linjc16/ctgov huggingface dataset:
Dry Eye Evaluation After Transepithelial PRK

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the severity of dry eye syndrome following excimer laser vision correction using no-touch all-laser photorefractive keratectomy in comparison to conventional lasik

Detailed Description
-----------------
Prospective interventional clinical study 2 groups: Group A : 20 eyes of 10 patients undergoing transepithelial PRK Group B: 20 eyes of 10 patients undergoing LASIK using mechanical microkeratome Tear Break Up Time and Schirmer 2 tests are used to evaluate severity of dry eye before surgery and 1 , 3 and 6 months postoperative Follow up period : 6 months

Official Title
-----------------
Evaluation of Dry Eye Following Transepithelial Photorefractive Keratectomy in Comparison to Conventional LASIK: a Comparative Study

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Procedure: transepithelial PRK
* Procedure: LASIK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Myopia -1 to -6 diopters Astigmatism -0.5 to - 4 diopters Exclusion Criteria: Pregnancy and lactation Keratoconus Previous refractive surgery Previous herpetic keratitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transepithelial PRK<br>20 eyes to undergo a no touch , all-laser advanced surface ablation technique termed transepithelial PRK using the Amaris laser platform (Schwind eye-tech solutions Gmbh, Germany) | Procedure: transepithelial PRK<br> <br> |
| Active Comparator: Conventional LASIK<br>20 eyes to undergo LASIK using a mechanical microkeratome (M2, Moria Surgical, Antony, France) and the Mel 80 excimer laser system(Carl Zeiss Meditec) | Procedure: LASIK<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| qualitative assessment of dry eye syndrome | Tear Break Up time is used as a qualitative measure of dry eye after surgery | 6 months | 
| quantitative of dry eye after surgery | Schirmer test is used as a quantitative measure of dry eye after surgery | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| haze | haze is a known possible complication of surface ablation Its severity can be graded according to a slit lamp scoring system | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transepithelial PRK, Dry eye, Schirmer test, Tear break up time, Dry eye after advanced surface ablation technique
Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation

Study Overview
=================
Brief Summary
-----------------
The clinical and pathological similarities between LRRK2 related parkinsonism and idiopathic Parkinson's disease (PD) indicate that monogenetic LRRK2 parkinsonism may be a paradigm for the development of Lewy bodies disease, and a careful look at discrepancies between these two conditions may provide insight into the pathogenesis of PD. The early involvement of the enteric nervous system (ENS) during PD led to theories that an as yet unidentified external agent entering the ENS causes PD . If lesions of the ENS are found in patients who present with a genetic form of parkinsonism would go against this notion, and thus provide insight to the pathophysiology of the disease.

Official Title
-----------------
Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: colonoscopy or rectosigmoidoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 30-80, both genders Parkinson's disease patients Parkinson's disease patients with G2019S mutations Controls: patient at risk of colic cancer for whom a coloscopy is required

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Colonic biopsies<br>Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy | Other: colonoscopy or rectosigmoidoscopy<br>* Usual procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of intestinal permeability in biopsies using Ussing's chambers |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, gut, colon, biopsies, LRRK2
Difference Strain Ratio Ultrasound Elastography Between Benign and Malignant Peripheral Lung Lesions

Study Overview
=================
Brief Summary
-----------------
Diagnostic accuracy study to investigate the sensitivity and specificity of sonographic elastography using strain ratio to differentiate between benign and malignant peripheral lesions in comparison to biopsy, clinically, or radiologically.

Detailed Description
-----------------
This is a diagnostic accuracy study with comparison to gold standard tests e.g., chest computed tomography, transthoracic biopsy, or microbiological analysis. All patients included in this study will give informed consent according to the guidelines of ethics committee, Alexandria Faculty of Medicine. (http://www.med.alexu.edu.eg/wp-content/uploads/2012/04/Checklist-FINAL- 20141.pdf-)

Official Title
-----------------
Difference In Strain Ratio Ultrasound Elastography Between Benign And Malignant Peripheral Parenchymal Lung Lesions.

Conditions
-----------------
Peripheral Lung Lesions

Intervention / Treatment
-----------------
* Procedure: Transthoracic biopsy
* Radiation: CT chest


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) Adult patients above age of 18 years old. 2) Patients with peripheral lung lesion. Exclusion Criteria: Pure pleural lesions. Clinical instability to reach the final diagnosis. Inaccessibility by ultrasound.

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 |
| --- | --- |
| benign lung lesions<br>Patient who were diagnosed with peripheral lung lesions including consolidation, atelectasis, or cavitation | Procedure: Transthoracic biopsy<br>* Us guided transthoracic biopsy<br>Radiation: CT chest<br>* Computed tomography<br>|
| malignant lung lesions<br>patients diagnosed with malignant lung lesions | Procedure: Transthoracic biopsy<br>* Us guided transthoracic biopsy<br>Radiation: CT chest<br>* Computed tomography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cut off value strain ratio | To differentiate between benign and malignant lung lesions using strain ratio | 6-9 months |
Pattern of Cell Death Following Neoadjuvant Therapy for Metastatic Colon Cancer

Study Overview
=================
Brief Summary
-----------------
Systemic chemotherapy for metastatic colon cancer is often used in the neoadjuvant setting for patients undergoing liver resection. This treatment is given either to keep the tumor at bay or reduce its size before the time of resection. While many metastatic tumors might appear to respond well and even radiographically disappear following neoadjuvant therapy, it is unclear whether grossly or radiographically negative areas of previous disease are microscopically free of tumor cells. As such, when possible, resection boarders typically follow 1 cm margins from the tumor size prior to neoadjuvant therapy. These margins might be necessary to encompass all histologically present disease or they might be unnecessarily large, serving only to increase the mortality and morbidity of the operation. This study begins to address this question by a histological examination of the pattern of cell death in areas of metastases removed after neoadjuvant therapy. Furthermore, clinical cases in which neoadjuvant therapy allowed for resection of previously unresectable cancer will be examined to determine whether there is an increased rate of recurrence despite negative resection boundaries in these cases.

Official Title
-----------------
Pattern of Cell Death Following Neoadjuvant Therapy for Metastatic Colon Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be ≥ 18 years old. Patients must have colon cancer metastases to the liver. Patients must be candidates and be scheduled for liver resection. Patients must have received and have had a response to neoadjuvant therapy prior to liver resection. Patients must have signed Institutional Review Board (IRB) approved written consent form prior to registering in the study. Exclusion Criteria: Patients who are < 18 years old. Patients who do not have colon cancer metastases to the liver. Patients who are not surgical candidates. Patients who do not schedule or who cancel a liver resection. Patients who have not received neoadjuvant therapy. Patients who have received neoadjuvant therapy but who have had no response or who have had tumor progression.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metastatic colorectal cancer, liver metastasis, tumor margins, neoadjuvant therapy
Buprenorphine Dose Alteration Study - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects in buprenorphine dose alterations in opioid dependent individuals being maintained on buprenorphine.

Official Title
-----------------
Buprenorphine Dose Alteration Study

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 41 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid withdrawal |  |  | 
| Subjective dose estimate |  |  | 
| Drug effect characteristics: ARCI |  |  | 
| Physiological changes in: pupil diameter |  |  | 
| Physiological changes in: blood pressure |  |  | 
| Physiological changes in: heart rate |  |  | 
| Physiological changes in: respiration |  |  | 
| Physiological changes in: skin temperature |  |  |
Dose-adjusted EPOCH-R in MYC Positive DLBCL

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.

Detailed Description
-----------------
The prognosis of MYC positive diffuse large B-cell lymphoma (DLBCL) is very poor even treated with R-CHOP regimen. Recently, dose-adjusted EPOCH-R was shown to be effective in patients with DLBCL and relapsed/refractory Burkitt lymphoma. The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.

Official Title
-----------------
Dose-adjusted EPOCH-R in Patients With Diffuse Large B-cell Lymphoma: a Phase II Study

Conditions
-----------------
Diffuse Large B-cell Lymphoma

Intervention / Treatment
-----------------
* Drug: DA-EPOCH-R


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously untreated MYC positive diffuse large B-cell lymphoma Age range 18-70 years old Eastern Cooperative Oncology Group performance status 0-2 Life expectancy of more than 3 months Adequate organ function Exclusion Criteria: Primary or secondary central nervous system involvement Previous serious cardiac disease History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Pregnant or lactating women Serious uncontrolled diseases and intercurrent infection

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA-EPOCH-R<br>rituximab 375mg/m2 IV day 0, etoposide 50mg/m2/d CIV days 1-4, doxorubicin 10mg/m2/d CIV days 1-4, vincristine 0.4mg/m2/d CIV days 1-4, cyclophosphamide 750mg/m2 IV day 5, prednisone 50mg PO days 1-5 twice per day | Drug: DA-EPOCH-R<br>* rituximab 375mg/m2 IV day 0, etoposide 50mg/m2/d CIV days 1-4, doxorubicin 10mg/m2/d CIV days 1-4, vincristine 0.4mg/m2/d CIV days 1-4, cyclophosphamide 750mg/m2 IV day 5, prednisone 50mg PO days 1-5 twice per day<br>* Other names: mabthera;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year progression-free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | 4 months | 
| 3-year overall survival |  | 3 years | 
| Toxicity |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DLBCL, DA-EPOCH-R
Bariatric Surgery and Pharmacokinetics of Lamotrigine

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on lamotrigine are investigated.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics Lamotrigine: BAR-MEDS Lamotrigine

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Lamotrigine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lamotrigine|Patients are tested for their normal prescription lamotrigine medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lamotrigine concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Lamotrigine
Neuromas as the Cause of Pain

Study Overview
=================
Brief Summary
-----------------
Neuromas are frequent after trauma and surgery, including amputation and can be identified by high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is uncertain. The investigators therefore wish to explore if spontaneous and evoked pain will be relieved by injection of local anesthetics near painful neuromas in subjects with peripheral nerve injury.

Official Title
-----------------
Infiltration of Neuromas With Local Anesthetics to Eliminate Pain: A Double-blinded Crossover Study

Conditions
-----------------
Neuropathic Pain, Neuroma

Intervention / Treatment
-----------------
* Drug: Lidocaine
* Drug: Isotonic Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with peripheral nerve injury 3 months prior to participation Exclusion Criteria: Severe somatic or psychiatric diseases Other peripheral neuropathy Lack of ability to cooperate to the clinical examination Allergy to Lidocaine or similar analgetics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>Lidocaine 2 ml injection with 2% Adrenaline | Drug: Lidocaine<br> <br> |
| Placebo Comparator: Isotonic Saline<br>Isotonic Saline 2 ml Injection | Drug: Isotonic Saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous pain on numerical rating scale (NRS 0-10) | The participant will be asked about spontaneous pain | 15 minutes after injection | 
| Evoked pain on numerical rating scale (NRS 0-10) |  | 15 minutes after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brush allodynia | Assesment of area (cm^2) using a SOMEDIC brush | 15 minutes after injection | 
| Pinprick hyperalgesia | Assesment of area (cm^2) using a von Frey filament (60 g) | 15 minutes after injection | 
| Cold allodynia | Assesment of area (cm^2) using a roll (20 degrees celcius) | 15 minutes after injection | 
| Heat allodynia | Assesment of area (cm^2) using a roll (40 degrees celcius) | 15 minutes after injection |
Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide a tool for physicians to compare outcome data related to the use of the HALO Ablation Systems. This study is a single-center patient registry which will contribute to a framework for treatment and follow-up of patients with Barrett's Esophagus.

Official Title
-----------------
Single Center Patient Registry Using Radio Frequency Ablation of Barrett's Esophagus Using HALO System

Conditions
-----------------
Barrett's Esophagus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: candidate for ablation of Barrett's Esophagus with the HALO Ablation System (Prospective) received an ablation with the HALO Ablation System to treat Barrett's Esophagus (Retrospective) candidate agrees to proposed follow-up schedule of yearly surveillance following treatment signs consent Exclusion Criteria: has not been diagnosed with Barrett's Esophagus
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-Dysplastic IM, LGD, HGD<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic clearance rate for Barrett's Esophagus |  | Outcome measure is assessed at Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological clearance rate for intestinal metaplasia |  | Biopsy taken at 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RFA