linjc16/ctgov huggingface dataset:
A Study to Evaluate Satisfaction With Care in Patients With Cancer Receiving Immunotherapy Treatment at Home

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study in France is to evaluate changes in satisfaction with care in participants with solid tumors who transitioned from receiving immunotherapy treatment in the hospital outpatient setting to receiving treatment at home

Official Title
-----------------
A French Non-interventional Prospective Multicenter Study Evaluating Quality of Care Perception of Cancer Patients Treated by Immunotherapy at Home - SATISFACT-HOME

Conditions
-----------------
Cancer, Solid Tumors

Intervention / Treatment
-----------------
* Drug: Immunotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ 18 years old Participants whose oncology specialist has already initiated treatment with immune checkpoint inhibitors (ICIs) in the outpatient hospital setting for an advanced solid tumor (as monotherapy or in combination) or as adjuvant therapy, in an indication approved and reimbursed in France Participants whose oncology specialist has independently of the study defined their eligibility for hospital at home (HAH) before contacting the HAH unit for final admission Participants who provide oral informed consent to participate in the study Exclusion Criteria: Participants who have expressed an opposition to their data collection Participants under guardianship Participants taking part in an interventional study for cancer treatment with at least one ICI as an investigational drug

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 |
| --- | --- |
| Participants receiving immunotherapy at home<br> | Drug: Immunotherapy<br>* Immune checkpoint inhibitors in approved indications<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient satisfaction on the European Organisation for Research and Treatment of Cancer satisfaction with cancer care core questionnaire (EORTC PATSAT-C33) when transitioning from Outpatient Hospital to Hospital at Home to receive immunotherapy |  | Participants follow up approximately 24 weeks after transition to treatment at home |
Impact of a History of Tonsillectomy or Adenoidectomy on the Severity of COVID-19 : AMYVID Study

Study Overview
=================
Brief Summary
-----------------
Little is known about the impact of tonsillectomy and/or adenoidectomy on the severity and presentation of respiratory infections, let alone COVID-19. Current knowledge of the role of NALT suggests that its absence may be associated with an increased risk of severe disease. Assessing the impact of tonsillectomy and adenoidectomy on the risk of adverse evolution in COVID-19 would help to better identify patients at risk of adverse evolution, so that they can be rapidly offered appropriate treatment. It would also provide a better understanding of the pathophysiology of this infection. Primary objective: to determine whether there is a link between a history of tonsillectomy or adenoidectomy and the risk of severe COVID-19. Primary endpoint: proportion of patients with a history of tonsillectomy or adenoidectomy among those hospitalized for severe COVID-19. The results of this study will be compared with a data-driven study of Covid patients without severe disease.

Official Title
-----------------
Impact of a History of Tonsillectomy or Adenoidectomy on the Severity of COVID-19 : AMYVID Study

Conditions
-----------------
Tonsillectomy, COVID-19, Adenoidectomy

Intervention / Treatment
-----------------
* Other: health questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 to 80 Hospitalized in SMIT at CHU d'Angers between 01/03/2020 and 30/11/2021 for severe COVID-19 infection (at least 1 severity criterion) Exclusion Criteria: Long-term home oxygen therapy prior to COVID-19 infection Vaccination against COVID-19 with at least one dose of vaccine received prior to COVID-19 infection Confidential Page 11 of 15 Inability to ascertain the presence or absence of a history of tonsillectomy or adenoidectomy Person objecting to participation in research

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: health questionnaire|Telephone interview with patient to verify medical history, including tonsillectomy and adenoidectomy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with a history of tonsillectomy or adenoidectomy. |  | immédiat |
A US Non-interventional, Effectiveness and Safety Study of Patients Treated With SKYTROFA

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to genrate evidence on long-term effectiveness and safety of SKYTROFA (lonapegsomatropin) in patients with growth hormone deficiency under routine clinical care

Detailed Description
-----------------
Patients will be treated according to routine clinical practice, and no additional visits, examinations or tests will be required beyond those performed as part of routine clinical practice except for COAs.

Official Title
-----------------
A US Multi-center, Prospective, Non-interventional, Long Term, Effectiveness and Safety Study of Patients Treated With SKYTROFA (Lonapegsomatropin)

Conditions
-----------------
Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are on treatment with SKYTROFA (lonapegsomatropin) Patients being clinically managed in USA Patients with an appropriate written informed consent/assent as applicable for the age of the patient Exclusion Criteria: Patients participating in any interventional clinical study

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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 |
| --- | --- |
| Patients on SKYTROFA Treatment<br>Patients on SKYTROFA Treatment managed in USA with appropriate written Informed Consent | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety of patients treated with SKYTROFA (Lonapegsomatropin) | Incidence of Adverse Events and Serious Adverse Events | 5 years | 
| Assess the effectiveness of patients treated with SKYTROFA (Lonapegsomatropin) | Near adult height (cm) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess clinical outcome assessments (COAs) | Change in Quality of Life in Short Stature Youth (QoLISSY) scores from baseline through End of Study (QOLISSY scores range on a scale of 0 to 100 with higher scores representing better quality of life. (For both child and parent version)) | 5 years | 
| Assess clinical outcome assessments (COAs) | Change in Treatment Satisfaction Questionnaire for Medicine (TSQM-9) scores from baseline through End of Study (The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain) | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human Growth Hormone, SKYTROFA
Kaitoh Atherectomy FIH

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single-center and single-arm clinical study to assess the initial safety and effectiveness of the Kaitoh Atherectomy System for the treatment of de novo and/or restenotic lesion(s) in the peripheral arteries.

Official Title
-----------------
Kaitoh Atherectomy System: Peripheral Artery Revascularization of Stenotic/Restenotic Disease Using the Atherectomy System in the Peripheral Arteries

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: Kaitoh Atherectomy System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years old Rutherford Classification: 3-5 in target limb; a. Rutherford Classification 3 subjects may be enrolled but will be capped to a limit of 20% of the total enrollment (no more than two Rutherford Class 3 subjects may be enrolled into the study). Able and willing to provide informed consent, and comply with follow-up visits at both 30 days and 180 days (6 months) Able to comply with antiplatelet therapy as required Exclusion Criteria: Females who are pregnant or lactating Pre-existing illness with life expectancy <1 year Known or suspected systemic infection Endovascular or surgical procedure performed on the target lesion within 3 months of the index procedure Subjects scheduled to undergo a planned major amputation of the lower limb above the ankle on the target limb Allergic to any of the components of the atherectomy device system Intraprocedural complications prior to use of the investigational device

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kaitoh Atherectomy System<br>Eligible participants will undergo atherectomy using the Kaitoh Atherectomy System. | Device: Kaitoh Atherectomy System<br>* The Kaitoh Atherectomy System is a handheld device which initiates mechanical rotation of the blade to debulk atherosclerotic lesions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from major adverse events (MAEs) | Primary Safety | 30 days post-procedure | 
| Technical success as confirmed by angiography core lab | Effectiveness | through completion of interventional 1 day procedure |
Prevalence of Glaucoma in Belgium: a Multicenter National Trial

Study Overview
=================
Brief Summary
-----------------
To screen for the presence of glaucoma in a Belgian population over 40 years old using an AI algorithm developed for the detection of glaucoma based on fundus pictures.

Detailed Description
-----------------
In this study, we aim to detect individuals with glaucoma and refer them for further evaluation and treatment when necessary. In so doing, we want to get an estimation of the prevalence of glaucoma in the Belgian population of 40+ years. A fundus picture will be acquired without pupil dilation. This examination will be followed by an intra-ocular pressure measurement. The results will be discussed with the participating subject by the present physician. For each subject, both eyes will be evaluated. In case of suspected glaucoma, the subject will be referred to an ophthalmologist for further evaluation.

Official Title
-----------------
Prevalence of Glaucoma in Belgium: a Multicenter National Trial

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

Intervention / Treatment
-----------------
* Device: AI algorithm for the detection of glaucoma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 40 years or above Exclusion Criteria: Aged under 40 years Insufficient knowledge of Dutch, French or English required to complete the imaging protocol and questionnaire Physical or mental inability to participate

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Subjects<br>A fundus picture will be acquired without pupil dilation. This examination will be followed by an intra-ocular pressure measurement. The results will be discussed with the participating subject by the present physician. For each subject, both eyes will be evaluated. In case of suspected glaucoma, the subject will be referred to an ophthalmologist for further evaluation. | Device: AI algorithm for the detection of glaucoma<br>* The investigational device that will be used during this study is an AI algorithm embedded into an API for the detection of glaucoma developed by MONA.health<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of glaucoma in Belgium | To study the prevalence of glaucoma in the Belgian population over 40 years old | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of AI algorithm | To validate an existing AI-based algorithm for automatic detection of glaucoma | 7 months |
NIRST and ICG-based Perfusion Imaging in Acute Compartment Syndrome

Study Overview
=================
Brief Summary
-----------------
This is a prospective observational study of patients with suspected Acute Compartment Syndrome. The primary objective of this work is to determine whether intensity changes associated with the NIRST signal, reflecting oxy- and deoxy-hemaglobin and water concentrations or ICG fluorescence signal, reflecting tissue perfusion, can be associated with development of Acute Compartment Syndrome and identification of at-risk soft tissue and muscle.

Official Title
-----------------
Near-infrared Spectroscopic Tomography (NIRST) and ICG-based Perfusion Imaging to Diagnose and Assess Muscle Viability in High Energy Trauma at Risk for Acute Compartment Syndrome: A Pilot Study

Conditions
-----------------
Compartment Syndromes, Compartment Syndrome of Lower Leg, Compartment Syndrome of Forearm

Intervention / Treatment
-----------------
* Procedure: Lower extremity and/or upper extremity surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Clinical suspicion of acute compartment syndrome based on orthopaedic provider assessment. Clinical suspicion would be based upon the presence of one or more of these findings: Pain out of proportion to visible findings Escalating doses of pain medication Pain with passive stretch of toes and/or fingers Pallor, paresthesias, pulselessness Tense soft tissues High energy tibia or forearm fracture Provision of informed consent Exclusion Criteria: History of allergy to ICG and/or iodine Pregnant women or nursing mothers Any patient with an open wound for whom NIRST device cannot be applied >4cm from the open wound will be excluded from NIRST imaging.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lower leg Trauma<br>High-energy lower leg trauma at risk for Acute Compartment Syndrome | Procedure: Lower extremity and/or upper extremity surgery<br>* Lower extremity and/or upper extremity surgery<br>|
| Forearm Trauma<br>High-energy forearm trauma at risk for Acute Compartment Syndrome | Procedure: Lower extremity and/or upper extremity surgery<br>* Lower extremity and/or upper extremity surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of NIRST or ICG measurements with development of ACS | The primary objective of this work is to determine whether total hemoglobin, oxygen saturation and water content imaged by NIRST or ICG fluorescence signal, reflecting tissue perfusion, can be associated with development of Acute Compartment Syndrome and identification of at-risk soft tissue and muscle. | 36 months |
Carboxytherapy in the Treatment of Atrophic Scars

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of CO2 versus fractional CO2 laser versus platelet rich plasma in treatment of atrophic scars using clinical assessment and ultrasonography

Official Title
-----------------
Efficacy of Carboxy Therapy Versus Fractional Laser CO2 Versus Platelet Rich Plasma in Atrophic Scars, a Comparative Study.

Conditions
-----------------
Atrophic Scar

Intervention / Treatment
-----------------
* Device: Carboxytherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: traumatic and surgical scar Exclusion Criteria: active infections

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carboxytherapy<br>Device | Device: Carboxytherapy<br>* Device generating CO2 gas<br>|
| Active Comparator: Fractional CO2 laser<br>Device | Device: Carboxytherapy<br>* Device generating CO2 gas<br>|
| Active Comparator: Platelet rich plasma<br>platelet rich plasma | Device: Carboxytherapy<br>* Device generating CO2 gas<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Vancouver score |  | 12 weeks |
Injecting Plasma-rich Platelets & Hyaluronic Acid for Patients With Stress Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
Injection of PRP and hyaluronic acid in stress incontinence patients

Detailed Description
-----------------
Operative details Dissection of the ant vag wall from the urethra and lower part of the bladder Identify the bladder neck using Foly s catheter injection of 1.5 to 2 ml PRP combined with Hyaluronic acid suburethra almost at the level of mid urethra (avoiding the bl neck) then closure of the vag wall ( after removal of the excess vag tissue.

Official Title
-----------------
A Pilot Study of Injecting Plasma-rich Platelets and Hyaluronic Acid for Patients With Stress INCONTINENCE; A NON-RANDOMIZED CLINICAL TRIAL

Conditions
-----------------
Stress Incontinence, Female

Intervention / Treatment
-----------------
* Procedure: PRP injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stress incontinence patients Exclusion Criteria: prolapse patients

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Other: Stress incontinence patients<br>PRP injection | Procedure: PRP injection<br>* Injection of PRP and hyaluronic acid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress incontinence change | Visual Assessment System assessment | 6 months |
Compare The Effect of Pendulum Exercises With the Kaltenborn Mobilization Among the Patients of Adhesive Capsulitis

Study Overview
=================
Brief Summary
-----------------
To determine the effect of pendulum exercises with the kaltenborn mobilization among the patients of adhesive capsulitis

Official Title
-----------------
Compare The Effect of Pendulum Exercises With the Kaltenborn Mobilization Among the Patients of Adhesive Capsulitis

Conditions
-----------------
Adhesive Capsulitis

Intervention / Treatment
-----------------
* Diagnostic Test: Pendulum Exercises
* Diagnostic Test: Kaltenborn Mobilization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be of the age group of 40-60 years. Can be male or female Diagnosed with adhesive capsulitis by orthopedic or physical therapist. Pain, stiffness, and limitation of passive shoulder lateral rotation, abduction, and internal rotation of more than 50% compared with the opposite side for at least 3 months Exclusion Criteria: Presence of neurological disorders (e.g., stroke, Parkinson's disease) leading to deficiency of shoulder muscles activity, Severe trauma related to painful stiff shoulder which leads to bony changes of the affected shoulder on radiographs, Previous surgeries and manipulation under anesthesia of the affected shoulder

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pendulum Exercises<br> | Diagnostic Test: Pendulum Exercises<br>* Compare The Effect of Pendulum Exercises Among the Patients of Adhesive Capsulitis<br>|
| Experimental: Kaltenborn Mobilization<br> | Diagnostic Test: Kaltenborn Mobilization<br>* Compare The Effect of Kaltenborn Mobilization Among the Patients of Adhesive Capsulitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Pain assessed by Visual Analog Scale |  | 6 Months | 
| disability index |  | 6 Months |