linjc16/ctgov huggingface dataset:
Assessment of Rosacea Patients' Clinical Trial Experiences

Study Overview
=================
Brief Summary
-----------------
Taking part in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. This study will admit a wide range of data on the clinical trial experience of Rosacea patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Rosacea patients.

Official Title
-----------------
An Evaluation of Medical Study Experiences of Patients With Rosacea

Conditions
-----------------
Rosacea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is at least 18 years of age Diagnosis of Rosacea Ability to understand the study procedures, benefits and risks, and sign a written informed consent document. Exclusion Criteria: Inability to perform regular electronic reporting Women who are pregnant, intend to become pregnant, or are lactating Enrolled in another research study

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 |
| --- | --- | --- |
| Rate of patients who decide to join in an Rosacea clinical study |  | 3 months | 
| Number of Rosacea patients who remain in clinical trial until completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rosacea
A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, open-label phase 2 study to evaluate the long-term safety and efficacy of CM310 in subjects with moderate-to-severe atopic dermatitis.

Detailed Description
-----------------
The study consists of an screening period, treatment period, and safety follow-up period.

Official Title
-----------------
An Multi-center, Open-label, Single-arm Phase 2 Study to Evaluate the Long-term Safety and Efficacy of CM310 in Subjects With Moderate-to-severe Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Biological: CM310


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have the ability to understand the study and voluntarily sign a written informed consent form (ICF). Age ≥ 18 and ≤ 75 years old. With Atopic Dermatitis. Exclusion Criteria: Not enough washing-out period for previous therapy. Concurrent disease/status which may potentially affect the efficacy/safety judgement. Major surgeries are planned during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: CM310<br> | Biological: CM310<br>* CM310, subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) | Incidence of adverse events (AEs). | up to Week 60 |
Preclinical Research for Personalized TCR-T Therapy for Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
This study will obtain tumor samples from patients with head and neck cancers and aims to develop personalized TCR-T therapy for head and neck cancer by determining the reactive TCR clone sequences in head and neck cancer.

Official Title
-----------------
Preclinical Research for Personalized TCR-T Therapy for Head and Neck Cancer

Conditions
-----------------
Head and Neck Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gender is not limited, age 18-75 years old; Estimated survival is greater than 3 months; Newly diagnosed patients with head and neck cancer without any treatment, or patients with refractory recurrent advanced head and neck cancer for which there is no available effective treatment; Patients with head and neck cancer whose tumor tissue can be surgically harvested; Volunteer to join the study and sign the informed consent. Exclusion Criteria: Infected or had been infected with COVID-19; Active hepatitis B or C virus, HIV infection, or other uncured active infected persons; Patients with head and neck cancer who had received the following treatments: The patient had a history of using PD-1 and other immune checkpoint inhibitors 8 weeks before surgery; History of chemotherapy drug use 8 weeks before surgery; A history of hormone drug use within 4 weeks before surgery; Other situations that are not appropriate to be included in the clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experiment<br>The excess tumor tissue from patients following surgical resection will be collected for further analysis. | Other: No intervention<br>* This is a preclinical study. No intervention will be performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical prognosis | Observation of the clinical prognosis including overall survival, progression-free survival, event-free survival, and recurrence-free survival. | 5 year postsurgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TCR-T therapy
Stability of Driving Pressure Changes During Best Positive End Expiratory Pressure (PEEP) Trial

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to better understand in changes in lung compliance as indicated by driving pressure (a non-invasive marker) following changes in positive end expiratory pressure (PEEP; a standard of care ventilator parameter). The main question it aims to answer is: The time to stability of driving pressure after a change in PEEP is made Type of study: observational study participant population/health conditions Participants will undergo a best PEEP trial which is a standard intensive care intervention for patients undergoing invasive mechanical ventilation. This involves changing the patient's PEEP and looking for response in driving pressure. This will be done in a more protocolized format and data will be collected.

Official Title
-----------------
Stability of Driving Pressure Changes During Best Positive End Expiratory Pressure (PEEP) Trial

Conditions
-----------------
Acute Respiratory Failure, Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients >18 years of age Undergoing intubation and mechanical ventilation in Medical Intensive Care Unit (MICU) or Medical Critical Care Unit (MCCU) at the University of Alabama Birmingham. Exclusion Criteria: Prisoner Pregnant Age <18 years of age Intensive Care Unit (ICU) team declines participation Unstable oxygenation (requiring 100% FiO2 to maintain saturations greater than 90% oxygen saturation following initial PEEP titration by primary team) Hemodynamic instability: vasopressor requirement of >0.3 mcg/kg/min of norepinephrine or equivalent Pneumomediastinum Pneumothorax without chest tube Previous enrolled in trial Need for immediate travel out of ICU following intubation for procedures, tests

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Stability of change in Driving Pressure after PEEP manipulation | Our study attempts to find the time point when driving pressure reaches stability. The primary outcome will be the first time point (3 breaths, 30 seconds, 1 minute, 3 minutes, 5 minutes, 10 minutes) where driving pressure is not statistically different from the baseline measurement. | 10 minutes total |
System Accuracy of BGM GL22

Study Overview
=================
Brief Summary
-----------------
This study assesses the system accuracy of a blood glucose monitoring system pursuant to ISO 15197

Official Title
-----------------
Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GL22 gemäß DIN EN ISO 15197:2015.

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Diagnostic Test: Glucometer Test
* Diagnostic Test: Refernce Measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male or female patients with hypo-, eu- or hyperglycaemia The written informed consent had to be signed The volunteers must be older than 18 years The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved Exclusion criteria: Pregnancy or lactation Acute or chronic diseases with the risk of aggravation by the measure A current constitution that does not allow participating in the study Participation in another study or activity with the blood glucose measuring system evaluated in the present study Application of substances listed in Appendix A of DIN EN ISO 15197:2015

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subject glucometer measurement<br> | Diagnostic Test: Glucometer Test<br>* blood glucose measurement using finger tip capillary blood using BGM<br>Diagnostic Test: Refernce Measurement<br>* blood glucose measurement using finger tip capillary blood using reference method<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of system accuracy based on DIN EN ISO 15197 | Assessment of the analytical measurement performance of the blood glucose monitor | Day 1 |
Gene Editing as a Therapeutic Approach for Rett Syndrome

Study Overview
=================
Brief Summary
-----------------
We designed the project to validate CRISPR/Cas9-based gene editing combined with AAV-based delivery for correction of the most common MECP2 mutations both in vitro and in vivo.

Detailed Description
-----------------
The project aims to validate CRISPR/Cas9-based gene editing combined with AAV-based delivery for correction of the most common MECP2 mutations both in vitro and in vivo. The laboratory of the principal investigator is an active member of the European Reference Network for rare malformation syndromes and rare intellectual and neurodevelopmental disorders (ERN-ITHACA).

Official Title
-----------------
Personalized MECP2 Gene Therapy Using CRISPR/Cas9 Technology Coupled to AAV-mediated Delivery in 3D Cell Culture and KI Mice

Conditions
-----------------
Rett Syndrome

Intervention / Treatment
-----------------
* Other: Gene editing in vitro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients -exclusively female- since the pathology is linked to the X chromosome, with a clinical diagnosis of Rett syndrome confirmed at the genetic level by the identification, through NGS analysis, for one of the recurrent mutations (mutational hotspots) in the MECP2 gene object of the study: c. 473C>T - (p.(T158M)), c.502C>T (p(R168X)), c.763C>T (p.(R255X)), c.916C>T (p.(R306C)); Age above 6 months; Availability of parents or legal guardians to provide free and informed consent to participate in the study Exclusion Criteria: NGS diagnosis with the normal outcome; Positive NGS diagnosis for mutation in MECP2 but with the presence of a mutation different from those under study. Unwillingness of parents or legal guardians to provide free and informed consent to participate in the study;

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Gene editing in vitro|Testing of gene editing efficiency in vitro in human cellular models derived from patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Editing efficiency | Percentage of gene editing achieved for each mutation | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Editing specificity | Evaluation of off-targets | 3 years |
Optimizing Open Label Placebo Rationales

Study Overview
=================
Brief Summary
-----------------
A 3-arm randomized trial where all chronic pain patients will receive honest placebos, but the information about the placebos will differ between conditions. Outcomes are measured for 21 days and a qualitative survey will be conducted.

Official Title
-----------------
Optimizing Open Label Placebo Rationales for Chronic Pain

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic pain 18 years old English speaking have a smartphone or computer with video access Taking prescription opioids for chronic pain the chronic pain is concentrated into the patient's lower back. Exclusion Criteria: suspect an allergy to any placebo ingredient problematic substance use cancer diagnosis causing pain anticipated change in opioid script during the study period.

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TAU Rationale<br>Rationale based on prior OLP studies (e.g. Kaptchuk et al., 2010) | Other: Placebo<br>* Open Label Placebo + Rationale<br>|
| Other: Mindfulness Rationale<br>Rationale based on mindfulness meditation | Other: Placebo<br>* Open Label Placebo + Rationale<br>|
| Other: Suspension of Disbelief Rationale<br>Rationale based on suspending disbelief about the placebo | Other: Placebo<br>* Open Label Placebo + Rationale<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Reports | Brief Pain Inventory: Pain intensity and pain interference | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioids | Quantity of prescription opioids taken | 21 Days |
Screening Protocol

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to collect data for the development and validation a screening process using aggregate data. In this study, data collection will encompass both retrospective and prospective approaches across multiple sites in the United States.

Official Title
-----------------
Data Collection for Development of Topcon Health Score

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

Intervention / Treatment
-----------------
* Device: Maestro2 OCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 22 years of age or older on the date of data collection (retrospective) or informed consent (prospective). For prospective data collection or missing retrospective data collection, subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent. BCVA 20/40 or better (each eye). Exclusion Criteria: For prospective or missing retrospective data collection, subjects unable to tolerate ophthalmic testing. Concomitant diseases known to affect the visual field: history of leukemia, dementia, Parkinson's disease, Alzheimer's disease, stroke, or autoimmune diseases. History of intraocular surgery (uncomplicated cataract or glaucoma surgeries are accepted) Ocular findings or history of co-morbidities, including, but not limited to: uveitis, non-glaucomatous optic neuropathy, trauma, retinal detachment, vein or artery occlusions, wet age-related macular degeneration, geographic atrophy, proliferative diabetic retinopathy, vitreous hemorrhage, severe cataract, severe non-proliferative diabetic retinopathy. Controlled diabetes and hypertension participants can be included. Unreliable VF testing and/or poor-quality OCT scans. Poor fixation.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pathology (glaucoma) arm<br> | Device: Maestro2 OCT<br>* 3D Wide (12mmx9mm) OCT scan using the Maestro (Topcon, Japan)<br>|
| Other: Normal arm<br> | Device: Maestro2 OCT<br>* 3D Wide (12mmx9mm) OCT scan using the Maestro (Topcon, Japan)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RNFL and GCL thickness | Using Maestro2 OCT | 1 day |
Prognosis of Cerebral Small Vessel Disease

Study Overview
=================
Brief Summary
-----------------
Prognosis of small vessel disease (SVD) depends on the underlying type of SVD and index manifestation. The aim of this prospective, observational cohort study is to determine the risk of different outcome events among patients with SVD according to the type of index presentation.

Official Title
-----------------
Prognosis of Cerebral Small Vessel Disease - a Prospective Cohort Study (PRO-SVD)

Conditions
-----------------
Cerebral Amyloid Angiopathy, Small Vessel Cerebrovascular Disease, Cadasil, CAA - Cerebral Amyloid Angiopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertensive deep perforator arteriolopathy (DPA), clinically symptomatic with either ICH, ischaemic stroke, cognitive impairment or severe radiological manifestation (Fazekas ≥II) Cerebral amyloid angiopathy (CAA according to modified Boston or Edinburgh criteria), clinically symptomatic with either ICH (including cSAH), amyloid spells, cognitive impairment or severe radiological manifestation (CMB≥2) Other SVD (i.e. CADASIL or other sporadic or genetic SVD) Exclusion Criteria: Life expectancy of <6 months due to not-SVD related causes (i.e. cancer) Patient is unlikely to attend follow-up visits

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Intracerebral haemorrhage (ICH) | Non-traumatic, intracerebral haemorrhage (ICH, including convexity subarachnoid haemorrhage) | 1 year | 
| Ischaemic stroke | Defined by CT and/or MRI | 1 year | 
| Cardio-vascular death | According to the treating physician | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other intracranial bleeding | Subdural haematoma, subarachnoid haemorrhage | 1 year | 
| Other (transient) neurological attacks | Including transient ischaemic attack (TIA), transient neurological attack (TNA), amyloid spells, (focal) seizures | 1 year | 
| Cognitive impairment | Montreal Cognitive Assessment (MoCA, range 0-30 points) < 26 points (corresponding to impaired cognitive function) and/or new impairment in activities of daily living as defined by the treating physician. | 1 year | 
| New-onset of extracranial vascular disease | As judged by the treating physician | 1 year | 
| Functional outcome | Modified Rankin scale score (ordinal score, range 0-6, a score of 0 corresponds to no symptoms at all, while a score of 6 corresponds to death) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
small vessel disease, CAA, cerebral amyloid angiopathy, hypertensive arteriopathy, deep perforator arteriopathy, CADASIL