linjc16/ctgov huggingface dataset:
Prognostic Value of The Age, Creatinine, and Ejection Fraction Score for Non-infarct-related Chronic Total Occlusion Revascularization After Primary Percutaneous Intervention in Acute ST-elevation Myocardial Infarction Patients: A Retrospective Study

Study Overview
=================
Brief Summary
-----------------
The age, creatinine, and ejection fraction (ACEF) score has been used to evaluate the clinical prognostic to patients who underwent PCI. However, it is not known if ACEF score could evaluate the prognostic of recanalization of non-infarct-related coronary arteries (non-IRA) chronic total occlusions (CTO) in patients who successful underwent primary PCI. The objectivity of current study was to assess the prognostic value of ACEF score in acute ST-segment elevation myocardial infarction (STEMI) patients with non-IRA CTO after successful primary PCI.

Conditions
-----------------
Cto, Acef Score

Intervention / Treatment
-----------------
* Procedure: ACEF score


Participation Criteria
=================
Eligibility Criteria
-----------------
Among the 2952 patients with STEMI successful treatment by PCI, 395 patients (13.4%) had a non-IRA CTO lesion. 18 patients were excluded from current study as they death within 7 days (n=6) or were not to follow-up (n=7). Due to unavailability of ejection fraction or renal function before CTO-PCI, ACEF score could not be calculated in 5 patients. The remaining 377 patients (95.4%) were finally analyzed in the study. 279 patients performed a staged CTO-PCI attempt(ranging 7-28 days) and was successful in 221 of them. Due to low possibility of PCI success or patients refused to perform PCI, 98 patients did not undergo the PCI attempt. The patients were then divided into successful CTO-PCI group (221 patients) and failed/ non-attempted CTO-PCI group (156 patients). -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Successful CTO-PCI group<br>low ACEF score <1.215 (n = 79), intermediate ACEF score from 1.215 to 1.493 (n=70), and high ACEF score≥1.493 (n=72) | Procedure: ACEF score<br> <br> |
| Failed/non-attempted CTO-PCI group<br>low ACEF score<1.215 (n=45), intermediate ACEF score from 1.215 to 1.493 (n=57), and high ACEF score≥1.493 (n=54). | Procedure: ACEF score<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary end point | Primary end point in the current study was a composite of all-cause death, nonfatal myocardial infarction, ischemia-driven coronary revascularization and hospitalization for heart failure at 1year. | 1 year |
Weight Loss in Pre-diabetic, Obese Women

Study Overview
=================
Brief Summary
-----------------
This is a six (6) month, single center, randomized, double-blind, parallel, controlled-feeding weight-loss study comparing two dietary groups (triglyceride and olestra) in pre-diabetic obese women.

Official Title
-----------------
A Study Among Pre-diabetic, Obese Women to Evaluate the Weight Loss Effects of a Non-Digestible Fat Substitute

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Low calorie diet
* Dietary Supplement: Olestra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premenopausal BMI 30-45 kg/meter squared waist circumference greater than 88 cm blood glucose level 5.8-6.9 mmol/l Exclusion Criteria: Pre-diabetic pregnant nursing food preferences not compatible with the study diet allergies or food sensitivities with any of the study diet

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Placebo Comparator: 1<br> | Dietary Supplement: Low calorie diet<br>* low calorie diet<br>|
| Experimental: 2<br> | Dietary Supplement: Olestra<br>* low calorie Olestra diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight maintained |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pre-diabetic, obese
Manipulating Narrative Presentations of Information to Encourage Good Foot Care Practice in People With and Without Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The study explores the role of health messages (narrative, non-narrative vs. control condition [no message]) to enhance good foot care practices among people with diabetes and the general population.

Official Title
-----------------
Manipulating Narrative Presentations of Information to Encourage Good Foot Care Practice in People With and Without Diabetes Mellitus

Conditions
-----------------
Diabetic Foot, Health Behavior, Foot Diseases

Intervention / Treatment
-----------------
* Behavioral: Online leaflet about foot care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years of age at the time of consent; able to read and speak the English language; able and willing to give written informed consent prior to study entry; able to complete the protocol requirements Exclusion Criteria: has a cognitive impairment or acute psychopathology (self-reported formal diagnoses of down syndrome, traumatic brain injury, brain tumour, autism, dementia, schizophrenia, and/or schizoaffective disorder), ie that which could interfere with his or her ability to provide written consent and complete the study has taken part in any other research on foot care with the University of Chichester in the past year

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Online leaflet about foot care in a narrative format Online leaflet about foot care in a non-narrative format No leaflet (control)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online leaflet in narrative format<br> | Behavioral: Online leaflet about foot care<br>* Short text-based leaflet about foot care, presented online<br>|
| Active Comparator: Online leaflet in non-narrative format<br> | Behavioral: Online leaflet about foot care<br>* Short text-based leaflet about foot care, presented online<br>|
| No Intervention: No leaflet (control)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-item Foot Care Detection Behaviour Scale | Questionnaire asking participants how many days in the past 7 they have checked their feet to detect cuts, blisters, sores, calluses, and red patches | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Foot care, narrative, diabetes, health behaviour, health psychology
Glucose Metabolism in Patients With Non-Small Cell Lung Cancer Treated With Targeted Therapy and Chemotherapy

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Measuring changes in glucose metabolism in patients with cancer may help doctors predict how patients respond to treatment. PURPOSE: This clinical trial is studying glucose metabolism in patients with non-small cell lung cancer treated with targeted therapy and chemotherapy.

Detailed Description
-----------------
OBJECTIVES: Determine the prognostic significance of changes in glucose metabolism measured by fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan in patients with non-small cell lung cancer treated with targeted drugs comprising gefitinib, erlotinib hydrochloride, or other ErbB inhibitors, cyclooxygenase-2 inhibitors, or estrogen receptor blockers in combination with conventional chemotherapy. OUTLINE: This is a prospective study. Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET) scan and CT scan at baseline and at 2 weeks and 12 weeks after receiving targeted anticancer treatment. Metabolic changes detected by FDG-PET and size changes identified by CT scan are related to patient outcome and tumor response to treatment. PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Official Title
-----------------
Monitoring Targeted Lung Cancer Treatments With FDG-PET/CT

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: computed tomography
* Procedure: positron emission tomography
* Radiation: fludeoxyglucose F 18


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed non-small cell lung cancer Any disease stage allowed Undergoing targeted treatment Exclusion Criteria: None

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

| Intervention/Treatment |
| --- |
|Procedure: computed tomography|nan|
|Procedure: positron emission tomography|nan|
|Radiation: fludeoxyglucose F 18|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of glucose metabolic response with progression-free survival, overall survival, and changes in tumor size as measured by fludeoxyglucose F 18 positron emission tomography/CT scan |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent non-small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Erythropoietin Resistance in Anemia of Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Our goal of this pilot project is to identify inflammatory biomarkers that correlate with epo-resistance among CKD patients.

Official Title
-----------------
Novel Biomarkers of Erythropoietin Resistant Anemia Among Patients With Chronic Kidney Disease

Conditions
-----------------
Anemia, Kidney Failure, Erythropoietin

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prevalent patients greater than or equal to 18 years old with CKD defined as a glomerular filtration rate < 60 cc/min Exclusion Criteria: active GI bleeding or history of GI bleed in the prior 3 months uncontrolled hyperparathyroidism (PTH>500) untreated iron deficiency (transferrin saturation < 20% and ferritin < 100 overt infection active hemolysis hemoglobinopathies known adverse response to erythropoietin prior kidney transplant aluminum toxicity

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 |
| --- | --- |
| Epo-resistant<br>Patients with CKD (estimated GFR < 60cc/min) not on hemodialysis who are receiving greater than or equal to 100IU/kg/week of epoetin alpha and/or 1mcg/kg/week darbepoetin to obtain target hemoglobin or hematocrit. | |
| Epo-responsive<br>Patients with CKD (estimated GFR < 60cc/min) not on hemodialysis who are requiring <100IU/kg/week of epoetin alpha and/or 1mcg/kg/week of darbepoetin to obtain target hemoglobin/hematocrit. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Blood Loss Between Surgical Blade and Unipolar Electrocautery in TKA

Study Overview
=================
Brief Summary
-----------------
Using of surgical blade may have less blood loss than unipolar electrocautery in Total Knee Arthroplasty (TKA).

Official Title
-----------------
Comparison of Blood Loss Between Surgical Blade and Unipolar Electrocautery in Primary Total Knee Arthroplasty

Conditions
-----------------
Blood Loss

Intervention / Treatment
-----------------
* Procedure: surgical blade
* Procedure: electrocautery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty age 50-85 years old ASA class 1-3 Exclusion Criteria: unable to perform spinal anaesthesia history of coagulation disorder renal impairment (CrCl <30 mL/min) or cirrhosis platelet count < 100,000 or abnormal coagulogram on pacemaker stop anti-platelet or anti-coagulogram less than 7 days

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgical blade<br> | Procedure: surgical blade<br>* Using surgical blade all the time of surgery<br>* Other names: hot knife;|
| Active Comparator: Unipolar electrocautery<br> | Procedure: electrocautery<br>* Using electrocautery all the time except at skin incision<br>* Other names: cold knife;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | - detected total blood loss from hemoglobin at 24,48 hours after surgery, maximum Hb drop and blood loss collected in radivac drain | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammation | determine inflammatory response with C-rective protein (CRP) at post-op 48 hours | 48 hours | 
| Knee function | measured with WOMAC | 3 months | 
| knee range of motion |  | 3 months | 
| complication | detected with wound dehiscence, wound infection | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hot knife, total knee arthroplasty, cold knife, unipolar electrocautery, surgical blade, Blood loss
A Study to Evaluate the Long Term Safety and Effectiveness of Novantrone Therapy Followed by Copaxone Treatment for Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
It is thought that treating Multiple Sclerosis with Novantrone for a short period of time prior to treatment with Copaxone may enhance the onset effect of Copaxone.

Official Title
-----------------
A Multi-Centered, Two Arm, Open Label Extension Study (to Protocol NC-100) to Evaluate the Long-Term Safety and Efficacy of Short-Term Induction Treatment With Mitoxantrone (Novantrone®) Preceding Treatment With Glatiramer Acetate (Copaxone®) vs. Chronic Treatment With Glatiramer Acetate Alone in Relapsing Forms of Multiple Sclerosis

Conditions
-----------------
Relapsing Remitting Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation & completion of the NC-100 Clinical Trial. Able and willing to sign an Informed Consent. Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 57 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 |
| --- | --- | --- |
Beneficial Effect of Adding Pentoxifylline to Processed Semen Samples on ICSI Outcome in Infertile Males

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of pentoxifylline used in preparation of semen samples that will be used for ICSI in infertile men complaining of mild and moderate asthenozoospermia (i.e. cases which does not need motility enhancement prior to ICSI) in comparison to semen samples without pentoxifylline preparation on the outcome of ICSI.

Detailed Description
-----------------
The primary outcome measures were the number of oocytes retrieved, the number of oocytes injected, number of oocytes fertilized, fertilization rate, number of embryos and their quality (G1: good embryos, G2: fair embryos and G3: bad embryos), number of embryos transferred (ET), number of embryo sacs, embryo implantation rate, pregnancy rate and abortion rate for all 3 groups and pregnancy rate and abortion rate for both group (I) and group (II).

Official Title
-----------------
Beneficial Effect of Adding Pentoxifylline to Processed Semen Samples on ICSI Outcome in Infertile Males With Mild and Moderate Asthenozoospermia: Randomized Controlled Prospective Crossover Study

Conditions
-----------------
Pentoxifylline Allergy

Intervention / Treatment
-----------------
* Other: effect of pentoxifylline on ICSI outcome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: seeking ICSI for infertility Exclusion Criteria: Pyospermia, presence of antisperm antibodies. Azoospermia, severe male factor, severe asthenozoospermia. Past history of orchitis. Patients who received empirical treatment for asthenozoospermia e.g. oral Pentoxifylline, l-carnitine or antioxidants during the past 3 to 6 month. Diabetics, hypertensives or patients with any other chronic systemic illnesses. Wife's age more than 35 years. Low antral count. Presence of any ovarian factor contributing to infertility e.g. polycystic ovaries.

Ages Eligible for Study
-----------------
Maximum Age: 35 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 |
| --- | --- |
| Other: Pentoxifylline<br>effect of pentoxifylline on ICSI outcome | Other: effect of pentoxifylline on ICSI outcome<br>* semen processing with pentoxifylline prior to ICSI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICSI outcome |  | from October 2010 to April 2011. |
Assessing Response to Treatment in Non-Hodgkin's Lymphoma Patients Using 64Cu-DOTA-Rituximab PET/CT

Study Overview
=================
Brief Summary
-----------------
Rituximab is an antibody targeted against the CD20 antigen found primarily on B-cells. Therefore, an imaging agent targeting CD20 expression may provide a more accurate evaluation of extent of disease and response to therapy than the current standard of care, F-18 FDG PET/CT. The main purpose of the study is to investigate a new PET/CT imaging probe for detection and follow up of lymphoma. Following are the 3 aims of the study: a) Phase I testing in lymphoma patients of Cu-64 labelled Rituxan for defining normal tracer biodistribution, stability, pharmacokinetics and radiation dosimetry; b) comparison of Cu-64 Rituxan and F-18 FDG PET/CT in lymphoma patients; c) evaluation of changes in uptake of Cu-64 Rituxan in response to rituximab-based treatment in CD20-positive B-cell NHL

Official Title
-----------------
Assessing Response to Treatment in Non-Hodgkin's Lymphoma Patients Using 64Cu-DOTA-Rituximab PET/CT

Conditions
-----------------
Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: Cu-64 Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have a diagnosis of CD20-positive B-cell NHL and a staging 18F FDG PET/CT prior to the 64Cu-DOTA-Rituximab PET/CT Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them Patients must be scheduled for rituximab-based therapy Patients must be older than 18-year-old Exclusion Criteria: Patients who cannot complete a PET/CT scan Pregnant women Patients participating in other research protocols will be excluded from this 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 64Cu-DOTA<br>Subjects will be injected with less than 14 mCi of 64Cu-DOTA-Rituximab. This is a slow infusion, done over 20 minutes. | Drug: Cu-64 Rituximab<br>* Up to 14 mCi, iv<br>* Other names: Genentech/MIPS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pre and post treatment SUV max value on the 64CU-DOTA-Rituximab PET/CT and 18F FDG PET/CT | Pre- and post-treatment tumor SUVmax value on the 64Cu-DOTA-Rituximab PET/CT and 18F FDG PET/CT, and resulting EORTC-based classification of patients as responding or not responding to treatment. | baseline and 6 weeks |