linjc16/ctgov huggingface dataset:
Checklist Application and Mortality

Study Overview
=================
Brief Summary
-----------------
The study investigates the impact of the implementation of a surgical checklist on the mortality 30 days and 90 days after surgery. Patients scheduled for elective surgical procedures (excluding cardiac surgery) lasting at least 15 minutes are eligible. Surgery is performed in a single tertiary care center. The study is an open trial before and after intervention (implementation of the checklist safe surgery saves lifes).

Official Title
-----------------
Impact of the Surgical Checklist on 30-day and 90-day Mortality in Elective Non-cardiac Surgery

Conditions
-----------------
Mortality, Outcome

Intervention / Treatment
-----------------
* Procedure: implementation surgical checklist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective surgery in general or regional anesthesia lasting > 15 min Exclusion Criteria: urgent / emergent surgery
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: before surgical checklist<br> | |
| Active Comparator: after implementation surgical checklist<br> | Procedure: implementation surgical checklist<br>* a checklist according to the suggestions raised by the WHO is implemented<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in over all mortality |  | within 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in over all mortality |  | within 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, team, team performance, surgery, outcome
A Pilot Study of Using Video Images in Advance Care Planning in Malignant Glioma Patients

Study Overview
=================
Brief Summary
-----------------
A randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer.

Detailed Description
-----------------
A randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer. Subjects will have three options for their goals of care: life prolonging care, basic medical care, or comfort care.

Official Title
-----------------
A Pilot Study of Using Video Images in Advance Care Planning in Malignant Glioma Patients

Conditions
-----------------
Advanced Brain Cancer

Intervention / Treatment
-----------------
* Behavioral: Video intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced brain cancer English Speaking Able to provide informed consent Exclusion Criteria: Folstein mini mental status score of 23 or less

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: verbal group<br>Verbal description of goals of care. | |
| Experimental: Video group<br>Video decision aid. | Behavioral: Video intervention<br>* Video of goals of care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| end of life preference at time of interview |  | 5 minutes after survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uncertainty regarding end of life preference at time of interview |  | 5 minutes after survey | 
| knowledge of end of life preference at time of interview |  | 5 minutes after survey |
Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine

Study Overview
=================
Brief Summary
-----------------
This is an open label, single-center study to determine whether certain nasal medication interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients with allergic rhinitis.

Detailed Description
-----------------
To assess separately the effects of a nasal vasoconstrictor (oxymetazoline) and of a nasal steroid on the rate and extent of intranasal absorption of PMI-150 30 mg.

Official Title
-----------------
A Randomized, Open Label, Single Center, Single-Dose Study to Assess the Effects of Certain Nasal Medications on the Pharmacokinetics, Safety and Tolerability of PMI-150 (Intranasal Ketamine Hydrochloride) 30 mg

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: intranasal ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults Patients with Allergic Rhinitis Exclusion Criteria: Under age 18

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>intranasal ketamine | Drug: intranasal ketamine<br>* drug interaction<br>|
| Experimental: B<br>oxymetazoline plus intranasal ketamine | Drug: intranasal ketamine<br>* drug interaction<br>|
| Experimental: C<br>intranasal steroid plus intranasal ketamine | Drug: intranasal ketamine<br>* drug interaction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | multiple |
An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders

Study Overview
=================
Brief Summary
-----------------
Study 22003, An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders(ASD) currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with ASD. This study (22007) will enter subjects who complete Study 22003 into a long-term, open-label study.The open-label extension protocol will provide necessary data on the long-term safety and tolerability of STX209 among subjects with ASD who receive treatment under conditions more closely reflective of their general medical care.

Official Title
-----------------
An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects With Autism Spectrum Disorders

Conditions
-----------------
Autism Spectrum Disorders

Intervention / Treatment
-----------------
* Drug: arbaclofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have completed all scheduled visits in protocol 22003 and have shown they can adequately follow the protocol, with sufficient medical justification to continue on open-label treatment with STX209, as assessed by the principal investigator Exclusion Criteria: Subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. The occurrence or continuation of any adverse event or condition during study 22003 that, in the opinion of the Investigator, should exclude the subject from participating in this open-label extension

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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: STX209<br>STX209 (arbaclofen) | Drug: arbaclofen<br>* A flexible dose titration will be utilized during the first four weeks to define the optimal titrated dose (OTD) for each subject. Investigators will use clinical judgment to adjust doses to the oral OTD. The starting dose will be 1 mg BID. The dose may be increased every four to five days to 2 mg BID, 3 mg BID, 5 mg BID and then 10 mg BID<br>* Other names: R-baclofen, STX209, arbaclofen;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritability subscale of the Aberrant Behavior Checklist |  | every 2 to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autism
Study Evaluating Premarin and Bazedoxifene Potential Interaction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of bazedoxifene (BZA) 20 mg tablet when administered together with multiple doses of Premarin (conjugated estrogens or CE) to healthy postmenopausal women. Information will also be obtained regarding the safety and tolerability of this combination in healthy, postmenopausal women.

Official Title
-----------------
An Open-Label, Single/Multiple Dose Non-Randomized, 3-Period, Crossover Study To Determine The Potential Drug Interaction Of Conjugated Estrogens (CE) On Bazedoxifene In Healthy Postmenopausal Women.

Conditions
-----------------
Postmenopause

Intervention / Treatment
-----------------
* Drug: Premarin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For inclusion into the study, women must be healthy and postmenopausal (either naturally or surgically) between the ages of 35 and 70, inclusive. Blood hormone levels must be consistent with a postmenopausal state (for specified subjects). They can either be a non-smoker or smoke less than 10 cigarettes per day, and be able to abstain from smoking during clinic confinements Exclusion Criteria: A subject will be excluded from participation if they : Have participated in a clinical drug study within 30 days prior to study medication administration; Have a history of drug or alcohol abuse within 1 year or consume more than 2 standard units per day of alcohol (a standard unit equals 12 ounces of beer, 1 ½ ounces of 80-proof alcohol or 6 ounces of wine); Donate any other plasma or blood during the total study.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: Premarin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (absorption, distribution, breakdown and elimination in the body) parameters |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To continue assessment of the safety profile as well as the tolerability the two drugs administered in combination in this population. |  | 3 months |
Electromyography and Yoga

Study Overview
=================
Brief Summary
-----------------
This study examined the muscle activity, movement patterns, and oxygen consumption during a series of yoga poses with slow and rapid transitions.

Official Title
-----------------
Differences in Energy Expenditure of Two Commonly Used Yoga Protocols

Conditions
-----------------
Yoga

Intervention / Treatment
-----------------
* Other: High-speed yoga
* Other: Low-speed yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have at least 1 year of yoga experience; Practice a minimum of twice per week (app 2 hours or more); Demonstrate good form in the poses (asanas) making up the Sun A and Sun B sequences; Exclusion Criteria: If they have any uncontrolled neuromuscular, orthopedic or cardiovascular disease; If they have been advised by their physicians that they should not exercise; If they cannot complete three cycles each of the Sun A and B sequence in good form.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-speed then low-speed yoga<br>Subjects received a single session of High-speed yoga and within one week a single session of Low-speed yoga | Other: High-speed yoga<br> <br> Other: Low-speed yoga<br> <br> |
| Experimental: Low-speed then high-speed yoga<br>Subjects received a single session of Low-speed yoga and within one week a single session of High-speed yoga | Other: High-speed yoga<br> <br> Other: Low-speed yoga<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of energy expenditures for high-speed and low-speed yoga | We measured calories for all subjects across both conditions | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of muscle activities for high-speed and low-speed yoga | We measured muscle activities for all subjects across both conditions | Day 3 | 
| Comparison of oxygen utilization for high-speed and low-speed yoga | We measured oxygen consumption for all subjects across both conditions | Day 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aerobic, muscle activity, energy expenditure
Pathway CH S&E Registry

Study Overview
=================
Brief Summary
-----------------
Monitor the safety and performance of the Pulsante Microstimulator System.

Official Title
-----------------
Pathway CH S&E Registry: Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache - ATI Neurostimulation System is Branded Internationally as Pulsante™ Microstimulator System

Conditions
-----------------
Cluster Headache

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient meets CE marked labeling for cluster headache. Patient has the ability to read, comprehend and reliably record information as required by the Protocol. Patient is able to provide written informed consent prior to participation in the study. Exclusion Criteria: 1. Patient has other significant pain problem that might confound the study assessments in the opinion of the Investigator.

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 |
| --- | --- | --- |
| Characterization of all device/procedure related Adverse Events | Outcome will be assessed at Implant, 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant. | Through five years post implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute response to therapy | Outcome will be assessed at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant. | Through five years post implant |
Modified Cervical Inversion During CS in Placenta Previa

Study Overview
=================
Brief Summary
-----------------
There is an increasing rates of placenta previa nowadays

Detailed Description
-----------------
several techniques were described to control bleeding .

Official Title
-----------------
Alalfy Modofied Cervical Inversion During CS in Placenta Previa

Conditions
-----------------
Placenta Previa

Intervention / Treatment
-----------------
* Procedure: Cervical inversion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women 38 weeks or more with placenta previa Exclusion Criteria: pregnant ladies with normally implanted placenta or placenta accreat , increta or percreta

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Using cervical inversion during cesarean section
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cervical inversion<br> | Procedure: Cervical inversion<br>* inverting the cervical lip after delivery<br>|
| No Intervention: no cervical inversion<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of women whose placental bed bleeding will be controlled by cervical inversion cervical inversion | how can the cervical inversion technique controls the placental bed bleeding | within an hour |
To Determine the Feasibility of a Fidaxomicin Study in Neonates and to Assess C. Difficile (Clostridium Difficile) Involvement in the Pathogenesis

Study Overview
=================
Brief Summary
-----------------
The objective of this multi-center, prospective observational study is to determine the feasibility of a potential interventional study with fidaxomicin. The incidence and clinical aspects of Clostridium difficile infection (CDI) in neonates will be determined, and it will be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy might improve outcome.

Official Title
-----------------
An Observational, Non-interventional Study to Determine the Role of Clostridium Difficile in the Pathogenesis of Disease Observed in Neonates and to Investigate the Feasibility of a Potential Study to Evaluate Safety, Efficacy and Pharmacokinetics of Fidaxomicin Oral Suspension in Neonates With Clostridium Difficile Associated Disease (CDAD)

Conditions
-----------------
Clostridium Difficile

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is suffering from diarrhea or other signs or symptoms consistent with CDAD (as described in section 5.2.3) Presence of either toxin A or B (or both) of C. difficile in the stool within 24 hours prior to enrollment using the C. difficile Quik Chek Complete® diagnostic test, provided by the sponsor Exclusion Criteria: Subject will be excluded from participation if any of the following apply: Preterm neonates Negative C. difficile toxin test

Ages Eligible for Study
-----------------
Maximum Age: 27 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonates<br>Neonates with CDAD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the feasibility of a potential interventional study with fidaxomicin | The incidence and clinical aspects of clostridium difficile infection (CDI) in neonates will be determined, and it will be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy might improve outcome. | 40 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CDAD, Neonates, Clostridium difficile
Prospective Study to Validate the Diagnostic Performance of IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to conduct a prospective evaluation of the diagnostic performance of the IVD CAPSULE COVID-19-NP test for antigenic determination of SARS-CoV-2 virus on the abioSCOPE® instrument. The objective of the clinical study is to demonstrate that the IVD CAPSULE COVID-19-NP test: shows sensitivity: ≥ 80% when testing unselected symptomatic participants within the first seven days of symptom onset or asymptomatic participants when diagnosis is confirmed by RT-PCR; Or ≥ 90% for subjects with Ct ≤ 25. show ≥ 98% specificity.

Official Title
-----------------
Prospective Field Study to Validate the Diagnostic Performance of the IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2 on abioSCOPE®

Conditions
-----------------
COVID-19, COVID-19 Pandemic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: provide valid informed consent before taking the tests; in the case of symptomatic patients, be tested within the first seven days after the onset of symptoms. Male or female, aged equal to or older than 18 years of age. Exclusion Criteria: Symptomatic participants who take the test after seven days after the onset of symptoms are excluded from the study

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of the IVD CAPSULE COVID-19-NP antigenic test | The purpose of this work is to carry out a prospective evaluation of the diagnostic performance of the IVD CAPSULE COVID-19-NP test for the antigenic determination of the SARS-CoV-2 virus on the abioSCOPE instrument. | through study completion, an average of 1 month |