linjc16/ctgov huggingface dataset:
Compare the Analgesic Effect of Different Anesthesia and Postoperative Analgesic Methods in Uniportal VATS Lung Surgery

Study Overview
=================
Brief Summary
-----------------
This is a single center, randomized, single blind study to compare the analgesic effect of different anesthesia and postoperative analgesic methods in uniportal VATS lung surgery.

Detailed Description
-----------------
Combining epidural with general anesthesia is regarded as the gold standard of general thoracic surgery. The uniportal VATS lung surgery have advantages of minimal invasive surgical incision, less postoperative pain, and so on. Whether general anesthesia can become an alternative method of combining epidural with general anesthesia in uniportal VATS lung surgery, investigators thus plan to make a comparison on intraoperative stress response, postoperative pain, immune function of patients，and hospital expenses.

Official Title
-----------------
Compare the Analgesic Effect of Different Anesthesia and Postoperative Analgesic Methods in Uniportal VATS Lung Surgery

Conditions
-----------------
Postoperative Pain, Single-incision Thoracoscopic Surgery

Intervention / Treatment
-----------------
* Combination Product: general anesthesia
* Combination Product: epidural anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients elective uniportal VATS lung surgery; BMI 18-30 kg/m2. Exclusion Criteria: Patient refuse; ASA≥3; Patients allergic to use anesthetics (propofol,rocuronium), patients with liver and/or kidney and/or mental dysfunction.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: general anesthesia group<br>The patients in this group receive general anesthesia preoperatively, and use patient controlled intravenous analgesia postoperatively. | Combination Product: general anesthesia<br>* The investigators used general anesthesia preoperatively in uniportal VATS lung surgery<br>|
| Active Comparator: epidural group<br>The patients in this group receive general anesthesia combined with epidural anesthesia, and use patient controlled epidural analgesia postoperatively. | Combination Product: epidural anesthesia<br>* The investigators used general anesthesia combined with epidural anesthesia preoperatively in uniportal VATS lung surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale（VAS） | This scale mainly reflects the patient's pain | 1 year |
Early Detection of Skin Cancer With Sensor Technology

Study Overview
=================
Brief Summary
-----------------
Skin cancer represents a large problem in today's healthcare setting. The majority of cancer diagnoses are attributed to malignant skin diseases including its major types: basal cell carcinoma, squamous cell carcinoma and melanoma. Early diagnoses is critical given early detection of malignant lesions largely increases chances of successful treatment. The current gold standard of diagnosis is histopathological examination of biopsied skin. Biopsies are not only invasive and expensive, they have variable positive predictive value, meaning they may often be preformed unnecessarily. As such, the investigators have developed a skin scanner, which is less bulky and expensive than existing similar technologies, as a tool to evaluate skin lesions prior to determining the need for a biopsy. Their objective is to obtain information in order to validate this skin scanner in the context of its ability to accurately identify basal cell carcinoma skin lesions.

Official Title
-----------------
Early Detection of Skin Cancer Using Millimetre-Wave Waveguide Reflectometers

Conditions
-----------------
Carcinoma, Basal Cell

Intervention / Treatment
-----------------
* Device: WR-22 model microwave sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient requiring skin biopsy for suspected basal cell carcinoma skin lesion 18 years of age or older Exclusion Criteria: -Poor english fluency, Pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WR-22 model microwave sensor<br> | Device: WR-22 model microwave sensor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value |  | Immediately pre-biopsy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Detection
Metabolic and Appetite Parameters Following Addition of Whey Protein to a Carbohydrate-based Breakfast

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether the addition of whey protein to a breakfast high in carbohydrate content will influence acute metabolic and appetite responses, as well as responses to a subsequent lunch meal.

Official Title
-----------------
The Influence of Whey Protein Addition to a Carbohydrate-based Breakfast on Metabolic and Appetite Parameters Following a Second Meal

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

Intervention / Treatment
-----------------
* Dietary Supplement: Whey Protein (Arla Foods Ingredients Group)
* Other: Breakfast meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-40 years old (male) Recreationally active (>30 minutes of structured exercise, 5 times/week) Exclusion Criteria: Metabolic disease (e.g. Type 2 diabetes, thyroid disorders) Taking any prescribed medication Regular breakfast skipper Food allergies or intolerances Eating disorders Smoker

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breakfast - Carbohydrate + Whey Protein<br>Addition of whey protein isolate (20 g dissolved in flavoured water) to breakfast meal composition | Dietary Supplement: Whey Protein (Arla Foods Ingredients Group)<br>* 20 g whey protein isolate added to breakfast meal<br>Other: Breakfast meal<br>* Carbohydrate breakfast served as a standard portion (1799 kJ, 93/2/9% energy from carbohydrate/fat/protein)<br>|
| Placebo Comparator: Breakfast - Carbohydrate<br>Only flavoured water consumed with breakfast meal | Other: Breakfast meal<br>* Carbohydrate breakfast served as a standard portion (1799 kJ, 93/2/9% energy from carbohydrate/fat/protein)<br>|
| No Intervention: No Breakfast<br>Only water consumed at breakfast time point | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial blood glucose responses | Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast and post-lunch | 0-360 minutes post breakfast | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute subjective appetite responses | Subjective appetite ratings determined from Visual Analogue Scales sampled at regular intervals | 0-360 minutes post breakfast | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postprandial glycemia, metabolic health measures
Noninvasive Intracranial Pressure and Hydrocephalus Patients

Study Overview
=================
Brief Summary
-----------------
Using a pulse oximeter, we have developed an algorithm that estimates intracranial pressure (ICP) based on patients who have had traumatic brain injuries. Patients with hydrocephalus are typically treated with a shunt in order to reduce ICP. At times the shunt can malfunction. We believe that our algorithm will help identify when a hydrocephalus patient's shunt has malfunctioned.

Detailed Description
-----------------
A malfunctioning ventriculoperitoneal (VP) shunt will typically cause a rise in intracranial pressure, which can be difficult to identify without costly imaging. Novel, state-of-the art machine learning techniques can be leveraged to develop an algorithm that noninvasively estimates intracranial pressure. The resulting algorithm will accurately determine the presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus.

Official Title
-----------------
Continuous Noninvasive Estimation of Intracranial Pressure to Assess Ventriculoperitoneal Shunt Malfunction in Patients With Hydrocephalus

Conditions
-----------------
Hydrocephalus

Intervention / Treatment
-----------------
* Device: Pulse oximetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 31 days - 35 years Patients seen at Children's Hospital Colorado Neurosurgery clinic, Emergency Department or on an inpatient service Either hydrocephalus patients with a VP shunt in place (with or without suspicion of VP shunt malfunction), or patients with no known intracranial pathology. Exclusion Criteria: Pregnant patients Incarcerated patients Patients who object at any time to participating in the study.

Ages Eligible for Study
-----------------
Minimum Age: 31 Days
Maximum Age: 35 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 |
| --- | --- |
| VP shunt functioning<br>No intervention, just a physiological category--patients with VP shunts that are functioning normally. | Device: Pulse oximetry<br>* Pulse oximetry<br>|
| VP shunt malfunctioning<br>No intervention, just a physiological category--patients with VP shunts that are malfunctioning. | Device: Pulse oximetry<br>* Pulse oximetry<br>|
| No known intracranial pathology<br>No intervention, just a physiological category--patients without VP shunts that have no known intracranial pathology. | Device: Pulse oximetry<br>* Pulse oximetry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus | The algorithm development | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VP shunted, Normal intracranial pathology, patients
Safety, Pharmacokinetic, Pharmacodynamic Study of LAPS-IFNa in Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
Study design: This is a randomized, double-blind, placebo- and active-controlled, single-dose study in 4 groups of 12 healthy male subjects each. In each group, 8 subjects will receive a dose of HM10660A, 2 subjects will receive a single dose of placebo and 2 subjects will receive a single dose of a currently marketed PEG-interferon.

Detailed Description
-----------------
Primary objective: to study the safety and tolerability of HM10660A, including immunogenicity, as compared to PEG-interferon alpha-2a Secondary objective: to study the pharmacokinetics and pharmacodynamics of HM10660A as compared to PEG-interferon alpha-2a

Official Title
-----------------
A Randomized, Double-Blind, Placebo- And Active-Controlled Study Of The Pharmacokinetics, Pharmacodynamics And Safety Of Single Ascending Doses Of HM10660A (LAPS-INTERFERON ALPHA-2B) In Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Biological: HM10660A
* Biological: HM10660A placebo
* Biological: Pegasys


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18 - 45 Years, Inclusive BMI: 18.0 - 28.0 kg/m2 Are Non-smokers or Smoker of Fewer Than 5 Cigarettes Per Day as Determined by History Exclusion Criteria: Mental Handicap Evidence of Clinically Relevant Pathology History of Type 1 Diabetes or Thyroid Disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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: HM10660A<br> | Biological: HM10660A<br>* Single dose of HM10660A 1.5, 2.25, 3.0, or 4.0 ug/kg<br>|
| Active Comparator: Pegasys<br> | Biological: Pegasys<br>* Single dose of Pegasys 180ug<br>|
| Placebo Comparator: HM10660A Placebo<br> | Biological: HM10660A placebo<br>* Single dose of HM10660A Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change | Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change among HM10660A receivers will be assessed. It can be compared to those numbers in Active comparator group. | 43 days |
Screening of Microalbuminuria Using a Semi-quantitative UACR Test

Study Overview
=================
Brief Summary
-----------------
Microalbuminuria is an important biomarker for the development of diabetic nephropathy and cardiovascular complications. Since microalbuminuria is not easily detected on routine urinalysis, current guidelines recommend measuring spot urine albumin-to-creatinine ratio (uACR) annually in a patient with diabetes mellitus. While the standard method is quantitative measurement using turbidimetric immunoassay, it requires high cost and special laboratory equipment. This may be a hurdle that prevents screening for microalbuminuria in many patients with diabetes. Therefore, a semi-quantitative uACR test, which is rapid and inexpensive, could be used as a substitute to the current standard quantitative measurement. The investigators aimed to assess the diagnostic accuracy of a semi-quantitative urine albumin-to-creatinine ratio test, URiSCAN 2ACR, as a screening tool for microalbuminuria in patients with diabetes.

Official Title
-----------------
Accuracy of a Semi-quantitative Urine Albumin-to-creatinine Ratio Test as a Screening Tool for Microalbuminuria in Patients With Diabetes

Conditions
-----------------
Diabetes, Microalbuminuria

Intervention / Treatment
-----------------
* Diagnostic Test: semi-quantitative urine albumin-to-creatinine ratio test
* Diagnostic Test: standard quantitative spot urine albumin-to-creatinine ratio


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetes Exclusion Criteria: microscopic hematuria pyuria urinary cast

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 |
| --- | --- |
| diabetes<br>Diabetes patients with normal renal function and normal urinalysis | Diagnostic Test: semi-quantitative urine albumin-to-creatinine ratio test<br>* measurement of urine albumin-to-creatinine ratio using URiSCAN 2ACR, a semi-quantitative urine albumin-to-creatinine ratio test<br>Diagnostic Test: standard quantitative spot urine albumin-to-creatinine ratio<br>* measurement of urine albumin-to-creatinine ratio using a standard turbidimetric immunoassay<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Sensitivity and Specificity | Diagnostic Sensitivity and Specificity of URiSCAN 2ACR compared with standard method | through study completion, an average of 18 months |
Assessment of Effectiveness and Safety of Dysport® for the Treatment of Hemifacial Spasm

Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness and safety of Dysport® with the domestic Botulinum Toxin Type A (manufactured by Lanzhou Biologic Product Institute, P.R. China) for the treatment of hemifacial spasm.

Official Title
-----------------
A Phase III, Multicentre, Randomised, Assessor-blind, Parallel Groups, Reference Drug Controlled Study to Assess the Efficacy and Safety of a Single Administration, by Subcutaneous Injection of Dysport® for the Treatment of Hemifacial Spasm

Conditions
-----------------
Hemifacial Spasm

Intervention / Treatment
-----------------
* Biological: Botulinum toxin type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient suffering from hemifacial spasm with at least 6 months duration (prior to visit 1) Cohen scale ≥ to grade II Exclusion Criteria: Botulinum toxin type A treatment history within last 16 weeks prior to visit 1 Hemifacial spasm secondary to facial palsy Previous alcohol or phenol injections or surgical therapy of the facial muscles Requirement for botulinum toxin injection to site(s) of the body other than in this study

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Botulinum toxin type A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels) |  | At the end of week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels after medication) |  | At the end of week 1 and 12 | 
| Improvement degree of spasm (Jankovic scale) |  | At the end of week 1, 4 and 12 | 
| Assessment of efficacy by the subjects |  | At the end of week 1, 4 and 12 |
Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin

Official Title
-----------------
An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin NPH
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insulin detemir naive Type 1 diabetes for at least 12 months HbA1c lesser than or equal to 11.0% Exclusion Criteria: Significant concomitant diseases

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: insulin detemir<br>insulin detemir + insulin aspart | Drug: insulin detemir<br>* s.c. injection, once or twice daily.<br>Drug: insulin aspart<br>* s.c. injection, at main meals.<br>|
| Experimental: NPH insulin<br>NPH insulin + insulin aspart | Drug: insulin NPH<br>* s.c. injection, once or twice daily.<br>Drug: insulin aspart<br>* s.c. injection, at main meals.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated Haemoglobin A1c (HbA1c) | Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory. | after 52 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting Adverse Events | Number of subjects reporting adverse events during the trial (from week -2 to week 52). For details, please refer to the adverse events section. | from week -2 to week 52 | 
| Observed Insulin Antibody Values | Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies. | at 0 and 52 weeks |