linjc16/ctgov huggingface dataset:
Safety and Efficacy of Intranasal Ketamine for the Treatment of Postoperative Dental Pain

Study Overview
=================
Brief Summary
-----------------
Once patients' postoperative pain intensity reaches a moderate-to-severe level, they are randomized to receive intranasal ketamine or placebo. Patients remain in the study unit for 3 hours post administration and assess pain intensity and pain relief throughout the 3 hour postoperative period.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Efficacy of 10 mg, 30 mg, and 50 mg of Transnasal Ketamine Hydrochloride (PMI-100) for the Treatment of Postoperative Dental Pain

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: intranasal ketamine
* Drug: intranasal ketamine
* Drug: intranasal ketamine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy patients at least 16 years of age requiring two or more third molar extractions Exclusion Criteria: Less than 16 years old Other exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 16 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: A<br>Intranasal ketamine low dose | Drug: intranasal ketamine<br>* low dose<br>|
| Experimental: B<br>intranasal ketamine medium dose | Drug: intranasal ketamine<br>* medium dose<br>|
| Experimental: C<br>intranasal ketamine high dose | Drug: intranasal ketamine<br>* high dose<br>|
| Placebo Comparator: D<br>placebo | Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total pain relief over 0-3 hours following dosing |  | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| other pain assessments |  | 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental, surgery, analgesia, 2-4 impacted third molars
The Efficacy of Severe Whitening and Delayed Fading in Acetic Acid-enhanced Endoscopy for Diagnosing Gastric Intestinal Metaplasia

Study Overview
=================
Brief Summary
-----------------
Investigators found that the degree and the duration of aceto-whitening differed between gastric intestinal metaplasia(GIM) and the surrounding normal mucosa: the area of GIM showed a severe degree of aceto whiteness and the whitening continued longer than the surrounding normal mucosa, which investigators called severe whitening and delayed fading, and investigators realized that GIM could possibly be diagnosed by using these differences.The aim of this prospective study was to investigate the efficacy of severe whitening and delayed fading for diagnosing GIM.

Conditions
-----------------
Gastric Intestinal Metaplasia

Intervention / Treatment
-----------------
* Procedure: acetic acid-enhanced endoscopy
* Drug: Acetic Acid
* Device: endoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: long-lasting upper gastrointestinal symptoms (>15 years) atrophic gastritis or GIM identified at surveillance endoscopy Exclusion Criteria: presence of advanced adenocarcinoma in the stomach presence of acute gastrointestinal bleeding presence of coagulopathy, uncontrolled impaired renal or liver disease presence of pregnancy or lactation presence of allergy to acetic acid age younger than 18 years or older than 80 years inability to provide written 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?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acetic acid-enhanced endoscopy<br>Acetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid. | Procedure: acetic acid-enhanced endoscopy<br>* Acetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid.<br>Drug: Acetic Acid<br>* The concentration of acetic acid used in this study is 1.5%.<br>Device: endoscope<br>* This study using an EG-29-i10 endoscope (Pentax, Tokyo, Japan) and an EPK-i7010 processor (Pentax, Tokyo, Japan).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of severe whitening for diagnosing gastric intestinal metaplasia |  | 6 months | 
| accuracy of delayed fading for diagnosing gastric intestinal metaplasia |  | 6 months |
Characterization and Prediction of Atrial Fibrillation-caused Adverse Events After Hospital Discharge for Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the research is to identify the frequency and severity of adverse events related to atrial fibrillation that occur after discharge from hospital where the patient underwent cardiac surgery. The Specific Aims of the proposed study are to: Identify the predictors of postoperative atrial fibrillation after discharge from hospital. Identify the frequency of readmission to hospital, or other resource use such as Emergency Department or outpatient visit, for the treatment or prophylaxis of postoperative AF and consequent stroke or bleeding outcomes. Identify the risks for stroke, death and other morbidity in patients after cardiac surgery and the effect of postoperative AF upon subsequent stroke or bleeding outcomes.

Official Title
-----------------
Massachusetts-wide Study of the Incidence of ATrial Fibrillation and Stroke Occurring After Discharge From Cardiac Surgery (MATRICeS)

Conditions
-----------------
Death, Atrial Fibrillation, Stroke, Acute

Intervention / Treatment
-----------------
* Procedure: Cardiac surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent cardiac surgery in Massachusetts between 2012 - 2016 Exclusion Criteria: surgical procedures that do not include coronary artery bypass graft surgery, aortic valve surgery or mitral valve surgery; surgical procedures that include MAZE surgery, or pulmonary vein isolation, ventricular assist device, heart transplantation, congenital heart surgery, bacterial endocarditis, cardiac trauma, cardiac tumor, ventricular septal defect repair, left ventricular aneurysm repair, pulmonary thromboendarterectomy, sub-aortic stenosis resection or surgical ventricular restoration; surgical procedures on patients that have undergone MAZE surgery, AF ablation procedures, pulmonary vein isolation or left atrial appendage resection or ablation (such as Watchman devices).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 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 |
| --- | --- |
| Adult patients who underwent cardiac surgery in Massachusetts<br>No interventions. A retrospective cohort study of patients who underwent cardiac surgery in Massachusetts in calendar years 2012 - 2016. | Procedure: Cardiac surgery<br>* Retrospective cohort study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent atrial fibrillation | Recurrent atrial fibrillation | Up to six years after surgery | 
| Acute ischemic stroke | Acute ischemic stroke | Up to six years after surgery | 
| Mortality | Mortality | Up to six years after surgery |
Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients

Study Overview
=================
Brief Summary
-----------------
Comparison of metabolic and nutritional effects of an enteral immune enhancing diet with those of a standard polymeric one, in ICU patients

Official Title
-----------------
Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients

Conditions
-----------------
Neurological Diseases, Pneumopathy, Major Abdominal Surgery, Acute Pancreatitis

Intervention / Treatment
-----------------
* Dietary Supplement: Crucial (enteral tube feeding)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18<age<89, ASA score<4 , SAPS II score>10 requiring the administration of an exclusive tube feeding nutrition during 7 days and beginning at the latest in the three days following the aggression ICU patients hospitalized for: neurologic affections pneumopathy major abdominal surgery or serious acute pancreatitis written informed consent Exclusion Criteria: pregnancy or breast feeding immunosuppressive therapy radiotherapy or chemotherapy in the last six month uncontrolled septic choc auto-immune disease hepatic,renal or digestive insufficiency hyperlipidemia diabetes mellitus type 1 digestive malabsorption life threatening situation treatments with growing hormone, glutamine or its metabolites or precursors such as ornithine alpha keto glutarate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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: I<br>Sondalis HP | Dietary Supplement: Crucial (enteral tube feeding)<br>* Evaluation of new enteral product, Crucial, in ICU patients<br>|
| Experimental: II<br>Crucial | Dietary Supplement: Crucial (enteral tube feeding)<br>* Evaluation of new enteral product, Crucial, in ICU patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of Glutamine after 90 min of enteral product administration |  | J5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional parameters, immunologic parameters, functionality renal, Biological marker of oxidative stress |  | J1, J5, J8 | 
| Tolerance |  | Daily until J8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU patients
Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the addition of intrathecal fentanyl to low dose mepivacaine spinal anesthesia provides adequate surgical anesthesia with shorter duration of motor blockade. It is hypothesized that lower doses of spinal mepivacaine when combined with fentanyl will result in adequate surgical block for knee arthroscopy surgery with faster recovery and discharge compared to mepivacaine alone.

Official Title
-----------------
Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy Surgery

Conditions
-----------------
Knee Arthroscopy

Intervention / Treatment
-----------------
* Drug: Mepivacaine without fentanyl
* Drug: Mepivacaine with Fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having unilateral arthroscopic surgery of the knee; ASA I-III status; Age 18-80 years; BMI< 35. Exclusion Criteria: Patients who have previous history of hypersensitivity to local anesthetics or contraindications for spinal anesthesia (i.e. bleeding diathesis, coagulopathy); Patients with radiating low back pain and neurological deficits in lower extremities; Patients who are incapable of giving an 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Mepivicaine for spinal anesthesia | Drug: Mepivacaine without fentanyl<br>* 45 mg 1.5% mepivacaine injection for spinal anesthesia<br>|
| Experimental: 2<br>Mepivacaine with Fentanyl for spinal anesthesia | Drug: Mepivacaine with Fentanyl<br>* 10 micrograms fentanyl with 30 mg 1.5% mepivacaine injection for spinal anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete motor block regression (0) as measured by modified Bromage scale. |  | Every 2 minutes from administration of the spinal until complete onset. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Block success, peak, and duration; time to ambulation, urination, discharge; incidence of adverse events. |  | Up to 72 hours after surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal anesthesia, mepivacaine, fentanyl, duration of anesthesia, knee arthroscopy, regional anesthesia, Spinal anesthesia for knee arthroscopy
Cardiovascular Effects of a Soccer Match in Viewers With With Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
Watching football matches could cause increased blood pressure and heart rate induced by catecholamines and thus increase the incidence of cardiovascular events. However, no studies have evaluated the responses of blood pressure and heart rate in soccer spectators. This study evaluates the hemodynamic response in Brazilian soccer fans suffering from coronary artery disease during a dispute over a game of your favorite team.

Official Title
-----------------
Cardiovascular Effects of a Soccer Match in Viewers With With Coronary Artery Disease

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

Intervention / Treatment
-----------------
* Behavioral: Soccer
* Behavioral: Movie


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary artery disease; Avai or Figueirense (brazilian soccer teams) fans Exclusion Criteria: Acute coronary syndrome in less than 7 days

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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soccer<br>Watching the soccer match at the time that the favorite team is playing | Behavioral: Soccer<br>* Watching the soccer match at the time that the favorite team is playing<br>|
| Placebo Comparator: Movie<br>Watching a movie at the time that the favorite team is playing | Behavioral: Movie<br>* Watching a movie at the time that the favorite team is playing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average mean arterial pressure | To evaluate the difference between the average mean arterial pressure in patients with coronary artery disease, or not watching a game of soccer your favorite team; | 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean heart rate | To evaluate the difference between the mean heart rate; | 90 minutes | 
| Systolic blood pressure | To evaluate the difference between the systolic blood pressure; | 90 minutes | 
| Diastolic blood pressure | To evaluate the difference between the diastolic blood pressure; | 90 minutes | 
| Double product | To evaluate the difference between the double product (the product of heart rate and systolic blood pressure); | 90 minutes | 
| Angina | To evaluate the difference between the presence of angina; | 90 minutes |
Acute Kidney Injury in Neonates at NICU in Assiut University Children Hospital Descriptive Study

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury (AKI) is a complex disorder with clinical manifestations ranging from mild dysfunction to complete anuric kidney failure. Its leads to sudden and rapid decline in renal excretory function within hours to days,accompanied by accumulation of nitrogenous waste products such creatinine,urea and other clinically un measured products

Detailed Description
-----------------
Acute kidney injury (AKI) is an under-recognized morbidity of neonates; the incidence remains unclear due to the absence of a unified definition of AKI in this population and because previous studies have varied greatly in screening for AKI with serum creatinine and urine output assessments. Premature infants may be born with less than half of the nephrons compared with term neonates, predisposing them to chronic kidney disease (CKD) early on in life and as they age. AKI can also lead to CKD, and premature infants with AKI may be at very high risk for long-term kidney problems. AKI in neonates is often multifactorial and may result from prenatal, perinatal, or postnatal insults as well as any combination thereof.

Official Title
-----------------
Acute Kidney Injury in Neonates at NICU in Assiut University Children Hospital Descriptive Study

Conditions
-----------------
Neonatal Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All cases of acute kidney injury in neonates who will be admitted to NICU Assiut University Children Hospital during the duration of the study. Exclusion Criteria: Cases with chronic renal affection Any case with congenital anomalies

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnosed as acute kidney injury<br>Sure diagnosed as acute kidney injury | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosed as acute kidney injury | Diagnosis of acute kidney injury | 10-21 days |
Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of AZD1722 in Healthy Male and Female Japanese Subjects

Study Overview
=================
Brief Summary
-----------------
The study is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy Japanese subjects at increasing doses given for 7 days in order to allow for including Japanese subjects in future global studies. A cohort of Caucasian subjects will be included in the study to evaluate cardiac effects, assessed by digital ECGs (dECG) recordings, also in Caucasian subjects.

Official Title
-----------------
A Phase I, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects in Healthy Male and Female Japanese Subjects After Single and Multiple Doses (Bid) of AZD1722

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: AZD1722
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy man or woman Body mass index between 18 and 29.9 kg/m2, inclusive Exclusion Criteria: Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal (GI) tract Any surgery on the small intestine or colon, excluding appendectomy Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial or that would present a safety risk to the subject.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD1722<br>Dose escalation from 5 mg to 90 mg BID | Drug: AZD1722<br> <br> * Other names: Tenapanor;Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events | Measurement of safety laboratories, ECGs, vital signs, and physical exams | up to 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacodynamic activity | 24-hour stool sodium and phosphorus | up to one week | 
| pharmacokinetics | plasma drug concentration to calculate AUC, if possible | up to one week |