linjc16/ctgov huggingface dataset:
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

Detailed Description
-----------------
The duration of treatment is 24 hours.

Official Title
-----------------
A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study to Evaluate the Efficacy of Rofecoxib and a Dosing Regimen of Oxycodone With Acetaminophen Over 24 Hours in Patients With Postoperative Dental Pain

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

Intervention / Treatment
-----------------
* Drug: MK0966, rofecoxib
* Drug: Comparator: oxycodone with acetaminophen, placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Impaction of a molar tooth requiring removal Exclusion Criteria: Any known allergy to the study drugs

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0966, rofecoxib|nan|
|Drug: Comparator: oxycodone with acetaminophen, placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-op dental pain over 6 hours as measured by pain intensity/relief scores, patient global assessment, and time to perceptible/meaningful pain relief. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental surgery, molar removal
Effect of SGLT2 Inhibitor on Blood Glucose Profile in Type 2 Diabetic Patients Using Basal Insulin

Study Overview
=================
Brief Summary
-----------------
The change of glycemic variation and insulin dose after adding SGLT2 inhibitor in type 2 diabetic patients treated with basal insulin was observed in a single center.

Official Title
-----------------
Effect of SGLT2 Inhibitor on Blood Glucose Profile in Type 2 Diabetic Patients Using Basal

Conditions
-----------------
Type2 Diabetes

Intervention / Treatment
-----------------
* Drug: SGLT2 inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999; Patients were using glargine with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 2 month would be recruited into this study; Patients had relatively constant diet and exercise in 2 month before the study. Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose <22.2mmol/L Exclusion Criteria: Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure; Patients with severe infectious diseases; Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis; Patients with history of psychiatric disorders and were unsuitable to use CGMS; Patients used GLP-1 analogues，SGLT2 or more than once insulin injection in the past 3 months Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGLT2i treatment<br>The patients who are using basal insulin therapy with or without oral hypoglycemic drugs will be added SGLT2 inhibitor treatment | Drug: SGLT2 inhibitor<br>* Patients will be gave SGLT2 inhibitor 10mg per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of glycemic variation | Changes of glycemic variation assessed by CGM before and after SGLT2 inhibitor adding | Week 1-5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of insulin dose | Change of insulin dose before and after SGLT2 inhibitor adding | Week 1-5 |
ADenoVirus Initiative Study in Epidemiology in UK

Study Overview
=================
Brief Summary
-----------------
The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.

Detailed Description
-----------------
Epidemiological, prospective, open, multicentric trial in patients suffering from acute conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization. This epidemiological study will include approximately 500 patients in the United Kingdom. The planned duration of the study is one year from the first patient visit to the last patient visit.

Official Title
-----------------
Epidemiological, Prospective, Multicentric, Open Study To Assess The Characteristics And Frequency Of Adenoviral Conjunctivitis As Diagnosed With The Point Of Care AdenoPlus® Test In Patients Suffering From Acute Conjunctivitis

Conditions
-----------------
Viral Conjunctivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms. Patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data. No history of hypersensitivity to corn starch, talcum powder or Dacron (sampling fleece components). Exclusion Criteria: Current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result. Previous enrolment in the present study. Any direct involvement with the study conduct at site or any family link with study site staff.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
| Frequency of patients with adenovirus conjunctivitis | The percentage of patients with adenovirus conjunctivitis documented by a positive AdenoPlus® test over the tested population of male and female patients who present signs and symptoms of acute conjunctivitis. | During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test
Alzheimer's Disease Acitretin Medication

Study Overview
=================
Brief Summary
-----------------
The trials investigates the changes of cerebral spinal fluid (CSF) soluble alpha-secretase cleaved APP (APPsα) levels under oral therapy with acitretin 30mg daily in patients with mild to moderate Alzheimer's disease (AD).The present study aims to demonstrate an enhancement of the α-secretase activity by acitretin as measured by increased CSF APPSα levels in human AD. Second, the safety and tolerability of acitretin in AD patients should be proven.

Official Title
-----------------
Changes of Cerebral Spinal Fluid APPSα Levels Under Oral Therapy With Acitretin 30 mg Daily in Patients With Mild to Moderate Alzheimer's Disease: a Multicenter Prospective Randomised Placebo-controlled Parallel-group Study

Conditions
-----------------
Alzheimer Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to moderate AD (NINCDS-ADRDA criteria) Mini-Mental State Examination (MMSE): 27-14 points Geriatric Depression Scale ≤ 14 Exclusion Criteria: hereditary cognitive impairment known history of brain injuries Insufficient German language skills actual treatment with other potential disease modifying drugs of AD multimorbidity or significant organ (esp. liver or renal) dysfunction evidence of Non-AD neurodegenerative disorder (e.g. Parkinson) contraindication to acitretin such as osteoporosis, hypoalbuminaemia

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acitretin<br>oral, 30 mg per day, day 1-28 | Drug: Acitretin<br>* 30mg per day from Day 1 to Day 28<br>* Other names: Neotigason, Acicutan;|
| Placebo Comparator: Placebo<br>oral, day 1-28 | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline | Values were assessed via Western blotting technique. Normalization was conducted using hSA levels of the individual samples. | baseline and 4 weeks (visit 3) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's Disease
Compensation for Smaller Portion Sizes and Portion Size Normality

Study Overview
=================
Brief Summary
-----------------
Reducing food portion size is a potential strategy to reduce energy intake. However it is unclear at what point consumers compensate for reductions in portion size by increasing energy intake from other items. The investigators tested the hypothesis that reductions to food portion size will only result in significant compensatory eating when the reduced portion size is no longer visually perceived as 'normal'. In two within-subjects experiments, participants (Study 1: N = 45, M BMI = 26.9; Study 2: N = 37, M BMI = 26.9; 51% female) were served different sized portions of a lunchtime meal on three occasions: a 'large-normal', a 'small-normal', and a 'smaller than normal' portion. Both the reduction from 'large-normal' to 'small-normal' and from 'small-normal' to 'smaller than normal' portions represented the same change in food volume and energy content (84g, 77kcal Study 1; 98g, 117kcal Study 2). Participants were able to serve themselves additional helpings of the same food (Study 1), or dessert items (Study 2).

Official Title
-----------------
Compensation for Smaller Portion Sizes and Portion Size Normality: Two Laboratory

Conditions
-----------------
Portion Size

Intervention / Treatment
-----------------
* Behavioral: portion size


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: general liking and willingness to consume the test foods in each study Exclusion Criteria: food allergies, intolerances or specific dietary requirements (including being vegetarian or vegan) a history of eating disorders;

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

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: portion size|Smaller than normal portion size - the intervention is the meal size perceived as 'smaller than normal' that participants are provided with during a lunchtime session in the laboratory. 'Small-normal' portion size - the intervention is the meal size perceived as 'small normal' that participants are provided with during a lunchtime session in the laboratory. 'Large normal' portion size - the intervention is the meal size perceived as 'large normal' that participants are provided with during a lunchtime session in the laboratory.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meal energy intake | Energy intake from the served portion | Immediate | 
| 'Compensatory' (additional) energy intake | Energy intake from additional food provided for consumption after the portion-manipulated meal | Immediate |
Randomized Trial for Pharmacogenomics-based Proton Pump Inhibitor Therapy in Children

Study Overview
=================
Brief Summary
-----------------
Proton pump inhibitors are administered to children as off-label use in Japan. The purpose of this study is to evaluate the effects of CYP2C19 genotypes on pharmacokinetic /pharmacodynamic profiles of PPI in children. The results will provide the beneficial information for the individualized medicine of PPI in children.

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

Intervention / Treatment
-----------------
* Drug: Lansoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with gastroesophageal reflux The patient's parent or guardian gives written informed consent including pharmacogenomic analysis The patient is willing and able to give assent to participate. Exclusion Criteria: Serious hepatic disease, pulmonary disease, renal disease and blood disorder Inadequate clinical conditions

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 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

| Intervention/Treatment |
| --- |
|Drug: Lansoprazole|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
-----------------
gastroesophageal reflux, children, lansoprazole, cytochrome P450 2C19 (CYP2C19), pharmacogenomics, genetic polymorphisms, individualized medicine, pharmacokinetics/dynamics
microRNA Profile in Umbilical Cord Blood NK Cells

Study Overview
=================
Brief Summary
-----------------
Umbilical cords contain immature blood cells, including a group of lymphocytes, that are important in the so-called natural immunity. We want to study the cytokine levels in umbilical cord NK cells and its regulation a family of newly identified small RNAs (microRNAs).

Detailed Description
-----------------
Our preliminary data pointed to the possibility of cytokine regulation by microRNAs in NK lymphoma and NK lymphoma cell lines. We want to use umbilical cord blood as controls for the biological significance in normal NK cell development.

Official Title
-----------------
microRNA Profile in Umbilical Cord Blood NK Cells

Conditions
-----------------
Pregnant Women

Intervention / Treatment
-----------------
* Other: blood donation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal pregnant women Exclusion Criteria: None
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A1<br>A group of 3 to 5 pregnant women as donors for umbilical cord blood | Other: blood donation<br>* obtaining cord blood<br>* Other names: cord blood donation;|

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
-----------------
umbilical cord blood
Marker Guided Breathhold Radiotherapy in NSCLC

Study Overview
=================
Brief Summary
-----------------
Proof of concept study evaluating safety and performance of a gel marker (BioXmark) used for image guidance in deep inspiration breathhold radiotherapy (DIBH IGRT) in patients with locally advanced non-small cell lung cancer (NSCLC)

Official Title
-----------------
Proof of Concept Study Evaluating Safety and Performance of a Gel Marker (BioXmark) Used for Image Guidance in Deep Inspiration Breathhold Radiotherapy (DIBH IGRT) in Patients With Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Device: BioXmark


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Age > 18 years old Histologically confirmed non-small cell lung cancer (NSCLC) Stage T1-4N1-3M0 Performance status ≤ 2 Inoperable FEV1 ≥ 1 l Ability to hold deep inspiration breathhold for > 15 seconds Accepting treatment at Rigshospitalet Eligible for concomitant chemo-radiotherapy If a woman is of childbearing potential, a negative pregnancy test must be documented Ability to understand the given information Signed written consent for inclusion into the study Exclusion criteria Prior thoracic radiotherapy Allergy to Iodine or iodine based contrast In the opinion of the investigator, the patient will not be able to follow the study procedures or is considered not eligible for other reasons

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br> | Device: BioXmark<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visibility of the injected gel marker during the course of radiotherapy delivery | Stability of the geometrical configuration and visibility of the injected gel marker in 2D kV x-rays and CBCT (cone-beam computed tomography) acquired throughout the treatment course and quantified by vectors and contrast to noise ratio (CNR) | 3 months | 
| Number of pneumothoraxes in relation to placement procedure of the gel | Counting number of pneumothoraxes caused in relation to the placement procedure of the gel | 0-1 week after placement of gel |
Evaluation of the Reliability, Validity, and Acceptability of the London Measure of Unplanned Pregnancy in a U.S. Population of Women

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the reliability, validity, and acceptability of the London Measure of Unplanned Pregnancy (LMUP) in a U.S. population of women. The researchers hypothesize that the LMUP will be acceptable to a U.S. population and will be reliable and valid.

Detailed Description
-----------------
The concept of unplanned pregnancy is used frequently in health research and policy. The majority of tools used to assess unplanned pregnancy planning have not been validated. Recently the London Measure of Unplanned Pregnancy (LMUP) has been developed and validated. The LMUP had been found to be valid and reproducible, but has not been studied outside of the United Kingdom. If we are able to validate this measure in a U.S. population, its use in studies will improve the quality of data about family planning in U.S. women.

Official Title
-----------------
Evaluation of the Reliability, Validity, and Acceptability of the London Measure of Unplanned Pregnancy in a U.S. Population of Women

Conditions
-----------------
Unplanned Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women Basic literacy in English or Spanish needed to participate. Exclusion Criteria: Literacy level lower than 11 years of age

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| English prenatal<br>English speaking women recruited from the general OB/GYN clinic | |
| Spanish prenatal<br>Spanish speaking (monolingual) women recruited from the general OB/GYN clinic | |
| English abortion clinic<br>English speaking women recruited from the abortion clinic | |
| Spanish abortion clinic<br>Spanish speaking (monolingual) women recruited from the abortion clinic | |

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
-----------------
Pregnancy, Unplanned pregnancy, Psychosocial, Measure