linjc16/ctgov huggingface dataset:
Clinicopathological Importance of Colorectal Medullary Carcinoma: Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
Medullary carcinoma (MC) is a rare tumor with solid growth pattern without glandular differentiation and constitute less than 1% of colorectal cancer. Lymph node positivity and distant organ metastasis were reported to be lower than other poorly differentiated adenocarcinomas. Therefore, the diagnosis of MC is pathologically important in terms of follow-up and treatment. MC is commonly localized in the right colon, has a large tumor size, and is mostly diagnosed in the T4 stage. As MC most likely have defects in DNA MMR, the correct pathological diagnosis is important for the postoperative treatment and the prognosis of the patients.

Detailed Description
-----------------
427 patients with colorectal cancer who were underwent surgery between January 2011 and December 2017, were evaluated retrospectively into 2 groups as MC (n:13) and non-MC (n:414) in terms of demographic characteristics, pathological data and oncological outcomes.

Official Title
-----------------
Clinicopathological Importance of Colorectal Medullary Carcinoma: Retrospective Cohort Study

Conditions
-----------------
Colorectal Medullary Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: colorectal cancer diagnosis, medullary carcinoma Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medullary carcinoma of colorectal cancers<br> | |
| non-medullary carcinomas of the colorectal cancers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival of medullar colorectal carcinomas |  | 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medullary carcinoma, Colorectal cancer, Microsatellite instability
Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to determine the intra-prostatic concentration of sexual steroids when castration resistance appears in castration-resistant prostate cancer patients compared to patients naif of hormonal treatment

Official Title
-----------------
Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Biological: intra-prostatic concentration of sexual steroids
* Procedure: Trans-rectal biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: group 1: patients with a locally advanced prostate cancer naif of any hormonal treatment group 2: Patients with a castration-resistant prostate cancer resisting defined by a biological progression group 2a: without radiotherapy group 2b: with radiotherapy Affiliated to a social security scheme Having given a written consent. Exclusion Criteria: Patient unable to supply a written consent (patient not understanding French, under guardianship patient). neuro-endocrine form or sarcomatoid form prostate cancer

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prostate cancer patients resistant to castration<br> | Biological: intra-prostatic concentration of sexual steroids<br> <br> Procedure: Trans-rectal biopsy<br> <br> |
| Experimental: patients naif of hormonal treatment<br> | Biological: intra-prostatic concentration of sexual steroids<br> <br> Procedure: Trans-rectal biopsy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra-prostatic concentration of sexual steroids |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Androgen receptor immuno-histochemical expression level |  | 2 weeks | 
| Androgen receptor RNA expression level |  | 2 weeks | 
| Steroid 5-alphareductase immuno-histochemical expression level |  | 2 weeks | 
| Steroid 5-alphareductase RNA expression level |  | 2 weeks | 
| Steroid aromatase immuno-histochemical expression level |  | 2 weeks | 
| Steroid aromatase RNA expression level |  | 2 weeks |
Predictors of Adherence to Orencia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the relationship between loading dose and adherence to Orencia.

Official Title
-----------------
Predictors of Adherence to Orencia

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be identified based on the presence of first infusion claim during study period for Orencia At least 1 medical or facility claim for rheumatoid arthritis at the time of or 6 months prior to index date Patients are required to be continuously enrolled for a minimum pre-index and follow-up period as detailed below Patients with a minimum of 3 infusion claims for Orencia Only those patients will be included whose first 3 infusion claims occur within 84 days Exclusion Criteria: Patients less than 18 years of age at index date. One or more diagnoses of regional enteritis (including Crohn's disease), ulcerative colitis, anal or intestinal fistula, ankylosing spondylitis or other inflammatory spondylopathy, psoriatic arthropathy, or psoriasis any time during the 6-month pre-index period Patients who switch between biologics within their first three infusion claims Restarts, defined as those patients who go back on Orencia after a gap of 42 days Patients who are on other biologics at the same time as Orencia

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 with rheumatoid arthritis new to Orencia<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of days on Orencia therapy |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rheumatoid arthritis-related and total healthcare costs |  | 6 months |
Prophylactic Coagulation for the Prevention of Bleeding in Endoscopic Mucosal Resection of Large Sessile Colonic Polyps

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that prophylactic coagulation therapy with coagulation forceps to visible vessels within the mucosal defect for colonic Endoscopic Mucosal Resection (EMR) will reduce the rate of delayed bleeding when compared with current established standard EMR technique.

Detailed Description
-----------------
Delayed bleeding from the site of the resection remains one of the most common complications following EMR, occurring in up to 12% of patients. The purpose of the study is to prevent such bleeding with the use of a technique known as: coagulation therapy. This therapy involves using a small dose of heat energy that results in clotting(coagulation) of a blood vessel. It is already used widely in the stomach and we intend using this on a lower setting to blood vessels that are exposed after the resection.

Official Title
-----------------
Prophylactic Endoscopic Coagulation for the Prevention of Bleeding in Endoscopic Mucosal Resection (EMR) of Large Sessile Colonic Polyps: A Multi-centre, Randomised Control Trial

Conditions
-----------------
Adenomatous Polyp of Large Intestine

Intervention / Treatment
-----------------
* Procedure: Prophylactic use of coagulation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to Westmead Hospital Endoscopy unit for endoscopic removal of a large sessile colonic polyp sized >20mm Age >18 years Able to give informed consent to involvement in trial Exclusion Criteria: Pregnancy: currently pregnant or attempting to become pregnant Lactation: currently breastfeeding Taken clopidogrel within 7 days Taken warfarin within 5 days Had full therapeutic dose unfractionated heparin within 6 hours Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours Known clotting disorder

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: nil prophylactic coagulation<br> | |
| Active Comparator: Prophylactic coagulation<br> | Procedure: Prophylactic use of coagulation therapy<br>* The procedure is completed as per usual, and if the patient has been randomized to the intervention group the appropriate coagulation therapy will be applied immediately after standard EMR to visible vessels within the mucosal resection area.<br>* Other names: Soft coagulation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of delayed bleeding |  | 14 days |
Study of VX-770 and Rifampin in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to evaluate the effects of multiple doses of rifampin on the single-dose pharmacokinetics of VX 770.

Detailed Description
-----------------
This is a single-center, nonrandomized, open-label, 2-period, 1-sequence crossover study to investigate the safety, tolerability and pharmacokinetics of VX 770 when administered alone or with rifampin. All enrolled subjects will receive the same treatments and undergo the same procedures. In Period 1, subjects will receive a single dose of VX 770 on Day 1. In Period 2, subjects will receive a daily dose of rifampin on Days 1 through 10 and a single dose of VX 770 on Day 6.

Official Title
-----------------
An Open-Label Phase 1 Study to Examine the Effect of Multiple Doses of Rifampin on the Single-Dose Pharmacokinetics of VX 770 in Healthy Subjects

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: VX-770
* Drug: Rifampin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be male and between 18 and 55 years of age Subject must have a body mass index (BMI) from 18 to 30 kg/m2 Exclusion Criteria: History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject Subjects who have active tuberculosis, human immunodeficiency virus, hepatitis C, or active hepatitis B

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VX-770<br> | Drug: VX-770<br>* In Period 1, subjects will receive a single oral dose of VX-770 150 mg on Day 1. In Period 2, subjects will receive a single oral dose of VX-770 150 mg on Day 6.<br>|
| Experimental: Rifampin<br> | Drug: Rifampin<br>* In Period 2, subjects will receive a daily oral dose of rifampin 600 mg on Days 1 through 10<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VX 770 pharmacokinetic (PK) parameters |  | 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VX 770 metabolite PK parameters in plasma |  | 17 days | 
| Rifampin concentration at time zero (C0) and AUC at steady state (AUCtau) following the administration of multiple doses of rifampin |  | 17 days | 
| Safety as measured by adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments |  | 17 days |
The Effect of North American Ginseng on Blood Pressure in Individuals With Hypertension

Study Overview
=================
Brief Summary
-----------------
To determine the effect of North American ginseng on blood pressure in individuals with hypertension.

Detailed Description
-----------------
Ginseng lacks proper clinical scrutiny for its effect on blood pressure (BP), in spite of observational evidence linking its intake to hypertension. This should be addressed considering the potential overlap between the prevalence of ginseng use and hypertension. We undertook a single centre, randomized, controlled, double-blinded, crossover trial to determine the effect of North American ginseng (NAG) on 24-hour BP and renal function. After a 4-week placebo run-in, we randomly assigned participants to NAG or placebo treatment for 12-weeks at a dose of 3g/day. This was followed by an 8-week washout, and a subsequent 12-week period in which the opposite treatment was consumed. At run-in, and at weeks 0 and 12 of each treatment period, participants were fitted with an ambulatory BP monitor to assess 24-hour BP and serum cystatin C was measured.

Official Title
-----------------
The Effect of North American Ginseng on Blood Pressure in Individuals With Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: North American Ginseng (Panax Quinquefolius)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18 to 85 years hypertension as defined by the use of antihypertensive drugs or a seated systolic blood pressure greater than or equal to 140 mm Hg or a diastolic BP greater than or equal to 90 mm Hg at each of 3 pre-study visits. Exclusion Criteria: secondary hypertension diabetes kidney liver disease unstable angina ginseng use for two months prior to or during the study any changes in the type or dose of antihypertensive drugs one month prior to or during the study

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: North American Ginseng (Panax Quinquefolius)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean 24 Hour Ambulatory Blood Pressure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Daytime Ambulatory Blood Pressure |  |  | 
| Mean Nighttime Ambulatory Blood Pressure |  |  | 
| Cystatin C |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Blood Pressure, Ambulatory Blood Pressure Monitoring, Complementary and Alternative Medicine, Herbal, North American Ginseng, Panax Quinquefolius
Risk Factors Contributing to the Development of Microalbuminuria

Study Overview
=================
Brief Summary
-----------------
This research project will look at the relationship between baseline variables, and the new onset of microalbuminuria and the response to treatment with an angiotensin receptor blocker, losartan, in a cohort of 246 early hypertensives and normotensives who are being brought back for a 4-5 year follow up visit as part of a continuing project. We hypothesize that the new onset of microalbuminuria is associated with higher blood pressure levels at baseline and 1 year as well as being associated with elevated left ventricular mass index. The rate of new onset microalbuminuria in non-diabetics is not established and this prospective study will provide data.

Detailed Description
-----------------
The primary objective of this research project is to determine risk factors related to the development of microalbuminuria. The secondary objective is to determine whether uric acid levels at the final visit are correlated with the onset of microalbuminuria. Of participants returning for a 4-5 year follow up visit as part of a continuing project, we will examine the proportion that have developed microalbuminuria. Subjects found to have microalbuminuria will be offered therapy with the ARB losartan and will be followed at three months to determine if there has been a reduction in levels.

Official Title
-----------------
Risk Factors Contributing to the Development of Microalbuminuria Over a 5 Year Period

Conditions
-----------------
Microalbuminuria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participation in the Double Exposure study elevated microalbuminuria

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| To determine risk factors related to the development of microalbuminuria. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether uric acid levels at the final visit are correlated with the onset of microalbuminuria. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microalbuminuria, risk factors
UV Sensor in Patients With Actinic Keratosis

Study Overview
=================
Brief Summary
-----------------
To validate the use of Ultraviolet (UV) radiation sensor in patients with actinic keratosis, to identify barriers to its use in prospective longitudinal studies.

Detailed Description
-----------------
To prevent both acute and chronic damage from exposure to UV A and UV B radiation. Personal UV exposure can be assessed by portable sensors. Having an accurate awareness of one's own behavior (assessed by the accuracy of the UV sensor), can motivate and engage with skin protection.

Official Title
-----------------
Pilot Feasibility Study of Using UV Sensor in Patients With Actinic Keratosis

Conditions
-----------------
Keratosis, Actinic

Intervention / Treatment
-----------------
* Device: UV sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >=65 years presenting actinic keratosis on scalp and/or face Exclusion Criteria: Patients who, due to health problems or lifestyle habits, do not expose themselves regularly to UV radiation (outdoor) for at least one hour a day.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: UV sensor|Use of UV sensor to be informed about the sun exposure daily through a mobile application|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL UV sensor | Questionnaire will be carried out to qualitatively evaluate different aspects of the usability of the UV device, Minimum Value 0; Maximun Value 20, where higher value is the better. | Up to week 4 |
Trabeculectomy With Ologen

Study Overview
=================
Brief Summary
-----------------
Trabeculectomy is the gold standard procedure for the surgical treatment of glaucoma. Antimetabolites such as mitomycin-C (MMC)are widely used as an adjunctive during surgery to prevent scarring of the bleb. MMC has the risk for creating thin bleb walls, avascular blebs, and increased risk to infection, blebitis and endophthalmitis. Recently, a biodegradable porous collagen-glycosaminoglycan copolymer matrix implant (Ologen), has become available for glaucoma surgery.Although a few studies on filtering surgery with Ologen implantation have been performed, there is yet no conclusive evidence on effectivity and safety with Ologen implantation when compared to trabeculectomy with MMC. This is a prospective intervention pilot study to determine the degree of intraocular pressure (IOP) lowering of trabeculectomy with Ologen implantation in comparison to trabeculectomy with MMC. Additionally, the safety (per- and postoperative complications) of the two procedures will be compared. The study hypothesis is that trabeculectomy with Ologen will be a safer procedure than trabeculectomy with MMC, but probably at the cost of a less potent IOP lowering.

Official Title
-----------------
Trabeculectomy With Ologen-Pilot

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: Ologen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary open-angle glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication. Indication for trabeculectomy with mitomycin-C Exclusion Criteria: Unability to discontinue oral anticoagulants Difficulty in reading or speaking Dutch Previous ocular surgery (cataract surgery allowed) Pregnant and breastfeeding women

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ologen implantation (single arm)<br>Ologen implantation as an adjunctive to trabeculectomy | Device: Ologen<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative intraocular pressure level |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of glaucoma medications |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intraocular pressure, glaucoma, trabeculectomy, Ologen