linjc16/ctgov huggingface dataset:
ROTEM Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation

Study Overview
=================
Brief Summary
-----------------
Modern crystalloid and colloid solutions are balanced solutions which are increasingly used in perioperative period. However, studies investigating their negative effect on whole blood coagulation are missing. The aim of our study was to assess the effect of modern balanced crystalloid and colloid solutions on whole blood coagulation in vivo using rotational thromboelastometry.

Detailed Description
-----------------
Blood samples were obtained from 30 patients during knee arthroscopy before and after administration of 500 ml of modern balanced crystalloid, hydroxyethyl starch (HES) or gelatin. Rotational thromboelastometry (EXTEM, INTEM and FIBTEM tests) were performed to assess negative effect of fluid solutions on whole blood coagulation.

Official Title
-----------------
Rotational Thromboelastometry (ROTEM) Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation in Vivo

Conditions
-----------------
Coagulopathy

Intervention / Treatment
-----------------
* Other: hydroxyethyl starch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy patients undergoing knee arthroscopy Exclusion Criteria: receiving antiplatelet drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| hydroxyethyl starch<br>Patients who received hydroxyethyl starch | Other: hydroxyethyl starch<br>* After induction to anaesthesia patients received either hydroxyethyl starch or gelatin or crystalloids<br>|
| gelatin<br>Patients who received gelatin | Other: hydroxyethyl starch<br>* After induction to anaesthesia patients received either hydroxyethyl starch or gelatin or crystalloids<br>|
| crystalloids<br>Patients who received crystalloids | Other: hydroxyethyl starch<br>* After induction to anaesthesia patients received either hydroxyethyl starch or gelatin or crystalloids<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thromboelastometry assessment of coagulation | ROTEM tests- clotting time in seconds, Maximal clot firmness in mm, alpha angle of in degree of following tests EXTEM, INTEM, FIBTEM | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hydroxyethyl starch, gelatin, ROTEM, coagulation
Autism Spectrum Disorders (ASD) Driving Study

Study Overview
=================
Brief Summary
-----------------
The proposed pilot study will begin to assess whether driving impairments are included in the functional deficits associated with Autism Spectrum Disorders (ASDs). This will be completed by obtaining data on velocity, collision risk, and visual attention of subjects with ASDs who drive in a simulator. The study includes 2-3 visits for the screening period (approximately 6 hours of assessments) and one driving simulation visit (approximately 2.5 hours). The investigators expect to enroll 20 adolescents and adults (ages 16-50, inclusive) who have been identified as having an ASD from a prior diagnosis or participation in community conferences for individuals with ASDs.

Official Title
-----------------
A Study of the Driving Performance of Individuals With Autism Spectrum Disorders

Conditions
-----------------
Autism Spectrum Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients, aged 16-50 years Identification as having ASD from a prior diagnosis or participation in community conferences for individuals with ASD Exclusion Criteria: Major sensorimotor handicaps (e.g. deafness, blindness) Inadequate command of the English language Individuals who have never held a valid driver's license Mental retardation (IQ < 80)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 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 |
| --- | --- |
| ASD group<br>Adolescents and adults with Autism Spectrum Disorders (ASDs). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simulated driving performance of adolescents and adults with ASDs. | Data will be obtained on velocity, collision risk, and visual attention of subjects with ASDs who drive in the driving simulator at the Massachusetts Institute of Technology (MIT). | one-time observation (3 hour assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire measures of driving history and behavior of adolescents and adults with ASDs. | Subjects with ASD will complete two questionnaires, the Driver Behavior Questionnaire and the Driving History Questionnaire, to provide data on the frequency of violations, errors, accidents, and other aspects of driving history and behavior. | one-time assessment (2-6 hour screening visit) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Driving, Autism Spectrum Disorders, ASD, Attention Deficits, Adults, Adolescents, Pervasive Developmental Disorders
Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to investigate different types of task training to determine if training improves thinking processes following traumatic brain injury.

Official Title
-----------------
Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury, Brain Injuries, Traumatic

Intervention / Treatment
-----------------
* Behavioral: Task Switching Training
* Behavioral: Control Task


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: If you have had a Traumatic Brain Injury (TBI)or no history of neurological disease/damage. If you are between the ages of 19 and 65. Exclusion Criteria: For participants with Traumatic Brain Injury: If you have a history of prior neurological disorders (e.g., stroke, seizures, or brain tumor). If your Brain injury is less than 6 months ago. For healthy participants: -If you have a history of prior neurological disorders (e.g., head injury, stroke, seizures, or brain tumor). For All participants: If you have significant psychiatric history (such as schizophrenia or bipolar disorder.) If you have a alcohol or drug abuse history. If you are currently taking certain types of medications, which the study doctor will review. If you do not have a working knowledge of the English Language.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Task Switching Training<br>Participants will complete four, one-hour training sessions in which they will practice switching between tasks within an alternating runs task switching paradigm. | Behavioral: Task Switching Training<br>* Participants will complete four, one-hour training sessions in which they will practice switching between tasks within an alternating runs task switching paradigm.<br>|
| Placebo Comparator: Pure Task Training<br>Participants will complete four, one-hour training sessions in which they will perform a single task each session, alternating tasks between but not within sessions. | Behavioral: Control Task<br>* Participants will complete four, one-hour training sessions in which they will perform a single task each session<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in switch costs, measured via response time in milliseconds on task switch trials minus response time on task repetition trials, from baseline |  | 2 months |
Prediction of Chronic Postsurgical Pain in Adults

Study Overview
=================
Brief Summary
-----------------
This research will be a prospective single-centre observational cohort study in Denmark spanning approximately one year. The objective of this study is to develop a clinically applicable and generalizable prediction model for postsurgical pain in adults.

Official Title
-----------------
Prediction Model Development for Chronic Postsurgical Pain in Adults

Conditions
-----------------
Chronic Postsurgical Pain, Acute Post Operative Pain

Intervention / Treatment
-----------------
* Procedure: Cardiothoracic surgery
* Procedure: Breast surgery
* Procedure: Gastrointestinal surgery
* Procedure: Genitourinary surgery
* Procedure: Orthopaedic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consenting Danish-speaking adults aged 18 years and older Patients who undergo common inpatient or outpatient surgical procedures Exclusion Criteria: Patients with cognitive impairment Patients who refuse or unable to provide informed consent Patients who undergo re-operation within 3 months of their initial 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 |
| --- | --- |
| Surgery patients<br>Patients who undergo various common surgical procedures | Procedure: Cardiothoracic surgery<br>* Cardiac & large intrathoracic vessels, respiratory, thoracic, mediastinal & diaphragmatic procedures<br>Procedure: Breast surgery<br>* Breast resections & mastectomies<br>Procedure: Gastrointestinal surgery<br>* Digestive & spleen<br>Procedure: Genitourinary surgery<br>* Urinary tract, genital & retroperitoneal tissue<br>Procedure: Orthopaedic surgery<br>* Back & neck, shoulder & upper arm, hip & thigh, knees & lower leg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic post surgical pain | Pain related to the surgical procedure measured as average pain intensity on rest or movement using 11-point numeric rating scale (NRS; 0-10) where 0=no pain and 10=worst pain imaginable and/or average pain interference using 11-point NRS among any one of seven short-form Brief Pain Inventory items (general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, enjoyment of life) in the past one week, where 0=pain does not interfere and 10=pain completely interferes. | 3 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute post surgical pain | Acute post surgical pain intensity in the first 3 hours after surgery measured as pain at rest using 11-point numeric rating scale (NRS; 0-10) where 0=no pain and 10=worst pain imaginable. | First 3 hours after surgery |
Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis

Study Overview
=================
Brief Summary
-----------------
That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.

Official Title
-----------------
Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis

Conditions
-----------------
Chronic Sinusitis, Polyposis

Intervention / Treatment
-----------------
* Drug: pulmicort


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hyposmia and nasal obstruction for >12 weeks bilateral nasal polyposis candidate for surgery Exclusion Criteria: immunocompromised non-English speaking prisoner pregnant/lactating will not attend follow up appointments

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm; nostrils as experimental and comparator<br>each subject serves as their own control with one nostril being treated with pulmicort and one not | Drug: pulmicort<br>* applied to nasal packing after surgery<br>* Other names: budesonide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Olfaction | will be measured with the University of Pennsylvania Smell Identification Test (UPSIT), whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification | 3 weeks post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sinonasal Health | will be assessed with the Perioperative Sinus Endoscopy score (POSE), a 20 point scale where 0 is no sinus challenges and 20 represents the greatest blockage. | 3 weeks post operation | 
| Olfaction | Scored with the University of Pennsylvania Smell Identification Test, whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification | 24 weeks post operation | 
| Sinonasal Health | Assessed with Perioperative Sinus Endoscopy (POSE) score | 24 weeks post operation |
Impact of Blood Salvage Therapy on Outcomes After Oncologic Liver Surgery

Study Overview
=================
Brief Summary
-----------------
A before and after trial comparing the systematic use of blood salvage therapy with leucocyte filter during oncologic liver resections. Recurrence, survival, allogenic transfusion rates and surgical outcomes are compared with a representative historic cohort.

Detailed Description
-----------------
Blood salvage therapy in oncologic liver surgery is seldom used based on unproven concerns about the safety of the technique regarding potential cancer dissemination or recurrence. Nevertheless, the technique has proven advantages in other surgical settings regarding the allogenic transfusion outcomes. Allogenic blood transfusion has been scientifically proven to worsen prognosis in oncologic surgery. This study compares a cohort of patients systematically exposed the blood salvage therapy to one comparable cohort without the therapy and outcomes regarding transfusion rates, post-operative Hb measurement, recurrence, overall survival, and post-operative adverse events.

Official Title
-----------------
Impact of Blood Salvage Therapy During Oncologic Liver Surgeries on Allogenic Transfusion Events, Survival and Recurrence

Conditions
-----------------
Liver Neoplasms

Intervention / Treatment
-----------------
* Procedure: Blood salvage therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Oncologic liver surgery scheduled in our institution Exclusion Criteria: Condition precluding consent for trial Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| With blood salvage<br>Patients undergoing oncologic liver surgery with systematic use of blood salvage therapy | Procedure: Blood salvage therapy<br>* In the blood salvage group, blood is systematically given back when the minimal amount of blood loss required for reprocessing is met<br>|
| Without blood salvage<br>Patients undergoing oncologic liver surgery without any blood salvage therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival |  | 18 months | 
| Overall survival |  | 18 months | 
| Transfusion | Allogenic blood products requirements | Up to 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood salvage therapy, Oncologic liver surgery
The Involvement of Eukaryotic Translation Initiation Factor 4E (eIF4E) in Human Placental Implantation and in the Pathological Pregnancies: Preeclampsia and IUGR

Study Overview
=================
Brief Summary
-----------------
The involvement of eukaryotic translation initiation factor 4E (eIF4E) in human placental implantation and in the pathological pregnancies: preeclampsia and IUGR.

Detailed Description
-----------------
4 groups

Official Title
-----------------
The Involvement of Eukaryotic Translation Initiation Factor 4E (eIF4E) in Human Placental Implantation and in the Pathological Pregnancies: Preeclampsia and IUGR.

Conditions
-----------------
Pregnancy, Preeclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: post TOP or DELIVERY Exclusion Criteria: -

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| first trimester<br>first trimester | |
| third trimester<br>third trimester | |
| prgnancies complicated with IUGR<br>prgnancies complicated with IUGR | |
| preeclampsia<br>preeclampsia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure the Translation Initiation effect of experimental variables observational studies |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iugr pet eIF4E Translation Initiation Factor, 4E (eIF4E) in Human Placental Implantation and in the Pathological Pregnancies: Preeclampsia and IUGR
Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of hyper- and hypoxia can be accomplished during the first three days of life in infants born before 28 completed weeks of gestation. The investigators developed a treatment guideline and a randomised trial design to evaluate if cerebral rStO2 spent out of range in %hours can be reduced by 50%. The present trial is a non-randomised pilot study of the intervention in 10 infants.

Official Title
-----------------
Safeguarding the Brains of Our Smallest Children - a Pilot Study

Conditions
-----------------
Premature Infants, Near-infrared Spectroscopy, Oximetry

Intervention / Treatment
-----------------
* Device: cerebral oximeter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestational age at birth less than 28 completed weeks cerebral oximeter in place at 3 hours after birth Exclusion Criteria: decision not to provide full life support

Ages Eligible for Study
-----------------
Maximum Age: 3 Hours

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: cerebral oximetry + treatment guideline<br>Cerebral oximetry applied as soon as possible after birth and continued until 72 hours of life Clinical staff administer the routine medical management according to local practice as well as respond to out-of-range values with the help of the treatment guideline | Device: cerebral oximeter<br>* INVOS 5100c + SAFB-SM SOMASENSOR NONIN EQUANOX 7600 + sensor model 8000CA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of medical management elicited by cerebral oxygenation out of range | Recording of the type of change of management as defined by the treatment guideline | 0-72 hours of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse device effects | Expected and unexpected | 0-72 hours | 
| burden of hypo-and hyperoxia | measured as %hours out of the target range (55-85%) | 0-72 hours |