linjc16/ctgov huggingface dataset:
Effectiveness and Safety of Biphasic Insulin Aspart 70/30 in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. This is a clinical trial investigating the effectiveness of using Biphasic Insulin Aspart 70/30 in two different treatment regiments for 6 months in subjects with type 2 diabetes, not well controlled on their current oral anti-diabetic drug therapy.

Official Title
-----------------
Change in HbA1c With Biphasic Insulin Aspart 70/30 in Two Different Treatment Regiments in Subjects With Type 2 Diabetes Inadequately Controlled With Oral Anti-diabetic Drug Therapy.

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes HbA1C = 7.5% Insulin naïve Current treatment by Oral Anti-diabetic Drugs Exclusion Criteria: Severe medical conditions

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: biphasic insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | After 24 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 
| Weight change |  |  | 
| Fasting blood glucose |  |  | 
| Hypoglycaemic episodes |  |  | 
| 2-hour postprandial blood glucose |  |  | 
| after 24 weeks of treatment. |  |  |
Non-invasive Determination of Anemia in Children With Renal Failure

Study Overview
=================
Brief Summary
-----------------
Anemia and inflammation are very common in patients with renal diseases. The most common procedure to detect anemia is to determine blood hemoglobin concentrations. The Haemospect® is a portable device for non-invasive hemoglobin determination that works with a sensor that is applicable in infants and adults alike. The objective of this trial is to collect spectra with the non-invasive Haemospect® device in children of different age groups with renal failure and different hemoglobin concentrations. In parallel, corresponding hemoglobin values shall be obtained invasively to form the basis for the development of an algorithm for the device. To determine inflammation, the frequencies of vasomotion and oxygenation of the tissue are measured non-invasively with the Haemospect®. Various blood parameters for iron and inflammation will also be determined, such as ferritin, hepcidin, transferrin, serum iron, white blood cell count and CRP.

Official Title
-----------------
A Non-invasive Device to Determine Iron Deficiency Anemia in Children of Different Age Groups With Renal Failure

Conditions
-----------------
Renal Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all children in treatment for renal insufficiency in FUNDANIER Exclusion Criteria: none
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 |
| --- | --- | --- |
| Hemoglobin |  | 1 day | 
| Iron parameters | Serum iron, ferritin, transferrin, transferrin saturation, TIBC, hepcidin | 1 day | 
| Inflammation parameters | Ferritin, hepcidin, CRP, white blood cell count, ESR | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anthropometric data | weight, height, WAZ, HAZ and WHZ | 1 day |
Zeiss® IOLMaster 700 Corneal Topography Module Comparison With Schwind's Sirius Corneal Topography®

Study Overview
=================
Brief Summary
-----------------
In order to determine the intraocular lens to be implanted during cataract surgery, keratometry and axial length must be measured in preoperative. The axial length is obtained by ocular ultrasound mode B. Keratometry is obtained by means of an automatic refractometer or corneal topography. Currently, ultrasound scanners are being developed with a topography module to combine axial length and keratometry measurement. The investigators want to evaluate the corneal topography module of the Zeiss® IOL Master 700 biometer.

Official Title
-----------------
Zeiss® IOLMaster 700 Corneal Topography Module Comparison With Schwind's Sirius Corneal Topography®

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Other: measurement of axial length and keratometry by sonographers with a topographic module


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and Women Requiring CHV Cataract Surgery Aged 18 or over Insured under a social security scheme Having been informed of the clinical study and having given oral express consent Exclusion Criteria: Person unable to express consent Patient with a history of corneal dystrophy, corneal refractive surgery or keratoconus. History of chronic corneal 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corneal Topography with IOLMaster and Sirius topography.<br>The experimental group will have the two exams: the topography with the IOLMAster and the topography with Sirius topography. | Other: measurement of axial length and keratometry by sonographers with a topographic module<br>* measurement of axial length and keratometry by sonographers with a topographic module<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| keratometry measurements | to show that the keratometry measurements obtained using the topography module integrated in the IOL Master 700 are consistent with those obtained by a standard topography in patients operated for cataract surgery. The measures will be: K1 (steepest corneal meridian), K2 (flattest corneal meridian), Kmax (central corneal keratometry), the unit of measurement is the diopter. | day 1 |
Could Non-invasive Biochemical, Image or Physiological Index Predict Significant Coronary Arterial Stenosis in Symptomatic Adults?

Study Overview
=================
Brief Summary
-----------------
To validate the capability of non-invasive bio-image tests in prediction of significant coronary stenosis of symptomatic adults.

Detailed Description
-----------------
The main objective is to validate the capability of these non-invasive tests (CCS, hs-CRP and ABI) in prediction of significant coronary stenosis of symptomatic adults. The end-point will be the findings of coronary CT angiography. The investigators hope the results of our study could be applied on the interpretation of health examination and the advice of follow-up and therapy.

Official Title
-----------------
Could Non-invasive Biochemical, Image or Physiological Index Predict Significant Coronary Arterial Stenosis in Symptomatic Adults?

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Radiation: coronary calcium score measurement
* Biological: high sensitivity C reactive protein measurement
* Procedure: ankle brachial index measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects for a general health check-up protocol, which included CACS and CCTA, and biochemical measurements (total cholesterol, total triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, high sensitivity C reactive protein) Exclusion Criteria: anyone allergy to iodine contrast medium, unable cooperation for CT scanning, asymptomatic

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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 |
| --- | --- |
| significant coronary artery stenosis<br>anyone coronary segment > 50% diameter stenosis | Radiation: coronary calcium score measurement<br> <br> Biological: high sensitivity C reactive protein measurement<br> <br> Procedure: ankle brachial index measurement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coronary CT angiography |  | within one month |
Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

Study Overview
=================
Brief Summary
-----------------
Total parathyroidectomy with autotransplantation (TPTX+AT) and Total parathyr- oidectomy alone (TPTX) are the common surgical procedures.The purpose of the study was to compare the long-term benefits of surgery between the two groups.

Detailed Description
-----------------
The trial was performed as a nonconfirmatory randomized controlled pilot trial with 200 patients on long-term dialysis with otherwise uncontrollable SHPT to generate data on the rate of recurrent disease within a 5-year follow-up period after TPTX or TPTX+AT. Parathyroid hormone (PTH) and calcium levels, recurrent or persistent hyperparathyroidism, parathyroid reoperations, morbidity, and mortality were evaluated during a 5-year follow-up.

Official Title
-----------------
Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

Conditions
-----------------
Secondary Hyperparathyroidism;Parathyroidectomy

Intervention / Treatment
-----------------
* Procedure: Parathyroidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe renal secondary hyperparathyroidism Exclusion Criteria: Patients with diabetes a history of chronic inflammatory disease a history of malignant tumor a history of kidney transplantation a history of neck surgery a history of alcohol abuse a history of drug abuse inability to cooperate with the participants refusal to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total Parathyroidectomy Alone<br>Total Parathyroidectomy Alone , without autotransplantation | Procedure: Parathyroidectomy<br>* Total Parathyroidectomy With Autotransplantation or Total Parathyroidectomy Alone<br>|
| Active Comparator: Total Parathyroidectomy With Autotransplantation<br>Total Parathyroidectomy With Autotransplantation | Procedure: Parathyroidectomy<br>* Total Parathyroidectomy With Autotransplantation or Total Parathyroidectomy Alone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of recurrent | the rate of recurrent | 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Secondary Hyperparathyroidism;Parathyroidectomy;hemodialysis
Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Dextromethorphan and Quinidine at Two Dose Levels in the Treatment of the Pain of Diabetic Neuropathy

Conditions
-----------------
Pain, Diabetic Neuropathy

Intervention / Treatment
-----------------
* Drug: Neurodex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of diabetes mellitus Established diabetic therapy for at least 3 months Lab-supported diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy Pain the previous three months Not pregnant Exclusion Criteria: Patient failed adequate trial of 3 or more medications or has required narcotics for pain History of torsades de pointes Sensitivity to quinidine or opiate drugs (codeine, etc) Severe pain that could confound the assessment Patient has had any amputations Patient has participated in the past 30 days or is currently participating in another trial Patient has previously received treatment with dextromethorphan and quinidine

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Neurodex|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain rating scale obtained from patient diaries |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional diary rating scales and scores obtained from clinic visits |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
distal symmetrical, pain, lower extremities, dextromethorphan
Five-year Outcome of Laparoscopic Gastric Sleeve

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the long-term (5-year follow-up) results of laparoscopic gastric sleeve (LGS) in terms of weight loss and obesity related comorbidities, as well as the risk factors associated with postoperative nutritional deficiencies.

Detailed Description
-----------------
The consecutive patients who undergo LGS for the treatment of morbid obesity at Tartu University Hospital are followed prospectively in cohort study. The outpatient hospital follow-up visits are conducted at 3 months, 1 year and 5 years postoperatively.

Official Title
-----------------
Five-year Outcome of Laparoscopic Gastric Sleeve, Resolution of Comorbidities and Risk for Cumulative Nutritional Deficiencies.

Conditions
-----------------
Bariatric Surgeries, Metabolic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The criteria for bariatric surgery: BMI of >40, or >35 with certain obesity related comorbidities Exclusion Criteria: Patients who did not fill the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Five-year outcome of laparoscopic gastric sleeve | 5-year outcome in terms of weight loss, calculated in mean excess weight lost (%EWL). | 5-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Five-year outcome of laparoscopic gastric sleeve | 5-year outcome of resolution of obesity-related comorbidities (type 2 diabetes mellitus, hypertension, obstructive sleep apnea, dyslipidemia). Prevalence of comorbidities are presented in percentages. McNemar´s test is employed to analyse significance of resolution of comorbidities. | 5-year follow-up | 
| Five-year outcome of laparoscopic gastric sleeve | 5-year risk for cumulative nutritional deficiencies. According to blood analysis results and patient provided information about taking supplementations (eg vitamine B12 or iron), prevalence of nutritional deficiencies are calculated in percetanges. Backward stepwise logistic regression is used to evaluate the risk factors for nutrition. | 5-year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric sleeve
Does Statin Initiation Undermine Dietary Behavior?

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to improve our understanding of the effects that taking cholesterol reducing pills have on dietary behavior as well as other health related behaviors

Detailed Description
-----------------
This study explores the impact of initiating statin therapy on subsequent dietary as well as other lifestyle beliefs, attitudes and behaviors. Specific aims: To test whether the initiation of statin therapy increases dietary saturated fat intake among statin naive patients. To determine what role attitudes, beliefs, expectations, motivation, intention and self-efficacy regarding drug or diet therapy may play in observed changes in dietary behavior after starting statin therapy.

Official Title
-----------------
Does Statin Initiation Undermine Dietary Behavior?

Conditions
-----------------
All English Speaking Adults From the Manhattan VA Clinic Who Have Recently Received Their First Prescription for a Statin

Intervention / Treatment
-----------------
* Behavioral: Drug and Dietary behavior


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All English-speaking adults who have recently (within 1 week)received their first prescription for a statin will be eligible. Exclusion Criteria: Will include a history of any of the following: Prior CVD (myocardial infarction, angina, angioplasty, stroke, CABG. or arterial bypass surgery) Diabetes patients Psychiatric patients AIDS patients Substance abuse patients Prior cholesterol lowering medication use Inability to complete the interviews

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

| Intervention/Treatment |
| --- |
|Behavioral: Drug and Dietary behavior|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How drug or dietary therapy may play a role in dietary behavior. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Statin therapy, Dietary behavior, Attitudes and beliefs, Self efficacy
Reading Fluency and Accommodative Lag

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether special reading glasses improve children's ability to learn to read.

Detailed Description
-----------------
Many children are believed to under accommodate (have a lag of accommodation) when looking at near targets. If this occurs, the retinal image is out of focus. Children who have a lag of accommodation may have difficulty in focusing their eyes at near for long periods of time. This difficulty could reduce their ability to read fluently. Children with above average lags of accommodation will be randomly assigned to a group which receives special reading glasses or a group which does not. The groups will be assessed using a standard test for reading fluency.

Official Title
-----------------
Reading Fluency and Accommodative Lag

Conditions
-----------------
Ocular Accommodation

Intervention / Treatment
-----------------
* Other: Autorefractor, standard clinical instrument


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children in grades 1, 2 and 3 who consent and assent to participate Exclusion Criteria: Children in the special education program Children who are unwilling to have their eyes dilated or be tested Children who are unwilling to wear the glasses

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 9 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Autorefractor, standard clinical instrument|Autorefractor, standard clinical instrument was used to assess the children's focusing power at near.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DIBELS test scores . |  | 1 -2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ocular Accommodation, Reading