linjc16/ctgov huggingface dataset:
Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System

Study Overview
=================
Brief Summary
-----------------
The objective of the clinical study is to evaluate the AHPV-GT Assay using the PANTHER System in cervical cancer screening. This objective will be accomplished in the ASC-US Study by evaluating the performance characteristics of the AHPV-GT Assay using the PANTHER System in a sample population of women with ASC-US Pap test results who were 21 years of age or older (≥21 years of age) at the time of their Pap visit. For the Adjunct Study, this objective will be accomplished by evaluating the ability of the AHPV-GT Assay using the PANTHER System to identify women at increased risk of cervical disease in a sample population of women with negative (NILM)cytology results who were ≥30 years of age at the time of their Pap visit.

Official Title
-----------------
Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System in Women With ASC-US Pap Test Results and in Women 30 Years of Age or Older With Negative Pap Test Results Using ThinPrep Pap Test Specimens

Conditions
-----------------
Human Papillomavirus Infection

Intervention / Treatment
-----------------
* Device: APTIMA HPV Assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who were previously enrolled into the prospective, multicenter US clinical study for the APTIMA HPV Assay on the TIGRIS System (protocol 2007HPVASCUS30) will be eligible for inclusion in the study of the AHPV-GT Assay using the PANTHER System described in this protocol. All evaluable ASC-US Study subjects ≥21 years of age will be eligible for inclusion. Evaluable Adjunct Study subjects ≥30 years of age will be eligible if the following criteria are met: the subject attended the colposcopy visit, or the subject did not attend the colposcopy visit but the referral Pap sample had a positive APTIMA HPV Assay result in the APTIMA HPV Assay TIGRIS System study (protocol 2007HPVASCUS30) or in the APTIMA HPV Assay PANTHER System study (protocol AHPVPS-US11-003). Exclusion Criteria: Eligible subjects will be excluded if they do not have an evaluable sample. This may be due to insufficient volume or because the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions).

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Treatment<br> | Device: APTIMA HPV Assay<br>* In Vitro Diagnostics Assay<br>|

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
-----------------
HPV, APTIMA, cervix cancer
Age Gender Left Ventricular Mass and Cardiac Troponin T

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the influence of functional or anatomic cardiac parameters, age and gender on high sensitivity cTnT (TnThs) levels in healthy individuals.

Detailed Description
-----------------
We sought to investigate the relative contribution of functional or anatomic parameters as assessed by cardiac magnetic resonance tomography (cMRI, 1.5 Tesla), and clinical variables including increasing age and gender on high sensitivity cTnT (TnThs) levels in healthy individuals. Therefore we measured TnThs in serum samples of 120 healthy volunteers aged between 20 and 70 years. All individuals underwent cMRI including stress testing using dobutamine or adenosine.TnThs concentrations were related to cMRI and clinical findings. Partial correlation, as well as linear and hierarchical regression analyses were used to identify independent predictors and their relative contribution for prediction of TnThs values.

Official Title
-----------------
Relative Contribution of Age, Gender and Left Ventricular Mass as Quantified by Cardiac Magnetic Resonance Tomography to Detectable Levels of Cardiac Troponin T in a Healthy Reference Population Aged Below 70 Years

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: agreement, age > 18 years, men and women Exclusion Criteria: measurable heart disease, any chronic or acute disease, intake of meds, hypertension, Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| healthy volunteers<br> | |

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
-----------------
Age Gender left ventricular mass high sensitive Troponin T
Breath-hold Cardiac Hybrid SPECT/CCTA

Study Overview
=================
Brief Summary
-----------------
This study aims at combining inspiration breath-hold myocardial perfusion SPECT with coronary CT angiography.

Official Title
-----------------
Usefulness of Breath-hold Triggered SPECT-MPI in Cardiac Hybrid SPECT/CCTA Imaging

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Breathhold SPECT-MPI
* Device: Standard freebreathing SPECT-MPI
* Device: Coronary CT angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referral for cardiac hybrid SPECT/CCTA Male and female subjects 18 years of age or older Written informed consent by the participant after information about the project Exclusion Criteria: Contraindications for coronary CT angiography (including renal failure with a GFR <30ml/min/1.73m2, allergies to iodinated contrast agents) Pregnancy or breast-feeding Previous coronary revascularisation Inability to follow the examination procedure (e.g. due to language barriers, severe mental disease etc

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI<br> | Device: Breathhold SPECT-MPI<br>* Respiratory triggered SPECT myocardial perfusion imaging<br>Device: Standard freebreathing SPECT-MPI<br>* Clinically indicated, standard non-respiratory triggered SPECT myocardial perfusion imaging<br>Device: Coronary CT angiography<br>* Clinically indicated coronary CT angiography serving as standard of reference<br>* Other names: CCTA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality as visually assessed on a Likert scale |  | 1 day | 
| Number of image artefacts |  | 1 day |
Immune Dysfunction in Allergic Asthma

Study Overview
=================
Brief Summary
-----------------
We are using anti-IgE to investigate the role of pulmonary mast cells in asthma.

Detailed Description
-----------------
Subjects with mild allergic asthma are examined before, immediately after and 2 months after a course of treatment with anti-IgE. The following are examined: Allergen skin tests, allergen induced asthma, peripheral blood basophils, pulmonary bronchial mucosal mast cells.

Official Title
-----------------
Not a Drug Trial. We Are Using Anti-IgE to Examine the Role of Pulmonary Mast Cells in Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Xolair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild asthma, adults - Exclusion Criteria: children. on inhaled or systemic steroids -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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: xolair<br>This is a single arm, parallel study examining differences of therapeutic outcomes of Xolair. Xolair is being examined as an intervention that might change the outcome of immunization. | Drug: Xolair<br>* Patients are administered Xolair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-KLH Antibody. This is Measured by ELISA and Expressed as ELISA Units Which Are Derived by Dilution of Serum Samples Until the Result Falls on a Linear Portion of the Response Curve. Final Values Are Derived From ELISA Units and the Serum Dilution | Asthma and control patients are immunized with KLH. Mean levels of anti-KLH antibody as described above. This is measured by ELISA and expressed as ELISA units which are derived by dilution of serum samples until the result falls on a linear portion of the response curve. Final values are derived from ELISA units and the serum dilution | 6 months |
A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT.

Official Title
-----------------
A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Celgosivir hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV infection. Asymptomatic or mildly symptomatic. CD4 count 100 - 300 cells/mm3. Prior Medication: Allowed: Prior antiretroviral agents for up to 6 months per agent. Exclusion Criteria Co-existing Condition: Patients with the following condition are excluded: Unable or unwilling to comply with study procedures. Concurrent Medication: Excluded: Chemoprophylactic therapy for mycobacterial infection. Any nonstudy prescription medications without approval of investigator. Patients with the following prior conditions are excluded: History of grade 3 or 4 toxicity to <= 600 mg/day AZT. History of intolerance to lactose. Chronic diarrhea within 6 months prior to study entry. Unexplained intermittent or chronic fever, defined as temperature >= 38.5 C for any 7 days within the 30 days prior to study entry. Prior Medication: Excluded: Antiretroviral therapy within 2 weeks prior to study entry. Prior HIV vaccines. Biological response modifiers within 30 days prior to study entry. Prior foscarnet. Any investigational drug with a washout < 5 half-lives prior to study entry. Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry. Recent history of alcohol and/or drug abuse.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Celgosivir hydrochloride|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
-----------------
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, MDL 28574
MBSR for Work Active Seniors

Study Overview
=================
Brief Summary
-----------------
Testing Mindfulness-based Stress Reduction (MBSR) in 60-65 year old senior employees.

Detailed Description
-----------------
Outcome measures: HRV, blood pressure, weight, structural and functional brain scans, questionnaire

Official Title
-----------------
Mindfulness-baseret Forebyggelse og Sundhedsfremme i Den Sidste Del af Arbejdslivet

Conditions
-----------------
Health Promotion and Stress Prevention

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-Based Stress Reduction


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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR<br>receives 8-week MBSR course | Behavioral: Mindfulness-Based Stress Reduction<br>* yoga, meditation and psycho education<br>|
| No Intervention: control<br>receives intervention after experiment finishes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-perceived stress | questionnaire | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability |  | 2 years | 
| blood pressure |  | 2 years | 
| weight |  | 2 years |
The Benefit of Enhanced Day Care of Traditional Chinese Medicine: A Retrospective Study of Medical Records

Study Overview
=================
Brief Summary
-----------------
We collected medical records since June 2017 to November 2019., used pair-T test for questionnaire of CTCAE, BFT-I, WHOQOL to evaluate the benefit of enhanced day care of TCM for cancer patients.

Detailed Description
-----------------
using TCM method as Complementary and Alternative Medicine is worldwide. we collected medical records that using TCM methods for adverse event from cancer therapies. we used CTCAE BFI-T and WHOQOF-BREF to evaluate the benefit.

Official Title
-----------------
The Benefit of Enhanced Day Care of Traditional Chinese Medicine: A Retrospective Study of Medical Records

Conditions
-----------------
Chemotherapy-Induced Change

Intervention / Treatment
-----------------
* Combination Product: enhanced day care of TCM include acupuncture, massage, tai ji quan, TCM herbal medicine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - The medical records since June 2017 to December 2019 needed to meet the following criterial: (1)age>20 years old, (2)diagnosis meet ICD10:C00.0-C97 (3) needed to do Taiwan brief version of Common Terminology Criteria for Adverse Events Version4.0(Taiwan brief version scale of CTCAE), scale of the Taiwanese Version of the Brief Fatigue Inventory(BFI-T) and scale of the World Health Organization Quality of Life-BREF(WHOQOL-BREF), and those scales needed to be done pretest when patient came to the clinics and posttest when case end. Exclusion Criteria: - The subjects will be excluded if they do not complete pretest and posttest of the following scales:(1) Taiwan brief version scale of CTCAE, (2) BFI-T scale (3) WHOQOL-BREF scale

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Combination Product: enhanced day care of TCM include acupuncture, massage, tai ji quan, TCM herbal medicine|acupuncture twice in enhanced day care of TCM massage twice in enhanced day care of TCM tai ji quan one time in enhanced day care of TCM TCM herbal powder three times a day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scale of Taiwan brief version of Common Terminology Criteria for Adverse Events Version4.0(Taiwan brief version scale of CTCAE) | for chemotherapy related adverse effects in Taiwan | 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scale of the Taiwanese Version of the Brief Fatigue Inventory(BFI-T) | evaluate the level of fatique | 2020 | 
| scale of the World Health Organization Quality of Life-BREF(WHOQOL-BREF) | evaluate QOL | 2020 |
Abdominoplasty Under Epidural Anesthesia

Study Overview
=================
Brief Summary
-----------------
Abdominoplasty is one of the most popular body-contouring procedures, yet it is also among the most hazardous aesthetic procedures currently performed. It was shown, in many studies, to be associated with a significant complication rate, some of which are life-threatening. This study describes the investigators experience with a series of abdominoplasties performed under epidural anesthesia. Outcomes are presented, especially in terms of complication, and the practical advantages of this method are discussed.

Official Title
-----------------
Abdominoplasty Under Epidural Anesthesia: Safer for the Patient, Easier for the Surgeon.

Conditions
-----------------
Abdominoplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients that underwent abdominoplasty between January 2003 and March 2008 in a private hospital by Dr. Yitshak Ramon. Exclusion Criteria: Patients with concurrent operations requiring general anesthesia.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Abdominoplasty patients<br>All patients who underwent abdominoplasty at our institution without concurrent operations | |

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
-----------------
Abdominoplasty, Epidural
FemBloc® Permanent Contraception - Confirmation Feasibility Trial

Study Overview
=================
Brief Summary
-----------------
The trial objectives include evaluating the adequacy of proposed mitigations for the previous pivotal trial of the FemBloc Permanent Contraceptive System and validating the confirmation procedure by comparing FemChec (ultrasound) to fluoroscopic hysterosalpingogram (fluoro HSG) for post-occlusion in the same patient.

Official Title
-----------------
BLOC: Prospective, Multi-Center, Study of Subjects Undergoing FemBloc Permanent Contraception With Two Confirmation Procedures (FemBloc With FemChec and Fluoro HSG)

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Device: FemBloc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, 21 - 45 years of age desiring permanent birth control Sexually active with male partner Regular menstrual cycle for last 3 months or on hormonal contraceptives Exclusion Criteria: Uncertainty about the desire to end fertility Known or suspected pregnancy Prior tubal surgery, including sterilization attempt Prior endometrial ablation Presence, suspicion, or previous history of gynecologic malignancy Abnormal uterine bleeding requiring evaluation or treatment Scheduled to undergo concomitant intrauterine procedures at the time of procedure(s) Allergy to shellfish, betadine or iodinated contrast

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FemBloc<br>Investigational device and procedure | Device: FemBloc<br>* Treatment with FemBloc for women who desire permanent birth control (female sterilization)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliance Rate | Number of subjects told to rely divided by number of qualified subjects | within 1 year | 
| Concordance | Concordance between FemBloc confirmation with FemChec and Fluoro HSG confirmation | within 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
permanent contraception, birth control, pregnancy prevention