linjc16/ctgov huggingface dataset:
S8516-S8736-S9125-S9240 Research Study of Genes in Tissue Samples From Patients With B-cell Non-Hodgkin Lymphoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at genes in tissue samples from patients with B-cell non-Hodgkin lymphoma.

Detailed Description
-----------------
OBJECTIVES: To determine if toxicity following treatment for lymphoma varies according to genetic polymorphisms in oxidative stress-related genes (i.e., SOD2, CAT, GPX1, GSTM1, and GSTP1). To assess whether these genetic polymorphisms are associated with progression-free survival and/or overall survival in these patients treated for lymphoma. OUTLINE: Previously collected samples are used for biomarker analysis.

Official Title
-----------------
Pharmacogenomics of Oxidative Stress-Related Genes in Lymphoma

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Genetic: polymorphism analysis
* Other: laboratory biomarker analysis
* Other: pharmacogenomic studies


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of aggressive B-cell non-Hodgkin lymphoma Previously treated with curative intent using anthracycline-based therapies Previously collected paraffin-embedded diagnostic tissues from clinical trials that were collected as part of SWOG treatment protocols (S8516, S8736, S9125, S9240, and S9349) available PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease 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

| Intervention/Treatment |
| --- |
|Genetic: polymorphism analysis|nan|
|Other: laboratory biomarker analysis|nan|
|Other: pharmacogenomic studies|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of polymorphisms in oxidative stress-related genes with overall survival and/or progression-free survival |  | retrospectively | 
| Association of polymorphisms in these genes with rate of grade 4-5 hematologic toxicity |  | retrospectively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-Hodgkin lymphoma, cutaneous B-cell non-Hodgkin lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma
Using Computers to Assist in Parental Smoking Cessation in a Pediatric Setting

Study Overview
=================
Brief Summary
-----------------
The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. The investigators will be studying whether it can help to support parents in their efforts to quit smoking.

Detailed Description
-----------------
The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. The investigators will be studying in a randomized controlled trial whether it can help to support parents in their efforts to quit smoking.

Official Title
-----------------
Using Computers to Assist in Parental Smoking Cessation in a Pediatric Setting

Conditions
-----------------
Cigarette Smoking

Intervention / Treatment
-----------------
* Other: CHICA Smoking Cessation Module
* Other: CHICA Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent of child in our clinics who reported cigarette smoking Exclusion Criteria: Not smoking

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?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CHICA Smoking Cessation Module<br>This arm had the CHICA smoking cessation module turned on | Other: CHICA Smoking Cessation Module<br>* The CHICA module helped to screen parents for smoking and assist them in quitting.<br>|
| Placebo Comparator: CHICA Placebo<br>This arm had CHICA without the smoking cessation module | Other: CHICA Placebo<br>* This was CHICA without the study module.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental Smoking Quit Rate | This is the number of participants who quit smoking | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking, quitting, tobacco, Parental
The Ultrasonographic Changes of Intercostal Muscles and Diaphragm in Mechanically Ventilated Preterm Neonates

Study Overview
=================
Brief Summary
-----------------
Invasive mechanical ventilation induces ventilator induced diaphragmatic dysfunction particularly when used for long time and Intercostal muscles as well contribute to the important work of respiratory movement by expanding the thorax , and determining the thickness of them would be a useful parameter in evaluating respiratory muscle activity. This study will add the impact of mechanical ventilation on the diaphragm and intercostal muscles in preterm infants using ultrasound.

Official Title
-----------------
The Ultrasonographic Changes of Intercostal Muscles and Diaphragm in Mechanically Ventilated Preterm Neonates

Conditions
-----------------
Mechanical Ventilation Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants from 28-36 weeks gestation In need for invasive mechanical ventilation according to work of breathing, oxygen saturation and blood gases . Exclusion Criteria: 1) Significant congenital anomalies including cardiac, abdominal or respiratory. 2) Congenital anomalies involving the diaphragm. 3) Phrenic nerve paralysis. 4) Congenital muscular dystrophies. 5) Major upper or lower airway anomalies. 6) Storage diseases.

Ages Eligible for Study
-----------------
Minimum Age: 5 Minutes
Maximum Age: 28 Days

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 |
| --- | --- | --- |
| The impact of mechanical ventilation on diaphragm and intercostal muscles using ultrasound | Using Ultrasound to measure Intercostal Muscles thickness and diaphragmatic thickness and excursion for assessing the impact of the mechanical ventilation on muscle power predicting weaning from ventilation. | 6 months |
Impact of Non-invasive Brain Stimulation, Associated With Upper Limb Robot-assisted Therapy, on Motor Recuperation

Study Overview
=================
Brief Summary
-----------------
tDCS (transcranial direct current stimulation) and robot assisted therapy (RAT) will be used in chronic stroke patients to improve a variety of functions with upper limb.

Detailed Description
-----------------
tDCS and RAT will be used in chronic stroke patients to improve a variety of functions such as motor functions with upper limb. tDCS will be applied in a placebo-controlled, double-blind, randomised fashion. A session of RAT will be associated with tDCS/placebo. Behavioural data will be collected before and after tDCS, associated with RAT.

Official Title
-----------------
Impact of Non-invasive Brain Stimulation, Associated With Upper Limb Robot-assisted Therapy, on Motor Recuperation

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: tDCS (ELDITH) and RAT (REAplan)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stroke with at least slight deficit in upper limb Exclusion Criteria: epilepsy contraindication to tDCS presence of metal in the head inability to understand/complete behavioural tasks chronic intake of alcohol or recreative drugs major health condition (e.g. terminal renal failure, instable heart failure etc …) pregnancy

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real stimulation<br>real tDCS associated with robot-assisted therapy (RAT) | Device: tDCS (ELDITH) and RAT (REAplan)<br>* Transcranial direct-current stimulation( ELDITH) and Robot-assisted therapy by using REAplan<br>|
| Sham Comparator: Sham stimulation<br>Sham tDCS associated with RAT | Device: tDCS (ELDITH) and RAT (REAplan)<br>* Transcranial direct-current stimulation( ELDITH) and Robot-assisted therapy by using REAplan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Limb Kinematics |  | kinematic assessment of the upper limb at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and Block test |  | Manual dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT) | 
| Purdue Pegboard Test |  | Digital dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT) |
In Vitro Studies of Immunological and Stem Cell Function in Peripheral Blood Mononuclear Cells in Patients

Study Overview
=================
Brief Summary
-----------------
Peripheral blood mononuclear cells (PBMC) will be collected from patients who have leukemia or lymphoma or other medical conditions involving altered lymphohematopoietic stem cell or immunological function. These PBMC will be assessed for cellular markers by flow cytometry and will be studied for in vitro T helper, effector and suppressor cell functions, to determine whether cell mediated immunity is involved in the condition, or indicative of therapeutic efficacy or is predictive for outcome. Peripheral blood stem cells (PBSC) from untreated donors and from cytokine treated donors will be assessed for cellular markers and in vitro growth characteristics that might be useful for identifying normal stem cell populations.

Detailed Description
-----------------
Peripheral blood mononuclear cells (PBMC) and mobilized peripheral blood stem cells (PBSC) will be collected from patients who have leukemia or lymphoma or other medical conditions involving altered lymphohematopoietic stem cell or immunological function. These PBMC will be assessed for cellular markers by flow cytometry and will be studied for in vitro T helper, effector and suppressor cell functions, to determine whether cell mediated immunity is involved in the condition, or indicative of therapeutic efficacy or is predictive for outcome. PBSC will be assessed for cellular markers and in vitro growth characteristics that might be useful for identifying normal stem cell populations. Furthermore the capacity of stem cells to reconstitute the T lymphocyte lineage will be assessed using ex vivo explant cultures established with thymic or secondary lymphoid tissues.

Official Title
-----------------
In Vitro Studies of Immunological and Stem Cell Function in Peripheral Blood Mononuclear Cells in Patients

Conditions
-----------------
Immunologic Deficiency Syndrome, Leukemia, Lymphoma, Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients obtained from collaborators within and outside the NCI.
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
-----------------
Cancer, Transplantation, Cellular Immunity, Stem Cell Function, Immunodeficiency
The Effectiveness of Foley Airway Stylet Tool on Proseal LMA Insertion

Study Overview
=================
Brief Summary
-----------------
Due to its soft cuff easily folded to impede ProSeal LMA insertion, many tools are developed. The aim of the study is to investigate the efficiency of ProSeal LMA insertion guided by a soft, direct optical Foley airway stylet tool (FAST) and compared with the standard introducer-tool (I-Tool).

Official Title
-----------------
The Efficiency of ProSeal Laryngeal Mask Airway Insertion: Compared the Techniques of Foley Airway Stylet Tool With Introducer-Tool

Conditions
-----------------
Anesthesia Insertion Complication, Airway Morbidity

Intervention / Treatment
-----------------
* Device: Foley Airway Stylet Tool
* Device: introducer-tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with American Society of Anesthesiologists physical status I-II aged 20-65 years requiring LMA Intubation under general anesthesia unlimited mouth open unlimited neck motion Exclusion Criteria: mouth open < 3 cm limited neck motion BMI≧35 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foley group<br>The Foley Airway Stylet Tool was used to guide ProSeal LMA insertion | Device: Foley Airway Stylet Tool<br> <br> |
| Experimental: I-Tool group<br>the ProSeal LMA was inserted with a standard introducer-tool | Device: introducer-tool<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with successful airway establishment | successful airway establishment is defined as adequate ventilation with ProSeal LMA and its alignment with viewing of proper glottic and esophageal positions. | half an hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative sore throat | sore throat recorded in recovery room and in the coming morning | 2 days | 
| hoarseness | severity of hoarseness was recorded in recovery room and in the coming morning | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LMA, Foley Airway Stylet Tool (FAST), introducer-tool (I-Tool)
Israel Multicenter D-Serine Study (IMSER) for the Treatment of Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The goal of the present study is to evaluate the effect of D-serine, added to antipsychotic treatment, on negative and cognitive symptoms in schizophrenia. The investigators are hypothesizing that D-serine will improve cognitive functioning and negative symptoms.

Official Title
-----------------
D-Serine Adjuvant Pharmacotherapy for the Treatment of Schizophrenia

Conditions
-----------------
Schizoaffective Disorder, Schizophrenia

Intervention / Treatment
-----------------
* Drug: D-serine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) diagnosis of schizophrenia and\or schizoaffective disorder. Age between 18 to 64. PANSS negative symptom score higher than 19. SAS total score lower than 12. CDSS suicidal risk lower than 2 Exclusion Criteria: Epilepsy Meets DSM-IV criteria for mental retardation. Medical condition which confounds presentation or treatment (e.g. uncontrolled diabetes mellitus, history of kidney stones, acute drug toxicity, dementia, delirium, stroke, etc.) Meets DSM-IV criteria for alcohol or drug dependence in last 6 months. Meets DSM-IV criteria for alcohol or drug abuse in last one month. Treatment with clozapine. Current positive pregnancy test or not using acceptable method of birth control. Meets DSM-IV criteria for current anxiety or mood disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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

| Intervention/Treatment |
| --- |
|Drug: D-serine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SANS - Scale for the Assessment of Negative Symptoms - weeks 0, 8 and 16 |  |  | 
| Measurement and Treatment Research for Cognition in Schizophrenia (MATRICS) battery - visit weeks 0, 8 and 16 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale of Schizophrenia (PANSS) positive, negative, general and total score - weeks 0, 8 and 16 |  |  | 
| Simpson-Angus Scale (SAS) total score - weeks 0, 8 and 16 |  |  | 
| Clinical Global Impressions (CGI) score - weeks 0, 8 and 16 |  |  | 
| Calgary Depression Scale for Schizophrenia (CDSS) score - weeks 0, 8 and 16 |  |  | 
| Side effect check list |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
D-serine, Negative symptoms, Cognition, Schizophrenia, Amino acid
International Cross-sectional and Longitudinal Assessment on Asthma Control (Liaison)

Study Overview
=================
Brief Summary
-----------------
The study design consists of a cross-sectional survey on the clinical characteristics of patients with asthma and their level of asthma control and current quality of life, and on a prospective evaluation of the rate of switch from the uncontrolled/poorly controlled condition to the status of controlled asthma. Asthma control will be based on the Asthma Control Questionnaire scoring system, that has been fully validated for use in both clinical practice and clinical trials and has strong discriminative properties which means that it can detect small differences between patients with different levels of asthma control and it is very sensitive to within-patient change in asthma control over time. Quality of life as a reflection of the control of the disease, will also be evaluated by means of the Mini Asthma Quality of Life Questionnaire scoring system.

Official Title
-----------------
International Cross-sectional and Longitudinal Assessment on Asthma Control (Liaison)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria: Written informed consent obtained. Male or female adult (at least 18 years of age) patients with asthma diagnosed (according to GINA guidelines and confirmed by a chest physician) for at least 6 months. Patients in treatment with the same antiasthmatic drugs in the last 4 weeks before enrolment. Exclusion criteria: Patients enrolled in clinical trial in the previous 4 weeks or subjects already admitted in this study. Patients suffering from conditions and illnesses that might interfere with the study purpose, according to the investigator's evaluation.

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 |
| --- | --- |
| Controlled patients<br>Asthmatic patients with controlled asthma (according to ACQ score) | |
| Partly controlled/Uncontrolled patients<br>Patients with partly controlled or uncontrolled asthma (according to ACQ score) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Questionnaire score |  | 3 months | 
| Mini Asthma Quality of Life Questionnaire score |  | 3 months |
hsTnT After Elective Coronary Angiography

Study Overview
=================
Brief Summary
-----------------
A prospective Study, aiming to understand and analyse the key role of the novel High Sensitivity Troponin T (hsTnT) within a group of patients undergoing an uncomplicated coronary angiography without receiving any additional intervention. The peri-procedural elevation of the hsTnT indicates some other factors being responsible for the elevation of the hsTnT in absence of an acute coronary syndrome, such as physiological components or micro-injuries. A one year follow-up has been collected.

Official Title
-----------------
Rise of hscTnT After Elective Coronary Angiography Without Coronary Intervention

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Stable or unknown CAD Exclusion Criteria: - Acute Coronary Syndrome

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 |
| --- | --- |
| CAG without PCI<br> | |
| CAG with PCI<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality |  | Up to 12 months after procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prei-procedural, Elevation, cardia Troponin T, in stable, unknown