linjc16/ctgov huggingface dataset:
Gene Therapy for Subjects With RPGR Mutation-associated X-linked Retinitis Pigmentosa

Study Overview
=================
Brief Summary
-----------------
A clinical trial of gene therapy for patients with X-linked retinitis pigmentosa (XLRP).

Official Title
-----------------
An Open-label, Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intraocular Administration of FT-002 in Subjects With RPGR Mutation-associated X-linked Retinitis Pigmentosa.

Conditions
-----------------
X-Linked Retinitis Pigmentosa

Intervention / Treatment
-----------------
* Genetic: FT-002


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Subjects that are willing and able to follow study procedures; 2.Males aged 8-45 years old at the time of signing the Informed Consent Form; 4.Subjects who are confirmed with variants of RPGR ; Exclusion Criteria: 1.Have other retinal degenerative diseases, such as retinal degeneration caused by other known Inherited retinal disease gene variants or previously received an gene therapy product.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: X-linked retinitis pigmentosa patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose FT-002<br>Intraocular injection of a single low dose of FT-002 | Genetic: FT-002<br>* Comparison of different dosages of FT-002<br>|
| Experimental: Intermediate dose FT-002<br>Intraocular injection of a single Intermediate dose of FT-002 | Genetic: FT-002<br>* Comparison of different dosages of FT-002<br>|
| Experimental: High dose FT-002<br>Intraocular injection of a single High dose of FT-002 | Genetic: FT-002<br>* Comparison of different dosages of FT-002<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AEs | Number and proportion of Adverse Events | from FT-002 administration through up to 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual function | Change in retinal function as assessed by mean retinal sensitivity within the 30-degree visual field | from FT-002 administration through up to 1 years | 
| Change in retinal structure as assessed by Optical Coherence Tomography | Change in Outer Nuclear Layer Thickness from baseline as assessed by Optical Coherence Tomography | from FT-002 administration through up to 1 years |
Prospective Observational Study to Predict Severe Oral Mucositis Associated With Chemoradiotherapy in Nasopharyngeal Carcinoma Based on Deep Learning

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to apply the CNN-based DL method to extract the three-dimensional spatial information of IMRT dose distribution to predict the occurrence probability of serious radiotherapy and chemotherapy induced oral mucositis(SRCOM), and compare with a model based on dosimetry, NTCP or doseomics to improve the prediction accuracy of SRCOM, thus guiding the clinical planning design, reducing the occurrence probability of OM, and may have the potential value of preventing serious complications and improving the quality of life in patients with nasopharyngeal carcinoma.

Official Title
-----------------
Prospective Observational Study to Predict Severe Oral Mucositis Associated With Chemoradiotherapy in Nasopharyngeal Carcinoma Based on Deep Learning

Conditions
-----------------
Nasopharyngeal Carcinoma, Oral Mucositis

Intervention / Treatment
-----------------
* Other: observational group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Initial diagnosis, pathological histological diagnosis, the pathological type is non-keratotic carcinoma (according to the WHO pathological classification). Initial intensity-modulated radiotherapy (Intensity modulated radiation therapy, IMRT). No previous radiotherapy was received. Exclusion Criteria: Patients with recurrent nasopharyngeal carcinoma. Radiotherapy plan cannot be obtained. Previous history of malignancy; previous radiotherapy. The primary lesion and cervical metastatic lesions have received surgical treatment (except for diagnostic treatment).
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observational group|patients initially diagnosed with nasopharyngeal carcinoma treated with IMRT|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RTOG/EROTC Acute Radiation Reaction Scoring Standard | Toxicity records of oral mucosal Reaction in patients are conducted by professionally trained oncologists | through radiation therapy, an average of 7 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasopharyngeal Carcinoma, Oral Mucositis, deep learning
The Effect Of Proprioceptive Neuromuscular Facilitation Techniqueson in Patients With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the effects of PNF techniques on pain, motor function, fatigue and quality of life.

Official Title
-----------------
The Effect Of Proprioceptive Neuromuscular Facilitation Techniqueson Pain, Motor Functions, Fatique and Health Related Quality of Life in Patients With Multiple Sclerosis: A Randomized, Single-blind Study.

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: PNF Group
* Other: Control Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a clinical diagnosis of Relapsing-Remitting MS (RRMS) as defined by McDonald criteria 18-65 years of age an Expanded Disability Status Scale (EDSS) score < 4 relapse-free for the last 3 months cognitive impairment that was defined with mini mental test. Exclusion Criteria: a history of different neurological diseases having any contraindication for exercise having orthopedic, vision, hearing, or perception problems.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: PNF Group<br> | Other: PNF Group<br>* Exercise training and PNF training<br>|
| Sham Comparator: Control Group<br> | Other: Control Group<br>* Exercise training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | Pain | through study completion, an average of 1 year | 
| Multiple Sclerosis Quality of Life-54 (MSQoL-54) | Quality of Life | through study completion, an average of 1 year | 
| Fatigue Severity Scale and Fatigue Impact Scale (FIS) | Fatigue | through study completion, an average of 1 year | 
| Timed Up and Go (TUG) | Mobility and Balance | through study completion, an average of 1 year | 
| The Six-Minute Walk Test (6-MWT) | Functionality | through study completion, an average of 1 year | 
| Hand Dexterity | Hand Dexterity | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Proprioceptive Neuromuscular Facilitation, Pain, Motor Function, Fatigue, Quality of Life
Determining Clinical Trial Experiences of Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Participation 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 trial will admit a wide range of data on the clinical trial experience of lung cancer 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 lung cancer patients.

Official Title
-----------------
An Observational Study to Determine Experience Patterns in Participants of Lung Cancer Clinical Trials

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has been diagnosed with lung cancer Patient has self-identified as planning to enroll in an observational clinical trial Patient is a minimum of 18 years or older Exclusion Criteria: Pregnant or nursing patients Inability to perform regular electronic reporting Patient does not understand, sign, and return consent form

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 |
| --- | --- | --- |
| Number of lung cancer patients who decide to enroll in a clinical trial |  | 3 months | 
| Rate of patients who remain in a lung cancer clinical trial to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer
Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia

Study Overview
=================
Brief Summary
-----------------
To observe the clinical efficacy of TCM acupuncture combined with western medicine nimodipine for prevention of post-stroke dementia by comparing with clinical conventional treatment methods.

Official Title
-----------------
Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia:a Randomized Controlled Trial

Conditions
-----------------
Post-stroke Dementia

Intervention / Treatment
-----------------
* Drug: The control group received oral nimodipine tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Definite ischemic stroke or hemorrhagic stroke confirmed by head CT / MRI examination Memory or cognitive and executive dysfunction. Cognitive dysfunction will be determined after the mini mental state evaluation (MMSE) score Age limited to 40-85 years, irrespective of gender Stable condition, clear consciousness, no aphasia, oral medication available No major comorbidity, no major depression Consent and signed patient informed consent Exclusion Criteria: Had serious medical conditions, such as heart, liver, kidney, or endocrine disease Aphasia or hearing impairment Participants in other clinical trials Patients currently on medication to improve cognitive function

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>On the basis of the control group treatment, the treatment group also adopted the acupuncture treatment | Drug: The control group received oral nimodipine tablets<br>* The control group received oral nimodipine tablets<br>|
| Other: control group<br>The control group received oral nimodipine tablets | Drug: The control group received oral nimodipine tablets<br>* The control group received oral nimodipine tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hasegawa Dementia Scale |  | 24 weeks | 
| Montreal Cognitive Assessment |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
randomized controlled trial, post-stroke dementia, Acupuncture, nimodipine
We Collected Blood Samples From Septic Shock Patients and Measured ELABELA, Creatinine, and NGAL Levels. Survival After 7 Days Was Recorded and Analyzed to Evaluate the Potential of Serum ELABELA as an Early Diagnostic Marker for Sepsis-associated Acute Kidney Injury.

Study Overview
=================
Brief Summary
-----------------
The investigators selected patients diagnosed with sepsis who were admitted to the Intensive Care Unit (ICU) of Huai'an First People's Hospital between June 2022 and December 2023, as well as healthy individuals with normal kidney function during the same period, for the research. The investigators collected blood samples from patients with septic shock or sepsis at 6 hours, 12 hours, 24 hours, 48 hours, 3 days, 5 days, and 7 days after diagnosis， and also collected blood samples from the healthy individuals. The blood samples were stored in gel separation vacuum tubes containing heparin as an anticoagulant. The supernatant was removed and stored at -80°C, and the levels of plasma ELA (enzyme-linked immunosorbent assay) were measured using a standardized ELA kit. Additionally, serum NGAL (neutrophil gelatinase-associated lipocalin) and creatinine levels were measured simultaneously. The subjects were divided into three groups based on the KDIGO diagnostic criteria: sepsis-associated acute kidney injury (S-AKI) group, sepsis non-AKI group, and normal control group. Finally, the data were analyzed to determine the early diagnostic value of ELA for S-AKI. Approximately 70 specimens were collected in total.

Official Title
-----------------
The Value of Serum ELABELA in Early Diagnosis of Sepsis-Associated Acute Kidney Injury

Conditions
-----------------
Sepsis, Septic Shock, Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with sepsis admitted to the ICU. Exclusion Criteria: Under 18 years old; History of chronic kidney disease; Recipients of organ transplantation within the past year; Patients or their families could not give informed consent.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The value of ELABELA | Significance of serum ELABELA in the early diagnosis of sepsis-associated renal injury. | Venous blood samples were collected at 6 hours, 12 hours, 24 hours, 48 hours, 3 days, 5 days and 7 days after the diagnosis of sepsis or septic shock | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day survival rate | The significance of serum ELABELA in evaluating the short-term prognosis of sepsis-associated renal injury. | 7-day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis associated acute kidney injury, ELABELA
A Review of External Ventricular Drain Placement at the Bedside Versus Operating Room

Study Overview
=================
Brief Summary
-----------------
External ventricular drain (EVD) placement is a common neurosurgical procedure and provides a way to monitor intracranial pressure. EVDs are utilized in the management of a wide array of neurosurgical indications, such as subarachnoid hemorrhage, trauma, intraventricular hemorrhage, cerebrospinal fluid (CSF) leaks, and hydrocephalus.

Detailed Description
-----------------
External ventricular drain (EVD) placement is a common neurosurgical procedure and provides a way to monitor intracranial pressure. EVDs are utilized in the management of a wide array of neurosurgical indications, such as subarachnoid hemorrhage, trauma, intraventricular hemorrhage, cerebrospinal fluid (CSF) leaks, and hydrocephalus. While generally regarded as safe, EVDs are associated with a significant risk of complications, such as hemorrhage, infection, and improper placement resulting in a need for replacement and the patient undergoing an additional procedure1,2. Significant research has been conducted reducing these complications, with a major focus on issues with the procedure itself, instruments utilized for EVD placement, or post-procedure care of the EVD. To our knowledge, few investigations have focused on the EVD placement environment (i.e., the operating room [OR] versus the bedside). We aim to evaluate the circumstances and complications rates associated with EVD placement between these two settings at Methodist Dallas Medical Center (MDMC).

Official Title
-----------------
A Review of External Ventricular Drain Placement at the Bedside Versus Operating Room

Conditions
-----------------
External Ventricular Drain

Intervention / Treatment
-----------------
* Procedure: EVD placements in the OR versus the bedside.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients ≥18 years old Any patient undergoing EVD placement at MDMC between January 2018 and August 2022 Exclusion Criteria: • Any patient not meeting criteria in section 3.1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: EVD placements in the OR versus the bedside.|Reducing EVD-related complications|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EVD Placement Success | development of best-practice recommendations for future EVD placements | 30 Days |
Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to provide expanded access to and characterize the safety profile of tarlatamab in participants with advanced small cell lung cancer (SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen).

Official Title
-----------------
A Phase 3b, Multicenter, Single-arm, Expanded Access Protocol of Tarlatamab (AMG 757) for the Treatment of Subjects With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Tarlatamab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Histologically or cytologically confirmed SCLC Extensive-stage, unable to be encompassed in a tolerable radiation plan Progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1 Minimum life expectancy of 12 weeks Exclusion Criteria: Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology Untreated or symptomatic central nervous system (CNS) metastases Active hepatitis B or hepatitis C virus infection Eligible for participation in any Amgen-sponsored ongoing clinical study of the investigational product Currently or previously enrolled in a prior tarlatamab study Female participants and/or male participants with female partners who are pregnant, breastfeeding, planning to become pregnant or donate eggs while on study through 72 days after the last dose of tarlatamab Male and female participants unwilling to practice abstinence and/or use protocol specified method of contraception

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tarlatamab|Tarlatamab will be administered as a 60-minute intravenous infusion with 1 mg step dose on cycle 1 day 1 followed by a 10 mg target dose on cycle 1 day 8 and cycle 1 day 15 in a 28-day cycle. Subsequent doses (10 mg) will be administered every 2 weeks.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, Extensive-stage small cell lung cancer, Tarlatamab, AMG 757, Bispecific T-Cell Engager, BiTE, Immunotherapy, Immuno-oncology, Delta-like ligand 3