linjc16/ctgov huggingface dataset:
Investigation of the Accuracy of Temporal Artery Thermometers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether temporal artery thermometers are accurate tools in temperature measurements of patients presenting to the Emergency Department. The investigators´ hypothesis is that there is a difference of > 0,3 degrees centigrade (Bland-Altman) between the temperatures measured with the temporal artery thermometers used at the investigators´ hospital (Exergen TAT-5000) and those measured with rectal thermometers (OMRON MC-341-E), which is considered to be the gold standard in Denmark defined by the Danish Center for Clinical Guidelines. The investigators furthermore hypothesize that the difference between these measurements is greater if measured in a patient with hyperthermia (temperature > 37,9 degrees Centigrade).

Detailed Description
-----------------
Accurate temperature measurement on patients presenting to the Emergency Department is of great importance since it has significant influence on the further treatment of the patient. At Bispebjerg Hospital temporal artery thermometers are being implemented as they provide a fast and comfortable temperature measurement compared to rectal thermometers, who are considered to be the gold standard, defined by the Danish Center for Clinical Guidelines. The scientific proof for their accuracy compared to rectal thermometers in adult patients is insufficient though. The purpose of this study is to determine the difference between temperatures measured by a temporal artery thermometer (Exergen TAT-5000) and a rectal thermometer (OMRON MC-341-E) in patients presenting to the Emergency Department at Copenhagen University Hospital: Bispebjerg. The investigators hypothesize that there will be an average difference of at least 0,3 degrees centigrade between those two types of measurements (Bland-Altman). Based on a significance of 5% and a power of 80% the number of patients was calculated to 385, including an estimated 10% dropout.

Official Title
-----------------
Investigation of the Accuracy in the Use of Temporal Artery Thermometers for Non-invasive Temperature Measurement

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: given informed consent Exclusion Criteria: constipation anal disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Difference between temperatures measured by temporal artery thermometers and rectal thermometers |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility of temporal artery thermometers' measurements |  | 6 months |
Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the effectiveness of three lifestyle treatment programs varying in level of intensiveness on prevention of pioglitazone-induced weight gain and to measure the composition of the change in body weight.

Detailed Description
-----------------
The three lifestyle interventions were usual care (1 visit), standard care (4 total visits) and intensive care (10 total visits)

Official Title
-----------------
Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone

Conditions
-----------------
Type 2 Diabetes, Obesity

Intervention / Treatment
-----------------
* Behavioral: Lifestyle modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes with BMI 27 or greater, glycated hemoglobin 7% or greater Exclusion Criteria: insulin treated

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>usual care. Subjects had one 90 minute visit with registered dietitian | |
| Active Comparator: 2.<br>Standard care. Subjects had 4 sessions with registered dietitian | Behavioral: Lifestyle modification<br>* lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling<br>* Other names: lifestyle behavioral counseling;|
| Active Comparator: 3<br>Intensive care. subjects had 10 visits with registered dietitian | Behavioral: Lifestyle modification<br>* lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling<br>* Other names: lifestyle behavioral counseling;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in body weight |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in body composition |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, obesity, weight gain, thiazolidinediones
Frequency and Type of Genetic Abnormalities Found in Antenatal Corpus Callosum Malformation

Study Overview
=================
Brief Summary
-----------------
Corpus callosum malformation (CCM) is the most frequently detected cerebral defect diagnosed in the prenatal setting. The most common CCM is corpus callosum agenesis (CCA) which is found in 2 to 3% of patients presenting with intellectual disability. When CCM is diagnosed, the risk of chromosomal disorder is estimated to be 16%, be it aneuploidy such as trisomy 18, trisomy 13 or mosaic trisomy 8, or a chromosome structure anomaly, copy number variation or more complex rearrangement In France, since 2013 oligoarray-based comparative genomic hybridization (aCGH) analysis is performed in the prenatal period for most malformations after approval by a multidisciplinary prenatal diagnosis ethics committee (Centre Pluridisciplinaire de Diagnostic Prénatal, CPDPN) . However, to date only a few studies have been published which report recurrent Copy Number Variations (CNV) associated with CCM and estimate the risk for a chromosomal disorder, thus making counseling difficult in this context of prenatal diagnosis.

Official Title
-----------------
Frequency and Type of Genetic Abnormalities Found in Antenatal Corpus Callosum Malformation

Conditions
-----------------
Corpus Callosum Malformation, Prenatal Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prenatal diagnosis of corpus callosum malformation, isolated or not, between 01/01/2013, and 31/05/2018 Fetal DNA available Mother's informed consent obtained Exclusion Criteria: No amniocentesis performed Refusing to participate

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of chromosomal abnormalities | The main objective is to describe the frequency of chromosomal abnormalities associated with a prenatal diagnosis of corpus callosum agenesis in the hope of improving genetic counseling. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of chromosomal abnormalities | Describe the type of chromosomal abnormalities associated with a prenatal diagnosis of corpus callosum agenesis and thus identify recurrent copy number variations. | 6 months |
Study of Eye Movement Testing and Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the ability of several eye movement monitors, used in clinical practice, to identify children with poor reading eye movements. A second purpose of the study is to evaluate the effectiveness of eye movement therapy.

Conditions
-----------------
Saccadic Eye Movement Deficiency, Oculomotor Deficiency, Oculomotor Dysfunction

Intervention / Treatment
-----------------
* Procedure: eye movement therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children ages 8 to 13 with saccadic eye movement deficit Exclusion Criteria: Previous saccadic eye movement therapy

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 13 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: eye movement therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ambulatory Blood Pressure Reduction After Rosiglitazone Treatment In Normotensive Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine the effects of rosiglitazone in normotensive type 2 diabetic patients with regard to its blood-pressure-reducing effects.

Detailed Description
-----------------
The first study to evaluate the effects of troglitazone on blood pressure in humans was published recently, which demonstrated a 5/4 mm Hg reduction in ambulatory blood pressure in 18 nondiabetic obese subjects after 12 weeks' treatment. Another study in 18 hypertensive subjects with diabetes mellitus showed an 18/12 mm Hg decline in office blood pressure after 8 weeks of treatment.

Official Title
-----------------
Study of PPAR Gamma Agonist-Rosiglitazone in Normotensive Type 2 Diabetics With Ambulatory Blood Pressure Monitoring

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

Intervention / Treatment
-----------------
* Drug: rosiglitazone(drug), blood pressure lowering effect


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blood pressure of patients were in normotensive limits according to the JNC VII Diabetes mellitus treated with oral antidiabetics or diet Exclusion Criteria: Any known hypertension, coronary artery disease, congestive hearth failure, renal disease or liver disease Anti-hypertensive treatment

Ages Eligible for Study
-----------------
Minimum Age: 49 Years
Maximum Age: 65 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: rosiglitazone(drug), blood pressure lowering effect|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory blood pressure monitors used to determine the subjects blood pressure before and after the treatment. At the end of three months period wit rosiglitazone treatment diastolic blood pressure decreased. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Pressure,, rosiglitazone,Diabetes Mellitus, Type 2,
Vitamin C for the Prevention of UTI in Women Who Undergo Elective GYN Surgeries

Study Overview
=================
Brief Summary
-----------------
This open-label randomized trial aims at assessing the role of Vitamin C pills in the prevention of catheter-associated urinary tract infections in women undergoing elective gynecological surgeries.

Official Title
-----------------
Vitamin C for the Prevention of UTI in Women Who Undergo Elective GYN Surgeries: a Study Protocol for a Randomized Controlled Trial

Conditions
-----------------
Catheter-Associated Urinary Tract Infection, Ascorbic Acid

Intervention / Treatment
-----------------
* Drug: Ascorbic Acid 1000 MG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non pregnant women at least 18 years of age visiting the Preadmission unit (PAU) or the OBGYN floor (7N), presenting for elective GYN surgery at the American University of Beirut Medical Center (AUBMC). Exclusion Criteria: Any women with the following: Nephrolithiasis Congenital anomaly or neurogenic bladder Allergy to ascorbic acid Who require therapeutic anticoagulant medicine during the 6 weeks after surgery Surgery did involve a fistula repair or a vaginal mesh removal Positive Urinalysis in the PAU Recurrent UTI's Diabetes G6PD Hemochromatosis Renal disorders Patients already taking Vitamin C supplementation will also be excluded from the study.

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women on a vitamin C regimen<br>Women who are undergoing elective gynecological surgeries and who are randomized to take 1000 mg of vitamin C for one month, | Drug: Ascorbic Acid 1000 MG<br>* 1000 mg ascorbic acid (Vitamin C) for 1 month post-op after an elective gynecological surgery.<br>|
| No Intervention: Women not taking vitamin C<br>Women who are undergoing elective gynecological surgeries and who are randomized not to take any vitamin C for one month. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who experienced clinically diagnosed and treated UTI. | Urinary tract infection is diagnosed by a positive urine culture. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin C, CAUTI
Restless Legs Syndrome in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
Our study aimed to examine a possible association between Restless legs syndrome and cerebrovascular disease, by examining patients during hospitalization for acute stroke or transient ischemic attack, in a matched case-control design.

Official Title
-----------------
Restless Legs Syndrome in Stroke Patients

Conditions
-----------------
Restless Legs Syndrome, Stroke, Transient Ischemic Attack

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or older Hospitalization for stroke or transient ischemic attack Exclusion Criteria: 18 years old or younger No stroke or transient ischemic attack

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 |
| --- | --- |
| Patients with stroke or transient ischemic attack<br>Interview regarding restless legs syndrome | |
| Subjects without stroke or transient ischemic attack<br>Interview regarding restless legs syndrome | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Restless legs syndrome in patients with stroke or Transient ischemic attack vs. prevalence in controls. | The frequency (prevalence) of restless leg syndrome (RLS) in patients who have suffered stroke or TIA will be compared to that of subjects who have not suffered stroke or TIA (controls). The two groups will be stratified with regard to age and gender. Statistical comparison will be made by univariate analyses and by multivariate logistic regression analyses (which will include cerebrovascular risk factors besides stroke or TIA). | At time of interview | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Restless legs syndrome, Stroke, Transient ischemic attack, Cerebrovascular risk factors
The Effects of Kinesio Taping in Archery

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the effects of KT on archery athletes' performance.

Detailed Description
-----------------
Archery is a sport that requires strength, endurance, stabilization, and coordination of the upper body and shoulder girdle muscles. Kinesio taping (KT), which increased in popularity with the use in the athletes in the 2008 summer Olympics, is commonly investigated in the literature. KT is claimed to reduce pain and edema, increase functional performance, joint position sense, and blood-lymph flow, provide stability, and improve range of motion, flexibility, and strength. The aim of the study is to investigate the effects of KT on archery athletes' performance.

Official Title
-----------------
Does Kinesio Taping Affect Shooting Performance Acutely in Archery Athletes?

Conditions
-----------------
Sports Physical Therapy

Intervention / Treatment
-----------------
* Other: Kinesiotaping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be archery in the elite category for at least 1 year Attending training sessions at least 2 days a week Exclusion Criteria: Having any neurological problems Having a Turkish-speaking and reading disability

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 14 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Kinesiotaping|Kinesio taping will be applied on the lower part of the trapezius.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Archery Shooting Performance | The archery shooting performance will be assessed with the target paper which includes 5 scoring colors. The subject will be placed within 18 meters distance of the target paper. The subjects will have 12 arrows to make the shoot. The best 6 shoots will be taken to calculate the total score. | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Proprioception | The proprioception will be assessed with the angle reproduction test. | 15 minutes | 
| Evaluation of Scapular Dyskinesis | Dyskinesis will be assessed with scapular lateral slide test. | 5 minutes |
A Long-term Study on the Side Effects of TRADIANCE in Japanese Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Study objectives is to investigate the safety of long-term daily use of TRADIANCE® Combination Tablets AP and BP in Japanese patients with Type 2 Diabetes mellitus (T2DM) used in routine care.

Official Title
-----------------
Post Marketing Surveillance in Japan on Long Term Drug Use of TRADIANCE® Combination Tablets AP and BP in Patients With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: TRADIANCE® Combination Tablets AP
* Drug: TRADIANCE® Combination Tablets BP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese patients with Type 2 Diabetes mellitus (T2DM) who are prescribed with TRADIANCE® Combination Tablets AP or BP Patients who have never been treated with TRADIANCE® Combination Tablets AP or BP before enrolment Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with type 2 Diabetes Mellitus<br> | Drug: TRADIANCE® Combination Tablets AP<br>* Fixed dose combination<br>Drug: TRADIANCE® Combination Tablets BP<br>* Fixed dose combination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Drug Reactions (ADRs) | The number of participants with adverse drug reactions is reported. | From first dose of study medication until last dose + 7 days, up to 102.1 weeks. |