linjc16/ctgov huggingface dataset:
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Ulcerative Colitis

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Ulcerative Colitis

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis, Ulcerative Colitis Chronic

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study Male or female patients of any age. Diagnosis of Ulcerative Colitis Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with Ulcerative Colitis diagnosis | Other: No intervention<br>* There is no intervention for this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Sequencing Methods | To validate the methods used to sequence samples. | One year |
Feasibility of Lymph Edema-induced Reticulation Subtraction Based on Computerized Tomography

Study Overview
=================
Brief Summary
-----------------
Development of lympho-proliferation reticulation quantification using CT.

Detailed Description
-----------------
It is known that fibrosis of the subcutaneous soft tissue progresses over time in the lymph edema, and this change progresses to reticulation pattern. Authors will develop a digital subtraction technique for the extraction of lympho-proliferative reticulation using the Housfield unit of non-reticulation structure (bones, muscles, tendons, vessels, nerves) in the axial image of CT. Based on the medical records, authors will develop an early diagnosing tool by checking the correlation of the values derived the new technique with circumference, multi-frequency bio-electric impedance analysis, ISO sub-stage, and lymphascintigraphy, and qualify the cut-off values showing high sensitivity and specificity through the receiver operating characteristics (ROC) curve analyses.

Official Title
-----------------
Feasibility of Lymph Edema-induced Reticulation Subtraction Based on Computerized Tomography.

Conditions
-----------------
CT, Lymphedema, Secondary Lymphedema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In- and out-patients who was diagnosed a secondary lymphoma and undertook CT on their limbs Exclusion Criteria: Primary lymph edema (congenital lymph edema, lymph edema precox, lymph edema tarda) Lymph edema simultaneously involving both limbs Patients who undertook implantation of electrical devices such as cardic pacemakers
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal limb<br>Normal | |
| Abnormal limb<br>Lymph Edema | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reticulation Ratio from Computerized Tomography | calculated value of reticulation | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multi-frequency bio-electric impedance analysis | comparative ratio using 1KHz | 1 week |
An Open-Label Evaluation of Degree of Accommodation in Pseudophakic Patients Bilaterally Implanted With Monofocal Intraocular Lenses

Study Overview
=================
Brief Summary
-----------------
This study will determine the ability of three different intraocular lenses to accommodate in patients who have previously undergone bilateral intraocular lens implantation.

Conditions
-----------------
Pseudophakia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 18 and older Patients must have undergone cataract surgery and have bilateral implants of the same model. The models eligible for inclusion include: Crystalens Crysalens HD Tecnis One monofocal Patients must have a healthy cornea and macula Patients must have 20/25 or better best corrected vision Able to provide written informed consent Exclusion Criteria: BCVA of less than 20/25 On oral medications that could potentially block accommodation: First generation antihistamines Anticholinergic agents Anti-psychotic medications Antidepressant medications

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 |
| --- | --- |
| Bilateral intraocular lens implantation.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude of accommodation on COAS and how it correlates with: spherical aberration on the COAS, pupil size at near as measured with COAS, spherical aberration on the topography, patient reported nead for spectacles for reading |  | one study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude of accommodation on pushdown test - and how it compares to the COAS test results |  | one study visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients who have previously undergone bilateral intraocular lens implantation
Ultrasound Elastography in Imaging Patients With Thyroid Nodules

Study Overview
=================
Brief Summary
-----------------
This clinical trial studies how well ultrasound elastography works in assessing the cancer status of potentially malignant thyroid nodules.

Detailed Description
-----------------
PRIMARY OBJECTIVES: Determine the utility of ultrasound elastography in evaluation of thyroid nodules being evaluated for the presence of cancer. Elastography measures the passages of ultrasound shear waves through tissue to gauge the stiffness and compressibility of the tissue, collectively tissue stiffness, and may be a better way to image thyroid nodules. Tissue stiffness is a physiological parameter that is being evaluated for differences between non-cancerous (benign) and cancerous thyroid nodules. Participants will undergo elastography over the 10 minutes prior to either fine needle aspiration of a biopsy specimen or surgical resection of the thyroid nodule. Tissue specimens from the biopsy specimen or surgical resection will be assessed pathologically to determine actual cancer status.

Official Title
-----------------
Elastography in Thyroid Nodule Evaluation

Conditions
-----------------
Malignant Thyroid Gland Neoplasm, Thyroid Gland Nodule

Intervention / Treatment
-----------------
* Device: Siemens Acuson S3000 ultrasound system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of a thyroid nodule that is amenable to ultrasound guided fine needle aspiration Exclusion Criteria: Patients who are unable to lie supine for a biopsy Pregnant patients

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Siemens Acuson S3000 ultrasound system
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tissue Stiffness by Elastography<br>Potentially cancerous thyroid nodules were assessed by elastrography, then a fine needle biopsy specimen or the surgically-excised nodule was assessed pathologically to determine cancer status. | Device: Siemens Acuson S3000 ultrasound system<br>* Shear Wave Elastography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stiffness of Thyroid Nodules as Measured by Elastography | Potentially cancerous thyroid nodules will be assessed elastographically, and cancer status will be determined from a fine needle aspiration biopsy results or the surgically excised nodule. The outcome will be reported as median tissue stiffness with standard deviation for nodules that were determined non-cancerous (benign), cancerous, or indeterminate. | 1 week |
American Breast Laser Ablation Therapy Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of this patient tracking program is to monitor long term safety and effectiveness of the Novilase™ device and method in real world application.

Detailed Description
-----------------
ABLATE is a prospective, observational multi-center tracking database which will evaluate clinical outcomes from patients undergoing Novilase for benign breast conditions (i.e. fibroadenomas, papillomas, etc). Data captured will assess the potential advantages and disadvantages of the procedure as compared with lumpectomy. Tumor characteristics, equipment used, complications, patient satisfaction and cosmesis ratings will also be tracked.

Official Title
-----------------
American Breast Laser Ablation Therapy Evaluation (ABLATE): Monitoring the Long Term Safety and Efficacy of Novilase™ Breast Interstitial Laser Therapy in Real World Application

Conditions
-----------------
Benign Breast Conditions; Breast Fibroadenomas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis confirmed by needle core biopsy Tumors detected either by physical exam or imaging Tumors do not exceed 2 cm in diameter and measure at least 0.5 cm away from the skin and chest wall Single, multiple and/or bilateral tumors Patient has given consent prior to being treated with Novilase™ Exclusion Criteria: Patient is pregnant or lactating Hypercellularity suggestive of phyllodes Atypia Equivocal pathology report (e.g., discordance between radiographic and microscopic results) Fibroadenomas with stromal solidarity

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

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

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 |
| --- | --- | --- |
| To monitor and measure long term safety and effectiveness Novilase |  | ongoing | 
| To help refine, improve and/or validate breast tumor best practices and standard of care |  | ongoing | 
| To help establish uniform and standardized imaging, pathological assessment and ablation timing protocols |  | ongoing | 
| To support the medical and patient communities through transparency--by contributing and publishing relevant, useful and meaningful data to support the development and design of future research |  | ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibroadenomas, Papillomas, Breast, Minimally invasive, Interstitial laser therapy, Laser ablation, Benign, Non-cancerous, Breast lesion, Breast tumor
Effect of the 3C Model in Students and Teachers From Vaupés, Boyacá and Amazonas

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effectiveness of the 3Cs - Conmigo, Contigo y Con todo strategy in strengthening resilience and compassion in students and teachers from three regions from Colombia: Vaupés, Amazonas and Boyacá. It will also evaluate its relevance in the design of programs aimed at mental health in educational settings.

Detailed Description
-----------------
Colombia has experienced a long-lasting internal armed conflict that has impacted society at all levels and on people of all ages. This has led to changes in behavior and the way people cope with psychosocial distress. Focusing on children and adolescents, this study aims to assess the effectiveness of the 3Cs - Conmigo, Contigo y Con todo strategy in strengthening resilience and compassion. The changes in the scores of the CD-RISC and ECOM instruments will be evaluated through a mixed methods analysis that will evaluate the pre and post intervention results and the perception of all the actors involved in the development and implementation of the 3Cs program.

Official Title
-----------------
Efecto Del Modelo Conmigo, Contigo y Con Todos (3Cs) en Niños, Niñas y Adolescentes y Sus Profesores en Vaupés, Boyacá y Amazonas

Conditions
-----------------
Resilience, Compassion

Intervention / Treatment
-----------------
* Behavioral: 3Cs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Students and teachers from public institutions Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is based on a mixed-methods experimental design and concurrent triangulation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3Cs<br> | Behavioral: 3Cs<br>* The 3Cs program is an educational strategy aimed at fostering resilience and compassion in people. It is based on improving the mental well-being of the participants by transforming their attitudes and behaviors through increased consciousness.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD-RISC | CD-RISC score | 36 months | 
| ECOM | ECOM score | 36 months |
The Princess Alexandra Hospital and the QIMR Berghofer Medical Research Institute Head and Neck Cancer Study

Study Overview
=================
Brief Summary
-----------------
This study is designed to refine the aetiological causes of cancers of the head and neck and investigate the ways in which human papillomavirus and life-style factors cause head and neck cancers. This study will determine if these factors affect the treatment of cancer. All patients attending the Head and Neck Clinic at the Princess Alexandra Hospital is invited to complete a risk factor questionnaire and give consent for their clinical data and tissue samples to be available for future research activities. The risk factor questionnaire is based on existing validated instruments developed by the QIMR Berghofer Medical Research Institute Cancer Control Group, and will collect standardised information relating to demographics and causal factors (tobacco and alcohol intake), risk modifiers (dentition, asprin and non-steroidal anti-inflammatory drugs (NSAIDS), height, weight, physical activity, diet quality etc) and behaviours (oral sex etc)

Detailed Description
-----------------
Data is collected using a simple four-page paper-based questionnaire. Information to be collected include age, sex, height and weight (at age 20, current age, and heaviest ever), history of cancer (own and partner). Questions about recreational physical activity, smoking history and alcohol consumption, acid reflux, heartburn, denture use and tonsillectomy, frequency of use of paracetamol, antihistamine and NSAIDS. The questionnaires also ask participants some detailed questions about sexual behaviour and history if they are comfortable to give this information.

Official Title
-----------------
An Epidemiological Study of Mucosal Squamous Cell Carcinomas of the Head and Neck

Conditions
-----------------
Head and Neck Squamous Cell Carcinoma, Human Papillomavirus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients presenting to the Head and Neck Cancer Clinic at the Princess Alexandra Hospital Brisbane Australia. Exclusion Criteria: nil
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Head and neck cancer<br>All patients presenting to the Head and Neck Cancer Clinic at the Princess Alexandra Hospital, Brisbane, Australia are invited to participate. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify exposures associated with an increased risk of head and neck squamous cell carcinoma |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head and Neck Squamous Cell Carcinoma, Human Papillomavirus, Aetiology, prevalence, risk factors, clinical outcome
A Recurrence Nomogram for Hepatoid Adenocarcinoma of the Stomach

Study Overview
=================
Brief Summary
-----------------
This study aims to develop a nomogram to predict postoperative recurrence of HAS and guide individually tailored surveillance strategies.

Detailed Description
-----------------
Patients were included from the China Hepatoid Adenocarcinoma of the Stomach Study Group (China-HASSG) database, which comprises 14 tertiary referral centers. All the patients who had undergone complete resection of a primary HAS between April 2004 and December 2019 were included. First, univariate analysis was performed in Cox regression to identify the risk factors associated with RFS. Next, variables with P< 0.05 in univariable analysis were included in the multivariable model, and the forward likelihood ratio method was used for analysis to confirm the independent prognostic factors associated with RFS. Finally, based on the results of multivariable analysis, variables that achieved significance at P< 0.05 were selected to formulate a nomogram.

Official Title
-----------------
A Recurrence Nomogram to Guide Surveillance Strategies After the Resection of Hepatoid Adenocarcinoma of the Stomach: a China Hepatoid Adenocarcinoma of the Stomach Study Group Database Study

Conditions
-----------------
Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had undergone complete resection of a primary HAS between April 2004 and December 2019 Exclusion Criteria: Patients with metastatic disease, patients who had undergone palliative surgery, patients who had died within 30 days, and patients who were lost to follow-up
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 |
| --- | --- | --- |
| Reurrence-free survival | Reurrence-free survival was defined as the time interval from the date of the operation to the date of first recurrence or death from any cause. | 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reurrence-free survival, Nomogram
Aggressive Prostate Cancers in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
Patients aged 70 years or older had a higher possibility of high risk cancer than younger patients.

Detailed Description
-----------------
Patients aged 70 years or older had a higher risk of advanced prostate cancer and shorter BCR-free survival than younger ones. Definite treatment of clinically localized prostate cancer should be actively considered in well-selected healthy patients older than 70 years.

Official Title
-----------------
Patients Aged More Than 70 Had More Aggressive Prostate Cancers and Higher Risk of Biochemical Recurrence in Korea

Conditions
-----------------
Prostatic Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically localized prostate cancer good health status follow-up period more than 12 months Exclusion Criteria: insufficient clinical data poor health status clinically advanced prostate cancer

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients older than 70 years<br> | |
| patients 70 years or younger<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemical recurrences (BCR) | BCR was defined as two consecutive increasing PSA values of more than 0.2 ng/mL | 5 year-BCR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathologic outcomes | biopsy or pathologic Gleason scores, mean percent of positive cores and tumor volume percent, Extracapsular extension and seminal vesicle invasion | postoperative 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate-specific antigen, radical prostatectomy