linjc16/ctgov huggingface dataset:
MEDITOXIN® in Treatment of Crow's Feet Line

Study Overview
=================
Brief Summary
-----------------
to determine the efficacy and safety of Meditoxin® in treatment of crow's feet line

Official Title
-----------------
A Randomized, Double-blind, Active Drug Controlled, Multi-center, Phase Ⅰ/Ⅲ Study to Determine the Efficacy and Safety of Meditoxin® in Treatment of Crow's Feet Line

Conditions
-----------------
Crow's Feet Lines

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of at least 20 to 65 years old Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator Exclusion Criteria: Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis Patients with allergy or hypersensitivity to the investigational drugs or their components Patients who have bleeding tendency or taking anti-coagulant Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.) Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening Patients who are unable to communicate or follow the instructions Patients who are not eligible for this study based on the judgment of an investigator

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEDITOXIN<br> | Drug: botulinum toxin type A<br>* 24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas<br>* Other names: MEDITOXIN;|
| Active Comparator: BOTOX<br> | Drug: botulinum toxin type A<br>* 24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas<br>* Other names: BOTOX;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale(FWS) | The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported. | 4 weeks |
A Pilot MRI Study of Osteopathic Manipulative Treatment of Acute Low Back Pain

Study Overview
=================
Brief Summary
-----------------
This is a pilot project intended to determine the feasibility of detecting soft tissue changes in response to osteopathic manipulative treatment (OMT). MRIs of the lumbar and pelvic regions of low back pain (LBP) patients will be taken once before and at two different time points after OMT. Images obtained will be quantitatively analyzed for changes in the volumes of back muscles and for changes (T2 signals) indicative of activity levels or pathological conditions. Electromyography (EMG) will be used as an independent measure of back muscle activity for comparison with MRI results.

Official Title
-----------------
A Pilot MRI Study of Osteopathic Manipulative Treatment of Acute Low Back Pain

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

Intervention / Treatment
-----------------
* Other: osteopathic manipulative treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patients (18-55) Patients with LBP with acute symptoms (within last 3 weeks) Test positive for lumbar somatic dysfunction Exclusion criteria: History of any spinal injuries/surgeries Positive findings of frank neurological signs during physical exam Any other orthopedic or neurological impairment Unsuitable for MRI imaging: Cardiac pacemaker or defibrillator Severe Claustrophobia Injured by a metallic object that was not removed Cochlear (ear) implants Surgery involving a metallic implant (e.g. knee replacement) Weight more than 300 lbs/136 kg (weight limit for scanner bed)

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MOT<br>Treatment will focus on the thoracolumbar junction, L5, the sacrum, and the pubes. Treatment will primarily utilize two techniques, muscle energy and ligamentous-articular release, but will be tailored to the findings of the individual patient. | Other: osteopathic manipulative treatment<br>* Treatment will focus on the thoracolumbar junction, L5, the sacrum, and the pubes. Treatment will primarily utilize two techniques, muscle energy and ligamentous-articular release, but will be tailored to the findings of the individual patient.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI T2 signal changes |  | within 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI anatomic changes and EMG changes |  | within 72 hours |
Treatment for Migraines With an Implantable Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of an implantable device for difficult to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed.

Official Title
-----------------
Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Device: Precision


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Be diagnosed with multiple migraines per month of moderate to severe intensity; Be refractory to medication; Be an appropriate candidate for the surgical procedures required for this study; Be willing and able to comply with all study related procedures; Be capable of reading and understanding patient information materials and giving written informed consent. Key Exclusion Criteria: Have onset of migraine after age 50; Have a significant psychiatric disorder; Have previously been treated with occipital nerve stimulation; Have had an injection of botulinum toxin in the head or neck within 6 months prior to enrollment; Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade or radio frequency procedure currently in effect; Have a condition currently requiring or likely to require the use of MRI or diathermy; Have an active implantable device; Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Active occipital nerve stimulation (stimulation on) | Device: Precision<br>* Implantable neurostimulator<br>|
| Sham Comparator: Control<br>Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on. | Device: Precision<br>* Implantable neurostimulator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine Frequency at 12 Weeks | Change from baseline in migraine days/month at 12 weeks | Baseline and 12 weeks | 
| Frequency of Adverse Event | Cumulative frequency of adverse events from randomization to 26 weeks | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Headache, Migraine, Refractory, Chronic, Pain
Immunologic Analysis of Peripheral Blood and Aspirated Thromb In AMI Patients

Study Overview
=================
Brief Summary
-----------------
Researchers use FCM to analyze the immunol cell feature and its corresponding activation status, as well as the thromb aspirated through the thromb aspiration device in AMI patients

Official Title
-----------------
Immunologic Analysis of Aspired Thromb and Circulatory Immune Cell in AMI Patients

Conditions
-----------------
Immunol Feature in Circulation and Thromb in AMI Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: uncomplicated AMI patients Exclusion Criteria: any self immune disease and recent (within 1 month) or any chronic infection

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| immunologic feature of AMI patients |  | 1 month |
Exploratory Study of QBKPN SSI in Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, compliance and mechanism of action of study drug (QBKPN SSI) in subjects with two or more second primary pre-invasive or invasive adenocarcinoma following surgical section of Stage 1 NSCLC.

Detailed Description
-----------------
Please refer to summary above.

Official Title
-----------------
Open Label,Single Arm,Exploratory Study to Evaluate the Safety,Tolerability,Compliance and MOA,of QBKPN SSI in Subjects With 2 or More Second Primary Pre-invasive/Invasive Adenocarcinoma Following Surgical Resection of Stage I NSCLC

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

Intervention / Treatment
-----------------
* Biological: QBKPN SSI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female who is at or above the age of consent Histologically confirmed original diagnosis of lung cancer Life expectancy greater than 12 months ECOG performance status 0, 1, or 2 at screening Female subjects who agree to practice two effective methods of contraception from the time of signing the informed consent form through one month after the last dose of study drug Male subjects who agree to practice effective barrier contraception during the entire study drug period and through one month after the last dose of study drug Exclusion Criteria: Extra-thoracic lung cancer progression Any active malignancies Any uncontrolled or major organ dysfunction Any past or current radiation or systemic therapies for the treatment of lung cancer Known HIV infection or other immunosuppressive disorder Concurrently participating in another study with an investigational immunotherapy or have received investigational immunotherapy within 3 months prior to screening

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QBKPN SSI<br>Individualized maintenance dose administered subcutaneously for 12 weeks | Biological: QBKPN SSI<br>* QBKPN SSI is administered subcutaneously for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability and compliance variables | Assess the number of adverse events and subject reported data | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory variables | Assess and identify biomarkers associated with immune response | 16 weeks |
Expectant Versus Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW

Study Overview
=================
Brief Summary
-----------------
Compared the interest of one week expectancy vs immediate medical treatment in the taking care of the evacuation of the no evolutionary pregnancies before 13 GW.

Detailed Description
-----------------
Randomized control trial comparing one week expectancy vs immediate medical treatment (mifepristone 200mg and misoprostol 400ug) in the taking care of the evacuation of the no evolutionary pregnancies before 13 GW.

Official Title
-----------------
Comparison Expectant With Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW

Conditions
-----------------
Pregnancy Complications

Intervention / Treatment
-----------------
* Drug: MIFEPRISTONE 200 mg and misoprostol 400 µg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Agreed women aged over 18 yrs old Non evolutive pregnancy before 13GW : Non evolutive pregnancy with no fetal cardiac activity Non evolutive pregnancy with embryonic structures Trophoblastic material in uterine cavity P bhCG < 10UI/L Exclusion criteria: Age < 18 years pregnancy evolutionary not evolutionary pregnancy after 13 weeks of amenorrhoea characterized by the presence of an scan image intra-uterine ANECHOGENE furthermore of 50mm of diameter amenorrhoea of more than 13 weeks pregnancy twin pregnancy molar pregnancy extra-uterine Extra-uterine pregnancy one or many contraindications in the mifepristone: Allergy known about the MIFEPRISTONE Incapacity suprarenal corticosteroid therapy in the long price confusions of the haemostasis (thrombopenia < in 100000 / mm3) anaemia (rate Hg < in 9 g / dl) contraindication in the misoprostol allergy known about PROSTAGLANDINES BEANCE cervical

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 Years

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

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 |
| --- | --- |
| Experimental: 1<br>MIFEPRISTONE 200 mg and misoprostol 400 µg | Drug: MIFEPRISTONE 200 mg and misoprostol 400 µg<br>* MIFEPRISTONE 200 mg and misoprostol 400 µg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of surgical evacuation in each group | Number of surgical evacuation in each group | during de study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy Complications
The Initiating Factors of Myopia Among Primary and Secondary School Students in Tianjin

Study Overview
=================
Brief Summary
-----------------
There was a prospective cohort observational study. Forty hyperopic children, 40 myopic children and 120 emmetropia children were randomly selected from grade 1 to grade 3, and were followed up every six months for 3 years. All patients received cycloplegic refraction examination, ocular biological test, binocular visual function test and a questionnaire related to daily eye habits. A multi-level and multi-dimensional data analysis model was constructed to explore the possible factors affecting the occurrence and development of myopia in children.

Official Title
-----------------
The Initiating Factors of Myopia Among Primary and Secondary School Students in Tianjin

Conditions
-----------------
Myopia; Refractive Error

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: students in grades 1-3 Can cooperate with the examination of students Exclusion Criteria: Obvious strabismus and amblyopia Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases History of ocular surgery

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 11 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| children with hyperopia<br>The refractive error and axial length of eye were observed | Other: No intervention<br>* There was no intervention in each group, and only the natural development was observed<br>|
| children with emmetropia<br>The refractive error and axial length of eye were observed | Other: No intervention<br>* There was no intervention in each group, and only the natural development was observed<br>|
| children with myopia<br>The refractive error and axial length of eye were observed | Other: No intervention<br>* There was no intervention in each group, and only the natural development was observed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of refractive error | The changes of refractive error between visit time in every 6 months | Every 6 months for a period 3 years | 
| The changes of axial length | The changes of axial length between visit time in every 6 months. | Every 6 months for a period 3 years |
Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the non-inferiority of Z-213 compared to Saccharated Ferric Oxide using the maximum change in Hb from baseline over 12 weeks in patients with Iron-deficiency Anemia (IDA)

Official Title
-----------------
Phase III Study of Z-213 in Subjects With Iron-deficiency Anemia

Conditions
-----------------
Iron Deficiency Anemia

Intervention / Treatment
-----------------
* Drug: Z-213
* Drug: Saccharated Ferric Oxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with iron deficiency anemia Exclusion Criteria: Patients with anemia caused by conditions other than iron deficiency Patients with abnormal laboratory test values at screening for Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase Patients with liver, kidney or circulatory system disease Patients with a history or present illness that is a malignant tumor or autoimmune disease Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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 |
| --- | --- |
| Experimental: Z-213<br> | Drug: Z-213<br>* The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed)<br>|
| Active Comparator: Saccharated Ferric Oxide<br> | Drug: Saccharated Ferric Oxide<br>* The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV two or three times per week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum change in Hb value |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hb value |  | 12 weeks | 
| Proportion of responders |  | 12 weeks | 
| Proportion of subjects with normalization in Hb value |  | 12 weeks | 
| Proportion of cumulative dosage |  | 12 weeks | 
| Dosing period and the number of doses |  | 12 weeks | 
| Incidence of Adverse Events |  | 12 weeks | 
| Incidence of Adverse Drug Reactions |  | 12 weeks |