linjc16/ctgov huggingface dataset:
Intensive Therapy Archival Research

Study Overview
=================
Brief Summary
-----------------
This is an internal treatment evaluation to determine whether eye movement desensitization and reprocessing (EMDR) or progressive counting (PC) should become the preferred trauma treatment for the investigator's clients. The investigator is using routine/existing in-house measures and case files to track symptom reduction, trauma treatment time, rate of treatment switching (from EMDR to PC or vice versa), and rate of trauma treatment refusal. This is retrospective as well as prospective archival research.

Official Title
-----------------
Intensive Therapy Archival Research

Conditions
-----------------
Trauma, Psychological

Intervention / Treatment
-----------------
* Behavioral: EMDR
* Behavioral: PC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Victims of crimes, including assault, rape, robbery, intimate partner violence, child abuse, kidnapping, vehicular homicide, and suicide Witnesses and family members of victims
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult victims of sexual assault<br> | Behavioral: EMDR<br>* Eye movement desensitization and reprocessing (intensive format)<br>Behavioral: PC<br>* Progressive counting (intensive format)<br>|
| Children who have been exposed to domestic abuse<br> | Behavioral: EMDR<br>* Eye movement desensitization and reprocessing (intensive format)<br>Behavioral: PC<br>* Progressive counting (intensive format)<br>|
| Women with perinatal emotional complications<br> | Behavioral: EMDR<br>* Eye movement desensitization and reprocessing (intensive format)<br>Behavioral: PC<br>* Progressive counting (intensive format)<br>|
| Teens with behavior problems and histories of abuse<br> | Behavioral: EMDR<br>* Eye movement desensitization and reprocessing (intensive format)<br>Behavioral: PC<br>* Progressive counting (intensive format)<br>|
| Veterans with military-related trauma<br> | Behavioral: EMDR<br>* Eye movement desensitization and reprocessing (intensive format)<br>Behavioral: PC<br>* Progressive counting (intensive format)<br>|
| Survivors of intimate partner violence<br> | Behavioral: EMDR<br>* Eye movement desensitization and reprocessing (intensive format)<br>Behavioral: PC<br>* Progressive counting (intensive format)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TSI-2 following treatment | Trauma Symptom Inventory-2 | Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment | 
| Change in TSCC following treatment | Trauma Symptom Checklist for Children | Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment | 
| Change in PRS following treatment | Problem Rating Scale | Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment |
Invasive and Non-Invasive Assessment of Cerebral Oxygenation in Patients With Severe Traumatic Brain Injury (TBI)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the relationship among regional transcranial oxygen saturation (rSO2), brain tissue oxygen pressure (PbtO2) and cerebral perfusion pressure (CPP) in patients with severe traumatic brain injury (TBI).

Detailed Description
-----------------
Experience with rsO2 assessed by near infrared spectroscopy (NIRS) in patients with severe TBI is lacking. Reports about the usefulness of rSO2 are contradictory as regards its technical reliability and clinical value. Continuous time-domain analysis comparing rSO2, PbtO2 and CPP has never been carried out and the correlation among these variables remains largely unknown. A significant association between rSO2 and these clinically important variables would suggest that cerebral oximetry provides relevant data signifying that rSO2 might be a useful tool assessing cerebral oxygenation in selected patients with TBI.

Official Title
-----------------
Validation of Non- Invasive Regional Transcranial Oxygen Saturation (rSO2) by Comparison With Invasive Brain Tissue Oxygenation (PbtO 2) Measurement in Patients With Severe Traumatic Brain Injury

Conditions
-----------------
Brain Injuries

Intervention / Treatment
-----------------
* Device: transcranial oxygen saturation measurement (INVOS Somanetics 5100C)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe Traumatic Brain Injury (Glasgow Coma Scale < 9) Having an intraparenchymal cerebral ICP/PbtO2 catheter previously inserted. Expected length of ICU stay > 1 days Exclusion Criteria: Patient's relatives refusal to patient's inclusion in the study Patients necessitating ongoing resuscitation End-stage in which death is imminent Deficient signal of rSO2 impeding its proper valuation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: transcranial oxygen saturation measurement (INVOS Somanetics 5100C)|rSO2 measurement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between rSO2 and PbtO2 |  | four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between rSO2 and CPP |  | four months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
traumatic, brain injury, brain regional oxygen saturation (rSO2), brain tissue oxygenation (PbtO2), cerebral perfusion pressure (CPP)
Behavioral Modulation of Intrusive Memories

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine whether sleep affects the development of intrusive memories.

Official Title
-----------------
Behavioral Modulation of Memory Traces: Influence of Sleep on Emotional Regulation and the Consolidation of Intrusive Memories

Conditions
-----------------
Intrusive Memories

Intervention / Treatment
-----------------
* Behavioral: Sleep Deprivation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy participants German on a native level Exclusion Criteria: former or present psychiatric disorders physical illnesses history of trauma pregnancy or lactation period

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Sleep<br>Sleep | |
| Experimental: Sleep Deprivation<br>Sleep Deprivation | Behavioral: Sleep Deprivation<br>* Sleep Deprivation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrusive memories | Intrusive memories measured with an intrusion diary | seven consecutive days |
Switch From Premixed Human Insulin to Biphasic Insulin Aspart in the Netherlands

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this observational study is to observe and investigate the process of switching from premixed human insulin 30/70 (BHI 30) to biphasic insulin aspart 30/70 (BIAsp 30) in an outpatient setting.

Official Title
-----------------
SWITCH Mixtard® 30 NovoLet® to NovoMix® 30 FlexPen®. An Observational Study

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic subjects treated with BHI 30
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BIAsp 30 users<br> | Drug: biphasic insulin aspart 30<br>* Prescription at the discretion of the treating physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycosylated haemoglobin) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hypoglycaemic events |  |  | 
| Treatment satisfaction: ITSQ (Insulin Treatment Satisfaction Questionnaire) |  |  | 
| Quality of Life (QoL) using the World Health Organization Wellbeing Index (WHO-5) |  |  |
Effect of Hemodialysis on Toe Pressure- and Finger Pressure and Skin Autofluorescence in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the vascular condition of hemodialysis patients with toe pressure measurement, finger pressure measurement and measuring glycated and oxidated proteins by skin autofluorescence. Hypothesis: Lowering of finger pressure/toe pressure during hemodialysis, especially in whom with a arteriovenous fistula, may contribute to critical limb ischemia in the extremities.

Detailed Description
-----------------
To determine the macrovascular status of hemodialysis patients by measuring toe pressure, finger pressure and skin autofluorescence. Measuring toe- and finger pressure before and during hemodialysis to determine the chance of developing critical limb ischemia in the extremities. To assess the differences in finger pressure in hemodialysis patients before and during hemodialysis in patients with either arteriovenous fistula in the upper extremity or not. To predict mortality and cardiovascular disease by determine the fastness of accumulation of Advanced-Glycation-Endproducts (this concerns follow-up measurements of skin autofluorescence; another study has collected data of skin autofluorescence in hemodialysis patients in our centre in 2003)

Official Title
-----------------
The Effect of Hemodialysis on Toe Pressure- and Finger Pressure Measurements and Measurement of Skin Autofluorescence; a Pilot Study in the Assessment of Critical Limb Ischemia in Hemodialysis Patients.

Conditions
-----------------
End Stage Renal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with End Stage Renal Disease with hemodialysis therapy Exclusion Criteria: Hemodialysis during the night Dark coloured skin towards unreliable skin autofluorescence measurements

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
End Stage Renal Disease, Hemodialysis, Critical Limb Ischemia, Autofluorescence
Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a Registered Trademark of the GSK Group of Companies.

Study Overview
=================
Brief Summary
-----------------
This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in combination with insulin in improving the control of blood sugar when compared with taking insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both AVANDIA and metformin are medicines which are individually licensed for the treatment of type II diabetes mellitus. Because they act in different ways, it is thought that combining them may give an increased benefit of treating diabetes and reducing blood sugar.

Official Title
-----------------
A 24 Week, Randomised, Double Blind, Parallel Study to Compare the Change in HbA1c With AVANDAMET® (8.0mg / 2.0g) Plus Insulin to Placebo Plus Insulin, in Subjects With Type 2 Diabetes Starting Insulin Therapy

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Rosiglitazone/metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have been diagnosed with type II diabetes mellitus and not have adequate glycaemic controlled while receiving at least 1.5g of metformin. Patients must have a body mass index of greater than 25 kg/m2 and must not suffer from ankle swelling. Exclusion Criteria: Patients cannot have any form of congestive heart failure or severe or unstable angina. Patients cannot be currently receiving insulin, but be prepared to begin insulin treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Rosiglitazone/metformin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AVANDAMET insulin type 2 diabetes
A Retrospective Case Series Study for Acute Abdomen in General Surgery Ward

Study Overview
=================
Brief Summary
-----------------
The acute abdomen is a clinical situation in which an acute an change in the condition of intra-abdominal organ, commonly attached to inflammation or infection need urgent and correct diagnosis .

Detailed Description
-----------------
A special data collection sheet designed to collect data regarding the diagnosis, age and sex from the profile of patients retrospectively. Data entry was performed by using Microsoft Excel and all the data were analysed by SPSS.

Official Title
-----------------
A Retrospective Case Series Study for Acute Abdomen in General Surgery Ward

Conditions
-----------------
The Study Was Aimed to Assessing the Clinical Profile of Acute Abdomen and Their Frequency According to Age and Sex

Intervention / Treatment
-----------------
* Procedure: surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All of patients with acute abdomen that is admitted in general surgery ward of Aliabad teaching hospital. Exclusion Criteria: traumatic abdominal injury, abdominal pain due to urological and gynaecological origin.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 94 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: surgery|Our study is observational and we use secondary data|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A retrospective case series study for acute abdomen in general surgery ward of Aliabad teaching hospital |  | 21 March 2018-21 March 2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute abdomen, Abdominal pain, Acute appendecitis, intestinal obstruction
Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation

Study Overview
=================
Brief Summary
-----------------
Diagnosis and follow up of a lupus cohort in a multidisciplinary consultation in Brest ( France)

Detailed Description
-----------------
all patients coming to the LUPUS multidisciplinary consultation in brest ( France) will have a clinical examination, a biological and immunogical blood samples, cutaneous biopsies or renal biospies if necessary, an ultrasonographic articular and salivary glandular examination if needed. In case of articular involvement, some Xrays ( hands and feet) will be done at the inclusion and during the follow up each year during 5 years .

Official Title
-----------------
Cohort Follow-up of Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation at the CHRU of Brest

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Other: description of a lupus patient cohort


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women or men, more than 18 years old, coming to the multidisciplinary consultation in brest ( France). With written consentment Exclusion Criteria: patients less than 18 years old refusing to participate Under legal protection

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: diagnosis and follow up of a lupus cohort
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: lupus cohort follow up<br>it is a descrption lupus patients study | Other: description of a lupus patient cohort<br>* description of a lupus patient cohort<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort lupus: epidemiologic lupus study about diagnosis and follow up | epidemiologic lupus study in collecting data ( description of the population, biologic and immunologic data collection, data of articular damges with xrays datas) about Diagnosis and follow up of a cohort lupus in a multidisciplibnary consultation in brest hospital ( France). | five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cutaneous lupus
Changes in Oral Vitamin K Intake for Optimization of Chronic Oral Anticoagulation: A Randomized Trial

Study Overview
=================
Brief Summary
-----------------
The primary hypothesis of this trial is that changes in oral vitamin K intake, based on simple food registries, may be superior to conventional changes in doses of medications in order to stabilize chronic oral anticoagulation.

Official Title
-----------------
Changes in Oral Vitamin K Intake for Optimization of Chronic Oral Anticoagulation: A Randomized Trial

Conditions
-----------------
Blood Coagulation Disorders

Intervention / Treatment
-----------------
* Behavioral: Changes on Oral Vitamin K Intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with any clinical indication for chronic oral anticoagulation with one INR level out of target, without a clear clinical cause for INR instability (unplanned changes in coumadin medications, other pharmacological interactions, clinical illnesses and laboratory errors). Exclusion Criteria: Clinical evidence of bleeding or thrombosis. INR > 4 or INR < 1,5.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Changes on Oral Vitamin K Intake|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients on target International Normalized Ratio (prothrombin time) on day 90th after randomization |  |  | 
| Stabilization of International Normalized Ratio (prothrombin time) during follow-up (90 days after randomization) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Oral Anticoagulation
Bladder Flap Technique In Elective Cesarean Section

Study Overview
=================
Brief Summary
-----------------
Cesarean section is a surgical procedure used to deliver one or more babies. cesarean section is usually performed when vaginal delivery will put the mother or child's health or life at risk. In recent years, the number of cesarean section has risen worldwide.

Official Title
-----------------
Bladder Flap Versus Non Bladder Flap Technique In Women Undergoing Elective Cesarean Section A Randomized Controlled Trial

Conditions
-----------------
Cesarean Delivery

Intervention / Treatment
-----------------
* Procedure: creation of bladder flap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective primary cesarean section previous cesarean section gestational age 32 or more. Exclusion Criteria: Patients undergoing emergent cesarean section Patients undergoing planned vertical uterine incision. Patients undergone previous laparotomies. Gestational age less than 32 weeks . Patient refusing to participate in the study Women with body mass index >35

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bladder flap<br>The bladder flap is made by superficially incising and dissecting the peritoneal lining to separate the urinary bladder from the lower uterine segment. | Procedure: creation of bladder flap<br>* Creation of the bladder flap, i.e., dissecting the urinary bladder from the lower segment of the uterus is a standard part of cesarean section (CS).<br>|
| No Intervention: Non bladder flap<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the skin - delivery time |  | duration of surgery |