linjc16/ctgov huggingface dataset:
Association Between Low Back Pain and Quality of Sleep

Study Overview
=================
Brief Summary
-----------------
A prospective study to assess the association between the change in quality of sleep and the change in intensity of pain in Spanish patients seen for subacute or chronic low back pain. The objective is to determine the prevalence of sleep alterations, the association between quality of sleep and intensity of pain, degree of disability, intensity of catastrophizing and depression.

Official Title
-----------------
Study of the Association Between Low Back Pain and the Quality of Sleep

Conditions
-----------------
Quality of Sleep, Subacute or Chronic Low Back Pain, Disability, Catastrophizing, Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with non-specific low back pain of more than 14 days duration seen in health centers participating in the study who accept to participate and sign the consent form without age limits and regardless of gender Exclusion Criteria: inability to complete the questionnaires (illiteracy, dementia) inflammatory rheumatologic disease, fibromyalgia, cancer in last 5 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 |
| --- | --- |
| Subacute low back pain; chronic low back pain<br>Patients with subacute or chronic low back pain seen in the Primary Care Centers participating in the study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the association between low back pain and quality of sleep in patients with subacute or chronic low back pain. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the association between quality of sleep and disability, catastrophizing and depression in patients with subacute or chronic low back pain. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quality of sleep, low back pain, disability, catastrophizing, depression
Acute Comfort and Blur of Systane Ultra and Systane

Study Overview
=================
Brief Summary
-----------------
To evaluate drop comfort, acceptability, preference and blue profile between two marketed artificial tears in both dry eyes and non-dry eye patient population.

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: Systane Ultra Lubricant Eye Drops
* Other: Systane Lubricant Eye Drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of dry eye Exclusion Criteria: Use of contact lens within 7 days preceding enrollment

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane Ultra<br>Systane Ultra 1 drop each eye one time | Other: Systane Ultra Lubricant Eye Drops<br>* Systane Ultra Lubricant Eye Drops 1 drop each eye one time<br>|
| Active Comparator: Systane<br>Systane 1 drop each eye one time | Other: Systane Lubricant Eye Drops<br>* Systane Lubricant Eye Drops 1 drop each eye one time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drop Comfort | Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable, | once upon instillation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye, Artificial Tears
Identification of the Microcirculation of the Caput Femoris After Fracture of the Femoral Neck

Study Overview
=================
Brief Summary
-----------------
This project investigates wether the intra-capsular hematoma, that often occurs after fracture of the femural neck, decreases the capillary blood flow of the caput femoris. During operation the measuring device of the O2c-machine in placed on the joint capsula first and afterwards, after surgical opening of the capsula, on the femur directly. The integral of the microcirculation of both parts of the femur is measured in both settings. So the capillary blood flow is measured with the hematoma still in situ, eventually putting pressure on the caput femoris and after the capsula has been opened, the pressure relieved and the hematoma removed. Both measurements are compared for each patient. The O2c-machine measures non-invasive with light waves and laser-doppler. The sounding rod is packed in a sterile tube to prevent any contamination of the operation site.

Official Title
-----------------
Identification of Microcirculation in Fracture of the Femural Neck: How Does the Intracapsular Hematoma Affect the Capillary Bloodflow in the Caput Femoris?

Conditions
-----------------
Microcirculation of the Caput Femoris

Intervention / Treatment
-----------------
* Procedure: Measurement with O2c


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medial fracture of the femural neck surgical treatment (hip replacement) Exclusion Criteria:Polytrauma pathologic fracture conservative treatment soft tissue damage delay of surgery more than 3 days Immune default polytrauma

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 |
| --- | --- |
| Patient with fracture of femural neck<br>All patient with fracture of the femural neck in the listed period of time | Procedure: Measurement with O2c<br>* Intra-surgery measurement of the microcirculation with the O2c device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microcirculation of the caput femoris befor the capsula of the joint is opend | Four Values are measured: oxygen saturation local Hb local blood flow local blood velocity |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microcirculaiton of the caput femoris after the capusla of the joint has been surgically opened and the hematoma has been removed | Four values are measured: oxygen saturation local Hb local blood flow local blood velocity |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microcirculation, caput femoris
Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
The study is a prospective, multi-centre, observational study designed to assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis.

Detailed Description
-----------------
Study includes a bio-marker sub-study to determine differences in responders vs. non-responders. Additional consent is required for the sub-study.

Official Title
-----------------
Amevive Wisdom Acquired Through Real-world Evidence - 2 (A.W.A.R.E.-2) Program: Long-Term Study

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

Intervention / Treatment
-----------------
* Drug: Amevive exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with moderate to severe chronic plaque psoriasis who receive a new prescription for alefacept Exclusion Criteria: Subjects with a contraindication to alefacept Subjects with a history of cancer except for adequately treated basal cell carcinoma (maximum of 2 lesions) Subjects with any active cancer, including skin cancer Subjects having a serious local infection (eg. cellulitis, abscess) or serious systemic infection (eg. pneumonia, septicemia, tuberculosis), within the 3 months prior to the first dose of alefacept. Subjects known to be infected with the AIDS virus

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 |
| --- | --- |
| 1. Amevive Exposure<br>Canadian subjects with moderate to severe chronic plaque psoriasis | Drug: Amevive exposure<br>* Commercial alefacept prescribed by Physician<br>* Other names: ASP0485;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis |  | 8 Weeks following last dose of each treatment course throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the quality of life of subjects on alefacept based on completion of the Dermatology Life Quality Index |  | 8 Weeks following last dose of each treatment course throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plaque psoriasis, psoriasis, alefacept, Amevive
Effect of PRM-125 on Ambulatory Blood Pressure

Study Overview
=================
Brief Summary
-----------------
Evaluation of Once-Daily PRM125 On Ambulatory Blood Pressure in Adults with Hypertension

Detailed Description
-----------------
Approximately 60 subjects with primary hypertension are treated for 8 weeks with PRM125 to determine if Ambulatory Blood Pressure is changed.

Official Title
-----------------
Evaluation of Once-Daily PRM125 On Ambulatory Blood Pressure in Adults With Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: PRM-125


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary hypertension Exclusion Criteria: medical conditions that preclude evaluation and/or adversely effect subject safety

Ages Eligible for Study
-----------------
Minimum Age: 30 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRM125<br>PRM125 | Drug: PRM-125<br>* Antihypertensive<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24 hour Systolic Blood Pressure |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24 hour Diastolic Blood Pressure |  | 8 weeks |
DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether patients' age, total burned surface area, wound stage and wound depth determine wound healing response to pulsed electromagnetic therapy in burn patients

Detailed Description
-----------------
It will be hypothesized that Age may significantly affect burn wound healing's response to pulsed electromagnetic waves. TBSA may significantly affect burn wound healing's response to pulsed electromagnetic waves Depth of wound may significantly affect burn wound healing's response to pulsed electromagnetic waves Wound healing stage may significantly affect burn wound healing's response to pulsed electromagnetic waves This study will be conducted at the in-patient burn units. There will be only one intervention group. The duration of the study will be 6 weeks divided to 18 sessions (three sessions per week). Sixty patients (male and female) will be recruited from the burn units. Pulsed electromagnetic waves will be performed for 60 min 3 times per week till healing (maximum 8 weeks) on the wound area. PEMF therapy will be as (duration: 60 minutes; frequency: 12 Hz; intensity: 12 Gauss)

Official Title
-----------------
DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING

Conditions
-----------------
Burn Wound

Intervention / Treatment
-----------------
* Device: electromagnetic device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Partial thickness Burn wound depth. Age ranges from 20-50 years. TBSA more than 15% Sufficient understanding to perform the tests. Exclusion Criteria Diabetic patients. Patients receiving immunosuppressive drugs. Associated co-morbidities, such as neurological diseases, malnutrition, and other inﬂammatory and/or infectious diseases.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: burn wound receiving electromagnetic therapy<br>There will be only one intervention group. The duration of the study will be 6 weeks divided to 18 sessions (three sessions per week). Sixty patients (male and female) will be recruited from the burn units of Cairo university hospitals | Device: electromagnetic device<br>* electromagnetic waves for burn wound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing rate | tools for assessment of wound area changes before and after treatment | maximum of 6 weeks |
Investigation of Dysregulated Signaling in MPD Via Multiparameter Phospho-specific Flow Cytometry

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to better understand the underlying pathogenetic mechanisms of myeloproliferative disorders (MPDs). We will collect peripheral blood samples from MPD patients and utilize multiparameter phospho-specific flow cytometry to investigate dysregulated signaling in blood cells from these patients. This will provide deeper insights into the pathogenesis of MPDs and may lead to the identification of novel targets for therapeutic intervention.

Official Title
-----------------
Investigation of Dysregulated Signaling in Myeloproliferative Disorders Via Multiparameter Phospho-specific Flow Cytometry

Conditions
-----------------
Myeloproliferative Disorders, Myeloproliferative Disorders (MPD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Any patient who carries a diagnosis of a myeloproliferative disorder (MPD). Exclusion Criteria:Any patient who is not willing to give consent.

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 |
| --- | --- | --- |
Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent)or Travoprost

Study Overview
=================
Brief Summary
-----------------
Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Detailed Description
-----------------
Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Official Title
-----------------
A Prospective, Randomized Evaluation of Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent) or Travoprost Ophthalmic Solution 0.004%

Conditions
-----------------
Open-angle Glaucoma

Intervention / Treatment
-----------------
* Device: iStent
* Drug: Travoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phakic study eye IOP ≥ 21 mmHg and ≤ 40 mmHg at screening exam (OHT requires second screening) Exclusion Criteria: Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs) Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: iStent<br>Implantation of two iStent devices | Device: iStent<br>* Implantation of two iStent devices<br>|
| Active Comparator: Drug<br>Travoprost drops | Drug: Travoprost<br>* Travoprost drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open angle glaucoma, POAG, Ocular hypertension, Pseudoexfoliative glaucoma, Naïve to treatment
Relationship of Cricoid With the Right and Left Bronchial Diameters in the Pediatric Population Using Three-dimensional Imaging.

Study Overview
=================
Brief Summary
-----------------
Specific and objective guidelines for choosing endobronchial tube size for main-stem intubation in pediatric patients are lacking. The objective criteria for choosing an ETT size for OLV are likely to increase the safety and success. The primary aims of this study were to define the relationship between cricoid and mainstem bronchi (right and left) in children of various ages and to determine the effects of age, height and weight.

Detailed Description
-----------------
Understanding the relationship between cricoid and mainstem bronchi can provide to be a useful adjunct for lung isolation in children. The relationship between cricoid dimensions and the dimensions of main-stem bronchi (right and left) have been studied using 2 dimensional CT images and video-bronchoscopic images. The present study defines the volume-based relationship between the right main-stem bronchus (RMSB), left main-stem bronchus (LMSB) and the cricoid ring based on 3 dimensional CT derived images. Methods: The three dimensional CT images of 35 children, younger than 8 years, undergoing radiological evaluation unrelated to airway symptomatology were examined. The children were evaluated during spontaneous ventilation without airway devices either during natural sleep or with sedation. The 3-dimensional images of the airway column were evaluated at the level of cricoid, right mainstem bronchus and left main-stem bronchus, volumes were calculated and comparisons made between these levels. Univariate and multivariate regression analysis was used to determine whether one or more of the variables (age, gender, height, weight and cricoid) had a predictable relationship to the RMSB and the LMSB diameter.

Official Title
-----------------
Relationship of Cricoid With the Right and Left Bronchial Diameters in the Pediatric Population Using Three-dimensional Imaging.

Conditions
-----------------
Larynx, Oxygen, Intubation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 1 month to 8 years of age Exclusion Criteria: Patients with tracheostomy Tracheoesophageal fistula Presence of mediastinal mass Diaphragmatic hernia Preterm infants

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 96 Months

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison between cricoid and mainstem borncchi |  | 1 month to 8 years |
Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to assess bioequivalence of a potential generic 600 mb oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg dose, administered with food.

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Conditions
-----------------
Seizures, Epilepsy

Intervention / Treatment
-----------------
* Drug: Oxcarbazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results at screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with any known enzyme altering drugs. History of allergic or adverse response to oxcarbazepine or any other comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two Period, Seven day washout |