linjc16/ctgov huggingface dataset:
Dimensional Validation of the Hallux Valgus Orthosis

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to optimize the design of the orthosis by establishing the key volumetric characteristics of the custom iterations in order to subsequently transpose them to a standard model and establish the increment proportions of the different sizes. The final product should reduce the pain by repositioning the phalanges of the first toe with the first metatarsal in its axis.

Official Title
-----------------
Dimensional Validation of the Hallux Valgus Orthosis

Conditions
-----------------
Hallux Valgus

Intervention / Treatment
-----------------
* Device: Hallux Valgus orthosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Painful hallux valgus three people maximum per shoe size Exclusion Criteria: People with diabetes ; People with severe obesity ; People with hallux rigidus; People wearing full-time foot orthosis; People wearing high heel shoes regularly ; People with degenerative disease ; People with neuromuscular pathology ; People with a circulatory disorder ; People who have had major lower body surgery; People with epilepsy or with a history of epilepsy.

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: Painful Hallux Valgus<br> | Device: Hallux Valgus orthosis<br>* Custom designed orthosis and manufactured by 3D printing.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in big toe deviation angle during gait at 1 month | The big toe deviation angle is the angle between the big toe and the gait axis and measured with a motion capture system. | At baseline and 1 month | 
| Change in pain at 1 month | Pain is measured with a Likert scale from 1 (decrease of pain) to 5 (increase of pain). | At baseline and 1 month | 
| Change in comfort at 1 month | Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable). | At baseline and 1 month |
Double-bed SPECT/CT for Bone Scintigraphy in Initial Staging of Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Bone scintigraphy is currently a reference test in the initial staging of cancer. Bone scintigraphy historically consists in a planar whole-body scintigraphy (WBS). SPECT/CT has been shown to dramatically reduce the proportion of inconclusive results and increase the specificity of bone scintigraphy. Therefore, in most of nuclear médicine centers, the usual protocol for staging of bone metastases consists in a whole-body planar acquisition followed, if needed, by a targeted SPECT/CT to characterize suspicious or equivocal uptakes seen on WBS. The aim of this study is to assess the incremental diagnostic utility of a systematic double-bed SPECT/CT acquisition for bone scintigraphy in initial staging of cancer patients compared with the conventional WBS plus single-bed targeted SPECT/CT strategy.

Detailed Description
-----------------
Images are interpreted by two nuclear medicine physicians in a 3-step procedure and by consensus. Firstly,only WBS planar images are considered. Secondly, a single-bed SPECT/CT chosen based on planar images is used if WBS demonstrated any equivocal or suspicious uptake. Finally, WBS and double-bed SPECT/CT images are used for interpretation. A per-lesion, a per-anatomical region and a per-patient analysis is performed. At each step, lesions, regions and diagnostic conclusions are classified using a 3-level scale, as negative for malignancy, equivocal or suspicious for metastasis

Official Title
-----------------
Incremental Diagnostic Utility of Systematic Double-bed SPECT/CT for Bone Scintigraphy in Initial Staging of Cancer Patients

Conditions
-----------------
Bone Metastases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred for bone scintigraphy for initial staging of biopsy proven malignancy. Exclusion Criteria: monoclonal gammapathy patients under 18 years of age Technical issues not allowing a double-bed SPECT/CT acquisition double bed SPECT/CT acquisition not centered from the upper cervical spine to the proximal femora

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 |
| --- | --- | --- |
| Diagnostic impact of a systematic double SPECT/CT as compared to a oriented single-bed SPECT/CT bone scintigraphy for staging of malignancies with bone scintigraphy |  | day 1 |
Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis (RA) patients have an underlying immune deficiency and typically treated with immunosuppressive drugs, which may increase the risk of COVID-19 infection. Hydroxychloroquine (HCQ) has been found to possess antiviral activity against COVID-19. Thus, the aim of this study to investigate the ability of HCQ to reduce the risk of COVID-19 among RA patients.

Official Title
-----------------
Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients: A Retrospective, Case-control Study

Conditions
-----------------
Rheumatoid Arthritis, COVID

Intervention / Treatment
-----------------
* Drug: Traditional antirheumatic drugs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Data of all definite cases of RA were collected and reviewed from complete medical records of patients by a team that included 2 trained physicians using a pretested data collection form. Exclusion Criteria: The exclusion criteria were included incomplete medical records or those with difficulty to communicate with the patients. Patients with acute lethal organ injury (e.g., acute myocardial infarction, acute coronary syndrome, acute pulmonary embolism, or acute stroke) Patients with decompensated or end stage chronic organ dysfunction (e.g., decompensated cirrhosis, decompensated chronic renal insufficiency, or severe congestive heart failure), diabetes mellitus, data of pregnant females, acquired immune deficiency syndrome (aids), and leukemia or other malignancies.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Rheumatoid Arthritis with COVID-19<br> | Drug: Traditional antirheumatic drugs<br>* Hydroxychloroqine, Methotrexate, Glucocorticoids, Leflunomide, and Sulphasalazine<br>|
| Rheumatoid Arthritis without COVID-19<br> | Drug: Traditional antirheumatic drugs<br>* Hydroxychloroqine, Methotrexate, Glucocorticoids, Leflunomide, and Sulphasalazine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The risk of COVID-19 infection among RA patients | Realtion between hydroxychloroquine use and COVID-19 infection | 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of hospitalization for Covid-19 patients. | Number of cases and number of hospitalization days | 12 week |
Asthma Inpatient Research on Education

Study Overview
=================
Brief Summary
-----------------
Children with asthma are admitted for asthma attacks very frequently in the U.S. The families and children are given basic education about asthma but studies are needed to improve this education so that it makes a meaningful difference in health outcomes and asthma care. This study compares two inpatient education models for children hospitalized with asthma.

Detailed Description
-----------------
The current standard is to review an asthma action plan with families and to review inhaler medication administration. In this study, investigators will be assigning families to either a control (current standard education) or and intervention group. In the intervention group, participants will receive interactive education based on learning theories that are thought to enhance long term memory. Participants in the interactive group will build their own action plan using colored templates and pictures. Participants will also learn to use their inhaler using teach-back methodologies. Investigators will then compare the two groups in terms of ER visits, hospitalizations, family confidence in managing asthma, asthma knowledge, and quality of life.

Official Title
-----------------
Asthma Inpatient Research on Education: A Randomized Clinical Trial

Conditions
-----------------
Asthmatic Attack

Intervention / Treatment
-----------------
* Behavioral: Interactive Asthma Education
* Behavioral: Standard Asthma Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma Exclusion Criteria: Active Cardiac Disease Speaks language other than English or Spanish

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interactive Education<br>Interactive asthma education | Behavioral: Interactive Asthma Education<br>* Active participation to develop asthma action plan and teach back cycles for asthma inhaler teaching/training<br>|
| Active Comparator: Standard Education<br>Standard asthma education | Behavioral: Standard Asthma Education<br>* Basic review of asthma action plan and inhaler use<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ER visits | Number of ER visits in the year after education | 1 year |
Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias

Study Overview
=================
Brief Summary
-----------------
A randomized, parallel, open study comparing catheter ablation versus antiarrhythmic drugs for outflow tract ventricular arrhythmias

Conditions
-----------------
Ventricular Tachycardia, Ventricular Premature Complexes

Intervention / Treatment
-----------------
* Drug: antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)
* Procedure: Catheter Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. presence of ventricular ectopic beats (VEB) with left-bundle-branch block morphology or right-bundle-branch block morphology and positive concordance throughout the chest leads, inferior axis and at least one of the following: >2000 isolated VEB/24h symptomatic monomorphic ventricular tachycardia left ventricular disfunction supposed to be due to tachycardia-induced cardiomyopathy Exclusion Criteria: known structural heart disease pregnancy life expectancy < 1 year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: Antiarrhythmic drugs<br>Flecainide or Propafenone or Sotalol (oral, standard dosage) | Drug: antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)<br> <br> |
| Experimental: ABLATION<br>Catheter Ablation | Procedure: Catheter Ablation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 score | Quality of life improvement according to SF-36 score variations | 6 months |
Bevacizumab for Neovascular Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
Age-related macular degeneration (AMD) is one of primary blinding eye disease among people over 65 years in China. The anti-VEGF antibody treatment is proved useful for Neovascular Age-related Macular Degeneration (nAMD) by many studies. Bevacizumab is the only available low-cost type of anti-VEGF drug currently in China. This study is a multi-center, randomized trial of Bevacizumab effective dose and safety for nAMD. This study is to explore the effective therapeutic approach that the majority of patients in China can bear establishing a suitable treatment for China.

Official Title
-----------------
Randomized Multi-center Clinical Study：Bevacizumab for Neovascular Age-related Macular Degeneration

Conditions
-----------------
Exudative Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Bevacizumab 1
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of neovascular Age-related macular degeneration Signed informed consent Exclusion Criteria: No other ocular fundus diseases

Ages Eligible for Study
-----------------
Minimum Age: 50 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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bevacizumab 1<br> | Drug: Bevacizumab 1<br>* Bevacizumab, 1.25mg/0.05ml, every 6 weeks, 42weeks<br>|
| Active Comparator: Bevacizumab 2<br> | Drug: Bevacizumab<br>* Bevacizumab, 1.25mg/0.05ml, 0week(baseline), 6week, 12week, 24week, 36week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EDTRS visual acuity score | EDTRS visual acuity score is assessed at each timepoint for every group | 0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| macular thickness in OCT | macular thickness is assessed at each timepoint for every group | 0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neovascular age-related macular degeneration, Bevacizumab, Multicenter Randomized Study
Research of the EML4-ALK Gene Expression in the Pleural Effusion or Tumor Tissue From Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
We wants to analyse the EML4-ALK mutation rate in the patients who have non-small cell lung cancer.

Official Title
-----------------
Research of the EML4-ALK Gene Expression in the Pleural Effusion or Tumor Tissue From Lung Cancer Patients

Conditions
-----------------
Lung Cancer Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 or more than 20 years of age The pathological diagnosis confirmed lung cancer Patients have achieved pleural effusion, or surgical biopsy to obtain tumor tissue specimens The patient had signed inform consent Exclusion Criteria: pleural effusion or tumor tissue can not be obtained the patient is not suitable to join the research according to the judgement by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 20 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
-----------------
lung cancer
Genetic and Functional Analysis of Craniometaphyseal Dysplasia (CMD)

Study Overview
=================
Brief Summary
-----------------
CMD can be inherited in an autosomal dominant or recessive trait. CMD may also be caused by de novo mutations. The goal of this study is to identify genes and regulatory elements on chromosomes that are the cause for CMD. The investigators also study blood samples and tissue samples from patients to learn about the processes that lead to this disorder. The investigators long-term goal is to find mechanisms to slow down bone deposition in CMD patients.

Detailed Description
-----------------
CMD is a very rare bone disorder that affects mostly bones of the head (=cranial bones) but also long (=tubular) bones. Therefore, CMD has been added to the class of craniotubular bone disorders. There are a number of disorders in this group and sometimes they are difficult to distinguish. Typical signs for CMD are the lifelong bone deposition in bones of the face and head (=progressive craniofacial hyperostosis) and the widening of the ends of long bones (=metaphyseal flaring). Typical facial characteristics are wide-set eyes and a prominent jaw (=mandible). CMD is sometimes diagnosed in infants. The best way to confirm diagnosis is by molecular genetics.

Official Title
-----------------
Identification of Mutations That Lead to Craniometaphyseal Dysplasia in Families and Isolated Cases and Studies of Cellular and Molecular Mechanisms

Conditions
-----------------
Craniometaphyseal Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CMD; unaffected individuals only if part of a participating CMD family Exclusion Criteria: No CMD; unaffected individuals only as part of a participating CMD family
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 |
| --- | --- | --- |
| Identification of genetic elements | The goal is to identify relevant genes or genetic elements that cause the disease or contribute to the disease progression and severity. | at time of identification | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Craniometaphyseal dysplasia, bone, hyperostosis, osteoblast, osteoclast
Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients

Study Overview
=================
Brief Summary
-----------------
Organ transplant patients and staff members at the Transplant Institute have received pandemic H1N1 influenza vaccine (Pandemrix) and specific antibody production was measured by haemagglutination inhibition according to the clinical guidelines and policy, respectively. This study retrospectively assessed the immune response after vaccination.

Detailed Description
-----------------
A total of 100 organ transplant patients and 36 healthy controls were included in the study. All individuals were vaccinated between October and November 2009 and received 2 doses of Pandemrix. Serum samples were collected at baseline before vaccination and 1 month after the first and second vaccination. Individual hemagglutination-inhibiting serum antibody titers were measured.Frequency of > 4 -fold increase in antibody titers and seroconversion from non-protective prevaccination titers to protective postvaccination titers were recorded. Adverse events were reported.

Official Title
-----------------
Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients

Conditions
-----------------
Organ Transplantation

Intervention / Treatment
-----------------
* Biological: H1N1 vaccine Pandemrix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cohort number 1:Organ transplant patients who were vaccinated and serum sample drawn at baseline. Cohort number 2: Staff members who were vaccinated and serum sample drawn at baseline. Exclusion Criteria: Cohort number 1: Organ transplant patients who were vaccinated and no serum sample drawn at baseline. Cohort number 2: Staff members who were vaccinated and no serum sample drawn at baseline.

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 |
| --- | --- |
| organ transplant patients<br> | Biological: H1N1 vaccine Pandemrix<br> <br> |
| healthy controls<br> | Biological: H1N1 vaccine Pandemrix<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of responders in organ transplant patients and controls |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of >4-fold titre rise in organ transplant patients and controls |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
2009 H1N1 influenza vaccine, organ transplant patients