linjc16/ctgov huggingface dataset:
A Phase 3 Clinical Study of KHK 4827

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the safety and efficacy of long-term exposure to KHK4827 in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) who have completed Study 4827-003 (Study 003)and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004).

Official Title
-----------------
An Extension Study of KHK4827 in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

Conditions
-----------------
Psoriasis Vulgaris, Psoriatic Arthritis, Pustular; Psoriasis, Palmaris Et Plantaris, Psoriatic Erythroderma

Intervention / Treatment
-----------------
* Drug: KHK4827 140mg SC
* Drug: KHK4827 210mg SC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has voluntarily signed the written informed consent form to participate in this study Subject has completed the week 52 evaluation either in Study 003 or 004 Exclusion Criteria: Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration) Subject has been judged to be ineligible for participation in the study by the investigators/sub investigators

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KHK4827 140mg SC<br> | Drug: KHK4827 140mg SC<br>* Experimental1:KHK4827 140mg subcutaneous injection<br>|
| Experimental: KHK4827 210mg SC<br> | Drug: KHK4827 210mg SC<br>* Experimental2:KHK4827 210mg subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and types of adverse events and adverse reactions |  | 28 weeks | 
| Anti-KHK4827 antibody |  | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study. |  | 28 weeks | 
| Percent improvement in PASI |  | 28 Weeks | 
| PASI 50, 75, 90, and 100 |  | 28 Weeks | 
| Static physician's global assessment (sPGA) of 0 (clear) or 1(almost clear) |  | 28 Weeks | 
| sPGA of 0 (clear) |  | 28 weeks | 
| Change in body surface area involvement (BSA) of lesion |  | 28 weeks | 
| Clinical Global Impression (CGI) |  | 28 weeks | 
| American College of Rheumatology (ACR) 20 |  | 28 weeks | 
| Pustular symptom score |  | 28 weeks | 
| Serum KHK4827 concentration |  | 28 weeks |
Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection

Study Overview
=================
Brief Summary
-----------------
Validate a simple and cost-effective Nucleic Acid Test for HIV Detection in order to develop a rapid, highly sensitive and specific, one-stage test for the diagnosis of HIV infection. Blood samples collected will be assayed using the BioHelix Corporation helicase-dependent amplification or the Cepheid Xpert HIV-1 Quant Assay. A false negative or false positive rate of >1.0% would make this test unacceptable as a screening test for HIV viremia.

Official Title
-----------------
Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current patient in the Medical Faculty Associates Infectious Diseases (ID) clinic with known HIV infection Suspected to be viremic at the time of their clinic visit based on history and/or current symptoms Able to provide informed consent 18 Years or older Exclusion Criteria: Patient unable to provide informed consent. 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection | A false negative or false positive rate of > 1.0% would make this test unacceptable as a screening test for HIV viremia. | Participation will last 1 hour for subjects to consent and provide a single blood sample. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV validation helicase-dependent amplification
Sternal Wound and Aortic Graft (SWAG), an Observational Cohort Study.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to systematically explore the perioperative presence of P acnes in all layers of sternal wound incision as well as contamination of graft material and prosthetic valves during primary operation. Secondly, to compare if different regimes of antibiotics affects the bacterial growth. Cultures will be taken from the skin, subcutaneous, and from the implanted valve prostheses with a rayon swab.Graft and Felt material will, after being pressed subcutaneous for 15 sec, placed into prepared sterile bottles containing broth for aerobe and anaerobe cultures. Surgical gloves will be cultured.

Official Title
-----------------
The Presence of Skin Bacteria in the Sternal Wound and Their Possible Ability to Contaminate Implantation Materials During Cardiac Surgery

Conditions
-----------------
Surgical Site Infection, Sternal Wound Infection

Intervention / Treatment
-----------------
* Other: Bacterial cultures taken during surgery.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Open cardiac surgery; coronary artery bypass grafting, valve replacement/repair or a combination of these. Exclusion Criteria: Skin conditions such as eczema, psoriasis. Revision surgery Aortic surgery
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients planned for elective open cardiac surgery<br> | Other: Bacterial cultures taken during surgery.<br>* Cultures taken from skin, subcutaneous tissue, surigal materials and surgical gloves at incision and after two hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial growth, C acnes | Growth of C acnes in cultures taken both from patients and surgical materials used in the primary operation. | Five months | 
| Bacterial growth, other | Growth of bacteria in cultures taken both from patients and surgical materials | Five months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between subgroups | Difference in bacterial growth between subgroups. | Five months |
Urine Levels of Metanephrin and Normetanephrin in Patients With Frequent Ventricular Premature Complex

Study Overview
=================
Brief Summary
-----------------
Enhanced automaticity process is the underlying mechanism for arrhythmias due to excess catecholamines. Catecholamines may increase in patients with PVC. Metabolites of catecholamines are metanephrine and normetanephrine. Our aim is to measure 24 hours urine levels of metanephrine and normetanephrine.

Detailed Description
-----------------
Premature ventricular complex is a very frequent arrhythmia. Suggested mechanisms for PVCs are reentry, triggered activity, and enhanced automaticity. Enhanced automaticity process is the underlying mechanism for arrhythmias due to excess catecholamines. Catecholamines may increase in patients with PVC. Half-lives of catecholamines are very short and rather changeable. Therefore, 24 hours urine levels of catecholamines are the more sensitive than plasma levels. Metabolites of catecholamines are metanephrine and normetanephrine. Our aim is to measure 24 hours urine levels of metanephrine and normetanephrine.

Official Title
-----------------
Urine Levels of Metanephrin and Normetanephrin in Patients With Frequent Ventricular Premature Complex

Conditions
-----------------
Premature Ventricular Contraction

Intervention / Treatment
-----------------
* Diagnostic Test: 24 hours urine levels metanephrine and normetanephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PVC's rate is more than % 5 in 24 hours rhythm recording Exclusion Criteria: ischemic heart disease hyperthyroidism patients with low ejection fraction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 24 hours urine levels metanephrine and normetanephrine|24 hours rhythm recording and 24 hours urine measurement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metanephrine and normetanephrine levels | metanephrine and normetanephrine levels asociated premature ventricular complex frequents | about 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
premature, pvc
Evaluation of New MRI Sequences Including 3D-FGAPSIR for the Optimization of Inflammatory Spinal Cord Lesions Research

Study Overview
=================
Brief Summary
-----------------
verification of inclusion and non-inclusion criteria information and collection of consent standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), 3D STIR and 3D PSIR sequence. 3D FGAPSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 40 minutes (instead of 30 minutes)

Detailed Description
-----------------
verification of inclusion and non-inclusion criteria information and collection of consent standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), 3D STIR and 3D PSIR sequence. 3D FGAPSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 40 minutes (instead of 30 minutes)

Official Title
-----------------
Evaluation of the Performance of a 3D FGAPSIR Sequence by MRI in the Detection and Characterization of Spinal Cord Injuries in Patients With Multiple Sclerosis

Conditions
-----------------
Spinal Cord Injuries

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years old To benefit from a medullary exploration planned by 3T MRI as part of a first evaluation or a reassessment of inflammatory involvement of the nevrax Express consent to participate in the study Affiliate or beneficiary of a social security scheme Exclusion Criteria: Patient benefiting from a legal protection measure Pregnant, parturient or breastfeeding woman Absolute or relative contraindication to MRI

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 |
| --- |
|Device: MRI|standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), 3D STIR and 3D PSIR sequence. 3D FGAPSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 40 minutes (instead of 30 minutes)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimate the number of lesions detected with the 3D FGAPSIR sequence and not detected with the 3D PSIR sequence. | estimate the number of lesions detected with the 3D FGAPSIR sequence and not detected with the 3D PSIR sequence. | 1 DAY |
Objective Measure of Recovery After Outpatient Surgery

Study Overview
=================
Brief Summary
-----------------
This is a study using wearable monitoring devices, patient activity and sleep patterns to monitor pre and post operative following outpatient inguinal hernia surgery to determine when these parameters return to baseline.

Official Title
-----------------
Assessment of Physical Activity to Determine When Patients Return to Baseline Levels of Activity Following Outpatient Inguinal Hernia Surgery

Conditions
-----------------
Hernia, Inguinal, Convalescence

Intervention / Treatment
-----------------
* Device: GENEactiv


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting for outpatient inguinal hernia repair without significant medical comorbidities Patients who consent to participating and willing to wear device for designated time period per protocol Exclusion Criteria: History of chronic opioid use Inability to speak English Inability to give informed consent

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open repair<br>Repair group to be monitored with wearable activity monitors pre and post op. | Device: GENEactiv<br>* To wear a monitoring device for a period of time prior to surgery and post surgery<br>|
| Laparoscopic group<br>Laparoscopic surgical repair group to be monitored with wearable activity monitors pre and post op. | Device: GENEactiv<br>* To wear a monitoring device for a period of time prior to surgery and post surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine time of return to baseline activity following elective outpatient hernia repair using wearable accelerometers that measure physical movement. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine pain levels on visual analog scale after outpatient hernia repair via telephonic questionnaire. |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recovery of function
Vitamin D Status in Pediatric Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate level of vitamin D in pediatric asthma and relationship between vitamin D and level control of asthma.

Detailed Description
-----------------
cross-sectional study

Official Title
-----------------
Vitamin D Status in Pediatric Asthma

Conditions
-----------------
Vitamin D Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children between the age of 6 years and 18 years with the diagnosis of asthma who are attending the outpatient pediatric department, pediatric allergy clinic Exclusion Criteria: patients who have chronic pulmonary, heart disease, chronic renal failure, liver disease, endrocrine disorder, or receieve antiepileptic drugs, vitamin D supplement

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- |
| asthma patients<br>controlled asthma partly controlled asthma uncontrolled asthma | |

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
-----------------
vitamin D, asthma
Atrial Fibrillation/Sinus Rhythm Before and After Cardioversion

Study Overview
=================
Brief Summary
-----------------
This study´s aim is to collect scientific data about patients with atrial inflammation by two principles of sensors measuring congestive heart failure.

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with atrial fibrillation and planned cardioversion male and female patients aged at least 18 years patients being able to understand and to follow the study staff´s instructions signed informed consent Exclusion Criteria: persons being hosted in an institution by administrative order or court injunction pregnancy or breast feeding persons not being able to consent persons with implanted electronic devices material incompatiblity acute or chronic inflammation of the external or middle ear canal abnormal anatomic ear canal (congenital or pathological) persons in a dependent relationship to the investigator or employment contract

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| scientific data |  | 1 hour |
DeFRA Questionnaire as an Anamnestic Form

Study Overview
=================
Brief Summary
-----------------
The DeFRA questionnaire is a new validated algorithm derived from FRAX. Here we use the DeFRA as a primary anamnestic from to identify subjects at risk of osteoporosis in a population never screened before and never treated for this disease.

Detailed Description
-----------------
There is an increasing recognition that the management of osteoporosis requires the characterization of fracture risk to be based on absolute risk rather than single measures such as bone mineral density (BMD). However, the threshold for pharmacological intervention for osteoporosis remains controversial. The aim of the present project is to perform a large scale study to identify subjects at risk of osteoporosis by administering the DeFRA questionnaire in a population never screened or treated before for osteoporosis. DeFRA questionnaire will be administered before and after DEXA scanning, to further validate the questionnaire and to highlight the predictive value of this protocol as a tool to screen the general population.

Official Title
-----------------
Use of the DeFRA Questionnaire as a Primary Anamnestic Form Through a Large Scale Screening of the Population

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 50 to 70 years no overt pathologies never screened before for osteoporosis no prior use of drugs for osteoporosis signed informed consent form Exclusion Criteria: overt pathologies (cancer, neurodegenerative diseases, renal or hepatic insufficiency) use of the following drugs: cortisones, loop diuretics, antiepileptic drugs, aromatase inhibitors, dicoumarols, thyroxin in suppressive therapy, antiosteoporosis drugs) patients who underwent radiation therapy hypercalcemia or alterations of the phospho-calcic metabolism patients with metabolic diseases of the bone (including hyperparathyroidism or Paget disease)

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 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> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent risk of a fracture | The DeFRA questionnaire is administered within the same day with or without the DeXA measurement, to evaluate statistically significant differences in the percent risk of a fracture | day 1 |