linjc16/ctgov huggingface dataset:
Finnish Patient-Reported Outcomes Initiative for Shoulder and Elbow

Study Overview
=================
Brief Summary
-----------------
The purpose of φ-PROMISE project is to carry out a cultural adaptation (translate into Finnish and validate) some of the most frequently used shoulder- and elbow-specific patient-reported outcome measures, PROMs. In addition, we aim to investigate which outcome measures are the most relevant for assessing the severity of complaints and treatment outcomes. Also, we will define the Patients Acceptable Symptomatic State (PASS) and the Minimal Important Difference (MID) of the individual outcome measures.

Official Title
-----------------
Finnish Patient-Reported Outcomes Initiative for Shoulder and Elbow

Conditions
-----------------
Cultural Adaptation of Shoulder and Elbow PROMs, Definition of the Patients Acceptable Symptomatic State, Definition of the Minimal Important Difference

Intervention / Treatment
-----------------
* Procedure: Surgical or non-surgical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Orthopedic outpatient visit at the Helsinki University Hospital Signed informed consent Age over 18 years Finnish as language of communication Exclusion Criteria: Recent surgery (within 2 months) Insufficient compliance

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 |
| --- | --- |
| Shoulder<br>Patients with shoulder problems presenting to the orthopaedic outpatient clinic of the Helsinki University Hospital | Procedure: Surgical or non-surgical treatment<br>* Surgical treatment (depending on diagnosis) Non-surgical treatment (such as exercise therapy, pain medication, watch and wait)<br>|
| Elbow<br>Patients with elbow problems presenting to the orthopaedic outpatient clinic of the Helsinki University Hospital | Procedure: Surgical or non-surgical treatment<br>* Surgical treatment (depending on diagnosis) Non-surgical treatment (such as exercise therapy, pain medication, watch and wait)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation | Assessment of inter- and intra- observer reliability of different outcome measures | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASS | Definition of the Patients Acceptable Symptomatic State for different outcomes | 1 year | 
| MID | Definition of the Minimal Important Difference for different outcomes | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shoulder, elbow, patient reported outcomes, validation, transcultural adaptation, patients acceptable symptomatic state (PASS), minimal important difference (MID)
Incidence and Risk Factors of Central Line Catheter Related Thrombosis

Study Overview
=================
Brief Summary
-----------------
Central venous catheters are frequently used for monitoring haemodynamic status and rapidly delivering fluid therapy during the peri- and postoperative periods. Indwelling central venous catheters are typically used 7-14 days postoperatively for additional monitoring and treatment, but patients may develop asymptomatic catheter-related thrombosis, leading to life-threatening pulmonary embolism and death. Early detection helps to avoid such complications. This prospective observational study investigated the risk factors associated with catheter-related right internal jugular vein thrombosis in pediatric patients. The study enrolled 80 pediatric patients who were scheduled to receive central venous catheter. To detect thrombus formation, Doppler ultrasound examinations from the thyroid cartilage level to the supraclavicular region were used after CVC placement and on each of the following days until the catheter was removed.

Official Title
-----------------
Study About the Incidence and Risk Factors of the Central Line Catheter Related Right Internal Jugular Vein Thrombosis in Pediatric Patients

Conditions
-----------------
Central Line Complication

Intervention / Treatment
-----------------
* Other: ultrasound examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients who were scheduled to catheterize central venous catheter Exclusion Criteria: patients who had skin infections on the right side of the neck, making them unsuitable for placement of the catheter via the right side of the neck patients who had blood coagulation lesions or bleeding tendencies patients with thrombocytopenia patients with a history of right internal jugular vein thrombosis patients who presented right internal jugular vein thrombosis or stenosis on preoperative Doppler ultrasound examination

Ages Eligible for Study
-----------------
Maximum Age: 6 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ultrasound examination|Doppler ultrasound examinations from the thyroid cartilage level to the supraclavicular region were used after CVC placement and on each of the following days until the catheter was removed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thrombus formation using doppler ultrasound examination of internal jugular vein |  | after central venous catheter placement and on each of the following days until the catheter was removed (maximum 5 days) |
Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
Compare once daily vs on demand treatment in men with erectile dysfunction. Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks + 4 weeks wash-out: A: once daily at bedtime for 12 weeks followed by 12 weeks of placebo B: once daily at bedtime for 24 weeksC: PRN for 24 weeks

Official Title
-----------------
A Randomized, Explorative, Double-blind, Double-dummy, Multi-center, Parallel Group Study to Assess Sustainable Efficacy of Once Daily Vardenafil (10 mg) for 12 and 24 Weeks Versus Vardenafil PRN in Men With Mild or Mild to Moderate ED

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Levitra (Vardenafil, BAY38-9456)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males 18-64 years of age Mild or mild to moderate ED (defined as >15 and <21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit) History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease Stable, heterosexual relationship for more than six months Exclusion Criteria: Primary hypoactive sexual desire History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month Nitrate therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* Vardenafil 10 mg on demand use<br>|
| Experimental: Arm 2<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* Vardenafil daily dosing 10 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile Dysfunction change score from baseline of the ED change score from baseline of the International Index of Erectile Function (IIEF-EF) |  | 12- 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SEP 2 |  | 12- 24 weeks | 
| SEP 3 |  | 12- 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile dysfunction, Vardenafil
To Investigate the Prevalence of Children Asthma in China

Study Overview
=================
Brief Summary
-----------------
Asthma is the most common chronic respiratory disease in children and has much effect on their life and study, which leads to huge economic burden and pressure to the whole families. Some children will develop into adult patients so that asthma can be the life-long vigorous trouble. In recent years, the prevalence rate of children asthma is increasingly going up worldwide. The prevalence rate in last 12 months reported in USA, United Kingdom, Australia, New Zealand was between 12% to 30%. Center for Asthma Prevention and Education of Capital Institute of Pediatrics investigated the national asthma prevalence in 900 thousands children in 27 provinces and cities, which average rate was 0.11% to 2.03% in 1990. In 2000, we investigated it again in 31 provinces(43 cities) and the average national children asthma prevalence rate was 1.97%(0.25% to 4.63%) which was much higher than that in 1990.

Detailed Description
-----------------
Objectives To investigate the national children(0-14 years old)asthma prevalence; To compare the prevalence rate between that in 1990 and 2000; To analyse the asthma manifestations including the ages, seasons, causes, trigger and hereditary factors and their impact on the asthma patients, families and society; To identify the risk factors by questionnaires in case-control research. Study Design / Clinical Plan The screening stage: to distinguish suspected asthma from the children age from 0 to 14 years old. To obtain identified asthma from the suspected asthma. To evaluate the prevalence and severe degree of 0 to 14-year-old children asthma and gain the main risk factors by case-control research.

Official Title
-----------------
To Investigate the Prevalence of Children Asthma in China and Compare With That of the Last 20 Years

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children age from 0 to 14 years Exclusion Criteria: none

Ages Eligible for Study
-----------------
Maximum Age: 14 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 |
| --- | --- |
| Asthma children<br>children with asthma symptoms through screening | |
| normal children<br>children without symptoms of asthma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of asthma |  | Apr 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of allergic rhinitis |  | Apr 2013 |
Effect of Ketoconazole on Biliary Excretion of AZD0837

Study Overview
=================
Brief Summary
-----------------
This is an explorative study and the scientific question to be investigated is if the biliary excretion of AZD0837 and its metabolites AR-H069927XX and AR-H067637XX are affected by co-administration with ketoconazole

Official Title
-----------------
An Open, Randomised, Cross-over, Single Centre Pharmacokinetic (Phase I) Study of the Biliary Excretion Following Single Doses of AZD0837, Given in the Duodenum Via a Loc-I-Gut Catheter, Alone or in Combination With Ketoconazole (Once Daily for 4 Days), to Young Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: AZD0837
* Drug: Ketoconazole
* Drug: ketoconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body mass index (BMI) between 19 to 30 kg/m2 and body weight between 50 to 100 kg inclusive Exclusion Criteria: Significant illness, trauma or surgical procedures. Clinically significant laboratory abnormalities. Clinically significant medical history

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD0837<br>* Oral solution, dosing through the Loc-I-Gut catheter, single dose<br>|
| Active Comparator: 2<br>AZD0837 + Ketoconazole | Drug: AZD0837<br>* Oral solution, dosing through the Loc-I-Gut catheter, single dose<br>Drug: Ketoconazole<br>* tablets, orally, once daily for 3 days<br>Drug: ketoconazole<br>* dissolved tablets, dosing through the Loc-I-Gut catheter, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of AZD0837, AR-H069927XX, and AR-H067637XX in bile and biliary clearance of AZD0837, AR-H069927XX, and AR-H067637XX. |  | Frequent sampling through a Loc-I-Gut catheter for up to 3 hours post dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables of AZD0837, AR-H069927XX, and AR-H067637XX. |  | Frequent sampling during 24 hours. | 
| Adverse events, physical examination, safety laboratory variables, blood pressure, pulse and electrocardiography. |  | Some of the safety variables will be followed at each visit, some less frequent. | 
| Pharmacogenetics |  | One sampling during the study. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics
Screening for Primary Ciliary Dyskinesia Using Nasal Nitric Oxide

Study Overview
=================
Brief Summary
-----------------
Background: Primary ciliary dyskinesia (PCD) is a rare genetic disease characterised by recurrent respiratory infections and subfertility due to dysfunction of cilia (brushes) of the lining cells. Undiagnosed and untreated it can result in an irreversible crippling chronic lung disease. The diagnosis of PCD is a difficult one and involves the complex assessment of ciliary structure and function. Thus, PCD is under diagnosed and appropriate preventative and symptomatic treatment may be denied in many patients. In addition, the gene responsible for PCD is at present unknown, thus preventing pre-natal diagnosis and genetic counseling. Working hypothesis and aims: Recently, it has become apparent that the evaluation of nasally expired nitric oxide (NO) constitutes a simple and non-invasive diagnostic method, which discriminates between PCD patients, PCD carriers and healthy controls at high rate of specificity and sensitivity. Testing is simple and last approximately one minute. We have recently identified a unique isolated Druze population with high prevalence of PCD. The high frequency of disease places this closed community at a high risk of undiagnosed PCD. The aim of this project is to use nasal NO measurement as a screening tool to identify possible undiagnosed cases of PCD and PCD carriers in this high risk Druze population.

Official Title
-----------------
Screening for Primary Ciliary Dyskinesia Using Nasal Nitric Oxide

Conditions
-----------------
Primary Ciliary Dyskinesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Voluntary willing to participate Exclusion Criteria: Recent URTI Steroids use 2 weeks prior to testing
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 |
| --- | --- | --- |
| Nasal NO < 105 ppb |  | at enrollment |
A Registry Study on Tanreqing（a Chinese Medicine Injection）Used in Hospitals in China

Study Overview
=================
Brief Summary
-----------------
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in December 2012. The purpose of this study is to make a event monitoring to see whether Tanreqing injection is safe and the characteristic and mechanism of anaphylactic reaction used Tanreqing injection in hospitals in China.

Detailed Description
-----------------
It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice. In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Tanreqing injection safety surveillance with 3000 patients will be conducted from Jan.2013 to Mar.2013.At the same time,Patients who have anaphylactic reaction are selected as the allergic group and not have anaphylactic reaction are selected as the control group.The proportion of allergic group and control group is 1:4.All the patients who are selected should draw blood. Eligibility criteria Patients who will use Tanreqing injection in selected hospitals.

Official Title
-----------------
a Study of Clinical Safety Monitoring and the Mechanism of Anaphylactic Reaction Used Tanreqing(a Chinese Medicine Injection)in Hospitals in China

Conditions
-----------------
Pneumonia;, Bronchitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients using Tanreqing injection from January to March 2013 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 80 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 |
| --- | --- |
| Allergic group<br>All patients who used Tanreqing Injection have anaphylaxis. | |
| Control group<br>All patients who used Tanreqing Injection don't have anaphylaxis.One allergic group patient should matched four control group patients. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with anaphylactic reaction;the blood of participants with anaphylactic reaction |  | to assess Tanreqing's 'anaphylactic reaction' .during patients' hospital stay, administration information of Tanreqing will be registered every day. The registry procedure will last 3 month only for patients using Tanreqing |
Salivary Bacteria and Oral Health Status in Children With ADHD

Study Overview
=================
Brief Summary
-----------------
Attention deficit and hyperactivity (ADHD) affect 6% of school-aged children. Few studies reported higher prevalence of caries and restorations among children with ADHD. Methylphenidate is the drug of choice to treat ADHD. according to the medical literature methylphenidate can cause xerostomia. Our study will investigate saliva parameters (such as quantity, bacteria in saliva, buffer capacity), oral hygiene and diet habits and their influence on caries among children with ADHD and among healthy children. Our hypothesis is: Children with ADHD will have more caries. Children with ADHD will have more detrimental oral hygiene and diet habits. There will be a difference in the saliva parameters between children with ADHD and healthy children.

Official Title
-----------------
Changes in Salivary Bacteria and Oral Health Status in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Conditions
-----------------
Attention Deficit Hyperactivity Disorders, Caries, Dental, Xerostomia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: test group- diagnosis of ADHD. control group- ASA1 Exclusion Criteria: control group administration of medicine at the time of the check-up.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 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 |
| --- | --- |
| ADHD medication<br>Children with ADHD and pharmacologic treatment | |
| ADHD without medication<br>Children with ADHD without pharmacologic treatment | |
| healthy<br>Healthy children ASA1 | |

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
-----------------
ADHD, saliva, caries