linjc16/ctgov huggingface dataset:
A Bioequivalence Study Comparing Clopidogrel/Aspirin Combination Tablet With Coadministration of Clopidogrel and Aspirin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of clopidogrel and aspirin in free combination as HCP0911.

Official Title
-----------------
A Sequence-randomized, Open-label, Single Dose, Crossover Study to Evaluate Pharmacokinetics and Safety After Oral Administration of Clopidogrel and Aspirin in Free Combination and Fixed-dose Combination as HCP0911 in Healthy Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: HCP0911 / clopidogrel, aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20 and 55 Signed informed consent Exclusion Criteria: Has a history of hypersensitivity to IP ingredients Hypotension or hypertension Has a history of acute infection within 14days of screening

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCP0911<br>clopidogrel/aspirin combination tablet | Drug: HCP0911 / clopidogrel, aspirin<br>* combination tablet vs coadministration<br>|
| Active Comparator: clopidorel and aspirin<br>coadministration of clopidogrel and aspirin | Drug: HCP0911 / clopidogrel, aspirin<br>* combination tablet vs coadministration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | 0-24 hrs | 
| AUC |  | 0-24 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clopidogrel, aspinin, combination
Does Use of a Wound After-care Summary Improve Patient Satisfaction and Time to Wound Healing?

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate a patient education program for chronic wound care. The wound care nurse practitioner (NP) at the Ann Arbor VAMC will use a wound self-management after-care summary with approximately half of her patients. This study will examine whether using this patient education tool for self-management of wound care results in improved patient outcomes.

Official Title
-----------------
Does Use of a Wound After-care Summary Improve Patient Satisfaction and Time to Wound Healing?

Conditions
-----------------
Wounds

Intervention / Treatment
-----------------
* Behavioral: After-care summary
* Behavioral: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients presenting for outpatient wound care at the Ann Arbor VA Medical Center NP wound care clinic, who meet the following inclusion criteria for chronic wounds: stage II, III, IV pressure ulcers; venous stasis ulcers, and diabetic ulcers. Exclusion Criteria: Cognitively impaired patients who cannot give informed consent.

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 |
| --- | --- |
| Experimental: Arm 1<br>These patients receive the experimental intervention--the after-care summary. | Behavioral: After-care summary<br>* The wound care NP will measure the wound and assess adherence to the following self-management activities: visiting the wound care clinic as scheduled; offloading; applying dressings; obtaining assistance at home; and participating in social activities. This information will be entered into a computer database on a VA computer that will generate a summary chart showing the relationship between adherence and wound healing. The generated after-care summary will be discussed with the patient and used to set self-management goals.<br>|
| Active Comparator: Arm 2<br>These patients are the control group and receive usual care. | Behavioral: Control group<br>* Patients in the control group will receive usual counseling for self-management.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction, frequency of self-management activities, time to healing |  | Outcomes are measured at each participating patient's visit for one year or until the patient's wound is healed, whichever comes first. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wound healing, self-management, patient education
Stem Cell Therapy for Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
The effect of autologous bone marrow mononuclear cells on duration of survival in Amyotrophic Lateral Sclerosis patients.

Detailed Description
-----------------
Survival duration in Amyotrophic Lateral Sclerosis patients who received cellular transplantation was compared to patients who did not receive cellular transplantation. Kaplan-Meier survival analysis was used for this comparison.

Official Title
-----------------
The Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on the Survival Duration in Amyotrophic Lateral Sclerosis - A Retrospective Control Study

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Biological: Stem cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with the diagnoses of definite amyotrophic lateral sclerosis. Clear information about date of onset of symptoms, documented contact information and follow up information Exclusion Criteria: Patients with diagnoses of Progressive Lateral sclerosis, Progressive bulbar plasy, Progressive spinal muscular atrophy, Progressive muscular atrophy, monomelicamyotrophy or madras motor neuron disease. patients with co-morbidities like presence of acute infections such as Human Immunodeficiency Virus/Hepatitis B Virus/Hepatitis C Virus, malignancies, bleeding tendencies, renal failure, severe liver dysfunction and other acute medical conditions such as respiratory infection and pyrexia.

Ages Eligible for Study
-----------------
Minimum Age: 26 Years
Maximum Age: 76 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem cell<br>Autologous bone marrow mononuclear cells intrathecal and intramuscular transplantation | Biological: Stem cell<br>* Autologous bone marrow derived mononuclear cells were administered via intrathecal and intramuscular routes.<br>|
| No Intervention: Control<br>No cell transplantation was done | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of survival |  | 56 months |
A Cognitive Behavioral Therapy-Based Text Message Intervention for Methamphetamine Dependence

Study Overview
=================
Brief Summary
-----------------
This Phase I behavior therapy development study seeks to improve treatment outcomes for methamphetamine (MA)-dependent subjects by developing a novel cognitive behavioral therapy- (CBT-) based short message service (SMS) text messaging intervention.

Official Title
-----------------
A Cognitive Behavioral Therapy-Based Text Message Intervention for Methamphetamine Dependence

Conditions
-----------------
Amphetamine-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: CBT- based SMS text messaging intervention
* Behavioral: CBT group therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English-speaking adults ≥ 18 years who are seeking treatment for MA addiction. Own a cellular phone with SMS text messaging capability and have an unlimited text messaging plan. Available to attend CBT therapy groups. Agreeable to conditions of the study and signed an informed consent form. Exclusion Criteria: Projected to be unavailable > 12 hours/day to read and send text messages. Any medical or psychosocial condition that would preclude safe, useful, or consistent participation,

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT- based SMS text messaging intervention<br>cognitive behavioral therapy- (CBT-) based short message service (SMS) text messaging intervention | Behavioral: CBT- based SMS text messaging intervention<br> <br> Behavioral: CBT group therapy<br> <br> * Other names: Cognitive Behavioral Group Therapy;|
| Placebo Comparator: Placebo Texts<br>Placebo texts will be given instead of interventional texts | Behavioral: CBT group therapy<br> <br> * Other names: Cognitive Behavioral Group Therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of MA-negative urine samples between the 2-week CBT text period and the 2-week control period | The primary efficacy measure for this study is the difference in proportion of MA-negative urine samples between the 2-week CBT text period and the 2-week control period. Urine samples will be analyzed for MA by immunoassay with a cutoff of 1,000 ng/mL. | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methamphetamine dependence, texting, short message service, addiction, amphetamine, outpatient
Observational Study of Efficacy and Safety of Travogen Cream and Travocort Cream in the Treatment of Mycoses

Study Overview
=================
Brief Summary
-----------------
An assessment of the efficacy and safety of Travogen cream and Travocort cream in the treatment of local skin mycoses

Official Title
-----------------
Observational Study of the Efficacy, Safety and Tolerance of Travogen Cream (Isoconazole) and Travocort Cream (Isoconazole, Diflurcortolone) in the Treatment of Patients With Local Skin Mycosis of Various Etiology and Localization

Conditions
-----------------
Skin Mycoses

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of skin mycosis Exclusion Criteria: Allergies to study medication
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>All patients treated | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Travogen / Travocort in the treatment of skin mycoses / Travogen Cream and Travocort Cream will be prescribed by a physician |  | Baseline to end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction |  | Baseline to end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mycoses
Association Study Between Periodontal Disease and Male Infertility

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to examine the association between fertility parameters and the periodontal status of men attending fertility and in vitro fertilization clinic.

Detailed Description
-----------------
An association has been found between periodontal diseases and preterm low birth weight, coronary heart disease, and cerebral infarction. Anaerobic gram negative bacterial plaque that forms subgingivally is the direct causative factor for the development of Gingivitis and Periodontitis. However, its possible association with male infertility have not yet been investigated.

Official Title
-----------------
Periodontal Status of Males Attending in Vitro Fertilization Clinic

Conditions
-----------------
Periodontitis, Sub-fertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consent to participate in study Exclusion Criteria: Systemic uncontrolled disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Males attending in vitro fertilization clinic<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive association between periodontitis and infertility |  |  |
Twice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to find out the response rate of twice weekly paclitaxel and cisplatin and weekly HDFL in recurrent or metastatic esophageal carcinoma patients who need palliative Chemotherapy.

Detailed Description
-----------------
The primary objective of this study is to find out the response rate of twice weekly paclitaxel and cisplatin and weekly HDFL in recurrent or metastatic esophageal carcinoma patients who need palliative Chemotherapy. The secondary objectives include overall survival, progression-free survival, and toxicity.

Official Title
-----------------
A Phase II Study of Twice Weekly Paclitaxel, Cisplatin and Weekly 24-Hour Infusion of High-Dose 5-Fluorouracil and Folinic Acid in the Treatment of Recurrent or Metastatic Esophageal Cancer

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

Intervention / Treatment
-----------------
* Drug: Paclitaxel,Cisplatin,5-Fu,Folic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically proven esophageal squamous cell or adenocarcinoma Recurrence or metastasis Measurable disease (> 1 X 1 cm) by CXR, CT scan or MRI,Age > 18, KPS > 60% , Cre < 1.5mg/dl, AST/ALT < 3.5 X N, Bil < 2.0mg/dl WBC > 4,000/mm3, ANC > 2,000/ mm3, Plt > 100,000/mm3 Exclusion Criteria: Prior chemo (except as radiosensitizers)Recurrent, treated esophageal lesion only (except > 2 months)

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

| Intervention/Treatment |
| --- |
|Drug: Paclitaxel,Cisplatin,5-Fu,Folic Acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Progression-free survival |  |  | 
| Toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Combination,Chemotherapy,Esophageal Cancer
Testing of Radiofrequency Coil for Clinical 19F MRI

Study Overview
=================
Brief Summary
-----------------
Testing of a dual tuned proton/fluorine MRI radio frequency coil Images were collected from plastic fluorine phantoms taped to the upper thigh of health volunteers. This trial was performed as part of an application for a Health Canada Investigational Device Exemption (Protocol # 226949)

Conditions
-----------------
Diagnostic Imaging

Intervention / Treatment
-----------------
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteer Exclusion Criteria: MRI incompatible patient claustrophobia
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI<br>Eppendorf tubes containing 10% fluorine-19 diluted in agar were taped to the upper thigh of participants. Investigational device was used to image the phantom with Magnetic resonance imaging (MRI). Imaging was performed for anatomical (proton) and fluorine (agent detection). Total scan time was under 1 hour. Objectives: Verify RF coil functionality Obtain preliminary detection threshold limits using a human coil loading | Device: MRI<br>* Investigational device is a dual tuned (fluorine/proton) MRI surface coil designed and produced by Clinical MR solutions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verify radio frequency coil imaging functionality on humans | Proof of successful MRI signal acquisition with use of investigation device. | 1 hour of scanning | 
| Measure signal repeatability in different patients | MRI signal strength is expected to vary slightly based on patient weight. | 1 hour of scanning |
A Non-Invasive Cervical Cancer Screening Modality: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
Cervix cancer is a major global health concern. A way to screen and immediately treat precancerous lesions (Screen-and-Treat) is greatly needed. Developed by MobileOCT, polarized difference imaging and conventional imaging are used to identify suspicious lesions. We aim to compare this non-invasive method with colposcopy. Patients at the Dickens Clinic will have 3-5 minutes of non-invasive imaging before colposcopy. Pathology will be compared both to colposcopy impression versus MobileOCT.

Official Title
-----------------
A Non-Invasive Cervical Cancer Screening Modality: A Pilot Study

Conditions
-----------------
Women With Abnormal Pap Smears

Intervention / Treatment
-----------------
* Device: non-invasive multimodal imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects capable of giving informed consent or have an acceptable surrogate capable of giving consent on subjects behalf. Subjects are 18 years of age or older Subjects are scheduled for colposcopy clinic based on screening with abnormal pap smear or have repeat colposcopy indicated for specific clinical indications, based off of American Society of Cosposcopy and Cytology. Subjects are women. Exclusion Criteria: Pregnancy. Males (males do not have a cervix and thus cannot undergo colposcopy).

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: non-invasive multimodal imaging|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of suspicious lesions identified |  | 2 years |
Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III guidelines, overall and by country, in the following sub-populations: Primary/secondary prevention patients. Patients with metabolic syndrome (according to NCEP III definition). In addition, the purpose is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task Force guidelines/national guidelines, in the survey population and in the following sub-populations: Primary/secondary prevention patients. Patients with metabolic syndrome.

Official Title
-----------------
Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: On lipid-lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks. · Subject must sign informed consent Exclusion Criteria: Subjects who are unwilling or unable to provide informed consent.

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 |
| --- | --- | --- |
| To establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III guidelines, overall and by country. |  | 6 months- One visit only, no follow up visits. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients reaching the LDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III in the following sub-populations - Primary/secondary prevention patients - Patients with metabolic syndrome (according to NCEP III definition). |  | 6 months - One visit only, no follow up visits. | 
| The proportion of patients reaching the LDL-C goals according to the Third Joint European Task Force guidelines / national guidelines, in the following sub-populations:-Primary/secondary prevention patients -Patients with metabolic syndrome. |  | 6 months- One visit only, no follow up visits. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypercholesterolemia, The study is focusing on the undertreatment of hypercholesterolemia