linjc16/ctgov huggingface dataset:
An Investigational Drug Study to Treat Respiratory Symptoms Associated With Respiratory Syncytial Virus (RSV) Bronchiolitis (0476-272)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at whether an investigational drug can treat the breathing symptoms of RSV bronchiolitis in children 3 to 24 months of age.

Official Title
-----------------
A Randomized, 2-Period, Multicenter, Dble-Blind, Parallel-Group Study Comparing Effects of 2 Doses of MK0476 and Placebo in the Tx of Respiratory Symptoms Associated w/ Respiratory Syncytial Virus-Induced Bronchiolitis in Children 3 to 24 Mths

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Drug: montelukast sodium
* Drug: Comparator: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized or in an urgent/emergent-care setting at least 24 hours for a first or second episode of RSV-induced bronchiolitis. Approximately twenty percent of patients will be allowed in the study with a stay of less than 24 hours but need to meet a minimum predefined Respiratory Severity Score as required by the study. Exclusion Criteria: Asthma or other wheezing disorder. The Primary Investigator will evaluate whether there are other reasons why a child may not participate.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 24 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

| Intervention/Treatment |
| --- |
|Drug: montelukast sodium|Duration of Treatment: 6 months|
|Drug: Comparator: placebo|Duration of Treatment: 6 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Symptom-Free Days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients with Exacerbations and Percentage of Bronchiolitis-Free Days |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RSV Bronchiolitis
Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of vitreoretinal surgery combined with anti-VEGF therapy in the replacement of intraoperative PRP in PDR therapy.

Official Title
-----------------
Feasibility Study of Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy

Conditions
-----------------
PRP, Anti-VEGF, Proliferative Diabetic Retinopathy, Vitrectomy

Intervention / Treatment
-----------------
* Procedure: anti-VEGF
* Procedure: PRP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≥18 years old; type 1 or type 2 diabetes. proliferative diabetic retinopathy with vitreous hemorrhage, and conservative treatment of vitreous hemorrhage without obvious absorption for 1 month requires vitreoretinal surgery; The postoperative refractive medium is clear and the pupil is large enough to obtain sufficient clear fundus Exclusion Criteria: Previously received panretinal photocoagulation or unfinished panretinal photocoagulation; Pulling retinal detachment involving the macula or the presence of extensive fiber proliferation requires silicone oil filling; anterior chamber neovascularization or neovascular glaucoma; other vascular diseases such as retinal vein occlusion, arterial occlusion, etc; received intraocular anti-VEGF therapy or triamcinolone acetonide treatment which are still in the treatment period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: anti-VEGF<br>experimental group: vitreoretinal surgery combined with intraoperative anti-VEGF | Procedure: anti-VEGF<br>* vitreoretinal surgery combined with intraoperative anti-VEGF<br>|
| Active Comparator: PRP<br>Control group: vitreoretinal surgery combined with intraoperative PRP | Procedure: PRP<br>* vitreoretinal surgery combined with intraoperative PRP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in best-corrected visual acuity (BCVA) | Assessed using the ETDRS protocol | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in visual field | Assessed on Humphery(30-2 and 60-4) | 3 years | 
| chang from baseline in sructure of retina | Assessed on Optical Coherence Tomography(OCT) | 3 years | 
| chang from baseline in retinal neovascularization | Assessed on Fundus Fluorescein Angiography(FFA) | 3 years |
BTT1023 in Psoriasis

Study Overview
=================
Brief Summary
-----------------
Patients with plaque psoriasis will be enrolled. They will be dosed with repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the pharmacokinetics of BTT-1023 will be assessed. The patient allocation to treatment groups will occur at random, and the actual treatment will not be revealed to the investigator or to the patient during the trial.

Official Title
-----------------
A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Repeated Intravenous Doses of BTT-1023 in Patients With Plaque Psoriasis - a Double-blind Randomized Placebo-controlled Sequential Group Trial

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: BTT1023
* Drug: Placebo
* Drug: BTT1023


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Plaque psoriasis affecting at least 8% of the body surface area and scoring 8 or higher in the psoriasis area and severity index Exclusion Criteria: Seropositive for infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus; Tuberculosis; Acute systemic infection; Treatment with a monoclonal antibody therapy within 12 weeks prior to study entry; An absolute indication for a known effective treatment

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* intravenous, three infusions over three weeks<br>|
| Experimental: Single 0.3<br> | Drug: BTT1023<br>* Test challenge<br>|
| Experimental: Repeat 1.0<br> | Drug: BTT1023<br>* intravenous, three infusions over three weeks<br>|
| Experimental: Repeat 2.0<br> | Drug: BTT1023<br>* intravenous, three infusions over three weeks<br>|
| Experimental: Repeat 4.0<br> | Drug: BTT1023<br>* intravenous, three infusions over three weeks<br>|
| Experimental: Repeat 8.0<br> | Drug: BTT1023<br>* intravenous, three infusions over three weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 12 weeks | 
| Plasma concentrations of BTT1023 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Psoriasis Area and Severity Index (PASI) |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plaque psoriasis, BTT1023, safety, pharmacokinetics
Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs.

Official Title
-----------------
Randomized, Double Blind, Crossover, Single Centre Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects

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

Intervention / Treatment
-----------------
* Other: Formulation buffers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects(no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory. Body mass index of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs). Exclusion Criteria: Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Acute disease state (e.g., nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Platform II, PASS, ARG 100<br> | Other: Formulation buffers<br>* Platform II: Histidine, Polysorbate-80 PASS: Phosphate, Arginine, NaCl ARG 100: Phosphate, 100 mM Arginine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative perception of pain of platform II versus PASS using a likert scale |  | 0 minute after injections | 
| Relative perception of pain of platform II versus PASS using a likert scale |  | 2 minute after injections | 
| Relative perception of pain of PASS versus Arg 100 using a likert scale |  | 0 minute after injections | 
| Relative perception of pain of PASS versus Arg 100 using a likert scale |  | 2 minute after injections | 
| Perception of pain of Platform II, PASS and Arg 100 using VAS scale. |  | 0 minute after injections | 
| Perception of pain of Platform II, PASS and Arg 100 using VAS scale. |  | 2 minute after injections | 
| Perception of burning of Platform II, PASS and Arg 100 using VAS scale. |  | 0 minute after injections | 
| Perception of burning of Platform II, PASS and Arg 100 using VAS scale. |  | 2 minute after injections |
Help in the Emergency Room to Detect Organ Dysfunction

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective, non-interventional clinical study is to assess the clinical validity of a number of markers (including Heparin Binding Protein (HBP), Procalcitonin (PCT), C-reactive protein (CRP), White cell count (WCC) and lactate) for indicating the presence of organ dysfunction, or outcome, of patients with organ dysfunctions following emergency department admission or hospitalization. Secondary objectives are to identify novel putative biomarkers and to identify risk factors for negative long-term effects of acute critical illness The HBP assay is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Heparin Binding Protein in human plasma.

Official Title
-----------------
Help in the Emergency Room to Detect Organ Dysfunction - The HERO Study

Conditions
-----------------
Sepsis, Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: i) ≥18 years of age ii) 1 or more of the following criteria: Saturation<90% without oxygen or <93% with oxygen or reported saturation<90%, Respiratory frequency >25/min, Altered mental awareness, Heart rate >120/min, Systolic blood pressure <100 mm Hg. iv) informed consent. Exclusion Criteria: None

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 |
| --- | --- |
| Lund ED<br>appr 100-200 patients at Lund ED | |
| Helsingborg ED<br>appr 100-200 patients at Helsingborg ED | |
| Vancouver ED<br>appr 100 patients at St Paul's hospital ED | |
| Bern ED<br>appr 100 patients at Bern ED | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infection-induced organ dysfunction | To evaluate the presence or development of infection-induced organ dysfunction within a 72 hour time period from enrolment at the Emergency Department. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the specificity, sensitivity and accuracy of HBP against other biochemical markers |  | 72 hours | 
| To investigate the specificity, sensitivity and accuracy in biochemical markers to predict mortality, ICU-care, days in hospital and the persistence of organ dysfunction. |  | 90 days | 
| To investigate and identify risk factors for a negative long-term (5-10 year) outcome. |  | 10 years | 
| • Organ dysfunction 24-36 and 72 hours after arriving at the hospital |  | 72 hrs | 
| • Primary diagnosis infection (y/n) |  | 72 hrs | 
| • number of days on ward and ICU |  | 90 days | 
| • number of days of antibiotics , time to effective antibiotics |  | 72 hrs |
Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis

Study Overview
=================
Brief Summary
-----------------
Extracoporeal shock wave therapy(ESWT) was perfomed on the plantar fascia of chornic plantar fasciitis patients. Pre-ESWT and post-ESWT pain intensity, sonography and sonoelastrography of the plantar fascia was checked. Our hypothesis is that the plantar fascia stiffness increased after ESWT as clinical symptom improves.

Detailed Description
-----------------
For patient who met the inclusion criteria, we check sonography and sonoelastography for their plantar fascias and obtain a thorough evulation questionaire for clinical symptom and pain condition and intensity in various conditions, also SF-36 questionaire first. Inform consent was done. After the ESWT, we follow patient with questionaire and sonography/sonoelastography at 1-week, 1-month, 3-month, 6-month, 9-month, and 12-month post-ESWT time. The colored sonoelastographic image was analysed by computer software Image-J with hue analysis method and relative stiffness of selected area within proximal plantar fascia wasa obtained for statistical analysis.

Official Title
-----------------
Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis

Conditions
-----------------
Chronic Plantar Fasciitis

Intervention / Treatment
-----------------
* Device: Extracoporeal shock wave


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pain for more than 6 months，poor response to the conservative treatments Sonography showed plantar fasciitia>4.0mm) Exclusion Criteria: Acute infection of soft tissue/bone Malignant primary disease Blood coagulation disorders Pregnancy Patients with pacemaker foot deformity

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: Extracoporeal shock wave<br>Extracoporeal shock wave, 3000 shots/time, once a week for 3 weeks, treatment duration:30 minutes/time, shock wave freqency：2-4Hz, energy level:0.8-1.0 mJ/mm2 | Device: Extracoporeal shock wave<br>* Extracoporeal shock wave, 3000 shots/time, once a week for 3 weeks, treatment duration:30 minutes/time, shock wave freqency：2-4Hz, energy level:0.8-1.0 mJ/mm2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sonoelastographic changes of plantar fascia after ESWT |  | pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plantar fascia thickness |  | pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month |
Impact of the Navilas ® Micropulse Laser Treatment for Macular Edema Within the CHU Brugmann Hospital Macular Edema

Study Overview
=================
Brief Summary
-----------------
The Navilas® micropulse laser can be used to treat patients with macular edema and good visual acuity, which therefore do not fall within the indications for conventional treatments by intravitreal injections. The CHU Brugmann Hospital is the only center to own this laser in Belgium.This study aims to evaluate the efficacy of this laser.

Official Title
-----------------
Retrospective Study Within the Brugmann University Hospital of the Navilas ® Micropulse Laser Treatment for Macular Edema

Conditions
-----------------
Macular Edema

Intervention / Treatment
-----------------
* Other: Data extraction from medical files


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diffuse macular edema without focal edema source accessible by focal laser (e.g. capillary telangiectasia) Central retinal thickness ≤ 400microns. Patient does not meet the reimbursement criteria for intra-vitreous injections(IVI) of anti-VEGF (eg AV> 5/10). IVI are contraindicated. Physician considers that it is preferable to space out the injections because of the side effects (eg. ocular disturbance during IVI, eye pain, sensation of a foreign body, spots in the visual field generating a visual gene etc.) Patient wishing to space the anti-VEGF IVI. Exclusion Criteria: Macular edema of a different etiology than diabetic macular edema or venous thrombosis (e.g. cataract extraction, vitreomacular traction, epiretinal membrane etc.) Central retinal thickness > 400 microns. The eye presents a focal edematous maculopathy accessible to conventional laser.

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 |
| --- | --- |
| Macular edema<br> | Other: Data extraction from medical files<br>* Data extraction from medical files<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | Baseline versus three months after treatment | 
| Retinal thickness change |  | Baseline versus three months after treatment | 
| Periodicity of anti-VEGF injections |  | Baseline versus three months after treatment | 
| Scar - assessed by optical coherence tomography |  | Three months after treatment | 
| Scar - assessed by fluorescein angiography |  | Three months after treatment | 
| Scar - assessed by auto-fluorescence fundus images |  | Three months after treatment |
Examination of Microcirculation of the Caput Humeri After Proximal Humerus Fracture

Study Overview
=================
Brief Summary
-----------------
This study examines the microcirculation of the caput humeri after proximal humeral fracturation using O2C light probes. During the operation the blood circulation is measured at four points (tuberculum majus, tuberculum minus, neck and head of the humerus) directly on the bone. The O2C light probes are a none-invasive technique of measuring blood flow, velocity and oxygen concentration. The data is analysed in respect to the fracture type according to the classification of Neer. Valuable additional information for the correct treatment and prognosis of humeral fractures is expected.

Official Title
-----------------
Intraoperative Examination of Microcirculation of the Caput Humeri After Traumatic Proximal Humerus Fracturation.

Conditions
-----------------
Proximal Humeral Fractures

Intervention / Treatment
-----------------
* Procedure: Measurement with O2C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: traumatic fractures of the proximal humerus surgical treatment over eighteen years of age Exclusion Criteria: pathological fractures conservative treatment soft tissue damage delay of surgery more than three days immunological defects multiple trauma

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 |
| --- | --- |
| Type 1<br>One segment fracture | Procedure: Measurement with O2C<br>* Measurement of microcirculation using O2C light probes.<br>|
| Type 2<br>Two segment fracture | Procedure: Measurement with O2C<br>* Measurement of microcirculation using O2C light probes.<br>|
| Type 3<br>Three segment fracture | Procedure: Measurement with O2C<br>* Measurement of microcirculation using O2C light probes.<br>|
| Type 4<br>Four segment fracture | Procedure: Measurement with O2C<br>* Measurement of microcirculation using O2C light probes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microcirculation of the caput humeri | oxygen saturation, haemoglobin, blood flow, velocity of blood flow | during surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microcirculation, proximal humeral fractures, O2C