linjc16/ctgov huggingface dataset:
Prognostic Biomarker for CRC

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research project is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in colorectal cancer.

Detailed Description
-----------------
This is a prospective observational study. Tumor tissue specimens and surgical specimens are obtained from the Sixth Affiliated Hospital, Sun Yat-sen University. The samples are analyzed for biomarkers. The biomarkers are correlated with clinical outcomes (failure-free survival, overall survival, tumor response to treatment (e.g. tumor regression grade for rectal cancer), distant metastasis, recurrence and death). The aim of the analysis is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in . This will lead to the definition of risk groups and stratification of patients and will help to precision medicine of colorectal cancer.

Official Title
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Prospective Study for Prognostic And Predictive Biomarkers of Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Colon or rectal cancer diagnosed by endoscopic biopsy histopathology; Complete sample information, including sample number, gender, age and clinical molecular diagnostic information, etc.; Sufficient surgical tissue samples are available for testing; untreated colon or rectal cancer patients; Patient able to understand and sign written informed consent No evidence of distant metastasis (M0) Exclusion Criteria: Previously treated CRC, including cytotoxic drug therapy, targeted drug therapy, etc.; Other malignant tumors; Pregnant women; Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome

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 |
| --- | --- | --- |
| Failure-free Survival |  | 3 years | 
| Tumor regression grade | For rectal cancer patients who receive neoadjuvant treatment | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 3 years |
MRI in Patients With Kennedy Disease

Study Overview
=================
Brief Summary
-----------------
Kennedy disease is an inherited neuromuscular disorder that is characterized by progressive muscle wasting and weakness. It typically starts with muscle spasms and tremors in the arms, followed by muscle weakness and atrophy of muscles in the arms and legs. The facial and bulbar muscles are also involved. However, the muscle involvement pattern has not been investigated systemically in Kennedy disease. The primary aim of the study is to investigate the muscle involvement in patients with Kennedy disease using MRI. Secondary aims are to examine disease severity and to test MRI as a potential outcome measure for future clinical trials in Kennedy disease. Approximately 40 patients with Kennedy disease and 20 gender and age matched healthy voluntary controls will be recruited. The study consists of one visit per subject lasting 4-5 hours.

Official Title
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MRI in Patients With Kennedy Disease

Conditions
-----------------
Bulbo-Spinal Atrophy, X-Linked, Kennedy Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with Kennedy disease: Inclusion Criteria: Confirmed Kennedy disease Exclusion Criteria: All contraindications for undergoing an MRI scan Healthy controls Inclusion Criteria: Fit age and gender criteria Exclusion Criteria: All contraindications for undergoing an MRI scan

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Kennedy disease<br>Men over 18 years old with confirmed Kennedy disease. | Other: No intervention, observational<br> <br> |
| Healthy, voluntary controls<br>Gender and age matched healthy, voluntary controls. | Other: No intervention, observational<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle fat fraction | The Dixon MRI will be used to quantify the fat fraction in skeletal muscle. | One MRI scan per subject (exam lasts approximately 60 min.) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Isokinetic muscle dynamometry will be used to measure muscle strength. | One muscle strength test per subject (exam lasts approximately 60 min.) | 
| Minimal dataset for data collection in Kennedy disease | The 'minimal dataset for data collection in Kennedy disease' will be used to investigate the clinical spectrum of Kennedy disease. | Data will be collected once for patients with Kennedy disease (exam lasts approximately 90 min.) |
A Follow-Up Survey of Oral Hygiene and Health Outcomes for Women Previously Enrolled in OHMOM

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess oral health, oral hygiene knowledge, and daily oral hygiene practices of women who participated in a randomized controlled trial (2011001) at University of Alabama Birmingham during the period 2012-2014. Additional objectives of the research include evaluation of possible cultural, biological or other mechanisms for outcomes observed in the OHMOM clinical trial, and oral health screening of children born to mothers during the study for the purposes of understanding possible multigenerational effects of oral hygiene education.

Official Title
-----------------
A Follow-Up Survey of Oral Hygiene and Health Outcomes of Women Enrolled in the OHMOM Clinical Trial at the University of Alabama Birmingham

Conditions
-----------------
Gingivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be at least 18 years of age sign an informed consent form and be given a copy be a former subject in study 2011001 at University of Alabama Birmingham with a live birth outcome from that study. Exclusion Criteria: any medical condition requiring pre-medication prior to dental procedures any diseases or conditions that might interfere with the subject safely completing the study inability to undergo study procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Löe-Silness Gingivitis Index |  | 1 Day |
COVID-19 and Acute Invasive Fungal Rhinosinusitis

Study Overview
=================
Brief Summary
-----------------
Data for acute invasive rhinosinusitis was obtained from the Otorhinolaryngology departments at our tertiary hospital at the period from January 2017 to December 2020. Then the risk factors of comorbid diseases and fungal types between post-Covid-19 and non-Covid-19 groups regarding the incidence of invasive rhinosinusitis are compared.

Official Title
-----------------
The Impact of COVID-19 Outbreak on The Incidence of Acute Invasive Fungal Rhinosinusitis

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Fungal rhinosinusitis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of any age and sex. invasive rhinosinusoitis diagnosis based on clinical , endoscopic diagnosis Positive findings for acute sinusitis on sinus computed tomography (CT) scan in addition to fungal determination by histopathological examination of specimen of affected tissues for detection of the type of fungi. Positive PCR was confirmed from the patient's files at the isolation hospitals for COVID 19 group. Exclusion Criteria: Patients who completed management outside our hospital

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-COVID19 patients<br>All acute invasive fungal rhinosinusitis patients managed in our hospital from January 2017 up to February 2020 | Diagnostic Test: Fungal rhinosinusitis<br>* Pathology examination<br>|
| COVID19 patients<br>All acute invasive fungal rhinosinusitis patients managed in our hospital from February 2020 up to December 2020 with positive COVID19 PCR test | Diagnostic Test: Fungal rhinosinusitis<br>* Pathology examination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fungus detection | Culture and microscopic examination by the light microscope to examine the different types of the fungi using hematoxylin & eosin stain and Periodic acid-Schiff stain which is positive in fungi | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fungal sinusitis, rhinosinusitis
Comparison of Attention of Physician After Outpatient Clinic

Study Overview
=================
Brief Summary
-----------------
The attention and clinical performance of physician might be decreased after outpatient clinic session compared to those measured before outpatient clinic.

Detailed Description
-----------------
A large body of data shows that fatigue impairs human performance. Additionally, many studies have provided evidence that fatigue can worsen mood, as indicated by increased scores on measures of depression, anxiety, confusion, and anger. In this context, we examined attentional and emotional changes in physicians after they completed an overwhelming outpatient clinic in a university-affiliated tertiary referral hospital in South Korea.

Official Title
-----------------
Comparison of Performance, Attention, and Emotion of Physician Before and After Outpatient Clinic Session

Conditions
-----------------
Disturbance of Activity and Attention

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: physicians with outpatient clinic sessions in Seoul National University Hospital age 30 59 internal part or external part Exclusion Criteria: physicians who do not agree to participate in the study physicians who are taking drugs known to affect the sleep/wake cycle or daytime alertness physicians who have current psychiatric illness or sleep disorder

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 59 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 |
| --- | --- |
| participants<br>Full-time faculty with morning and afternoon outpatient clinics on the same day in SNUH | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference of response time in PVT(Psychomotor vigilance task) before and after outpatient clinic session |  | change from baseline in response time in PVT after opd session (average 7hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of physician's clinical mistakes during morning and afternoon session in outpatient clinic |  | for the duration of opd session, average up to 7hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
attention
Influenza Vaccination Among the Elderly Individuals

Study Overview
=================
Brief Summary
-----------------
The aims of the study are to a) identify individuals with a poor response to influenza vaccination and b) identify factors associated with a poor response to influenza vaccination.

Detailed Description
-----------------
This is a population-based prospective cohort study. Potential participants, males and females between 65 and 80 years of age, were selected randomly through the resident registration office in Hannover city, Germany and invited with a personalized letter to participate in the study. Initially, a blood sample (40 ml) will be drawn from each participant (day 0). Furthermore, participants will be vaccinated against influenza with FLUAD 2014/2015. FLUAD is a trivalent, surface antigen, inactivated influenza virus vaccine adjuvanted with MF59C.1. Additional five blood samples will be collected during the study period of four months (at days 3, 7, 21, 70 and 130). Information about current and past infections, chronic diseases and basic sociodemographic data will be collected through a self-administered questionnaire.

Official Title
-----------------
Determinants of Vaccine Response to Influenza Vaccination Among Individuals Over 65 Years of Age - a Population-based Study

Conditions
-----------------
Influenza

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals between 65 and 80 years of age Exclusion Criteria: Individuals with a known hypersensitivity to any of the excipients and to eggs, chicken Protein, kanamycin and neomycin sulphate, formaldehyde, and cetyltrimethylammonium bromide Individuals, who have an acute infection during the visit at the study Center Individuals with cognitive impairment Individuals already vaccinated with influenza vaccination in the influenza season 2014/15

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 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 |
| --- | --- |
| A cohort of elderly individuals<br>A cohort of elderly individuals between 65 and 80 years of age were vaccinated with Fluad, a seasonal inactivated trivalent adjuvanted influenza vaccine. Blood samples before (day 0) and at days 1/3, 7,21 and 70 after vaccination were collected. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serological evidence of vaccine response to influenza vaccination |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza vaccination, Elderly individuals, Prospective cohort study, response
Identification of Spine Structures by Using BIP-Needles

Study Overview
=================
Brief Summary
-----------------
The main purpose of the study is to assess the feasibility and clinical performance of impedance based tissue identification in various spine structures.

Official Title
-----------------
INJ-SPINE-01 Identification of Spine Structures by Using BIP-Needles

Conditions
-----------------
Spinal Puncture

Intervention / Treatment
-----------------
* Device: Injeq Bioimpedance Probe (BIP) Needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Voluntary adult patients going through medical operation involving spinal puncture, spinal fluid sampling or intrathecal drug injection. Exclusion Criteria: Participation to other clinical study Exclusion criteria are the same as generally for spinal anaesthesia and lumbar punctures. Exclusion criteria includes infection on skin area, systemic anticoagulation, sepsis, anatomical unsuitability and refusal In addition for not giving (or not capable to give) the consent personally for any reason is an absolute exclusion criterion. In practice this means that study is for adult patients only.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injeq Bioimpedance Probe (BIP) Needle<br>Injeq Bioimpedance Probe (BIP) Needle is a spinal needle that has bioimpedance measurement capability. | Device: Injeq Bioimpedance Probe (BIP) Needle<br>* Injeq Bioimpedance Probe (BIP) Needle is a spinal needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with cerebrospinal fluid.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| True positive and false positive detection of cerebrospinal fluid marked in case report form | Measurement device indicates with a sound and visual feedback when needle reaches cerebrospinal fluid (CSF). Physician verifies the location by removing the needle stylet and testing whether CSF flows from the needle, similarly as in traditional process. Detection is true positive if CSF flows from the needle and false positive if not. Even if the device does not detect the spinal fluid, physician performs the CSF test when needed. Physician marks to the case report form whether the device provided detections during the spinal puncture and were the detections true or false detections. | During spinal puncture |
Outcomes After Centrifugation Versus PureGraft for Fatgrafting to the Breast

Study Overview
=================
Brief Summary
-----------------
Breast-conserving treatment (BCT) leads to a progressive and deteriorating breast deformity. Fatgrafting is ideal for breast reconstruction after BCT. The most frequently utilized technique for fat processing is centrifugation. The PureGraft device (Cytori Therapeutics, USA) is a new method that involves washing and filtering the fat to prepare the graft. The investigators compared the subjective and objective outcomes of two fat-processing methods, centrifugation and PureGraft filtration. Thirty patients underwent breast reconstruction performed by a single surgeon (OM) after BCT in our department between April 2011 and September 2012. The patients were preoperatively divided into two groups randomly: 15 received fatgrafts processed by centrifugation, and 15 received fatgrafts processed by washing in PureGraft bags. The patients were followed up for 12-30 months.To measure the subjective outcome, the investigators distributed the BREAST-Q questionnaire to all the patients both preoperatively and one year postoperatively. The BCCT.core software evaluated the objective outcome of breast reconstruction by fatgrafting.

Official Title
-----------------
Outcomes After Centrifugation Versus PureGraft for Fatgrafting to the Breast After Breast-conserving Therapy

Conditions
-----------------
Fatgrafting to a Breast After Breast Conserving Therapy

Intervention / Treatment
-----------------
* Other: Puregraft
* Other: Centrifugation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: State after breast conserving therapy
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Centrifugation<br>Patients recieved fatgraft processed by Centrifugation | Other: Centrifugation<br> <br> |
| Active Comparator: Puregraft<br>Patients recieved fatgraft processed by Puregraft | Other: Puregraft<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcomes after centrifugation versus PureGraft for fatgrafting to the breast after breast-conserving therapy |  | 1 year |
Symbicort Usage in Asthma Treatment and Impact of a New Therapeutic Strategy on Compliance and Asthma Control in France

Study Overview
=================
Brief Summary
-----------------
Descriptive pharmacoepidemiological study on the use of Symbicort Turbuhaler in the treatment of asthma in France and impact of a new therapeutic strategy on the compliance and control of asthma

Official Title
-----------------
Descriptive Pharmacoepidemiological Study on the Use of Symbicort Turbuhaler in the Treatment of Asthma in France and Impact of a New Therapeutic Strategy on the Compliance and Control of Asthma

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthmatic patients treated for this disease with Symbicort Turbuhaler Patients monitored for asthma by the doctor for at least 12 months Patients seen in outpatient care at the baseline visit Patients agreeing to participate in the study Exclusion Criteria: Patients with any chronic lower respiratory disease other than asthma Patients receiving anti-IgE agents in the last 4 months Patients receiving desensitisation treatment outside of the maintenance phase Patients deemed to be unable to respond to the study for linguistic or cognitive reasons
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients treated with Symbicort basic treatment | |
| 2<br>Patients treated with Symbicort basic treatment + treatment of symptoms as needed | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of control of the asthma |  | 3 months | 
| Evaluation of compliance with treatment |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Symbicort Turbuhaler, asthma, cohort study, France