linjc16/ctgov huggingface dataset:
Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess in France the impact of Prevenar on the possible evolution of the pneumococcal serotypes distribution and antibiotic resistance in NP samples of children with AOM.

Official Title
-----------------
Observational Study of the Rhinopharyngeal Carriage of Streptococcus Pneumoniae (Sp) in Infants With Acute Otitis Media (AOM)

Conditions
-----------------
Otitis Media, Otitis Media With Effusion, Pneumococcal Infections

Intervention / Treatment
-----------------
* Drug: Prevenar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants aged from 6 to 24 months Presenting with AOM (ear infection) Patients must not have received any antibiotic therapy within the past 7 days. Other inclusion applies. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 24 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Prevenar|nan|

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
-----------------
Middle Ear Infection
Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
Purpose: To evaluate the efficacy and safety of levetiracetam on chronic neuropathic pain after spinal cord injury, and to examine its effect on spasms and evoked pain.

Detailed Description
-----------------
Study design: Randomized double-blind cross-over study of levetiracetam (Keppra) against corresponding placebo with a 1 week baseline period followed by 2 x 5 weeks treatment periods separated by a 1 week wash-out period. Methodology: Levetiracetam and corresponding placebo is gradually increased during two weeks from 500 mg x 2 daily to 1500 mg x 2 daily (1000 mg x 2 daily is allowed if 1500 mg x 2 is not tolerated), and kept on that dose for three weeks. The study will be monitored by the GCP units of Aarhus and Copenhagen University.

Official Title
-----------------
Effects of Levetiracetam on Chronic Neuropathic Pain Following Spinal Cord Injury: a Randomized, Double-blind, Placebo-controlled, Cross-over, Multi-center Study

Conditions
-----------------
Injuries, Spinal Cord, Pain

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. age 18 or more 2. neuropathic pain (that have lasted at least 3 month) after a spinal cord injury with a pain intensity of at least 4 on a 0-10 point numeric rating scale Exclusion Criteria: 1. pregnancy or lactation 2. allergy to levetiracetam 3. alcohol or substance abuse, mental disease, epilepsy, depression and psychiatric disorders, severe liver disease, decreased kidney function, and known concomitant cerebral damage

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Levetiracetam<br>* Tablets 2000-3000 mg per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in median pain intensity (measured daily on a 10 point NRS) of spontaneous pain from baseline week to last week of treatment. |  | Last week of each 5-week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spasms and spasticity; pain relief for total, at- and below-level pain; evoked pain; escape medication; NPSI; predictive value of the presence of evoked pain; Global impression of change; sleep disturbance. |  | Last day of each 5-week treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal cord injury, Neuropathic pain, Spasms
Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children

Study Overview
=================
Brief Summary
-----------------
This is a passive-surveillance study that will accrue subjects for surveillance. For each accrued subject, surveillance for outcomes will continue for six months following the first dose. If a second dose is given within that time, then surveillance will be continued for six months following the second dose. Observational Objective: To describe and characterize adverse events occurring after vaccination with Menactra vaccine.

Detailed Description
-----------------
The study will be carried out in collaboration with the Kaiser Permanente Medical Care Program (KPMCP) under the direction of the Kaiser Permanente Vaccine Study Center (KPVSC). KPMCP is a closed-panel healthcare organization that maintains comprehensive encounter databases that capture all medical care received by enrollees. Vaccination will be according to routine clinical practice. Vaccination databases will be reviewed to identify eligible persons receiving Menactra vaccine within the KPMCP system.

Official Title
-----------------
Post-licensure Safety Surveillance Study of Menactra® Vaccine When Administered As a 2-dose Schedule to Children 9 Months Through 23 Months of Age.

Conditions
-----------------
Meningitis, Meningococcal Infection

Intervention / Treatment
-----------------
* Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 9 to 23 months at the time of receipt of the first dose of Menactra vaccine during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 9 Months
Maximum Age: 23 Months

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 |
| --- | --- |
| Study Group<br>Participants must have received Menactra Vaccine according to routine clinical practice. | Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate<br>* 0.5 mL, Intramuscular<br>* Other names: Menactra®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Incidence rates for each event were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. | Day 0 up to Day 75 post-vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meningitis, Meningococcal Infection, Menactra®
AZD6280 Multiple Ascending Dose Study

Study Overview
=================
Brief Summary
-----------------
This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD6280 after single and repeated ascending doses.

Official Title
-----------------
A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6280 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of Non-child Bearing Potential

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: AZD6280


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects must be of non-child bearing potential. Exclusion Criteria: Clinically significant illness within 2 weeks before the study start. Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2 Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD6280<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs |  | Assessments are made at each visit, at least daily, during the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation and characterization of the pharmacokinetics of AZD6280 |  | Blood samples will be taken during the study. | 
| Evaluation of the pharmacodynamic effects of AZD6280 |  | Test batteries will be performed at specified times both before and following study drug administration | 
| Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6280. |  | A single blood sample will be obtained. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I, Pharmacokinetics
Kinematics of Lower Limb, Pain and Function of the Women With Patellofemoral Pain Syndrome

Study Overview
=================
Brief Summary
-----------------
Assess pain, function, trunk and lower limbs kinematic during functional tasks after hip muscle strengthening versus hip muscle strengthening and sensory motor training in lower limbs.

Official Title
-----------------
Kinematics of Lower Limb, Pain and Function of the Women With Patellofemoral Pain Syndrome Who Underwent Two Types Treatment: Randomized Clinical Trial

Conditions
-----------------
Patellofemoral Pain Syndrome

Intervention / Treatment
-----------------
* Other: Strength
* Other: Sensorimotor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sedentary women, previous knee pain last 3 months in at least two of the following activities: sitting for long periods, walk up or down stairs, squat, running and jumping Exclusion Criteria: Lower limb surgery, patella displacement knee instability Heart or locomotor disorders which might influence the evaluation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sensorimotor<br>Sensorimotor, this arm will receive sensorimotor and hip muscle strengthening. | Other: Sensorimotor<br> <br> * Other names: Sensorimotor, balancing exercises, motor coordination, proprioceptive stimuli.;|
| Active Comparator: Strength<br>Strength, this arm will receive only hip muscle strengthening. | Other: Strength<br> <br> * Other names: Hip abductors and lateral rotators and knee extensors strengthening;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function and pain intensity |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength of the hip and knee muscles |  | 4 weeks | 
| Three-dimensional kinematics of the trunk and lower limbs during the step down task |  | 4 weeks | 
| Function and pain intensity |  | 3 and 6 months after randomization |
Percutaneous Electrolysis Versus Dry Needling in Levator Scapulae

Study Overview
=================
Brief Summary
-----------------
The objective will be to determine the effectiveness of ultrasound-guided percutaneous electrolysis versus ultrasound-guided dry needling in active myofascial trigger points of the levator scapulae muscle on pain intensity, disability and range of motion. A randomized clinical trial will be carried out. Fifty-four patients with at least one active myofascial trigger point in the levator scapulae muscle were recruited and divided into ultrasound-guided percutaneous electrolysis (n = 27) and ultrasound-guided dry needling (n=27). Pain intensity, disability and range of motion will measured before, immediately after and 1 week after intervention.

Official Title
-----------------
Effectiveness of Ultrasound-guided Interventions of Percutaneous Electrolysis Versus Dry Needling in Levator Scapulae Active Myofascial Trigger Points

Conditions
-----------------
Trigger Point Pain, Myofascial, Myofascial Pain

Intervention / Treatment
-----------------
* Other: Percutaneous electrolysis
* Other: Dry needling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neck pain At least two active myofascial trigger point in the levator scapulae muscle Exclusion Criteria: Systemic diseases Cognitive impairment

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound-guided percutaneous electrolysis<br> | Other: Percutaneous electrolysis<br>* Ultrasound-guided percutaneous electrolysis in the active myofascial trigger point of the levator scapulae muscle<br>|
| Active Comparator: ultrasound-guided dry needling<br> | Other: Dry needling<br>* Ultrasound-guided dry needling the active myofascial trigger point of the levator scapulae muscle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Neck pain intensity scores from 0 to 100 points measured by the visual analogue scale | Change from baseline pain intensity immediately and at 1 week after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability | Neck disability scores measured from 0 to 50 points measured by the Neck Disability Index | Change from baseline pain intensity at 1 week after intervention | 
| Range of motion | Neck rotation range of motion measured with an universal goniometer | Change from baseline pain intensity immediately and at 1 week after intervention |
Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity

Study Overview
=================
Brief Summary
-----------------
Infection and inflammation is related to increased encephalopathy of prematurities.

Detailed Description
-----------------
Animal studies have verified intravenous immunoglobin can reduce brain injury. However, no studies in preterm infants were reported.

Official Title
-----------------
Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity

Conditions
-----------------
Preterm Infants

Intervention / Treatment
-----------------
* Drug: human gamma globulin
* Drug: non-human gamma globulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm infants with encephalopathy Exclusion Criteria: refuse the participate in the trial

Ages Eligible for Study
-----------------
Maximum Age: 6 Hours

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: human gamma globulin<br>human gamma globulin for infants with encephalopathy of prematurities | Drug: human gamma globulin<br>* human gamma globulin for preterm infants with encephalopathy of prematurities<br>Drug: non-human gamma globulin<br>* Non-human gamma globulin for preterm infants with encephalopathy of prematurities<br>|
| Active Comparator: non-human gamma globulin<br>non-human gamma globulin for infants with encephalopathy of prematurities | Drug: human gamma globulin<br>* human gamma globulin for preterm infants with encephalopathy of prematurities<br>Drug: non-human gamma globulin<br>* Non-human gamma globulin for preterm infants with encephalopathy of prematurities<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| structural changes of brain injury | MRI/ultrasound will be used to assess the structural severities of brain injury. | 100-days | 
| functional changes of brain injury | Bayley score will be used to assess the functional severities of brain injury. | 100-days |
Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether azathioprine is effective for mucosal healing in UC patients who achieved clinical remission by the first course of corticosteroids but not mucosal healing in endoscopy.

Detailed Description
-----------------
The sample size was calculated based on the previous study showing the difference of mucosal healing rate between azathioprine (58%) and 5-aminosalicylate (21%). With a two-tailed test of α = 0.05 and 1 - ß = 0.8, 52 patients were required. The placebo drug which is identical to azathioprine will be provided by Celltrion drug company. Differences in the categorical variables between the groups are examined with χ2 or the Fisher exact test. For comparisons of continuous variables, a Student t test is used.

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Azathioprine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ulcerative colitis patients with moderate to severe activity who achieved a clinical remission by the first course of corticosteroids Newly diagnosed or without steroid use during last 1 year Endoscopic Mayo subscore >0 Exclusion Criteria: Patients with azathioprine or biologics therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: Azathioprine<br>Azathioprine (1.5mg/kg) po for 1 year | Drug: Azathioprine<br> <br> |
| Placebo Comparator: Sugar pill<br>Placebo drug identical to azathioprine (1.5mg/kg) po for 1 year | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal healing status | Mucosal healing status will be assessed by sigmoidoscopy using Mayo endoscopic score. | one year |
App-based Symptom Tracking After Corona Vaccination (CoCoV)

Study Overview
=================
Brief Summary
-----------------
The study investigates the side effects of different COVID-19 vaccines.

Detailed Description
-----------------
In this observational study side effects of COVID-19 vaccines will be documented using an open-source mobile application. Participants are invited to answer a questionnaire on a daily basis. Common and unknown events are queried and collected. The primary result of this study will be a descriptive analysis of the collected data.

Official Title
-----------------
App-based Symptom Tracking After Corona Vaccination (CoCoV)

Conditions
-----------------
Adverse Events in COVID-19 Vaccination

Intervention / Treatment
-----------------
* Biological: COVID-19 vaccines


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: received COVID-19 vaccination age ≥ 18 years mobile device (iOS or Android) Exclusion Criteria: No knowledge of German or English language No written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: COVID-19 vaccines|Participants will be vaccinated with one of the approved COVID-19 vaccines|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related side effects | Number of participants with treatment-related side effects as assessed by the toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (status September 2007) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution and deviation of documented side effects | Descriptive statistics for different side effects | 4 weeks |