linjc16/ctgov huggingface dataset:
Preservative-free Tafluprost Eye Drops in Newly Diagnosed Patients With Glaucoma

Study Overview
=================
Brief Summary
-----------------
Glaucoma encompasses a collective group of optic neuropathies characterized by progressive degeneration of retinal ganglion cells and their axons, resulting in cupping, a distinctive appearance of the optic disc, and a pattern of visual loss

Detailed Description
-----------------
Saflutan® is the first preservative-free prostaglandin analog introduced to the Egyptian market. It contains the PG analog tafluprost. Better tolerability, higher adherence to treatment and improvement of patients' quality of life are associated with using preservative-free eye drops.

Official Title
-----------------
Preservative-free Tafluprost Eye Drops in Newly Diagnosed Patients With Glaucoma: A Prospective Clinical Study

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Preservative-free tafluprost eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males and females, newly diagnosed with glaucoma, naïve to glaucoma medications and surgery, able to read, comprehend, and complete the Ocular Surface Disease Index (OSDI) questionnaire, and able to provide informed consent form. Exclusion Criteria: Unable to provide informed consent form

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
Intervention Model: Single Group Assignment
Interventional Model Description: This was an open-label, non-randomized clinical study that aimed to assess the ocular signs and symptoms in 60 eyes of 30 newly diagnosed Egyptian glaucoma patients receiving preservative-free tafluprost eye drops.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preservative-free tafluprost<br>This was an open-label, non-randomized clinical study that aimed to assess the ocular signs and symptoms in 60 eyes of 30 newly diagnosed Egyptian glaucoma patients receiving preservative-free tafluprost eye drops | Drug: Preservative-free tafluprost eye drops<br>* This was an open-label, non-randomized clinical study that aimed to assess the ocular signs and symptoms in 60 eyes of 30 newly diagnosed Egyptian glaucoma patients receiving preservative-free tafluprost eye drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure (IOP) | Intraocular pressure (IOP) | 12 weeks |
Evaluation of the Efficacy and Tolerance of Plasmapheresis by Double Cascade Filtration in a University Centre

Study Overview
=================
Brief Summary
-----------------
A study is being carried out to evaluate the biological, technical and clinical/biological efficacy of this technique, the practice of which is standardized in the department, in order to evaluate our practices and to improve them if necessary. As part of this study, the investigators will ask all patients scheduled for this procedure to participate in this observational prospective study without changing usual practices.

Detailed Description
-----------------
The objective of the study is to conduct a prospective evaluation of the practice of apheresis by Double Filtration System Cascade system in a university centre in current practice with evaluation of the technical and biological effectiveness as the main objective and clinical and biological tolerance as the secondary objective for all consecutive sessions performed in a university centre over a period of 1 year.

Official Title
-----------------
Evaluation of the Efficacy and Tolerance of Plasmapheresis by Double Cascade Filtration in a University Centre

Conditions
-----------------
Kidney Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age I indication for plasmapheresis and hospitalized at Chu de Nimes. Exclusion Criteria: Under guardianship or curatorship Refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 99 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apheresis by DFPP and biological efficiency | quantification of the purification carried out (volume) | over a period of one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical side effects | catheter dysfunction | within 1 hour of all session | 
| Biological side effects | Bleeding rate | within 1 hour of all session | 
| variation of Hb, platelet and albumin before and after session | % of Hb, platelet and albumin | within 1 hour of all session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic hemodialysis
Exercise Intervention - and Impact on Hospitalization

Study Overview
=================
Brief Summary
-----------------
Skeletal muscle abnormalities (sarcopenia) and frailty are common complications seen in patients with end-stage liver disease. The presence of these complications portends poor prognosis. The purpose of this study is to assess the impact of a formal home based video strengthening program (REST) on sarcopenia and frailty. We also want to assess the impact of this exercise program on complication rates, hospitalization, on quality of life (QOL) and on survival.

Official Title
-----------------
Exercise Intervention and Its Impact on Hospitalization - a Mulitcentered Study

Conditions
-----------------
Sarcopenia, Debility Due to Disease

Intervention / Treatment
-----------------
* Behavioral: exercise
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
inclusion= waitlisted for liver transplant with poor 6MWT Exclusion criteria include: age < 18 years, recent hospitalization (within 14 days) due to decompensation, variceal bleeding in the previous 1 month, large esophageal varices without primary prophylaxis, active excessive alcohol intake (in the previous 3 months), current overt uncontrolled hepatic encephalopathy, hepatopulmonary syndrome with uncontrolled hypoxia, portopulmonary hypertension, inability to perform exercise, or marked symptomatic comorbidities (cardiac, pulmonary, renal). multiorgan transplant

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: home exercise vs standard care with cross-over
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: home exercise<br>participate in home exercise program | Behavioral: exercise<br>* home exercise program<br>|
| Placebo Comparator: standard care<br>encouraged to join physical therapy and walking goals | Other: placebo<br>* encourage walking and physical therapy per standard care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6MWT | 6 minute walk | 3 months | 
| hand grip | hand grip | 3 months |
Reliability and Validity of the ISNCSCI in Patients With Non-traumatic Spinal Cord Lesions

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to assess the psychometric properties of the International Standards for Neurological Classification of Spinal Cord Injury in subjects with non traumatic lesions.

Detailed Description
-----------------
All patients with non-traumatic SCI consecutively admitted to three Italian SCI centers (IRCCS Fondazione Santa Lucia, Montecatone Rehabilitation Hospital and Istituti Clinici Scientifici Maugeri IRCCS of Pavia) between January 1st 2017 and June 30th 2020 have been prospectively enrolled in the study.

Official Title
-----------------
Reliability and Validity of the International Standards for Neurological Classification of Spinal Cord Injury in Patients With Non-traumatic Spinal Cord Lesions

Conditions
-----------------
Spinal Cord Injuries

Intervention / Treatment
-----------------
* Other: rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having a non-traumatic SCI acute / subacute phase any level and severity (ASIA Impairment Scale) of injury having a cognitive status that allows collaboration in the exam. Exclusion Criteria: presence of dementia or cognitive decline; having a pathology of the peripheral nervous system that may affect the evaluation of ISNCSCI; having a multiple sclerosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: rehabilitation|Patients underwent ususal rehabilitation treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interanational Standards for Neurological Classification of Spinal Cord Injury | standards to evaluate neurological status of subject with spinal cord injury | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal Cord Independence Maesure | Outcome measure to evaluate the independence in daily life activities for subjects with spinal cord injury | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non traumatic spinal cord injury, ISNCSCI, inter-rater reliability, rehabilitation
Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome

Study Overview
=================
Brief Summary
-----------------
To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS).

Official Title
-----------------
Use of 3,4-Diaminopyridine(3 4-DAP)in the Treatment of Lambert-Eaton Syndrome (LEMS)

Conditions
-----------------
Lambert Eaton Myasthenic Syndrome

Intervention / Treatment
-----------------
* Drug: 3, 4-Diaminopyridine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older, Diagnosed with LEMS, If female, have a negative pregnancy test, and If premenopausal, be willing to practice an effective form of birth control during the study, Tested and found by ECG not to have a prolonged QT syndrome, Agree to have a second ECG at the time of peak drug effect, Has understood and signed the Informed Consent. Exclusion Criteria: Is known to have a sensitivity to 3, 4-DAP, Has a history of: past or current seizures, cardiac arrhythmia, hepatic, renal or hematologic disease, or severe asthma, Is believed by the investigator to be unable to comply with the protocol.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 3, 4-Diaminopyridine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Hypoxia Blood Validation in Multiple Pulse Oximeters

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the SpO2 accuracy and performance of multiple pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. This study is observational in nature which quantifies device performance and accuracy in comparison to a Reference Standard.

Detailed Description
-----------------
The purpose of this study is to evaluate the SpO2 accuracy and performance of pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the pulse oximeters. It is expected that the Accuracy Root Mean Square (Arms) performance of pulse oximeters will meet a specification of 3 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification

Official Title
-----------------
Accuracy Validation in Multiple SpO2 Systems

Conditions
-----------------
Hypoxia

Intervention / Treatment
-----------------
* Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy individuals between the age of 18-50 years. Exclusion Criteria: Clotting disorders, diabetes, currently taking psychotropic medications.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Healthy volunteer<br>Smoker or non-smoker | Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature<br>* Measurement of physiological parameters.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of study by all subjects |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulse Oximetry, Temperature, Respiratory Rate, Respiratory Gases, This study determine the measurement accuracy of the physiological parameters
Tear Evaluation Between Habitual Contact Lens Wearers and Non Contact Lens Wearers

Study Overview
=================
Brief Summary
-----------------
to evaluate tears between habitual contact lens wearers and non contact lens wearers

Detailed Description
-----------------
The objective of this study is to evaluate tears between habitual contact lens wearers and non contact lens wearers using a Schirmer Strip for tear collection.

Official Title
-----------------
Tear Evaluation Between Habitual Contact Lens Wearers and Non Contact Lens Wearers Using a Schirmer Strip for Tear Collection

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

Intervention / Treatment
-----------------
* Device: Contact Lens Wear
* Device: Contact Lens Wear
* Other: Non-Contact Lens Wear


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have no allergic conjunctivitis. Not be using any topical ocular medications. Exclusion Criteria: Considered by the Investigator to not be a suitable candidate for participation

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Contact Lens Wear<br>Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution | Device: Contact Lens Wear<br>* Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye.<br>Device: Contact Lens Wear<br>* Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye.<br>|
| Non-Contact Lens Wear<br> | Other: Non-Contact Lens Wear<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyaluronan Levels | Tear samples collected using a Schirmer tear strip and analyzed for hyaluronan (HA) levels, a lubricant found throughout the body, including tears. Levels will be compared between the lens wearers and non-lens wearers. | 7 days following lens insertion |
GlideScope Groove Versus Macintosh Blade for Double-Lumen Endotracheal Tube Intubation

Study Overview
=================
Brief Summary
-----------------
A new GlideScope videolaryngoscope has been developed, which utilizes a track on the superior surface of the blade to guide the endotracheal tube, which is advanced in the track as opposed to free-hand along the inferior surface, where the camera is located. This new GlideScope can be used for double-lumen endotracheal tubes (DLT). The investigators hypothesize that this GlideScope will be easier to use than the Macintosh blade.

Official Title
-----------------
Comparison of GlideScope Groove to Macintosh Blade for Orotracheal Intubation With Double-Lumen Endotracheal Tube: a Randomised Controlled Trial

Conditions
-----------------
Intubation, Intratracheal

Intervention / Treatment
-----------------
* Device: GlideScope Groove
* Device: Control: Macintosh blade


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any adult patient booked for elective surgery requiring orotracheal intubation with a double lumen endotracheal tube. Exclusion Criteria: Any patient with cervical spine abnormalities. Any patients with known or probable difficult airways. Any patient requiring rapid sequence induction.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GlideScope Groove<br>Patient will be intubated using the GlideScope Groove device. | Device: GlideScope Groove<br>* GlideScope Groove<br>* Other names: Verathon;|
| Active Comparator: Control<br>Control Group: Macintosh Blade | Device: Control: Macintosh blade<br>* Control: Patients will be intubated using the Macintosh blade<br>* Other names: Mac 3, 4;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Intubation | The intubation will be timed using a stopwatch. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intubation attempts | Number of intubation attempts | Day 1 | 
| Number of failures to intubate | Number of failures to intubate | Day 1 | 
| Use of external laryngeal pressure | Whether or not external laryngeal pressure was needed to facilitate tracheal intubation | Day 1 | 
| Laryngoscopic grade distribution | Cormack and Lehane Grade observed during laryngoscopy | Day 1 | 
| Presence of Sore throat | Sore throat will be graded on POD #2 as none, mild, moderate, or severe | Day 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intubation, double lumen tube
Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01. Up to 12 subjects who completed ApoGraft-01 study will be offered to participate in this follow-up study. Subjects who completed ApoGraft-01 study and have signed informed consent for this follow-up study will be eligible to enroll. Subject will attend in-clinic visits up to 2 years post transplantation, and will undergo the following evaluations: acute and chronic graft versus host disease (GvHD) assessments, survival status (overall, relapse-free), disease status (disease relapse/recurrence), physical examination, safety laboratory and concomitant medication use.

Official Title
-----------------
A Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study

Conditions
-----------------
Acute Myelogenous Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Non Hodgkin Lymphoma (NHL), Hodgkin Lymphoma, Adult

Intervention / Treatment
-----------------
* Other: non intervational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who completed study ApoGraft-01 through 180 days (6 months) post-transplantation Ability to comply with the requirements of the study. Signed written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| one group, ApoGraft Follow up Study<br>Non-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01 | Other: non intervational<br>* Subjects who completed ApoGraft-01 study (through 180 days post-transplantation) and have signed informed consent for this follow-up study will be eligible to enroll. Subject will attend 4 in-clinic visits, once every 6 months up to 2 years post transplantation, and will undergo the following evaluations: acute and chronic graft versus host disease (GvHD) assessments, survival status (overall, relapse-free), disease status (disease relapse/recurrence)<br>* Other names: ApoGraft follow up;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence, grade and stage of acute GvHD and chronic GvHD | GVHD will be assessed according to NIH criteria 2005; current and maximal score at each visit. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-relapse-related mortality |  | 18 months | 
| Proportion of subjects with disease relapse/recurrence |  | 18 months | 
| Proportion of subjects with relapse free and overall survival |  | 18 months |