linjc16/ctgov huggingface dataset:
A 2 Week Blinded Study For Pain Due To Arthritis Of The Knee

Study Overview
=================
Brief Summary
-----------------
The primary aim is to assess if PF-00592379 is able to reduce pain in patients with osteoarthritis of the knee.

Official Title
-----------------
A 2 Week, Randomized, Double Blind, Placebo And Positive Controlled, Parallel Group, Multicentre Study To Assess The Efficacy And Tolerability Of PF-00592379 In Patients With Moderate To Severe Pain Due To Osteoarthritis

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

Intervention / Treatment
-----------------
* Drug: Oxycodone
* Drug: Placebo
* Drug: PF-000592379


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of any race Between the ages of 18 and 75 years Knee Pain due to osteoarthritis Exclusion Criteria: Pregnant Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline History of malignancy, convulsions, chronic infections, arthroscopy of the worst knee within the past year

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxycodone<br> | Drug: Oxycodone<br>* Oxycodone: oral controlled release, 20 mg, twice a day for 2 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo: oral for 2 weeks.<br>|
| Experimental: PF-00592379<br> | Drug: PF-000592379<br>* PF-00592379: oral, 30 mg, once a day for 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the pain score averaged over the last week of treatment |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment |  | 2 weeks | 
| Patient Global Impression of Change |  | 2 weeks | 
| Patients Global Assessment of Osteoarthritis |  | 2 weeks | 
| Pharmacokinetic trough levels |  | 2 weeks |
Ghrelin With Anorexia Nervosa

Study Overview
=================
Brief Summary
-----------------
The PICOWO research group in corporation with the University of Amsterdam (Artificial Intelligence) has developed a computer simulationmodel of eating disorders (Bosse, Delfos, Jonker & Treur, 2003). In a running Phd project we want to add ghrelin to the model. The idea for this current research is to collect clinical information about the functioning and (patho)physiology of ghrelin in patients with AN, so we can extend the simulation.

Detailed Description
-----------------
Eating disorders are in need of new perspectives. A better understanding of the appetite in patients with eating disorders, especially Anorexia Nervosa, could be investigated by the levels of ghrelin in patients with and without tube feeding.

Official Title
-----------------
Level of Ghrelin With Anorexia Nervosa (AN) Patients. Subgroup AN: With and Without Tubefeeding.

Conditions
-----------------
Anorexia Nervosa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Studypopulation: Patiënts: all female, non -age coupled. Subgroup patients without tube feeding, with tube feeding and a healthy matched control group. Control group: healty volunteers of the University of Maastricht. Exclusion Criteria: Patients with a history of eating disorder different than AN or a psychiatric history. Control group: no history of eating disorders or other psychiatric disabilities. Normal physical examination, ecg, laboratorium (blood cells, liver, kidneys)

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 35 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>Anorexia with tube feeding | |
| 2<br>Anorexia without tube feeding | |
| 3<br>Control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of ghrelin in blood. |  | 1 morning | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anorexia Nervosa
Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection

Study Overview
=================
Brief Summary
-----------------
Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection.

Official Title
-----------------
A Multinational, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil Administered On Demand to Asian Men With Erectile Dysfunction

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Drug: tadalafil
* Drug: tadalafil
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of erection problems Anticipate a monogamous female sexual relationship Abstain from other erection treatments at least 4 weeks before first dose and throughout the study Must be able to make required sexual intercourse attempts Exclusion Criteria: Other primary sexual disorders History of radical prostatectomy or other pelvic surgery that affected being able to have an erection History of penile implant or clinically significant penile deformity Nitrate use Certain heart problems

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: 2<br>10 mg tadalafil tablet | Drug: tadalafil<br>* 10 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day<br>* Other names: IC351;|
| Active Comparator: 3<br>20 mg tadalafil tablet | Drug: tadalafil<br>* 20 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day<br>* Other names: IC351;|
| Placebo Comparator: 1<br>placebo tablet | Drug: placebo<br>* placebo tablet taken by mouth as needed for 12 weeks not more than once a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF Erectile Function Domain score from Questions 1-5 and 15. SEP Diary responses to Questions 2-3 and the entire Diary for baseline and endpoint scores. |  | 4, 8, and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF questions and scores, Global Assessment Questions, Patient's SEP Diary |  | 12 weeks |
Opinion of Patients Under Treatment That Meets the Criteria of New Treatment Strategy According to GINA 2006

Study Overview
=================
Brief Summary
-----------------
Cross-sectional, one visit study. All the data will be collected through questionnaires. Descriptives statistics will be applied to the data. 832 patients will participate to the study and 104 physicians.

Official Title
-----------------
Opinion of Patients Under Treatment That Meets the Criteria of New Treatment Strategy According to GINA 2006

Conditions
-----------------
New Strategies, GINA 2006, Patient Opinion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with persistent asthma (GINA 2005) for at least 6 months before entering the study Patients who are under treatment according to the new strategies described in GINA 2006 for at least 3 months before entering the study Exclusion Criteria: Patients who are not willing to sign the Informed Consent Form COPD Patients

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 |
| --- | --- | --- |
| Percentage (%) of Asthma treatment satisfaction and control grading |  | single visit / once | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of treatment compliance |  | single visit / once | 
| Patients quality of life under treatment |  | single visit / once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma treatment, GINA 2006, patient perception
Survivin as Predictive Biomarker for RA

Study Overview
=================
Brief Summary
-----------------
Purpose: to examine the possibility of using the onco-protein survivin as a predictive biomarker for identifying individuals at risk of developing rheumatoid arthritis within a cohort of patients seeking treatment for joint pain/stiffness. Secondly, to study survivin as a prognostic marker for joint destruction, refractory and highly active disease in patients with established RA.

Detailed Description
-----------------
The study will analyse survivin levels in a non-selected material within a cohort of patients seeking help at their primary health care for joint pain, stiffness, swelling etc. Patients presenting with such symptoms (not explained by injury or other factors) are suspected to have an arthritic condition such as RA, and are routinely tested for presence of autoantibodies RF and ACPA. In this observational study we add measurement for survivin to the blood analyses of these patients. Information about patients expressing high levels of survivin will be reported to the referring doctor at the primary health care, and for patients not previously having been examined by a rheumatologist this will be offered. The study will be performed at Sahlgrenska university hospital Gothenburg and Umeå university hospital.

Official Title
-----------------
Survivin as Predictive Biomarker for Development of Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis, Arthralgia, Joint Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients seeking treatment at the primary health care for problems with their joints (pain, stiffness). Exclusion Criteria: Patients diagnosed with RA
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 |
| --- | --- | --- |
| Survivin positive | Survivin positive: > 0,45 ng/ml Survivin negative: < 0,45 ng/ml | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
predictive factor, prognostic factor
A Retrospective Observational Study on Compliance in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab) in Clinical Practice (REMISSION II)

Study Overview
=================
Brief Summary
-----------------
This multicenter, retrospective observational study will evaluate compliance an reasons for withdrawal in patients with moderate to severe active rheumatoid arthritis on treatment with intravenous RoActemra/Actemra (tocilizumab) in daily clinical practice. Data will be collected from each eligible patient over a period of 6 months.

Official Title
-----------------
Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION II Study)

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Moderate to severe rheumatoid arthritis according to the revised 1987 ACR criteria at baseline RoActemra/Actemra treatment must have been initiated 6 months prior to ICF signing Patient eligible according to the summary of product characteristics (SPC) and routine clinical practice/European recommendations for the use of biologic DMARDs for the treatment of rheumatoid arthritis Exclusion Criteria: Rheumatic autoimmune disease other than RA Participation in interventional clinical trials during the observational period

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients on RoActemra/Actemra at 6 months after initiating treatment |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of withdrawal (according to reasons) |  | 12 months | 
| Frequency of dose modifications |  | 12 months | 
| Change in disease activity (DAS28) |  | from baseline to Month 6 or withdrawal, whichever comes first |
Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
To investigate the safety and efficacy of long-term use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation for preventing the occurrence of ischemic stroke or systemic embolism (SEE).

Official Title
-----------------
Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Patients With Nonvalvular Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Prazaxa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Patients with nonvalvular atrial fibrillation who have never received Prazaxa Capsules for preventing the occurrence of ischemic stroke and systemic embolism will be included. 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 |
| --- | --- |
| Patients with NVAF<br> | Drug: Prazaxa<br>* Dabigatran etexilate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency (Percentage) of Participants With Adverse Drug Reactions | Percentage of participants with adverse drug reactions (ADRs) is presented. An ADR is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Prazaxa® Capsules either as Related, Probably related, or Cannot be denied. | Up to 104 weeks from first administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of Stroke and Systemic Embolism (SEE) | Incidence rate of Stroke and SEE (number of patients per 100 patient year) with 95% confidence interval (CI) is reported. Stroke and SEE were recorded as adverse events (AEs) of special interest. Exact Poisson confidence intervals are presented for incidence rate. | Up to 104 weeks from first administration of study drug |
Pediatric Acute and Critical Care COVID-19 Registry of Asia

Study Overview
=================
Brief Summary
-----------------
In December 2019, an outbreak of pneumonia of unknown aetiology was first reported in the city of Wuhan, Hubei Province, People's Republic of China. Since then, a novel coronavirus, 2019 novel Coronavirus (2019-nCoV) has emerged as the most likely causative agent. To date, it has evolved into a pandemic involving over a million cases and thousands of deaths have been identified, including a high burden in countries like Italy, Spain, United Kingdom and the United States. This study aims to investigate the clinical epidemiology of 2019-novel coronavirus (2019-nCoV) pandemic in Asia.

Detailed Description
-----------------
A retrospective/prospective outbreak study of all suspect cases admitted to hospital since the beginning of the pandemic (December 2019). Clinical and epidemiological information will be extracted from medical databases for analysis.

Official Title
-----------------
Pediatric Acute and Critical Care COVID-19 Registry of Asia

Conditions
-----------------
COVID, Pediatric Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 suspected cases (by whatever definition) COVID-19 confirmed cases (based on PCR or serum specific IgM and IgG antibody of novel coronavirus; serum specific IgG of novel coronavirus from negative to positive or 4 times higher in convalescence than in acute phase) </=21years of age Exclusion Criteria: COVID-19 suspected cases should not be SARSCoV-2

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- |
| Control cases<br>Children who suspected COVID-19 cases but tested negative for COVID-19 | |
| Confirmed cases<br>Children who tested positive for COVID-19 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall severity of illness | Mild, moderate, severe, critical | 60days (or duration of hospital stay) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory complications | e.g. URTI, bronchiolitis, pneumonia, pneumothorax, effusion, pneumonitis, ARDS | 60days (or duration of hospital stay) | 
| Respiratory support | e.g. oxygen, HFNC, NIV, mechanical ventilation | 60days (or duration of hospital stay) | 
| Other systems complications | e.g. cardiovascular, renal, hepatic, neurological, haematological dysfunction | 60days (or duration of hospital stay) | 
| Mortality |  | 60days (or duration of hospital stay) | 
| Length of hospital stay |  | 60days (or duration of hospital stay) |
The Efficacy and Safety of 2.5 mg Chlorhexidine Gluconate Chip (PerioChip®) in Frequent Treatment Versus Routine Treatment in Therapy of Adult Chronic Periodontitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and the safety of Chlorhexidine Gluconate Chip (PerioChip®) in frequent treatment versus routine treatment in therapy of adult chronic periodontitis.

Official Title
-----------------
The Efficacy and Safety of 2.5 mg Chlorhexidine Gluconate Chip (PerioChip®) in Frequent Treatment Versus Routine Treatment in Therapy of Adult Chronic Periodontitis

Conditions
-----------------
Generalized Adult Periodontitis

Intervention / Treatment
-----------------
* Drug: PerioChip ®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated Informed Consent Form. Good general health. Male or female patients aged >21 years old. Availability for the 25 week duration of the study. Chronic periodontal disease on natural teeth Females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method of birth control during the study. Exclusion Criteria: Oral health or factor that may influence the outcome of the study. History of allergy to Chlorhexidine . Patient uses Chlorhexidine oral rinses/mouthwashes on a regular basis. Patients treated with medications that may influence the outcome of the study. Presence of any of the following conditions: Type 1 diabetes, un-controlled type II diabetes, major recurrent aphtae stomatitis, abscesses and related oral pathologies. The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study. Patient participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Each one of the two selected periodontal pockets (target pockets) will be randomized to the Frequent PerioChip® treatment or to the Routine PerioChip®. | Drug: PerioChip ®<br> <br> |
| Placebo Comparator: Arm 2<br>Each one of the two selected target pockets will be randomized to the Frequent PerioChip® treatment or to the Frequent Placebo Chip treatment. | Drug: PerioChip ®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |