linjc16/ctgov huggingface dataset:
Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Children in the Paediatric A&E.

Study Overview
=================
Brief Summary
-----------------
Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Acutely Ill Children in a High Prevalent Setting: The Paediatric Accidents & Emergencies through prospective observational data collection concerning specific items from the clinical and technical examination in diagnosing serious infections, such as meningitis, sepsis, pneumonia, pyelonephritis, bronchiolitis with hypoxia. Eventually we will attempt to validate a vital signs and symptoms rule derived from multiple low to high prevalent settings of acutely ill children.

Official Title
-----------------
Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Children in a High Prevalent Setting: the Paediatric A&E.

Conditions
-----------------
Community-Acquired Infections, Respiratory Tract Infections, Sepsis, Urinary Tract Infections, Meningitis, Gastroenteritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 1 month to 16 years Acute illness episode of maximum 5 days Exclusion Criteria: recent trauma neurological conditions intoxication psychiatric of behavioural disorders without a somatic cause acute exacerbation of a chronic condition (asthma, known immunodeficiency, diabetes, cystic fibrosis, etc)

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 16 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 |
| --- | --- |
| Children with an acute illness<br>Children aged 1 month to 16 years of age, which attend the A&E department of UZLeuven with an acute illness episode of maximum 5 days. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serious infections: meningitis, sepsis, pneumonia, pyelonephritis, osteomyelitis and cellulitis, gastroenteritis with sever dehydration, complicated urinary tract infection and complicated viral airway infection with hypoxia. |  | within 24 hours after assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
serious infections, meningitis
Scotoma Reduction in AMD Patients Treated With Ranibizumab

Study Overview
=================
Brief Summary
-----------------
This is a trial aimed at patients with advanced wet macular degeneration and macular scarring treated wiht intravitreal injections of Lucentis.

Detailed Description
-----------------
Patients with severe wet macular degeneration and scarring in the center of the retina may benefit from treatment if the size of the blind spot is reduced wiht injections of Lucentis.

Official Title
-----------------
A Phase I/II Study to Evaluate Scotoma Reduction in And Limited Visual Acuity in aGe Related Macular Degeneration Patients Treated With Intravitreal Lucentis

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: intravitreal injection Lucentis (ranibizumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BCVA < 20/320 Disciform macular degeneration wiht exudation Exclusion Criteria: Non-amd CNV

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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: intravitreal injection Lucentis (ranibizumab)|intravitreal injection Lucentis (ranibizumab)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scotoma reduction |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improved visual function |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amd, disciform, fibrosis, Lucentis, scotoma
Total Knee Arthroplasty Outcome Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures.

Detailed Description
-----------------
The purpose of this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures. The MIS™ Minimally Invasive Solutions™ Total Knee Arthroplasty System has been cleared for use by the Food and Drug Administration. You are invited to participate in this data collection study, comparing the MIS system to standard knee replacement systems. The decision about which system and operation will be best for you has already been made by you and your orthopaedic surgeon. The information will be used to compare minimally invasive surgery and the standard surgery procedures. The results of this study will provide information that will add to the knowledge base of knee replacement surgery.

Official Title
-----------------
MIS™ Minimally Invasive Solutions™ Total Knee Arthroplasty Outcome Study #02-800

Conditions
-----------------
Total Knee Replacement

Intervention / Treatment
-----------------
* Device: MIS™ Minimally Invasive Solutions™ TKA System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of a severely disabled joint secondary to painful osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis that warrants primary knee arthroplasty. Gender - Males and females will be included. The male-to-female ratio will depend upon the patient population at each institution conducting the study. Age - Minimum of 18 years-old. Stable Health - The patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history. Patient or patient's legal representative has read and signed the Letter to the Patient form. Exclusion Criteria: Patient is skeletally immature. Previous ipsilateral knee arthroplasty. Previous Patellectomy. Patient is pregnant or breastfeeding. Presence of clinically significant disease of the cardiovascular, renal, hepatic, hematologic, respiratory, endocrine, neurological, gastrointestinal, genitourinary, immune systems or other medical condition which is not well controlled. Patients who have received an investigational drug or device within the last 30 days. Patient is unwilling or unable to cooperate in a follow-up program.

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 |
| --- |
|Device: MIS™ Minimally Invasive Solutions™ TKA System|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Exercise Adherence in a Behavioral Weight Loss Program

Study Overview
=================
Brief Summary
-----------------
To develop intervention strategies that improve long-term exercise adherence in obese adults in in order to improve long-term weight loss.

Detailed Description
-----------------
BACKGROUND: Even though exercise improves long-term weight loss maintenance and reduces the risks of cardiovascular disease and Type II diabetes mellitus, obese adults are prone to drop out of exercise programs. Dr. Jakicic's prior findings suggest that exercise adherence can be enhanced and short-term weight loss can be improved by making exercise more convenient via prescribing exercise in multiple short bouts, rather than one bout per day. Effects on long-term exercise adherence and weight loss have not been examined, however. His findings also suggest that providing more exercise options by placing exercise equipment in the home may also increase adherence, as evidenced by a significant correlation between the presence of home exercise equipment and physical activity. However, no experimental studies have tested whether placing exercise equipment in the home actually increases exercise adherence and weight loss. DESIGN NARRATIVE: The study tested the hypothesis that prescribing exercise in multiple short bouts would improve long-term exercise adherence and long-term weight loss, and that the addition of home exercise equipment would further improve these outcomes. A total of 148 overweight women were recruited and randomized to one of three treatments: 1) long-bout exercise; 2) short-bout exercise; 3) short- bout exercise + home exercise equipment. All subjects participated in an 18-month behavioral weight loss program, in which body weight was assessed at 0, 6, 12, and 18 months and exercise adherence was assessed throughout the 18 months. Cardiorespiratory fitness and cardiovascular disease risk factors were measured at 0, 6, and 18 months. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Obesity

Intervention / Treatment
-----------------
* Behavioral: exercise
* Behavioral: weight loss


Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: exercise|nan|
|Behavioral: weight loss|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Cervical Epidural Waveform Analysis Using Pressure Monitoring Kit

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze the reliability of epidural wave form during cerivical epidural injection.

Detailed Description
-----------------
The epidural space can be confirmed by loss of resistance (LOR) technique. However, LOR has very low specificity, although its sensitivity is high. Especially, cysts between ligaments, clefts in ligamentum flavum, paraspinal muscle and nonspecific spaces between muscles make false LOR. Epidural wave form analysis (EWA) is very simple and reliable method which can substitue the LOR technique. If the epidural needle is located correctly in the epidural space, the investigators can observe a pulsatile wave and this pulsatile wave corresponds to arterial wave. Generally, sensitivity of EWA through needle is known to be superior to the sensitivity of EWA through catheter and most studies were focused on catheter EWA. Cervical epidural space shows high false LOR rate and Lee et al demonstrated that false LOR at cervical epidural space was 68.7%. Therefore, nonspecificity of LOR technique require substitution method which can confirm epidural space.

Official Title
-----------------
Reliability of Epidural Waveform Analysis for Cervical Epidural Blocks

Conditions
-----------------
Analysis, Event History

Intervention / Treatment
-----------------
* Procedure: cervical epidural injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cerivical Herniated nucleusus Cerivical spinal stenosis acute herpes zoster Exclusion Criteria: Coagulopathy Infectious cervical disease Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| cervical epidural injection group<br>cervical epidural injection group | Procedure: cervical epidural injection<br>* sensitivity, specificity, positive predictive value, negative predictive value<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| epidural wave form reliability (sensitivity, specificity) analysis |  | 1 minute after the completion of the epidural injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical epidural space, wave form analysis
Efficacy of Dead Sea Peloid Gel in Chronic Endometritis

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of Dead Sea Peloid Gel in the treatment of Chronic Endometritis in women with reproductive disorders. Half of participants will receive Dead Sea Peloid Gel and antibiotics, while the other half will receive Placebo Gel and antibiotics. Patients with reproductive disorders who visited Research Medical Center of Family Health Problems and Human Reproduction were recruited.

Detailed Description
-----------------
Dead Sea Peloid Gel achieves improvement of blood circulation and receptor sensitivity of endometrium.

Official Title
-----------------
Efficacy of Intravaginal Dead Sea Peloid Gel Administration in Complex Treatment of Chronic Endometritis and Reproductive Disorders: Randomized Placebo-controlled Prospective Study

Conditions
-----------------
Chronic Endometritis

Intervention / Treatment
-----------------
* Drug: Dead Sea Peloid Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with miscarriage associated with chronic endometritis Women without mental disorders able to swallow tablets Exclusion Criteria: Clinical diagnosis of: sexually transmitted diseases endometrium hyperplasia and/or polyps uterina fibroids endocrine disorders trombophilia

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

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

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: Doxycycline,Dead Sea Peloid Gel,placebo<br>Group -1 stage: Doxycycline 100mg 2 times per day 10 days; followed by Dead Sea Peloid Gel , 60 ml per day fo 12 days, intravaginally Group -1 stage: Doxycycline 100mg 2 times per day 10 days; followed by placebo gel, 60 ml per day fo 12 days, intravaginally | Drug: Dead Sea Peloid Gel<br>* intravaginally<br>* Other names: Placebo Gel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of spontaneous pregnancy the first year after treatment |  | during first year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of women with morphological status of chronic endometritis by the 3 months after treatment. |  | during 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic endometritis, Miscarriage, Infertility
Marginal Bone Loss in Single Implant Restaurations With Different Methods

Study Overview
=================
Brief Summary
-----------------
The investigator is going to measure the marginal bone loss in single implant restaurations with three different methods: direct overcast, milled cad/cam direct to implant restauration and milled cad/cam implant restauration using an transepithelial pilar

Detailed Description
-----------------
The investigator has chosen a statistically significant sample (compared with other similar studies) to analize the bone marginal loss in different types of restauration with single dental implants

Official Title
-----------------
Marginal Bone Loss in Single Implant Restaurations With Three Different Methods

Conditions
-----------------
Bone Loss

Intervention / Treatment
-----------------
* Device: Bti Unit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with single implants restaurations treated in Leon University Exclusion Criteria: pregnant mayor heath issues patients who do not agree to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Overcast implant single restauration<br> | Device: Bti Unit<br>* Comparison with or without the device<br>|
| Active Comparator: Cad/cam direct implant restauration<br> | Device: Bti Unit<br>* Comparison with or without the device<br>|
| Active Comparator: Cad/cam implant restauration with transepithelial pilar<br> | Device: Bti Unit<br>* Comparison with or without the device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of marginal loss in single dental implants | To evaluate the vertical loss of bone in milimiters around the implant | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Implants with Prosthetic complications | The investigator is going to analyze if there is porcelain chipping (yes or not) and screw loosening (yes or not) | 6 months |
Effect of Perioperative Factors on the Analgesia Nociception Index

Study Overview
=================
Brief Summary
-----------------
The Analgesia Nociception Index (ANI) is a new unitless marker derived from Heart Rate Variability spectral analysis, ranging between 0 and 100 and expressing the parasympathetic tone. The ANI is proposed as surrogate marker for the analgesia nociception balance. However, many perioperative factors such as medications, position, maneuvers may influence the ANI values and may lead to misinterpretation. Moreover the ability of the ANI to guide opioid dosing has never been tested. Therefore, the aim of our study is to collect in a database all the perioperative factors and to study their influence on the ANI.

Official Title
-----------------
Effect of Perioperative Factors on the Analgesia Nociception Index

Conditions
-----------------
Intraoperative Neurophysiological Monitoring

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing scheduled surgery Exclusion Criteria: Non sinusal rhythm Pace maker or defibrillator holders Pregnancy or feeding American Society of Anesthesiology physical status 4

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 |
| --- | --- | --- |
| Variation of the ANI index |  | Before and 2 minutes afer the factor occurrence |
Remicade in the Treatment of Patients With Active Ankylosing Spondylitis

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to evaluate the efficacy of infliximab (IFX) treatment, 5 mg/kg every 6 weeks, in patients with active ankylosing spondylitis (AS) and to determine whether IFX dose reduction and interval extension, 3 mg/kg every 8 weeks during the second year sustained the treatment effect. The study was started in 2003 an finished in 2008.

Official Title
-----------------
Remicade in the Treatment of Patients With Active Ankylosing Spondylitis

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Drug: Infliximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients had to fulfill the following four inclusion criteria: (I) Age between 18 and 60 years, (II) proven diagnosis according to the modified New York criteria 12 for definitive AS, (III) active disease with Bath AS Disease Activity Index (BASDAI) score above 4 and (IV) current or previous treatment with conventional non-steroidal anti-inflammatory drugs (NSAID) in adequate doses without sufficient effect. Exclusion Criteria: current signs or symptoms of severe, progressive or uncontrolled hepatic, hematological, pulmonary, cardiac, neurological or cerebral disease; ongoing or past serious infection (including HIV and past or current tuberculosis); pregnancy or breast feeding; current malignancy or history of malignancy within the past five years; congestive heart failure and any contraindication to MRI.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Infliximab<br>Patients with active AS defined as BASDAI score above 4 and no exclusion criteria were consecutively included in this single-armed unblinded trial. | Drug: Infliximab<br>* 5 mg/kg every 6 weeks during the first year and 3 mg/kg every 8 weeks during the second year. Concomitant treatment with methotrexate 7.5 mg/week.<br>* Other names: Remicade;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bath AS disease activity score (BASDAI) | The proportion of responders at week 16 defined as a reduction of 50% and/or 2 units improvement from baseline of Bath AS disease activity score (BASDAI) | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankylosing Spondylitis, infiximab, single armed trial