linjc16/ctgov huggingface dataset:
Johnston County ADHD Study: Environmental, Reporductive, and Familial Risk Factors for Attention-Deficit Hyperactivity Disorder (ADHD)

Study Overview
=================
Brief Summary
-----------------
We propose a population-based case-control study among 7000 elementary school children in semi-rural Johnston County, NC. Teachers will complete a screening form on each child. Controls will be randomly selected. Mothers of potential cases and controls will be interviewed by telephone about their child's symptoms of ADHD and exposure history, their family history of ADHD, and their reproductive and exposure history. Children's shed baby teeth will be analyzed for lead. Mothers will complete brief parenting scales and the Child Behavior Checklist. School records will be collected. The study goals are to identify risk factors for ADHD including preterm delivery and childhood lead exposure.

Detailed Description
-----------------
We propose a population-based case-control study among 7000 elementary school children in semi-rural Johnston County, NC. Teachers will complete a screening form on each child. Controls will be randomly selected. Mothers of potential cases and controls will be interviewed by telephone about their child's symptoms of ADHD and exposure history, their family history of ADHD, and their reproductive and exposure history. Children's shed baby teeth will be analyzed for lead. Mothers will complete brief parenting scales and the Child Behavior Checklist. School records will be collected. The study goals are to identify risk factors for ADHD including preterm delivery and childhood lead exposure.

Official Title
-----------------
Johnston County ADHD Study: Environmental, Reproductive and Familial Risk Factors for Attention-Deficit Hyperactivity Disorder (ADHD)

Conditions
-----------------
Attention-Deficit Hyperactivity Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: During the first phase of the study, all children will be screened by the homeroom teacher, EXCEPT for those students in certain self-contained classrooms. Self-contained classrooms for students with an IQ less than 70 or autism will be omitted from the screening. In the second phase of the study, children designated as LEP, or Low English Proficiency, will be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 8 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lead, Children, Behavior, Epidemiology, Learning Disorder
Empyema Following Pneumonectomy for Non Small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
Empyema following pneumonectomy for Non Small Cell Lung Cancer (NSCLC) is a known problem that occurs in about 2% of pneumonectomy patients.

Detailed Description
-----------------
The development of an empyema following pneumonectomy is a devastating complication, especially if associated with an underlying fistula. Whilst the perioperative mortality of pneumonectomy overall is now less than 5%, this rises to around 25% when complicated by empyema, and about 50% when associated with fistula. In addition, there is the morbidity and social cost of long-term drainage, chronic sepsis and often multiple operations.

Official Title
-----------------
Incidence, Risk Factors and Outcome of Empyema Following Pneumonectomy for Non Small Cell Lung Cancer (NSCLC)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pneumonectomy for NSCLC Exclusion Criteria: Pneumonectomy for other reasons (infectious pathology, trauma, mesothelioma, ...)

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 |
| --- | --- |
| EFP<br>Empyema following pneumonectomy | |
| nEFP<br>No empyema following pneumonectomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | overall 5-year survival after empyema following pneumonectomy | 5 years from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence rate | incidence of empyema, accompanied with broncho-pleural fistula or not, divided in short term (less than 1 yr postoperatively) and long term (up to 5 years postoperatively) incidence. | 1 and 5 years from surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, NSCLC
A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced emphysema.

Detailed Description
-----------------
The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced homogeneous or heterogeneous emphysema.

Official Title
-----------------
A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema

Conditions
-----------------
Chronic Pulmonary Obstructive Disease, Emphysema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmation of completion of Aeris' post market follow-up Continuation Study, 03-C10-001PLV.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| Change in number of Serious Adverse Events (SAE) | Count number of SAEs during weeks: 48, 96, 120, 144 as a function of long term safety | Weeks 48, 96, 120, 144 following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vital Signs | Change from baseline at 48, 96, 120 and 144 weeks of Vital Signs | weeks 48, 96, 120, 144 following treatment | 
| Change in Oxygen (O2) Use | Change in amount of O2 used (at rest, with activity, during sleep) in weeks 48, 96, 120 and 144 from baseline. | Weeks 48, 96, 120, 144 following treatment | 
| Change in medications | Change in medication regiment in weeks 48, 96, 120 and 144 from baseline. | week 48, 96, 120, 144 following treatment | 
| Change in Pulmonary Function Tests (PFT) | Change in PFT (Spirometry, Diffusing Capacity, Plethysmograpy) in weeks 48, 96, 120 and 144 from baseline | Weeks 48, 96, 120, 144 following treatment | 
| Change in notable radiology results | Change in notable radiology results (infiltrates, mass lesions, pleural abnormalities) from baseline in weeks 48, 96, 120 and 144. | weeks 48, 96, 120, 144 following treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AeriSeal, treatment, device, breathing, COPD, emphysema, polymeric lung volume reduction (PLVR), biologic lung volume reduction (BLVR), heterogeneous, homogeneous, Respiratory Tract Diseases, Lung Diseases, Pulmonary Disease, Chronic Obstructive
Clinical Evaluation of New Computerized Labor Monitoring System

Study Overview
=================
Brief Summary
-----------------
The study is an open label feasibility study. The purpose of the study is to evaluate the ease of use of the Cervical ITR in terms of duration of attachment and number of detachments.

Detailed Description
-----------------
Every year, millions of babies are born worldwide. Yet, despite great advances in medical technology, the method used to obtain the most critical parameter in labor management - cervix dilatation, remains a vaginal (manual) examination. This vaginal examination, intended to estimate the dilatation of the cervix and the progress of the baby's head, is inaccurate, non-continuous and involves the risk of infection to both fetus and mother. It is also uncomfortable to the mother. The consequences of infections or delayed treatment may range from simple complications to irreversible damage. Early detection of abnormal patterns of labor progress could prevent complications and shorten the labor process and hospitalization, thereby saving both aggravation and cost. To truly manage the labor process, a labor management system is required. Such a system is expected to provide the obstetrical staff with the flow of accurate, continuous, real-time information, such as cervix dilatation.

Official Title
-----------------
Clinical Evaluation of New Computerized Labor Monitoring System.

Conditions
-----------------
Obstetrics, Labor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laboring women referred to the Maternity Center in active labor (3cm dilatation and contractions). Gestational age 37-42 weeks. (GA) Single fetus Subjects who understood, agreed and signed the informed consent form Exclusion Criteria: Women with abnormal placentation (placenta previa) Women with coagulation abnormalities. Abnormal fetal presentation (breech presentation) Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes. Preterm premature rupture of membranes. Need for immediate delivery (cord prolapsed or suspected placental abruption

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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 |
| --- | --- |
| 1<br>Women in active labor | |

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
-----------------
Labor, Obstetric, cervical dilatation
Reducing Dietary Energy Density by Incorporating Vegetables in Order to Decrease Energy Intake

Study Overview
=================
Brief Summary
-----------------
This study will test the hypothesis that incorporating vegetables into meals as a method of reducing the energy density will result in increased vegetable intake and decreased energy intake.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Incorporating vegetables into the diet to reduce energy density


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults aged 20-45 years

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Incorporating vegetables into the diet to reduce energy density|The entree portion of breakfast, lunch, and dinner meals will be manipulated to be a standard energy density, a 15% reduction in energy density, or a 25% reduction in energy density.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy intake |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vegetable intake |  | 3 weeks |
Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.

Study Overview
=================
Brief Summary
-----------------
This registry aims to monitor the safety of Qizhi Tongluo Capsules and to identify the potential risk factors for its adverse drug reactions.

Official Title
-----------------
Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.

Conditions
-----------------
Safety Surveillance, Adverse Drug Events, Adverse Drug Reactions, Severe Adverse Events, Severe Adverse Reactions

Intervention / Treatment
-----------------
* Drug: Qizhi Tongluo Capsules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who use Qizhi Tongluo Capsules in the monitoring hospitals. 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 |
| --- | --- |
| Qizhi Tongluo Capsules<br>Qizhi Tongluo Capsules will be given to the patients, and the investigators will record all the information including ADR, application of Qizhi Tongluo Capsules and the combined medications, etc. | Drug: Qizhi Tongluo Capsules<br>* Qizhi Tongluo Capsule, a Chinese patent medicine composed of 26 Chinese herbs, has been approved by China Food and Drug Administration for treating recovery period of ischemic stroke (drug approval numbers: B20171001).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse drug reactions (ADR) to the Qizhi Tongluo Capsules |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse drug event (ADE) to the Qizhi Tongluo Capsules |  | 3 years | 
| The incidence of new ADRs to the Qizhi Tongluo Capsules |  | 3 years | 
| The incidence of serious adverse drug event (SADE) to the Qizhi Tongluo Capsules |  | 3 years | 
| Changes in biological indicators of patients with serious adverse events | Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for liver function (ALT, AST, ALP, TBIL, DBIL) | 3 years | 
| Changes in biological indicators of patients with serious adverse events | Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for renal function (BUN, SCr, UA) | 3 years | 
| Changes in biological indicators of patients with serious adverse events | Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for immune indicators (IgA, IgE, T-lymphocyte, B lymphocyte, cell surface antigen, serum histamine concentration and complement). | 3 years |
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182)

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 and acetaminophen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Impaction of a molar tooth requiring removal Exclusion Criteria: 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 and acetaminophen|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
Plain Magnetic Resonance (MR) in the Assessment of Patients With Acute Abdomen

Study Overview
=================
Brief Summary
-----------------
At present, CT is the gold standard in the assessment of patients with acute abdomen. Yet, one CT of the abdomen exposes patients to a radiation dose equivalent to several years of background radiation. MR can be expected to yield the same information without ionizing radiation, but tends to be more time consuming. In this study, patients with nontraumatic acute abdominal pain referred to CT of the abdomen by the department of surgery will also have performed an additional MR scan covering the entire abdomen with few fast imaging sequences in approximately 15min. CT is the diagnostic test. The MR scan is only used for scientific purposes. It will be evaluated by a radiologist blinded for the results of the CT scan. Fourteen days after admission, a final diagnosis is established based on clinical, peroperative, pathological and lab. findings. The performance of CT and MR will then be compared. The investigators hypothesize that MR can provide a diagnostic accuracy comparable to CT.

Official Title
-----------------
Assessment of Patients With Nontraumatic Acute Abdominal Pain With Plain MR of the Abdomen - a Comparison With CT

Conditions
-----------------
Acute Abdomen

Intervention / Treatment
-----------------
* Device: MR scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent form Age > 18 years old Nontraumatic acute abdomen Weight < 120kg Can keep apnoea for 15s Surgeon in charge considers patient fit for participation in study Exclusion Criteria: Contraindications of MRI Suspicion of acute vascular disease Severe cardial or pulmonal insufficiency Pregnancy Untreated psychiatric illness

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MR scan|axial and coronal free breathing HASTE sequences 3D T1 weighted gradient echo breathhold|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy of CT vs. MR |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute abdomen, CT, MRI, fast imaging
Beta Cell Function and Related Pharmacodynamics of HMS5552 in T2DM Patients

Study Overview
=================
Brief Summary
-----------------
This study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and tolerability after 4 weeks treatment of 75mgBID or 75mgQD of HMS5552.

Official Title
-----------------
A Single-centre, Randomized, Open-label, 2-arm, 4-week Treatment Study to Investigate the Beta Cell Function and Related Pharmacodynamics in Type 2 Diabetes Mellitus (T2DM) Patients

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: HMS5552


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female,age 18-65 years Has type 2 diabetes mellitus BMI 20 to 29kg/m2 Willingness to adhere to the protocol requirement Exclusion Criteria: Patients with type1 diabetes mellitus Received any antidiabetic drug within run-in or during screening Hepatic diseases Kidney diseases Clinical abnormal finding in EVG,labs and physical exams Women of child-bearing potential

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HMS5552 dose 1<br>HMS5552 75mg.Oral administration,twice per day. | Drug: HMS5552<br> <br> * Other names: Sinogliatin;|
| Experimental: HMS5552 dose 2<br>HMS5552 75mg.Oral administration,once per day. | Drug: HMS5552<br> <br> * Other names: Sinogliatin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| beta cell function | will be assessed by change of beta cell function index | 4 weeks | 
| HbA1 |  | 4 weeks | 
| 24-hour glucose change |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The study drug concentration in blood samples to be collected after drug administration |  | 4 weeks | 
| Composite measure of adverse events monitoring, physical examinations,12 lead ECGs, vital sign,and safety laboratory measurement |  | 4 weeks |