linjc16/ctgov huggingface dataset:
A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the real-world safety of fedratinib for the treatment of adult participants with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential thrombocythemia myelofibrosis (post-ET MF) who were previously treated with ruxolitinib. Participants will represent the overall patient population with PMF, post-PV MF or post-ET MF who lost adequate response to and/or are intolerant to ruxolitinib. Inadequate response definitions will follow Ministry of Food and Drug Safety-approved label and reimbursement criteria of the Health Insurance Review & Assessment Service.

Official Title
-----------------
Inrebic® (Fedratinib) Post-Marketing Surveillance in Korean Patients With Myelofibrosis

Conditions
-----------------
Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis

Intervention / Treatment
-----------------
* Drug: Fedratinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants 19 years of age or older Participants who will receive fedratinib according to the approved label For the first 2 years after marketing authorization, all participants who have received or are receiving fedratinib will also be registered Participants who signed the informed consent form Exclusion Criteria: Participants who have been prescribed fedratinib for an indication not approved in Korea Participants who have been prescribed fedratinib at a dose not approved in Korea Participants for whom fedratinib is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety

Ages Eligible for Study
-----------------
Minimum Age: 19 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 with myelofibrosis receiving fedratinib<br> | Drug: Fedratinib<br>* According to the approved label<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to Inrebic® (fedratinib) | Up to 6 months |
Transcutaneous Levator Recession for Non-thyroid Lid Retraction

Study Overview
=================
Brief Summary
-----------------
This work aims to describe and assess the efficacy of transcutaneous levator palpebrea superioris muscle recession as a surgical procedure for treatment of upper lid retraction of various causes other than thyroid eye disease

Official Title
-----------------
Transcutaneous Levator Recession for Non-thyroid Lid Retraction

Conditions
-----------------
Eye Diseases

Intervention / Treatment
-----------------
* Procedure: Transcutaneous levator recession


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from upper eyelid retraction of various causes other than thyroid eye disease Exclusion Criteria: Patients refused to participate in the study, patients with systemic diseases causing lid retraction (such as Guillain-Barré syndrome), pseudo retractions, contralateral ptosis, local skin condition (as scar adherence), medication (such as sympathomimetic drugs, lithium, and steroid), neurological conditions (such as dorsal midbrain syndrome and hydrocephalus) and thyroid related lid retraction

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 55 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 |
| --- | --- |
| Other: Transcutaneous levator recession<br> | Procedure: Transcutaneous levator recession<br>* recession of the upper and lower eyelid retractors can improve the upper eyelid contour if the patient has lateral flare (common in TED). The choice of procedure depends on severity of lid retraction and associated features like proptosis, status of extraocular muscles, and corneal condition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Margin reflex distance (MRD1) | MRD1 is a commonly used parameter in the assessment of patients with blepharoptosis and is defined as the distance between the upper lid margin and the corneal reflex when the eye is in the primary position | Baseline | 
| Margin reflex distance (MRD1) | MRD1 is a commonly used parameter in the assessment of patients with blepharoptosis and is defined as the distance between the upper lid margin and the corneal reflex when the eye is in the primary position | at one month post operative |
Following Outcomes Remotely Within Addiction Recovery Domains

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe outcome of people with opioid use disorder over the long-term by collecting monthly and yearly data on their recovery. Adults with opioid use disorder who participate will complete surveys monthly online and once per year by phone about their substance use, mental health, treatment involvement and functioning. The goal of this study is to better understand how people with opioid use disorder recover over time to improve intervention for this group.

Detailed Description
-----------------
This is a longitudinal follow-up study that will collect yearly outcomes data on adults with opioid use disorder (OUD) who participated one of two prior clinical trials in the NIDA Clinical Trials Network. This longitudinal, observational study will entail annual phone and online assessments of domains of interest (e.g., substance use, treatment engagement) as well as monthly assessments that are distributed via text messaging and email to be completed electronically by the participant. No participant randomization will occur for this study, and study data will be considered observational in nature. We aim to characterize the long-term course of OUD and to evaluate the long-term course and recovery of OUD.

Official Title
-----------------
CTN-0126 Following Outcomes Remotely Within Addiction Recovery Domains

Conditions
-----------------
Opioid Use Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be an enrolled participant in one of two applicable clinical trials and be no longer than 24 months after the final expected assessment for that trial. Be willing and able to provide locator information for survey distribution (mobile number and/or email address). Be willing to allow the linkage of prior clinical trial study data to the current study record. Exclusion Criteria: Unable to understand or communicate to complete consent or study assessments. Are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities. Other factors that would cause harm or increased risk to the participant or close contacts or preclude the participant's full adherence with or completion of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Opioid Use | Count of months of opioid use. | 12 months | 
| Engagement in Treatment | Count of months engaged in treatment for opioid use disorder | 12 months |
Use of Axillary Ultrasound to Guide Breast Cancer Management in the Genomic Assay Era

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to determine if axillary ultrasound can reliably distinguish between patients with limited or high nodal burden, so that the patients with limited nodal burden can potentially avoid chemotherapy and instead receive upfront surgery followed by gene assay testing.

Official Title
-----------------
Use of Axillary Ultrasound to Guide Breast Cancer Management in the Genomic Assay Era: A Retrospective Cohort Study

Conditions
-----------------
Axillary Ultrasound

Intervention / Treatment
-----------------
* Diagnostic Test: axillary ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast cancer patients with T1-3, HR-positive and HER2-negative disease. aged≥ 50 years old had axillary ultrasound prior to operation axillary lymph node dissection Exclusion Criteria: Patients with neoadjuvant chemotherapy bilateral cancers

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: axillary ultrasound|usefulness of axillary ultrasound in predicting need for chemotherapy or upfront surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of abnormal nodes on ultrasound | the number of abnormal nodes on ultrasound which was done at the time of diagnosis will be measured | from the date of diagnosis to the date of surgery, up to 12 weeks |
Efficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the hair growth efficacy of a Food for Special Medicinal Purposes (FSMP) Pantovigar® vegan after 3 and 6 months of intake.

Official Title
-----------------
Efficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss

Conditions
-----------------
Diffuse Hair Loss in Females

Intervention / Treatment
-----------------
* Dietary Supplement: Pantovigar® vegan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diffuse hair loss Modified Savin Score I to III Hair length of at least 2 cm Exclusion Criteria: Pathological hair loss (like alopecia areata, universalis or totalis; scarring alopecias; androgenic alopecia; inflammatory conditions of the scalp) Symptomatic diffuse alopecia due to pathological low iron concentration or thyroid gland disorder Acute telogen effluvium Recent or concomitant treatment with any drugs that may cause hair loss Concomitant diseases that can cause hair loss

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 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
Interventional Model Description: Intra-individual comparison
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pantovigar vegan treatment<br> | Dietary Supplement: Pantovigar® vegan<br>* Oral application of 1 capsule three times a day (morning, noon, evening) for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-assessment questionnaire for product acceptance by subjects |  | Months 3 | 
| Self-assessment questionnaire for product acceptance by subjects |  | Months 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on hair growth assessed by phototrichogram analysis |  | Baseline up to month 6 | 
| Change from baseline of blood parameters: Ferritin |  | Baseline up to month 6 | 
| Change from baseline of several blood parameters: Vitamin B1 |  | Baseline up to month 6 | 
| Change from baseline of several blood parameters: Biotin |  | Baseline up to month 6 | 
| Change from baseline of several blood parameters: Folic acid |  | Baseline up to month 6 | 
| Change from baseline of several blood parameters: Hematocrit |  | Baseline up to month 6 | 
| Change from baseline of several blood parameters: Pantothenic Acid |  | Baseline up to months 6 | 
| Occurrence of treatment-emergent adverse reactions and treatment-emergent serious adverse reactions |  | Baseline up to months 6 |
Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
BCDx is a urine-based multi-omic assay for early cancer recurrence detection in patients with a history of bladder cancer. This prospective, blinded study evaluates its efficacy in detecting recurrent NMIBC, offering a noninvasive monitoring solution.

Detailed Description
-----------------
BCDx is a urine-based multi-omic/multiplex molecular assay offers a promising solution for detecting cancer recurrence. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer. This is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel multi-omics test for the detection of recurrent NMIBC in patients with a history of bladder cancer undergoing surveillance.

Official Title
-----------------
Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer

Conditions
-----------------
Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 22 Years and older Patients who have been diagnosed with incident or recurrent NMIBC within the past 2 years and undergoing standard of care/routine monitoring cystoscopy. Patients who are able to provide legally effective informed consent. Patients who are able to provide minimum 40mL of voided urine. Exclusion Criteria: Patients planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma.

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- | --- |
| Sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of BCDx (the proportion of negatives that are correctly identified as such by the gold standard) |  | Participants' urine samples will be collected before cystoscopy and analyzed using the BCDx test within 6 months to establish its overall performance characteristics. |
Quality of Life in Italian Visually Impaired Patients

Study Overview
=================
Brief Summary
-----------------
Clinical register of visual rehabilitation activity and observational study on the validation of the VA LV VFQ questionnaire in the Italian context

Official Title
-----------------
Observational Study on Quality of Life in Visually Impaired Patients Through the Questionnaire VA LV VFQ in Italy

Conditions
-----------------
Visual Impairment

Intervention / Treatment
-----------------
* Other: WEB Register


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged 18 years or older, suffering from any visual pathology, who are admitted to specialised visual rehabilitation centres for visual rehabilitation. Ability to understand and sign the informed consent for participation in the study. Exclusion Criteria: Less than 18 years of age. Cognitive impairment that, in the opinion of the investigator, limits understanding of the informed consent or the questionnaire.

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 |
| --- | --- |
| Group A<br> | Other: WEB Register<br>* Observational, non-profit, multicentre longitudinal study on the assessment of quality of life and its association with demographic variables and visual function of visually impaired patients attending the visual rehabilitation service.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VA-LV-VFQ-48 questionnaire score | Clinical register of visual rehabilitation activity and observational study on the validation of the VA LV VFQ questionnaire in the Italian context | 10 years |
Multicenter Survey About Acute Uncomplicated Diverticulitis Management

Study Overview
=================
Brief Summary
-----------------
Acute uncomplicated diverticulitis is a quite prevalent situation and consultation in the emergency department. Its management has progresively changed towards a more conservative one and it is currently recommended in several guidelines the option of avoiding antibiotics in certain highly selected cases. Nevertheless, the implantation of such recommendations in current clinical pratice is unknown and, hypothesizing it was still low, the reasons for such reluctancy are also unknown. Both aspects can be considered quite interesting in order to design a specific plan in order to overcome such difficulties. In order to do so, an online survery was designed and colorectal surgeons along Spain, based in the census of the Young Group from the Spanish Association of Colorectal Surgery were invited to participate. Invitations were distributed along usual communication channels of this group, such as email or chat mobile phone applications. All the responses to the survey will be analyzed in order to find out how many hospitals are using current managemente without antibiotics, its characteristics and, opposite, what are the main reasons for those hospitals that are not using it yet.

Official Title
-----------------
Multicenter Survey About Acute Uncomplicated Diverticulitis Management

Conditions
-----------------
Acute Uncomplicated Diverticulitis

Intervention / Treatment
-----------------
* Behavioral: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colorectal surgeons. Surgeons with emergency surgery activity. Exclusion Criteria: Any other medical speciality.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Survey|This is a nationalwide survey developed in order to know the management of patients diagnosed of acute uncomplicated diverticulitis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute uncomplicated diverticulitis management without antibiotics | Rate of hospitals that includes management without antibiotics | 3rd january 2023-30th may 2023 |
Treatment Patterns With Brolucizumab in Germany - a Retrospective Cohort Study Based on Longitudinal Prescription Data: REALIZE Study

Study Overview
=================
Brief Summary
-----------------
REALIZE was a single-arm retrospective cohort study which described treatment patterns with brolucizumab, including treatment intervals between anti-vascular endothelial growth factor (VEGF) injections before and after a switch to brolucizumab. This study was conducted using German patient-level prescription data and the prescription date was used as a proxy for anti-VEGF injection date. The study period was defined from the date of the first available anti-VEGF injection in the dataset to 30 November 2021. The index date for each patient was the date of the first brolucizumab injection, which could be anytime between 01 March 2020 (since brolucizumab became available in Germany for use outside of clinical trials in March 2020) and 30 November 2021. The date of the patient's first neovascular age-related macular degeneration (nAMD) diagnosis was assumed to be the date of the first anti-VEGF prescription in the database for that patient, from January 2015 onwards.

Official Title
-----------------
Treatment Patterns With Brolucizumab in Germany - a Retrospective Cohort Study Based on Longitudinal Prescription Data: REALIZE Study

Conditions
-----------------
Neovascular Age-related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients aged ≥50 years with a nAMD diagnosis, who received ≥1 brolucizumab prescription regardless of prior anti-VEGF treatment, and had a minimum of 12-month follow-up from index date. Exclusion Criteria: Patients without a record of prescription of any drug in the six months before the index date (pre-index period). Patients with evidence of bilateral treatment with brolucizumab.

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| 12-month follow-up cohort<br> | |
| Treatment-naïve 12-month sub-cohort<br> | |
| Treatment-experienced 12-month sub-cohort<br> | |
| Treatment-experienced, persistent 12-month sub-cohort<br> | |
| 18-month follow-up cohort<br> | |
| Treatment-naïve 18-month sub-cohort<br> | |
| Treatment-experienced 18-month sub-cohort<br> | |
| Treatment-experienced, persistent 18-month sub-cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of brolucizumab injections |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time difference between the last anti-VEGF treatment interval before switch to brolucizumab and the last brolucizumab treatment interval at 12 months |  | Up to 12 months |