linjc16/ctgov huggingface dataset:
Biomarkers in Samples From Patients With Chronic Lymphocytic Leukemia Treated on Clinical Trial ECOG-2997

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of cells in the laboratory from patients with cancer may help identify biomarkers related to cancer. It may also help doctors learn how patients respond to treatment. PURPOSE: This laboratory study is analyzing samples of cells from patients with chronic lymphocytic leukemia who were treated on clinical trial ECOG-2997.

Detailed Description
-----------------
OBJECTIVES: To analyze the expression of a variety of informative molecules using a unique high-resolution flow cytometric immunophenotyping technology in samples from patients with chronic lymphocytic leukemia enrolled in clinical trial ECOG-2997. OUTLINE: Cell samples are analyzed for the following prognostic biomarkers: ZAP-70, phospho-Syk, phospho-GSK-3β, phospho-Akt, phospho-ZAP-70, cyclin D1, cyclin D2, p21cip1, phospho-ReIA, IkappaBα, Bax, Mcl-1, PTEN, phospho-Erk1/2, and phospho-MEK1/2. Biomarker signals are amplified using enzymatic amplification staining to obtain high resolution detection of cell-surface markers on leukemic cells. Biomarker expression levels are measured using fluorescence activated cell sorting analysis. Relationships between clinical outcomes, standard flow cytometric analysis, cytogenetic studies, and high resolution immunophenotyping will also be assessed.

Official Title
-----------------
Proposed Study of CLL Samples

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Genetic: cytogenetic analysis
* Other: flow cytometry
* Other: fluorescence activated cell sorting
* Other: immunoenzyme technique
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Stored frozen viable cells from patients with chronic lymphocytic leukemia treated on clinical trial ECOG-2997 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: cytogenetic analysis|nan|
|Other: flow cytometry|nan|
|Other: fluorescence activated cell sorting|nan|
|Other: immunoenzyme technique|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of biomarker analysis and correlation with outcome response |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic lymphocytic leukemia
US-Guided Superficial Cervical Plexus Block

Study Overview
=================
Brief Summary
-----------------
This retrospective observational study compare ultrasound-guided plane and landmark-based superficial cervical plexus block

Detailed Description
-----------------
Traditionally, the superficial cervical plexus is blocked using a subcutaneous infiltration of local anesthetics along the posterior border of the sternocleidomastoid muscle.Recently, ultrasound has been used to identify intermuscular planes to carry out transversus abdominis plane and obturator nerve blocks.Thus, to validate this new method, the investigators conducted a retrospective observational study comparing ultrasound and the conventional landmark-based technique for superficial cervical plexus.

Official Title
-----------------
Comparison Between Ultrasound-Guided and Landmark-Based Superficial Cervical Plexus Block：A Retrospective Observational Study

Conditions
-----------------
Nerve Block

Intervention / Treatment
-----------------
* Procedure: Ultrasound-Guided Superficial Cervical Plexus Block
* Procedure: Landmark-Based Superficial Cervical Plexus Block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing surgery of the shoulder and clavicle Urgent or planned surgery Exclusion Criteria: Refused to sign informed consent Pregnant women Allergic to the local anesthetic

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Ultrasound-Guided<br>Ultrasound-Guided Superficial Cervical Plexus Block | Procedure: Ultrasound-Guided Superficial Cervical Plexus Block<br>* Ultrasound-Guided Superficial Cervical Plexus Block<br>|
| Landmark-Based<br>Landmark-Based Superficial Cervical Plexus Block | Procedure: Landmark-Based Superficial Cervical Plexus Block<br>* Landmark-Based Superficial Cervical Plexus Block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | Number of Participants wit absence of pain sensation for all 4 branches of the superficial cervical plexus | At 15 mins after nerve block | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound-Guided Superficial Cervical Plexus Block, Landmark-Based Superficial Cervical Plexus Block
A Canadian Open-Label Study to Evaluate the Safety and Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriatic Arthritis (PsA) (ACCLAIM)

Study Overview
=================
Brief Summary
-----------------
To further assess the safety and effectiveness of adalimumab 40mg in the treatment PsA who have had an unsatisfactory response or intolerance to prior or ongoing DMARDs

Official Title
-----------------
A Canadian Open-Label Study to Evaluate the Safety and Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriatic Arthritis (PsA) (ACCLAIM)

Conditions
-----------------
Psoriatic Arthritis

Intervention / Treatment
-----------------
* Drug: Adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active psoriatic arthritis defined by >= 3 tender or painful joints and >= 3 swollen joints despite standard psoriatic arthritis therapy Has had an unsatisfactory response or intolerance to at least two prior or ongoing DMARDs (one of which has to be methotrexate) Exclusion Criteria: Has a history of cancer or other than certain skin or cervical cancers Has a history of, or current acute inflammatory joint disease of origin other than PsA, e.g., systemic lupus erythematosus etc. Has other, unstable diseases, including congestive heart failure, inflammatory bowel disease, recent stroke, leg ulcers or other condition which would put the subject at risk History of active tuberculosis, history of histoplasmosis or listeriosis Latent TB or risk factors for the activation of latent TB, e.g. previous exposure to TB, and has not initiated TB prophylaxis prior to the first adalimumab treatment

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: Adalimumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20 response |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR50 |  | Week 12 | 
| ACR70 |  | Week 12 | 
| PsARC |  | Week 12 | 
| DAS28 |  | Week 12 | 
| PASI50/75 |  | Week 12 | 
| HAQ-DI |  | Week 12 | 
| PsAQoL |  | Week 12 |
Adult Influenza Vaccination Text Message Reminders

Study Overview
=================
Brief Summary
-----------------
Influenza infection leads to on average 24,0000 deaths and 150,000 hospitalizations annually. While vaccination is the cornerstone of preventing influenza infection, vaccination coverage in adults is low with only 35% vaccinated by end of November. Latino adults have the lowest coverage rates. Text message reminders have been used successfully for improving influenza vaccination for children. This study will assess the use of text messaging to improve influenza vaccination coverage rates in a largely minority, publicly insured adult population.

Official Title
-----------------
Adult Influenza Vaccination Text Message Reminders

Conditions
-----------------
Influenza Vaccination

Intervention / Treatment
-----------------
* Behavioral: Text Messages


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > or = 18 years of age, at least one visit to the AIM clinic during the previous year a cell phone number in the registration system fluent in English or Spanish. Exclusion criteria Exclusion Criteria: - Receipt of influenza vaccination during the 2013-2014 influenza season prior to randomization.

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Text Message | Behavioral: Text Messages<br> <br> |
| No Intervention: Usual Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timeliness of vaccination | Days from start of intervention to vaccination | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of influenza vaccine dose | Proportion of individuals in each group receiving an influenza dose by December 31, 2013 | 15 weeks | 
| Receipt of Influenza vaccine dose, end of season | Proportion of individuals in each group receiving an influenza dose by March 31st, 2014 | 28 weeks |
Effectiveness of Cognitive Behavioral Therapy of Reduction of Test Anxiety

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the role of Group Cognitive Behavioral Therapy in test anxiety. The study participants will be psychology undergraduates with social work and psychology majors. The students will be selected among those who score three or more in Westside Test Anxiety Scale will participate in the study. Westside Test Anxiety will be used two weeks after completion of the group Cognitive Behavioral Therapy protocol (Flaxman, Bond & Keogh. 2004). The result will be analyzed using the t-test and Cohen's d.

Official Title
-----------------
Test Anxiety: Pervasiveness, Link With Academic Achievement and Impact of Cognitive-behavioral Intervention in Its Reduction

Conditions
-----------------
Test Anxiety

Intervention / Treatment
-----------------
* Behavioral: Group CBT for test anxiety


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those Studying Social work and Psychology as Major subjects, Those who have scored 3 and above in Westside Test Anxiety scale Exclusion Criteria: Those scoring below 3 in Westside Test Anxiety Scale
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Cognitive Behavioral Therapy (Group CBT)<br>Intervention Group will receive ten-session group CBT for test anxiety. Two sessions will be carried out each week. | Behavioral: Group CBT for test anxiety<br>* The cognitive-behavioral therapy protocol developed by Flaxman, Bond & Keogh (2004) will be used as the intervention protocol. This protocol consists of 10 Sessions which are provided twice a week (each group will have 10 students).<br>|
| No Intervention: Control Group<br>The Control group will be waiting for the control group who will receive intervention if they demand after final assessment for outcome measure. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Westside Test Anxiety Scale (WTAS) | The WTAS consists of 10 items, each using a Likert response scale where 1= Never true and 5= always true. Total score is divided by 10 to obtain final scores. The total score ranges from one to five. Score of 1-2.9 is considered normal test anxiety and score of 3-5 is labelled as high test anxiety. | Change from Baseline Test Anxiety Scores after completion of Group Cognitive Behavioral Therapy ( after one and half month) |
Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the autoinjector and pre-filled syringe of SB4 in healthy male subjects.

Official Title
-----------------
A Randomised, Open-label, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, and Tolerability of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects aged 18-55 years Have a body weight between 60.0 - 85.5 kg (inclusive) and a body mass index between 20.0 - 28.0 kg/m2 (inclusive) Exclusion Criteria: Have a history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to etanercept or to any of the excipient Have either active or latent TB or who have a history of TB Have clinically significant active infection within 4 weeks before the first IP administration Have had a history of serious infection Have previously been exposed to etanercept, if known Have previously been exposed to a biological agent or immunosuppressive agent within 120 days prior to the first IP administration Have a history of invasive systemic fungal infections or other opportunistic infections judged as relevant by the Investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>SB4 (etanercept) 50 mg/mL PFS and AI | Drug: Etanercept<br>* 50 mg/mL PFS and AI<br>|
| Experimental: Sequence 2<br>SB4 (etanercept) 50 mg/mL AI and PFS | Drug: Etanercept<br>* 50 mg/mL PFS and AI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf ACUinf | Area under the concentration-time curve from time zero to infinity | 56 days | 
| AUClast | Area under the concentration-time curve from time zero to the last quantifiable concentration | 56 days | 
| Cmax | Maximum serum concentration | 56 days |
CYT003-QbG10 for Treatment of Allergic Asthma Bronchial

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test whether treatment with CYT003-QbG10 can improve asthma symptoms in patients with allergic bronchial asthma. The active treatment will be compared against placebo.

Official Title
-----------------
A Double-blind, Placebo-controlled Study to Assess Pharmacodynamic and Clinical Efficacy of CYT003-QbG10 in Patients With Persistent Allergic Asthma Bronchial

Conditions
-----------------
Allergic Bronchial Asthma

Intervention / Treatment
-----------------
* Drug: CYT003-QbG10
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persistent allergic asthma bronchial requiring long-term treatment with inhaled corticosteroids Further criteria as defined in the study protocol Exclusion Criteria: Use of oral corticosteroids within past 3 months Hospitalization for asthma exacerbation within past 6 months Uncontrolled asthma Contraindication to any study test or procedure Further criteria as defined in the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: CYT003-QbG10<br>* subcutaneous injection<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Markers for inflammation and asthma |  | 1-3 months |
Pregnancy Chances in Classic Galactosemia

Study Overview
=================
Brief Summary
-----------------
With this study, in which the incidence of pregnancy in classic galactosemia patients is studied, we aim to provide new insights to improve counselling. Our hypothesis is that the chance that a galactosemic woman with POI becomes pregnant is higher than the 5-10% that has been reported for women with POI due to other causes. Chance of spontaneous pregnancy will be evaluated through semi standardized interview in women with classic galactosemia aged 18 years or older. During the interview, questions will be asked regarding fertility and pregnancy.

Official Title
-----------------
Pregnancy Chances in Classic Galactosemia

Conditions
-----------------
Galactosemias, Primary Ovarian Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Classic galactosemia diagnosed by GALT enzyme activity assay or GALT-gene mutation analysis Eighteen years of age or older Diagnosed with POI defined as symptoms of hypergonadotrophic hypogonadism measured by serum concentrations of FSH and estradiol Capable of giving informed consent Exclusion Criteria: Any known congenital or acquired disease or disorder negatively affecting pubertal development and/or fertility.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Females with classic galactosemia and POI<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy incidence despite POI diagnosis | Will be assessed during semi-standardized interview | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether women have tried to conceive | Will be assessed during semi-standardized interview | day 1 | 
| Time to pregnancy (in case a participant has been pregnant) | Will be assessed during semi-standardized interview | day 1 | 
| Menstrual history | Will be assessed during semi-standardized interview | day 1 | 
| Hormonal replacement therapy usage | Will be assessed during semi-standardized interview | day 1 |
The Effect of Anesthesia on Systemic Inflammatory Immune Index in Major Abdominal Cancer Surgeries

Study Overview
=================
Brief Summary
-----------------
The effects of different anesthesia methods on the immune system are variable. In this study, we investigated the effect of inhalation anesthesia and total intravenous anesthesia on the SII value in major abdominal cancer surgeries.

Detailed Description
-----------------
The study was planned prospectively, observationally, on a total of 90 patients who underwent major abdominal cancer surgery. 84 patients were evaluated. The patients were seperated in two groups as inhalation anesthesia and total intravenous anesthesia (TIVA). The demographic data of the patients, type of cancer, type of surgery performed, ASA classification, preoperative chemotherapy intake, preoperative hemogram, postoperative 2nd and 24th hour hemogram, intraoperative and postoperative blood transfusion, and duration of surgery were recorded. Platelet, neutrophil, lymphocyte and SII values were saved.

Official Title
-----------------
The Effect of Inhalation Anesthesia and Total Intravenous Anesthesia on Systemic Inflammatory Immune Index in Major Abdominal Cancer Surgeries

Conditions
-----------------
Systemic Immune Activation, Cancer Gi, Cancer of Endometrium

Intervention / Treatment
-----------------
* Other: Systemic inflammatory immmune index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: major abdominal cancer surgeries Exclusion Criteria: blood transfusion in last 72 hours patients with infection hematologic malignancy patient controlled analgesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Inhalation anesthesia<br>Sevoflurane for opioid remifentanyl used | Other: Systemic inflammatory immmune index<br>* Systemic Inflammatory Immune index calculated from platelet, neutrophil and lymphocyte count<br>|
| Total Intravenous Anesthesia<br>Propofol for opioid remifentanyl used | Other: Systemic inflammatory immmune index<br>* Systemic Inflammatory Immune index calculated from platelet, neutrophil and lymphocyte count<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| investigate the effect of anesthesia management on the change of preoperative systemic inflammatory immune index(SII) and postoperative 2.hour and 24.hour SII value | systemic inflammatory immune index calculated by (platelet x neutrophil)/lymphocyte | preoperative SII noted, postoperative 2.hour noted and postoperative 24.hour noted |