linjc16/ctgov huggingface dataset:
Influence of Opioid Analgesia on Circulating Tumor Cells in Laparoscopic Colorectal Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
To compare the effects of three types of perioperative analgesia on the number of circulating tumor cells following radical colorectal cancer surgery. To find correlations with other perioperative factors and clinical/pathological disease characteristics.

Official Title
-----------------
Influence of Peri-operative Opioid Analgesia on Circulating Tumor Cells in Patients Undergoing Laparoscopic Colorectal Cancer Surgery - Multi-center, Randomized Clinical Trial

Conditions
-----------------
Colorectal Cancer, Circulating Tumor Cell

Intervention / Treatment
-----------------
* Drug: Morphine
* Drug: Piritramid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing open radical surgery for colorectal cancer age over 18 years signed informed consent Exclusion Criteria: intolerance of the study drugs history of CRC surgery neoadjuvant therapy other malignancy not in permanent remission chronic opioid medication or opioid administration within 7 days preoperatively immunosuppressive or corticosteroid therapy surgery within 30 days preoperatively (except minor) chronic or acute infection

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: Morphine<br>Morphine-based perioperative analgesia | Drug: Morphine<br>* Morphine intravenous<br>|
| Active Comparator: Piritramid<br>Piritramid-based perioperative analgesia | Drug: Piritramid<br>* Piritramid intravenous<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery | Baseline number of circulating tumor cells will be recorded prior to surgery in a venous blood sample. Number of circulating tumor cells will be measured 2 - 4 weeks after surgery in a venous blood sample. These two values will be compared. | 1 - 3 days before surgery to 4 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment | Pain intensity assessed using Numerical Rating Scale (0-10) | Time Frame: 3 days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perioperative analgesia, Colorectal Cancer, Circulating Tumor Cell
Study of Sildenafil in Advanced Heart Failure.

Study Overview
=================
Brief Summary
-----------------
Despite advances in medical therapy for patients with heart failure, one-third of patients remain limited by fatigue and shortness of breath. Our previous study concluded that one dose of sildenafil (Viagra) lead to an improvement in heart pressure and exercise capacity. Currently sildenafil is not FDA approved for the treatment of heart failure. The purpose of this study is to determine if treatment with sildenafil for 12 weeks in patients with heart failure can improve exercise capacity and quality of life in people with heart failure.

Detailed Description
-----------------
This study will compare two groups of patients. One group will receive sildenafil and the other group will receive a placebo (a pill which looks like sildenafil, but contains no medication). Patients will undergo a heart catheterization, echocardiogram and exercise stress test. Patients will then take study medication for 12 weeks. A repeat heart catheterization, echocardiogram and exercise stress test will then be performed.

Official Title
-----------------
Phase 3 Study of the Effects of Chronic Sildenafil Citrate Therapy on Exercise Tolerance and Hemodynamics in Patients With Advanced Heart Failure.

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

Intervention / Treatment
-----------------
* Drug: sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Ejection fraction <40% Heart failure limited by fatigue and shortness of breath Pulmonary artery hypertension Exclusion Criteria: Patients taking the following medications: nitroglycerine pill/patch/paste, isordil, Imdur, antifungal agents and certain antidepressants. Patients with a history of optic neuropathy or unexplained visual impairment. Patients with anemia. -

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients will have the following performed at baseline and again after taking study medication for 12 weeks: exercise capacity measured by exercise stress test, heart pressure measured by a heart catheterization and |  |  | 
| quality of life measured by questionnaires at baseline and at 12 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise stress test
Total Hip Arthroplasty Using Small Direct Anterior Incision: The Role of Short Femoral Stem

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate short-term outcomes following the use of two femoral stems used during Total Hip arthoplasty: the Fitmore Femoral stem and the M/L Taper Femoral stem.

Conditions
-----------------
Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Procedure: Total Hip Arthoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient signed an IRB, study specific informed patient consent. Patient is a male or non-pregnant female age 18 years or older at the time of study device implantation. Patient has primary diagnosis of non-inflammatory degenerative joint disease. Patient is a candidate for primary cementless total hip replacement. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. Exclusion Criteria: Patient has a Body Mass Index (BMI) > 40 Kg/m2. Patient has an active or suspected infection at the time of device implantation. Patient is immunologically suppressed. Patient requires revision surgery of a previously implanted total hip replacement. Patient has a known sensitivity to device materials.

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 |
| --- | --- |
| Active Comparator: Total Hip Arthroplasty using Fitmore femoral stem<br> | Procedure: Total Hip Arthoplasty<br> <br> |
| Active Comparator: Total Hip Arthroplasty using M/L Taper Femoral stem<br> | Procedure: Total Hip Arthoplasty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term hip function | Early functional outcome will be measured using the modified Harris Hip score at the first post-operative visit | within six weeks post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-Term Pain Levels of direct anterior and anterolateral surgical approaches | Short-term (6 weeks post-op) pain will also be compared between the approach used for the total hip replacement: namely direct anterior and anterolateral using a VAS pain scale |  |
Epidemiology of Conjunctivitis in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
Epidemiology of Conjunctivitis in the Emergency Department of a Reference Ophthalmological Hospital in Goiânia.

Detailed Description
-----------------
The purpose of this study was to determine the epidemiology of ocular emergencies in a Reference Ophthalmological Hospital in Goiânia, with emphasis on acute infectious conjunctivitis, morbidity with a higher incidence in this Service. It aims to delineate the main etiologies found among infectious conjunctivitis and to compare them with those found in several other reference services in Ophthalmology.

Official Title
-----------------
Epidemiology of Conjunctivitis in the Emergency Department of a Reference Ophthalmological Hospital in Goiânia

Conditions
-----------------
Acute Conjunctivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All those patients who were submitted to a initial care performed by the First Year Resident (R1) of the Hospital and who were admitted during the period described. Exclusion Criteria: The patients who were admitted in the Emergency Department outside this period The patients who were not attended by a First Year Resident (R1) The patients who did not have all the data filled in the medical record The patients who needed to return, being attended in the hospital more than once.
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 |
| --- | --- | --- |
| Evaluation of the main etiologies of acute infectious conjunctivitis in the Emergency Department of a Reference Hospital in Goiânia. | Through clinical diagnosis in the Emergency Department | 126 days |
Defibrotide Compassionate Use for Patients With Life Threatening Veno-Occlusive Disease of the Liver

Study Overview
=================
Brief Summary
-----------------
Severe veno-occlusive disease (VOD) of the liver is a life threatening complication of blood and marrow transplantation. Treatment with currently available (Food and Drug Administration [FDA] approved) agents fails in most cases. Recently conducted clinical studies indicate that patients benefit from defibrotide, a non-FDA approved agent. This protocol has been developed not with a research intent, but rather to ensure that defibrotide is used by the blood and marrow transplant programs at Children's Healthcare of Atlanta and at Emory University in a safe, effective and ethical manner.

Detailed Description
-----------------
Severe veno-occlusive disease (VOD) of the liver is a life threatening complication of blood and marrow transplantation. Treatment with currently available (FDA approved) agents fails in most cases. Recently conducted clinical studies indicate that patients benefit from defibrotide, a non-FDA approved agent. This protocol has been developed not with a research intent, but rather to ensure that defibrotide is used by the blood and marrow transplant programs at Children's Healthcare of Atlanta and at Emory University in a safe, effective and ethical manner.

Official Title
-----------------
Defibrotide Compassionate Use Protocol for Patients With Life Threatening Veno-Occlusive Disease of the Liver

Conditions
-----------------
Liver Diseases

Intervention / Treatment
-----------------
* Drug: Defibrotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Veno-occlusive disease of the liver

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 22 Years

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

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

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

Arms and Interventions

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

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
-----------------
Venous occlusive disease, VOD
Comparison of Fenofibrate and Niacin in Patients With Hypertriglyceridemia and Low High-Density Lipoprotein (HDL)-Cholesterol

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the efficacy and tolerability of fenofibrate 160 mg and niacin 1500 mg in patients with hypertriglyceridemia and low HDL-cholesterol. The primary end point is the percent change of apoB/A1 and the secondary end points are other lipid parameters and biomarkers.

Conditions
-----------------
Hypertriglyceridemia With Low HDL-cholesterol

Intervention / Treatment
-----------------
* Drug: lipid modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Triglyceride 150-500 mg/dL and HDL-cholesterol < 45 mg/dL after 8 week dietary run in period 20-79 years old Exclusion Criteria: Low-density lipoprotein (LDL)-cholesterol ≥ 130 mg/dL without any lipid-modifying drug History of cerebrovascular or cardiovascular diseases Creatinine > 2.0 mg/dL Transaminase > 2x upper limit of normal Gall bladder disease Cancer Pregnant or breast feeding women History of adverse events associated with test drugs

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: niacin arm<br> | Drug: lipid modification<br>* 1) fenofibrate 160 mg po for 16 weeks, 2) niacin 500 mg po for 4 weeks, niacin 1000 mg po for 4 weeks, niacin 1500 mg po for 8 weeks<br>|
| Active Comparator: fenofibrate arm<br> | Drug: lipid modification<br>* 1) fenofibrate 160 mg po for 16 weeks, 2) niacin 500 mg po for 4 weeks, niacin 1000 mg po for 4 weeks, niacin 1500 mg po for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent change of apoB/A1 |  | after 16 weeks of drug treatment |
Measurement of Bite Force in Humans

Study Overview
=================
Brief Summary
-----------------
This protocol is for a clinical trial to evaluate the reliability of the bite fork as a diagnostic instrument in subjects with pulpal necrosis and apical periodontitis.

Detailed Description
-----------------
This clinical trial consists of two parts. We will first use the bite fork in normal volunteers to evaluate its test-retest and inter-rater reliability. We will then use the bite fork in subjects with differing endodontic diagnoses and compare these results with the standard clinical diagnostic test (percussion).

Official Title
-----------------
Measurement of Bite Force in Humans

Conditions
-----------------
Dental Pulp Necrosis, Periapical Periodontitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be at least 16 years of age. Clinical indication for non-surgical root canal therapy (NSRCT). 1st or 2nd maxillary or mandibular molar or premolar Diagnosis must be chronic apical periodontitis (CAP) with or without symptoms. Intact, mature apices. American Society of Anesthesiologists (ASA) I or II. Exclusion Criteria: Failure to meet any of the above Previous NSRCT Previous pulpotomy or pulpectomy Suppurative apical periodontitis Patients taking medications which can affect their pain rating or medications which affect their immune system (such as glucocorticoids)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, Normal pulp and normal periodontal status, Chronic apical periodontitis of pulpal origin
Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights.

Official Title
-----------------
Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (P/318/08/C)

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Narafilcon A contact lens
* Device: Lotrafilcon A contact lens
* Device: Galyfilcon A contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is at least 17 years of age and has full legal capacity to volunteer Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction Has had an ocular examination in the last two years Is a current soft (hydrogel or silicone hydrogel) contact lens wearer Has clear corneas and no active ocular disease Can be successfully fit with the lenses to be used in the study Other protocol-defined inclusion/exclusion criteria may apply Exclusion Criteria: Is pregnant or lactating Has undergone corneal refractive surgery Currently wears lenses on an extended wear basis or was on extended wear within six months prior to the study Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 17 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lotrafilcon A<br>Lotrafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis. | Device: Lotrafilcon A contact lens<br>* Commercially marketed, silicone hydrogel, spherical soft contact lens<br>|
| Active Comparator: Narafilcon A<br>Narafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis. | Device: Narafilcon A contact lens<br>* Investigational, silicone hydrogel, spherical soft contact lens<br>|
| Active Comparator: Galyfilcon A<br>Galyfilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis. | Device: Galyfilcon A contact lens<br>* Commercially marketed, silicone hydrogel, spherical soft contact lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Front Surface Lens Deposits | Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe. | Period 2, Day 6 |
Ankle Tracking Training in Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the improvement in ankle control and brain activation in subjects with stroke resulting from two different forms of telerehabilitation: tracking training, emphasizing accurate movements, versus movement training, involving simple movements. Hypotheses: The Track group will show greater improvement in ankle range of motion compared to the Move group. The Track group will show greater improvement in ankle tracking accuracy and greater changes in fMRI (increase in relative volume of activation for ipsilesional sensorimotor cortex, increase in laterality index, and decrease in blood-oxygen-level-dependent (BOLD) signal intensity index) compared to Move group. The Track group will show greater improvement in tracking accuracy at an untrained joint (knee) compared to the Move group. The Track group will show greater improvement in standing balance. The Track group will show greater improvement in walking speed and ankle dorsiflexion during gait compared to the Move group.

Official Title
-----------------
Ankle Tracking Training in Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: ankle tracking training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single stroke with an ischemic infarct. Between 18 and 85 years of age. Time since stroke onset must be >6 months. Cannot be receiving any rehabilitation therapy. Impaired ankle dorsiflexion/plantarflexion but at least 10 degrees of active motion. Cognition level must be at least 24 out of 30 on the Mini-Mental Examination 7. Able to ambulate at least 100 feet independently. training. Exclusion Criteria: Cannot have any neuromuscular disorder other than stroke that impairs ankle motion. Cannot have an executive function score on Stroop Interference Test of <37. Cannot have a score on the Beck Depression Inventory of >10. Cannot have ataxia, apraxia, receptive aphasia, hemi-neglect, or severe visual field cut . Cannot be pregnant nor have indwelling metal or medical devices incompatible with fMRI.

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ankle tracking<br>subjects track a target with ankle movement | Behavioral: ankle tracking training<br>* one group will use the ankle for tracking, the other group will use the ankle for simple movement<br>|
| No Intervention: ankle movement<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ankle range of motion |  | Measurement at pretest, posttest and followup |