linjc16/ctgov huggingface dataset:
Intra-arterial Chemotherapy for Children With Retinoblastoma

Study Overview
=================
Brief Summary
-----------------
Retinoblastoma is a cancer of the eye that occurs exclusively in children. The treatment for retinoblastoma may include surgery, chemotherapy, radiation and local treatments to the eye such as freezing (cryotherapy) and local radiation (brachytherapy). In some cases, a child with retinoblastoma will have active cancer in a single remaining eye with useful vision. In such cases, it is sometimes necessary to remove this eye. In such cases, the injection of chemotherapy directly into the artery that supplies the eye and the tumor may lead to regression of the tumor without the need to remove the eye. This form of treatment was pioneered by a group in New York (Abramson et al). In this study the investigators will assess the efficacy and safety of the technique in a group of children with retinoblastoma.

Official Title
-----------------
Phase 1-2 Study of Injection of Melphalan Into the Ophthalmic Artery in Children With Retinoblastoma

Conditions
-----------------
Retinoblastoma

Intervention / Treatment
-----------------
* Drug: Intra-arterial injection of melphalan
* Drug: Injection of melphalan into the ophthalmic artery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with retinoblastoma in a single remaining eye with useful vision Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 10 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: Intra-arterial melphalan<br>The patients will be treated by injection of chemotherapy (melphalan) into the ophthalmic artery of an eye affected by retinoblastoma | Drug: Intra-arterial injection of melphalan<br>* Injection of 5 milligrams of melphalan into the ophthalmic artery once every 3 weeks for a total of 6 courses<br>Drug: Injection of melphalan into the ophthalmic artery<br>* Injection of 5 milligrams of melphalan into the ophthalmic artery in an eye affected by retinoblastoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salvage of eye and vision |  | Three years from intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinoblastoma
Fatal Cerebral Infarction After Nasal Augmentation With Hyaluronic Acid

Study Overview
=================
Brief Summary
-----------------
this study discussed the pathogenesis, treatment, and prognosis of severe cerebral infarction and ophthalmic artery occlusion for Aisan induced by hyalruonic acid filler injection.

Detailed Description
-----------------
Intra-arterial thrombolysis and retrobulbar injection of hyaluronidase have been used for HA-induced ophthalmic artery obstruction.

Official Title
-----------------
Fatal Cerebral Infarction and Ophthalmic Artery Occlusion After Nasal Augmentation With Hyaluronic Acid - A Case Report and Review

Conditions
-----------------
Magnetic Resonance Angiography

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of cerebral infarction Exclusion Criteria: fat embolism
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 |
| --- | --- | --- |
| pulse | Monitore the beats per minute over the past 6 days. | 0-6 day | 
| blood pressure | Monitor the blood pressure and record with mm Hg over the past 6 days. | 0-6 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral Infarction Hyaluronic Acid Embolism
Clinical Study to Evaluate Dental Plaque

Study Overview
=================
Brief Summary
-----------------
Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.

Official Title
-----------------
Clinical Study to Evaluate Dental Plaque

Conditions
-----------------
Gingival Diseases

Intervention / Treatment
-----------------
* Drug: Triclosan/Fluoride
* Drug: Fluoride/triclosan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female volunteers at least 20 - 51 years of age Good general health Must sign informed consent form Minimum of 15 natural uncrowned teeth (excluding third molars) must be present No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study Exclusion Criteria: Subjects unable or unwilling to sign the informed consent form Medical condition which requires pre-medication prior to dental visits/procedures Moderate or advanced periodontal disease or heavy dental tartar (calculus) 5 or more decayed untreated dental sites at screening (cavities) Other disease of the hard or soft oral tissues. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation). Use of medications that are currently affecting salivary function Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1 Pregnant or nursing women Participation in any other clinical study within 1 week prior to enrollment into this study Use of tobacco products Subjects who must receive dental treatment during the study dates Current use of Antibiotics for any purpose Presence of an orthodontic appliance which interferes with plaque scoring History of allergy to common toothpaste ingredients History of allergy to arginine (amino acid) Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 51 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Triclosan/Fluoride<br>* Brush twice daily for 3 weeks<br>|
| Experimental: B<br> | Drug: Fluoride/triclosan<br>* Brush daily for 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Plaque Index | Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque | 4 Day |
Monaldi Hospital Rhythm Registry

Study Overview
=================
Brief Summary
-----------------
The study is a prospective registry. Consecutive patients with indications of implant / replacement or upgrade of pacemaker (PM), implantable cardioverter defibrillator (ICD), Implanted loop recorder (ILR) will be enrolled. The primary objective of the study is to describe the clinical events during a long-term follow-up of non-selected population of patients implanted with an PM, ICD or ILR.

Official Title
-----------------
Registry of Patients Underwent Cardiac Implanted Electronic Device Implantation at Monaldi Hospital

Conditions
-----------------
ICD, Pacemaker, Implanted Loop Recorder

Intervention / Treatment
-----------------
* Device: Device implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients underwent PM/ICD/ILR implantation Patient is willing and able to sign an authorization to use and disclose health information or an Informed Consent Patient must be able to attend all required follow-up visits at the study center for at least 12 months Exclusion Criteria: No informed consent Patient is participating in another clinical study that may have an impact on the study endpoint Exclusion Criteria: No informed consent

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with PM<br>All patients underwent PM implantation | Device: Device implantation<br>* Implantation of single chamber, dual chambers or triple chambers PM/ICD<br>|
| Patients with ICD<br>All patients undeerwent ICD implantation | Device: Device implantation<br>* Implantation of single chamber, dual chambers or triple chambers PM/ICD<br>|
| Patients with ILR<br>All patients underwent ILR implantation | Device: Device implantation<br>* Implantation of single chamber, dual chambers or triple chambers PM/ICD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CIEDs Infection | The number of patecipants with infections following implantation of cardiac implantable electronic devices | through study completion, an average of 1 year | 
| Appropriate ICD Therapies Antitachycardia pacing therapy or shock delivered by ICD for device detected ventricular arrhythmia | The number of partecipants with a least one episode of antitachycardia pacing therapy or shock delivered by ICD for device detected ventricular arrhythmias. | through study completion, an average of 1 year | 
| Inappropriate ICD Therapies | The number of partecipants with at least one episode of antitachycardia pacing therapy or shock delivered by ICD for device detected sopraventricular arrhythmias. | through study completion, an average of 1 year |
Immunologic Aspects of the Pathogenesis of Chronic Sinusitis in Children

Study Overview
=================
Brief Summary
-----------------
Chronic sinusitis is a common pediatric disease; it ranks among the top five infectious diseases of the upper respiratory tract. Its treatment is limited and may be due largely in part to a lack of understanding of its cause. The investigators have preliminary data to support the notion that pediatric chronic sinusitis is a distinct disease, different from acute sinusitis and adult chronic sinusitis. We are proposing to perform pathogenesis studies in children with chronic sinusitis. Specifically, we wish to elucidate the microbiologic features and immunologic factors involved in the formation of this disease. The study plan calls for microbiologic (bacterial, viral, and fungal) and immunologic (inflammatory mediators and leukocyte populations) data to be evaluated through a maxillary sinus washing and mucosal biopsies. Four populations will be studied and they are: 10 children with chronic sinusitis, 5 children with acute sinusitis (positive control), 5 children without sinusitis (negative control) and 5 adults with chronic sinusitis (positive secondary control).

Conditions
-----------------
Sinusitis

Intervention / Treatment
-----------------
* Procedure: pathogenesis study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic sinusitis confirmed by imaging study for greater than 12 weeks subjects have failed medical therapy

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: pathogenesis study|nan|

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
-----------------
chronic sinusitis
Clinical Evaluation of Ultrashort-term Heat Inactivation of Cytomegalovirus (CMV) Containing Raw Breast Milk to Prevent CMV-infection of Preterm Infants

Study Overview
=================
Brief Summary
-----------------
To evaluate, in a prospective multicenter study, ultrashort-term heat inactivation for the prevention of Cytomegalovirus (CMV) transmission in preterm infants (<32 weeks gestational age or <1500 g birth weight) under clinical conditions. Inactivation will be done only during the period of infectivity of breast milk, characterized by viral excretion strongly associated with subsequent infection, monitored by periodic virologic examinations of BM and urine of the infant. Thus the investigators hypothesis is that no CMV transmission through breast milk will occur using a gentle ultrashort heat inactivation procedure applied to infective breast milk. The protocol has been approved by the ethics committee of Tuebingen University Hospital.

Official Title
-----------------
Clinical Evaluation of a Gentle But Safe Ultrashort-term Heat Inactivation Procedure of Raw Breast Milk (BM) Containing Virulent Cytomegalovirus for Preventing CMV-infection of Preterm Infants

Conditions
-----------------
Cytomegalovirus Infection, Preterm Infants

Intervention / Treatment
-----------------
* Procedure: ultrashort heat inactivation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: <32 Weeks or GA or <1500g BW mother CMV IgG positive breast milk feeding Exclusion Criteria: parents disagree

Ages Eligible for Study
-----------------
Minimum Age: 23 Weeks
Maximum Age: 40 Weeks

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mother CMV positive<br> | Procedure: ultrashort heat inactivation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with CMV viruria |  | 40 weeks gestational age, or at discharge from NICU (if this is earlier) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with specific neonatal outcome parameters as a measure of neonatal quality | Intracranial hemorrhage (ICH) Periventricular leucomalacia (PVL) Necrotizing enterocolitis (NEC) Bronchopulmonary dysplasia (BPD) Retinopathy of prematurity (ROP) | 40 weeks of gestational age or at discharge from NICU (if this is earlier) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postnatal CMV infection of preterm infants, breast milk
Rehabilitation Post Lumbar Microdiscectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a rehabilitation program following lumbar microdiscectomy influences short-term (4 months) and long-term (up to 5 years)outcomes in quality of life, activity and endurance.

Detailed Description
-----------------
Exercise

Conditions
-----------------
Low Back Disorder

Intervention / Treatment
-----------------
* Procedure: Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-60 years old Single level lumbar microdiscectomy Exclusion Criteria: Potential subjects will be excluded is they exhibit symptoms suggestive of facet arthrosis or neurogenic claudication, or if their plain radiographs showed more than 50 percent loss of disc height at the relevant level. Patients in whom the protrusion occupied more than 50 percent of the sagittal diameter of the spinal canal or in whom sequestrated fragments were seen on MRI will also be excluded. Other exclusion criteria will include: Previous back surgeries Presence of any other concurrent foot pathology besides leg and low back pain and associated single level disc injury Nervous system problems (e.g., stroke, dementia, seizures) Cognitive dysfunction (e.g. TBI, CVA, Alzheimer's) Uncontrolled cardiovascular disease Evidence of cord compression Uncontrolled hypertension Infection Severe respiratory disease Pregnancy Rheumatic joint disease Peripheral vascular disease with sensory loss of the foot Any condition that the subject identifies that might limit participation in physical activity

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Other: Exercise|exercise 3 times per week for 12 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ODI |  | pre and post intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise
Involvement of Translation Initiation Factors in the Immune Response in the Elderly

Study Overview
=================
Brief Summary
-----------------
The investigators propose that the translation initiation factors eIF4E and eIF4GI may be involved in resolution of acute inflammation (regardless of age). Furthermore, the investigators suggest that differences in translation initiation factors state of activation may contribute to inflammation. Finally, the investigators hypothesize that differences in translation initiation factors state of activation may underlie the immune compromised state of the very elderly affording additional explanation for the heightened morbidity from infection in this group. In the current study the investigators aim to test these hypotheses by measuring the levels of eIF4E and eIF4G, their regulators, and targets in elderly (65-84yrs) and very elderly (85yrs<) patients hospitalized at Meir hospital for acute infection and after their recovery (detailed in study design).

Official Title
-----------------
Characterization of the Involvement of Translation Initiation Factors in the Immune Response to Acute Infection in the Elderly and Very Elderly

Conditions
-----------------
Elderly Patient, Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elderly patients (65<) hospitalized for acute infection (fever 38c<, leukocytosis) Exclusion Criteria: patients with dementia who can not sign informed consent of institutional Helsinki committee patient with active cancer with active chemotherapy treatment

Ages Eligible for Study
-----------------
Minimum Age: 65 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
-----------------
elderly patients, acute infection, translation initiation factors, eIF4E, eIF4G
Osseointegration of Hydroxyapatite-coated Femoral Stems in Femoral Neck Fractures Over 80 Years

Study Overview
=================
Brief Summary
-----------------
This study aimes to prove that osseointegration of hydroxyapatite coated stem is possible for patients over 80 years with femoral neck fracture, without the risks of cemented stems. The hydroxyapatite has a local effect which can improve cortical index.

Official Title
-----------------
Osseointegration of Hydroxyapatite-coated Femoral Stems in Femoral Neck Fractures Over 80 Years

Conditions
-----------------
Femoral Neck Fractures

Intervention / Treatment
-----------------
* Procedure: Hemiarthroplasty with hydroaxyapatite coated stem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 80 years 1 year follow-up femoral neck fracture Exclusion Criteria: bad-realized radiographs

Ages Eligible for Study
-----------------
Minimum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Femoral neck fracture<br>Patients over 80 years when suffering of femoral neck fracture with at least one year follow-up. | Procedure: Hemiarthroplasty with hydroaxyapatite coated stem<br>* Hemiarthroplasty with non cemented femoral stem, using the hydroxyapatite-coated femoral stem Pharo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engh and Massin score | Measure of the osseointegration | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CBR | Mesure of level of osteoporosis | 1 month |