linjc16/ctgov huggingface dataset:
Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture

Study Overview
=================
Brief Summary
-----------------
This is clinical feasibility study on the device performance with paediatric patients. The main objective is to validate the performance of investigational device in distinguishing and identifying the cerebrospinal fluid (CSF) inside the subarachnoid space during a lumbar puncture on paediatric patients.

Official Title
-----------------
Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture

Conditions
-----------------
Pediatric Lumbar Puncture

Intervention / Treatment
-----------------
* Device: Injeq IQ-Needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children whose diagnosis or treatment plan requires lumbar puncture to acquire a CSF sample. Consent from the parents Exclusion Criteria: Being a high risk patient (as determined by the investigator) Any contraindication to a common lumbar puncture apply also in the investigation

Ages Eligible for Study
-----------------
Maximum Age: 18 Months

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

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

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: Injeq IQ-Needle<br>Lumbar puncture is performed using Injeq IQ-Needle | Device: Injeq IQ-Needle<br>* Injeq IQ-Needle is a spinal needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with cerebrospinal fluid.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of true/false positive and true/false negative detections of cerebrospinal fluid marked in case report form | Measurement device indicates with a sound and visual feedback when needle reaches cerebrospinal fluid (CSF). Physician verifies the location by removing the needle stylet and testing whether CSF flows from the needle, similarly as in traditional process. Detection is true positive if CSF flows from the needle and false positive if not. Even if the device does not detect CSF, physician performs the CSF test when needed. Physician marks to the case report form whether the device provided detections during the lumbar puncture and were the detections true or false detections. | During lumbar puncture |
Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm

Study Overview
=================
Brief Summary
-----------------
The study investigates safety, feasibility and effectiveness of cervical spinal cord stimulation (SCS) in prevention of cerebral arterial vasospasm following aneurysmal subarachnoid hemorrhage (aSAH). It is postulated that 2 week long stimulation of the cervical spinal cord using an implanted epidural electrode will prevent or decrease severity of cerebral arterial vasospasm following aSAH.

Detailed Description
-----------------
Continuous stimulation of the cervical spinal cord for 14 days after electrode implantation (within 3 days after aneurysmal subarachnoid hemorrhage). The single-arm single-institution non-randomized prospective study evaluates effects of cervical spinal cord stimulation on prevention of cerebral arterial vasospasm. The patients are followed for 12 months after completion of stimulation.

Official Title
-----------------
Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage Using MTS Trial System 3510

Conditions
-----------------
Aneurysmal Subarachnoid Hemorrhage

Intervention / Treatment
-----------------
* Device: spinal cord stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 Subarachnoid hemorrhage (SAH) within 72 hours Ruptured aneurysm confirmed by angiography of CT angiography Fisher grade 2-4 Hunt & Hess grade 2-4 Aneurysm is secured Ability to obtain informed consent Exclusion Criteria: Pregnancy Allergy to IV contrast or to any component of SCS system Non-aneurysmal SAH Previous cervical spine surgery or any anomaly of cervical spine that would prevent electrode insertion Coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Spinal cord stimulation | Device: spinal cord stimulation<br>* electrode is inserted into cervical epidural space for continuous spinal cord stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of cerebral vasospasm |  | 14-17 days after aSAH | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any complication of spinal cord stimulation |  | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vasospasm, spinal cord stimulation, aneurysm, subarachnoid hemorrhage
Study Evaluating PD-0299685 for the Treatment of Vasomotor Symptoms (Hot Flashes / Flushes) Associated With Menopause

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to determine if PD-0299685 is effective and safe in the treatment of vasomotor symptoms (hot flashes / flushes) associated with menopause.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study Evaluating PD-0299685 for Treatment of Vasomotor Symptoms Associated With Menopause

Conditions
-----------------
Hot Flashes

Intervention / Treatment
-----------------
* Drug: PD-0299685


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal as defined by 6 months of spontaneous amenorrhea with serum FSH levels >40mlU/ml and estradiol < than = 25 pg/mL or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy and FSH levels > 40 mlU/ml and estradiol < than = 25 pg/mL Women reporting at least 50 moderate to severe vasomotor symptoms per week, recorded for seven consecutive days Aged 40 to 70 years Exclusion Criteria: No estrogen monotherapy or estrogen/progesterone containing drug products within applicable wash out period prior to screening Use of SERMs, clonidine within 4 weeks of screening Use of CNS active medication within 1 week of screening Use of medications (SSRI; SNRI), herbal or dietary supplements, including black cohosh, soy, phytoestrogens or over the counter agent known to possibly be effective for the treatment of vasomotor symptoms, within 4 weeks of screening Participation in clinical trial within 30 days Significant medical or psychiatric illness within past 12 months

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PD-0299685|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of PD-0299685 in reducing both the frequency and severity of vasomotor symptoms, from baseline to week 4 and week 12. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety profile of PD-0299685; the benefit of PD-0299685 in quality of life measures and treatment satisfaction of PD-0299685, when compared with placebo. |  |  |
fMRI of Stress in Smoking Behavior

Study Overview
=================
Brief Summary
-----------------
To examine the influence of current daily tobacco smoking on brain activation during stress, tobacco cue, and neutral relaxing conditions

Detailed Description
-----------------
Subjects will participate in an fMRI session to examine changes in frontal and limbic brain regions with tobacco cues, stress and neutral/relaxing imagery. During each fMRI session subjects will participate in six imagery trials: 2 different neutral/relaxing, 2 different stress and 2 different tobacco cue scripts.

Official Title
-----------------
fMRI of Stress in Smoking Behavior

Conditions
-----------------
Smoking

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-50 years inclusive; able to read and write English; for women, being in follicular phase of menstrual cycle; 5) Tobacco dependent sample: smokes 10 or more cigarettes daily for the past year; Non-smokers, no tobacco consumption for more than one year and never having used tobacco daily. Exclusion Criteria: any major neurological illness or injury and any current or prior clinically significant mental health (including PTSD) or substance use disorder (with possible exception of nicotine dependence) as determined by SCID interview; use of any psychoactive medication within past four weeks; any significant unstable medical condition such as asthma or heart disease for which increased cardiovascular reactivity during stress challenge might constitute a significant risk; IQ<70 based on past intelligence testing; any metal in body that would pose a risk with MRI; and claustrophobia that would interfere with MRI; alcohol and drug use in the 72 hours prior to scanning, with the exception of tobacco; pregnancy for women.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Smokers<br>Nicotine dependent individuals otherwise medically healthy | |
| Healthy<br>Medically healthy individuals who do not smoke | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No outcome measures for this study, this is an imaging study only |  | Upon study completion |
To Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of GC1111 (recombinant human iduronate-w-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) patients

Official Title
-----------------
Randomized, Single-blind, Active-controlled, Phase 1/2 Study to Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) Patients

Conditions
-----------------
Mucopolysaccharidosis II

Intervention / Treatment
-----------------
* Drug: GC1111_0.5mg/kg
* Drug: GC1111_1.0mg/kg
* Drug: Elaprase_0.5mg/kg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of MPS II based on both clinical and biochemical criteria Male, ages 6 to 35 years old Patients who are able to comply with the study requirements Patients who have given voluntary written consent to participate in the study Patients who is acceptable for using an appropriate method of contraception Exclusion Criteria: History of a tracheostomy or a bone marrow transplant Known hypersensitivity to idursulfase Known shock to idursulfase History of receiving treatment with another investigational therapy within the past 30 days History of a stem cell transplant Known hypersensitivity to any of the components of idursulfase Female

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Male

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: GC1111_0.5mg/kg<br> | Drug: GC1111_0.5mg/kg<br> <br> |
| Experimental: GC1111_1.0mg/kg<br> | Drug: GC1111_1.0mg/kg<br> <br> |
| Active Comparator: Elaprase_0.5mg/kg<br> | Drug: Elaprase_0.5mg/kg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome | measurement of % change of Urine GAG | baseline, every 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome | Measurements of the six-minute-walk test (6-MWT) Measurements of liver volume Measurements of heart size and heart function Measurements of joint range of motion Measurements of urine GAG levels Measurements of pulmonary function Evaluate the safety: vital signs, physical examination, laboratory tests, adverse events, immunogenecity | baseline, every 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hunter syndrome, MPS II, Idursulfase
A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01

Study Overview
=================
Brief Summary
-----------------
This is a continuation trial of LymphoStat-B™ to evaluate the long-term safety in subjects with Rheumatoid Arthritis that completed study LBRA01 and benefitted from treatment.

Detailed Description
-----------------
This is a multi-center, open label, continuation trial of LymphoStat-B™ in Rheumatoid Arthritis (RA) subjects who achieved at least an ACR20 response in the Phase 2 study LBRA01 (NCT00071812).

Official Title
-----------------
A Multi-Center, Open-Label, Continuation Trial of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) Who Completed the Phase 2 Protocol LBRA01

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: belimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Primary Inclusion Criteria: Have completed the LBRA01 trial. Have achieved at least an ACR20 response at the end of LBRA01. Primary Exclusion Criteria: Have switched NSAIDs due to worsening RA disease activity, used more than 10 mg/day of oral prednisone, or were given a corticosteroid injection during the last 30 days of LBRA01. Required a new DMARD (not otherwise excluded in protocol LBRA01) to replace an ineffective one, or an additional DMARD (not to exceed 2 DMARDs in total) within the last 60 days of LBRA01. Used prohibited medications during their participation in LBRA01. These medications include the following: Other investigational agents. Biologic response modifiers Cyclophosphamide. Corticosteroid injections (except 1 injection of up to 40 mg of prednisone into an inflamed joint or intramuscularly every 6 months). 2 new DMARDs. 1 new DMARD plus high dose prednisone >10 mg/day.

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: Belimumab<br> | Drug: belimumab<br>* IV 10mg/kg Q28 days<br>* Other names: LymphoStat-B™;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA. | SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION. | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF). | NOT ANALYZED | up to 5 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis, RA
Comparison of Two New Generations Dressings in Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
Intravascular devices in intensive care units are often associated to complications. The investigators estimate that 23.5% of catheters placed and used in intensive care are subject to at least one complication; the goal is to demonstrate the effectiveness of the new Tegaderm ™ IV Advanced dressings to achieve a decrease of 35% in the number of complications associated with intravascular catheters in intensive care.

Official Title
-----------------
Comparison Between Two New Generation Dressings in the Prevention of Intravascular Catheter Related Complications in Intensive Care Units

Conditions
-----------------
Catheter Related Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years with a central venous catheter, an arterial catheter, a hemodialysis catheter, a Swan Ganz catheter or a peripheral catheter inserted in the ICU or within the 24 before their arrival at the ICU in another ICU setting. Patients benefiting from the social security protection. Exclusion Criteria: Patients under 18 years of age, Patients having known allergy or sensitivity to adhesive dressing materials

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 |
| --- | --- |
| Tegaderm HP<br>Patients whose intravasculare devices dressings are made exclusevely with Tegaderm HP dressings. | |
| Advanced<br>Patients whose intravasculare devices dressings are made exclusevely with Advanced dressings | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of catheters presenting any kind of complications. |  | From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infections related to poor adherent dressings. |  | From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention, Dressings, Catheters
Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach

Study Overview
=================
Brief Summary
-----------------
This is retrospective study that will be done in Cardiothoracic surgery department in Assuit university hospitals for one year duration aiming to compare minimal invasive technique to conventional median sternotomy for mitral valve surgery regarding early postoperative outcomes and pain

Detailed Description
-----------------
This is retrospective study that will be done in Cardiothoracic surgery department in Assuit university hospitals for one year duration and the study tools will be: Part I (Demographic data): Age, Gender, Weight, Height ,Smoke history Part II (Preoperative data): Medical history, Clinical assessment, Preoperative investigation Part III (Intraoperative data): Surgical time, and Ischemic time Part IV (Postoperative data): Early ambulation, ICU stay, length of ventilation, using of analgesic drugs, post op bleeding, deaths

Official Title
-----------------
Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach

Conditions
-----------------
Mitral Valve Disease

Intervention / Treatment
-----------------
* Device: mitral valve replacement
* Device: conventional mitral valve replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic patients with mitral valve disease indicated for valve surgery Exclusion Criteria: Double valve disease or other valve disease Mitral or aortic valve disease associated with ischemic heart disease Mitral or aortic valve disease associated with congenital heart disease Patients subjected to prior heart surgery

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 |
| --- | --- |
| mitral valve replacement<br>patients whom underwent Mitral valve replacement through minimal invasive incision | Device: mitral valve replacement<br>* early postoperative outcome regarding pain in minimal invasive technique<br>Device: conventional mitral valve replacement<br>* early postoperative outcome regarding pain in conventional median sternotomy<br>|
| conventional mitral valve replacement<br>patients whom underwent Mitral valve replacement through conventional sternotomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating of postoperative pain by using numerical rating scales (NRS) | its a score result from gathered information from the patient | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating early postoperative outcome | e.g., bleeding | one year |