linjc16/ctgov huggingface dataset:
Safety and Efficacy of the Penumbra™ System in Acute Middle Cerebral Artery (MCA) Stroke

Study Overview
=================
Brief Summary
-----------------
Stroke prognosis is intimately related to reperfusion. Reperfusion in acute setting can be achieved with different strategies - varying from intravenous rtPA from mechanical thrombectomy. Recently, interventional approaches have been gaining attention and playing an increasing role in stroke care. However, no solid scientifical data is available to date. The investigators want do conduct a pilot trial to test if the use of the Penumbra™ System can improve clinical outcomes in a specific stroke setting.

Official Title
-----------------
Randomized Clinical Trial Comparing Intravenous Thrombolysis With Thrombectomy by the Penumbra™ System in Patients With Middle Cerebral Artery Stem Occlusion - Pilot Study

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: Penumbra™ System
* Drug: Recombinant tissue plasminogen activator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient enrolled in acute ischemic stroke protocol Up to 3,5h from symptoms onset Clinical findings compatible with middle cerebral artery syndrome Angiotomographic evidence of proximal middle cerebral artery occlusion Exclusion Criteria: NIHSS < 10 Overt contraindication to thrombolysis or angiopgraphy Disagreement with informed consent term or refusal to participate
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thrombectomy<br> | Device: Penumbra™ System<br>* Patients assigned to the Thrombectomy arm will be conducted to the angio suite. Mechanical thrombectomy will be attempted with the use of the Penumbra™ System, and can be assisted by intraarterial thrombolysis (rTPA up to 20 mg)<br>|
| Active Comparator: Usual Care<br> | Drug: Recombinant tissue plasminogen activator<br>* Patients assigned to Usual Care arm will be thrombolysed according to the NINDS protocol (rtPA 0,9 mg/kg, 10% IV bolus and remaining in the next hour, up to 90 mg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional independence (modified Rankin Scale 0-2) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal or no disability (modified Rankin Scale 0-1) |  | 3 months | 
| Overall mortality |  | 7 days and 3 months | 
| Symptomatic cerebral bleeding rate |  | 48 hours, 7 days and 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, mecanical thrombectomy
TNFalfa Blocking Treatment of Spondylarthropathies

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to establish a Danish cohort of spondylarthropathy (SpA) patients who are being treated with TNFalfa blockers. By following the TNFalfa blocking treated patients the researchers want to identify better biomarkers for disease activity and disease progression. In addition, the researchers want to identify predictors for disease progression.

Official Title
-----------------
TNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With Spondylarthropathies

Conditions
-----------------
Spondylarthropathies, Ankylosing Spondylitis, Psoriatic Arthritis

Intervention / Treatment
-----------------
* Drug: Infliximab
* Drug: Etanercept
* Drug: Adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years old Spondylarthropathies according to the European Spondylarthropathy Study Group (ESSG) criteria Sacroiliitis by X-ray or magnetic resonance imaging (MRI) Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)>3 No signs of tuberculosis (TB) Sufficient contraception Exclusion Criteria: Wish of pregnancy or nursing Previous treatment with TNFalfa blocker Disease-modifying anti-rheumatic drugs (DMARDs) other than methotrexate (MTX) later than 4 weeks before inclusion Steroid treatment later than 4 weeks before inclusion Immunosuppressing agents later than 4 weeks before inclusion Severe infections within 3 months HIV-infection Active hepatitis B and C Active or latent TB Severe chronic diseases Heart insufficiency (New York Heart Association [NYHA] 3 and 4) Malignancy Systemic lupus erythematosus (SLE) or SLE-like disease Abuse of narcotics or alcohol Major psychiatric disorders

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Infliximab|nan|
|Drug: Etanercept|nan|
|Drug: Adalimumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Survival Trends in Myocardial Infarction 1994 - 2010

Study Overview
=================
Brief Summary
-----------------
Practice in management of myocardial ischemia and infarction has changed significantly over the past 20 years, both in terms of immediate management and secondary prevention. The aim of this observational study is to utilize the established record linkage data available in Tayside to investigate the trends in survivors of myocardial infarction in Tayside since 1994.

Official Title
-----------------
Survival Trends in Myocardial Infarction 1994 - 2010

Conditions
-----------------
Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myocardial Infarction Exclusion Criteria: Nil
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Myocardial Infarction - STEMI<br> | |
| Myocardial Infarction - NSTEMI<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Mortality | All cardiovascular mortality | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular hospitalisation | Hospitalisation for cardiovascular cause after initial presentation | 20 years |
Development and Validation for Taiwan Version ID Pain Questionnaire (ID Pain-T) and DN4 Questionnaire.

Study Overview
=================
Brief Summary
-----------------
This prospective cohort and multi-site study aims to develop Taiwan version (ID Pain-T) based on the original versions of ID Pain and also DN4, and validate both ID Pain-T and DN4 applied in Taiwanese subjects at the clinical setting.

Official Title
-----------------
Development and Validation for Taiwan Version ID Pain Questionnaire (ID Pain-T) and DN4 Questionnaire.

Conditions
-----------------
Neuralgia, Nerve Pain, Neuropathic Pain

Intervention / Treatment
-----------------
* Other: ID-Pain DN4 Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects without headache pain over 30 days and at least 18 years old who will visit the clinic, inclusive of male and female. Subjects who are able to complete the ID Pain-T Questionnaire. Exclusion Criteria: Subjects who are illiterate or unable to complete questionnaire. Subjects who are currently participating in another study or have participated in another pain study within one month of study entry. Subjects with low back pain are unable to participate in this study; as the sciatica caused by the piriformis (exclusive of the other types of sciatic pain), lumbago, unclear identification in nerve injury (e.g. complex regional pain syndrome type I) or mixed origin (e.g. cancer pain).

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

| Intervention/Treatment |
| --- |
|Other: ID-Pain DN4 Questionnaire|This is a non-interventional questionnaire validation study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the optimal cut-off score of ID Pain-T Questionnaire for screening of neuropathic pain |  | end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the predictive power of ID Pain-T Questionnaire for diagnosis of neuropathic pain |  | end of study | 
| Develop and evaluate validity of a short form diagnostic tool based on DN4 structure |  | end of study |
Safety and Efficacy of Stem Cell Therapy in Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to study the effect of stem cell therapy on common symptoms of spinal cord injury patients.

Detailed Description
-----------------
Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by standard rehabilitation therapy.

Official Title
-----------------
Autologous Bone Marrow Mononuclear Cell Therapy for Spinal Cord Injury

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

Intervention / Treatment
-----------------
* Biological: Autologous bone marrow mononuclear cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed cases of any type of chronic Spinal cord injury Age above 6 months Exclusion Criteria: presence of acute infections such as Human immunodeficiency virus/ Hepatitis B Virus/ Hepatitis C Virus malignancies bleeding tendencies pneumonia renal failure severe liver dysfunction severe anemia [Hemoglobin < 8] any bone marrow disorder other acute medical conditions such as respiratory infection pregnancy and lactation

Ages Eligible for Study
-----------------
Minimum Age: 8 Months
Maximum Age: 63 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: Stem cell<br>Autologous bone marrow mononuclear cell transplantation | Biological: Autologous bone marrow mononuclear cell transplantation<br>* Bone marrow is aspirated by a standard procedure. Mononuclear cells are separated by density gradient method and then injected intrathecally by a standard lumbar puncture procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical symptoms | clinical symptoms were assessed based on the observation of the experts | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence Measure (FIM) | Functional Independence Measure (FIM) is a standard scale performed before and 6 months after the intervention to measure the functional ability of the patients. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal cord injury, autologous bone marrow mononuclear cells, stem cell therapy
Dynamic Changes of Tim-3 on Monocytes and Soluble Tim-3 in Patients With Sepsis

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators will dynamically detect the expression of an immune regulator- T cell Ig and mucin domain protein 3 (Tim-3) in patient with sepsis.

Detailed Description
-----------------
In this study, we will collect the peripheral blood of 1,3,5,7,10,14 day after diagnose of sepsis.All the patients rolled in this study will be divided into three groups which is sepsis, severe sepsis and septic shock group according their severity. Then,the flow cytometry will be used to detect the express of Tim-3 on monocyte and ELISA will be used to exam the plasm soluble Tim-3.IL-6,IL-10,IL-12 and TNF-αin the peripheral blood will also be detected. We would like to find a new marker to predict the severity and prognosis of sepsis patients.

Official Title
-----------------
Dynamic Changes of Tim-3 on Monocytes and Soluble Tim-3 in Patients With Sepsis

Conditions
-----------------
Sepsis, Severe Sepsis, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than one of the following: clinical manifestations: (1) a body temperature greater than 38℃ or less than 36℃; (2) a heart rate greater than 90 beats/minute; (3)tachypnea, manifested by a respiratory rate greater than 20 breaths per minute, or hyperventilation, as indicated by a PaCO2 of less than 32 mmHg; and (4)an alteration in the white blood cell count, such as a count greater than 12×10^9/L, a count less than 4×10^9/L, or the presence of more than 10 percent immature neutrophils Exclusion Criteria: (1)patients younger than 18 years of age; (2)agranulocytosis (granulocyte counts,0.5×10^9/L); (3) those discharged within 24 h; (4) those diagnosed with HIV infection or cancer; and (5) patients who refused to participate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| normal control<br>healthy people | |
| sepsis<br>mild response to infection | |
| severe sepsis<br>infection with at least one organ dysfunction | |
| septic shock<br>patients with septic shock | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | 28 days |
Intraoperative Trocar Slippage Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out how much a trocar might slide during a typical laparoscopic hysterectomy. We also want to find out if there is a difference between how much three commonly used trocars slide and if a device called LaproStop has an effect on the slippage. Patients will be randomly assigned into the different trocar groups. After this assignment has been made, we will then assign the Laprostop to one of the two trocars by chance.

Official Title
-----------------
A Pilot Study to Determine the Extent of Intraoperative Laparoscopic Trocar Slippage.

Conditions
-----------------
Trocar Slippage

Intervention / Treatment
-----------------
* Device: LaproStop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing a hysterectomy at Brigham and Women's Hospital and Faulkner Hospital. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ethicon Xcel Trocars<br>Ethicon Xcel trocars will be used in this arm with Laprostop device | Device: LaproStop<br>* One of the subject's trocars will be randomized to be used with a LaproStop device.<br>|
| Active Comparator: Covidien Veraport Trocars<br>Covidien Veraport Trocars will be used in this arm with the Laprostop device | Device: LaproStop<br>* One of the subject's trocars will be randomized to be used with a LaproStop device.<br>|
| Active Comparator: Storz Reusable Trocars<br>Storz Reusable Trocars will be used in this arm with the Laprostop device | Device: LaproStop<br>* One of the subject's trocars will be randomized to be used with a LaproStop device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trocar Slippages With LaproStop | Number of participants with slippages with LaproStop | During the hysterectomy procedure, up to 2 hours and 32 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trocar Slippages Without LaproStop | Number of participants with slippages with LaproStop | During the hysterectomy procedure, up to 2 hours and 32 minutes |
Gait Parameters of Persons With Down Syndrome With and Without Orthotics Using GaitRite

Study Overview
=================
Brief Summary
-----------------
This is a research study of persons with Down Syndrome between 2 and 80 years old who are independently walking. The purpose of this study is to see what effect orthotics have on how people with Down Syndrome walk.

Official Title
-----------------
Gait Parameters of Persons With Down Syndrome With and Without Orthotics Using GaitRite

Conditions
-----------------
Down Syndrome

Intervention / Treatment
-----------------
* Procedure: custom orthotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Down Syndrome, independent walkers Exclusion Criteria: Down Syndrome, not independently walking

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 80 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 |
| --- | --- |
| Persons with Down Syndrome who use orthotics<br>Orthotic users | Procedure: custom orthotics<br>* Orthotics are fabricated uniquely for each patient and use molds or casts of their foot as the template. They are fabricated by a licensed orthotist. There is no device or brand name other than custom orthotics.<br>|
| Persons with Down Syndrome who do not use orthotics<br>Non orthotic users | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait will be measured with the GaitRite gait evaluation system. | Specific temporal and spatial parameters of gait will be measured with the GaitRite gait evaluation system. Subjects will walk with and without their orthotics. Measurement will be by changes in the previously noted gait parameters between the orthotics and non-orthotics groups. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elucidate patterns in the development of walking in persons with Down Syndrome using GaitRite®. | The previously described parameters of gait as measured by the GaitRite system will be used to establish an overview of the development of gait in persons with Down Syndrome. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Down Syndrome, Orthotics, Gait Analysis
Impact of Iron Stores on Wound Healing in Plastic Surgery

Study Overview
=================
Brief Summary
-----------------
In breast reduction surgery, delayed wound healing may increase surgical site infections, cutaneous necrosis and may be related to psychological harm.Some risk factors have been identified : smoking, diabetes, overweight. A normal healing involve cellular and biochemical reactions in which iron plays an important role such as cellular respiration, redox reactions and regulation of genes involved in the cell cycle. This trial will study the relationship between iron stores and postoperative wound healing after bilateral breast reduction surgery in patients without preoperative anaemia.The primary outcome of this trial is the comparison of wound healing at post operative day 15, between patients with and without iron deficiency.

Official Title
-----------------
Impact of Iron Stores on Wound Healing in Plastic Surgery

Conditions
-----------------
Healing Wound, Iron-deficiency, Surgical Wound

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years female scheduled bilateral breast reduction surgery biological exams with ferritin and transferrin saturation coefficient taken the day before surgery No anemia : haemoglobin >=12g/dL (preoperative biological assessment ) if genetic disease of haemoglobin, haemoglobin between 10 and 12g/dL and no Anaemia by iron deficiency absence of clinical inflammatory syndrome (no clinical signs of infection or no fever) non-opposition of the patient to participate Exclusion Criteria: Anaemia by iron deficiency

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

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

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 |
| --- | --- | --- |
| Proportion of good breast tissue healing on each breast | Good healing is defined as a score of 0, 1 or 2 on a 16 points-specifc scale. The scale evaluate proportion of disunity for periareolar vertical and horizontal incisions | 15 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of healing on the 16 points specific scale |  | 15 days after surgery | 
| Proportion of early complications |  | up to 15 days after surgery | 
| Proportion of closed drainage orifices |  | 15 days after surgery | 
| Correlation between serum ferritin levels before surgery and score on the healing scale |  | 15 days after surgery | 
| Intra-class correlation coefficient for the healing scale |  | 15 days after surgery |