linjc16/ctgov huggingface dataset:
Modeling Technical Error and Adverse Outcomes

Study Overview
=================
Brief Summary
-----------------
The investigators' objective was to develop a theoretical model exploring the relationship between technical errors and adverse patient outcomes. To achieve this aim, the investigators interviewed surgeons from a diverse group of surgical specialties, asking them about their adverse outcomes from surgery and their most granular surgical techniques. the investigators' focus was on adverse outcomes that could be predictably associated with imperfect surgical technique and therefore prevented with proper technique.

Detailed Description
-----------------
Background: Minute technical errors performed by the surgeon have the potential to lead to adverse patient outcomes. The objective was to gain a deeper understanding of this relationship through the development of an intraoperative model. Materials and Methods: The investigators used Constructivist Grounded Theory methodology, including a comprehensive review of the literature and interviews with surgeons, focusing on avoidance of technical errors. The investigators used the Observational Clinical Human Reliability Assessment system, which categorizes granular, technical intraoperative errors, as their conceptual framework. The investigators iteratively interviewed surgeons, from multiple adult and pediatric surgical specialties, refined our semi-structured interview, and developed a model. The model remained stable after interviewing 11 surgeons, and it was reviewed it with earlier interviewed surgeons.

Official Title
-----------------
A Model of the Relationship Between Technical Error and Adverse Patient Outcome: A Constructive Grounded Theory Study

Conditions
-----------------
Surgical Errors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgical teacher Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgeons Interviewed<br>We recruited surgeons from two University academic health centers, one specializing in adults and the other in children. The surgeons were selected through a snowball technique and emailed to participate. DK and GS interviewed eleven surgical attendings representing 10 surgical specialties. (Table 2) Each subject had at least 10 years of experience in their respective fields and regularly taught residents. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Model of the relationship between minute, technical motions by a surgeon and intraoperative adverse events, and eventually adverse patient outcomes | This is a qualitative study interviewing surgeons about the link between technical motions and adverse patient outcomes. Our primary outcome will be a model, developed from their answers. | approximately 2 years |
Airway Management With Supraglottic Devices in Unruptured Intracranial Aneurysms

Study Overview
=================
Brief Summary
-----------------
Endovascular techniques for the treatment of intracranial aneurysms are growing.

Detailed Description
-----------------
Retrospective analysis of the investigators experience in the last 8 years with the airway management in endovascular therapy for unruptured aneurysms. A total of 206 participants will be included from 2010 to 2018. Airway management (anticipated difficult airway, need for LM repositioning, orotracheal intubation because of failed laryngeal mask insertion, airway complication), intraoperative monitoring, aneurism size and location, intraoperative and perioperative complications will be registered. Statistics will be compared between groups with t test or x test, as appropriate.

Official Title
-----------------
Airway Management With Supraglottic Devices in Unruptured Intracranial Aneurysm Endovascular Therapy

Conditions
-----------------
Airway Management

Intervention / Treatment
-----------------
* Device: supraglottic device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients that underwent endovascular treatment for unruptured aneurysm Exclusion Criteria: ruptured aneurysm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: supraglottic device|airway management will be collected|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Security in the use of supraglottic devices in the unruptured intracranial aneurysms. | security; the incidence of adverse events during the procedure and post-procedure will be recorded, also morbidity and mortality in patients managed with supraglottic devices during unruptured aneurysm embolization | ten years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
supraglottic devices
Study of Docosahexaenoic Acid (DHA) Supplementation in Patients With X-Linked Retinitis Pigmentosa

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the potential of nutritional docosahexaenoic acid (DHA) supplementation to normalize the level of DHA in red blood cells, and to retard the progression of visual function loss in patients with early stage X-linked retinitis pigmentosa.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, parallel, double blind study. Patients receive 2 gel capsules per day of either docosahexaenoic acid (DHA) enriched oil or a placebo oil. Oral DHA supplementation continues daily for 3 years. All patients are followed every 6 months for the 3 year duration of the study. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Retinitis Pigmentosa

Intervention / Treatment
-----------------
* Drug: docosahexaenoic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of X-linked retinitis pigmentosa Early stage disease Sufficient cone function determined by recordable ERG (30 Hz amplitude; greater than 0.32 microvolts) Visual fields greater than 20 degrees Sufficient rod function (greater than 3.0 microvolts amplitude) Media clarity sufficient for fundus photography --Prior/Concurrent Therapy-- No concurrent use of anticoagulant medication --Patient Characteristics-- No chronic metabolic disease that may interfere with fatty acid metabolism No bleeding of clinical significance
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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docosahexaenoic acid|nan|

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
-----------------
ophthalmologic disorders, rare disease, retinitis pigmentosa
Dose-response Effects of Soybean Oil in Salad Dressing on Carotenoid/Fat-soluble Vitamin Bioavailability in Salad Vegetables

Study Overview
=================
Brief Summary
-----------------
The objectives will be to evaluate the dose-response between the amount of soybean oil in salad dressing and the absorption of: 1) carotenoids, phylloquinone, and tocopherols in salad vegetables; 2) retinyl palmitate formed from the provitamin A carotenoids, alpha- and beta-carotene.

Conditions
-----------------
Biological Availability

Intervention / Treatment
-----------------
* Other: Soybean oil in salad dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General good health as determined by interview, blood biochemistry profile, complete blood count, and plasma lipid and lipoprotein profile Exclusion Criteria: Cigarette smoking, frequent alcohol consumption Use of vitamin/mineral supplements Lactose intolerance Known food allergies Body mass index (BMI) 30 or higher Eating disorder or restrained eating Vegetarianism Hyperlipidemia Current or planned pregnancy Use of hormonal contraceptives (affects chylomicron clearance); use of plant sterols or medications known to affect lipid metabolism

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Soybean oil in salad dressing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve for carotenoids, phylloquinone, tocopherols, and retinyl palmitate in the plasma chylomicron fraction |  | 0-9.5 hours postprandially | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carotenoids, phylloquinone, tocopherols, vitamin A
Anti-Mullerian Hormone (AMH) and Antral Follicle Count as Markers of Ovarian Reserve- Prospective Followup of Young Cancer Patients

Study Overview
=================
Brief Summary
-----------------
young female cancer patients have improving chances of survival. the main risk is a chronic damage to their ovarian reserve. This may lead to future infertility.

Detailed Description
-----------------
our objective is to prospectively follow patients before and after their cancer treatment. this should help us learn of the gonadotoxicity of various treatments as well as be able to better consult these and future patients of the need of fertility preservation techniques.

Official Title
-----------------
Phase 1 Prospective Study of Markers of Ovarian Reserve in Young Female Cancer Patients

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Biological: blood tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all females prior and after chemotherapy Exclusion Criteria: do not consent

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer patients<br>women 5-45 yr olf pre and post chemotherapy | Biological: blood tests<br>* time 0 is pretreatment time 3, 6 , 9, 12 months from the end of chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti mullerian hormone |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antral follicle count |  | 2 years | 
| FSH |  | 2 years | 
| inhibin b |  | 2 years | 
| menstrual history |  | 2 years | 
| E2 and prog |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chemotherapy, AMH, gonadotoxicity, ovarian reserve, patients exposed to chemotherapy, cancer
IV Haloperidol for the Treatment of Headache in the ED

Study Overview
=================
Brief Summary
-----------------
Single center, double-blind, randomized, placebo-controlled trial evaluating analog pain scores in patients who present to the emergency department (ED) with a complaint of headache. A total of 150 patients age 13-55 presenting to the emergency department with headache will be enrolled from October 2015 - October 2016. Patients will be randomized and pain scores and side effects will be recorded at 0, 30, 60, and 90 minutes. Follow-up will be performed by telephone at 24 hours.

Official Title
-----------------
Intravenous Haloperidol for the Treatment of Headache in the Emergency Department

Conditions
-----------------
Headache, Migraine Disorders

Intervention / Treatment
-----------------
* Drug: Haloperidol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emergency Department patients that complain of headache or migraine Males and females age 13-55 English is primary language Exclusion Criteria: Abnormal blood pressure (>200/100) Sudden rapid onsent (normal to worst pain in minutes) Fever Trauma Any history of masses, strokes, head injury or other causes of abnormal anatomy QT greater than 450 ms on EKG Allergy to Haldon Any altered mental status (GCS <15) Pregnancy Any abnormalities on neurologic exam Any clinician concern that would require CT scan of brain Any prisoner or ward of state

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Haloperidol<br> | Drug: Haloperidol<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> * Other names: 0.9% Sodium Chloride;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| >50% reduction in pain per Visual Analog Scale (VAS) |  | 90 minute interval |
Computed Tomography (CT) Guided Lung Biopsy: Core or Fine Needle Aspiration

Study Overview
=================
Brief Summary
-----------------
This study is a comparison of core needle biopsy with fine needle aspiration biopsy in the evaluation of lung nodules.

Official Title
-----------------
CT Guided Lung Biopsy: Core or Fine Needle Aspiration

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Device: lung biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients having a lung biopsy Exclusion Criteria: Lymphoma

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: lung biopsy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate |  |  |
Biotherapy Treatment on Features of Microcrystalline Polyarthritis

Study Overview
=================
Brief Summary
-----------------
The study will involve adult patient who had received any biologic agent for microcrystalline disease in western France (Tours, Le Mans, Orléans, Angers, Rennes, Poitiers et Brest) between 01/01/2010 and 31/12/2018. Investigators will answer retrospectively a questionnaire that covers patient and disease data, biologic agent use, efficacy and adverse events.

Detailed Description
-----------------
This is a retrospective multicentric study of all patients treated by biologic for microcrystalline disease in France in western France (Tours, Le Mans, Nantes, La Roche sur Yon, Orléans, Angers, Rennes, Poitiers et Brest) between 01/01/2010 and 31/12/2018. The investigators will collect all clinical (diagnosis of gout CCPD or hydroxyapatitis, tender and swollen joint count), biological (blood results: ESR, CRP, uric acid, synovial analysis), radiological data (X-rays performed and their description) .

Official Title
-----------------
Features of Microcrystalline Polyarthritis Treated by Biologics and Evolution - FUMBLE Study

Conditions
-----------------
Crystal-Induced Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Crystal- induced arthritis Treatment by biologic In western France Exclusion Criteria: None
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 |
| --- | --- | --- |
| Treatment duration | Duration of treatment by biologic in days | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of synovitis | number of synovitis on 44 | inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crystal-Induced Arthritis
Effect of One-lung Ventilation on BIS Values

Study Overview
=================
Brief Summary
-----------------
In this observational study, all enrolled patients having a thoracic surgical procedure requiring lung isolation will have a bispectral index (BIS) monitor placed at time of induction. BIS monitors are used to assist in determining depth of anesthesia. This study will evaluate changes in BIS before, during and after lung isolation.

Official Title
-----------------
Effect of One-lung Ventilation on BIS Values

Conditions
-----------------
Thoracic, Surgery

Intervention / Treatment
-----------------
* Device: Bispectral index monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients coming for thoracic surgery with anticipated need for lung isolation Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Bispectral index monitor|BIS monitor is a novel measure of the level of consciousness by algorithmic analysis of a patient's electroencephalogram during general anesthesia.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BIS | Comparing the BIS readings while on two lung ventilation to the BIS readings after switching the one lung ventilation. | From baseline to one lung ventilation (average time frame of 30 mins. - 1 hr.) |
Phase I Study to Investigate the Drug Interaction After Oral Administration of Tamsulosin and SK3530

Study Overview
=================
Brief Summary
-----------------
To assess the pharamcodynamic effects of coadministrated SK3530(PDE5 inhibitor) and tamsulosin, phase I study in healthy volunteers was designed.

Detailed Description
-----------------
During each of the two periods of a randomized, double-blind, placebo-controlled, crossover study, 16 healthy men received tamsulosin 0.2 mg daily for 7 days and either a single 100 mg of SK3530 or placebo on day7. The blood pressure and heart rate were monitored before and for 24 hours after SK3530 or placebo.

Official Title
-----------------
Clinical Trial to Investigate the Influence of Drug Interaction After Oral Administration of Tamsulosin and SK3530 in Healthy Male Volunteers

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: SK3530


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 20 to 50 body weight of IBM±20% Exclusion Criteria: cardiovascular disease color-blindness or weakness hypotension, hypertension, orthostatic hypertension abmormal QTc (>430 ms)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SK3530|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal decrease from baseline in supine SBP |  | within 6 hrs after SK3530 or placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal decrease from baseline in standing SBP, supine/standing DBP & HR |  | within 6 hrs after SK3530 or placebo | 
| Outlier analysis: i) Standing/supine SBP < 85 mmHg, DBP < 45 mmHg; ii) Change in standing/supine SBP > 30 mmHg, DBP > 20 mmHg |  | within 6 hrs after SK3530 or placebo | 
| Incidence of postural hypotension |  | within 6 hrs after SK3530 or placebo | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SK3530, tamsulosin, hemodynamic interaction, safety