linjc16/ctgov huggingface dataset:
An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNF Therapy (REPEAT)

Study Overview
=================
Brief Summary
-----------------
This observational study will assess the efficacy and safety of MabThera/Rituxan (Rituximab) in patients with active rheumatoid arthritis who have had an inadequate response or are intolerant to anti-TNF therapy. Data will be collected from patients initiated on MabThera/Rituxan therapy according to standard of care in routine clinical practice. For each patient data will be collected for 92 weeks.

Official Title
-----------------
MabThera Post Marketing Observational Study in TNF-IR Patients to Assess Efficacy and Safety of REPeated Courses in routinE ClinicAl pracTice

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Active Rheumatoid Arthritis Inadequate response to anti-TNF Eligible for MabThera/Rituxan therapy according to physician's decision Exclusion Criteria: According to Summary of Product Characteristics

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Change in Disease Activity Score - erythrocyte sedimentation rate (DAS28 - ESR) |  | from baseline to Week 92 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 4 years |
Prevalence Study of Amyloidosis in Patients With Surgery of Suspect Bilateral Carpal Tunnel (AMYLYONCARP)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the prevalence of amyloidosis in population of patient affected by suspect bilateral carpal tunnel with indication of surgery

Official Title
-----------------
Prevalence Study of Amyloidosis in Patients With Surgery of Suspect Bilateral Carpal Tunnel (AMYLYONCARP)

Conditions
-----------------
Carpal Tunnel Syndrome Bilateral

Intervention / Treatment
-----------------
* Diagnostic Test: tenosynovial tissue biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bilateral carpal tunnel with indication of surgery and judged suspect: age of 50 years old and more non-traumatic or undetermined neuropathic etiology or cardiac history (atrial arrhythmia or Heart Failure or cardiac stimulation) or family history of hereditary amyloidosis or monoclonal gammopathy Exclusion Criteria: patient with diagnosis of amyloidosis traumatic bilateral carpal tunnel or linked to rheumatoid arthritis

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: tenosynovial tissue biopsy|Biopsy of tenosynovial tissue during surgery for amyloid aggregate search|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of amyloid aggregate | Research of amyloid aggregate in tenosynovial tissue | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Typing of amyloid aggregate | Caracterization of amyloid aggregate in tenosynovial tissue | During surgery |
The Added Value of Intraoperative CT Scanner and Screw Navigation in Operative Treatment of Displaced Acetabular Fracture With Dome Impaction

Study Overview
=================
Brief Summary
-----------------
The acetabulum fracture result from a trauma with high energy at the young adult or from a trauma of low energy at the old osteoporotic patient. Anatomic reduction is known to be necessary to give functional result to patient.However, it's technically difficult because of the pelvic bone conformation. The presence of dome impaction makes the surgery more difficult. Per operatory scanner associated to 3D navigation is proved his value-added in spinal surgery.The aim of the study is show that this association permit a technical improvement for the surgeon in the precision of fracture reduction.and restore the articular congruence.

Official Title
-----------------
The Added Value of Intraoperative CT Scanner and Screw Navigation in Operative Treatment of Displaced Acetabular Fracture With Dome Impaction

Conditions
-----------------
Acetabular Fracture, Acetabular Surgery

Intervention / Treatment
-----------------
* Procedure: use of O-arm surgical imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age> 18 surgery for acetabular fracture within 30 days with dome impaction Exclusion Criteria: disability of inferior limb

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 |
| --- |
|Procedure: use of O-arm surgical imaging|during acetabular fracture surgery , use of O-arm surgical imaging with|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dome impaction reduction measurement | dome impaction reduction measurement on scanner per operatory and post operatory | day1 |
Correlation of Cardiac Computed Tomography Angiography Dimensions and Ethnicity in Trinidad

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare coronary artery dimensions on Cardiac CT angiography amongst different ethnicities in Trinidad.

Detailed Description
-----------------
The aim of this study is to compare coronary artery dimensions on Cardiac CT angiography amongst different ethnicities in Trinidad.

Official Title
-----------------
Correlation of Cardiac Computed Tomography Angiography Dimensions and Ethnicity in Trinidad: The CADET Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CCTA for chest pain All ethnicities All genders Exclusion Criteria: 1. Patients who did not provide consent.

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 |
| --- | --- |
| CCTA Group<br>This is an all-comers group, of all ages and ethnicities who have been evaluated with a CCTA from 2017-2020. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary Artery Dimension | Coronary Artery Dimension of proximal, middle and distal LAD, LCx and RCA | 2 years |
Identification of Novel Genetic Factors That Contribute to Risk for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify novel genetic factors which distinguish breast cancer in younger women compared to older women. By identifying these novel genetic factors we believe more specific therapies can be developed and breast cancer may be prevented among women with an increased cancer risk. A woman does not have to live in St. Louis to participate.

Detailed Description
-----------------
Breast cancer takes its greatest toll on younger women, as it is the leading category of cancer deaths for women 20-39 years of age. Sadly, survival rates are lowest among women diagnosed at a young age. This impact is most significant among African-American women who have the highest incidence and mortality rate among women less than 45 years of age. The goal of our program is to identify the genetic factors which distinguish breast cancer in younger women compared to older women. Women who were diagnosed with invasive breast cancer 40 years of age or younger are invited to participate. The age at diagnosis is used to determine eligibility, not a woman's current age. Women who have undergone genetic testing of the BRCA1, BRCA2, p53, pTEN, e-cadherin, or LKB1 genes are eligible to participate. Young women with breast cancer are asked to: sign a consent form, submit a sample of blood, release their cancer related records, and answer some family history questions. We will use a family based case control approach in our analysis. As such, if a woman's parents are living, they will be invited to participate as a comparison group. The parents are asked to: sign a consent form, submit a sample of blood, and release any cancer records. A woman does not have to live in St. Louis to participate. All study related materials can be mailed directly to the young woman or her parents. There is no expense to the family. All materials are kept strictly confidential and participation is completely voluntary.

Official Title
-----------------
Identification of Novel Genetic Risk Factors That Contribute to the Risk for Breast Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women diagnosed with invasive breast cancer 40 years of age or younger. If their parents are living, the parents are also invited to participate, regardless of their history of cancer. Exclusion Criteria: Women diagnosed with in-situ breast cancer.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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
-----------------
Breast, Cancer, Young, Women
The Singapore Chinese Health Study

Study Overview
=================
Brief Summary
-----------------
The Singapore Chinese Health Study is a cohort study established by the Department of Epidemiology and Public Health in National University of Singapore, together with collaborators from several universities in the United States of America. This is a long-term study to help doctors and scientists understand the influence of diet, lifestyle and environment on the development of common diseases among Singaporean men and women. This includes cancer, heart disease, stroke, dementia, osteoporosis, high cholesterol and diabetes. The aim is to help us understand the causes of these diseases and to discover effective and efficient approaches for prevention and treatment.

Detailed Description
-----------------
The cohort consists of more than 60,000 men and women who were enrolled in the Singapore Chinese Health Study during 1993-1998. At the time of enrollment, participants were interviewed in-person regarding their dietary habits and other lifestyle factors. About half of them also donated small amounts of blood and urine for research between 2000 and 2004.

Official Title
-----------------
The Singapore Chinese Health Study

Conditions
-----------------
Cancer, End Stage Renal Disease, Diabetes, Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Housing estate residents, ages 45-74 years, Chinese Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 74 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer incidence | Linkage to national cancer registry | 1993 to 2025 | 
| End-stage Renal Disease | Linkage to national renal registry | 1993 to 2025 |
Impact of Initial Diagnosis on Mortality for Patients Hospitalised With Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the impact of an initial non-specific / non-cardiac diagnosis on mortality among patients hospitalised with acute myocardial infarction.

Official Title
-----------------
Impact of Initial Diagnosis on Mortality for Patients Hospitalised With Acute Myocardial Infarction: A National Cohort Study

Conditions
-----------------
ST-elevation Myocardial Infarction, Non ST-elevation Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged between 18 and 100 years patients discharged alive with STEMI or NSTEMI Exclusion Criteria: patients who die in hospital patients not discharged with STEMI or NSTEMI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| STEMI<br>Patients discharged with STEMI | |
| NSTEMI<br>Patients discharged with NSTEMI | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Mortality censored 1 year after discharged from hospital |
Supportive Care Needs of Caregivers of People With Erdheim-Chester Disease and Other Histiocytic Diseases

Study Overview
=================
Brief Summary
-----------------
This study is being done to answer the following question: What are the supportive care needs of informal caregivers of people with Erdheim-Chester disease and other histiocytic diseases?

Official Title
-----------------
A Study to Identify the Supportive Care Needs of Caregivers of Patients With Erdheim-Chester Disease and Other Histiocytic Diseases

Conditions
-----------------
Supportive Care Needs of Caregivers

Intervention / Treatment
-----------------
* Behavioral: online surveys


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-identified informal caregiver (family member or friend who provides unpaid support) for a patient with Erdheim-Chester Disease (or LCH, RDD, or JXG for the exploratory aim). Proficiency to complete study assessments in English, evaluated at the time of consent. Age 18 or over. Exclusion Criteria: Participant unwilling to sign consent. Participant unable to complete web-based assessments.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Caregivers of Patients<br>This is an observational study of informal caregivers (ICs) of patients with Erdheim-Chester Disease (ECD) and other histiocytic diseases. That will collect data cross-sectionally, at a single time point. Caregiver-reported data will be completed in the form of online surveys by the participants themselves using the Research Electronic Data Capture Platform [RedCAP] platform. | Behavioral: online surveys<br>* Survey data about supportive care needs, mood, and the experience of IC's finding meaning and purpose in the caregiving experience.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supportive Care Needs of informal caregivers | measured by the McGill Quality of Life in Life Threatening Illness - Family Carer Version (QLLTI-FC) | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Supportive care, Erdheim-Chester Disease, Other Histiocytic Diseases, 19-213
Role of Surgery for the Primary in Patients With Breast Cancer Stage IV.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine benefits of surgery for the primary in patients with breast cancer stage IV in randomized controlled study.

Official Title
-----------------
Role of Surgery for the Primary in Patients With Breast Cancer Stage IV - A Prospective Randomized Multicenter Controlled Trial

Conditions
-----------------
Carcinoma Breast Stage IV

Intervention / Treatment
-----------------
* Procedure: Surgery for primary breast tumor.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy breast cancer stage IV patients with resectable primary breast tumor. Resectable breast cancer stage IV patients who well response of visceral metastasis to systemic therapy and fit for surgery. Exclusion Criteria: Breast cancer stage IV patients with local complication of primary breast tumor that require surgery for palliation such as uncontrolled bleeding,large and non-healing ulcer or intractable pain. Breast cancer stage IV patients with unresectable primary breast tumor or extensive chest wall disease.
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 |
| --- | --- |
| No Intervention: Controlled<br>No surgery for primary breast tumor. | |
| Experimental: Study<br>Surgery for primary breast tumor. | Procedure: Surgery for primary breast tumor.<br>* Complete resection of primary breast tumor(Lumpectomy or mastectomy)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life & Uncontrolled chest wall disease |  | Five years |
Effect of Prebiotic FOS on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease

Study Overview
=================
Brief Summary
-----------------
FOS improve gut colonization by Faecalibacterium prausnitzii in patients with Crohn's disease

Detailed Description
-----------------
To demonstrate that FOS increases counts of Faecalibacterium prausnitzii in faecal samples from Crohn's disease patients

Official Title
-----------------
Effect of Prebiotic Fructo-oligosaccharides (FOS) on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Dietary Supplement: FOS
* Drug: Adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 18 and 65 years old Crohn's disease patients Inflammatory activity confirmed by imaging techniques (colonoscopy or magnetic resonance imaging (MRI)) Refractory inflammatory luminal disease (with or without perianal involvement) at any level of the gastrointestinal tract requiring therapy with adalimumab,according to standard clinical practice. Stable maintenance of any other medication (corticosteroids and / or immunosuppressants and/or 5-aminosalicylic acid (5-ASA)) for the past 4 weeks Screening tests required for a safe administration of anti tumour necrosis factor (anti-TNF) antibodies will be performed according to standard clinical practice Exclusion Criteria: Subjects consuming prebiotic supplements (inulin, FOS, galactooligosaccharides (GOS)) in their regular diet. Antibiotic use within the past 2 months Previous anti-TNF therapy.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: adalimumab + FOS<br>Adalimumab will be administered during 12 weeks in combination with daily FOS 6g. (FOS administration will start 2 weeks before Adalimumab) | Dietary Supplement: FOS<br> <br> Drug: Adalimumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FOS increases counts of Faecalibacterium prausnitzii in faecal samples from Crohn's disease patients |  | 14 weeks |
Child Asthma : What Parents Attitude During an Asthma Attack at Home Before Consulting the Pediatric Emergencies

Study Overview
=================
Brief Summary
-----------------
prospective multicenter observational study. Parents whose children meet the inclusion criteria complete a questionnaire assessing the child's follow-up, the management of the current asthma attack, and the treatment provided at home. The main objective is to calculate the prevalence of placement of short-acting bronchodilators. The secondary objectives are to describe the factors associated with their implementation.

Official Title
-----------------
Prevalence of Preoperative Short-acting Mimetic beta2 Therapy by Parents of Asthmatic Children Attending Emergency Room for Asthma Attack

Conditions
-----------------
Asthma in Children, Asthma Attack, Therapeutic Adherence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: child over 2 years emergency room consultant for asthma attack child whose parents did not express their opposition to participate and completed the non-objection form child consultant in pediatric emergencies of Quimper and Brest Exclusion Criteria: child whose age is not between 2 and 15 years old cough equivalent of asthma history of cardiac or pulmonary pathology or prematurity refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 15 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 |
| --- | --- | --- |
| prevalence of short-acting bronchodilator induction in children attending emergency room for asthma attack |  | 1 hour |