linjc16/ctgov huggingface dataset:
Identification of New Colorectal Cancer Genes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define new genes for family risks of developing colon cancer.

Detailed Description
-----------------
Colorectal cancer is one of the most significant causes of cancer morbidity and mortality in the United States. In 1997, approximately 130,000 men and woman were diagnosed with colorectal cancer (fourth most common cancer site) and approximately 55,000 died of this disease (second most common cause of cancer deaths); (Cancer Facts & Figures, 1997). Genetic factors clearly contribute to the etiology of colorectal cancer. Because there is evidence to suggest genetically determined susceptibility to colorectal cancer exists in a proportion of newly diagnosed cases each year, we are conducting a study to identify new genes that are associated with an increased susceptibility to familial colorectal cancer by analysis of families with a clustering of colorectal cancers.

Official Title
-----------------
Identification of New Colorectal Cancer Genes

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or greater Able to provide informed consent Any family in which a minimum of two first-degree relatives either are, or have previously been, affected with primary colorectalcancer. These minimum inclusion criteria must be met within three generations of the proband or kindreds in which colorectal cancer and lymphoma or renal cell cancer are present or in kindreds in which lymphoma alone or lymphoma and renal cell cancer are present Exclusion Criteria: Age less than 18 years Family not at increased risk for familial colorectal cancer (see Section 4.1) Family with a hereditary polyposis syndrome (e.g. classic FAP) Not able to provide informed consent

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 |
| --- | --- | --- |
| Evidence of mutations in selected candidate genes |  | 10 years 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal cancer, Genetic testing, Genetic mutations
Bioequivalency Study of Losartan Potassium 100 mg Tablet Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Losartan Potassium 100 tablet under fasted conditions.

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment Bioequivalency Study of Losartan Potassium Tablets 100 mg Under Fasted Conditions

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

Intervention / Treatment
-----------------
* Drug: Losartan Potassium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to losartan potassium or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Losartan Potassium|100 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 15 days |
NeuroVision® Dynamic Screw Test Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to gather information about the NeuroVision System (which is FDA cleared for this indication) during the placement of pedicle screws. NeuroVision is a machine that monitors nerve activity during surgery and will alert the surgeon if there are any nerve-related issues during screw placement. The use of nerve monitoring is standard of care at most centers during spine surgery. The standard monitoring for screws placed is performed after the screw is placed, to ensure it is well positioned in the bone (if it is not, the screw may be removed and/or repositioned). The NeuroVision System has a novel feature called Dynamic Screw Test that allows for that monitoring to be performed as the screw is placed, rather than after the fact. This study is being done to determine if this real-time monitoring of screw placement provides beneficial additional information to the operating surgeon to prevent misplacement of screws before it happens.

Official Title
-----------------
A Prospective Evaluation of the Dynamic Function of the NeuroVision® System for the Placement of Lumbar Pedicle Screws

Conditions
-----------------
Degenerative Spinal Conditions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients who are at least 18 years of age. Surgical candidates for posterior instrumented lumbar fusion surgery. Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study. Exclusion Criteria: Patients with underlying neurological disease or neurological deficits that are not associated with the condition for which they are seeking surgical intervention. Patients who have had previous instrumented surgery at the involved lumbar level. Participants in any other clinical study involving an investigational device or drug within 30 days of enrollment into the current study.

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 |
| --- | --- | --- |
| Sensitivities/specificities of NeuroVision Basic and Dynamic Screw Test monitoring modalities to predict (1) pedicle breach and (2) neural injury |  | 6 weeks postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in subject self-reported pain ratings (Visual Analog Scales, leg and back pain) from the preoperative period through postoperative follow-up. |  | 6 weeks postoperative | 
| Intraoperative time (in minutes) taken to place Basic vs Dynamically tested screws. |  | Intraoperative | 
| Intraoperative fluoroscopy (in minutes) used to place Basic vs Dynamically tested screws. |  | Intraoperative |
Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.

Official Title
-----------------
Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Drug: Adalimumab
* Drug: Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject 18 years of age or older Able and willing to give written informed consent and to comply with the requirements of the study protocol Subject met the definition of Ankylosing Spondylitis (AS) based on ASAS Criteria Subject with active AS, has had an inadequate response, an intolerance or an to one or more nonsteroidal anti-inflammatory drugs Exclusion Criteria: Previous adalimumab treatment or previous treatment with more than one anti TNF alpha therapy. Previous methotrexate treatment, not stopped 3 month before inclusion Surgery scheduled during study Female subject without method of contraception Contraindication to adalimumab or methotrexate

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adalimumab<br>adalimumab 40mg every 2 weeks | Drug: Adalimumab<br>* adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26<br>* Other names: Humira;|
| Experimental: Adalimumab + Methotrexate<br>adalimumab 40mg every 2 weeks and methotrexate 10mg per week | Drug: Adalimumab<br>* adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26<br>* Other names: Humira;Drug: Methotrexate<br>* methotrexate, subcutaneous injection, 10mg per week, week -2 until week 26<br>* Other names: Metoject;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence or absence of antibodies against adalimumab |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS) |  | 6 months | 
| Change from baseline of T and B cells concentrations. |  | 6 months | 
| Change from baseline of APRIL and TNF alpha concentrations |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ankylosing spondylitis
Patients With Renal Impairment and Diabetes Undergoing Computed Tomography (CT)

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue (iopamidol) or Visipaque in diabetic patients with moderate to severe chronic renal impairment undergoing clinically indicated contrast enhanced multidetector computed tomography (MDCT). Serum creatinine will be measured before and up to 48-72 hours post dose.

Official Title
-----------------
Patients With Renal Impairment and Diabetes Undergoing Computed Tomography

Conditions
-----------------
Kidney Diseases

Intervention / Treatment
-----------------
* Drug: Iopamidol 370 mgI/dL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred for contrast enhanced MDCT Documented predose eGFR of greater than or equal to 20 and less than 60 mL/min/1.73m2 Diagnosed as having diabetes mellitus Exclusion Criteria: Unstable renal function Unstable diabetes Concurrent administration of nephrotoxic drugs Undergoing dialysis

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Iopamidol 370 mgI/dL|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in serum creatinine (SCr) at 48-72 hours post dose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in estimated glomerular filtration rate (eGFR) at 48-72 hours post dose; occurrence of adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contrast induced nephropathy
Exisulind Prior to Radical Prostatectomy

Study Overview
=================
Brief Summary
-----------------
This trial will compare no treatment to exisulind therapy. Patients enrolled on the treatment arm will begin treatment 4 weeks prior to the scheduled date of surgical removal of the prostate and will take 375 mg by mouth daily for the 4 weeks prior to radical prostatectomy. Participants will be followed for total of 2 months from the time of starting study drug.

Official Title
-----------------
A Prospective Controlled Phase II Study of Preoperative Exisulind Therapy Initiated Prior to Radical Prostatectomy: Effect on Apoptosis

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Drug: Exisulind Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Males 40 years of age and older with prostate cancer who are scheduled to undergo surgical removal of the prostate at Mayo Clinic Rochester, Mayo Clinic Jacksonville, or Mayo Clinic Arizona may be eligible for this protocol.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Exisulind Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4 week changes in apoptosis biomarkers |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4 week changes in surrogate endpoint biomarkers |  |  |
CCRT With Twice Weekly Paclitaxel and Cisplatin Followed by Surgery for Locally Advanced Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
CCRT with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.

Detailed Description
-----------------
The purpose of this study is to find out the clinical and pathological response rates of pre-operative concurrent chemoradiotherapy (CCRT) with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.

Official Title
-----------------
A Phase II Study of Concurrent Chemoradiotherapy With Twice Weekly Paclitaxel and Cisplatin (Twice Weekly TP) Followed by Surgery for Locally Advanced Esophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: Paclitaxel, Cisplatin,Surgery, CCRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically proven SCC or adenocarcinoma of esophagus . Locally advanced esophageal cancer , defined as T3 and/or N1 disease.( AJCC 1998) M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer . Age ≧ 18 ys KPS ≧ 60% Hemogram : WBC ≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl . Exclusion Criteria: Invasion to surrounding organ ( T4 disease ) . Distant metastasis , except M1a disease . Patients who refuse operation .

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Paclitaxel, Cisplatin,Surgery, CCRT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and pathological response rates |  | 2000 2004 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 2000 2004 | 
| overall survival |  | 2000 2004 | 
| Toxicity |  | 2000 2004 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Concurrent Chemoradiotherapy, Esophageal Cancer
A Longitudinal Observational Follow-up of the PRECEPT Study Cohort

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to longitudinally follow consenting clinical trial participants who participated in PRECEPT (A Randomized, Double Blind, Placebo Controlled, Dose Finding Study to Assess the Efficacy and Safety of CEP 1347 in Patients With Early Parkinson's Disease). The study will assess the clinical and imaging outcomes relevant to the natural history of Parkinson's disease (PD), as well as determine early biomarkers of the disease.

Official Title
-----------------
A Longitudinal Observational Follow-up of the PRECEPT Study Cohort

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in the PRECEPT study Willing and able to give informed consent Exclusion Criteria: Patients will be excluded from participating in the the study if either of the criteria stated above is not met

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- | --- |
| Unified Parkinson Disease Rating Scale (UPDRS) and β-CIT SPECT imaging of the dopamine transporter. |  | Annual, ongoing assessments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| University of Pennsylvania Smell Identification Test (UPSIT) |  | Annual, ongoing assessments | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson disease, observational, longitudinal
Pharmaco-epidemiological Study Describing a Population of Hypertensive Patients Treated With a Fixed-dose Combination of Telmisartan and Hydrochlorothiazide

Study Overview
=================
Brief Summary
-----------------
Study to compare the level of blood pressure control in hypertensive, hypertensive diabetics and hypertensive with renal insufficiency (observed data) in the study population, with the objectives of the High Authority for Health recommendations (benchmark)

Official Title
-----------------
Pharmaco-epidemiological Study Describing a Population of Hypertensive Patients Treated in General Practice With a Fixed-dose Combination of Telmisartan and Hydrochlorothiazide, the Level of Blood Pressure Control and the Modalities of Arterial Hypertension Management

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

Intervention / Treatment
-----------------
* Drug: Telmisartan and hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertensive patients already treated for at least 1 month with Telmisartan plus hydrochlorothiazide, consulting the physician consecutively for whatever reason Exclusion Criteria: NA
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypertensive patients<br> | Drug: Telmisartan and hydrochlorothiazide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with low blood pressure | lower than 140/90 mmHg in the general population of hypertensive patients, hypertensive diabetics and hypertensive with renal insufficiency | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | up to 4 weeks |
Factors Influencing Quality of Bowel Cleansing for Colonoscopy in Patients With Colorectal Cancer Surgery; Prospective Observational Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to clarify the factors influencing quality of bowel cleansing for colonoscopy in patients with colorectal cancer surgery and confirm the adequate bowel cleaning method for patients with colorectal cancer surgery. Through this, ultimately in patients with a history of colorectal cancer who have high risk of colorectal cancer, it could be possible to detect cancerous lesions early and increase the survival rate. This study is based on observational study Subjects are the patients with colorectal cancer surgery who visits the out patients clinic for follow-up colonoscopy The patient's medical records on the basis of information collected at the point of the colonoscopy performed Quality of bowel cleansing is calculated with the Boston bowel preparation scale Patient compliance and satisfaction are measured.

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

Intervention / Treatment
-----------------
* Procedure: Colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 20 patients who underwent colorectal cancer surgery patients who underwent follow-up colonoscopy as a conventional medical procedures Exclusion Criteria: age < 20 patients who have ileus or bowel obstruction patients in pregnant status Patients who did not consent to research

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Colonoscopy<br>patients undergoing colonoscopy after colorectal cancer surgery | Procedure: Colonoscopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston bowel preparation scale (BBPS) | In this scale, the colon is divided in three segments: the right side (including cecum and ascending colon), the transverse colon (including the flexures) and the left sided colon, which includes the descending colon, sigmoid and rectum. Mucosal view should be scored after cleansing maneuvers like suctioning or washing have been performed. For all three sections cleansing is assessed and given a score ranging from 0 to 3. Therefore, the maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0. BBPS score ≥6 in considered an adequate bowel preparation. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bowel cleansing, colorectal cancer surgery