linjc16/ctgov huggingface dataset:
Ultrasound Guided Intermediate Cervical Plexus Block for Congenital Muscular Torticollis

Study Overview
=================
Brief Summary
-----------------
Congenital Muscular Torticollis (CMT) is a postural deformity of head and neck detected at birth or shortly after birth, primarily resulting from unilateral shortening of Sternocleidomastoid Muscle (SCM). Surgery could be chosen for the treatment for some children, which is accompanied by moderate pain and discomfort. The investigators focused the effectiveness of intermediates cervical plexus block because the dermatome of sensory of cervical plexus block is correlated to that of torticollis. So the effect of analgesia could decrease the use of analgesics.

Official Title
-----------------
Randomized Controlled Trial of the Postoperative Analgesic Efficacy of Ultrasound Guided Intermediate Cervical Plexus Block for Unipolar Sternocleidomastoid Release in Patient With Congenital Muscular Torticollis

Conditions
-----------------
Congenital Muscular Torticollis

Intervention / Treatment
-----------------
* Other: intermediate cervical plexus block
* Drug: Fentanyl
* Drug: Ibuprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II Undergoing general anesthesia for unipolar sternocleidomastoid release in patient with congenital muscular torticollis Exclusion Criteria: coagulation disorder kidney or liver disease allergy to local anesthetics

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 7 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Block<br>ultrasound guided intermediate cervical plexus block with 0.25% ropivacaine 0.2 ml/kg. Fentanyl in postanesthesia care unit(PACU), Ibuprofen in ward when pain scale (FLACC) is equal to or more than 4. | Other: intermediate cervical plexus block<br>* ultrasound guided intermediate cervical plexus block with 0.25% ropivacaine 0.2 ml/kg<br>* Other names: ultrasound guided intermediate cervical plexus block;Drug: Fentanyl<br>* fentanyl 0.5 µg/kg in postanesthetic care unit when more or equal to FLACC scale 4.<br>Drug: Ibuprofen<br>* ibuprofen in ward when more or equal to FLACC scale 4.<br>|
| Placebo Comparator: No block<br>Fentanyl in PACU, Ibuprofen in ward when pain scale (FLACC) is equal to or more than 4. | Drug: Fentanyl<br>* fentanyl 0.5 µg/kg in postanesthetic care unit when more or equal to FLACC scale 4.<br>Drug: Ibuprofen<br>* ibuprofen in ward when more or equal to FLACC scale 4.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on the FLACC scale |  | at 5 min after postanesthesia care unit admission |
Use of Electromyography With Bio-Feedback for the Treatment of Craniomandibular Disorders

Study Overview
=================
Brief Summary
-----------------
The treatment of craniomandibular disorders is a challenging task. Many different treatments are yet available with occlusal splints being one of the most commonly used. A relative new diagnostic and treatment alternative is the Grindcare device. This enables the electromyographic (EMG) assessment of the activity of the temporal muscle and the contigent electrical stimulation of this muscle as bio-feedback whenever the EMG activity exceeds a certain limit. This stimulation results to a sudden break of the muscle activity. Aim of this study is to compare the therapeutic efficacy of the Grindcare device in pain reduction at female non-chronic CMD patients to that of a Michigan-type splint. Our null-hypothesis was that there is no difference between the device and the splint in the reduction of pain intensity.

Official Title
-----------------
Anwendung Von Elektromyographie Mit Gleichzeitigem Bio-Feedback Zur Behandlung Von Craniomandibulären Dysfunktionen Und/Oder Bruxismus.

Conditions
-----------------
Craniomandibular Dysfunction, Orofacial Pain

Intervention / Treatment
-----------------
* Device: Grindcare
* Device: Michigan-type occlusal splint


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent form Age between 18 and 70 years Non-chronic painful CMD with/without mandibular movement restriction Female Exclusion Criteria: Pregnancy or breastfeeding Chronic Pain Status higher than 2 Known allergic reaction against the gel pads Electronic implants (pacemaker, defibrilator, insulin pump) Facial pain of dental or neuropathic etiology Traumatic injuries of the face / operations Dental treatment need Problems with swallowing reflex

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Michigan-type occlusal splint<br>Occlusal splint, Michigan-type | Device: Michigan-type occlusal splint<br> <br> |
| Active Comparator: Grindcare<br>Biofeedback device | Device: Grindcare<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst perceived pain |  | 1 week |
Insulin Glargine Benefits in Japanese Pts Outside of Japan (US or Brazil)

Study Overview
=================
Brief Summary
-----------------
To estimate the efficacy of combination therapy with Lantus plus Amaryl in controlling blood glucose in Japanese patients with type 2 diabetes having failed OAD therapy, and document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy

Official Title
-----------------
A 24 Week, Open-Label, Single Arm, Multi-Center Clinical Study to Document the Benefits of the Combination of Lantus and Amaryl in Ethnic Japanese Type 2 Diabetic Patients Living Outside of Japan (in US or Brazil), Who Failed Good Metabolic Control With Oral Antidiabetic Drugs (OADs)

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Lantus, Amaryl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients planned for enrollment into this study had to have noninsulin-dependent diabetes mellitus (NIDDM) (type 2 diabetes) and were not able to maintain good metabolic control with OADs. Enrolled patients could be male or female, of documented Japanese ethnic origin, and between the ages of 20 and 70 years, inclusive.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lantus, Amaryl|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the efficacy of combination therapy with Lantus plus Amarylin controlling blood glucose in Japanese patients with type 2 diabetes having failed oral antidiabetic drug therapy |  | Hemoglobin A1c values were measured at Screening and at every visit thereafter. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy |  | 24 weeks |
The Cohort Study of Early Esophageal Cancer or Precancerous Lesions Treated With Endoscopic Resection

Study Overview
=================
Brief Summary
-----------------
Endoscopic Submucosal Dissection (ESD) is currently the main method of treatment of early esophageal cancer and precancerous lesions. Therefore, the investigators are looking forward to conduct a cohort study on early esophageal cancer patients undergoing endoscopic treatment collected from Zhongshan Hospital, Fudan University, comparing the WHO standard with Japanese standard of endoscopic therapy diagnosis. In addition，the investigators will collect patients' detailed informations and analyze the risk factors for metastasis and recurrence of early esophageal cancer.

Official Title
-----------------
The Cohort Study of Early Esophageal Cancer or Precancerous Lesions Treated With Endoscopic Resection

Conditions
-----------------
Early Esophageal Cancer or Precancerous Lesions Treated With Endoscopic Resection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 15-year-old Undergoing endoscopic Submucosal Dissection (ESD) in ZhongShan Hospital Exclusion Criteria: Preoperative patients with recurrence and Lost to follow-up of patients within 1 year

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| WHO diagnostic standard<br> | |
| Japan diagnostic standard<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison WHO diagnosis standard with JAPAN in Early Esophageal Cancer patients by accessing pathological section. | Comparison WHO diagnosis standard with JAPAN in Early Esophageal Cancer patients by accessing pathological section. | December 1st,2017-December 1st,2018 |
Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the Efficacy and Safety of NABOTA in treatment of essential blepharospasm

Official Title
-----------------
A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase II/III Clinical Trial to Compare the Safety and Efficacy of NABOTA Versus BOTOX in Treatment of Essential Blepharospasm

Conditions
-----------------
Blepharospasm

Intervention / Treatment
-----------------
* Drug: Clostridium Botulinum Toxin Type A
* Drug: Clostridium Botulinum Toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male of female of at least 18 years old Grade 2 4 in Scott's scale

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: NABOTA<br>Single-dose | Drug: Clostridium Botulinum Toxin Type A<br> <br> * Other names: NABOTA;|
| Active Comparator: BOTOX<br>Single-dose | Drug: Clostridium Botulinum Toxin Type A<br> <br> * Other names: BOTOX;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in Scott's Scale Score |  | At 4 weeks |
Safety and Efficacy of Infrared Diode Laser on Improvement of Scar and Prevention of Recurrence of Excised Keloid

Study Overview
=================
Brief Summary
-----------------
A pilot study will be conducted on 2 type of subjects, one with plastic surgery scar with a randomization of laser treated portions, and other with keloid excision scar with a complete laser treatment. The aim is to evaluate the infra-red diode laser influence on keloid recurrence and scar prevention. The keloid recurrence rate will be evaluated at each visit, and the scar prevention in plastic surgery will be evaluated comparing laser treated portion and non-treated portion.

Official Title
-----------------
Effect of Infra-red Diode Laser on Improvement of Surgical Scar and on the Prevention of Excised Keloids Recurrence-Pilot Study

Conditions
-----------------
Keloid, Surgical Scar

Intervention / Treatment
-----------------
* Device: infra-red diode laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older Skin type from I to VI (Fitzpatrick classification scale) Scar longer than 4cm for plastic surgery's patients OR scar longer than 2cm for keloid patients Exclusion Criteria: Malignant tumor pathology Infectious or viral skin disease Immunosuppressive pathology and/or immunosuppressive treatment, Long-term corticosteroid treatment Pregnant woman

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: infra-red diode laser<br>one session, one dose | Device: infra-red diode laser<br>* laser treatment of scar after keloid excision laser treatment of surgery scar<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment tolerability assessed by natures, intensity and incidences of the side effects, with a special oversight of skin burn lesion |  | 10 days after surgery or excision | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of scarring for plastic surgery group | Vancouver Scar Scale score Comparative scar assessment scale Observer assessment score (POSAS) | 12 months after surgery | 
| keloid recurrence, an intralesional corticotherapy will be set up as soon as there is a recurrence. | Lesion size Vancouver scar scale Observer scar scale (POSAS) | 12 months after excision | 
| quality of life assessment for keloid group | VQ-dermato satisfaction questionnaire | 12 months after excision | 
| Socio and medical economic evaluation for keloid group |  | 12 months after excision | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laser, keloid, scar
The Establishment of Large-sample Database of Multiple-MRI/Gene/Cognition

Study Overview
=================
Brief Summary
-----------------
Aim to establish a large-sample database of Multiple-MRI/Gene/Cognition for healthy Chinese (sample number, 5000; age, 6-70 years). This is a fundamental but very necessary work for future researches such as development, aging, relation of gene and behavior, relation of gene and neuroimaging, relation of behavior and neuroimaging. Importantly, this work will provide a norm for researches on psychological or neurological patients. This large-sample will be shared with world-wide researchers.

Detailed Description
-----------------
A part of data have been used in a publication which is preparing to submit.

Official Title
-----------------
The Establishment of Large-sample Database of Multiple-MRI/Gene/Cognition

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Chinese Age: 6-70 years old Right handed No smoking or alcoholic addiction Exclusion Criteria: Psychological or neurological patients Hypertension or cardiopathy patients Pregnant woman Take medicine or drink tea/coffee before scanning-

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 70 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 |
| --- | --- |
| Large-sample healthy participants<br>MRI scanning. | Device: MRI<br>* fMRI, sMRI, ASL and DTI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The distribution of the amplitude of blood oxygenation level dependent(BOLD) signal in healthy subjects | The amplitude of BOLD-functional magnetic resonance imaging(fMRI) signal is a common measure to estimate the brain activity during resting-state. We try to establish its distribution on healthy subjects, which could be a control to examine abnormal brain function in patients. | up to 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple-MRI, Gene, Cognition
A First-in-Human Study of BNZ132-1-40

Study Overview
=================
Brief Summary
-----------------
This is an open-label, single ascending dose study to characterize the safety and PK/PD profile of IV BNZ132-1-40, a novel peptide inhibitor of multiple cytokines in the IL-2 family.

Detailed Description
-----------------
This is a open-label study of single doses of intravenous BNZ132-1-40 administered to healthy adult subjects. Subjects are followed for 30 days after treatment for collection of safety, PK and PD data. Cohorts of up to 6 subjects will be enrolled for each dose level.

Official Title
-----------------
A First-in-human Study to Characterize the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of BNZ132-1-40

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: BNZ132-1-40


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and non-pregnant, non-lactating females no ongoing clinically significant medical condition willing and able to provide informed consent no use of Rx or OTC medications, other than oral contraceptives Exclusion Criteria: Recent systemic infections Clinically-significant abnormal clinical labs, ECG or physical examination Immunization 30 days prior to study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BNZ132-1-40<br>a range of IV doses | Biological: BNZ132-1-40<br>* pegylated peptide inhibiting IL-2, IL-9 and IL-15<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with related, treatment-emergent adverse events |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK: Exposure as determined by maximum plasma concentration (Cmax) |  | 1 Day | 
| PK: Exposure as determined by area under the concentration-time curve (AUC) |  | 30 days | 
| PD: Effects of BNZ132-1-40 on the expression of T cells as determined by FACS analysis |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytokines, interleukin-2, Safety Issues
National Collaborative to Improve Care of Children With Complex Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this initiative is to improve care and outcomes for infants with HLHS by expanding the NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, by improving the use of standards into everyday practice across pediatric cardiology centers, and by engaging parents as partners in the process.

Detailed Description
-----------------
The purpose of this initiative is to improve care and outcomes for infants with HLHS by: 1) expanding the established NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, 2) improving implementation of consensus standards, tested by teams, into everyday practice across pediatric cardiology centers, and 3) engaging parents as partners in improving care and outcomes.

Official Title
-----------------
National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children With Complex Congenital Heart Disease

Conditions
-----------------
Hypoplastic Left Heart Syndrome (HLHS)

Intervention / Treatment
-----------------
* Other: Collaborative Learning Network


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fetuses or newborns diagnosed with HLHS or other univentricular condition Intended to undergo Norwood procedure Exclusion Criteria: None

Ages Eligible for Study
-----------------
Maximum Age: 15 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypoplastic Left Heart Syndrome<br>Infants diagnosed with Hypoplastic Left Heart Syndrome (HLHS) | Other: Collaborative Learning Network<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between the implementation of changes in care delivery with changes in the process | The purpose of this data sharing is to facilitate QI and research activities. As more information is gathered in this registry, the study team will determine the data analyses methods to determine if the knowledge gained led to changes in care delivery and/or to better patient outcomes. | 15 months |