linjc16/ctgov huggingface dataset:
An Observational Retrospective Study to Evaluate Treatment Patterns of Botulinum Toxin Type A

Study Overview
=================
Brief Summary
-----------------
This is a retrospective chart review to evaluate treatment patterns of botulinum toxin Type A for the treatment of facial lines.

Conditions
-----------------
Facial Rhytides

Intervention / Treatment
-----------------
* Drug: botulinum toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously treated for glabellar lines (hyperfunctional facial lines) with botulinum toxin Type A preparation Received 2 treatment cycles wtih botulinum toxin Type A (BOTOX®) prior to at least 1 treatment with botulinum toxin Type A (Xeomin®) Exclusion Criteria: None

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| botulinum toxin Type A<br>Previous treatment with botulinum toxin Type A for treatment of facial lines | Drug: botulinum toxin Type A<br>* Previous treatment with botulinum toxin Type A for treatment of facial lines<br>* Other names: Xeomin®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Total Dose Per Treatment Period | Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose. | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-Injection Interval Duration of Each Treatment Period | Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle. | 24 Months | 
| Percent of Subjects Reporting Satisfaction With Treatment Effects | Percent of subjects reporting satisfaction with treatment effects per chart notes. | 24 Months |
Evaluation and Comparison of Systemic Exposure to Ibuprofen After Single Oromucosal Versus Oral Administrations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the systemic exposure to ibuprofen after single oromucosal administration of the test product V0498 and single oral administration of a reference product.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: V0498 - A mg
* Drug: Ibuprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subject aged 18 to 45 years (inclusive), 18.5 < or = Body Mass Index < or = 30 kg/m², Non-smoker for at least 6 months Subject agreed to be registered in the Belgium national register VIP Check International for this study participation . Exclusion Criteria: Positive serology for Hepatitis B Virus antigens, Hepatitis C Virus or Human Immunodeficiency Virus 1 or 2 antibodies, Organic disorder likely to modify absorption, distribution or elimination of the medication, History of sensitivity to ibuprofen or other NonSteroidal Anti-Inflammatory Drugs (NSAIDs) or to any of the excipients Subject who has donated blood within the past 3 months, Subject who has forfeited his freedom by administrative or legal award, or who is under guardianship or who has been admitted in a sanitary or social institution, Participation in another clinical trial in the previous month or subject still within the exclusion period of a previous clinical trial or is participating in another clinical trial,

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sequence 1<br>Test Drug (V0498 - A mg) - Reference (Ibuprofen) | Drug: V0498 - A mg<br>* Single oromucosal administration<br>Drug: Ibuprofen<br>* Single oral administration<br>|
| Other: Sequence 2<br>Reference (Ibuprofen) - Test drug(V0498 - A mg) | Drug: V0498 - A mg<br>* Single oromucosal administration<br>Drug: Ibuprofen<br>* Single oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) |  | 11 time points up to 10h after administration | 
| Time of Maximum Concentration |  | 11 time points up to 10h after administration | 
| Area Under Curve (AUC0-72) |  | 11 time points up to 10h after administration |
Effect of Intensive Language Therapy in Subacute Stroke Patients

Study Overview
=================
Brief Summary
-----------------
Early stroke rehabilitation is known to be an effective and essential therapy in gaining functional independence and preventing complications. However, there was no consensus of proper amount of language rehabilitation in stroke patients. In this study, the investigators investigated the effects of the intensive language rehabilitation during subacute phase to improve language function in patients with first-ever strokes.

Detailed Description
-----------------
Intensive language rehabilitation group - language rehabilitation therapy by language therapist for 1 hours on every working day for 4 weeks Conventional language rehabilitation group - language rehabilitation therapy by language therapist for 30 minutes on every working day for 4 weeks

Official Title
-----------------
Effect of Intensive Language Therapy in Subacute Stroke Patients

Conditions
-----------------
Rehabilitation, Language, Stroke

Intervention / Treatment
-----------------
* Procedure: language rehabilitation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute first-ever stroke Left hemispheric stroke Korean version of Frenchay Aphasia Screening Test(K-FAST) < 25 (less than 65 years old), K-FAST <20 (65 years old and more than 65 years old) at 7 days after stroke onset Right handedness Exclusion Criteria: Transient ischemic stroke

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Intensive group<br>language rehabilitation therapy by language therapist for 1 hours on every working day for 4 weeks | Procedure: language rehabilitation therapy<br>* language therapy is language rehabilitation by language therapist during subacute phase in stroke patients<br>|
| Active Comparator: Conventional group<br>language rehabilitation therapy by language therapist for 30 minutes on every working day for 4 weeks | Procedure: language rehabilitation therapy<br>* language therapy is language rehabilitation by language therapist during subacute phase in stroke patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean version-Western Aphasia Battery (AQ) |  | Change of Korean version- Western Aphasia Battery after language rehabilitation for 4 weeks |
Animated Picture to Improve Provider Adherence to CT Scan for Head Injury Rule

Study Overview
=================
Brief Summary
-----------------
It is difficult for Pediatric Emergency Department providers to recognize clinically significant head injuries that are likely to require neurosurgical intervention or close monitoring from those that can be safely discharged. Research Question How do a combination of education and an animated picture depicting the PECARN CT Head Injury rules impact compliance to these rules and reduce unnecessary head CT scans? Design This is a within subject, repeated measures study design.

Conditions
-----------------
Minor Head Injury

Intervention / Treatment
-----------------
* Behavioral: Pop-up picture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting to Children's ED will be included if they: Are between 0 and 18 years of age (inclusive) Receive a discharge diagnosis of head injury Present to the ED within 24 hours of the head injury GCS of 14 or greater Exclusion Criteria: Patients will be excluded if they : Had a CT scans done in an outside transferring institution Have obvious penetrating head injuries Had a trivial injury mechanisms such as ground-level falls or walking or running into stationary objects Have no signs or symptoms of head trauma other than scalp abrasions and lacerations. Have known brain tumors, pre-existing neurological disorders complicating assessment, ventricular shunts, bleeding disorders

Ages Eligible for Study
-----------------
Maximum 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: Pop-up picture<br> | Behavioral: Pop-up picture<br>* An animated picture depicting the key elements of the PECARN CT scan head injury rules will be explained. The picture will pop-up when a provider selects the order set for a CT scan due to head injury. Providers will need to select a box stating the patient either meets criteria or does not meet criteria in order to close the animated picture window.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to the PECARN CT Scan Head Injury rules |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased rate of CT scans |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
head injury, CT, emergency, radiation
CTCs and Novel Target Bio-marker Analysis for Prediction and Monitoring of Metastasis/Recurrence in Post-surgery Colorectal Cancer Patients Using MiSelect R Rare Cell System

Study Overview
=================
Brief Summary
-----------------
Despite the growing public awareness and recent progress in multimodality therapy to the colorectal cancer (CRC), CRC still ranks high on the list of the most common and deadly cancers in Taiwan. The cause of CRC mortality is due mainly to the occurrence of distant metastasis. Several reports suggested that circulating tumor cells (CTCs) highly associated with metastasis suggesting that targeting CTCs may offer an unprecedented opportunity to prevent the development of metastasis. Early detection and characterization of CTCs is therefore important as a potential strategy to monitor the progression of CRC. The current proposal is focused on detecting CTCs from peripheral blood of CRC patients using Miselect R system. We will monitor the amount of CTCs and correlate with CRC progression and prognosis.

Official Title
-----------------
CTCs and Novel Target Bio-marker Analysis for Prediction and Monitoring of Metastasis/Recurrence in Post-surgery Colorectal Cancer Patients Using MiSelect R Rare Cell System

Conditions
-----------------
Circulating Tumor Cells, CTC

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 20 and less than 90 years of age. Colorectal cancer stage II/III patients who will undergo surgical resection. Subject having agreed to participate in the study and follow the study procedures by providing written informed consent prior entering the study. Exclusion Criteria: Have other cancer history. Subject being identified with any blood borne infectious disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Disease Free Survival |  | 5 years |
Effect of Myofascial Release Technique on Reducing Symptoms in Patients With Chronic Disc Protrusion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether myofascial release technique are effective in the treatment of low back pain due to lumbar disc herniation.

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Procedure: Myofascial release technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lumbar disc herniation Muscular trriger points independent ambulated patients Exclusion Criteria: Neoplasm Lumbar surgery history fracture inflammatory disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myofascial release technique<br> | Procedure: Myofascial release technique<br> <br> |

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index |  |  |
Feeding Intolerance in Formula-Fed Infants

Study Overview
=================
Brief Summary
-----------------
This is a non-randomized, single-group, multi-center, two phased study to evaluate formula intolerance.

Official Title
-----------------
Evaluation of Feeding Intolerance in Formula-Fed Infants: A Non-Randomized, Single-Group, Multi-Center Study

Conditions
-----------------
Feeding Intolerance

Intervention / Treatment
-----------------
* Other: Partially Hydrolyzed Infant Formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria for Stage 1: Singleton full term birth with birth weight of > 2500g. Infant between 0 and 60 days of age. Discontinuation of medications that might affect gastrointestinal (GI) tolerance. Infant is exclusively formula-fed a full-lactose, intact cow milk protein-based infant formula (CMF) for less than 7 days prior to enrollment. Inclusion Criteria for Stage 2: Infant was fed according to protocol in Stage 1 of the study. Infant was identified as being fussy using the Intolerance Assessment Tool in Stage 1. Exclusion Criteria: Exclusion Criteria for Stage 1: Chromosomal or major congenital anomalies. Suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism. Hospitalization, other than for delivery, prior to enrollment. Severe uncontrolled eczema, visible bloody stools or milk protein allergy prior to enrollment. More than 1 substitution of an infant formula other than full-lactose, intact cow milk formula (CMF) since birth. Use of a prokinetic drug within 7 days before enrollment. Exclusion Criteria for Stage 2: Infant's intolerance symptom was caused by another reason, for example known infection/illness, food allergy, or response to vaccination(s). Infant has immunization(s) within 3 days of enrollment in Stage 2.

Ages Eligible for Study
-----------------
Maximum Age: 60 Days

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Partially Hydrolyzed Infant Formula<br>Fed ad lib. | Other: Partially Hydrolyzed Infant Formula<br>* Commercially available infant formula<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Fussiness | Study phase 2; Parent completed questionnaire. | 0 to 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diarrhea | Study phase 1; Parent completed questionnaire. | 0 to 4 weeks | 
| Constipation | Study phase 1; Parent completed questionnaire. | 0 to 4 weeks | 
| Spit-up | Study phase 1; Parent completed questionnaire. | 0 to 4 weeks | 
| Gassiness | Study phase 1; Parent completed questionnaire. | 0 to 4 weeks |
CONDOR Temporomandibular Muscle and Joint Disorders (TMJD) Survey

Study Overview
=================
Brief Summary
-----------------
The purpose of study was to characterize using an online questionnaire the feasibility of recruiting dentists in primary care dental practices in the practice-based research network and documenting their current initial care for their TMJD pain patients.

Detailed Description
-----------------
The overall goal of this project was to collect data to be used in preparing an application for a Clinical Trial Planning Grant and then in designing a subsequent Phase III clinical trial. The ultimate goal of this series of research projects is to determine the most practical approach to conduct a randomized clinical trial (RCT) to evaluate initial intervention for patients with painful temporomandibular muscle and joint disorders (TMJD) using NIDCR's Collaboration of Networked Dental and Oral Health Research (CONDOR) group consisting of three dental Practice-Based Research Networks: The Dental Practice-Based Research Network (DPBNR), Northwest Practice-Based Research Collaborative in Evidence-based Dentistry (PRECEDENT), and Practitioners Engaged in Applied Research and Learning (PEARL).

Official Title
-----------------
Primary Care Management for TMJD Pain

Conditions
-----------------
Temporomandibular Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DPBRN dentist practitioner-investigator (general dentists or specialists) who had completed a DPBRN Enrollment Questionnaire 22 years of age or older

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Temporomandibular disorders<br> | |

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
-----------------
TMJD pain, feasibility
MMRF Molecular Profiling Protocol

Study Overview
=================
Brief Summary
-----------------
This protocol is now being used as screening for the MyDRUG study

Detailed Description
-----------------
Here we propose an integrative sequencing approach utilizing a 1500 gene exome comparative analysis between multiple myeloma or related plasma cell malignancies and normal cells coupled to capture transcriptome sequencing to provide a nearly comprehensive landscape of the genetic alterations for the purpose of identifying informative and/or actionable mutations in patients with multiple myeloma and plasma cell malignancies. The approach will enable the detection of point mutations, insertions/deletions, gene fusions and rearrangements, amplifications/deletions, and outlier expressed genes among other classes of alterations.

Official Title
-----------------
Clinical-grade Molecular Profiling of Patients With Multiple Myeloma and Related Plasma Cell Malignancies

Conditions
-----------------
Multiple Myeloma, Plasma Malignancy

Intervention / Treatment
-----------------
* Genetic: genetic sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have a diagnosis of multiple myeloma or related malignancy Patients are undergoing standard of care bone marrow aspirates Patients (male or female) from any race or ethnicity must be at least 18 years of age at the time of registration. Procedure-specific signed informed consent form prior to initiation of any study-related procedures. Exclusion Criteria: It is the enrolling study physician's discretion to decide if a patient is not fit enough to undergo a bone marrow aspirate. Patients who are incarcerated are not eligible to participate. Women who are pregnant Patients who have had another malignancy within the last five (5) years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix) where there is a possibility to contaminate the bone marrow aspirate.

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

| Intervention/Treatment |
| --- |
|Genetic: genetic sequencing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| actionable mutations report |  | 10-14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rates |  | Overall survival | 
| Disease Recurrence |  | Time to Progression | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
genetic sequencing, relapsed