linjc16/ctgov huggingface dataset:
Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Advanced Upper Lobe Predominant (ULP) Emphysema

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in treating patients with advanced upper lobe predominant emphysema.

Detailed Description
-----------------
Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications,which often provide little or no benefit. In recent years, lung volume reduction surgery has become an accepted therapy for advanced emphysema. Lung volume reduction surgery involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. This procedure, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk. Aeris Therapeutics has developed the Biologic Lung Volume Reduction (BLVR) System to achieve lung volume reduction without surgery and its attendant risks. With BLVR, a physician uses a bronchoscope to direct treatment to the most damaged areas of the patient's lungs. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a bioabsorbable gel. The gel is comprised of clotting proteins that deliver the treatment, an antibiotic to prevent infection and drugs designed to remodel damaged areas of the lungs-actually using the body's natural scar formation response to permanently collapse the diseased areas. This reduction in lung volume creates more space for adjacent healthier parts of the lungs to function more effectively.

Official Title
-----------------
Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema

Conditions
-----------------
Advanced Upper Lobe Predominant Emphysema

Intervention / Treatment
-----------------
* Drug: BLVR


Participation Criteria
=================

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: BLVR<br> | Drug: BLVR<br>* BLVR 20 mL<br>|
| Sham Comparator: Saline<br> | Drug: BLVR<br>* BLVR 20 mL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in pulmonary function and respiratory symptoms |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emphysema, chronic obstructive pulmonary disease, COPD, lung volume reduction, LVRS, BLVR, Aeris
Spherical Aberration and Contrast Sensitivity Function in Eyes Implanted With Spherical and Aspheric Intraocular Lenses: A Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Aspheric intraocular lenses can effectively reduce higher-order aberrations and improve contrast sensitivity function after cataract surgery.

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: Intraocular lens
* Device: Intraocular lens
* Device: Intraocular lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Senile cataract Exclusion Criteria: Glaucoma, corneal opacity, retinal abnormality, previous history

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sensar IOL<br> | Device: Intraocular lens<br> <br> |
| Active Comparator: Tecnis IOL<br> | Device: Intraocular lens<br> <br> |
| Active Comparator: AcrySof IQ<br> | Device: Intraocular lens<br> <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
-----------------
higher-order aberrations, contrast sensitivity
X-Chromosome Inactivation Status and Premature Ovarian Failure

Study Overview
=================
Brief Summary
-----------------
Women who are affected with premature ovarian failure will exhibit skewed X-chromosome inactivation patterns compared to women with normal menstrual function (as defined by being pregnant), indicating a possible X-chromosome defect.

Detailed Description
-----------------
Premature ovarian failure (POF) affects approximately 1% of women. For most women a cause is not found, but structural abnormalities of the X-chromosome commonly lead to POF, suggesting genes on the X-chromosome are necessary for normal ovarian function. It is known that certain gene mutations on the X-chromosome can lead to changes in the normal random pattern of X-chromosome inactivation in females. We propose to study X-inactivation patterns in a cohort of women with idiopathic POF, and compare their pattern to a mean age-matched cohort of women with normal menstrual function. We hypothesize that some women with POF will show skewed X-inactivation, suggesting a mutation on the X-chromosome as the etiology of their POF.

Official Title
-----------------
X-Chromosome Inactivation Status and Premature Ovarian Failure

Conditions
-----------------
Premature Ovarian Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women diagnosed with POF. A chromosomal analysis must have been performed to evaluate X-chromosomal abnormalities, and the results are known to be normal. Exclusion Criteria: Patients who have a known etiology for their POF and/or an inability to obtain karyotype results for these patients or unknown X-chromosome abnormalities.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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 |
| --- | --- | --- |
| Skewed X-Inactivation appears increased in women with Premature Ovarian Failure |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature Ovarian Failure, X-Chromosome Inactivation
Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat

Study Overview
=================
Brief Summary
-----------------
Evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat

Detailed Description
-----------------
DWJ211 is a injectable drug for improvement in the appearance of moderate to severe submental fat (SMF)

Official Title
-----------------
A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat

Conditions
-----------------
Submental Fat

Intervention / Treatment
-----------------
* Drug: Normal saline
* Drug: DWJ211


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Submental fat grade by the investigator as 2 or 3 using the PA-SMFRS and graded by the subject as 2 or 3 using the SA-SMFRS as determined on Visit 1. Dissatisfaction with the submental area expressed by the subject as a rating of 1 3 using the SSS as determinded on Visit 1. Less than 35kg/m2 in body mass index on Visit1. Subject who will agree with the no treatment for the procedure that may affect to reduction or the submental fat. Exclusion Criteria: History of any intervention to treat SMF History of trauma associated with the chin or neck areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment. Evidence of any cause of enlargement in the submental area. History or current symptoms of dysphagia.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Inject the Drug into submental fat via subcutaneous | Drug: Normal saline<br>* Inject the Drug into submental fat via subcutaneous<br>|
| Experimental: DWJ211 group<br>Inject the Drug into submental fat via subcutaneous | Drug: DWJ211<br>* Inject the Drug into submental fat via subcutaneous<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PA-SMFRS, SA-SMFRS | Proportion of subject who simultaneously have at least a 1 grade, 2grade improvement from baseline on the PA-SMFRS, SA-SMFRS after the last treatment | 12 week after last treatment |
Regional-anaesthesiological Infiltration Techniques for the Management of Chronic Pain: a Retrospective Study

Study Overview
=================
Brief Summary
-----------------
There is a significant debate whether local infiltration techniques may be a method to treat complicated chronic pain syndromes, e.g. refractory headache. Until now there is a lack of evidence regarding efficacy of this treatment especially in long term follow up. Similarly, indication and management are under debate. Aim of this trial is to analyse pain scores during first treatment with anaesthesiological infiltration series.

Official Title
-----------------
Regional-anaesthesiological Infiltration Techniques for the Management of Chronic Pain: a Retrospective Study

Conditions
-----------------
Chronic Pain, Trigeminal Neuralgia, Cluster Headache, Post-Zoster Neuralgia, Post Zoster Pain, Neuropathic Pain

Intervention / Treatment
-----------------
* Procedure: regional-anaesthesiological infiltration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with chronic pain disease undergoing regional-anaesthesiological infiltration series Exclusion Criteria: pregnancy patients in legal custody age <18 years

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

| Intervention/Treatment |
| --- |
|Procedure: regional-anaesthesiological infiltration|Patients with therapy refractory chronic pain are treated with local infiltration techniques using e.g. local anaesthetics, opioids or drug combinations. Targeted structures are e.g. Ganglion stellatum, Ganglion pterygopallatinum, Trigeminal nerve branches (V1-V3). Patients receive a context- sensitive number of blocks in a series of infiltrations depenting on their pain course.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS reduction during therapy | Reduction (relative and absolute) of pain during series of infiltrations comparing NRS scores before and after infiltrations | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of blocks in a series | Number of blocks in a series to achieve the targeted NRS reduction | 4 weeks | 
| Time till recurrent pain | Time until a new series of blocks is requested by the patient | 24 weeks | 
| clinical course of pain | NRS development during series of infiltrations | 2 weeks | 
| type of infiltration | location of infiltrations with medication used | 2 weeks | 
| co-parameters of pain chronification | co-factors of pain like co-morbidity, duration of pain disease, psychological diseases and association with primary outcome | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
regional-anaesthesiological infiltration, block series, invasive pain treatment
Study of the Safety of Orencia in Japanese Children and Adolescents With Active Juvenile Arthritis of Unknown Origin

Study Overview
=================
Brief Summary
-----------------
Observational study of abatacept in the treatment of JIA in Japan.

Official Title
-----------------
ORENCIA Safety Surveillance in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis (JIA)

Conditions
-----------------
Undifferentiated Arthritis

Intervention / Treatment
-----------------
* Other: Non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All JIA participants who initiate treatment with Orencia in accordance with the prescribing information Exclusion Criteria: Participants receiving Orencia for an off-label indication Other protocol defined inclusion/exclusion criteria could apply
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| JIA participants<br> | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by number of participants who receive at least 1 dose of Orencia |  | 1 year | 
| Efficacy measured by number of participants who receive at least 1 dose of Orencia |  | 1 Year |
Ventriculomegaly and Gait Disturbance in the Senior Population in the Region of Västerbotten

Study Overview
=================
Brief Summary
-----------------
Idiopathic normal pressure hydrocephalus (INPH) is a treatable disease of the elderly, typically causing gait impariment, dementia and urinary incontinence. The objective of this study is to make an epidemiological survey of INPH in Umeå, Sweden. Subjects with self-perceived gait impairments will be identified through a questionnaire. They will go through clinical examinations and have an MRI of the brain. A control population will also be investigated to enable comparisons between the populations. The main hypothesis is that the prevalence of INPH in the population is higher than what is previoulsy known.

Official Title
-----------------
Gait and Balance Impairment, Dementia and Wide Brain Ventricles in the Ages 65-84 Years

Conditions
-----------------
Dementia, Idiopathic Normal Pressure Hydrocephalus (INPH), Brain Diseases, Central Nervous System Diseases, Gait Disorders, Neurologic, Hydrocephalus, Normal Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Living in Umeå, Sweden. Exclusion Criteria: Age <65 or >84 years when the questionnaire was sent out. Death at the time for the clinical evaluation.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 84 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>Subjects with subjective gait impariment according to questionnaire answers. | |
| Control<br>Subjects without subjective gait impariment according to questionnaire answers. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Idiopathic Normal Pressure Hydrocephalus | Diagnosis of INPH based on clinical evaluation and MRI. | Through study completion, an average of approximately 1 month. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopathic Normal Pressure Hydrocephalus
Zinc Supplementation of Imipramine Therapy

Study Overview
=================
Brief Summary
-----------------
Examination of the effect of zinc supplementation on imipramine therapy in major depression.

Detailed Description
-----------------
A placebo-controlled, double blind study of zinc supplementation in imipramine therapy was conducted in sixty, depressed patients fulfilling the DSM-IV criteria for major depression without psychotic symptoms. After a one week washout period, patients were randomized into two groups treated with imipramine and receiving once daily either placebo (n=30) or zinc supplementation (n=30) for 12 weeks.

Official Title
-----------------
The Role of Zinc in Therapy of Unipolar Depression

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Dietary Supplement: Zincas Forte
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with fulfilled DSM-IV criteria for moderate or severe depressive episode one week washout period without any pharmacotherapy Exclusion Criteria: psychotic symptoms

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>zinc + imipramine | Dietary Supplement: Zincas Forte<br>* 25 mgZn/day + imipramine (100-200mg/day)<br>* Other names: Imipramin (Polfarma, Poland);|
| Placebo Comparator: 2<br>placebo + imipramine | Dietary Supplement: Placebo<br>* placebo + imipramine (100-200mg/day)<br>* Other names: Imipramin (Polfarma, Poland);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess unwanted side effects in both groups |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, antidepressant treatment, zinc, placebo
Use of Procalcitonin in the Diagnosis of Pleural Effusion

Study Overview
=================
Brief Summary
-----------------
Among several markers of inflammation and sepsis, procalcitonin (PCT) markers is being studied to investigate their accuracy for the diagnosis of bacterial infections. PCT is the prehormone of calcitonin, which is normally secreted by the C cells of the thyroid in response to hypercalcemia; under these normal conditions, negligible serumPCT concentrations are detected. The mechanism proposed for PCT production after inflammation and its role are still not completely known. It is believed that PCT is produced by the liver and peripheral blood mononuclear cells, modulated by lipopolysaccharides and sepsis-related cytokines. It binds to polysaccharides in pathogens, activating the classical complement pathway. The reported diagnostic accuracy of PCT for the diagnosis of bacterial infections has varied across studies.

Official Title
-----------------
Evaluation of Procalcitonin as a Diagnostic Tool for Patients With Pleural Effusion

Conditions
-----------------
Pleural Effusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of pleural effusion Pleural effusion proved by chest sonography Exclusion Criteria: Conditions for which thoracentesis are contraindicated Pregnancy

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pleural effusion, procalcitonin
BMP-2 and ALP Levels Following Laser Therapy With Scaling and Root Planing in Periodontitis- RCT.

Study Overview
=================
Brief Summary
-----------------
Patients with periodontitis will be treated by either SRP only or SRP in combination with laser. Samples from GCF will be collected immediately after treatment and at 3 months follow-up time. Levels of BMP-2 and ALP will be assessed at these time points. Statistical analysis to compare the results will be performed.

Official Title
-----------------
Assessment of BMP-2 and ALP Levels Following Laser Therapy as an Adjunct to Scaling and Root Planing for Treatment of Periodontitis- A Randomized Clinical Trial.

Conditions
-----------------
Periodontitis, Laser

Intervention / Treatment
-----------------
* Device: SRP+Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Periodontitis Exclusion Criteria: Uncontrolled medical condition
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SRP only<br> | Device: SRP+Laser<br>* Non-surgical periodontal therapy in combination with Laser<br>|
| Experimental: SRP+Laser<br> | Device: SRP+Laser<br>* Non-surgical periodontal therapy in combination with Laser<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of attachment gain | Described in mm | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of BMP-2 in GCF | ELISA test | 3 months | 
| Level of ALP in GCF | Colorimetry | 3 months |