linjc16/ctgov huggingface dataset:
The Use of PET for the Early Response Evaluation in Patients With Diffuse Large B-cell Lymphoma.

Study Overview
=================
Brief Summary
-----------------
Non-Hodgkin lymphoma (NHL) is one of the more frequent cancers in the western world with approx. 800 new cases annually in Denmark. Diffuse large B-cell lymphoma (DLBCL) in Denmark accounts for almost 40% of newly diagnosed NHL cases. Treatment with the combination of chemotherapy and monoclonal antibodies has significantly improved prognosis over the past decade, but a large proportion of patients with DLBCL will continue to relapse with our current treatment options. Therefore, there is a need for reliable methods for detection of treatment response as early as possible in the treatment course in order to identify patients who respond poorly to standard treatment and potentially would benefit from a change in treatment strategy. This has still not been established, but a valid early marker is required in order to allow randomized trials of treatment stratified by early response. One of the most promising applications of PET is the metabolic assessment of the early response of cancer treatment. This study is a national prospective multicenter study emanating from the Danish Lymphoma Group (DLG). Patients are scanned after each of the early 4 cycles of chemo therapy. The aim is to establish the correct timing of response evaluation. Additionally, the investigators wish to investigate the optimal qualitative and quantitative method of response assessment in order to predict post-therapeutic remission and long-term prognosis.This study will contribute to interim-PET being implemented in the most optimal way in daily clinical practice.

Official Title
-----------------
The Use of 18 F-FDG Positron Emission Tomography (PET) in the Early Response Evaluation of Diffuse Large B-cell Lymphoma.

Conditions
-----------------
Diffuse Large B-cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Age>18 years Exclusion Criteria: Previously treatment with chemotherapy or irradiation Primary CNS lymphoma Recurrent lymphoma Transformation from indolent lymphoma Presence of diabetes mellitus, HIV, chronic inflammatory disease or infections Planned for curative 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DLBCL<br>Patients with newly diagnosis of diffuse large B-cell lymphoma is offered enrollment in this protocol. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 2 years | 
| Progression free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years, 3 years |
Socioeconomic Influences on Complementary and Alternative Medicine Use in Cancer Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether differences in the use of complementary and alternative medicine (CAM) are influenced by the socioeconomic status and ethnicity of cancer patients.

Detailed Description
-----------------
The use of CAM is common among patients with cancer. However, there may be differences in participation, treatment preferences, and quality of life that are influenced by socioeconomic factors and ethnicity. This study will compare two distinct socioeconomic groups to determine differences in CAM use. Participants in this study will complete a questionnaire regarding demographics, socioeconomic status, disease specifics, and facilitators and barriers to CAM use. Participation in an introductory seminar and in various CAM programs will be monitored. Participants will also complete a quality of life scale that will provide insight into the way different populations perceive and use CAM and will identify potential obstacles to integrating CAM into other cancer treatment programs.

Official Title
-----------------
Socioeconomic Diversity of CAM Integration in Oncology

Conditions
-----------------
Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer diagnosis Able to read and understand English

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

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complementary Therapies
Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures

Study Overview
=================
Brief Summary
-----------------
The Informed Consent (IC) of a medical procedure is the aceptation of a diagnostic or therapeutic procedure by the patient, after receiving the necessary and accurate information about it. Freedom, information and understanding have to be the main requirements in this proccess. The main goal of this study is to assess if patients that are going to be operated at Hospital de la Santa Creu i Sant Pau in the CSI (Surgery without previous hospitalization) unit, really understood the information about the procedure.

Official Title
-----------------
Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures

Conditions
-----------------
Informed Consent

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing surgery and admitted by CSI unit Provide written informed consent to participate in the study Exclusion Criteria: Patients who need a legal representative to read, understand and sign the CI

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 |
| --- |
|Other: Questionnaire|A questionnaire asking the patients for several questions related to the Informed Consent Form they have signed before surgery, will be administered.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Understanding degree | Assessment of the understanding degree of the IC by the patient | Before procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Informed consent
Association Between Subtypes of Anti Citrullinated Peptide Antibodies and Lung Damage in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis is a genuine systemic disease associated with diffuse interstitial pneumopathy and bronchial disorders. According to the literature review, the prevalence of PID on thoracic CT scan is one-third of patients. Diffuse interstitial pneumopathy is responsible for a significant morbidity and mortality, is currently under-diagnosed and its treatment is poorly codified. The lung seems to have a central role in the genesis of rheumatoid arthritis. It also appears that some subtypes of anti citrullinated peptide antibodies are preferentially present in the lungs. The hypothesis behind our project is that one or more subtypes of anti citrullinated peptide antibodies with a preferential tropism for the lung would attack the parenchyma and pulmonary airways. Currently, there are no data on interstitial pneumopathy in black and Afro-Caribbean subjects with rheumatoid arthritis.

Official Title
-----------------
Study of the Association Between Subtypes of Anti Citrullinated Peptide Antibodies and Lung Damage in Rheumatoid Arthritis in the West Indies

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Other: Descriptive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with rheumatoid arthritis ACR/EULAR 2010 Patient with a higher age or equal to 18 Patient receiving social security Patient giving his free and informed written consent Exclusion Criteria: Patient with overlap syndrome with another autoimmune disease Patients with known severe cardiopulmonary pathology Woman who is pregnant and breast feeding Patient with language difficulties or understanding

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 |
| --- |
|Other: Descriptive|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of the positivity of the anti citrullinated peptide antibodies and subtype | Presence of one or more subtypes of anti citrullinated peptide antibodies in the serum of patients with interstitial pneumopathy associated with rheumatoid arthritis who would be absent | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic analysis of the main mutations | Presence of mutation TERT, RTEL1, PARN et SFTPC | three years |
Non-returning Catheter Valve for Reducing CAUTI

Study Overview
=================
Brief Summary
-----------------
This study was to determine efficacy of the non-returning catheter valve for reducing catheter associated urinary tract infection compared with conventional urine bag in critically ill patients.

Detailed Description
-----------------
Non-returning catheter valve (generic name) used UnometerTM SafetiTM Plus (trade name)

Official Title
-----------------
A Pilot Study of Non-returning Catheter Valve for Reducing Catheter-associated Urinary Tract Infection in Critically-ill Patients

Conditions
-----------------
Catheter Associated Urinary Tract Infection, Critically Ill Patients

Intervention / Treatment
-----------------
* Device: Non-returning catheter valve
* Device: Conventional urine bag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participants who age more than 18 year and admitted to the medical intensive care unit or intermediate care unit All participants must be retained the urinary catheter. Exclusion Criteria: The participants were diagnosed urinary tract infection before retention of the urinary catheter.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-returning catheter valve<br>Non-returning catheter valve (UnometerTM SafetiTM Plus) was used in experimental group only. | Device: Non-returning catheter valve<br> <br> * Other names: UnometerTM SafetiTM Plus;|
| Active Comparator: Conventional urine bag<br>Conventional urine bag hasn't the non-returning catheter valve. | Device: Conventional urine bag<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence density of the catheter associated urinary tract infection (CAUTI) |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-returning catheter valve, Catheter associated urinary tract infection, Critically ill patients, Prevention
Cerebrospinal Fluid (CSF) Pharmacokinetics of Antimicrobials in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn more about antimicrobials, especially drug levels in the CSF that would normally be used in young children as part of standard care. These drugs are approved by the Food and Drug Administration (FDA) for treating infections. They are used extensively in children in the United States, but they have not been extensively studied in children or babies. The investigators do not have very much information on how children and babies handle these drugs; that is, how long it takes for the drugs to be removed from the blood circulation and to pass out of the body and how much goes into the central nervous system. The investigators also do not have good information to guide how often the investigators should give the drugs to children and babies to get the maximum effect on infections with the minimum amount of drug. Thus, the investigators will collect more information about how these drugs should be used in children and babies by doing this drug levels research study.

Official Title
-----------------
CSF Pharmacokinetics of Antimicrobials in Children

Conditions
-----------------
Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children receiving antimicrobial agents and having cerebrospinal fluid collected as part of standard of care Exclusion Criteria: Lack of consent

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSF:Serum Ratio of Vancomycin | CSF:serum ration of vancomycin | within 1 week of drug administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infections in Children
Citalopram vs Clomipramine vs Placebo in Recurrent Depression

Study Overview
=================
Brief Summary
-----------------
citalopram and clomipramine are better than placebo in preventing new episodes of depression in patients with recurrent depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Citalopram
* Drug: Clomipramine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with recurrent depression Sustained response achieved (3 consecutive monthly ratings at the HDS below 13)after a treatment requiring index episode Exclusion Criteria: Contraindications to study medications Pregnancy Substance abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: citalopram<br>citalopram | Drug: Citalopram<br> <br> |
| Active Comparator: clomipramnine<br>clomipramine | Drug: Clomipramine<br> <br> |
| Placebo Comparator: placebo<br>placebo | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 Hamilton Depression Rating Scale scores of at least 16 with one weeks interval or initiation of another antidepressant treatment |  | 2 years of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study termination due to adverse event or non-compliance |  | 2 years of follow-up |
Study to Evaluate Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)

Study Overview
=================
Brief Summary
-----------------
The purpose of the protocol is to evaluate the correlation between plasma lanreotide levels and Growth Hormone (GH)/Insulin Like Growth Factor 1 (IGF-1) dynamics and clinical improvement in patients with acromegaly treated with lanreotide Autogel (Somatuline ATG)

Official Title
-----------------
A Pilot Study to Evaluate the Correlation Between Plasma Lanreotide Levels and GH/IGF-1 Dynamics and Clinical Improvement in Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)

Conditions
-----------------
Acromegaly

Intervention / Treatment
-----------------
* Drug: lanreotide (Autogel formulation)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient on treatment with octreotide LAR 20 mg administered every 28 days for at least 3 months prior to visit 1. Patient must have serum GH level ≤ 2.5 ng/mL and serum IGF-1 ≤ 1.3 ULN, 28 days after their last injection of octreotide LAR 20 mg at visit 1. Patients must have serum GH level > 2.5 ng/mL AND serum IGF-1 level > 1.3 ULN, 6 or 8 weeks after their last injection of octreotide LAR 20 mg. Exclusion Criteria: The patient has received pituitary radiation therapy of any kind at any time prior to visit 1. The patient has received pituitary surgery within 3 months prior to visit 1. The patient's serum creatinine is higher than 150 µmol/l.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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> | Drug: lanreotide (Autogel formulation)<br>* 120 mg administered every 28 days via deep subcutaneous injection. A total of 4 injections will be administered during the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GH (basal and during Oral Glucose Tolerance Test (OGTT)) and IGF-1 levels, in acromegalic patients previously treated with octreotide long acting release (LAR) 20 mg. |  | Weeks 16, 18 & 20 | 
| Acromegaly symptoms. |  | Weeks 16, 18 & 20 | 
| Indices of insulin secretion & sensitivity |  | Weeks 16, 18 & 20 | 
| Adverse events |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with GH levels ≤ 2.5 ng/mL and the number of patients with IGF-1 level < upper limit of normal (ULN). |  | Weeks 16, 18 & 20. | 
| Serum lanreotide Autogel 120 mg concentrations. |  | Weeks 16, 18 & 20. | 
| ECG and gallbladder ultrasound |  | Week 20 |
Evaluation of Polyflex Stenting in Esophageal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.

Official Title
-----------------
Clinical Evaluation of Polyflex Stenting in Esophageal Cancer Patients Undergoing Chemotherapy and/or Radiation Therapy

Conditions
-----------------
Esophageal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older Willing and able to provide informed consent Willing to comply with follow-up requirements Biopsy-confirmed esophageal cancer (adenocarcinoma or squamous cell carcinoma) in mid or distal esophagus (clinical stage 3 or less) Indicated for chemotherapy and/or radiation therapy Ability to dilate stricture to 15mm diameter at extent of disease evaluation Placement of at least 18 x 23mm diameter and 120mm length PolyFlex stent Exclusion Criteria: Patients contraindicated for endoscopy Patients with prior esophageal stent placements Advance stage of disease, greater than T3 tumor or M1 disease

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 |
| --- | --- |
| Observation<br>Esophageal cancer patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefit of the Polyflex Esophageal Stent as a means to maintain oral nutrition during chemotherapy and/or radiation |  | 8 - 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophageal, stenting
Performance Status During Treatment With Pemetrexed in Patients With NSCLC

Study Overview
=================
Brief Summary
-----------------
The primary research objective of this observational study in pretreated patients with NSCLC of Stage IIIa/b or Stage IV is to evaluate patients' Karnofsky Index (KI) after the second cycle of second-line treatment with single agent pemetrexed in a real life setting, and to evaluate factors potentially influencing performance status in terms of KI, i.e. frequency of use of concomitant medications, in particular analgesics, folic acid, Vitamin B12, antiemetics, and medications against diarrhea; as documented in patient diary (days of use per week) and by the physicians.

Official Title
-----------------
Performance Status and Influencing Factors During Second-Line Treatment With Pemetrexed in Patients With Stage III/IVNon Small Cell Lung Cancer

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Pemetrexed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are 18 years of age or older Have NSCLC, Stage IIIa/b or IV, that is not amenable to curative therapy Have had one prior chemotherapy regimen with cytotoxic agents for the treatment of NSCLC (patients with adjuvant and neoadjuvant regimens are also eligible. However, patients with one prior cytotoxic chemotherapy followed by a targeted agent such as erlotinib are not eligible because the targeted agent would be regarded as second-line treatment) Are initiating second-line of treatment for NSCLC with pemetrexed Have been fully informed and have given written consent for the use of their data. Exclusion Criteria: Have received any prior treatment with pemetrexed Are participating in a study including administration of any investigational drug or procedure at entry into this study

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 |
| --- | --- |
| Second-line pemetrexed treatment in NSCLC<br>Patients with NSCLC who will start second-line treatment with pemetrexed. | Drug: Pemetrexed<br>* in-label use<br>* Other names: Alimta;|

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

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