linjc16/ctgov huggingface dataset:
A Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in patients with postoperative pain.

Detailed Description
-----------------
To verify the superiority to placebo and the noninferiority to etodolac of YM177 in terms of efficacy assessment in patients with postoperative pain. Also, to compare them in terms of safety assessment.

Official Title
-----------------
A Phase III Study of YM177 (Postoperative Pain) -- An Etodolac- and Placebo-controlled, Multicenter, Double-blind, Group Comparison Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients --

Conditions
-----------------
Post Operative Pain

Intervention / Treatment
-----------------
* Drug: YM177
* Drug: etodolac
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with spontaneous pain within 24 hours postoperatively The intensity of the pain: 4-categorical assessment: Moderate pain or Severe pain VAS assessment: 45.0 mm or higher Patients whose postoperative pain can be managed using an oral NSAID Exclusion Criteria: A past history of aspirin-induced asthma A past of ischemic heart disease, serious arrhythmia, congestive heart failure or cerebrovascular disease Patients who undergoes the surgical procedure under general anesthesia Patients taking excluded medications

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YM177 group<br> | Drug: YM177<br>* oral<br>* Other names: Celecox;|
| Active Comparator: etodolac group<br> | Drug: etodolac<br>* oral<br>* Other names: Hypen;|
| Placebo Comparator: placebo group<br> | Drug: Placebo<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient impressions (4-categorical assessments) |  | For 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity |  | For 2 days | 
| Pain intensity difference |  | For 2 days | 
| Discontinuation due to insufficient efficacy |  | For 2 days | 
| Safety assessed by AE, clinical lab tests and vital signs |  | For 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Celecoxib, Celecox, Pain, Surgery, NSAIDs
Platelet-Rich Fibrin in the Healing of Regional and Free Flaps

Study Overview
=================
Brief Summary
-----------------
Determine if the use of platelet-rich fibrin (PRF) versus historical treatment methods improves the post-operative management of healing complications from flap donor sites.

Official Title
-----------------
Role of Platelet-Rich Fibrin in the Healing of Regional and Free Flap Donor Sites for Head and Neck Surgery Patients: A Prospective Randomized Clinical Trial

Conditions
-----------------
Head and Neck Disorder, Free Flap

Intervention / Treatment
-----------------
* Procedure: Platelet Rich Fibrin (PRF) Application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had surgery involving a microvascular free flap or a myocutaneous regional flap for head and neck reconstruction who develop one of the following donor site complications: wound dehiscence, wound margin breakdown or contraction resulting in healing by secondary intention, myocutaneous fistula formation, or incomplete coverage of the donor site by a skin graft placed in the operating room. Exclusion Criteria: Patients under 18 years of age Patient's unable to participate in blood draw either due to medical compromise, inability to tolerate the procedure, or inability of the physician to successfully draw the blood at the time of appointment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Rich Fibrin (PRF) Group<br>Patients randomized to this group will receive treatment with a PRF graft in clinic at the time any pertinent post-operative complication is identified. | Procedure: Platelet Rich Fibrin (PRF) Application<br>* Platelet Rich Fibrin application to flap defect.<br>|
| No Intervention: No Platelet Rich Fibrin Group<br>Participants in the observational control group will be managed at the time of the complication by standard of care methods. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in healing time at 3 months post-operative | Improved healing of PRF patients compared to control group. | Up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Platelet-Rich Fibrin (PRF)
Sugars-sweetened Commercial Beverages on Short-term Food Intake

Study Overview
=================
Brief Summary
-----------------
The purpose of this experiment was to describe the effect of consuming 350 ml of 1% chocolate milk 60 minutes before a pizza meal on subjective appetite and short-term food intake when compared to cola, a fruit drink and a water control in normal weight and overweight/obese 9-14 year old boys and girls. It is hypothesized that 1% chocolate milk will increase meal time satiation to a greater extent than other sugars-sweetened commercially available beverages. Food intake will be measured 60 minutes after the consumption of 350 ml of water, fruit drink, cola or 1% chocolate milk.

Official Title
-----------------
Effect of Sugars-Sweetened Commercial Beverages on Short-Term Food Intake Regulation in Normal Weight and Overweight/Obese 9-14 Year Old Boys and Girls

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Water
* Dietary Supplement: Fruit drink
* Dietary Supplement: Cola
* Dietary Supplement: 1% chocolate milk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy boys and girls 9-14 years of age, stable weight, born at full term, normal birth weight Exclusion Criteria: restricted diet, taking medications that affect food intake, significant learning, behavioral or emotional problems, food allergies to test treatments

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 14 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: Water Control<br>Water Control | Dietary Supplement: Water<br> <br> |
| Experimental: Fruit drink<br>Fruit drink | Dietary Supplement: Fruit drink<br> <br> |
| Experimental: Cola<br>Cola | Dietary Supplement: Cola<br> <br> |
| Experimental: 1% chocolate milk<br>1% chocolate milk | Dietary Supplement: 1% chocolate milk<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food intake (kcal) |  | 60 min after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite (in mm) | Subjective appetite by visual analogue scale (mm) measured at 0, 15, 30, 45, 60 and 90 minutes. | 0-90 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevention
Epipericardial Fat Necrosis: A Misdiagnosed Condition

Study Overview
=================
Brief Summary
-----------------
Epipericardial fat necrosis is a benign and self-limited condition that mainly curses with acute pleuritic chest pain and therefore must be an important differential diagnosis for patients in emergency department (ED). The knowledge of characteristics symptoms and correct management may avoid misdiagnosis or mistakes with other severe conditions like pulmonary embolism, pericarditis or acute coronary disease. Despite the importance of this entity, only fewer than 40 cases have been reported since 1957, when the condition was first described. We have seen a couple of similar cases in our institution during a short period of time, and we suspect that these numbers doesn't mean the real prevalence of epipericardial fat necrosis, so maybe this condition could be underdiagnosed. Instead, there isn't a study that tried to estimate an incidence of this entity.

Official Title
-----------------
Epipericardial Fat Necrosis: A Misdiagnosed Condition

Conditions
-----------------
Epipericardial Fat Necrosis

Intervention / Treatment
-----------------
* Other: No intervention. It is a retrospective study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with imaging criteria of EFN (defined as a round fat attenuation lesion with peripheral stranding located in the epipericardial fat) Exclusion Criteria: no exclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EFN Cases<br>Cases of patients with epipericardial fat necrosis CT findings | Other: No intervention. It is a retrospective study<br>* No intervention. It is a retrospective study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determinate the incidence of epipericardial fat necrosis |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify misdiagnosed cases of epipericardial fat necrosis |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epipericardial Fat Necrosis, Fat Necrosis, Chest Pain, Pericardial Necrosis, Pleuritic pain
Determinants of Vasospasm and Delayed Ischemic Deficits in Aneurysmal Subarachnoid Hemorrhage

Study Overview
=================
Brief Summary
-----------------
The risk of delayed cerebral ischemia (DCI) after subarachnoid hemorrhage (SAH) is associated with large cerebral artery vasospasm, but vasospasm is not a strong predictor for DCI. Assessment of cerebral autoregulation with transcranial Doppler (TCD) may improve the prediction of DCI. The aim of this prospective study was to assess the value of TCD-derived variables to be used alone or in combination for prediction of DCI

Official Title
-----------------
Hemodynamic and Biochemical Determinants of Vasospasm and Delayed Ischemic Deficits in Aneurysmal Subarachnoid Hemorrhage

Conditions
-----------------
Ischemia

Intervention / Treatment
-----------------
* Procedure: CerebroSpinal fluid and plasma samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group 1 : • Patients who presented a ruptured aneurysm by aneurysmal subarachnoid hemorrhage (SAH) older than 72 hours. Diagnosis of SAH was confirmed by computed tomography, magnetic resonance imaging (MRI) or lumbar puncture as recommended symptomatic aneurysm treated with endovascular, Absence of achieving a lumbar puncture, Patients affiliated to a social security scheme, Patients who have given their free and informed consent and signed the consent or consent of the family. Group 2 : healthy volunteers with cerebrospinal fluid sample Exclusion Criteria: Patients with no readable acoustic temporal bone window Patients with previous disease that might impair cerebral autoregulation (e.g., carotid stenosis, history of stroke or head injury).

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with subarachnoid hemorrhage<br>Patients with subarachnoid hemorrhage will have CerebroSpinal fluid and plasma sample. | Procedure: CerebroSpinal fluid and plasma samples<br>* CerebroSpinal fluid and plasma samples for biological markers<br>|
| Active Comparator: Control subjects<br>healthy controls from a previous study with a CerebroSpinal fluid and plasma sample | Procedure: CerebroSpinal fluid and plasma samples<br>* CerebroSpinal fluid and plasma samples for biological markers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delayed cerebral ischemia | DCI was confirmed by CT or MR imaging | inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral ischemia
Amniotic Biomarkers for the Prediction of Postpartum Renal Function.

Study Overview
=================
Brief Summary
-----------------
The discovery of antenatal bilateral renal anomaly poses an essential question: can we predict postnatal renal function? Ultrasound is insufficiently precise to predict postnatal renal function evolution. The objective of this study is to estimate the specificity and sensitivity of amniotic fluid biomarkers to predict postnatal renal function in fetuses with bilateral developmental nephropathies. Both fetuses with bilateral renal anomalies and control (healthy) fetuses will be included. For this study amniotic fluid will only be collected according to routine clinical practice and only excess amniotic fluid sample will be used for the study. The potentially identified biomarkers will not change routine management of the pregnancies in the study.

Official Title
-----------------
Amniotic Fluid Biomarker Research for Prediction of Postnatal Renal Function in Fetus With a Bilateral Abnormal Renal Development: National, Multicenter, Prospective and Non-interventional Study.

Conditions
-----------------
Nephropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: All fetuses with a bilateral abnormal renal development (structure modification of the parenchyma with or without urinary tract abnormalities associated) The following sonographic criteria are used: Fetal kidney size <2.5ep or <2 standard deviation (SD) defining renal hypoplasia or renal size> 97.5ep or> 2 SD defining nephromegaly And / or hyperechogenicity (more echogenic than the liver kidney) And / or cysts And / or abnormal cortico-medullary differentiation (decrease or lack thereof) And / or bilateral cortical thinning And / or the possibility of an initial unilateral renal disease in the case of a pathology on which kidney damage is usually to become bilateral during evolution EXCLUSION CRITERIA: Foetuses with severe malformations that can change the amniotic or urine proteome: complex heart disease, digestive stenosis, fetal immobility. Fetus whose mother has chronic infectious diseases (HIV, hepatitis B and C) or acute infectious diseases such chorioamnionitis. Parental Refusal.
Sexes Eligible for Study
-----------------
All

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 |
| --- | --- | --- |
| Renal function (according to Schwartz formula) | Renal function (according to Schwartz formula) | month 24 |
Cozaar XQ Re-examination Study (MK-0954-349)

Study Overview
=================
Brief Summary
-----------------
This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Law and its Enforcement Regulation; its aim is to reconfirm the clinical usefulness of COZAAR XQ through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.

Official Title
-----------------
Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of COZAAR XQ in Usual Practice

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: amlodipine/losartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Participant with essential hypertension Participant who is treated with COZAAR XQ within local label for the first time Exclusion criteria: Participant who is treated with COZAAR XQ before contract and out of enrollment period Participant who has a contraindication to COZAAR XQ according to the local label

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 |
| --- | --- |
| All participants<br>Participants with hypertension treated with amlodipine/losartan(Cozaar XQ) | Drug: amlodipine/losartan<br>* amlodipine/losartan (COZAAR XQ) prescribed according to the current local label<br>* Other names: COZAAR XQ;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with any adverse experience |  | Up to 14 days after last treatment | 
| Change of sitting systolic and diastolic blood pressure (SiSBP, SiDBP) after treatment and overall efficacy evaluation by investigator |  | At 8 weeks after first treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of sitting systolic and diastolic blood pressure (SiSBP, SiDBP) after treatment and overall efficacy evaluation by investigator |  | At 24 weeks after first treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension
Multimodal Analgesic Protocol to Moderate Acute Pain

Study Overview
=================
Brief Summary
-----------------
With a prospective, observational study assess post-surgery pain levels and patient's use of opioids and other analgesic drugs to moderate pain following third molar surgery.

Detailed Description
-----------------
SPECIFIC AIMS Using the UNC surgery clinic multi-modal protocol of drugs/dosages to control acute pain after third molar surgery assess each post-surgery day(PSD) the patient reported pain levels post-surgery as recorded by Likert-type and Gracely scales quality of life(QOL) outcomes for lifestyle and oral function number of opioid doses taken by subject-patients number of NSAID and acetaminophen doses taken by subject-patients.

Official Title
-----------------
Prospective, Observational Study With a Multimodal Analgesic Protocol to Moderate Acute Pain After Third Molar Surgery

Conditions
-----------------
Pain, Post-operative

Intervention / Treatment
-----------------
* Procedure: third molar surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I,II At least two lower 3rd molars scheduled for removal Exclusion Criteria: Patient being treated for opioid addiction/abuse including having Rx for suboxone, methadone

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: third molar surgery|The patient is asked to complete the diary each post-surgery day for 14 days. Recovery is organized into three QOL domains: lifestyle, oral function, and pain.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of the surgery on the patient's post-surgery pain. | Likert scales for average pain and worst pain are assessed with 7-point scales with verbal anchors of no pain and worst pain imagined. Recovery for pain on the Likert scales is defined as the number of PSD until the patient reports a score of 1 or 2 on the 7-point scale. | 14 days |