linjc16/ctgov huggingface dataset:
Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder

Study Overview
=================
Brief Summary
-----------------
We aim to study the efficacy of Acupuncture versus sham acupuncture in children with ASD.

Detailed Description
-----------------
In Traditional Chinese Medicine (TCM) philosophy, the approach to Autistic Spectrum Disorder (ASD) is a holistic one. The objective is to study the efficacy of a short intensive course of Acupuncture versus sham acupuncture in improving the overall functional status of children with autism. A single-blind randomized control trial was conducted in 50 children. These children were randomly assigned to Treatment group with Tongue Acupuncture (40 sessions over 8 weeks) or Control group (Sham Tongue Acupuncture to non-acupoints in the tongue).

Official Title
-----------------
Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder

Conditions
-----------------
Autism, Autistic Disorder

Intervention / Treatment
-----------------
* Procedure: Tongue Acupuncture (Procedure)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with diagnosis of autism made according to the criteria of the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Autism Diagnostic Interview-Revised and with a score for Childhood Autism Rating Scale (CARS) greater than 30. Exclusion Criteria: Children with associated neurological disorders and epilepsy.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 11 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

| Intervention/Treatment |
| --- |
|Procedure: Tongue Acupuncture (Procedure)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Griffiths Mental Developmental Scale (GMDS) was conducted before (at Week 0) and after (at Week 9) acupuncture. |  |  | 
| Ritvo-Freeman Real Life Scale (RFRLS) was conducted before (at Week 0) and after (at Week 9) acupuncture. |  |  | 
| Reynell Language Developmental Scale (RLDS) was conducted before (at Week 0) and after (at Week 9) acupuncture. |  |  | 
| Symbolic Play Test (SPT) was conducted before (at Week 0) and after (at Week 9) acupuncture. |  |  | 
| Functional Independence Measure for children (WeeFIM) was conducted before (at Week 0) and after (at Week 9) acupuncture. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alternative Medicine (AM), Traditional Chinese Medicine, Tongue Acupuncture, Autistic Spectrum Disorder, Autism, Children
Effects of an Ankle-Foot Orthosis on Gait While Performing an Attention Demanding Task

Study Overview
=================
Brief Summary
-----------------
We hypothesize that: (1) gait stability will be increased when wearing an ankle-foot orthosis (plastic brace supporting the foot and ankle); (2) an attention demanding task will decrease gait stability and (3) the improvement in gait stability due to ankle-foot orthosis use will be greater during an attention demanding task.

Detailed Description
-----------------
A quasi-experimental, randomized 2 x 2 factorial within subjects study with the factor of walking condition (2 levels, walking with and without ankle-foot orthotic device) and attention condition (2 levels, walking with and without attention task).

Official Title
-----------------
Effects of an Ankle-Foot Orthosis on Gait While Performing an Attention Demanding Task in People With Poststroke Hemiplegia

Conditions
-----------------
Stroke, Gait, Hemiplegic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be over the age of 18; have the presence of hemiplegia after stroke; be wearing an ankle-foot orthosis for at least 6 weeks; be able to walk independently and comfortably for a minimum distance of 12 m with or without assistive aids (AFOs, canes and walkers); be able to read and understand English, follow verbal instructions and provide verbal answers to questions; be able to reach criterion on the attention task (described below) be competent to give informed consent as determined by clinical team and noted in the health chart Exclusion Criteria: have history of balance deficits not related to stroke; be at high risk of falling during the study; suffer from severe aphasia or dementia as determined by health chart and/or initial cognitive screening using the Montreal Cognitive Assessment (MoCA) test.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stroke<br>People who have had a stroke and have an ankle-foot orthosis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Velocity | walking velocity | up to one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| trunk acceleration | trunk acceleration during walking | up to one week | 
| Step length variability | variability of right and left step length during walking | up to one week | 
| The Berg Balance Scale | Functional balance measured using the Berg Balance Scale short form. | up to one week |
Study for Appropriate Operating Table Height for Endotracheal Intubation Under Direct Laryngoscopy

Study Overview
=================
Brief Summary
-----------------
Laryngeal view of the patient and anesthesiologist's discomfort level during endotracheal intubation in relation to the various heights of operating table has not been investigated. The investigators hypothesis is higher table height will improve the laryngeal exposure.

Detailed Description
-----------------
Eight anesthesiologists will be participated. For each anesthesiologist, 20 patients will be enrolled and they will be randomly allocated into one of 4 groups; T10, T8, T6 or T4. The height of operating table will be adjusted prior to commencement of anesthesia induction to place the patient's forehead at one of four anesthesiologist's dermatome levels (T10, T8, T6 or T4) depending on the group. The best laryngeal views will be graded before and after the anesthesiologist's postural change to improve laryngeal visualization of the patient during intubation. Subjective and objective measurement of anesthesiologists' joint flexion during intubation and discomfort ratings for the mask ventilation or intubation will be recorded.

Official Title
-----------------
Study for Appropriate Operating Table Height for Endotracheal Intubation Under Direct Laryngoscopy

Conditions
-----------------
Larynx

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have experiences of more than 100 cases of endotracheal intubation Exclusion Criteria: have acute or chronic musculoskeletal disease or pain
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 |
| --- | --- | --- |
| larynx |  | larynx |
Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19

Study Overview
=================
Brief Summary
-----------------
This expanded access program will provide access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.

Official Title
-----------------
Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19

Conditions
-----------------
COVID19

Intervention / Treatment
-----------------
* Biological: COVID-19 convalescent plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at least 18 years Laboratory confirmed diagnosis of infection with SARS-CoV-2 Admitted to an acute care facility for the treatment of COVID-19 complications Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease Informed consent provided by the patient or healthcare proxy Severe COVID-19 is defined by one or more of the following: dyspnea respiratory frequency ≥ 30/min blood oxygen saturation ≤ 93% partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300 lung infiltrates > 50% within 24 to 48 hours Life-threatening COVID-19 is defined as one or more of the following: respiratory failure septic shock multiple organ dysfunction or failure Exclusion Criteria: None

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: COVID-19 convalescent plasma|COVID-19 convalescent plasma|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Paracervical Block Before Intrauterine Device (IUD) Insertion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if a paracervical block containing 1% lidocaine administered prior to IUD insertion reduces insertion pain. The hypothesis is that women receiving paracervical analgesia will experience less pain during IUD insertion than those who do not receive such analgesia.

Official Title
-----------------
Pain Control for Intrauterine Device Insertion: A Randomized Trial of 1% Lidocaine Paracervical Block

Conditions
-----------------
Pain Control for Intrauterine Device Insertions

Intervention / Treatment
-----------------
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women age 18 -50 years A negative urine pregnancy test and clinically unlikely to be pregnant Seeking an intrauterine device for any indication Willing and able to sign an informed consent in English Exclusion Criteria: History of a prior IUD successful insertion Previous failed insertion of an IUD Known copper allergy Known levonorgestrel allergy Known lidocaine allergy Current cervicitis Pelvic Inflammatory Disease (PID) within 3 months Pregnancy within six weeks prior to IUD insertion Uterine anomaly or distortion of the uterine cavity Use of any other pain medication within 6 hours prior to IUD insertion Use of misoprostol within 24 hours prior to IUD insertion

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

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

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

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: Paracervical Block<br> | Drug: Lidocaine<br>* 1% Lidocaine<br>|
| No Intervention: No Paracervical Block<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Visual Analogue Score Measuring Pain | We asked participants to report their pain score on visual analogue scale (0mm=no pain and 100mm=worse pain possible) at the following time points: Speculum placement Tenaculum placement Paracervical block administration(if subject is in this arm) IUD insertion Five minutes post procedure | 1) Speculum placement 2) Tenaculum placement 3) Paracervical block administration(if subject is in this arm) 4) IUD insertion 5) Five minutes post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intrauterine device, local anesthetic
Comparison Of External Physical Vibration Lithecbole(EPVL) In Different Time After Retrograde Intrarenal Surgery(RIRS)

Study Overview
=================
Brief Summary
-----------------
The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to eliminate stone completely

Detailed Description
-----------------
To evaluate the efficacy and safety of external physical vibration lithecbole for the treatment of residual stone in different time (3 days ,7 days and 14 days) after the operation of RIRS

Official Title
-----------------
Effect Of Renal Residual Stones c Treated By External Physical Vibration Lithecbole(EPVL) In m Different Time n After Retrograde Intrarenal w Surgery(RIRS):At y Multi-center z Prospective Randomized Controlled Trial

Conditions
-----------------
Calculi

Intervention / Treatment
-----------------
* Procedure: 3 days after
* Procedure: 10days after
* Procedure: EPVL performed in30days after RIRS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Age of 18-75 years; Exclusion Criteria: 1.Urinary tract anomalies, stricture or obstruction;

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 3<br>Patients in 3 days | Procedure: 3 days after<br>* in 3 days after RIRS.<br>|
| Other: 10<br>Patients in10ys | Procedure: 10days after<br>* in10 days after RIRS.<br>|
| Experimental: 30<br>Patients in10ys | Procedure: EPVL performed in30days after RIRS<br>* Patients in Group C undergo EPVL in630days after RIRS.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from stone free rate(SFR) with different follow-up periods | Primary SFR is assessed by abdominal plain film （KUB）in different follow-up periods after operation. Stone-free status are defined as either the absence of any residual stone fragments. | Patients in group A and group B return hospital respectively in 1,2 and 4 weeks after RIRS,patients in group C return hospital respectively in 2 and 4 weeks after RIRS. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extracorporeal physical vibration complications | Complication is defined as any adverse event occurred | Patients in group A and group B return hospital respectively in 1,2 and 4 weeks after RIRS,patients in group C return hospital respectively in 2 and 4 weeks after RIRS. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stones, external physical vibration lithecbole
A Study Based on Medical Records That Looks at the Duration of Use of Two Types of Inhalers With Different Medicines in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
To compare the persistence in using two different medications from the same drug class (LAMA/LABA FDC) which are delivered through different devices, a dry-powder inhalers (DPI) and Soft Mist Inhalers (SMI).

Official Title
-----------------
The Role of Inhaler Device in the Treatment Persistence With Dual Bronchodilators in Patients With COPD

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Olodaterol/Tiotropium Bromide
* Drug: Umeclidinium/ Vilanterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: Aged <40 years Enrolment with medical and pharmacy coverage prior to the cohort entry < 180 days Never had COPD diagnosis on the cohort entry date or prior to cohort entry A record for dispensed Olodaterol/Tiotropium Bromide delivered with Respimat inhalator or Umeclidinium/Vilanterol delivered with the Ellipta Inhaler during the 180-day baseline prior to cohort entry Diagnosis of asthma any time prior to cohort entry Diagnosis of lung cancer any time prior to cohort entry Diagnosis of lung transplant any time prior to cohort entry

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 40 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 |
| --- | --- |
| Subjects with Chronic obstructive pulmonary disease<br> | Drug: Olodaterol/Tiotropium Bromide<br>* (Stiolto®) delivered via Respimat inhaler<br>Drug: Umeclidinium/ Vilanterol<br>* (Anoro®) delivered via Ellipta Inhaler<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Discontinuation of Index Treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol) | The primary outcome of interest was discontinuation of index treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol), defined as persistence, (i.e. no refill Claim within 60 days [not including treatment Switch, nor death] after end of supply) during follow-up. Persistence was assessed by calculating rates of discontinuation in the matched cohorts using a 60-day allowable gap. Rates of discontinuation are reported as the number of events divided by the number of Person-years at risk. Addition of another treatment to index treatment did not count as discontinuation. | From first day after the cohort entry date to the earliest occurence of the outcome (discontinuation or refills), or any censoring criteria (365 days of follow-up without discontinuation, death, disenrollment end of data). |
Study Evaluating Pneumococcal Meningitis in the Paediatric Population in Spain Four Years After the Marketing of Prevenar.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the prevalence of pneumococcal meningitis in the paediatric population in Spain four years after the marketing of Prevenar. Also secondary objectives are: 1) to determine the clinical characteristics and outcome of the disease; and 2) to determine serotypes and antibiotic resistance patterns.

Official Title
-----------------
Prevalence of Pneumococcal Meningitis in the Paediatric Population in Spain Four Years After the Marketing of Prevenar.

Conditions
-----------------
Pneumococcal Meningitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children from 0 up to 14 years with diagnosis of confirmed or probable pneumococcal meningitis or with diagnosis of suspected bacterial meningitis without bacterial or viral isolation will be included into the study.

Ages Eligible for Study
-----------------
Maximum Age: 14 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 |
| --- | --- | --- |
MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the efficacy and safety of the implant and intra-ocular pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery. The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.

Official Title
-----------------
A Prospective, Open, Multicenter Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

Conditions
-----------------
Open Angle Glaucoma

Intervention / Treatment
-----------------
* Device: MINIject implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier. Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System. Glaucoma not adequately controlled Exclusion Criteria: Diagnosis of glaucoma other than open angle glaucoma Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System. Neovascular glaucoma in the study eye Prior glaucoma surgery in the study eye Clinically significant corneal disease Patients with poor vision

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: implant<br> | Device: MINIject implant<br>* MINIject implant is used to reduce intra-ocular pressure (IOP) in the eye through a minimally-invasive Glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation | Change of Medicated diurnal IOP [mmHg] from pre-implantation Baseline to 6 months post-implantation, with or without the use of the allowed concomitant glaucoma hypotensive medication | 6 months after implantation surgery |