linjc16/ctgov huggingface dataset:
Kinetics of D-Dimers After Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the natural kinetics of D-dimers that occur after abdominal surgery.

Detailed Description
-----------------
Venous thromboembolism (VTE) is a potentially fatal disease with an estimated incidence of 0.1%. One third of the VTE occur as pulmonal embolism with a mortality up to 25% (White RH. Circulation 107:2003) Serum d-dimer levels are used as sensitive marker for the diagnosis of VTE (Kelly J et al. Arch Intern Med, 162: 2002). Because of its sensitivity, the determination of serum D-dimer levels is an accepted method to exclude VTE in the outpatient setting meaning that VTE may be excluded in case of normal D-dimer levels (Kelly J. Lancet 359: 2002). The specificity of the D-dimer testing, however, is low. This is true especially in the postoperative phase. The interpretation of elevated D-dimer levels in surgical patients remains elusive. The natural kinetics of D-dimers after surgery is not known. The question to what extent D-dimer levels rise after surgery and how long it may take D-dimer levels to return to normal after surgery is not yet determined. This information is needed to be able to use D-dimer testing for VTE diagnosis in surgical patients. In this study, D-dimer levels are measured in surgical patients immediately before (day 0) and repeatedly after surgery. D-dimer level measurement will be stopped after D-dimer levels returned to normal.

Official Title
-----------------
The Kinetics of D-Dimers After Abdominal Surgery as a Function of the Invasiveness of Surgery

Conditions
-----------------
Natural Kicetics of d-Dimers After Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective surgery Exclusion Criteria: age < 18 years patients not speaking german patients involved in another study pregnancy concommitant inflammatory disease patients with oral anticoagulation patients having received fresh frozen plasma

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
D-dimers, surgery, kinetics
Ibuprofen Suppositories Administration in Infants and Children

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the efficacy of Ibuprofen administered as suppositories in the treatment of fever in infants and children. Ibuprofen as suppositories is not yet registered in Israel, although widely used in Europe.

Detailed Description
-----------------
The drug will be used in 100 consecutive infants and children admitted with fever at the pediatric ER of the Soroka Medical Center. The information on the drug efficacy will be collected in appropriate parental questionnaires.

Official Title
-----------------
Ibuprofen Suppositories Administration for Fever Treatment in Infants and Children

Conditions
-----------------
Fever

Intervention / Treatment
-----------------
* Drug: ibuprofen suppositories


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants and children with rectal temperature > 38.5 C Exclusion Criteria: Infants < 6 months of age

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ibuprofen suppositories|5-10 mg/kg/day-suppositories|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fever decrease |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBUPROFEN, CHILDREN, FEVER
EEG Classification System for Dementia

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to construct a large database of EEG recordings from elderly individuals in predefined groups. The purpose of this database is to select groups of EEG recordings from the database in order to compare the electrophysiology, as measured by EEG, of the groups. In the clinical trial part all individuals are treated exactly the same and are therefore considered a single group. The categorization is performed during the data analysis. The groups in the data analysis will initially be based on the following: Healthy controls Mild Cognitive Impairment Alzheimers Disease (AD) Lewy-body Dementia Parkinsons Disease Dementia Vascular Dementia (VaD) Frontotemporal Dementia (FTD) Depression Other groups will be added if needed.

Official Title
-----------------
EEG Classification System for Dementia

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Other: EEG recording


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of participant in the range of 50-90 years Exclusion Criteria: Outside required age range

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: EEG<br>A non-invasive EEG recording | Other: EEG recording<br>* EEG is recorded once for each participant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classification system for dementia based on EEG | The EEGs recorded in the trial will be categorized into controls or predefined clinical groups based on the participants' clinical diagnosis. The classification system will be constructed using this categorization. | The quality of the classification system will be evaluated regularly, at least every 6 months, up to 6 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia, Diagnosis, Electroencephalography
Study to Evaluate an Oxaliplatin-based Chemotherapy in Patients With Resistant or Relapsing Non-Hodgkin Lymphoma.

Study Overview
=================
Brief Summary
-----------------
Evaluation of the efficacy, tolerance, quality of life and cost effectiveness of the association of Oxaliplatin, Gemcitabine, Rituximab and Dexamethasone for treatment of patients with refractory or relapsing non-Hodgkin lymphoma.

Official Title
-----------------
Study to Evaluate an Oxaliplatin-based Chemotherapy in Patients With Resistant or Relapsing Non-Hodgkin Lymphoma.

Conditions
-----------------
Non-Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Drug: oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years or above at the time of inclusion. Documented CD20+ NHL, refractory or relapsing after first line chemotherapy. No contraindication to Oxaliplatin, Gemcitabine, Dexamethasone or Rituximab. Exclusion Criteria: Other types of non-Hodgkin lymphoma Pregnancy and lactation. Patient unable to give written informed consent. Contra-indication ou intolerance to any of the components of the RGDOx chemotherapy.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxaliplatin<br>oxaliplatin associated with Rituxan,Gemcitabine, and Dexamethasone in patients with refractory or relapsed Non hodgkinien lymphoma | Drug: oxaliplatin<br>* oxaliplatin 100mg/m2 + Rituxan 375 mg/m2 + Gemcitabine 1000mg/m2 every 2 weeks for 8 cycles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate to RGDOx in patients with relapsing or refractory NHL |  | Within 3 months after chemotherapy (6-8 cycles) |
Long-term (3 Months) Safety of Femtosecond-laser Assisted Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
This clinical study is a prospective, post-market-clinical-follow-up study to investigate the long-term (3 months) safety of femtosecond laser assisted cataract surgery as a study follow-up extension to the Study #1304 titled as A Multi-centre, Multi-surgeon, Randomized, Controlled, Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Impact of Cataract Grade on the Efficacy and Safety of Femtosecond-laser Assisted Lens Fragmentation Procedure.

Official Title
-----------------
A Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Long-term (3 Months) Safety of Femtosecond-laser Assisted Cataract Surgery

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: Femtosecond laser cataract surgery
* Device: Manual cataract surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Only the patients who were successfully enrolled in Study #1304 are eligible for this follow-up extension study.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Femtosecond laser cataract surgery<br>Laser group: a pre-fragmentation of the ocular lens will be performed by VICTUS femtosecond laser lens fragmentation procedure. | Device: Femtosecond laser cataract surgery<br>* The VICTUS lens fragmentation procedure is part of the femtosecond laser assisted cataract procedure, which generates precise cuts inside the cataractous lens, leading to a softening and fragmentation of the lens.<br>|
| Active Comparator: Manual cataract surgery<br>Manual: manual group acts as a control group where the lens fragmentation are performed manually without femtosecond laser assisted lens fragmentation | Device: Manual cataract surgery<br>* Manual: manual group acts as a control group where the lens fragmentation are per-formed manually without femtosecond laser assisted lens fragmentation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Less or equal adverse events (e.g. retinal detachment, intraocular lens (IOL) malposition, etc.) in Laser group (pooled from all cataract grades) compared with Manual group (pooled from all cataract grades); p<0.05 will be considered statistically significant. The primary study end point is only based on adverse events and severe adverse events which are related to the treatment procedures. | 3 month |
Neuropsychological and Psychosocial Follow up of Children and Adolescents With Neuromuscular Disease

Study Overview
=================
Brief Summary
-----------------
This project is a retrospective and prospective investigation of neuropsychological and psychosocial development of children with a neuromuscular disease.

Detailed Description
-----------------
This project is a retrospective and prospective investigation of neuropsychological and psychosocial development of children with a neuromuscular disease. Children and adolescents in UZ Leuven will be evaluated according to a psychosocial and neuropsychological protocol including different psychological tests and patient questionaires.

Official Title
-----------------
Neuropsychological and Psychosocial Follow up of Children and Adolescents With Neuromuscular Disease

Conditions
-----------------
Neuromuscular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria children and adolescents (0-18 years) diagnosis of neuromuscular disease

Ages Eligible for Study
-----------------
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 |
| --- | --- |
| Neuromuscular disease<br>Children and adolescents with Neuromuscular disease children according to neuromuscular convention UZL | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological profile (questionnaires, neuropsychological testing) of children with myotonic dystonia type 1 | Compare the outcome of the questionnaires, IQ test and other neuropsychological test to a normal population | one year |
Effects of Subanesthetic Concentrations of Nitrous Oxide - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To examine effects of subanesthetic concentrations of nitrous oxide on cold-pressor pain in humans.

Official Title
-----------------
Effects of Subanesthetic Concentrations of Nitrous Oxide

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: 20% N2O
* Drug: 30% N2O
* Drug: 40% N2O


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 37 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Subject inhaled 0% N2O for 40 minutes with cold immersion at 10 and 30 minutes | |
| Active Comparator: 20% N2O<br>Subject inhaled 20% N2O for 40 minutes with cold immersion at 10 & 30 minutes | Drug: 20% N2O<br>* 20% inhaled N2O<br>|
| Active Comparator: 30% N2O<br>Subject inhaled 30% N2O for 40 minutes with cold immersion at 10 and 30 minutes | Drug: 30% N2O<br>* 30% inhaled N2O<br>|
| Active Comparator: 40% N2O<br>Subject inhaled 40% N2O for 40 minutes with cold immersion at 10 and 30 minutes | Drug: 40% N2O<br>* 40% inhaled N2O<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Subjects immersed non-dominant arm for 3 minutes twice in 2-3 degree C water while inhaling 0 (placebo), 20, 30, or 40% N2O for a total of 40 minutes | during cold test at 10 min & 30 min of inhalation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nitrous oxide, subjective effects, healthy volunteer
Emergence Agitation in Adult Patients After Intracranial Surgery

Study Overview
=================
Brief Summary
-----------------
Emergence agitation is a frequent complication that can have serious consequences during recovery from general anesthesia. However, agitation has been poorly investigated in patients after craniotomy. In this prospective multicenter cohort study, adult patients will be enrolled after craniotomy and emergence agitation will be evaluated. The incidence, risk factors and outcome will be investigated.

Official Title
-----------------
Emergence Agitation During Recovery From Intracranial Surgery Under General Anesthesia: a Prospective Multicenter Cohort Study

Conditions
-----------------
Intensive Care, Surgical, Postoperative Care, Neurosurgery

Intervention / Treatment
-----------------
* Procedure: Anesthesia recovery after intracranial surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both supratentorial and infratentorial intradural cranial operations Exclusion Criteria: Unarousable state (SAS=1) during the first 24 hours after the operation Interval longer than 24 hours between the end of the surgery and neurosurgical ICU admission

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Agitation group<br>Patient is evaluated by the sedation-agitation scale (SAS) during the anesthesia recovery after intracranial surgery under general anesthesia. SAS equals to 5-7 during the first 12 hours after surgery. | Procedure: Anesthesia recovery after intracranial surgery<br>* Intracranial surgery for brain tumor, traumatic brain injury, intracranial hemorrhage, subarachnoid hemorrhage and infection.<br>|
| Non-agitation group<br>Patient is evaluated by the sedation-agitation scale (SAS) during the anesthesia recovery after intracranial surgery under general anesthesia. SAS equals to 1-4 during the first 12 hours after surgery. | Procedure: Anesthesia recovery after intracranial surgery<br>* Intracranial surgery for brain tumor, traumatic brain injury, intracranial hemorrhage, subarachnoid hemorrhage and infection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence agitation | Emergence agitation is measured by sedation-agitation scale (SAS) and is defined as SAS=5-7. | 12 hours after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emergence agitation, intracranial surgery, general anesthesia, incidence, risk factor
Phase 2 Study of URC102 to Assess the Efficacy and Safety in Gout Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess safety, PK/PD and Urate Lowering Effect of URC102 in gout patients with hyperuricemia

Official Title
-----------------
A Placebo-controlled, Randomized, Double-blind, Multicenter Phase 2 Study to Assess the Efficacy and Safety of URC102 in Gout Patients

Conditions
-----------------
Gout, Hyperuricemia

Intervention / Treatment
-----------------
* Drug: URC102 0.25mg
* Drug: URC102 0.5mg
* Drug: URC102 1.0mg
* Drug: URC102 2.0mg
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with gout Exclusion Criteria: Participated in other clinical study within 12 weeks prior to enrollment, and received an investigational product (including placebo)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo x 2weeks | Drug: placebo<br> <br> |
| Placebo Comparator: URC102 0.25mg<br>0.25mg URC102 x 2weeks | Drug: URC102 0.25mg<br> <br> |
| Experimental: URC102 0.5mg<br>0.5mg URC102 x 2weeks | Drug: URC102 0.5mg<br> <br> |
| Placebo Comparator: URC102 1.0mg<br>1.0mg URC102 x 2weeks | Drug: URC102 1.0mg<br> <br> |
| Placebo Comparator: URC102 2.0mg<br>2.0mg URC102 x 2weeks | Drug: URC102 2.0mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trend of serum uric acid reduction and trend of serum uric acid levels | Frequency of patients with serum uric acid level reduced to < 6.0 mg/dL and < 5.0 mg/dL at each measurement | weekly for 3weeks |
Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries

Study Overview
=================
Brief Summary
-----------------
Muscle sprains of the back and neck are very common. In addition to pain and antiinflammatory medications the use of either cold or hot packs has been recommended. In the current study we will compare ice packs and heat packs to see which is more effective at relieving pain from back and neck sprains while in the Emergency Department.

Detailed Description
-----------------
as above

Official Title
-----------------
Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries

Conditions
-----------------
Back Strain, Neck Strain

Intervention / Treatment
-----------------
* Other: Heat
* Other: Cold


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Patients with acute neck or back pain who are able to consent and are in pain on arrival to Emergency Department. Exclusion Criteria: Those unable or unwilling to consent, those with suspected fractures or neurologic deficits.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Heat<br>Application of Heat pad to site of muscle sprain. | Other: Heat<br>* Application of heat pack to the back or neck sprain.<br>* Other names: warm pack;|
| Active Comparator: Cold<br>Application of ice pack to muscle sprain. | Other: Cold<br>* Application of ice pack to the back or neck sprain.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score After Treatment | Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Request for Rescue Analgesia | Number of participants requesting a rescue analgesic be given | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
muscular sprain, acute back pain, acute neck pain, heat treatment, cold treatment