linjc16/ctgov huggingface dataset:
Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the clinical specificity of the FilmArray NGDS Warrior Panel.

Official Title
-----------------
Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel

Conditions
-----------------
Evaluation of Test Panel

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Whole blood (prospectively collected via informed consent): Adult subject has a recorded or self-reported fever within the previous 24 hours Subject provides informed consent prior to enrollment and specimen collection Subject has not previously provided a whole blood specimen for this study Whole blood (residual) Whole blood (in EDTA) submitted to laboratory for standard of care testing Specimen is not from an individual with a specimen previously enrolled in the study Positive Blood Culture: Culture was detected as positive by an automated blood culture system Culture is not from a patient previously enrolled in the study Negative Blood Culture: Culture not detected as positive by an automated blood culture system Culture is not from a patient previously enrolled in the study Sputum: Specimen was accepted for testing by the respective site's microbiology laboratory Specimen is not from an individual that has a sputum already enrolled in the study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects/specimens that meet the inclusion criteria<br>Subjects/specimens that meet the inclusion criteria | Other: Observational study<br>* No intervention will be used in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical specificity of the FilmArray NGDS Warrior Panel |  | 8 months |
Vaginal Dinoprostone Administration Prior to Intrauterine Device Insertion

Study Overview
=================
Brief Summary
-----------------
To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces IUD insertion pain and difficulty in insertion in adolescents and young women.

Detailed Description
-----------------
Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Official Title
-----------------
Benefits of Self-administered Vaginal Dinoprostone Administration 12 Hours Prior to Intrauterine Device Insertion in Adolescent and Young Women: a Randomized Controlled Trial

Conditions
-----------------
IUD Insertion Pain

Intervention / Treatment
-----------------
* Drug: Dinoprostone
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nulliparous adolescent and young women requesting levonorgestrel-releasing intrauterine device Exclusion Criteria: pregnancy and contraindication or allergy to dinoprostone or contraindication to IUD insertion, chronic pelvic pain,pelvic inflammatory disease,analgesic intake 24 hours prior to IUD insertion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 22 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dinoprostone<br>1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) self-inserted by the patient 12 hours before IUD insertion. | Drug: Dinoprostone<br>* 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) self-inserted by the patient 12 hours before IUD insertion.<br>|
| Placebo Comparator: placebo<br>one tablet of placebo self-administered by the patient 12 hours before IUD insertion. | Drug: placebo<br>* one tablet of placebo self-inserted by the patient 12 hours before IUD insertion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in pain scores during intrauterine device insertion | The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10 | 10 minutes |
A Cohort Study of Environmental Endocrine Disrupting Chemicals and Female Reproductive Health

Study Overview
=================
Brief Summary
-----------------
Infertility is a disease that seriously affects the physical and mental health of women of childbearing age. The incidence of infertility has been increasing in recent years. Studies have shown that the occurrence of infertility may be related to environmental endocrine disrupting substances. This project was designed to establish a cohort study on environmental endocrine disrupting substances and in vitro fertilization (IVF) treatment, collect blood, urine, semen, follicular fluid, granulosa cells, chorionic decidua biological specimens, and then follow up on the pregnancy outcomes. The concentration of disrupting substances was detected and then found the associations between environmental endocrine disrupting substances and female reproductive health.

Official Title
-----------------
Adverse Effects and Mechanism of Environmental Endocrine Disrupting Chemicals on Female Reproductive health--the Peking University and Environment Reproductive Health Cohort

Conditions
-----------------
IVF

Intervention / Treatment
-----------------
* Other: there is no intervention in the study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of infertile patients undergoing IVF treatment Exclusion Criteria: Donor egg transplants excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: there is no intervention in the study|there is no intervention in the study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of eggs retrieved | the number of eggs retrieved in the process of in vitro fertilization (IVF) | immediately after the eggs retrieved | 
| the number of available embryos | the number of available embryos in the process of IVF | 1 week after the eggs retrieved | 
| the clinical pregnancy rate | the clinical pregnancy rate in the process of IVF | 4 weeks after the embryos transfer | 
| the miscarriage rate | the miscarriage rate in the process of IVF | 7 months after embryos transfer | 
| the live birth rate | the live birth rate in the process of IVF | 40 weeks after embryos transfer |
Supportive Periodontal Therapy Under Antiresorptive Therapy

Study Overview
=================
Brief Summary
-----------------
This observational study investigates the one-point in time and course of clinical periodontal and dental parameters during supportive periodontal therapy in patients under and without antiresorptive medication.

Official Title
-----------------
Supportive Periodontal Therapy Under Antiresorptive Therapy

Conditions
-----------------
Periodontitis, Antiresorptive Drugs

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing supportive periodontal therapy (SPT) after completing anti-infectious therapy (AIT) in the Section of Periodontology, Clinic of Conservative Dentistry, University Hospital Heidelberg Regular attendance to SPT (no interruption of interval of more than one year) Existing radiographs (orthopantomogram or dental status) of up to six months before AIT ART-group: patients on antiresorptive medication (underlying diseases: osteoporosis, cancer diseases) Understanding of participation in this study and given informed consent Exclusion Criteria: Patients < 18 years Patients who underwent radiation therapy Pregnancy

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 |
| --- | --- |
| ART-Group<br>Patients undergoing supportive periodontal therapy and independently antiresorptive therapy. | |
| Control Group<br>Patients undergoing supportive periodontal therapy without the need for antiresorptive therapy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is there a difference in the clinical attachment level between patients under antiresorptive therapy and without antiresorptive medication? |  | 0 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is Intraoral digital photography suitable for DMFT and implants assessment? |  | 0 months | 
| Is there a difference in the clinical attachmentlevel between baseline and 12 months after the beginning of supportive periodontal therapy in patients under antiresorptive therapy compared to patients without antiresorptive medication? |  | 12 months |
A Study To Evaluate The Safety And Pharmacokinetic Profile Of A P38 Inhibitor (PH-797804) In Subjects With Rheumatoid Arthritis Who Are Also Taking Methotrexate

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that the p38 inhibitor (PH-797804) will be safe and well tolerated in subjects with rheumatoid arthritis who are taking methotrexate and will not effect the blood levels of methotrexate.

Official Title
-----------------
A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Safety And Pharmacokinetic Profile Of 1 And 5 Mg Ph-797804 Administered Once Daily In Subjects With Rheumatoid Arthritis Who Are Taking Oral Methotrexate

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: PH-797804
* Drug: PH-797804


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult with RA for at least 6 months Stable weekly dosage of oral methotrexate 12.5- 25 mg/week Exclusion Criteria: Severe, progressive and/or uncontrolled other disease Chronic or recent serious infection; current infection Concomitant use of RA therapy other than methotrexate with some exceptions

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* Tablet, once daily for 4 weeks<br>|
| Experimental: 2<br> | Drug: PH-797804<br>* Tablet, 1 mg PH-797804, once daily for 4 weeks<br>|
| Experimental: 3<br> | Drug: PH-797804<br>* Tablet, 5 mg PH-797804, once daily for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, laboratory data, vital signs, 12-lead ECGs and physical examination findings |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the effects of multiple doses of PH-797804 on the pharmacokinetic profile of methotrexate in subjects with RA taking a stable dose of MTX |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthritis, rheumatoid
Difference of Plantar Pressure Distribution Between Surgical Treatment and Conservative Treatment for CAI

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to compare the difference of plantar pressure distribution between surgical treatment and conservative treatment for CAI.

Detailed Description
-----------------
The data of 20 patients who underwent surgery after reconstruction of the lateral collateral ligament of the ankle joint and 20 patients who underwent balance rehabilitation training were analyzed to compare the clinical effects of surgical treatment and conservative treatment for chronic ankle instability, in order to better guide the selection of the optimal intervention program for patients with chronic ankle joint.

Official Title
-----------------
Difference of Plantar Pressure Distribution Between Surgical Treatment and Conservative Treatment for Chronic Ankle Instability

Conditions
-----------------
Chronic Ankle Instability

Intervention / Treatment
-----------------
* Procedure: surgical treatment
* Procedure: conservative treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with CAI The contralateral ankle joint is healthy Exclusion Criteria: Accompanied by other musculoskeletal injuries
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| surgical treatment<br>Patients with CAI undergoing surgical treatment | Procedure: surgical treatment<br>* Anatomical contraction and termination reconstruction of the lateral ligament<br>|
| conservative treatment<br>Patients with CAI undergoing conservative treatment | Procedure: conservative treatment<br>* Rehabilitation intervention training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FAAM | Foot and Ankle Ability Measure Activity | pre-surgery, one year after sugery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IDFAI | Identification of Functional Ankle Instability questionnaire | pre-surgery, one year after sugery | 
| Ligament injury by MRI | To evaluate the condition of lateral collateral ligament using magnetic resonance imaging | pre-surgery, one year after sugery |
T-Wave Alternans (TWA) Reproducibility in CAD Patients

Study Overview
=================
Brief Summary
-----------------
Microvolt T-Wave Alternans (MTWA) is a relatively new non-invasive method for identifying patients at increased risk of sudden death from ventricular arrhythmias. MTWA can be measured during a routine exercise test, during pharmacologic stress or during cardiac pacing. Its clinical performance compares favorably with that of other non-invasive risk stratifiers and invasive electophysiologic studies. The purpose of the present study is to define the reproducibility of MTWA testing.

Detailed Description
-----------------
The study will be performed in the Cardiac Rehabilitation Center at Assaf Harofeh Medical Center. Patients with coronary artery disease will be eligible to enroll. Patient will undergo an exercise test on a stationary bicycle. TWA will be measured at heart rate of 105 and 115 BPM. The test will be repeated one week later in the same fashion. The patient will continue follow-up in the rehabilitation center as dictated by the rehabilitation program. Patients will be kept on their regular medications and there will be no change of the medications from the first TWA measurement to the second.

Official Title
-----------------
Reproducibility of T Wave Alternans Testing in Patients With Ischemic Heart Disease.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients enrolled in the cardiac rehabilitation center program Patients with CAD Age >18 and < 80 YO Patients with a pacemaker or defibrillator with normal AV conduction Exclusion Criteria: Patients with chronic AF Patients with multiple APB's or PVC's Patients who are unable to increase their heart rate to 115 BPM and don't have a pacemaker. Patients who are unable to exercise on a bicycle.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Reproducibility of TWA test results |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular arrhythmias during exercise |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microvolt T wave alternans, reproducibility
ELX/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients With at Least One F508del Mutation

Study Overview
=================
Brief Summary
-----------------
The purpose of this program is to provide elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) to CF patients in critical need who are 6 to 11 years of age with at least one F508del mutation in response to unsolicited physician requests.

Official Title
-----------------
ELX/TEZ/IVA Expanded Access Program for Patients 6 Through 11 Years of Age With Cystic Fibrosis Who Have At Least One F508del Mutation

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: ELX/TEZ/IVA
* Drug: IVA


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Patients with confirmed diagnosis of CF who have an F/any genotype Prior treatment for at least 6 months with an approved alternative CFTR modulator (if the patient is eligible for such treatment) Patients with percent predicted forced expiratory volume in 1 second (ppFEV1) <40 for a minimum of 60 consecutive days before the date of completion of the request form Key Exclusion Criteria: Patients with severe hepatic impairment Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ELX/TEZ/IVA|Fixed-dose combination tablet for oral administration.|
|Drug: IVA|IVA monotablet for oral administration.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy Study of School-located Influenza Vaccination Clinics to Increase Influenza Vaccination Rates in Monroe County, New York

Study Overview
=================
Brief Summary
-----------------
Children in schools in which influenza vaccination clinics are held during school hours will have higher rates of influenza vaccination than children in control schools (no school-located clinics offered)

Official Title
-----------------
Study of Effectiveness of a School-located Influenza Vaccination Program in Raising Influenza Vaccination Rates

Conditions
-----------------
Childhood Influenza Vaccination, School-located Influenza Vaccination

Intervention / Treatment
-----------------
* Other: School-located Influenza Vaccination Clinic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in participating, randomized school Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm<br>No school-located influenza vaccination clinic | |
| Experimental: School-located influenza vaccination clinics<br>School-located influenza vaccination clinics | Other: School-located Influenza Vaccination Clinic<br>* Children in the intervention arm are enrolled in schools in Monroe County, NY that are offering school-located influenza vaccination clinics during school hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza vaccination status | Vaccination status for the 2014/2015 influenza season will be assessed. The vaccination date will be recorded, as well as the provider name, to determine whether vaccine was received at the school-located influenza clinic | Within one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza vaccination rates