linjc16/ctgov huggingface dataset:
PET/MRI Perfusion and CT Perfusion in Solid Tumors

Study Overview
=================
Brief Summary
-----------------
Diagnostic comparison between PET/CT and PET/MRI with integrated perfusion measurement in CT and MR. Study aim is to gain knowledge about additional value of CT perfusion and MR perfusion in solid tumors concerning tumor physiology, diagnostic accuracy and possibly prognostic.

Official Title
-----------------
Diagnostic and Clinical Accuracy of Integrated Magnetic Resonance Imaging and Computed Tomography Perfusion in PET/MRI in Comparison to PET/CT in Solid Tumors

Conditions
-----------------
CT Perfusion and MRI Perfusion in Solid Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication as stated above written informed consent patients with suspected or confirmed solid malignant tumors of the neck, chest or abdomen who have an indication for a PET/CT Exclusion Criteria: pregnant or breast feeding women non compliance of the patient to follow the study instructions (e.g. hearing problems, dementia) Inclusion in another clinical trial 30 days prior to inclusion age < 30years contraindication for MRI (cardiac pacemaker, certain metal implants, claustrophobia known allergies to contrast CT or MRI contrast media patients with an glomerular filtration rate of < 60ml/min/1.73m2

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- | --- |
| Measurement of blood flow, blood volume and transfer constant (Ktrans) with CT-Perfusion and PET/MR-perfusion in solid tumors. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of blood flow, blood volume and transfer constant (Ktrans) measured with CT-Perfusion and PET/MR-perfusion with progression free survival in solid tumors. |  | 18 months |
A Study To Observe The Performance Of A Tablet Form Of PF-04531083 As Evidenced By The Concentration Of PF-04531083 In The Blood With Time Following Oral Administration To Healthy Volunteers.

Study Overview
=================
Brief Summary
-----------------
A new tablet form of PF-04531083 has been manufactured. Previously the compound was administered as a solution/suspension to healthy volunteers. This study will investigate the pharmacokinetics of PF-044531083 in tablet form and compare with the pharmacokinetics obtained, with the same dosing regimen, with the solution/suspension.

Official Title
-----------------
A Phase 1, Open Label Study To Investigate The Pharmacokinetics Of Multiple Doses Of PF-04531083 Tablets In Healthy Volunteers

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Drug: PF-04531083
* Drug: PF-04531083


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Young Healthy volunteers Exclusion Criteria: Elderly volunteers Patients with any existing medical conditions considered likely to impinge on study execution

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

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

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

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 |
| --- | --- |
| Active Comparator: Cohort 1: PF-04531083<br> | Drug: PF-04531083<br>* Dosed as a tablet in 100mg strengths. Dosage in the first cohort will be 300mg twice daily for 3 days followed by 200mg twice daily for 11 days<br>|
| Active Comparator: Cohort 2: PF-04531083<br> | Drug: PF-04531083<br>* Dosed as a tablet in 100mg strengths. Dosage in this optional second cohort will be optimised based on the data arising from Cohort 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of PF-04531083 in blood just before dosing on the 8th day of the study |  | Days 1 and 8 of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic parameters derived from the plasma concentration versus time profile of PF-04531083 following single and multiple dosing. AUCtau, Cmax, Tmax will be calculated. |  | Days 1, 8 and 14 of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, tablet performance, healthy volunteers, open label
A Pilot Observational Clinical Survey: Impacts of Tahitian Noni Juice on the Quality of Life of Patients With Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
Tahitian Noni Juice (TNJ) made from Morinda citrifolia (noni) fruits may provide a safe adjunctive treatment for osteoarthritis (OA) due to its anti-inflammatory and analgesic properties. In this study the investigators examined whether TNJ was able to improve the symptoms and quality of life (QOL) of OA patients. The investigators also sought to evaluate the tolerability and safety of TNJ. This was an open label three-month intervention pilot study. Data were collected by pre and post intervention survey as well as laboratory testing. Inclusion criteria were: adults of both sexes aged 40 to 75, with a diagnosis of OA on the hip or knee by their primary care physician, not on prescription medicine for OA, and who were willing to drink 3 oz of TNJ a day.

Official Title
-----------------
A Pilot Observational Clinical Survey: Impacts of Tahitian Noni Juice on the Quality of Life of Patients With Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Dietary Supplement: Noni Juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults aged 40 to 75 of both sexes with a physician diagnosis of OA of the hip or knee who were not taking prescription medicine for arthritis and were willing to drink 3 oz of TNJ daily for 12 weeks Exclusion Criteria: all others

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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

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

Design Details

Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noni Juice<br>This was an open label three-month intervention pilot study. Data were collected by pre and post intervention survey as well as laboratory testing. Inclusion criteria were: adults of both sexes aged 40 to 75, with a diagnosis of OA on the hip or knee by their primary care physician, not on prescription medicine for OA, and who were willing to drink 3 oz of TNJ a day | Dietary Supplement: Noni Juice<br>* This was an open label three-month intervention pilot study. Data were collected by pre and post intervention survey as well as laboratory testing. Inclusion criteria were: adults of both sexes aged 40 to 75, with a diagnosis of OA on the hip or knee by their primary care physician, not on prescription medicine for OA, and who were willing to drink 3 oz of TNJ a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis
Predictors for Recurrence of Atrial Fibrillation After Electrical Cardioversion

Study Overview
=================
Brief Summary
-----------------
In patients with persistent atrial fibrillation (AF), electrical cardioversion is very effective in restoring sinus rhythm if modern, biphasic cardioverters are used. However, approximately 50 per cent of the successfully cardioverted patients experience a recurrence of AF within a few weeks. Therefore, valid predictors for AF recurrence would be of great clinical relevance, to avoid unnecessary procedures. In the PRE-ELECTRIC study, we will investigate the predictive value of potential new biomarkers with respect to AF recurrence within 30 days after electrical cardioversion. We will investigate serum and plasma biomarkers, electrocardiological markers and echocardiographic variables in this respect. The study will be undertaken as a prospective cohort study at Bærum Hospital, Vestre Viken Hospital Trust, with national and international collaborators.

Official Title
-----------------
Predictors for Recurrence of Atrial Fibrillation After Electrical Cardioversion

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years referred for electrical cardioversion for persistent atrial fibrillation Signed, informed consent Exclusion Criteria: Patients < 18 years Patients with paroxysmal atrial fibrillation Patients unwilling to participate or without consent competence

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 |
| --- | --- | --- |
| Atrial fibrillation recurrence | ECG-documented atrial fibrillation recurrence after successful cardioversion | 30 days after electrical cardioversion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electrical Cardioversion
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Branch Retinal Vein Occlusion

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone for the treatment of macular edema associated with branch retinal vein occlusion.

Conditions
-----------------
Macular Degeneration, Macular Edema, Branch Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Drug: dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macular edema resulting from branch retinal vein condition The criteria for visual acuity and macular thickness are met Exclusion Criteria: History of glaucoma Diabetic retinopathy Known steroid-responder Use of systemic steroids Use of Warfarin/Heparin

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: dexamethasone|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
-----------------
eye diseases
Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
We will identify the influence of long-term treatment of Pitavastatin compared to non-treatment control group on the metabolic syndrome by evaluation of a change of metabolic syndrome component score. And we will additionally observe the changes of CVD risk factors like lipid profile, abdominal fat, insulin resistance and so on.

Official Title
-----------------
A Prospective Comparative Clinical Study to Identify Efficacy and Safety of Pitavastatin in Patients With a Metabolic Syndrome

Conditions
-----------------
Hypercholesterolemia, Metabolic Syndrome

Intervention / Treatment
-----------------
* Drug: pitavastatin
* Behavioral: Lifestyle Modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged between 18 and 75 Patients with LDL ≥ 100mg/dL Patients with metabolic syndrome IFG: Fasting glucose ≥ 100mg/dL Abdominal Obesity: Waist circumference: men≥90cm,women≥85cm 1 or more of the following Triglyceride ≥ 150mg/dL HDL-C: men < 40mg/dL, women < 50mg/dL Blood pressure: SBP ≥ 130mmHg or DBP ≥ 85mmHg or subject receiving anti-hypertensive treatment Exclusion Criteria: uncontrolled hypertension (DBP ≥ 95mmHg) taking diabetic drugs or with HbA1c > 8% LDL ≥ 190mg/dL or Triglyceride ≥ 400mg/dL coronary heart disease or other diseases caused by artherosclerosis malignancy within 6 months Serum creatinine ≥ 2.0mg/dL ALT or AST ≥ ULN*2.5 CPK ≥ ULN*2 hypothyroidism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: T<br>Lifestyle modification + active drug(Pitavastatin) | Drug: pitavastatin<br>* Pitavastatin 2mg daily once<br>* Other names: Livaro;|
| Other: C<br>Lifestyle Modification | Behavioral: Lifestyle Modification<br>* conducting mainly exercises and diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change of metabolic syndrome risk component |  | 48week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of cardiometabolic profiles : lipid profiles, hs-CRP, adiponectin, HMW adiponectin |  | 48week | 
| Changes of abdominal visceral fat |  | 48week | 
| Changes of insulin resistance : OGTT(75g), HOMA |  | 48week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pitavastatin, metabolic syndrome, metabolic syndrome risk score, hypercholesterolemia
ECLAXIR:Search for an Association Between CX3CR1 V249I Polymorphism, Preeclampsia and Endothelial Injury

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is the involvement of the couple CX3CR1/CX3CL1 in occurrence of endothelial injury in preeclampsia. According to this hypothesis, Carriers of the I249 allele who express less CX3CR1 shoud be protected against this risk. The main objective of the study is the search of an association between CX3CR1 V249I polymorphism and preeclampsia. The secondary aims are the search of an association with the most severe forms of preeclampsia and endothelial injury.

Detailed Description
-----------------
It is a case-control multicenter study 185 caucasian pregnant women with preeclampsia and 185 paired controls without preeclampsia will be included. The frequency of the V249I polymorphism in african black population will be determined by studying 200 subjects (100 cases and 100 controls). The V249I polymorphism will be identified by PCR followed by enzyme digestion. Endothelial injury will be identified using three assays : von Willebrand factor, soluble VCAM-1 and thrombomodulin plasma levels. CX3CR1 involvement in preeclampsia would have potential diagnostic and therapeutic consequences.

Conditions
-----------------
Preeclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cases: pregnant woman, evolutive pregnancy, preeclampsia, caucasian, consenting to the study Exclusion Criteria: Cases: multiple pregnancy, proteinuria > 300 mg/24h before 21th gestation week.
Sexes Eligible for Study
-----------------
Female

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Verticality Perception in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
The long-term goal of this research is to advance our knowledge of how information from the labyrinth is brought to perception and how adaptation to vestibular imbalance influences spatial orientation. In healthy human subjects verticality perception is accurate while upright.The strategy of this research is to quantify changes in verticality perception after unilateral lesions along the central graviceptive pathways and to assess the frequency and pattern of abnormal verticality perception in patients with acute stroke (ischemic or hemorrhagic). Our underlying hypothesis is that screening for erroneous verticality perception by use of a mobile device assessing the subjective visual vertical (SVV) during the acute phase (i.e., within 24-48 hours after symptom onset) reliably identifies those patients with defects. Early detection of deficits in verticality perception may help to initiate balance physiotherapy early.

Official Title
-----------------
Verticality Perception in Patients With Acute Lateralized Lesions Along the Central Graviceptive Pathways- Acute Assessment on the Ward and the Stroke Center

Conditions
-----------------
Verticality Perception in Stroke

Intervention / Treatment
-----------------
* Other: presentation of visual vertical


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 18-90 years informed consent for group 1: acute (i.e. symptom onset <3 days ago) lateralized ischemia or hemorrhage as confirmed by clinical examination and / or brain imaging (CT or MRI). absence of exclusion criteria Exclusion Criteria: history of a peripheral-vestibular deficit disturbed consciousness severe sensory or motor aphasia visual field deficits other neurological or systemic disorder which can cause dementia or cognitive dysfunction intake of antidepressants, sedatives, or neuroleptics

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

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: verticality measurements<br> | Other: presentation of visual vertical<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of verticality perception |  | during the measurement period (10 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test-re-test reliability of verticality perception |  | from session 1 (day 0) to session 2 (day 1) |
Single Ventricle Outcome

Study Overview
=================
Brief Summary
-----------------
The objective of this research proposal is to perform an ongoing single institution prospective clinical trial examining the overall clinical outcome of children with single ventricle physiology.

Detailed Description
-----------------
Congenital disease is the most common cause for infant death from a birth defect. Approximately 30,000 infants are born each year with congenital heart defects.Over one-third of those babies will require cardiac surgery. A particularly lethal cardiac defect is one with single ventricle physiology. The objective of this research proposal is to perform an ongoing single institution prospective clinical trial examining the overall clinical outcome of children with single ventricle physiology.

Official Title
-----------------
The Examination of Outcome in Children With Single Ventricle Physiology

Conditions
-----------------
Heart Disease, Congenital, Single Ventricle, Hypoplastic Left Heart Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with single ventricle physiology scheduled for ultimate Fontan surgical palliation at Children's Healthcare of Atlanta will be eligible. All subjects must sign informed consent prior to enrollment in study.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Disease, Congenital, Single Ventricle, Hypoplastic Left Heart Syndrome