linjc16/ctgov huggingface dataset:
Pilot Study of Measurement Agreement Between Morphological and Diffusion Tensor Imaging MRI for Pelvic Nerve Cartography

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that diffusion tensor imaging (DTI) will produce a similar map of autonomic pelvic innervation to that obtained using 3D morphological MRI sequences

Official Title
-----------------
Pilot Study of Measurement Agreement Between Morphological and Diffusion Tensor Imaging MRI for Pelvic Nerve Cartography

Conditions
-----------------
Pelvic MRI

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have given their free and informed consent and signed the consent form The patient must be a member or beneficiary of a health insurance plan The patient it at least 18 years old The patient has been admitted for an MRI examination of the pelvic region, for any reason Exclusion Criteria: The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study The subject refuses to sign the consent It is impossible to give the subject informed information The patient is under safeguard of justice or state guardianship The patient is pregnant or breast feeding There is a contra-indication for MRI (pacemaker, claustrophobic patient) The patient has had previous pelvic surgery

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 |
| --- | --- |
| Patients recruited for pelvic imaging examination<br> | Other: MRI<br>* 3D morphological MRI and diffusion tensor imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between DTI imaging measures versus 3D morphological MRI measures for point of penetration of the pelvic splanchnic nerves in the lower hypogastric plexus | Lin's concordance correlation coefficient and Bland-Altman Plot | Day 0 | 
| Agreement between DTI imaging measures versus 3D morphological MRI measures for point of penetration of the pelvic hypogastric nerves in the lower hypogastric plexus | Lin's concordance correlation coefficient and Bland-Altman Plot | Day 0 | 
| Agreement between DTI imaging measures versus 3D morphological MRI measures for origin of the cavernous nerves | Lin's concordance correlation coefficient and Bland-Altman Plot | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acquisition time | min | Day 0 | 
| Time necessary for sequence reconstruction | min | Day 0 | 
| Inter-operator agreement | Kappa coefficient of measurements between two operators | Day 0 | 
| Intra-operator agreement | Kappa coefficient of measurements from same operator 6 months apart | Month 6 |
Risk Factors and Outcomes of Immune-Mediated Encephalitis Following Exposure to Nivolumab

Study Overview
=================
Brief Summary
-----------------
A case series analysis of encephalitis events reported to the Sponsor for patients treated with nivolumab to assess the risk factors and outcomes of immune-mediated encephalitis.

Official Title
-----------------
Case Series Analyses of the Risk Factors and Outcomes of Immune-Mediated Encephalitis Following Exposure to Nivolumab

Conditions
-----------------
Encephalitis

Intervention / Treatment
-----------------
* Biological: Nivolumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate, severe, life-threatening or fatal encephalitis events occurring in patients treated with nivolumab and reported to the Sponsor Exclusion Criteria: Encephalitis cases identified through literature reviews and not reported to the Sponsor Encephalitis cases identified from company-sponsored observational studies with secondary data collection Spontaneous reports not submitted directly to the Sponsor Other protocol-defined inclusion/exclusion criteria apply
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 Treated with Nivolumab followed by Encephalitis Event<br>Case series reported to the sponsor from various health care facilities | Biological: Nivolumab<br>* Specified dose on specified days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcomes of Encephalitis | Time since onset of immune-mediated encephalitis to the date of outcome assessment (days) and outcomes defined as: resolved, resolving, death, physical disability (specified), cognitive disability (specified) | 1 year | 
| Risk factors of Encephalitis | Potential risk factors include but are not limited to medical history including event associated signs/symptoms, and data from brain imaging diffusion, results from lumbar puncture analyses, results from serum sample analyses and results from neurologic examinations | 1 year |
Validation of Low Anterior Resection Syndrome Score in Korean Version

Study Overview
=================
Brief Summary
-----------------
In contemporary era of rectal cancer treatment, development of surgical technique and tool, adaptation of chemoradiation therapy, as well as multidisciplinary approach have led increased survival as well as rate of sphincter preservation. However, poor anorectal function, such as fecal incontinence and/or urgency, has also been increased. Such anorectal dysfunction is named as low anterior resection syndrome, and its rate has been reported in 40 to 90% in rectal cancer patients who received sphincter preserving surgery. Low anterior resection syndrome is known to debilitate quality of life in survivors of rectal cancer. Previously, several studies attempted to evaluate the low anterior resection syndrome via questionnaires and scoring system. Adapting the low anterior resection syndrome score system created in Denmark, this study investigates the validity of the scoring system in Korean language.

Detailed Description
-----------------
In this study, the low anterior resection syndrome score questionnaire proposed by Therese Juul is translated to Korean language by 3 different professional translators. Patients who received sphincter saving surgery to treat rectal cancer will be asked to fill up the questionnaire. Compiling the results, the quality of life after sphincter preserving surgery will be investigated in the association with the low anterior resection syndrome.

Official Title
-----------------
Validation of Low Anterior Resection Syndrome Score in Korean Version

Conditions
-----------------
Surgery, Neoplasm of Rectum, Surgery--Complications

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 20-80 surgery undertook from Jan. 2009 to Dec. 2016 diagnosed with adenocarcinoma curative intent of surgery planned surgery sphincter saving surgery Exclusion Criteria: patients with stage IV emergency surgery patients with recurrent disease
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire|Rectal cancer patients who received sphincter saving surgery will be asked to fill up questionnaire related to bowel dysfunction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life in association to the severity of bowel dysfunction | The change in the quality of life will be evaluated based on the questionnaire in regard to bowel dysfunction | 3 months follow-up, 6 months follow-up, 1 year follow-up, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, beyond 5 year follow-up |
Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe the safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery in subjects with mild to moderate open-angle glaucoma.

Official Title
-----------------
Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry

Conditions
-----------------
Primary Open-angle Glaucoma

Intervention / Treatment
-----------------
* Device: iStent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive subjects in whom implantation of the iStent is attempted Exclusion Criteria: Please refer to approved indications in Directions for Use
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| iStent<br> | Device: iStent<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of sight-threatening adverse events |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other ocular adverse events |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary open-angle glaucoma (POAG), Trabecular meshwork, iStent
Differences in Exhaled Breath by Using Ion Mobility Spectrometry (IMS) in Subjects Tested for SARS-CoV-2 Infection (COVID-19 Disease)

Study Overview
=================
Brief Summary
-----------------
Breath gas analysis is the evaluation of exhaled breath. It aims to evaluate the volatile organic compounds (VOCs) in exhaled breath. In this feasibility study it is intended to find specific peaks/pattern in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).

Official Title
-----------------
Study to Evaluate Whether Differences in Exhaled Breath Can be Identified Using Ion Mobility Spectrometry (IMS) in Subjects Tested Positive for SARS-CoV-2 Infection and Subjects Tested Negative

Conditions
-----------------
SARS (Severe Acute Respiratory Syndrome), Covid19

Intervention / Treatment
-----------------
* Device: Ion Mobility Spectrometry (IMS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCR (= Polymerase Chain Reaction) testing for SARS CoV-2 will be/has been performed in a timely manner of sampling exhaled breath or PCR test for SARS-CoV-2 was performed within 96 hours, but preferably within 48 hours before sampling exhaled breath and PCR test result is already available Subject must be able to comply with study-specific procedures, e.g.is able to comply with breathing commands Exclusion Criteria: Previous (history) SARS-CoV-2 infection, independent of the current episode Participation in a therapeutic study prior to breath analysis which could influence the result of the breath analysis

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

| Intervention/Treatment |
| --- |
|Device: Ion Mobility Spectrometry (IMS)|Two breathing gas samples will be taken from each study participant using ion mobility spectrometry with an ultrasound-based spirometer. The total sampling time is 1 minute (at least 5-7 breath takes) following an analysis time of 5-12 minutes.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 related volatile organic compounds (VOC) |  | 1 hour after breath gas sampling | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 (Corona Virus Disease 2019) |  | within 1 hour |
DHPLC Determination of TPMT Polymorphisms.

Study Overview
=================
Brief Summary
-----------------
TPMT is a key enzyme in the metabolism of thiopurines. TPMT polymorphisms have been described and are associated with a decrease activity of such enzyme. Therefore, a higher risk of developing toxicity is present in patients requiring these drugs, which are indicated in acute lymphoblastic leukemia, as well as, immunosuppressors after organ transplantation. The frequency of heterozygotes polymorphisms ranges from 3 till 12 %, in different populations. Homozygous patients have a lower frequency, estimated 1 in 300 individuals. The frequency of such polymorphisms in mestizos mexican population has not been analyzed, and we considered important to determine this frequency in healthy and patients requiring thiopurines, particularly acute lymphoblastic leukemia.

Detailed Description
-----------------
Objectives: Determine by DHPLC analysis the frequency of TPMT polymorphisms in mestizos mexican population with acute lymphoblastic leukemia. To do a clinical correlation between the presence of polymorphism and thiopurine related- myelotoxicity. Inclusion criteria: Healthy volunteers or patients with acute lymphoblastic leukemia, age > 18 years, who attend to the National Institute of Cancerologia. Exclussion criteria: Patients with ALL, who are unable to have an adequate follow-up. Samples: Genomic DNA from peripheral blood leukocytes was isolated by standard methods. Known (wild-type and polymorphic) sequenced polymerase chain reaction (PCR) fragments of the TPMT gene were used as controls. TPMT gene fragments were amplified. PCR products were then analyzed by denaturating high performance liquid chromatography (DHPLC).

Official Title
-----------------
Prevention of Thiopurines Related Toxicity Through the Determination by DHPLC TPMT Polymorphisms in Patients With ALL.

Conditions
-----------------
Acute Lymphoblastic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy and patientes with acute lymphoblastic leukemia. Age: older than 18 years. Attend to the National Institute of Cancerologia Exclusion Criteria: Foreign patients with an irregular attendance to the National Institute of Cancerologia

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?
-----------------
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
-----------------
thiopurines, thiopurine methyl transferase, toxicity, pharmacogenomics
Chemoprevention With Folic Acid

Study Overview
=================
Brief Summary
-----------------
Colorectal neoplasia is the second most common cancer in the United States and other Western countries with about 140,000 newly diagnosed cases per year in the United States with a mortality rate of about 40%. The identification of a specific natural or synthetic compound with the ability to reverse or suppress the process of colon carcinogenesis would have profound implication in the development of colorectal adenomas and their subsequent transformation to colon cancer. Furthermore, the establishment of a correlative relationship between biomarkers of cell proliferation, differentiation, apoptosis and adenoma recurrence would provide pivotal data required to elucidate cell signaling mechanisms in future colon cancer chemoprevention trials.

Official Title
-----------------
3389 Colorectal Adenoma: Chemoprevention With Folic Acid

Conditions
-----------------
Colon Cancer, Adenoma, Colonic Polyps

Intervention / Treatment
-----------------
* Drug: Folic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Asymptomatic individuals from the age of 18 -80 years, undergoing clinically indicated colonoscopy for colon polyps noted on screening flexible sigmoidoscopy or as routine surveillance for a history of colon polyps, who are found to have at least one adenoma > 0.5cm will be eligible for entry.

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Folic Acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
the Effective Bolus Dose of Remifentanil for Laryngeal Mask Airway (LMA) Insertion in Children

Study Overview
=================
Brief Summary
-----------------
This research attempts to find the optimum dose of remifentanil that can prevent the unnecessary responses such as coughing, gagging, and movement when LMA is inserted during sevoflurane induction in pediatric patients.

Detailed Description
-----------------
Anaesthesia is induced by inhalation with 3% sevoflurane. A predetermined bolus dose of remifentanil is injected over 30 seconds. The LMA is attempted 60 seconds after bolus administration. The starting dose of remifentanil is 0.5μg/kg and a step size is 0.05μg/kg. If LMA insertion is successful or failed in previous patient, an decrement or increment of 0.05μg/kg remifentanil is injected to next patient, respectively.

Official Title
-----------------
the Effective Bolus Dose of Remifentanil for Laryngeal Mask Airway (LMA) Insertion in Pediatric Patients

Conditions
-----------------
Respiratory Complication

Intervention / Treatment
-----------------
* Drug: Remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists physical status 1 or 2 undergoing short elective surgery(i.e Strabismus surgery, Entropion surgery, Inguinal hernia surgery, etc) under general anesthesia Exclusion Criteria: suspected difficult airways respiratory disease (chronic obstructive pulmonary disease, upper respiratory infection) body mass index > 30 kg/m2 allergies to the study drugs a history of gastric reflux

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group R<br>The starting dose of remifentanil is 0.5μg/kg and a step size was 0.05μg/kg. | Drug: Remifentanil<br>* The starting dose of remifentanil is 0.5μg/kg and a step size is 0.05μg/kg. If LMA insertion is successful or failed in previous patient, an decrement or increment of 0.05μg/kg remifentanil is injected to next patient, respectively.<br>* Other names: remifentanil (ultiva);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients's response to the LMA insertion | Fail of LMA insertion is defined as body or limb movement, coughing or gagging with 2 minutes after LMA insertion, no proper jaw relaxation(difficult mouth opening), laryngospasm, bronchospasm, desaturation(SpO2<94%) | 2 minutes after LMA insertion |
Osteopathy and Latent Hypothyroidism

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effectiveness of stimulating the neurological segments c8-th5 in patients with latent hypothyroidism. One half of the participants will receive an osteopathic manuel treatment in order to stimulate the relevant segments, the other half will receive no treatment.

Detailed Description
-----------------
Patients with latent hypothyroidism show an increased hormone status in TSH and a normal hormone status in fT4. A study has shown that osteopathic treatment had positive effects to some symptoms in patients with latent hypothyroidism. The study was using the pain inventory as the instrument to measure the effect. In this study we want to evaluate the effectiveness of the treatment on the hormone status (TSH, fT4) The intervention group will receive a neurological osteopathic stimulation over 5 weeks. A parallel control group will not receive any therapy. A follow up blood screening (TSH, fT4) will be done. The results of both groups will be compared.

Official Title
-----------------
Osteopathy and Latent Hypothyroidism: Effectiveness of Osteopathic Treatment on TSH in Patients With Latent Hypothyroidism

Conditions
-----------------
Latent Hypothyroidism

Intervention / Treatment
-----------------
* Other: OMT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: latent hypothyroidism Exclusion Criteria: Factors that Alter Thyroxine and Triiodothyronine Binding in Serum Increased thyroxin-binding globulin Decreased thyroxin-binding globulin Binding inhibitors Inherited Salicylates Pregnancy Androgens Furosemide Neonatal state Anabolic steroids Free fatty acids Estrogens Glucocorticoids Phenytoin Hepatitis Severe illness Carbamazepine Porphyria Hepatic failure nonsteroidal antiinflammatory drug (variable, transient) Heroin Nephrosis Heparin Methadone Nicotinic acid Mitotane L-Asparaginase 5-Fluorouracil SERMS (e.g., tamoxifen, raloxifene) Perphenazine spinal pathologies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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 |
| --- | --- |
| Experimental: OMT-Group<br>The OMT-group will get an osteopathic treatment once a week for 1 hour for 5 weeks. The blood will be screened again after the treatment. | Other: OMT<br>* Manuel osteopathic treatment of the spine<br>|
| No Intervention: Controll Group<br>This group will receive no treatment. A blood screening is made again after 5 weeks. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TSH Concentration |  | 5 weeks |