linjc16/ctgov huggingface dataset:
Effect of Intranasal Mupirocin on Rate of Staphylococcus Aureus Surgical Site Infection Following Cesarean Sections

Study Overview
=================
Brief Summary
-----------------
The investigators believe that irradication of nose colonization of staphyloccocus aureus will reduce the incidence of surgical site infections after cesarean section.

Conditions
-----------------
Surgical Wound Infection, Cesarean Section, Staphylococcus Aureus

Intervention / Treatment
-----------------
* Drug: Mupirocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women assigned to undergo cesarean section Exclusion Criteria: All others
Sexes Eligible for Study
-----------------
Female

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Mupirocin<br> | Drug: Mupirocin<br>* Intranasal cream given to patient after confirmation of colonization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the incidence of surgical site infections after cesarean section |  | Four years |
Cognitive & Motor Training After Stroke For Everyday Walking Restoration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test a unique, combined cognitive and motor intervention designed to restore safe, more normal coordinated gait components into the real world environment for individuals with stroke.

Official Title
-----------------
Cognitive and Motor Training After Stroke for Everyday Walking Restoration

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

Intervention / Treatment
-----------------
* Device: FES-IM
* Other: Cognitive training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: greater than or equal to 6 months post stroke ability to give informed consent impaired gait medically stable Exclusion Criteria: pacemaker unstable/uncontrolled medical condition(s)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Gait training and Cognitive Training | Device: FES-IM<br>* implantable Functional Electrical Stimulation<br>Other: Cognitive training<br>* training of impaired cognitive processes<br>|
| No Intervention: 2<br>Able Bodied | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coordinated Components of gait using the Gait Assessment and Intervention Tool (G.A.I.T.) |  | post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, Gait training, Cognitive Training
Snoring in Pregnancy and Adverse Maternal and Fetal Outcomes

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the prevalence of sleep-disordered breathing in pregnant women during the third trimester of pregnancy and to investigate whether this is associated with high blood pressure in the mother and/or growth retardation in the baby.

Official Title
-----------------
The Impact of Sleep-Disordered Breathing on Adverse Pregnancy Outcomes

Conditions
-----------------
Sleep Apnea Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women attending obstetric clinics at University of Michigan Hospitals. Willing and able to provide informed consent. Aged 18 years or older Exclusion Criteria: Aged under 18 years

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 |
| --- | --- | --- |
| Maternal diagnosis of hypertension |  | 0-3 months after enrollment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant birth centile |  | 0-3 months after enrollment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep-Disordered Breathing, Snoring, Pregnancy, Fetal Growth Retardation, Pre-Eclampsia
Acetaminophen-Protein Adduct Resolution

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to better understand the pharmacokinetics of acetaminophen and further clinical interpretations of laboratory results that confirm the presence of acetaminophen-cys adducts. This study will determine how long adducts persist in serum after a therapeutic course of acetaminophen as taken in a previous study (COMIRB 06-1265). Subjects will be asked to complete three study visits, each three days apart, following termination of COMIRB 06-1265. Each study visit will include collection of blood samples for batch testing of aminotransferase, serum acetaminophen and protein adducts. No interventions are planned.

Official Title
-----------------
Serum Acetaminophen-Cysteine (APAP-cys) Adduct Concentrations After 16 Days of Acetaminophen Dosing

Conditions
-----------------
Acetaminophen-protein Adduct Formation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any subject randomized to the acetaminophen arm of COMIRB 06-1265 and meets completion criteria Exclusion Criteria: Subjects who enter the extended dosing period in protocol 06-1265. Subjects who were randomized to placebo.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Acetaminophen Group<br>Subjects who completed COMIRB 06-1265 and were assigned to the acetaminophen treatment group for that study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of the proposed study is to determine the proportion of subjects with acetaminophen-cys adduct concentrations above the limit of quantification at day 6 after stopping maximum acetaminophen dosing. |  | Day 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcomes of the proposed study are the serum acetaminophen-cys adduct concentrations at 3, 6, 9 days after stopping maximum acetaminophen dosing of the COMIRB 06-1265 study. |  | Days 3, 6, 9 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acetaminophen, paracetamol, protein adduct, healthy volunteer, acetaminophen-protein adduct formation
Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies

Study Overview
=================
Brief Summary
-----------------
Stroke is the first cause of death among Spanish women and main cause of disability. Reperfusion therapies of the occluded artery remain the only useful approach in acute ischemic stroke. However, the efficacy of these strategies is highly time-dependent and due to the need of neuroimaging (CT or MRI) to differentiate between ischemic and hemorrhagic stroke, impossible to be performed at the pre-hospital level. The investigators aim to set-up a point of-care (POC) device to validate a biomarker panel differentiating ischemic and hemorrhagic stroke at the pre-hospital level using a blood sample and to validate a second biomarker panel for the early identification of patients with large vessel occlusions (LVO), which are candidates for mechanical thrombectomy. For that, the investigators will recruit a 300 patients' cohort with pre-hospital blood samples using available POCs for each of those markers.

Official Title
-----------------
Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies (BIO-FAST)

Conditions
-----------------
Stroke, Ischemic Stroke, Hemorrhagic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: I.1: Patients > 18 years old. I.2: Stroke code activated by the coordinator centre. I.3: < 6 hours from symptoms onset. In the case of stroke with uncertain chronology or wake-up stroke, the initial time will be considered as the last moment the patient was seen fine. Exclusion Criteria: E.1: Prehospital diagnosis different of stroke. E.2: Impossibility of getting a prehospital blood sample. E.3: Refusal to provide the informed consent by the patient/relative.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke subtype diagnostic accuracy | Stroke subtype diagnostic (% ischemic versus % hemorrhagic and % stroke mimics) will be determined by clinical and neuroimaging criteria at hospital arrival and compared with diagnostic accuracy of a blood biomarkers based test | through study completion, an average of 2 years | 
| Reperfusion rates |  | through study completion, an average of 2 years | 
| Times to reperfusion |  | through study completion, an average of 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood biomarkers, stroke diagnosis, stroke, biomarkers, reperfusion therapies, acute stroke therapy, prehospital stroke management
CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)

Study Overview
=================
Brief Summary
-----------------
This Post Trial Access (PTA) Program enables access to rozanolixizumab for eligible patients who have taken part in the CIDP04 trial (NCT04051944) and are continuing to derive benefit from treatment.

Official Title
-----------------
CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)

Conditions
-----------------
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Intervention / Treatment
-----------------
* Drug: Rozanolixizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who has taken part in the CIDP04 (NCT04051944) study Patient who derives continued benefit from treatment All required safety information has been reported as per local laws/regulations, reported to Bionical, as appropriate, and documented in the patient's medical records Patient is not pregnant Exclusion Criteria:

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rozanolixizumab|Rozanolixizumab is dosed weekly. Patients should continue to receive the dose they were receiving in the CIDP04 (NCT04051944) trial.|

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
-----------------
Chronic inflammatory demyelinating polyradiculoneuropathy, CIDP, UCB7665, rozanolixizumab
Amitriptyline and Paroxetine Treatment of Major Depression

Study Overview
=================
Brief Summary
-----------------
Activation of the hypothalamus-pituitary-adrenal system is monitored using saliva cortisol sampling during the antidepressant treatment with amitriptyline and paroxetine in moderately to severely depressed patients. Additionally, serum and plasma are sampled during the 5-week study period in order to study endocrine and metabolic parameters.

Official Title
-----------------
Hypothalamus-pituitary-adrenal System: Role of the Mineralocorticoid Receptor and Longitudinal Study in Depressed Patients

Conditions
-----------------
Unipolar Depression

Intervention / Treatment
-----------------
* Drug: amitriptyline
* Drug: paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: above 18 depression according DSM-IV Exclusion Criteria: bipolar disorder substance dependency

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: amitriptyline<br> | Drug: amitriptyline<br>* 150 mg oral, daily, single evening dose, 35 days<br>|
| Active Comparator: paroxetine<br> | Drug: paroxetine<br>* 40 mg oral, single dose, morning, 35 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (21-item version) |  | baseline, weekly assessments for 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cortisol in saliva (8.00, 16.00, 22.00) during wash-out (6 days) and 35 days of treatment |  | daily during wash-out (days -6 to -1) and active treatment (days 1 to 35) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression
Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare patients who underwent decompression/discectomy with pedicle screw fusion to patients who received decompression/discectomy without fusion.

Detailed Description
-----------------
Lumbar disc herniations are quite common and typically improve after surgical correction. However, some patients develop recurrent herniations at the same level. Controversy exists as to why reherniated discs occur. Moreover, existing research does not settle the issue of whether a second decompression/discectomy or a repeat decompression/discectomy with pedicle screw fusion is the more successful treatment. This study is designed to compare differences in patient-reported pain, physical function, and satisfaction between the two types of surgery patients.

Official Title
-----------------
Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation

Conditions
-----------------
Low Back Pain, Recurrent Lumbar Disc Herniation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrent lumbar disc herniation by MRI or CT with history of decompression at the same level in the past Recurrent symptomatic history (with or without back pain) with radicular leg pain that improved following the first surgery Male or female 18-75 years old Flexion and extension x-rays that demonstrate an absence of sponylolisthesis or spondylolisthesis with less than 3 mm of movement Exclusion Criteria: Recurrence of disc herniation within 3 months of first decompression Multiple level herniated discs No history of lumbar back surgery except as in Inclusion criteria above Documented severe osteoporosis or osteopenia Symptoms of low back pain only Diabetes mellitus Patients with suspected or diagnosed psychological/psychiatric problems that could compromise the reliability of their results Lumbar spondylolisthesis on flexion/extension x-rays > 3 mm History of lumbar spine fractures (new or old) Any concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study Autoimmune diseases Age less than 18 or greater than 75 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
lumbar, disc, herniation, discectomy, fusion, spine
Chlorine Dioxide Versus Saline for Wound Irrigation

Study Overview
=================
Brief Summary
-----------------
This research is being done because the investigators are trying to examine the safety and effectiveness of this wound cleaning liquid, CACD (chlorine dioxide). The investigators are trying to see if this liquid has the ability to decrease infection rates and decrease the scarring effects from the healing process. In animal studies, CACD has been shown to decrease scar formation and decrease the risk of wound infections. CACD is also used for the treatment of burns to decrease infection rates and improve wound healing. CACD is not FDA approved for this specific use, but it is FDA and USDA approved for reducing bacterial contamination on meat and food products for human consumption. In addition, an investigational drug (IND) application has been submitted to the FDA for this study. The FDA has approved the use of this solution for this study.

Official Title
-----------------
Wound Irrigation: Comparison of Normal Saline With Chlorous Acid Chlorine Dioxide Solution

Conditions
-----------------
Wound - in Medical Care

Intervention / Treatment
-----------------
* Biological: chlorine dioxide
* Biological: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-100 years old simple laceration requiring irrigation & sutures patient has method of contact patient is willing to return to ED in 3-4 mths Exclusion Criteria: immunocompromised consult required for repair diabetic require antibiotics

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chlorine dioxide<br>2 arms | Biological: chlorine dioxide<br>* one time wash with 50ppm CD solution<br>|
| Active Comparator: saline<br>one time wash with 50-100cc of normal saline | Biological: saline<br>* one time wash with 50-100 cc normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cosmesis | Cosmesis will be assessed by taking pictures of the wound at presentation, upon receiving sutures, 48-72 hrs later, and 3-4 mths later. At 3-4 mths the patient will rate how well they think the wound healed, via a visual analog scale. At that time, two blinded ER physicians will do this as well. They will also designate a wound evaulation score, based on criteria that will be provided to them. Two blinded plastic surgeons will assess all photographs, visual analog scores. and wound evaluation scores, and provide their own visual analog scale assessment of how well each wound healed. | 72 hrs post-ED visit |
Investigating Reaction Time Among Children Who Snore

Study Overview
=================
Brief Summary
-----------------
The investigators feel that children who have OSA or sleep-disordered breathing may have a different reaction time than normal variants. Children who have OSA are known to have behavioral and sleep patterns that are different. It makes sense their reaction time may be different than normal as well. We plan to measure reaction times via a 10 minute psychomotor vigilance test device in children who snore who are coming in for a sleep study or for adenotonsillectomy.

Conditions
-----------------
Snoring

Intervention / Treatment
-----------------
* Device: PVT-192


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to understand how to perform reaction time test and complete without assistance. Exclusion Criteria: Children who are unable to understand or perform test or parents refusal.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- |
| PVT-192<br> | Device: PVT-192<br>* PVT-192 Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction time | We plan to measure reaction times via a 10 minute psychomotor vigilance test (PVT, Ambulatory Monitoring Inc., NY) device. | 10 minutes |