linjc16/ctgov huggingface dataset:
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fasting conditions.

Official Title
-----------------
A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 300 mg Cefdinir (Test Formulation) and Omnicel 300 mg Capsule (Reference Formulation) Each Given as a Single Oral Dose to Twenty-Eight Healthy Male and/or Female Volunteers in the Fasting State

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Cefdinir 300 mg Capsule (Sandoz, Austria)
* Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 56 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cefdinir 300 mg Capsule (Sandoz, Austria) | Drug: Cefdinir 300 mg Capsule (Sandoz, Austria)<br> <br> |
| Active Comparator: 2<br>Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA) | Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic
Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this study is to investigate Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in daily Practice.

Official Title
-----------------
Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects of age above 18 years as per Victoza® SmPC par.4.2 and 5.1 diagnosed with type 2 diabetes receiving the first prescription of liraglutide in 2011 Exclusion Criteria: None. Available data from all eligible patients for each center, will be included
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: liraglutide<br>* No treatment given.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of patients achieving HbA1c reduction of at least 1%-point |  | Week 0, week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (Glycosylated haemoglobin)) |  | Week 0, week 104 | 
| Change in body weight |  | Week 0, week 104 | 
| Frequency of patients achieving HbA1c reduction of at least 1%-point |  | After 4 and 24 months of treatment | 
| Frequency of patients achieving HbA1c target (<=7%) |  | After 4, 12 and 24 months | 
| Frequency of patients achieving a body weight reduction of at least 3% |  | After 4, 12 and 24 months | 
| Frequency of patients achieving the composite endpoint consisting in: HbA1c reduction of at least 1%-point and body weight reduction of at least 3% |  | After 4, 12 and 24 months | 
| Percentage of treatment discontinuation for any reason |  | At 4, 12 and 24 months | 
| Changes in blood pressure and lipid profile |  | Week 0, week 104 |
Study Comparing the Effects of Esomeprazole Adminstered Orally and Intravenously on Basal and Pentrigastrin-stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of Nexium at a dose of 40mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).

Official Title
-----------------
An Open, Randomised Two Way Crossover Study Comparing the Effects of 40mg of Esomeprazole Adminstered Orally and Intravenously as a 3 Minute Injection on Basal and Pentrigastrin-stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: Esomeprazole
* Drug: Esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heartburn on 2 out of the last 7 days prior to screening or a diagnosis of GERD (with or without a diagnosis of Erosive eosphagitis). Body Mass Index within the limits specified in the protocol Exclusion Criteria: History of esophageal, duodenal or gastric surgery History of severe liver disease. Any other significant disease or pathology judged to be clinically significant by the investigator

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>IV Nexium | Drug: Esomeprazole<br>* 40mg Intravenous infusion over 3 minutes<br>* Other names: Nexium;|
| Experimental: 2<br>Oral Nexium | Drug: Esomeprazole<br>* 40mg Oral<br>* Other names: Nexium;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration. |  | Every 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare basal acid output at steady state and when switching between Oral and IV adminstration of Nexium. |  | Post Day 10 | 
| To compare maximum acid output when switching between Oral and IV adminstration of Nexium |  | Post Day 10 | 
| Safety assessment via adverse event recording |  | At each visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroesophageal reflux disease, Nexium, Esomeprazole, Administration methods.
Guanfacine to Treat Borderline Personality Disorder

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate whether guanfacine (Tenex) is an effective treatment for borderline personality disorder (BPD), an illness often characterized by unstable mood and impulsive aggression. Guanfacine stimulates activity in the front portion of the brain, a region associated with attention and the control of behavior. We believe that guanfacine may improve symptoms of BPD by improving attention and aiding regulation of behavior.

Detailed Description
-----------------
This is an 8-week treatment study designed to test whether guanfacine is an effective treatment for borderline personality disorder (BPD). Prior to taking the study medication, subjects will have medical and psychiatric evaluations, complete self-report questionnaires, do a functional MRI scan, and complete a set of cognitive tests. While taking the study medication, participants will meet weekly with a study doctor and be administered interviews and questionnaires. At the end of the 8-week trial, participants will be asked to repeat the MRI scan and cognitive tests.

Official Title
-----------------
Guanfacine in the Treatment of Borderline Personality Disorder

Conditions
-----------------
Borderline Personality Disorder

Intervention / Treatment
-----------------
* Drug: guanfacine (Tenex)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This study includes men and women between the ages of 18 and 55 who meet criteria for borderline personality disorder with impulsive aggression. Exclusion Criteria: Subjects must not currently be taking any psychiatric medications. Subjects must not meet criteria for current substance dependence, current major depression, bipolar disorder, or schizophrenia-spectrum disorders.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: guanfacine (Tenex)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measures of impulsive aggression |  |  | 
| measures of affective disturbance |  |  | 
| measures of social and occupational functioning |  |  | 
| measures of overall clinical status |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
borderline personality disorder, guanfacine, impulsivity, aggression, affective instability
A Study to Assess the Efficacy and Safety of Two Dosing Regimens of Alefacept in Subjects Weighing Between 100kg and 150kg With Moderate to Severe Chronic Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
Comparison of two dosing regimens of Alefacept in subjects weighing between 100kg and 150kg with moderate to severe Chronic Plaque Psoriasis

Official Title
-----------------
A Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Weekly Intravenous Administration of 7.5mg and 0.075mg/kg Alefacept in Subjects Weighing Between 100kg and 150kg, With Moderate to Severe Chronic Plaque Psoriasis

Conditions
-----------------
Chronic Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: alefacept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight between 100kg and 150kg Diagnosis of Chronic Plaque Psoriasis with Body Surface Area (BSA) involvement of ≥ 10% Candidate for phototherapy or systemic therapy for Psoriasis CD4 + T lymphocyte counts > lower limit of normal Exclusion Criteria: Clinically significant abnormal hematology values or blood chemistry values ALT or AST value of ≥ 3x the upper limit of normal Other types of Psoriasis Serious infection within 3 months prior to 1st dose of study drug Antibody positive for HIV History of malignancy History of severe allergic or anaphylactic reactions History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease

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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose regimen 1 | Drug: alefacept<br>* IV<br>* Other names: ASP0485;|
| Experimental: 2<br>Dose regimen 2 | Drug: alefacept<br>* IV<br>* Other names: ASP0485;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects receiving a Psoriasis Area and Severity Index (PASI) score of ≥75 compared to baseline |  | 1 Week post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects in each dosing regimen receiving a PASI score of ≥75 compared to baseline |  | 1 Week post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Plaque Psoriasis, Alefacept
Pharmacist and Family Medicine Physician Collaboration for Pre-Visit Planning and Team Huddles for CCM Patients

Study Overview
=================
Brief Summary
-----------------
This is a novel project which incorporates clinic and community pharmacists in three aspects of the Patient-Centered Medical Home: pre-visit planning, pre-visit care team huddles, and chronic care management (CCM). Patients for the project are enrolled in the NEIFPC CCM program and have Greenwood pharmacy as their primary pharmacy. Community and clinic pharmacists will contribute to pre-visit medication reviews and document their drug therapy recommendations in a shared, templated note in the clinic EHR. NEIFPC pharmacists will attend pre-visit team huddles to relay drug therapy recommendations to the physician. Revenue from CCM services will be prorated and shared between Greenwood pharmacy and NEIFPC. The project will last 9 months. Primary aims are to describe the pharmacist pre-visit planning service, summarize the billing experience of a community pharmacist providing this service, and to describe the drug therapy interventions made by pharmacists.

Official Title
-----------------
Pharmacist and Family Medicine Physician Collaboration for Pre-Visit Planning and Team Huddles for Patients Receiving Chronic Care Management Services

Conditions
-----------------
Chronic Conditions, Multiple

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient enrolled in Medicare Patient enrolled in the Chronic Care Management (CCM) program at the Northeast Iowa Family Practice Center Patient's primary pharmacy is Greenwood Pharmacy Exclusion Criteria: Patient not enrolled in Medicare Patient not enrolled in CCM program Patient's primary pharmacy is any pharmacy other than Greenwood Pharmacy
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 |
| --- | --- | --- |
| Summary of Drug Therapy Interventions made by Pharmacists | Summarize drug therapy interventions made by community and ambulatory care pharmacists for pre-visit team huddles with Family Medicine physicians. | 07/01/2020- 03/31/2021 |
Discovering Laryngomalacia

Study Overview
=================
Brief Summary
-----------------
Laryngomalacia is the most common congenital malformation of the larynx. It results from abnormal prolapse of supraglottic structures during inspiration. Symptoms usually appear within the first 2 weeks of life. Its severity increases in up to 6 months. 15-60% of infants with laryngeomalacia have synchronous airway anomalies.

Detailed Description
-----------------
500 full term babies ≥37 weeks of both sexes delivered by different modes of delivery, with birth weights ≥2.5 kg, no history of natal or post-natal complications and from the same community. Mothers of these babies are from different socioeconomic standards and from the same community. These babies were diagnosed as having laryngomalacia. Clinical, flexible nasal and laryngeal scope, radiological and milk scintiscan were the tools used in our assessment. One thousand full term babies delivered with normal larynx, almost within the same period of time and from the same community were used as a control. Laryngomalacia was recognized with significant statistical difference in dacryostenosis, deviated nasal septum, adenoid hypertrophy and gastroesophageal reflux disease. No significant statistical difference in pectus excavatum, cleft lip or palate, congenital lobar emphysema fistula and choanal atresia.

Official Title
-----------------
Discovering Laryngomalacia

Conditions
-----------------
Laryngomalacia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 500 full term babies ≥ 37 weeks of both sexes were delivered by different modes of delivery, with birth weights of ≥ 2.5 kg, with no history of natal complications and from the same community. Mothers of these babies are from different socioeconomic standards with different educational levels. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 4 Weeks
Maximum Age: 12 Months

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 |
| --- | --- |
| Laryngomalacia<br>Patients with Laryngomalacia | |
| Control Group<br>Patients without Laryngomalacia | |

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
-----------------
Laryngomalacia, Congenital Anomalies, Associated Health Problems
The Efficacy and Safety of the Loading Dose of Tranexamic Acid in Scoliosis Surgery During Perioperative

Study Overview
=================
Brief Summary
-----------------
This study intends to make full use of the advantage of spinal orthopedic surgery in our medical center.Analyze the blood loss and blood coagulation function and the influence of safety of load dose tranexamic acid (TXA) in scoliosis surgery during perioperative.

Official Title
-----------------
The Efficacy and Safety of the Loading Dose of Tranexamic Acid in Scoliosis Surgery During Perioperative

Conditions
-----------------
Tranexamic Acid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age:18-60 years old American Society of Anesthesiologists (ASA):I-II The spinal orthopedic undergoing elective surgery Exclusion Criteria: Severe cardiopulmonary dysfunction Blood coagulation dysfunction Disorders of liver and kidney function Tranexamic acid allergies The history of pulmonary embolism and venous thrombosis of lower limbs Anticoagulant drugs and nonsteroidal anti-inflammatory drugs in 7 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Normal saline（I）<br>Intravenous infusion of 0.9% saline when start to cut the skin，do not intravenous tranexamic acid during the surgery | |
| Tranexamic acid（II）<br>Intravenous infusion of tranexamic acid 1g when start to cut the skin in 1 hour | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss | Intraoperative blood loss | At the end of the surgery | 
| Incision drainage Incision drainage Incision drainage after surgery | Incision drainage after surgery | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autologous blood doping | Recycle the blood during the intraoperative , back to the patient | At the end of the surgery | 
| red blood cell transfusion | red blood cell transfusion | At the end of the surgery | 
| Plasma infusion | Plasma infusion | At the end of the surgery | 
| HB | hemoglobin | Within 1 week before surgery；1 day after surgery | 
| WBC | White blood cells | Within 1 week before surgery；1 day after surgery | 
| PTL | platelet | Within 1 week before surgery；1 day after surgery | 
| PT | Prothrombin time | Within 1 week before surgery；1 day after surgery | 
| APTT | activated partial thromboplastin time | Within 1 week before surgery；1 day after surgery | 
| INR | International Normalized Ratio | Within 1 week before surgery；1 day after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tranexamic acid, Blood conservation