linjc16/ctgov huggingface dataset:
Human Papilloma Virus DNA Self-Test

Study Overview
=================
Brief Summary
-----------------
HPV DNA testing by a clinician has been shown to be highly sensitive in detecting cervical disease. Can we prove that HPV self-testing will be sufficiently sensitive to detect disease in high risk population who for various reasons would not have routine pap smear screening?

Detailed Description
-----------------
Women between the ages of 18 years to post-menopausal with documented abnormal pap smear atypical squamous cells of undetermined significance and higher will be enrolled into the study. Patients will be taught how to collect vaginal samples with dacron swab and vaginal tampons by means of instructional video and manufacturer's instruction guide respectively. Physicians will perform pap smear and colposcopy. All samples will be sent to the University of Louisville lab for processing for HPV DNA detection by Hybrid capture 2 method.

Official Title
-----------------
Human Papilloma Virus DNA Self-Test

Conditions
-----------------
Papilloma Virus, Human

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Abnormal pap smear ASCUS or higher Age 18-postmenopausal Exclusion Criteria: Less than 18 years old Prior hysterectomy Pregnancy Use of corticosteroids HIV positive

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

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

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 |
| --- | --- | --- |
| HPV DNA self-testing device to detect disease in patients with abnormal Pap smear | To assess the concordance of HPV DNA self-testing device to detect disease in patients with abnormal Pap smear. Patients with a positive HPV Self-test by vaginal swab or vaginal tampon will be compared to the physician test results for concordance. Following patient self-sample collection, physician will collect cervical samples using a spatula. A self testing device which patients can use at their convenience will be beneficial in decreasing the incidence of cervical cancer in Kentucky. | Patient will self-test immediately prior to their standard physician papsmear | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human Papilloma Virus
Symptoms and Endoscopic Results in Consideration of Pretreatment

Study Overview
=================
Brief Summary
-----------------
Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. gastroenterologists) are asked to document relevant data in patients with gastrointestinal disorders.

Official Title
-----------------
Symptoms and Endoscopic Results in Consideration of Pretreatment

Conditions
-----------------
Gastrointestinal Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with gastrointestinal disorders who need an endoscopy. Exclusion Criteria: limitiations; possible risks; warnings; contraindications mentioned in the SPC.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patients with gastrointestinal disorders who need an endoscopy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to gain insight into the relationship between subjective gastrointestinal symptoms and findings of a laryngopharyngeal-esophagogastric endoscopy with respect to the medicinal pre-therapy; |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to gain insight into the currently used treatment strategies with esomeprazole depending on endoscopic findings. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastrointestinal disorder, endoscopy, patient with gastrointestinal disorders for whom an endoscopy is performed and who is treated with esomeprazole afterwards.
Evaluation of Factors Affecting the Tear-film Lipid Layer Thickness

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators aim to determine the effects of age, sex, history of ocular surgery and contact lens use, and ocular surface and meibomian gland parameters on the lipid layer thickness (LLT) in normal subjects and patients with dry eye syndrome. Patients with dry eye syndrome and subjects with a healthy ocular surface will be enrolled. All participant will underwent LLT measurement with a LipiView interferometer, tear meniscus height measurement using optical coherence tomography, tear film break-up time (TBUT) determination, corneal and conjunctival staining, Schirmer's test, examination of the lid margins and meibomian glands, and assessment using the Ocular Surface Disease Index(OSDI) questionnaire.

Conditions
-----------------
Dry Eye Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. age over 19 years old, Patients with dry eye syndrome and normal subjects Exclusion Criteria: patients less than 18 years of age and patients with histories of ocular surgery within 3 months; ocular injury; and ocular diseases such as ocular infection, allergy, and autoimmune disease; and patients with the use of a punctal plug or topical ocular medications other than artificial tears. Patients who used artificial tears were instructed not to apply them for at least 12 hours 99 before the examinations

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dry eye<br>Patients with dry eye syndrome | |
| normal<br>Patients without dry eye | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Lipid Layer thickness measurement with a LipiView interferometer |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tear meniscus height measurement using optical coherence tomography |  | 1 day | 
| Corneal and conjunctival erosion grade(oxford score) |  | 1 day | 
| tear film break-up time (TBUT) |  | 1 day | 
| Schirmer's test (lacrimal secretion test) |  | 1 day | 
| evaluation of the score of lid margins and meibomian glands |  | 1 day | 
| Ocular Surface Disease Index(OSDI) questionnaire |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye, Lipiview, Tear Lipid Layer, meibomian gland dysfunction
Brain Tumor Treatment Satisfaction Survey

Study Overview
=================
Brief Summary
-----------------
Patients with recent diagnosis and treatment of a brain tumor will complete a short questionnaire concerning the patient's quality of life and emotional state since receiving treatment. Caregivers will complete a one-page questionnaire concerning the patient's quality of life and emotional state since receiving treatment.

Detailed Description
-----------------
Patients with a recent diagnosis and treatment of a brain tumor (primary or metastatic; N=105, 61% female, 39% male) were identified in the clinics of Semmes-Murphey Neurologic and Spine Institute or the Methodist University Hospital in Memphis, TN. Caregivers were recruited from among relatives and friends who provide the most day-to-day care to the patient. All participants were between 3 months and 1 year from their most recent brain tumor treatment. Participants were given a simple, 5-point based survey to asses treatment-specific satisfaction, patient education, posttreatment quality of life, and pre- and post-treatment emotional impact. Therapeutic modalities surveyed include: surgery, external beam radiotherapy, whole-brain radiotherapy, stereotactic radiosurgery, and chemotherapy.

Official Title
-----------------
Treatment Satisfaction Survey for Brain Tumor Patients and Their Caregivers

Conditions
-----------------
Brain Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are between 3 months and one year out from treatment for their brain tumor Karnofsky Performance Status (KPS) >= 60 Age 18 years or over, any gender, any race patient caregivers will be individuals who provide the most day-to-day care for their respective brain tumor patients Exclusion Criteria: No exclusions

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Brain tumor patients | |
| 2<br>Caregivers of brain tumor patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall satisfaction and emotional impact of treatments in patients who have undergone therapy(s)for brain tumors. |  | (greater than or equal to 3 months) from first treatment for brain tumor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observational data about the treatment course and emotional well-being of the brain tumor patient as provided by the caregiver. |  | (Greater than or equal to 3 months) from first treatment for brain tumor | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain Tumors, Survey
Improved Patient Safety Through Continuous Bi-channel RR and SpO2 Monitoring With Masimo Patient SafetyNet

Study Overview
=================
Brief Summary
-----------------
The investigator intend to perform an observational study, by adding Respiratory Rate monitoring to an already existing Patient SafetyNet system with SpO2 (Oxygen Saturation) and PR (Pulse Rate) monitoring. RRa will be blinded to the clinicians and all RRa alarms will be deactivated. Retrospective analysis of the observational data collected will be utilized to evaluate the potential benefits of additional continuous respiratory rate monitoring.

Detailed Description
-----------------
Addition of acoustic respiratory rate monitoring to an already existing standard of care patient surveillance system that includes oxygen saturation and heart rate monitoring by pulse oximetry will result in earlier and more sensitive detection of respiratory events and possibly early stages of developing sepsis in a post-surgical/orthopedic study population. An observational study with RRa is an additional blinded parameter to the already existing standard of care monitoring with SpO2 and PR on one post-surgical floor, (includes Trauma and orthopedic patients), where patients receive opioids for pain management. 300 consecutive patients will be enrolled and monitored with RRa for at least the first 24hours post-surgery, after discharge from the Recovery Room, & upon admission to the Surgical floor.

Official Title
-----------------
Improved Patient Safety Through Continuous Bi-channel Respiratory Rate and Oxygen Saturation Monitoring With Masimo Patient SafetyNet

Conditions
-----------------
Signs and Symptoms, Respiratory

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Adult 18yrs of age or older Post-surgical patient receiving opioid pain medication Exclusion Criteria: • Refusal of optical finger sensor and/or acoustic respiratory rate neck sensor placement Finger or skin abnormalities at sensor sites Expected opioid therapy duration less than 24 hours

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 |
| --- | --- | --- |
| Improved sensitivity of RRa by detecting the number and the incidence rate of respiratory depression events |  | with in 24 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time period between detection of first early symptoms of developing sepsis with RRa, PR and SpO2 monitoring compared to the first clinical diagnosis of developing sepsis. |  | with in 24 hours post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early detection, respiratory events, sepsis
Pharmacokinetics And Tolerability Of Subcutaneous Administration Of PF 04236921 In Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, tolerability, and pharmacokinetics of PF-04236921 administered as a single subcutaneous dose in healthy volunteers.

Detailed Description
-----------------
Tolerability and Pharmacokinetics of subcutaneously administered dose of PF-04236921 in healthy volunteers

Official Title
-----------------
Phase I Pharmacokinetics And Tolerability Of PF-04236921 Following Subcutaneous Administration To Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: PF-04236921


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males between 18-55 years, inclusive. Healthy females of non-childbearing potential between 18 and 55 years, inclusive. Exclusion Criteria: Evidence or history of clinically significant disease. Females of childbearing potential.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: PF-04236921<br>* single subcutaneous dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events |  | 5 months | 
| Incidence and severity of clinical findings on physical examination |  | 5 months | 
| Mean change from baseline in vital signs (blood pressure, pulse rate, oral or tympanic temperature) measurements |  | 5 months | 
| Mean change from baseline in 12-lead electrocardiogram (ECG) parameters: PRI, RR, QRS, QT, QTcF (Freidericia's correction) and HR (heart rate) |  | 5 months | 
| Serum PF-04236921 concentrations will be determined by a validated assay and noncompartmental PK parameters |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of clinical laboratory abnormalities including absolute neturophil count, hepatic transaminases and bilirubin levels, and lipid profiles |  | 5 months | 
| Incidence and level of ADA development |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety and tolerability, Pharmacokinetics, PF-04236921, Rheumatoid Arthritis
Budesonide / Formoterol in Treatment of Exacerbations of COPD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the budesonide+formoterol combination is effective in the treatment of exacerbations of COPD with a main emphasis on investigating the effects on inflammation and a secondary emphasis on clinical efficacy

Official Title
-----------------
Effects of High Dose Inhaled Budesonide+ Formoterol Versus Placebo and Oral Prednisolone on Biomarkers of Airway Inflammation in the Treatment of Exacerbations in Non-hospitalised Patients With Mild to Moderate COPD.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: budesonide/formoterol, 2x 200/6 microgram. 4 times daily
* Drug: prednisolone, 30 mg once daily and placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: smoking-induced COPD according to ATS criteria FEV1 <85% of predicted at enrolment and <70% of predicted but > 0.7 Liter at Exacerbation FEV1/IVC ratio <88% of predicted for men and <89% for women Exclusion Criteria: history of asthma known hypersensitivity to the study drugs serious concomitant diseases pregnancy or lactating abnormal Chest X-ray or blood gasses

Ages Eligible for Study
-----------------
Minimum Age: 40 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: budesonide/formoterol, 2x 200/6 microgram. 4 times daily|nan|
|Drug: prednisolone, 30 mg once daily and placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eosinophils in induced sputum (as % of Total Cell Count), change from the start of the exacerbation to the end of 14 days treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers in induced sputum, blood/serum and urine |  |  | 
| Lung function tests at clinic |  |  | 
| Diary cards for PEF and symptoms |  |  | 
| Patient Related outcomes |  |  | 
| Questioning for Adverse Events and in blood: routine tests and cortisol |  |  |
3-4 Year Outcomes Following Endovenous Steam Ablation for Venous Insufficiency

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the long-term effects of endovenous steam ablation (EVSA). Postoperative data at 3-4 year follow-up will be collected from patients treated with EVSA.

Detailed Description
-----------------
Endovenous steam ablation (EVSA) of saphenous veins (saphenous vein reflux) is one of the endothermal methods in the modern treatment of venous insufficiency. Good results and long-term follow-up have been published for endovenous laser ablation (EVLA) and radiofrequency ablation (RFA), while long-term effects of EVSA are less documented. Therefore, the aim of this study is to evaluate the effect of EVSA in 200 consecutive patients treated with EVSA and conduct prospective evaluations at 3-4 year follow-up. Standardized and validated measures will be compared to preoperative measures to evaluate change in patient-reported and clinical outcomes over time.

Official Title
-----------------
3-4 Year Outcomes Following Endovenous Steam Ablation of the Saphenous Veins for the Treatment of Venous Insufficiency

Conditions
-----------------
Varicose Veins

Intervention / Treatment
-----------------
* Procedure: Endovenous steam ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received steam ablation for treatment of saphenous vein reflux (clinical classes C2-C4) at Lovisenberg Diakonale Hospital 3-4 years (i.e, 36-48 months) prior to study enrollment. Ability to speak, understand, read, and write Norwegian in order to complete follow-up exams and questionnaires. Exclusion Criteria: <18 years of age

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: Endovenous steam ablation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vein obliteration or abolition of reflux | As determined by duplex scanning | 3-4 years after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent varicosities |  | 3-4 years after treatment | 
| Recanalization |  | 3-4 years after treatment | 
| Venous Clinical Severity Score |  | 3-4 years after treatment | 
| Aberdeen Varicose Vein Questionnaire |  | 3-4 years after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Steam ablation, Endothermal ablation, Varicose vein treatment, Venous insufficiency, Saphenous vein reflux, Recurrent varicosity
Study Evaluating AMG 706 in Subjects With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This study will determine the safety and pharmacokinetics of AMG 706 in subjects with advanced solid tumors.

Official Title
-----------------
A Phase 1, First in Human, Open-Label, Dose Finding Study Evaluating the Safety and Pharmacokinetics of AMG 706 in Subjects With Advanced Solid Tumors

Conditions
-----------------
Tumors

Intervention / Treatment
-----------------
* Drug: Anti-angiogenesis
* Drug: AMG 706


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exclusion Criteria:

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: AMG 706<br>AMG 706 QD | Drug: Anti-angiogenesis<br>* Anti-angiogenesis<br>Drug: AMG 706<br>* Anti-angiogenesis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting toxicity |  | Cycle 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose selection |  | Study completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, antiangiogenesis, Solid Tumors