linjc16/ctgov huggingface dataset:
ERILs Und SNILs Unter SOC

Study Overview
=================
Brief Summary
-----------------
How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment? How many SNILs occur between 7 and 30 days after acute ischemic event on standard treatment? How many of during acute event diagnosed lesions (ERILs) are (still) detectable after 30 days? Are there relevant risk faktors for the occurence of ERILs and SNILs (eg Diabetes or Biomarkers)?

Detailed Description
-----------------
In this trial, patients will be observed if they develop early recurrent ischemic lesions (= ERILs) or silent neurologic ischemic lesions (= SNILs) after acute stroke or transitoric ischemic attack (TIA) based on atherothrombosis (LAA-stroke) on standard therapy during 30 days (day 7 and day 30 after acute event) via DW-MRI (diffusion-weighted magnetic resonance imaging). We want to investigate if diffusion-weighted imaging of silent brain infarcts occuring during standard therapy is a suitable surrogate outcome measure for interventional studies

Official Title
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Early Recurrent Ischemic Lesions (ERILs) and Silent Neurologic Ischemic Lesions (SNILs) in Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) - a Pilot- Observational Study Under Standard of Care (SOC)

Conditions
-----------------
Stroke, Acute

Intervention / Treatment
-----------------
* Diagnostic Test: diffusion-weighted magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: LAA stroke or TIA ERILs or SNILs detected in initialDW-MRI signed informed consent Exclusion Criteria: planned surgical intervention iv Thrombolysis atrial fibrillation contra indications against DW-MRI

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: magnetic resonance imaging<br>DW-MRI after ischemic stroke | Diagnostic Test: diffusion-weighted magnetic resonance imaging<br>* diffusion-weighted magnetic resonance imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment? | DW-MRI to detect lesions | 7 days after acute stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2. How many SNILs occur between 7 and 30 days after acute ischemic event on standard treatment and how many of during acute event diagnosed lesions (ERILs) are (still) detectable after 30 days? | DW-MRI to detect lesions | 30 days after acute stroke |
Assessment of the Safety and Efficacy of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the safety and efficacy of BRM424 OS compared to vehicle in patients with neurotrophic keratitis.

Official Title
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A Double-Masked, Multi-Center, Randomized, Vehicle- Controlled, Phase II Trial of the Efficacy and Safety of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NK)

Conditions
-----------------
Neurotrophic Keratitis

Intervention / Treatment
-----------------
* Drug: BRM424 Ophthalmic Solution
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age; Provide written informed consent; Patients with NK Stage 2 (PED) or Stage 3 (corneal ulcer); Exclusion Criteria: Any active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to NK; Anticipated need to use therapeutic contact lenses or contact lens wear for refractive correction during the 28-days Treatment Period in the eye(s) with NK; Be a woman of childbearing potential who is not using an acceptable means of birth control;

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double Masking
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BRM424 Ophthalmic Solution<br> | Drug: BRM424 Ophthalmic Solution<br>* A topical drop of BRM424 ophthalmic solution.<br>|
| Placebo Comparator: Vehicle<br> | Drug: Vehicle<br>* A topical drop of vehicle (minus active) ophthalmic solution.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining |  | 4 weeks |
Oral Symptoms of COVID-19 Among Infected Medical Doctors

Study Overview
=================
Brief Summary
-----------------
Oral symptoms of corona virus disease have been reported by many studies. The lack of direct contact between the dentist and the patient during the active disease presented an obstacle to build a strong body of evidence. the aim of the study is to report the oral symptoms of COVID-19 and correlate the occurrence of these symptoms with various disease-related factors.

Detailed Description
-----------------
This is a cross-sectional web-based survey targeted Medical doctors infected with COVID-19. The survey questioned the diagnosis of the disease, the severity of the disease, the general symptoms, the oral symptoms along with drug and medical history. The survey comprised a total of 3 main sections. The first section included demographic data and diagnostic method for COVID-19 infection. The second section included question about duration of the disease, the general manifestations of the disease, the previous medical history. History of smoking, severity of COVID-19 infection and history of hospitalization. Drug history and treatments for COVID-19. Presence of blood discrepancies during COVID-19 infection. The third section targeted detailed oral manifestations of the disease and questions about the oral hygiene and presence of previous oral lesions. The questions about oral manifestations were designed based on a systematic search through the current literature, dated between 2019 and January 2021.

Official Title
-----------------
Oral Manifestations of COVID-19 Correlated to Medical History. A Survey on Infected Medical Doctors.

Conditions
-----------------
COVID-19 Respiratory Infection

Intervention / Treatment
-----------------
* Other: Medical doctors infected with COVID-19


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 infection Medical doctors Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Medical doctors infected with COVID-19|web-based survey|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of oral symptoms |  | 14 days of infection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Dysgeusia, Xerostomia
Effects of a 3D Printing Technology Learning Program

Study Overview
=================
Brief Summary
-----------------
3D printing technology helps rehabilitation professionals make an order-made assistive device (AD). However, most have not learned how to use the technology for clinical practice. The study is aimed to evaluate a 3D printing technology learning program for rehabilitation professionals. Eligible participants who have a licence for physical, occupational or speech-language therapy and have not experienced learning any 3D printing technology. The learning program was conducted in accordance with Kolb's Experiential Learning Theory (Morris TH, 2020). The program was conducted over eight weeks. The outcome measure included the Japanese version of the modified Technology Acceptance Model questionnaire (TAM-J). It consists of 13 items and four scales; Perception of usefulness (28 points total), Perception of ease of use (35 points total), Attitude toward use (14 points total) and Intention to use (14 points total). Within-group analyses were performed using the Wilcoxon signed-rank test for the TAM-J between different time points.

Official Title
-----------------
Effects of a 3D Printing Technology Learning Program for Rehabilitation Professionals: a Randomized Control Trial

Conditions
-----------------
Educational Problems

Intervention / Treatment
-----------------
* Behavioral: 3D printing technology learning program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible participants who have a licence for physical, occupational or speech-language therapy Exclusion Criteria: Participants who have experienced learning any 3D printing technology.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Effects of a 3D Printing Technology Learning Program<br> | Behavioral: 3D printing technology learning program<br>* The study is aimed to evaluate a 3D printing technology learning program for rehabilitation professionals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Japanese version of modified Technology Acceptance Model questionnaire | A higher score means the strong acceptance of 3D printing technology(score range is 13 to 91 points) | Change from Baseline a score of the Japanese version of modified Technology Acceptance Model questionnaire at 2 months |
Efficacy of Massage Versus Massage With Post Isometric Relaxation Exercises in Temporomandibular Disorders

Study Overview
=================
Brief Summary
-----------------
To determine effectiveness of massage versus massage with post isometric relaxation exercises in temporomandibular disorders for pain and limited joint mobility.

Official Title
-----------------
Efficacy of Massage Versus Massage With Post Isometric Relaxation Exercises in Temporomandibular Disorder

Conditions
-----------------
Pain, Joint

Intervention / Treatment
-----------------
* Diagnostic Test: Massage with post isometric relaxation exercises
* Diagnostic Test: Massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with clinical features with myofascial pain and limited mouth opening fulfilling the Axis Group I of RDC/TMD criteria, absence of temporomandibular disc displacement with or without reduction, good general health (absence of chronic diseases which may affect temporomandibular joint or the masticatory muscles), full dental arches with natural teeth or missing teeth replaced with fixed dental prostheses Exclusion Criteria: earlier splint therapy, pharmacotherapy (e.g., hormone replacement therapy, oral contraception and antidepressants), injury of masticatory organ, undergoing orthodontic treatment, inflammation in oral cavity (e.g., impacted molars and pulp inflammation) and fibromyalgia

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Massage with post isometric relaxation exercises<br> | Diagnostic Test: Massage with post isometric relaxation exercises<br>* Post isometric relaxation will be performed in supine position with neutrally positioned head.<br>|
| Experimental: Massage<br> | Diagnostic Test: Massage<br>* conservative physiotherapy protocol including massage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Massage exercises , Massage with post isometric relaxation exercises |  | 6 Months |
Interest of Performing Two 6-minute Walk Tests at the End of a Pulmonary Rehabilitation Program, in COPD Patients.

Study Overview
=================
Brief Summary
-----------------
In pulmonary rehabilitation, the 6-Minute Walk Test (6MWT) is essential to assess the effects of the program on patients' health. Current guidelines don't recommend to perform two 6MWT at the end of pulmonary rehabilitation. However, a more recent study shows that two 6MWT should be performed at the end of the program to accurately and reliably assess patients' capacities. The aim of this study is to compare the results of two tests performed at the end of the program by COPD patients to find out whether there is a benefit of performing two 6MWT at the end of pulmonary rehabilitation.

Official Title
-----------------
Interest of Performing Two 6-minute Walk Tests at the End of a Pulmonary Rehabilitation Program, in COPD Patients.

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with stage 2 to 4 (A to D) COPD Admitted to pulmonary rehabilitation unit of CH des Pays de Morlaix (CHPM) To follow a pulmonary rehabilitation program (4 weeks) Patient aged 18 or over Patient able to formulate his non-opposition to participate in the study Exclusion Criteria: Contraindication to perform the 6-Minute Walk Test Patient under legal protection Refusal of participation

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 |
| --- | --- | --- |
| 6 minute walk distance (6MWD) | Comparison of the 6MWD between the first and the second 6MWT performed at the end of pulmonary rehabilitation program. | Two hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary rehabilitation, exercise capacity
Development of a Multidisciplinary Network for Clinical and Laboratory Research for SMA

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to to establish profiles of clinical progression in patients affected by the different types of SMA (type I, II and III) treated with the currently approved drugs using a structured battery of clinical tests. Another goal of the study is to assess the progression of the disease in patients identified through neonatal screening.

Detailed Description
-----------------
The collection of 2-year longitudinal clinical data will be conducted in newly treated patients at baseline, 6-, 12-, 14- and 22-months post-treatment. Parameters will include motor function, fatigability, respiratory function, event-free survival and death, and swallowing and feeding modalities. It is anticipated that at least 30 new patients will be enrolled in the study. Importantly, information will also be collected on patients who may decide to switch treatment during the duration of our study, trying to establish if the switch to a new drug (or as an add-on should patients take a new treatment after being treated with gene therapy) may be associated with changes in clinical phenotype. The aim is to apply a newly established clinical protocol that allows identifying minor signs of disease that are easily missed in the absence of an NBS-detected diagnosis. Indeed, not all infants identified as SMA-positive through the NBS are truly asymptomatic, as a proportion of them may appear paucisymptomatic and their minor signs could be possibly not detected in the absence of a positive screening test.

Official Title
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Development of a Multidisciplinary Network for Clinical and Laboratory Research for Spinal Muscular Atrophy and Other Rare Motoneuron Diseases

Conditions
-----------------
Spinal Muscular Atrophy

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: All SMA patients Exclusion Criteria: Inability to understand or to provide informed consent.
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 |
| --- | --- | --- |
| Establish profiles of clinical progression in patients affected by the different types of SMA (type I, II and III) treated with the currently approved drugs using a structured battery of clinical tests. |  | 2-year | 
| Assess the progression of the disease in patients identified through neonatal screening |  | 2-year | 
| Identification of molecular biomarkers that associate with disease course and response to therapies |  | 2-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal muscular atrophy
Prospective Observational Study on Outcome of High-precision Hypo-fractionated Radiotherapy in Metastatic Breast Cancer (PRECISE-M)

Study Overview
=================
Brief Summary
-----------------
This study is a prospective observational study on outcomes of high precision hypo-fractionated radiotherapy in breast cancer with distant metastasis.

Official Title
-----------------
Prospective Observational Study on Outcome of High-precision Hypo-fractionated Radiotherapy in Metastatic Breast Cancer (PRECISE-M)

Conditions
-----------------
Breast Cancer, Metastatic Breast Cancer, Radiation Therapy Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed breast cancer presence of distant metastasis radiation therapy using IMRT, SBRT, or proton therapy is done or planned Able and willing to comply with the study protocol Exclusion Criteria: unable to adhere to the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
| Local control rate | LC after radiation therapy | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate |  | 1-year | 
| Disease-free survival | disease-free survival rate after the time of RT | 1-year | 
| Treatment-related toxicities | Acute and chronic radiation toxicities according to CTCAE v5.0 | 1-year |
Translation and Reliability of FAAM-U

Study Overview
=================
Brief Summary
-----------------
This study is designed to translate and validate the FAAM questionnaire to the Urdu language, to interpret its psychometric properties, and to determine the reliability of scores obtained from the population of Pakistan. The translated version of the gold standard tool will be used by the local population as well as Urdu-speaking immigrants across the globe to better understand and report the severity of their symptoms. Hence, to improve quality of life across cultures, there is a need of standard outcome measures in Urdu language.

Official Title
-----------------
Translation, Cross-Cultural Adaptation and Reliability of Urdu Version of The Foot and Ankle Ability Measures (FAAM-U)

Conditions
-----------------
Foot Injuries, Ankle Injuries

Intervention / Treatment
-----------------
* Other: FAAM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ankle and foot disorders, referred by a general physician or surgeon, Conscious Ambulatory Able to write and read Urdu language Exclusion Criteria: inflammatory disease vascular diseases neural diseases cancer

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 44 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 |
| --- | --- |
| Single Group<br>A total of 175 patients with a range of foot or ankle problems were included for the review. Informed consent was taken from the review members in written form. They all finished the Urdu version of FAAM in the test session. With a time, span of 3 days after the primary recording, a total of the 175 patients whose conditions were relied upon to stay stable were approached to complete the forms again in the retest meeting; no treatment was given during this time-frame. The FAAM is made out of two subscales including ADL and Sports subscales that have a complete score of 84 and 32, individually. Also, toward the finish of the structure, patients were approached to rate the current degree of function with a 4-point Likert scale. Patients evaluated everything as indicated by the trouble they go over with each undertaking on account of their foot or ankle condition. After assortment, information was saved in a safe spot to keep away from any dispositions. | Other: FAAM<br>* The FAAM is made out of two subscales including ADL and Sports subscales that have a complete score of 84 and 32, individually<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FAAM-U | The FAAM is made out of two subscales including ADL and Sports subscales that have a complete score of 84 and 32, individually. Also, toward the finish of the structure, patients were approached to rate the current degree of function with a 4-point Likert scale | 72 Hours |