linjc16/ctgov huggingface dataset:
Computed Tomography in Detecting Movement of the Esophagus in Patients Undergoing Radiation Therapy to the Chest

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Comparing results of diagnostic procedures, such as computed tomography scan (CT scan), done before and after radiation therapy to help detect movement of the esophagus may help doctors plan the best treatment. PURPOSE: This clinical trial is using CT scan to help detect movement of the esophagus in patients undergoing radiation therapy to the chest.

Detailed Description
-----------------
OBJECTIVES: Determine the inter- and intra-fraction movement of the esophagus using CT scans in patients undergoing thoracic radiotherapy. OUTLINE: This is a pilot study. Patients undergo CT scans at baseline and then once weekly during their scheduled radiotherapy sessions to determine esophageal placement while in the treatment position. CT scans are performed before and after the radiotherapy session. Pretreatment and post-treatment scans are compared. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.

Official Title
-----------------
Evaluation of Esophageal Motion by Computed Tomography (CT) During the Course of Thoracic Radiotherapy

Conditions
-----------------
Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Procedure: computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Planning to undergo definitive thoracic radiotherapy PATIENT CHARACTERISTICS: Age Not specified Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy See Disease Characteristics No concurrent palliative thoracic radiotherapy Surgery Not specified Other Concurrent participation in other clinical trials allowed
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: computed tomography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter- and intra-fraction movement of the esophagus as measured by CT scans |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unspecified adult solid tumor, protocol specific
Immune Modulation From Trichuris Suis

Study Overview
=================
Brief Summary
-----------------
Mucosal immunology during helminth infection

Detailed Description
-----------------
The present study investigates the effects of Trichuris suis on human mucosal and systemic immunity in a single self-infected individual.

Official Title
-----------------
Mucosal and Systemic Immune Modulation From Trichuris Suis in a Self-infected Individual

Conditions
-----------------
Crohn Disease, Ulcerative Colitis, Intestinal Helminthiasis

Intervention / Treatment
-----------------
* Biological: Trichuris suis eggs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The included volunteer is a researcher within parasitology with main focus on Trichuris trichiura and Trichiura suis. He planned to infect himself and contacted our department with the purpose of being monitored during this infection for safety (medical supervision) and research reasons. The only clinical criterion for his inclusion in the study was that he was healthy. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Trichuris suis eggs|Live eggs from swine whipworm, Trichuris suis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faecal egg excretion | Weekly monitoring of fecal egg counts by microscopy | 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal T cell associated cytokines | Biopsy sampling during established infection | 15 weeks | 
| Systemic immune parameters (eosinophilia, Subtypes of circulating T cells) | Blood samples every week | 15 weeks | 
| Adverse events | Clinical evaluation every week | 15 weeks |
Patient Satisfaction and Quality of Life Impact - PecFent®

Study Overview
=================
Brief Summary
-----------------
National multicenter, prospective, observational study in cancer patients with chronic background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic condition by a specialist in the treatment of cancer pain conditions. • Study objectives include assessment of early treatment satisfaction.

Official Title
-----------------
A Spanish , Multicentre, Open-label, Observational Study to Assess Quality of Life and Satisfaction in Subjects Taking PecFent® for the Treatment of Breakthrough Cancer Pain (BTPc)

Conditions
-----------------
Breakthrough Cancer Pain

Intervention / Treatment
-----------------
* Drug: PecFent® (fentanyl) nasal spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (aged ≥18 years) with cancer Taking at least 60 mg of oral morphine sulfate or equivalent per day for chronic background pain

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 |
| --- | --- |
| PecFent®<br> | Drug: PecFent® (fentanyl) nasal spray<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction | Satisfaction will be assessed using a 4-point Likert scale. | Satisfaction will be assessed approximately 1 hour after each breakthrough pain (BTPc) episode treated with PecFent® from completion of titration through Day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quality of life, PecFent, Lazanda, fentanyl, intranasal, breakthrough cancer pain
Deep Learning for the Discrimination Among Different Types of Keratits: a Nationwide Study

Study Overview
=================
Brief Summary
-----------------
Detecting the cause of keratitis fast is the premise of providing targeted therapy for reducing vision loss and preventing severe complications. Due to overlapping inflammatory features, even expert cornea specialists have relatively poor performance in the identification of causative pathogen of infectious keraitis. In this project, the investigators aim to develop an automated and accurate deep learning system to discriminate among bacterial, fungal, viral, amebic and noninfectious keratitis based on slit-lamp images and evaluated this system using the datasets obtained from mutiple independent clinical centers across China.

Official Title
-----------------
Deep Learning for the Discrimination Among Bacterial, Fungal, Viral, Amebic and Noninfectious Keratitis: a Nationwide Study

Conditions
-----------------
Keratitis, Automatic Judgement, Image

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Slit-lamp images with sufficient diagnostic certainty and showing keratitis at the active phase. Exclusion Criteria: Poor-quality images Images presenting mixed infections (i.e., cornea infected by two or more causative pathogens)

Ages Eligible for Study
-----------------
Minimum Age: 1 Week
Maximum Age: 100 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 |
| --- | --- | --- |
| Area under the receiver operating characteristic curve of the deep learning system |  | 2020-2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the deep learning system |  | 2020-2022 | 
| Sensitivity of the deep learning system |  | 2020-2022 | 
| Specificity of the deep learning system |  | 2020-2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keratitis, Slit-lamp Image, Deep Learning
Meta-Iodobenzylguanidine Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcomes in subjects with heart failure and in comparison to subjects without cardiovascular disease.

Official Title
-----------------
An Open-Label, Multicenter, Phase 3 Study Evaluating the Prognostic Usefulness of I-123 mIBG Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event

Conditions
-----------------
Heart Failure, Congestive

Intervention / Treatment
-----------------
* Drug: 123I-mIBG (meta-iodobenzylguanidine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study subjects must be adults with an established diagnosis of heart failure (New York Heart Association Class II or III) and reduced left ventricular ejection fraction (LVEF) (≤ 35%) or be healthy volunteers without heart disease. Exclusion Criteria: Healthy volunteers are not eligible if they have a history diabetes mellitus, signs/symptoms of neurological disease (eg, Parkinson's Disease, multiple system atrophy, Parkinsonian syndromes), or other diseases known to affect the sympathetic nervous system. Subjects with New York Heart Association Class I or IV heart failure are not eligible.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 123I-mIBG (meta-iodobenzylquanidine<br>Single dose | Drug: 123I-mIBG (meta-iodobenzylguanidine)<br>* Single dose<br>* Other names: meta-iodobenzylguanidine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship Between the Occurrence of Adverse Cardiac Event and 123I-mIBG Uptake on Planar Scintigraphy Categorized as High or Low Heart to Mediastinum (H/M) Ratio | H/M ratio for 123I-mIBG uptake at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Assessments were done by 3 independent readers. H/M ratios were categorized as 'Low' and 'High' based on being <1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data collected relative to time to adverse cardiac events. | Approximately 24 months from the date of administration of 123I-mIBG | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, nuclear cardiology, sympathetic innervation, 123I-mIBG
Comparison of Dynamic Distraction Systems in Proximal Interphalangeal Joint Fractures

Study Overview
=================
Brief Summary
-----------------
Fractures of the proximal interphalangeal joints continue to pose significant management challenges. Thus the aim of our study is to compare two dynamic finger joint distractors (Litos® and Ligamentotaxor®) in respect to the radiological standard follow-up examination and functional assessments.

Official Title
-----------------
Comparison of Dynamic Distraction Systems in Proximal Interphalangeal Joint Fractures

Conditions
-----------------
Proximal Interphalangeal Joint Fracture of the Hand

Intervention / Treatment
-----------------
* Device: LITOS
* Device: Ligamentotaxor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: proximal interphalangeal fracture treated with external dynamic fixator Operative care <21 days from trauma Age between 18 and 90 years. Male and female Exclusion Criteria: - additional fractures or disabilities of the hand

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| LITOS<br>Patients who received a LITOS dynamic distraction system after 31.12.2017 | Device: LITOS<br>* Patients who received a LITOS dynamic distraction system after 31.12.2017<br>|
| Ligamentotaxor<br>Patients who received a Ligamentotaxor dynamic distraction system after 31.12.2017 | Device: Ligamentotaxor<br>* Patients who received a Ligamentotaxor dynamic distraction system after 31.12.2017<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of Arm, Shoulder and Hand (DASH) score | Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5) | 3 months after explantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) pain | From 0mm (no pain) to 100mm (maximum pain imaginable) | 3 months after explantation | 
| Functional assessment: Goniometry | ROM of each joint of the injured fingert with a goniometer. | 3 months after explantation |
HKI-272 Ketoconazole Drug Interaction Study

Study Overview
=================
Brief Summary
-----------------
To investigate a potential pharmacokinetic drug interaction between HKI-272 and ketoconazole when co-administered.

Official Title
-----------------
An Open-label, Randomized, 2-period Crossover, Drug Interaction Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Ketoconazole and a Single Dose of HKI-272 Administered Orally to Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: neratinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: neratinib|HKI-272|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics; safety and tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetic, healthy subjects
Cardiovascular Response in Implant Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to observe the level of anxiety and its relationship with cardiovascular changes in each implant.

Official Title
-----------------
Changes in Cardiovascular Response and Dental Anxiety in Multiple Implant Surgery

Conditions
-----------------
Dental Anxiety, Cardiovascular Abnormalities

Intervention / Treatment
-----------------
* Behavioral: multiple implant surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 30 4 years and older implant in the same session Exclusion Criteria: patients with syndrome, having systemic disease, having heart problems, undergo another oral or maxillofacial procedure in the last 6 months, using medications that may cause changes in medical conditions and heart rate,

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: multiple implant surgery|Patients older than 30 years who will undergo elective dental implant surgery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | cardiovascular changes in implant surgery | 4 months |
Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of dimebon given to Alzheimer's disease patients currently on a stable dose and regimen of memantine or memantine plus donepezil.

Official Title
-----------------
A Multi-Center Phase 1 Study of the Safety and Tolerability of Dimebon in Alzheimer's Disease Patients on Memantine (Cohort 1) and Memantine Plus Donepezil (Cohort 2)

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Dimebon
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alzheimer's disease On Memantine Caregiver who is willing to accompany the patient to all clinic visits Exclusion Criteria: Unstable medical illnesses or significant hepatic or renal disease Other primary psychiatric or neurological disorders

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dimebon<br>20 mg dimebon by mouth 3 times per day | Drug: Dimebon<br> <br> |
| Placebo Comparator: Placebo<br>20 mg placebo by mouth 3 times per day | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of orally administered dimebon in patients with Alzheimer's disease (AD) on a stable dose and regimen of memantine, or memantine plus donepezil. | Treatment discontinuation due to adverse events, the frequency and severity of adverse events, and clinically significant changes in safety assessments (including physical examination findings, vital signs, laboratory values, and ECGs) in the dimebon group will be compared to those reported in the placebo group. | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the steady-state pharmacokinetics (PK) of orally-administered dimebon in patients with AD on a stable dose and regimen of memantine, or memantine plus donepezil. | The following key parameters will be used to assess the steady-state PK of dimebon: maximum plasma concentration (Cmax), time to maximum plasma concentration (tmax), Ctrough, area under the curve (AUC), and peak-to-trough ratio. | up to 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimers disease, donepezil, memantine
Resolvin D1 in Psoriasis Before and After Narrowband UVB Phototherapy

Study Overview
=================
Brief Summary
-----------------
• Assessment of tissue level of resolvin D1 in psoriasis in comparison to its level in healthy controls in order to verify its role in the pathogenesis of psoriasis.

Official Title
-----------------
Estimation of Tissue Level of Resolvin D1 in Psoriasis Before and After Narrowband UVB Phototherapy: a Case-control Study.

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Other: skin biopsy before and after NB-UVB phototherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with psoriasis (adults and children above 12years) Both sexes. New cases or cases not receiving any treatment for at least 3 months ago. Exclusion Criteria: Any contraindication to phototherapy treatment (e.g. Photosensitizing creams or medications, past skin cancer, especially melanoma, etc...) Erythrodermic and pustular psoriasis. History of autoimmune diseases or other systemic diseases (e.g. Alzheimer's disease, fibromyalgia, cystic fibrosis)

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: psoriasis patients<br>Tissue levels of resolvin D1 in psoriatic patients before and after NB-UVB. | Other: skin biopsy before and after NB-UVB phototherapy<br>* skin biopsy before and after NB-UVB phototherapy to measure tissue resolvin D1<br>|
| Experimental: controls<br>Tissue levels of resolvin D1 in controls | Other: skin biopsy before and after NB-UVB phototherapy<br>* skin biopsy before and after NB-UVB phototherapy to measure tissue resolvin D1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue levels of resolvin D1 in psoriatic patients before and after NB-UVB. |  | 6 months |