linjc16/ctgov huggingface dataset:
PLACE OF THE 18F-FDG-PET/CT IN THE DIAGNOSTIC WORKUP IN PATIENTS WITH CLASSICAL FEVER OF UNKNOWN ORIGIN (FUO)

Study Overview
=================
Brief Summary
-----------------
Objective : To explore the diagnostic contribution of the 18F-FDG-PET/CT in a population of patients with classical fever of unknown origin (FUO), to precise its place in the diagnostic decision tree in a real-life setting and to identify factors associated with a diagnostic 18F-FDG-PET/CT. Methods: All adult patients (age≥18 years) with a diagnosis of classical FUO who underwent a 18F-FDG-PET/CT in the University Hospital of Montpellier (France) between April 2012 and December 2017 were included. True positive 18F-FDG-PET/CT which evidenced a specific disease causing FUO were considered to be contributive.

Official Title
-----------------
PLACE OF THE 18F-FDG-PET/CT IN THE DIAGNOSTIC WORKUP IN PATIENTS WITH CLASSICAL FEVER OF UNKNOWN ORIGIN (FUO)

Conditions
-----------------
Fever of Unknown Origin

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age≥18 years a diagnosis of classical FUO who underwent a 18F-FDG-PET/CT Exclusion Criteria: -refusal to participate-
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 |
| --- | --- | --- |
| the diagnostic contribution of the 18F-FDG-PET/CT | the diagnostic contribution of the 18F-FDG-PET/CT in a population of patients with classical FUO. | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18F-FDG-PET/CT place in the diagnostic decision tree in a real-life setting | 18F-FDG-PET/CT place in the diagnostic decision tree in a real-life setting | day 1 | 
| factors associated with a diagnostic 18F-FDG-PET/CT. | factors associated with a diagnostic 18F-FDG-PET/CT. | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fever of Unknown Origin, 18F-FDG-PET/CT
Platelet Function in Patients Undergoing PCI

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine PLT function in PCI patients.

Conditions
-----------------
All PCI Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consented patients undergoing PCI Exclusion Criteria: Unable to consent

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 |
| --- | --- |
| Study Group<br>All those tested | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Position of EGD in Droplet Spreading

Study Overview
=================
Brief Summary
-----------------
The association between position of upper gastrointestinal endoscopy (EGD) and saliva droplet spreading has never been studied. In the era of contagious viral spreading, this pilot study is aimed to assess adenosine triphosphate (ATP) at the face shield of endoscopist which can represent the saliva droplet spreading of patients in left lateral and prone position during EGD.

Official Title
-----------------
The Comparison of Left Lateral Versus Prone Position in Saliva Droplet Spreading During Upper Gastrointestinal Endoscopy; a Pilot Study of Randomized Trial

Conditions
-----------------
Cotamination on Face Shield

Intervention / Treatment
-----------------
* Other: Left lateral Position during intervention
* Other: Prone Position during intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have the indication for upper gastrointestinal endoscopy Exclusion Criteria: Cannot be in prone position The endoscopist deny the assigned position in any reason.
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
Interventional Model Description: We will randomize the patients who need EGD into 2 groups; left lateral and prone position by block of 4.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Left lateral position<br>The patient will be in left lateral position during EGD | Other: Left lateral Position during intervention<br>* Left lateral position during EGD<br>|
| Experimental: Prone position<br>The patient will be in prone position during EGD | Other: Prone Position during intervention<br>* Prone position during EGD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of adenosine triphosphate (ATP) on face shield of endoscopist | Measuring the ATP on face shield of endoscopist by using ATP luminometer. It is measured in relative light unit (RLU). The level of ATP is concordant with the level of bacteria on that measuring object. | immediately following the procedure |
Combination Osteogenic Therapy in Established Osteoporosis

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine if combining parathyroid (PTH 1-34) with fluoride (MFPSR) therapy in a cyclic treatment regimen will: (1) produce a greater increase in bone density of the spine than would be produced by either treatment alone; (2) prevent the resistance (i.e., decreased bone formation and no further increase in bone density) that is observed within 18-24 months of PTH therapy; (3) eliminate the calcium deficiency and osteomalacia that can occur with fluoride; (4) prevent excessive bone fluoride content; and (5) result in an increase in bone density which is maintained after treatment is discontinued.

Detailed Description
-----------------
This is a 3-yr, single center, open label, active controlled, randomized study of approximately 99 postmenopausal females with osteoporosis of spine or femoral neck. Patients will be assigned to 1 of 3 groups: 1) PTH 1-34; 2) Fluoride; 3) PTH and fluoride. The treatment period is 3 years with 3-month cycles of therapy. PTH will be administered subcutaneously by injection 600 units daily for 28 days the first month of each 3-month cycle. Fluoride will be administered orally one 76mg tablet twice daily (providing 20 mg fluoride/day), during the last 2 months of each cycle. Calcium will be provided 800mg/day during month 1 and 1500-2000mg for months 2 and 3 of each cycle.

Official Title
-----------------
Combination Osteogenic Therapy in Established Osteoporosis

Conditions
-----------------
Osteoporosis, Post-Menopausal

Intervention / Treatment
-----------------
* Drug: PTH 1-34
* Drug: MFPSR-fluoride


Participation Criteria
=================
Eligibility Criteria
-----------------
Female, aged 60-80, Postmenopausal greater than or equal to 5 years, BMD -2.5 to -4.0 at lumbar spine or femoral neck and one standard deviation below young adult mean in the other site, or -2.0 with fracture. Vertebral fracture 0-1. Exclusion Criteria: More than 1 vertebral fracture in lumbar spine or more than 4 fracture in the T-L spine. Weight less than 45 kg or more than 80 kg, or more than 25% above ideal body weight. Present cardiac disease present. Diseases or conditions known to affect bone metabolism. Therapies with drugs that affect bone metabolism within 6 months. Fluoride or Biophosphonates at any time.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PTH 1-34|nan|
|Drug: MFPSR-fluoride|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
-----------------
osteoporosis
Oxis 9mcg Turbuhaler Clinical Experience Investigation

Study Overview
=================
Brief Summary
-----------------
The purpose of the investigation is to confirm the ADR development and the contributing factors possibly having an impact on the safety under the post-marketing actual use of Oxis 9 mcg Turbuhaler.

Detailed Description
-----------------
Oxis 9mcg Turbuhaler Clinical Experience Investigation

Official Title
-----------------
Oxis 9mcg Turbuhaler Clinical Experience Investigation

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients treated with Oxis for the first time due to 'relief of various symptoms associated with airway obstructive disorders of chronic obstructive pulmonary disease (Chronic bronchitis, Pulmonary emphysema), which is the indication of this drug.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oxis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event incidence |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic obstructive pulmonary disease,, COPD,, Oxis,
Hepatic Pseudoaneurysms After Trauma

Study Overview
=================
Brief Summary
-----------------
Hepatic pseudoaneurysm (HPA) is a rare complication after liver trauma, yet it is potentially fatal, as it can lead to sudden severe haemorrhage. The risk of developing posttraumatic hepatic pseudoaneurysm is one of the reasons why some trauma centres do follow-up CT of patients with liver injuries to take the therapeutic consequence. The aim of this study was to investigate the occurrence of HPA post liver trauma.

Official Title
-----------------
Hepatic Pseudoaneurysms After Conservatively Managed Liver Injuries

Conditions
-----------------
Pseudoaneurysm, Abdominal Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: conservatively managed liver trauma patients with follow-up CT or US Exclusion Criteria: patients who underwent laparotomy because of other intra-abdominal injuries

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 77 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 |
| --- | --- | --- |
| Incidence and nature of hepatic pseudoaneurysm after hepatic trauma | All admitted and conservatively treated patients with sustained lever injury due to trauma from 2000-2010 were reviewed in order to investigate the incidence and nature of hepatic pseudoaneurysms after liver trauma | 2000-2010 |
Sucking and Sucrose as Pain Relief for Infants

Study Overview
=================
Brief Summary
-----------------
Sucking and sucrose have been shown to reduce pain during venous puncture in neonates. Our study is designed to see if sucking and sucrose relieve pain during venous puncture in infants age 3-12 months.

Detailed Description
-----------------
100 infants age 3-12 months old without neurologic, developmental or cardio-respiratory impairment, needing venous puncture for IV access, or blood aspiration, will be randomly assigned to one of 2 groups - with or without pacifier. During the puncture, each patient with pacifier will receive either 1 cc of water or 1 cc of sucrose (the solutions prepared and marked blindly) . Each patient without pacifier 2 will receive 1 cc of water without pacifier,will receive either 1 cc of water or 1 cc of sucrose (the solutions prepared and marked blindly). FLACC pain score will be used for apin assessment before, during and after the puncture.Comparison of the four groups will be done after the end of the study.

Official Title
-----------------
Partial Blinded Controlled Study to Compare SucroseVs Water, With and Without Pacifier as Pain Reliever During Venous Puncture in Infants 3-12 Months Old

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Dietary Supplement: sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 3-12 months hospitalized in pediatric ward B need venous puncture Exclusion Criteria: neurological deficit developmental delay Cyanotic heart disease symptomatic respiratory disease known problematic venous access

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 12 Months

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 |
| --- | --- |
| No Intervention: AW<br>no pacifier , no sucrose | |
| Active Comparator: AS<br>sucrose without pacifier | Dietary Supplement: sucrose<br>* 1 cc of sucrose 33.5% with or without pacifier<br>* Other names: no other name;|
| No Intervention: PW<br> | |
| Experimental: PS<br>Pacifier and sucrose interventional | Dietary Supplement: sucrose<br>* 1 cc of sucrose 33.5% with or without pacifier<br>* Other names: no other name;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduced pain scoring |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| better Parent's scoring to the child's behavior |  | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sucrose, sucking, pain relief, infant, require venous puncture
Open Label Extension Study of Bifeprunox

Study Overview
=================
Brief Summary
-----------------
A one year extension study using flexible doses, 20 or 30 mg daily, of open-label bifeprunox.

Official Title
-----------------
An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Bifeprunox in the Treatment of Outpatients With Schizophrenia.

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Bifeprunox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients who have successfully completed Wyeth study 3168A1-311-US. A signed and dated informed consent form for this study. No major protocol violations in previous study. Exclusion Criteria: Clinically important abnormalities noted in preceding short-term study that have not resolved. Use of prohibited treatments in the preceding short-term study. Meeting any exclusion criteria for the preceding short-term study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 66 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: Bifeprunox|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight from baseline/first dose of bifeprunox at each observation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline/first dose of bifeprunox for triglyceride levels, Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impression (CGI)-Score, and waist circumference at each observation. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia
Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan

Study Overview
=================
Brief Summary
-----------------
This community-based trial will study misoprostol for the prevention of postpartum hemorrhage in rural Pakistan. Traditional birth attendants assisting home deliveries will administer study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women participating in the trial. Blood loss, hemoglobin levels, side effects, and other variables will be evaluated.

Official Title
-----------------
A Placebo-Controlled Randomized Trial of Misoprostol in the Management of the Third Stage of Labor in the Home Delivery Setting in Rural Pakistan

Conditions
-----------------
Anemia, Postpartum Hemorrhage

Intervention / Treatment
-----------------
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women in general good health, home delivery Must live in one of 78 study villages Exclusion Criteria: Hypertension Non-cephalic presentation Polyhydramnios Previous cesarean section Suspected multiple pregnancy Suspected still birth Antepartum hemorrhage Previous complication in 3rd trimester Anemia of <8 g/dl
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Misoprostol|600 mcg oral misoprostol administered during third stage of labor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum hemorrhage (blood loss >or= 500 mL) |  | Measured at 1 hour postpartum or until active bleeding has stopped | 
| Drop in hemoglobin > 2 g/dL from pre to post-delivery |  | Hemoblobin (Hb) level measured 3-5 days after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intermediate and severe PPH (blood loss >or=750 mL and >or= than 1000 mL) |  | Blood loss measured at 1 hr postpartum or until active bleeding stopped | 
| Mean blood loss |  | blood loss measured at 1 hr postpartum or until active bleeding stopped | 
| Side effects experienced among recently delivered mothers |  | Interviews conducted 1 day post-delivery | 
| Anemia (<9 g/dL and <11 g/dL) |  | Postpartum hemoglobin assessed 3 days post-delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postpartum hemorrhage, Misoprostol, Maternal morbidity, Developing countries, Traditional birth attendants
Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
An open-label, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetic interaction between DWP14012 and DWC202005 in healthy volunteers

Official Title
-----------------
An Open-Label, Multiple-Dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers

Conditions
-----------------
Drug-drug Interaction

Intervention / Treatment
-----------------
* Drug: DWC202005, alone
* Drug: DWP14012 + DWC202005
* Drug: DWP14012 + DWC202005, after multiple doses of DWP14012


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults aged 19 to 50 years with BMI between 18.5 kg/m2 and 30.0 kg/m2 Capable of understanding provided information and complying with protocol requirements Provide written informed consent to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 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 |
| --- | --- |
| Experimental: DWP14012 Cohort A<br> | Drug: DWC202005, alone<br>* DWC202005, as a single dose<br>|
| Experimental: DWP14012 Cohort B<br> | Drug: DWP14012 + DWC202005<br>* DWP14012 and DWC202005, as a single dose<br>|
| Experimental: DWP14012 Cohort C<br> | Drug: DWP14012 + DWC202005, after multiple doses of DWP14012<br>* DWP14012 and DWC202005, after multiple oral doses of DWP14012 once daily for 12 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma drug concentration-time curve | AUClast of DWC202005 | upto 48 hours postdose | 
| Peak Plasma Concentration (Cmax) | Cmax of DWC202005 | upto 48 hours postdose | 
| Incidence of Treatment-Emergent Adverse Events |  | up to 19 days |