linjc16/ctgov huggingface dataset:
Diagnostic Value of KL-6 in ILD

Study Overview
=================
Brief Summary
-----------------
KL-6 may be a useful biomarker in patients with interstitial lung disease, but there is limited information in non-Asian populations. Therefore, it is necessary to carry out studies in other populations to confirm the diagnostic values of the biomarker and its prognostic implication. Hypothesis KL-6 may be a useful biomarker in the management of interstitial lung diseases. But it is necessary to know more about its utility in the European population. Study Objectives: To determine the concentration of KL-6 in serum of patients with pulmonary fibrosis at the time of diagnosis compared to patients without pulmonary fibrosis Diagnostic yield of KL-6 in patients with pulmonary fibrosis. Correlation of KL-6 values with functional and radiological parameters of disease severity at diagnosis. Correlation of serum KL-6 values with the evolution of the disease.

Official Title
-----------------
Diagnostic Value of KL-6 in Interstitial Lung Diseases

Conditions
-----------------
Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Diagnostic Test: KL-6 levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects older than 18 years. Chronic respiratory diseases )including Fibrotic interstitial lung disease, asthma or COPD) related or not to a connective tissue disease. Acceptance of the patient to participate in the study by signing the informed consent after having discussed with the researchers the objectives, risks and potential benefits. Exclusion Criteria: Absence of informed consent Psychiatric disorder or limitation of collaboration (including language, socio-cultural problem, etc.).

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 |
| --- | --- |
| Case<br>50 subjects with fibrosing interstitial lung disease. 50 subjects with pulmonary fibrosis secondary to collagen diseases. | Diagnostic Test: KL-6 levels<br>* Measure of KL-6 in serum<br>|
| Control<br>75 subjects without pulmonary fibrosis but with other common respiratory diseases like asthma, COPD or bronchiectasis. 75 subjects with collagen disease without pulmonary fibrosis. | Diagnostic Test: KL-6 levels<br>* Measure of KL-6 in serum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum KL-6 levels in patients with pulmonary fibrosis at the time of diagnosis. |  | Baseline |
An Outcomes Assessment of the Utility of Belladerm Acellular Dermal Allograft in Ocular Lower Lid Retraction Repair

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to Evaluate the efficacy and longevity of a Human-derived, non-cadaveric, acellular dermal implant (BellaDerm) as a posterior spacer graft in the correction of lower eyelid retraction, taking into consideration issues associated with the use of acelular dermis such as contraction and potential regression of repairs.

Detailed Description
-----------------
To Evaluate the efficacy and longevity of a Human-derived, non-cadaveric, acellular dermal implant (BellaDerm) as a posterior spacer graft in the correction of lower eyelid retraction, taking into consideration issues associated with the use of acelular dermis such as contraction and potential regression of repairs.

Official Title
-----------------
Use of Non-Cadaveric Human Acellular Dermal Tissue (BellaDerm®) in Lower Eyelid Retraction Repair

Conditions
-----------------
Lower Eyelid Retraction

Intervention / Treatment
-----------------
* Procedure: Non Cadaveric Human Acellular Dermal Tissue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lower eyelid retraction, defined as inferior displacement of the lower eyelid margin with inferior scleral show, may be asymptomatic May have ocular irritation including foreign body sensation, burning, photophobia and tearing. May have aesthetically unsatisfactory eyelid appearance. Exclusion Criteria: Have a condition that would be contraindicated to surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: open label<br>Non Cadaveric human BellaDerm Acellular dermal tissue | Procedure: Non Cadaveric Human Acellular Dermal Tissue<br> <br> * Other names: Bella Derm;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre and Post operative margin reflex distance 2 MRD 2 | Pre and postoperative margin reflex distance 2 (MRD2) and inferior scleral show (ISS) was measured of each eyelid, and success was defined as a positive eyelid elevation and decrease in inferior scleral show. Long- term stability beyond 12 months was evaluated. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lower eyelid, retraction
GW273225 Therapy Added To Current Seizure Treatments In Patients With Partial Seizures

Study Overview
=================
Brief Summary
-----------------
Study to determine drug interactions between GW273225 and the anticonvulsants valproate, carbamazepine or phenytoin

Official Title
-----------------
An Open-label Evaluation of Drug Interactions, Safety, Tolerability and Efficacy of GW273225 Add-on Treatment of Partial Seizures, Whether or Not Secondarily Generalized

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: GW273225


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Confident diagnosis of epilepsy Currently on VPA, CBZ or PHT >or= 4 seizures/4 weeks prior to screen Exclusion criteria: Prior lamotrigine use (excluded if treatment discontinued for clinically significant safety reasons (i.e., rash, hypersensitivity)). Females of childbearing potential on hormonal contraceptives or hormone replacement therapy.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW273225|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic drug interactions with the most common inhibiting and inducing antiepileptic drugs AEDs: valproate(VPA), carbamazepine(CBZ) and phenytoin (PHT). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/tolerability of GW273225 in adults with refractory epilepsy Efficacy of GW273225 in adults with refractory epilepsy Potential initial starting doses for a subsequent placebo-controlled dose-ranging Phase IIb study. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epilepsy, refractory, seizure, drug interactions, pharmacokinetics
HPA Axis Study in Adults

Study Overview
=================
Brief Summary
-----------------
A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.

Detailed Description
-----------------
Assessment of safety, efficacy, pharmacokinetics and adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.

Official Title
-----------------
A Multicenter, Open Label Study to Evaluate the Adrenal Suppression Potential of Mapracorat 0.1% Ointment in Adults With Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis, Eczema

Intervention / Treatment
-----------------
* Drug: Mapracorat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Male or female subject aged >= 18 years Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria Investigator's Global Assessment (IGA) score of 3 (moderate) to 4 (severe) at baseline Normal ACTH response before start of treatment Exclusion Criteria: Pregnancy or lactation Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results Concomitant medical or dermatological disorder(s), which could interfere with the study conduct or the evaluation and interpretation of the study results Clinically manifest immunosuppressive disorder or known history of malignant disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Mapracorat<br>* Application of the investigational product on the affected skin areas<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPA axis response to Cosyntropin: Number of subjects with adrenal suppression |  | measured after 4 weeks of therapy |
Safety Study of DanshenDuofensuanyan(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 January 2013. It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'. DanshenDuofensuanyan is kind of Chinese Medicine injection used for treating coronary heart disease and angina pectoris in many Chinese hospitals. The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.

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 DanshenDuofensuanyan injection safety surveillance with 30000 patients will be conducted from Jan.2013 to Dec.2015. Eligibility criteria Patients who will use DanshenDuofensuanyan injection in selected hospitals.

Official Title
-----------------
Safety Study of DanshenDuofensuanyan(a Chinese Medicine Injection)Used in Hospitals in China

Conditions
-----------------
Coronary Heart Disease, Angina Pectoris

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients using DanshenDuofensuanyan injection from 2013 to 2014 Exclusion Criteria: none
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 |
| --- | --- | --- |
| Number of participants with adverse events; incidence of DanshenDuofensuanyan'adverse drug reaction（ADRs）and identify factors that contributed to the occurrence of the adverse reaction | All patients will be measured and assessed at the time DanshenDuofensuanyan is administered to them until they discharge. Patients using DanshenDuofensuanyan will be registered on a registration form including disease background, DanshenDuofensuanyan's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of DanshenDuofensuanyan. | to assess DanshenDuofensuanyan's 'adverse event' and 'drug adverse reaction' during patients' hospital stay. The registry procedure will last 2 years only for patients using DanshenDuofensuanyan |
Lipid Management in Clinical Practice (MK-0524A-115)

Study Overview
=================
Brief Summary
-----------------
The aim of this observational program is to generate data on the use of Tredaptive (nicotinic acid/laropiprant) for lipid management under routine medical practice conditions.

Official Title
-----------------
Lipid Management in Clinical Practice

Conditions
-----------------
Lipid Metabolism Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are 18 years of age or older with lipid disorder treated with nicotinic acid/laropiprant Exclusion Criteria: Patient is currently participating 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated within a disease management program<br>Participant prescribed Tredaptive® for dyslipidemia and also participated in a disease management program for treatment of diabetes mellitus, coronary heart disease or both. | |
| Patients treated outside a disease management program<br>Participant prescribed Tredaptive® for dyslipidemia and did not participate in a disease management program for treatment of diabetes mellitus, coronary heart disease or both. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Lipid Panel Control | Lipid Panel Control was defined as achieving target for one or more of the following parameters: low-density lipoprotein cholesterol (LDL-C) at goal (<100mg/dL), high-density lipoprotein cholesterol (HDL-C) within normal range (40mg/dL for males and 50mg/dL for females), and/or triglycerides within normal range (≤ 150mg/dL). | From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Reported Adverse Events |  | Up to 22 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lipid metabolism disorder
The Relationship Between the Growth Hormone (GH)- Insulin Like Growth Factor I (IGF-I) System and the Inflammatory System in Healthy Normal Persons

Study Overview
=================
Brief Summary
-----------------
Observations in patients with growth hormone (GH)-disturbances have suggested that GH/IGF-I might have anti-inflammatory effects. To elucidate this hypothesis the investigators have planned a study to investigate if 3 weeks administration of GH and subsequently the GH antagonist Pegvisomant (or vice versa) influence serum levels of different inflammatory markers in healthy volunteers.

Detailed Description
-----------------
To investigate if administration of 3 weeks og GH (10-30 microgram/kg/day) and subsequent Pegvisomant (10-15 mg/day) influence serum concentrations of the inflammatory variables Tumor Necrosis Factor α (TNF-α), Interleukin-6 (IL-6), high sensitive CRP (hsCRP) and the newly discovered acute phase protein YKL-40. The study involves 12 healthy volunteers age from 22-65 years.

Official Title
-----------------
The Relationship Between the Growth Hormone (GH)- Insulin Like Growth Factor I (IGF-I) System and the Inflammatory System in Healthy Normal Persons

Conditions
-----------------
Interaction Between the GH/IGF-I System and the Immune-system

Intervention / Treatment
-----------------
* Drug: Somatropin
* Drug: Pegvisomant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, normal blood tests Exclusion Criteria: Previous cancer

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 65 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GH<br> | Drug: Somatropin<br>* s.c injections once daily 10-30 mícrogram/kg/day<br>|
| Active Comparator: Pegvisomant<br> | Drug: Pegvisomant<br>* s.c. injections once daily (10-15 mg/day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between changes in serum levels of Tumor Necrosis Factor α (TNF-α), Interleukin-6 (IL-6), high sensitive CRP (hsCRP) and YKL-40 vs. changes in serum levels og IGF-I |  | 1/9 2009 - 1/3 2010 |
To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Forlax® is more effective than placebo in relieving chronic constipation in children who may also suffer from soiling or faecal incontinence.

Official Title
-----------------
Polyethylene Glycol Laxative (Macrogol 4000;Forlax®) for Treatment of Chronic Constipation in Children : A Phase III, Bicentric, Randomized, Double-blind, Lactulose Controlled Study.

Conditions
-----------------
Chronic Constipation

Intervention / Treatment
-----------------
* Drug: PEG 4000 (Forlax®)
* Drug: Lactulose active and Lactulose placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic constipation (defined as at least 3 months of less than 2 bowel movements (BMs) per week and/or one of the following symptoms : hard stool, painful defecation, encopresis) Constipation previously treated by dietary advice (high fiber diet) for at least two weeks without efficacy Exclusion Criteria: Organic bowel diseases Suspected GI obstruction History of GI surgery

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 36 Months

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 |
| --- | --- |
| Experimental: 1<br> | Drug: PEG 4000 (Forlax®)<br>* Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period.<br>|
| Active Comparator: 2<br> | Drug: Lactulose active and Lactulose placebo<br>* Powder for oral solution. 1 sachet of 3.3g lactulose active and 1 sachet of lactulose placebo. From baseline every two weeks over a 4 week treatment period.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel movement frequency |  | week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective symptoms associated with defecation. |  | At every visit |
Will Cleaning the Bowel With an Enema Before Vaginal Prolapse Surgery Prevent Complications?

Study Overview
=================
Brief Summary
-----------------
Traditionally, many gynecologic surgeons have asked patients to perform a cleansing enema the night before a vaginal surgery done to repair pelvic organ prolapse (dropped bladder, dropped uterus). The belief is that there is then less or no stool present at the vaginal incision and less chance of infection of the wound by bowel bacteria. However, not all surgeons follow this practice. There is no evidence in the medical literature if one way is better than the other. In this study, patients scheduled for vaginal surgery to correct prolapse will be randomly assigned to perform an enema or not to perform an enema.

Detailed Description
-----------------
The factors to be measured will be wound infection rates, and need to cleanse an incision of escaped stool.

Official Title
-----------------
Do Preoperative Enemas Prevent Complications in Vaginal Pelvic Reconstructive Surgery?

Conditions
-----------------
Colon Cleansing

Intervention / Treatment
-----------------
* Procedure: enema


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female, AND undergoing vaginal surgery for prolapse. Exclusion Criteria: pregnant women, age younger than eighteen, male sex, OR concurrent abdominal surgery.

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

Sexes Eligible for Study
-----------------
Female

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

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 |
| --- | --- |
| Active Comparator: treatment : receives pre operative enema<br>one arm will receive pre operative enema | Procedure: enema<br>* pre operative rectal enema one adult bottle to be used rectally the night before surgery<br>* Other names: adult over the counter enema;|
| No Intervention: no enema<br>this group will not receive pre operative enema | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound infection rate |  | 6 weeks post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of contamination of surgical field by stool during surgery |  | day of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
The focus of this study is to determine whether it is beneficial to administer enemas before surgery