linjc16/ctgov huggingface dataset:
Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in patients with relapsing forms of multiple sclerosis

Official Title
-----------------
Double-blind, Placebo-controlled, Randomized, Parallel-group Phase II Study in Subjects With Relapsing Forms of Multiple Sclerosis (MS) to Evaluate the Safety, Tolerability, and Effects of CDP323.

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: CDP323
* Drug: placebo
* Drug: CDP323


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: relapsing form of MS screening EDSS score 0 - 5.5, inclusive at least one clinical relapse in the 12 months before screening active disease, defined by set of MRI activity criteria failed prior treatment with beta-interferons or glatiramer acetate Exclusion Criteria: signs of silent infections, including positive tests for HIV1, HIV2 or Hepatitis B or Hepatitis C or tuberculosis known allergy to gadolinium-DTPA, and/or ingredients of the study drug formulation pre-treatment with immunosuppressive or immunomodulatory drugs prior to screening within certain time frames

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDP323 1000 mg/day<br> | Drug: CDP323<br>* 250 mg capsules, 500 mg bid (1000 mg/day)<br>|
| Experimental: CDP323 500 mg/day<br> | Drug: CDP323<br>* 250 mg Capsules, 500 mg, once daily<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* capsules, once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cumulative number of newly active lesions on standardized brain MRI scans after 24 weeks of treatment (Week 28). | The following lesions are considered newly active: new gadolinium enhancement on T1-weighted images; new lesions on T2-weighted images, but non-enhancing on T1-weighted images; new enlargement on T2-weighted images, but non-enhancing on T1-weighted images. | Cumulative number of newly active lesions from baseline to Week 28. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of any treatment emergent adverse event. |  | During up to 24 weeks of treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral Compound, CDP323, Relapsing Multiple Sclerosis, Magnetic Resonance Imaging, MS
Haematologic Predictors and Clinical Outcome in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The outcome predictors for cardiac surgery has been popular for many researchers and clinicians. Determining risk factors before surgery reduce morbidity and mortality after surgery. Some routine blood results have been used as predictors for cardiac surgery but none of the researches studied red cell distribution width, mean platelet volume, platelet/lymphocyte ratio and neutrophil/lymphocyte ratio. This study focused on these parameters and to see whether these parameters can be predictors for cardiac surgery.

Official Title
-----------------
Haematologic Predictors and Clinical Outcome in Cardiac Surgery

Conditions
-----------------
Cardiac Disease

Intervention / Treatment
-----------------
* Other: Red red cell distribution width


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective, on-pump cardiac surgery Exclusion Criteria: emergent cases pediatric cases congenital surgery heart transplantation

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Red red cell distribution width|Results from hemogram|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of combined adverse effects |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery, open heart surgery, hemogram
Study on the Incidence of Intussusception (IS) in Children Aged < 12 Months in Japan

Study Overview
=================
Brief Summary
-----------------
This study aims to analyse baseline data on IS in order to monitor the possibility of increased risk of IS in children aged <12 months after introduction of the Rotarix vaccination in Japan.

Official Title
-----------------
Observational Database Study on the Incidence of Intussusception in Children Aged < 12 Months in Japan

Conditions
-----------------
Intussusception

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female infant aged < 12 months at the time of IS diagnosis and affiliated to the JMDC-MDB database. An IS case should be identified as per the ICD-10 diagnostic code-K56.1 (any-field listed), examination codes, and procedural codes. Exclusion Criteria: Not applicable

Ages Eligible for Study
-----------------
Maximum Age: 12 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 |
| --- | --- |
| Case Group<br>Children aged < 12 months presenting with IS and covered by the Japan Medical Data Centre Company Limited (JMDC), Tokyo referred to as the JMDC Medical Data Bank (JMDC-MDB). | Other: Data collection<br>* Data source will be the Japan Medical Data Centre Company Limited (JMDC) - JMDC Medical Data Bank (JMDC-MDB) database. Aggregated data (age in months and years and gender) for all subjects recorded in the database and subject-level data for IS cases will be extracted from the database. This database will be reviewed to extract data for the period between January 2005 and April 2011. Cases of IS will be identified using the International Classification of Diseases-10 (ICD-10) diagnostic codes, examination codes and procedural codes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of IS in subjects aged < 12 months |  | Between January 2005 and April 2011 (6 years) | 
| Occurrence of age-specific and gender-specific incidence of IS among subjects aged < 12 months in Japan |  | Between January 2005 and April 2011 (6 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of IS cases hospitalized more than once among subjects aged < 12 months. |  | Between January 2005 and April 2011 (6 years) | 
| Occurrence of IS cases by calendar months and year among subjects aged < 12 months |  | Between January 2005 and April 2011 (6 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Japan, Retrospective, Observational, Epidemiological study, Children aged < 12 months, Intussusception
Characterization of Signs and Symptoms of Participants With and Without Meibomian Gland Dysfunction

Study Overview
=================
Brief Summary
-----------------
This is an exploratory study to evaluate endpoints used to characterize participants with and without meibomian gland dysfunction (MGD) and will evaluate the correlation between signs and symptoms of MGD. No investigational drug will be administered in this study.

Conditions
-----------------
Meibomian Glands

Intervention / Treatment
-----------------
* Procedure: Meibum Expression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Participants characterized as with or without Meibomian Gland Dysfunction. Exclusion Criteria: Lid heating therapy, therapeutic gland expression, or meibomian gland probing within 12 months of enrollment Contact lens use in the 30 days prior to enrollment Lid hygiene within 48 hours prior to enrollment Use of eye makeup within 8 hours of enrollment Eyelash growth-stimulating products within 30 days prior to enrollment Use of systemic vitamins and/or systemic supplements containing omega 3 fatty acids within 60 days of enrollment Use of systemic anti-histamines within 30 days prior to enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Non-MGD Participants<br>Participants without MGD who have meibum expressed as per protocol. No investigational drug is administered in this study. | Procedure: Meibum Expression<br>* Meibum expression as per protocol. No investigational drug is administered in this study.<br>|
| Mild-Moderate MGD Participants<br>Participants with Mild-Moderate MGD who have meibum expressed as per protocol. No investigational drug is administered in this study. | Procedure: Meibum Expression<br>* Meibum expression as per protocol. No investigational drug is administered in this study.<br>|
| Severe MGD Participants<br>Participants with Severe MGD who have meibum expressed as per protocol. No investigational drug is administered in this study. | Procedure: Meibum Expression<br>* Meibum expression as per protocol. No investigational drug is administered in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meibum Quality Score in the Study Eye as Assessed by the Investigator Using a 4-Point Scale |  | Day 22 |
Use Of Procalcitonin Level For Guidance of The Treatment of Suspected Community Acquired Pneumonia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to learn if a blood test is helpful to the doctors in deciding whether you need antibiotic therapy for possible pneumonia. The blood test is called a Procalcitonin level and sometimes the test reflects infection with certain bacteria (germs). When the doctors learn the results of these blood tests, they may be able to stop some of the antibiotic medications that they may have given to the patients. The study is designed, so that on a randomized basis (50/50 chance) the results from measuring Procalcitonin will be given to the patients' doctor. When the doctor receives these results, he/she may use this information, along with other information, to decide whether to continue antibiotic therapy.

Detailed Description
-----------------
To evaluate the usefulness of serum Procalcitonin level measured to guide the antibiotic treatment of patients with radiographic lung infiltrates.The subjects involved in the study will be divided in two arms ,study arm where the caregivers will know the result of Procalcitonin level and they can change /withheld the antibiotic for the subjects.In other arm only investigators will know the Procalcitonin level. We expect to enroll 100 patients.

Official Title
-----------------
Use Of Procalcitonin Level For Guidance of The Treatment of Suspected Community Acquired Pneumonia

Conditions
-----------------
Pneumonia, Radiographic Lung Infiltrates

Intervention / Treatment
-----------------
* Other: Procalcitonin level, caregiver informed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults New radiographic findings consistent with the presence of infiltrates Antibiotic therapy Exclusion Criteria: Critically ill patients on admission

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 |
| --- | --- |
| Procalcitonin level, caregiver informed<br>Procalcitonin level for patients with lung infiltrates:caregivers know/ do not know results | Other: Procalcitonin level, caregiver informed<br>* Procalcitonin levels will be measured and known by investigator, only 1/2 of the patients' caregivers will know the results of serial Procalcitonin levels. We will analyze the rate of antibiotic discontinuation for the two arms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in antibiotic discontinuation as an effect of the caregivers learning Procalcitonin levels for the therapy of new radiographic lung infiltrates |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumonia, Lung Infiltrates, Antibiotic discontinuation, De-escalation therapy
MSCs Source of Sweat Gland Cells of Large Area Skin Injury Patients Transplant of the Wound

Study Overview
=================
Brief Summary
-----------------
The main purpose of this test is to assess the umbilical cord mesenchymal stem cells (MSCs) UC between source sample sweat gland cells wound transplanted effectiveness and safety for the treatment of large area skin lesions of the subjects

Official Title
-----------------
Between Umbilical Cord Mesenchymal Stem Cells Sources Sweat Gland Samples of Large Area Skin Wound Injury Patients Before and After the Transplant Center, Open, Random, Own More Controlled Clinical Trials

Conditions
-----------------
MSCs

Intervention / Treatment
-----------------
* Biological: MSCs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign the informed consent form when the age of 18 and 60 years old or less or more men or women (not pregnancy) The burned area: 10-20% TBSA, can satisfy the self control Time: early for skin grafts For location: limbs, chest and back Exclusion Criteria: Serious allergic constitution; Have influence on the speed of wound healing of chronic disease patients; According to the researcher's judgment, may endanger the safety of the subjects or scheme compliance of any chronic disease or severe disease, including cancer, severe heart disease, kidney disease, liver disease, respiratory disease, nerve diseases of the nervous system, blood system diseases, etc.; Clinical researchers or for other reasons can't cooperate with the doctors, and other information is not suitable for clinical study of patients. Can not meet the requirement of the long-term follow-up of patients.

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

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

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

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: MSCs<br>The main purpose of this test is to assess the umbilical cord MSCs between source sample sweat gland cells wound transplanted effectiveness and safety for the treatment of large area skin lesions of the subjects | Biological: MSCs<br>* The main purpose of this test is to assess the umbilical cord MSCs between source sample sweat gland cells wound transplanted effectiveness and safety for the treatment of large area skin lesions of the subjects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Adverse Events | Frequency and severity of Adverse Events | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Wound Area Regression of 40% or More at 12 Week |  | 12 Week |
A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.

Study Overview
=================
Brief Summary
-----------------
This randomized, single blind study will compare the antiviral effect of Pegasys (pegylated interferon alfa-2a) plus placebo versus Pegasys plus tenofovir in patients with chronic hepatitis D. Patients will be randomized to receive 96 weeks of therapy with Pegasys (180 micrograms sc weekly) plus either placebo (orally daily) or tenofovir (245mg orally daily). Anticipated time on study treatment is 2+ years, target sample size is <50.

Official Title
-----------------
A Multicenter Randomised Study Comparing the Antiviral Efficacy of Pegylated Interferon-alfa-2a Plus Placebo vs. Pegylated Interferon-alfa-2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis

Conditions
-----------------
Hepatitis D, Chronic

Intervention / Treatment
-----------------
* Drug: peginterferon alfa-2a [Pegasys]
* Drug: placebo
* Drug: tenofovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >/=18 years of age chronic hepatitis D positive for HBsAg >/=6 months, for anti-HDV >/=3 months and for HDV-RNA at screening negative pregnancy test; fertile males and women of childbearing age should use two reliable forms of contraception throughout study Exclusion Criteria: antiviral therapy for chronic hepatitis D within the previous 6 months previous therapy with pegylated interferon alfa treatment with conventional interferon alfa for >12 months hepatitis A or C, or HIV infection decompensated liver disease (Childs B-C) history or evidence of medical condition associated with chronic liver disease

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: 1<br> | Drug: peginterferon alfa-2a [Pegasys]<br>* 180mcg sc weekly, 96 weeks<br>Drug: placebo<br>* orally daily, 96 weeks<br>|
| Experimental: 2<br> | Drug: peginterferon alfa-2a [Pegasys]<br>* 180mcg sc weekly, 96 weeks<br>Drug: tenofovir<br>* 245mg po daily, 96 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients becoming HDV-RNA negative |  | week 96 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology |  | weeks 48, 96 and after 24 weeks of follow-up | 
| Safety and tolerability: adverse events, laboratory parameters, vital signs |  | throughout 96 weeks of treatment |
Validation of a Novel Robot-aided Assessment of Gait Ability

Study Overview
=================
Brief Summary
-----------------
The aim of this study is the validation of a novel gait assessment method implemented in the Lokomat gait trainer with respect to established clinical gait assessment methods. The walking assessment method is based on the progressive reduction of the support of the device. The outcome measures of this algorithm will be the support needed in the different gait phases (guidance force of hip and knee joints) and the support required to the body weight support system (unloading). The hypothesis is that the guidance force and the support of the device will converge to a profile individual for each subject that is representative of one's impairment in the different gait phases. The reliability of the method will be tested collecting data from two sessions of Lokomat training. The validity of the method will be tested comparing the outcome of the assessment task with established clinical walking assessment measures.

Official Title
-----------------
Validation of Lokomat-aided Assessment of Gait Ability

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Device: Lokomat gait trainer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: individuals >1 year post Spinal Cord Injury or able bodied persons Exclusion Criteria: presence of contraindications to Lokomat training, inability or unwillingness to provide written informed consent or follow study procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Lokomat assessment<br> | Device: Lokomat gait trainer<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraclass Correlation Coefficient between Lokomat score. | Reliability of Lokomat assessment | up to one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Cord Injury, adaptive control, assessment, assist-as-needed, walking ability, Lokomat