linjc16/ctgov huggingface dataset:
Active Surveillance of Papillary Thyroid Microcarcinoma

Study Overview
=================
Brief Summary
-----------------
Papillary thyroid microcarcinoma are small thyroid cancer measuring 1cm or less. Most of this tumor are not palpable and are identified either through pathologic examination or from imaging modalities, such as CT scan or thyroid sono. Active surveillance of papillary microcarcinoma is to observe thyroid papillary cancer without immediate surgical approach. The purpose of this study is to understand more about the characteristics of papillary microcarcinoma, which has been known for the cancer slowly progression

Official Title
-----------------
Active Surveillance of Papillary Thyroid Microcarcinoma (PTMC) in Catholic Medical Center

Conditions
-----------------
Thyroid Cancer, Papillary

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: < 1 cm solitary nodule Surrounded by ≥ 2 mm normal thyroid parenchyma Subcapsular locations not adjacent to surrounding structures, recurrent laryngeal nerve, trachea, or carotid artery No evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery No extrathyroidal extension Clinically N0 and Clinically M0 ≥ 18 years Combined severe comorbidities or Inoperable condition (optional) No wish to surgery and Willingness to accept active surveillance No history of radiotherapy on head and neck area Accepted by the Board of Thyroid Cancer Meeting Exclusion Criteria: ≥ 1 cm nodule and multifocal nodules regardless of size Papillary thyroid carcinoma variants associated with poor prognosis (tall cell variant, columnar variant, hobnail variant) or other types of thyroid cancer) Subcapsular locations adjacent to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery Evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery Extrathyroidal extension Any of N1 or M1 Documented increase in size according to America Thyroid Association (ATA) guideline in a previously confirmed Papillary thyroid microcarcinoma < 18 years Not willing to accept observational active surveillance approach

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 |
| --- | --- | --- |
| Progression of papillary thyroid microcarcinoma | Using thyroid sonography, check any changes in size and shape of papillary thyroid microcarcinoma | 5 years after enrollment |
Avelox in Complicated Skin and Skin Structure Infections

Study Overview
=================
Brief Summary
-----------------
This international, prospective, non-interventional, non-controlled observational study obtains data on efficacy, safety and tolerability of Avelox treatment under daily-life treatment conditions. Specifically investigated are the improvement of clinical symptoms and the duration until infection improvement and cure.Any patient with a diagnosis of complicated skin and skin structure infection (cSSSI) treated with Avelox can be documented. The observation period for each subject covers the treatment period with Avelox. For each patient, the physician documents data at an initial visit and one or two follow-up visit(s) in line with routine practice.

Official Title
-----------------
ARTOS - Avelox® in Routine Treatment of Complicated Skin and Skin Structure Infections

Conditions
-----------------
Skin Diseases, Bacterial

Intervention / Treatment
-----------------
* Drug: Moxifloxacin (Avelox, BAY12-8039)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient with a diagnosis of complicated skin and skin structure infection (cSSSI) and for whom the decision was made by the attending physician to start treatment with Avelox before inclusion into and independent of the study. Exclusion Criteria: Exclusion criteria are those specified in the local product information.

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- |
| Group 1<br> | Drug: Moxifloxacin (Avelox, BAY12-8039)<br>* 400 mg, intravenous / oral, once daily, treatment duration at the discretion of the attending physician who must consult the local product information<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: course of severity of infection, course of clinical signs and symptoms, duration until improvement, duration until recovery, duration until wound closure, overall assessment of efficacy by the physician, reuse of Avelox |  | last documented follow-up visit, according to the respective praxis routine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events collection |  | during entire study course, according to the respective praxis routine | 
| Overall assessment of tolerability by the physician |  | last documented follow-up visit, according to the respective praxis routine | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin Diseases, Bacterial, Product Surveillance, Postmarketing
Monitoring Patient Cerebro-Spinal Fluid Drainage With an Ultrasonic Flow Sensor

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in hydrocephalic shunts. The ultrasonic sensor will measure cerebro-spinal fluid drainage in hydrocephalus patients with external ventriculostomies and extra-ventricular drainage systems. The sensor measurements will be compared with the volume of fluid collected by the drainage bag. After a 24-hour measurement period, the doctor will change the drainage bag position to simulate the patient sitting up and leaning back, to see if this temporarily stops flow through the drainage line. This data will show whether the sensor accurately measures typical drainage flows seen in hydrocephalus patients. This research will help develop an implantable flow monitor for pediatric hydrocephalus patients.

Official Title
-----------------
A Flow Monitor for Pediatric Hydrocephalic Shunts - Flow Sensor Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: newborn through age 20 Diagnosed with Hydrocephalus Instrumented with an Extra-Ventricular Drainage Line Exclusion Criteria: Age: older than age 20 Not diagnosed with Hydrocephalus Not instrumented with an Extra-Ventricular Drainage Line

Ages Eligible for Study
-----------------
Maximum Age: 20 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 |
| --- | --- |
| Extraventricular Drainage<br>Includes pediatric hydrocephalus patients that are in recovery from shunt explanation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. |  | 24-hour period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. |  | 24-hour period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hydrocephalus, shunt dysfunction, shunt flow
Insulin Glargine, INITIATE Metabolic and Economic Outcomes of Lantus

Study Overview
=================
Brief Summary
-----------------
To introduce initiation of glargine insulin treatment in primary care based on a patient education program. To show and compare feasibility of group education to individual education program.

Official Title
-----------------
A Multicentre, Multinational, Randomised, Open Study to Establish the Optimal Method for Initiating Lantus(Insulin Glargine) Therapy to Determine Metabolic and Economic Outcomes, Safety, and Satisfaction in Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Insulin Glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insulin-naive Type 2 Diabetes Mellitus subjects, aged ≥18 years and on stable oral anti-diabetic treatment for >6 months requiring basal long-acting insulin (HbA1c >7.5 % and <12.0 %). Exclusion Criteria: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin Glargine|Insulin glargine administered by subcutaneous injection daily at bedtime for 24 weeks.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superiority is based on observing clinically significant difference in glycaemic control (> than or = to 0,5 % HbA1c). Programs are defined as equally successful if the HbA1c differs less than 0,5 %. |  | HbA1c values at visits 1, 2, 5 and 10 |
Evaluate the Depth and Duration of Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the depth (mm) of anesthesia provided by the Synera topical patch (using sensory depth and pain depth evaluations), and to determine the duration (minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing and thermal sensory testing evaluations), compared with a matching heated placebo patch.

Official Title
-----------------
A Randomized, Double-Blind, Two-Period, Crossover Study to Evaluate the Depth and Duration of Anesthesia of Synera™ Patches Compared to Placebo Patches Applied to Healthy Adult Volunteers

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)
* Drug: Placebo Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Had no known significant diseases Normal 12-lead electrocardiogram Willing to refrain from using any local topical preparations Exclusion Criteria: Taken over-the-counter (OTC) or prescription analgesics in any form within 24 hours Known allergy or sensitivity to any component of the Synera patch, including lidocaine, sympathomimetic amines, other local anesthetics of the amide type, epinephrine, or other patch components Had an active dermatological disease of any origin that may have interfered with their ability to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synera<br> | Drug: Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)<br>* 30 minute applicable on antecubital fossa<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo Patch<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory and pain depth measurements |  | 0, 30, 60, 90, 120 and 150 minutes | 
| Dermal and thermal sensory testing evaluations |  | 0, 30, 60, 90, 120 and 150 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety and tolerability of the Synera topical patch compared with a matching heated placebo patch |  | Throughout the study | 
| Evaluate local effects on the skin at the site of patch application for dermal adverse events (AEs) |  | Throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Topical anesthesia, Analgesia
Surgical Versus Medical Treatment of Acromegaly

Study Overview
=================
Brief Summary
-----------------
Evaluate biochemical differences in acromegalic patients treated with surgery versus somatostatin analogues (SMS) (after surgery or alone). Hypothesis: Treatment modality exhibit different biochemical responses in acromegaly.

Official Title
-----------------
Surgical Versus Medical Treatment of Acromegaly: Effects on Biochemical Markers

Conditions
-----------------
Acromegaly

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acromegaly diagnosis treated with Somatostatin analogues or surgery in treatment control Exclusion Criteria: treatment with GH-antagonist never treated not in treatment control
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acromegaly patients, somatostain analogues<br> | |
| Acromegaly patients, surgery<br> | |

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
-----------------
Acromegaly, Somatostatin analogues, Treatment
Radiomics in Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The images of patients with pancreatic cancer were collected and analyzed based on the methodes of radiomics

Official Title
-----------------
Radiomics-based Detection and Outcome Prediction for Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gender unlimited, 18-80 years old; Received abdominal imaging; informed consent signed. Exclusion Criteria: Pregnant / lactating women； Contraindications of imaging examination。

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| patients with pancreatic cancer<br>Patients with pancreatic tumors diagnosed clinically or pathologically | |
| Participants without pancreatic cancer<br>Participants who judged the pancreas to be completely healthy through medical examination | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year survival rate |  | 1 week |
Evaluation of Autonomic Cardiac Function in Patients With CRPS

Study Overview
=================
Brief Summary
-----------------
To evaluate the autonomic cardiac function in patients with complex regional pain syndrome

Detailed Description
-----------------
Tilt table testing in patients with complex regional pain syndrome: Effects on heart rate variability and baroreceptor sensitivity. Primary outcome parameter: Autonomic cardiac function

Official Title
-----------------
Evaluation of Autonomic Cardiac Function in Patients With Complex Regional Pain Syndrome

Conditions
-----------------
CRPS (Complex Regional Pain Syndromes)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18 or older. Pain > 3 months. Diagnosed with CPRS acc. to diagnostic research criteria (Harder et al., 2005). Inclusion of healthy subjects: age-, gender-, and BMI-matched. Exclusion Criteria: Other significant disease affecting the parameters measured, including cardiovascular disease. Treatment with anticholinergics, sympathomimetics and parasympathomimetics, and alpha- and beta-adrenergics.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic cardiac function |  | 2 hours |
Vitamin D Deficiency Epidemiological Research in Sichuan, China

Study Overview
=================
Brief Summary
-----------------
Vitamin D insufficiency and deficiency is pandemic in the world.Sichuan Basin has a subtropical monsoon climate with China's lowest sunshine totals. Inferably, the prevalence of vitamin D insufficiency/deficiency in Sichuan basin is high, and possibly the highest in China. This study will research the serum 25OHD level to get the prevalence of vitamin D deficiency and insufficiency of urban and rural residents in Sichuan Province, China.

Official Title
-----------------
Vitamin D Status and Its Correlation to Bone Density, Bone Turnover Markers and Muscle Function in Community-dwelling People in Sichuan Province , P.R. China

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females aged 30 years old living in Sichuan province.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 90 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 |
| --- | --- |
| subjects<br>it is a cross-sectional research and there is only one group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum 25OHD | It is a cross-sectional study. All measurements will be performed once after subjects are enrolled. | 0 day. | 
| serum calcium and phosphate, creatinine, PTH, BALP and CTX | It is a cross-sectional study. All measurements will be performed once after subjects are enrolled. | 0 day | 
| Bone mineral density of lumbar spine and hip | It is a cross-sectional study. All measurements will be performed once after subjects are enrolled. | 0 day. | 
| Short physical performance battery | It is a cross-sectional study. All measurements will be performed once after subjects are enrolled. | 0 day. |
A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-220)(COMPLETED)

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

Detailed Description
-----------------
The duration of treatment is 6 weeks.

Official Title
-----------------
A Randomized, Placebo-Controlled, Parallel-Group, Double -Blind Study to Evaluate the Safety and Efficacy of Rofecoxib 12.5 mg and Celecoxib 200 mg in Patients With Osteoarthritis of the Knee

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: MK0966, rofecoxib
* Drug: Comparator: celecoxib, placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoarthritis of the knee which requires treatment with medication for pain relief Exclusion Criteria: Any known allergy to the study drugs

Ages Eligible for Study
-----------------
Minimum Age: 40 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: celecoxib, placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteoarthritis (OA) of the knee as measured by Patient Global Assessment of Response to Therapy (PGART) and WOMAC VA 3.0 over 6 weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OA of the knee as measured by PGART over 6 wks of treatment. |  |  | 
| WOMAC Question #1 over 6 wks of treatment. |  |  |