Other names: Revlimid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events and lab abnormalities |  | 1 month after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumor activity |  | Every other 21-day cycle | 
| Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA) |  | 1 month after last dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lintuzumab, Antigens, CD33, Antibodies, Monoclonal, Combined Modality Therapy, Myelodysplastic Syndromes, Hematologic Diseases, Preleukemia
EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Question: In which stage of an EBV-infection is a selective reduction of immunosuppressive medication reasonable to minimize the risk for PTLD, without putting the transplant recipient at risk of acute rejection episodes due to under immunosuppression? Aim of study: Identification of patients at high-risk for PTLD.

Detailed Description
-----------------
PTLD represents a heterogeneous group of abnormal lymphoid proliferations, generally of B-cells, that occur in the setting of ineffective T-cell function because of pharmacological immunosuppression. Because the vast majority of PTLDs are associated with Epstein-Barr virus (EBV) infection, surveillance of EBV infection may have the potential to prevent the development of PTLD by early intervention. However, the cut-off values of high EBV viral load remain badly defined due to a lack of prospective studies and assay standardization. The aim of this ongoing multicenter prospective study is the serial detection of primary EBV infection or reactivation in a homogeneous patient population of pediatric renal transplant recipients during the first 2 years posttransplant by the combined analysis of quantitative EBV viral load by a standardized quantitative PCR technique, EBV serology and EBV-specific T-lymphocytes for the identification of high-risk patients.

Official Title
-----------------
Surveillance of EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients - a Multicenter Prospective Study

Conditions
-----------------
Epstein-Barr Virus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female pediatric and adult renal transplant recipients with written informed consent Exclusion Criteria: psychological illness which does not allow patient to understand the study and participate following his own free will no written informed consent
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 |
| --- | --- | --- |
| EB viral load, serology and EBV-specific T cell in pediatric (and adult) renal transplant recipients with or without clinical symptoms of EBV, PTLD etc. |  | 9 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EBV, PTLD, RTx, pediatric
Correlation Between Respiratory Variability of R-R Intervals and Systolic Pressure Variability

Study Overview
=================
Brief Summary
-----------------
This prospective study is designed to assess and quantify the correlation between respiratory changes in R-R interval and the respiratory changed in invasive systolic blood pressure in ventilated patients during changes in posture and peak end expiratory pressure (PEEP) and following a fluid bolus

Official Title
-----------------
Correlation Between Respiratory Variability of R-R Intervals and in Invasive Systolic Blood Pressure During Changes in Posture and Positive End Expiratory Pressure

Conditions
-----------------
Heart Rate Determination

Intervention / Treatment
-----------------
* Other: posture changes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 Scheduled for surgery under general anesthesia requiring invasive blood pressure monitoring Exclusion Criteria: Heart Rate other than sinus Cardiac Pacemaker Status Transplanted Heart

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient scheduled for surgery under general anesthesia<br> | Other: posture changes<br>* Following induction of general anesthesia and initiation of positive pressure ventilation, patients will be tilted 15 degrees head up for 5 minutes with positive end expiratory pressure of 8 cm H2O, and then 15 degrees head down for 5 minutes with positive end expiratory pressure of 3 cm H2O<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistical Correlation between respiratory variability of R-R interval and systolic blood pressure |  | From immediately after induction of general anesthesia and mechanical ventilation to 20 minutes later |