linjc16/ctgov huggingface dataset:
Living Conditions of Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma in the Côte d'Or Region

Study Overview
=================
Brief Summary
-----------------
The development of new diagnostic tools and targeted therapy have significantly improved the management of non-Hodgkin's malignant lymphomas and thus their long-term prognosis. However, in the study of improved patient management, survival is not the only measurable indicator and preservation of quality of life is an essential component. In addition, there is little existing data regarding the determinants of quality of life in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) in the general population in France.

Official Title
-----------------
Living Conditions of Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma in the Côte d'Or Region

Conditions
-----------------
Diffuse Large Cell Diffuse Lymphoma, Follicular Lymphoma

Intervention / Treatment
-----------------
* Other: Questionnaires
* Other: Collection of clinical data and treatments


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with DLBCL or FL between January 1, 2010 and December 31, 2017, Alive as of January 1, 2021, Updated patient address. Exclusion Criteria: Other forms of Hematologic Malignancies at diagnosis, Minors. Person subject to legal protection (curatorship, guardianship) Person subject to a judicial safeguard measure Pregnant, parturient or breastfeeding woman Adults incapable of giving consent

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaires|QLQ-C30, SF-12, HADS, SARASON, EPICES, socio-professional data|
|Other: Collection of clinical data and treatments|clinical data and treatments|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generic Questionnaire SF-12 |  | At inclusion | 
| Specific questionnaire QLQ-C30 |  | At inclusion |
Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
The Cutaneous Lupus Erythematosus (CLE) database, established in 2006, is a multi-site database between the University of Pennsylvania and the University of Texas Southwestern (UTSW).

Detailed Description
-----------------
The database has yielded valuable information and clinical insights into the pathophysiology, disease processes, treatments and quality of life associated with CLE. The CLE database incorporates the CLASI (Cutaneous Lupus Activity and Severity Index), a validated outcome measure of disease responsiveness in patients and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with CLE (cutaneous lupus erythematosus). The CLE database has led to publication of significant studies on lupus and its clinical course, the effect of lupus on Quality of Life (QoL), including the effect of photosensitivity on QoL, and the effect of first line medications. The CLE database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease.

Official Title
-----------------
Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus

Conditions
-----------------
Cutaneous Lupus Erythematosus (CLE)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who meet the criteria for having CLE, using the Gilliam classifications, and/or a diagnosis of systemic lupus erythematosus (SLE), using the American Rheumatism Association/American College of Rheumatology criteria. Subjects must be 18 years or older. Exclusion Criteria: All subjects who do not meet the criteria for having CLE. Subjects who meet the criteria for CLE but who are not yet 18 years old

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
-----------------
CLE, Lupus, Lupus Erythematosus
Copy Number Variations, Inflammatory Cytokines and the Risk of Dementia

Study Overview
=================
Brief Summary
-----------------
Assess the association of copy number variation (CNV) and inflammatory cytokine with the risk of dementia.

Detailed Description
-----------------
This is a hospital-based case-control study. We plan to assess the association of CNV and inflammatory cytokine with the risk of dementia. Hopefully to find some genetic biomarkers to identify the risk of dementia at an early stage.

Official Title
-----------------
Copy Number Variations, Expression of Inflammatory Cytokines and the Risk of Dementia - A Two-stage Genome-wide Association Study

Conditions
-----------------
Dementia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospital recruited dementia patients and controls

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| 1<br>1:control(healthy subjects) | |
| 2<br>2:case(dementia patients) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dementia |  | Aug 2008-July 2011 |
Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus.

Study Overview
=================
Brief Summary
-----------------
In this trial we test the hypothesis that a probiotic containing Lactobacillus acidophilus and Lactobacillus rhamnosus is an effective therapy for patients with ulcerative colitis.

Detailed Description
-----------------
In the recent years there has been an increasing interest in the relationship between the gastrointestinal flora and gut function. Several studies have shown promising results for the use of probiotics in patient with inflammatory bowel disease. In this trial approximately 100 patients with ulcerative colitis will receive treatment with probiotic or placebo for 8 to 10 months as adjuvant therapy. The trial is double-blind, randomised and controlled.

Official Title
-----------------
Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus. A Randomised Placebo Controlled Trial

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Behavioral: Administration of probiotic (L. rhamnosus and L. acidophilus)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with known ulcerative colitis At least one prior flare of the disease Clinically and endoscopically active disease Age: 18 and above Exclusion Criteria: Changes in azathioprine dosage within the last three months Patients with toxic megacolon, peritoneal reaction or severe colonic bleeding Known immunodeficiencies On-going infectious disease On-going treatment with NSAID or cholestyramine Pregnant og lactating women

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Administration of probiotic (L. rhamnosus and L. acidophilus)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients in remission in the two groups at the end of the treatment period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in time to relapse in the two treatment groups |  |  | 
| Number of patients successfully obtaining remission |  |  | 
| Time to remission in the two groups |  |  | 
| Time ro relapse after study treatment is discontinued |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulcerative Colitis, Probiotic, Placebo controlled trial, Lactobacillus rhamnosus, Lactobacillus acidophilus
Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This study is being performed so that tumor and blood samples from patients who will receive breast cancer treatment prior to surgery can be collected and stored for future research.

Detailed Description
-----------------
This protocol will provide a systematic approach to obtaining, cataloging, and distributing research tissue and blood from patients who will receive neoadjuvant systemic therapy for localized breast cancer.

Official Title
-----------------
UMCC 2004.064: Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: tissue procurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients must have a primary measurable invasive breast cancer with the primary tumor intact (T1, 2, 3, or 4, any N, M0 or M1). Recurrent disease in the breast is also eligible. The patient's clinical plan will include neoadjuvant systemic therapy (chemotherapy, hormonal therapy, biologic therapy), prior to surgery on the breast. The clinical plan for patients with recurrent or M1 disease must include breast surgery after neoadjuvant systemic therapy. This would include patients with non-bulky M1 disease who the treating physicians feel would benefit from local control of disease after neoadjuvant systemic therapy. Patients must have had mammography performed at the University of Michigan, OR outside film review prior to enrollment. All patients are required to sign an informed consent regarding the experimental purpose of the research biopsies and serum banking, in accordance with the University of Michigan Institutional Review Board standards. - Exclusion Criteria: Breast tumors that are not measurable by any of the modalities, including physical examination, mammography, or ultrasound. Tumors diagnosed by excisional biopsy, or incisional biopsy that does not leave measurable disease by physical examination, mammography, or ultrasound. Patients must not have received any prior chemotherapy, hormonal therapy, or radiation therapy for their current breast cancer. Patients who received tamoxifen or other agents for prevention of breast cancer may be included. Patients with another active systemic malignancy in the past year. -

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 |
| --- | --- |
| 1<br>women with breast cancer | Procedure: tissue procurement<br>* tissue procurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Early High Risk Period for Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
Many people with heart failure either die or are admitted to the hospital in the first few months after the condition is diagnosed. The reasons for this are currently unclear- but may be due to worsening heart failure or other medical conditions such as angina, heart attack or sudden electrical problems of the heart. The investigators propose to recruit and follow-up 450 people, with a new diagnosis of heart failure for a minimum of six months in a multi-centre observational study at two hospital sites: The Hillingdon (Uxbridge) and The Conquest (Hastings) hospitals. The total study duration will be two years. People will be recruited after a diagnosis of heart failure is made and the study will assess reasons for death or admission to hospital and the psychological impact of the condition on both patients and their carers. This is an observational study and no change will be made to patients' conventional treatment. Hypotheses: The high mortality and hospitalisation rate in the early period after diagnosis of heart failure is related to progressive pump failure; or The high mortality in the early period after the diagnosis of heart failure is related to co-morbid events- principally major coronary events such as myocardial infarction or acute coronary syndrome. This research should help to identify ways of improving the outlook for people with newly diagnosed heart failure. The analysis of the data generated by this study will be supervised by a statistician. Clinical and demographic data will be described using mean + standard deviation, for continuous variables, and absolute numbers and percentages for categorical variables. Group differences will be examined by t-tests for continuous variables and Chi-square (x2) test for categorical variables. Survival will be reported in terms of Kaplan-Meier curves with differences analysed by Cox proportional hazards.

Official Title
-----------------
The Early High Risk Period for Patients With Incident Heart Failure: A Population Based Study

Conditions
-----------------
Heart Failure, Congestive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of heart failure Exclusion Criteria: Under age of 18 years Unable to give consent

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
-----------------
Heart Failure, Congestive, survival, patient admission
The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants

Study Overview
=================
Brief Summary
-----------------
In this research study, the investigators want to learn more about whether the Respiratory Volume Monitor (ExSpiron) can accurately measure breathing in infants less than 12 months of age. The Respiratory Volume Monitor uses up to 5 stickers that are placed on the chest to measure the amount of air going in and out of the lungs with each breath (Tidal Volume), the number of times per minute a breath is taken (Respiratory Rate), and the amount of air going in and out of the lungs per minute (Minute Ventilation). It is important for medical staff to be able to collect information about breathing non-invasively because it may help determine if certain children are experiencing breathing problems sooner than the way it is currently detected. The goal of this study is to determine if the Respiratory Volume Monitor works accurately in infants less than 12 months of age.

Official Title
-----------------
The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants

Conditions
-----------------
Respiratory Complications

Intervention / Treatment
-----------------
* Device: Respiratory Volume Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: less than 12 months of age currently intubated in the ICU Exclusion Criteria: ExSpiron monitor will interfere with a healing surgical procedure site or standard of care

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants less than 12 months<br>intubated infants in ICU | Device: Respiratory Volume Monitor<br> <br> * Other names: ExSpiron;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation |  | During 1 hour period in ICU | 
| Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation |  | During 1 hour period in ICU | 
| Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation |  | During 1 hour period in ICU |
Risk Factors for Post Whipple Pancreatic Fistula

Study Overview
=================
Brief Summary
-----------------
Postoperative pancreatic fistula (POPF) following pancreaticoduodenectomy is considered a life-threatening complication. This study was designed to analyze the risk factors for development of such fistula in a tertiary care center (Al-Rajhi Liver Hospital/ Assiut University).

Official Title
-----------------
Risk Factors Predicting Development of Pancreatic Fistula Following Pancreaticoduodenectomy

Conditions
-----------------
Pancreatic Fistula

Intervention / Treatment
-----------------
* Procedure: pancreaticoduodenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients underwent pancreaticoduodenectomy for pancreatic cancer Exclusion Criteria: All types of pancreatic resection other than pancreaticoduodenectomy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: pancreaticoduodenectomy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of pancreatic fistula following pancreaticoduodenectomy | Analysis of risk factors for development of pancreatic fistula following pancreaticoduodenectomy | Baseline |
Effect of the Level of Dietary Protein on Body Composition

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if toddlers and children who were fed breast milk or infant formulas at different levels of protein between 3 and 12 months of age have differences in growth and body composition at 3 and 5 years of age.

Official Title
-----------------
Effect of the Level of Dietary Protein on Infant Growth and Body Composition in the First Year of Life - Three and Five Year Growth and Body Composition Follow-up

Conditions
-----------------
Growth Acceleration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous participation in infant formula controlled protein study Body composition data from 6 month of age available Consent obtained from legal representative Within age parameters specified in protocol around the 3 and 5 year age points Exclusion Criteria: Unable to endure testing procedures upon evaluation of the Investigator Outside the age range of the study

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 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 |
| --- | --- |
| Breast Fed reference group<br>3 and 5 year olds from the above group | |
| Infant formula - protein level 1<br>3 ad 5 year olds from the above group | |
| Infant formula - protein level 2<br>3 and 5 year olds from the above group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean weight gain |  | 3 years | 
| Mean weight gain |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition |  | 3 years | 
| Body composition |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body composition, Protein Metabolism
Evaluation of the Proximal Femoral Nail Antirotation With Cement Augmentation in Osteoporotic Femoral Neck Fractures

Study Overview
=================
Brief Summary
-----------------
This is an open multicenter study, evaluating a new operative technique in femur neck fractures. The treatment consist of augmentated nails in cases of subtrochanteric or inter fracture due to osteoporosis.There two routine surgical techniques in femoral neck fractures: Insertion an intramedullary nail (without augmentation) to the bone. insertion a nail and metal plateto the bone. The major disadvantage of these methods is the relative high rate (4-10 precentages) of failure because of the femur head bone which is very brittle and osteoporotic. This new approach enables the nail a better grip as a result of the cement augmentation which consists of PMMA (Polymethyl methacrylate). The investigators main goal is to evaluate the use of this surgical technique

Conditions
-----------------
Proximal Femur Fracture

Intervention / Treatment
-----------------
* Device: Proximal Femoral Nail Antirotation(PFNA) with cement augmentation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PFNA augmentation is indicated for severe osteoporotic fractures (Subtrochanteric or intertrochanteric) in the proximal femur. Men and women above 80 years old that fuffer from fracture in the proximal femur. Exclusion Criteria: Patient can not come to the follow up clinic visits.

Ages Eligible for Study
-----------------
Minimum Age: 60 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
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proximal Femoral Nail Antirotation<br>Proximal Femoral Nail Antirotation(PFNA) with cement augmentation | Device: Proximal Femoral Nail Antirotation(PFNA) with cement augmentation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients reaching union at the 3-month and 6-month follow up | Proportion of patients reaching union at the 3-month and 6-month follow up will be assessed. Union is defined by both clinical evaluation-pain and weight bearing status, and radiological evaluation- three out of four cortices must be bridged as viewed on plain X-ray (AP and lateral views). |  |