linjc16/ctgov huggingface dataset:
Celecoxib Treatment for Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This proposal evaluates cyclooxygenase 2 (COX-2) inhibition as a means to decrease T regulatory cell activities and thus augment immune responses against lung cancer. The broad goal focuses on understanding how COX-2 expression regulates the malignant phenotype in non small cell lung cancer in an effort to foster an informed approach for the use of COX-2 inhibitors in prevention and therapy for lung cancer.

Official Title
-----------------
Celecoxib-Mediated Inhibition of T Regulatory Cells in Human Lung Cancer

Conditions
-----------------
Non-Small-Cell Lung Carcinoma

Intervention / Treatment
-----------------
* Drug: Celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed and surgically resectable non small cell lung cancer and subjects must be ineligible for or refuse, neoadjuvant therapy Exclusion Criteria: Hypersensitivity to celecoxib or NSAIDs, previous history of GI bleeding or ulceration, chronic or concurrent use of steroids and renal insufficiency

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>Celecoxib is an FDA approved drug for other indications such as osteoarthritis. It is not FDA approved for non-small cell lung cancer. | Drug: Celecoxib<br>* Eight subjects will be assigned to one of three cohorts. Subjects will receive Celecoxib in escalating doses per cohort, starting with 200mg twice a day by mouth; 400mg twice a day by mouth; and increasing to 600mg twice a day by mouth, for a total of 7 days. Subjects will have blood taken before the start of Celecoxib, and after completion of 7-days of Celecoxib.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure bio-markers; safety measures |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cyclooxygenase 2, lung cancer, lymphocytes, non small cell, therapeutics
Camrelizumab Plus Chemoradiotherapy for Patients With Locoregional Cancer of Nasal Cavity and Paranasal Sinuses

Study Overview
=================
Brief Summary
-----------------
Patients with locoregional cancer of nasal cavity and paranasal sinuses are candidate for this study. All the eligible patients receive three cycles of induction chemotherapy (docetaxel 60mg/m2+cisplatin 60mg/m2+5-FU2.5g/m2,civ48h, q3w) followed by concurrent two cycles of cisplatin (80mg/m2,q3w) with curative intensity modulated radiotherapy. Besides, camrelizumab (200mg) is administrated every three weeks for a total of 11 cycles since the first day of induction chemotherapy. We aim to evaluate the three years failure free survival of these patients by the combination of camrelizumab with curative radiotherapy and chemotherapy.

Official Title
-----------------
Camrelizumab Plus Chemoradiotherapy for Patients With Locoregional Cancer of Nasal Cavity and Paranasal Sinuses: a Phase II Multicenter Study

Conditions
-----------------
Nasal Cavity Cancer, Paranasal Sinus Cancer, Camrelizumab, Induction Chemotherapy, Intensity Modulated Radiotherapy, Concurrent Chemotherapy

Intervention / Treatment
-----------------
* Drug: camrelizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed squamous cancer of nasal cavity and paranasal sinuses T4bN0-3M0 (AJCC8th) or unresectable lymph nodes or refusal of surgery KPS≥70 NE≥ 1.5×10E9/L, HGB ≥ 100g/L and PLT ≥100×10E9/L ALT≤ 1.5 upper limit of normal (ULN), AST≤ 1.5ULN and bilirubin ≤ 1.5ULN creatinine clearance rate ≥ 60 ml/min (calculated by Cockcroft-Gault) Exclusion Criteria: older than 65 or younger than 18 HBsAg (+) and HBV DNA >1×10E3 copiers /mL HCV (+) HIV (+) autoimmune diseases interstitial lung diseases had other cancers before

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: camrelizumab group<br> | Drug: camrelizumab<br>* Camrelizumab was administrated with 200mg each time, every three weeks for a total of 11 cycles since the first day of induction chemotherapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year failure free survival | time from the randomization to the first treatment failure or death | 3-year |
Validation of Ferromagnetic Tracer in Melanoma Sentinel Node

Study Overview
=================
Brief Summary
-----------------
This study has been designed to validate a non-radioactive method to identify the sentinel lymph node using a superparamagnetic iron-oxide (SPIO) tracer respect to the traditional isotopic method. Both methods are used in every included patient and each patient is its own control.

Detailed Description
-----------------
Injection of the isotopic tracer in standard form and in the usual preoperative period (hours-day). Identical injection in three-four punctures of 2 mL of Sienna+ ® and local massage of 5-10 minutes. Optional: colorant injection in standard form. Local massage of 5-10 minutes. After 20 minutes: transcutaneous measurement with SentiMag® Valuing territories (lymphoscintigraphy information?) Surgical identification measures: st with SentiMag® nd with gamma detection probe Ex vivo check and HRD record

Official Title
-----------------
Isotopic Versus Magnetic Intraoperative Node Evaluation in Cutaneous Malignant Melanoma

Conditions
-----------------
Melanoma Stage, Sentinel Lymph Node

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (>18 years of age), with diagnosis of cutaneous melanoma and in which SLNB is indicated as a staging method, and with cN0 result after clinical-echographic-cytohistological evaluation. Exclusion Criteria: Previous treatment with systemic therapy. Recent previous surgery (<3 months) in the area susceptible of lymphatic drainage from the melanoma. Intolerance or hypersensitivity to iron or dextran compounds. Impossibility of use of radioisotope. Existence of pathology related to elevation of organic iron (hemosiderosis, hemochromatosis, iron deficiency anemia of metabolic or circulatory origin). Implantation of pacemakers or partially or totally metallic thoracic implants. Treatment with iron chelators (deferasirox, deferoxamine, ...).

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 |
| --- | --- | --- |
| SN detection | Detection of potential sentinel nodes using both methods (isotopic and ferromagnetic tracers). Máximum register of isotopic and ferromagnetic measurement will be the main criteria. | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SN agreement | Agreement in isotopic and ferromagnetic sentinel node identification. Measurement criteria will be coincidence in the same node (or nodes). | During surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cutaneous melanoma, Sentinel node biopsy
Reliability of Dosing With NovoLog® Mix 70/30 FlexPen® Compared With Vial and Syringe

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The aim of this trial is to compare desired (target) with actual target amounts of insulin dispensed using NovoLog® Mix 70/30 FlexPen® and vial and syringe in subjects with type 2 diabetes mellitus. No insulin is administered in this trial - insulin is dispensed into an empty vial.

Official Title
-----------------
Comparison of the Accuracy and Precision of NovoLog® Mix 70/30 FlexPen® to Vial and Syringe in Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2, Delivery Systems

Intervention / Treatment
-----------------
* Device: FlexPen®
* Device: vial and syringe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Insulin naive No previous experience administering injections Exclusion Criteria: Any condition that, in the Investigator and/or Sponsor's opinion, could interfere with the results of this trial

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: FlexPen®|nan|
|Device: vial and syringe|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined measure of accuracy and precision between target and measured amounts of insulin dispensed (mean square percent difference) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preference |  |  | 
| Accuracy (mean relative error) |  |  | 
| Precision (coefficient of variation) |  |  |
Professional Quality of Life in German Mental Health Nursing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess professional quality of life in German nurses working with patients with mental disorders.

Detailed Description
-----------------
The purpose of this study is to assess professional quality of life, which includes compassion satisfaction, burnout and secondary traumatization in nurses, working with patients with mental disorders, in Germany.

Official Title
-----------------
Professional Quality of Life in Nurses Working With Patients With Mental Disorders in Germany

Conditions
-----------------
Mental Disorder, Burnout, Professional, Burnout, Caregiver

Intervention / Treatment
-----------------
* Diagnostic Test: Online questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nurse Currently working with patients with mental disorders At least 18 years old Sufficient German skills for answering the questionnaire Exclusion Criteria: None

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nurses working with patients with mental disorders<br>Nurses in Germany currently working with patients with mental disorders | Diagnostic Test: Online questionnaire<br>* Online questionnaire via SoSciSurvey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compassion Satisfaction | Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL) - German Version - Subscale Compassion Satisfaction (Minimum: 10 - Maximum: 50 - Higher scores mean a higher compassion satisfaction) | 1 day | 
| Burnout | Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL) - German Version - Subscale Burnout (Minimum: 10 - Maximum: 50 - Higher scores mean a higher level of burnout) | 1 day | 
| Secondary Traumatization | Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL) - German Version - Subscale Secondary Traumatization (Minimum: 10 - Maximum: 50 - Higher scores mean a higher level of secondary traumatization) | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Professional quality of life, Compassion satisfaction, Burnout, Nursing, Mental disorder, Mental health
Respiratory Mechanics and Pleural Effusion

Study Overview
=================
Brief Summary
-----------------
The investigators aim to compare the respiratory mechanics in acute lung injury (ALI)/acute respiratory diseases syndrome (ARDS) patients with and without pleural effusion.

Detailed Description
-----------------
In ALI/ARDS we evaluated the respiratory mechanics (respiratory system, chest wall and lung elastance) at the bedside while pleural effusion was evaluated with CT scan. Thus we will be able to estimate any possible role of pleural effusion on the respiratory mechanics.

Official Title
-----------------
Estimation of Respiratory Mechanics (Respiratory System, Chest Wall and Lung Elastance) and Pleural Effusion at the Bedside With CT Scan.

Conditions
-----------------
Critically Ill, Acute Lung Injury, ARDS

Intervention / Treatment
-----------------
* Procedure: mechanical ventilation/CT Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALI/ARDS patients underwent invasive mechanical ventilation Exclusion Criteria: Haemodynamic instability Chronic obstructive pulmonary disease (COPD) patients

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| 1<br>ALI/ARDS patients | Procedure: mechanical ventilation/CT Scan<br>* evaluation of pleural effusion and respiratory mechanics, CT scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Role of pleural effusion and respiratory mechanics |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critically ill patients
Accidental Reactions in Peanut/Tree Nut Allergic Children

Study Overview
=================
Brief Summary
-----------------
Food allergy is an immune reaction, triggered by food protein allergens, of varying severity, from mild local reaction to life threatening anaphylaxis and fatalities. Peanut is a plant from the botanical family of the Fabaceae, more commonly known as legumes. The prevalence of peanut and tree nut allergy is increasing. In France (ELFE cohort), it is estimated to 0.93%. The tree nuts include mainly almond, hazelnut, pistachio, cashew nut, walnut, pecan nut and Brazil nut. Allergy's prevalence is estimated to 0.54% in children up to 5.5 years. Peanut allergy is a main cause of anaphylaxis and deaths due to food allergy. Recurrence of food allergy is a main concern. The risk has been estimated to 10% per year for peanut. In France, Data in real-life on the rate of recurrence of allergic reactions and anaphylaxis to peanut/tree-nut as well as risk factors, are lacking. The objective of this study is to assess the frequency of allergic reaction to peanut and tree-nuts, to describe the reactions' characteristics and risk factors.

Official Title
-----------------
Accidental Reactions in a French Cohort of Children With Peanut and/or Tree Nut Allergy.

Conditions
-----------------
Peanut and Tree Nut Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed allergy to peanuts and/or nuts Exclusion Criteria: Other chronic diseases, except allergic comorbidities (asthma, rhinitis, atopic dermatitis, other food allergy)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Allergic Children<br>Patients followed in the Pediatric Allergy and Pulmonology Unit, CHU Lille, aged 0-18 years with peanut and/or tree nut allergy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of episode of allergic reactions in real life |  | At 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the severity of the allergic reactions according to a validated scale (FASS scale) |  | At 1 year | 
| interview for the characteristics of the allergic reactions | the characteristics of the reactions: symptoms, triggering food and quantity, location, emergency kit available, treatment administered, evolution (hospitalization or emergency room) | At 1 year | 
| interview to defined the risks factor associated | risk factors for reaction: Other known allergies Asthma Atopic dermatitis Allergic rhinoconjunctivitis Patient characteristics: sex, age | At 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peanut allergy, tree nut allergy, peanut immunotherapy, anaphylaxis, real life
Internal Jugular Vein Distensibility and Pleth Variability Index(PVI) for Evaluating Fluid Responsiveness

Study Overview
=================
Brief Summary
-----------------
Assessment of intravascular volume status is crucial in order to predict the efficacy of volume status in major abdominal surgery. The aim of the study is to verify the feasibility and usefulness of the internal jugular vein distensibility index as an adjunct to the pleth variebility index(PVI) to predict fluid responsiveness in major abdominal surgery.

Detailed Description
-----------------
Forty patients above age 18 and ASA status I-III who are undergoing major abdominal surgery will be enrolled in the study. patients with right heart failure, arrythmia, severe valve stenosis or regurgitation will be excluded. After induction of general anesthesia, when the patients are hemodynamically stabilised, PVI and jugular vein distensibility will be calculated and recorded. after volume load with 500 ml gel infusion(in 15 min), measurements will be repeated within 10 minutes and recorded. Patients will be allocated to 2 groups according to the change in mean arterial pressure(MAP) after volume expansion: Responders will be defined as an increase in MAP by >%10; while nonresponders will be defined as an increase in MAP <%10 or decrease in MAP.

Official Title
-----------------
Internal Jugular Vein Distensibility and Pleth Variability Index for Evaluating Fluid Responsiveness

Conditions
-----------------
Intravascular Volume

Intervention / Treatment
-----------------
* Procedure: Assessment of fluid responsiveness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists(ASA) physical status I-III patients patients undergoing major abdominal surgery Exclusion Criteria: arrythmia severe right ventricle failure

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 |
| --- | --- |
| fluid responsiveness<br>Assessment of fluid responsiveness using pleth variebility index and jugular vein distensibility in patients undergoing major abdominal surgery | Procedure: Assessment of fluid responsiveness<br>* assessment of intravascular volume status using pleth variebility index and internal jugular vein distensibility in major abdominal surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with significant change in VJI distensibility and pleth variebility index | volume responders with significant change in jugular vein distensibility and pleth variebility index | during surgery at day 0 |
Topical Ocular Mecamylamine in Diabetic Macular Edema (DME)

Study Overview
=================
Brief Summary
-----------------
This is an open-label study evaluating the safety and tolerability of topical ocular mecamylamine given twice a day in patients with diabetic macular edema (DME). Patients will be treated for 12 weeks.

Official Title
-----------------
Phase 2 Study of the Safety and Bioactivity of Topical Ocular Mecamylamine for the Treatment of Diabetic Macular Edema (DME)

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: mecamylamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: macular edema due to diabetic retinopathy Exclusion Criteria: vision loss from other ocular disease intraocular surgery within 3 months intraocular anti-VEGF or steroids within 3 months HbA1c >12

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: mecamylamine|topical ocular drops|

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
-----------------
macular edema, DME, diabetic, mecamylamine, Comentis