linjc16/ctgov huggingface dataset:
Pain Management of Children With Appendicitis in the Emergency Department (ER)

Study Overview
=================
Brief Summary
-----------------
The aim of this retrospective study is to determine the percentage of children with appendicitis who were given analgesics or opioids in the ER, to reduce their pain.

Official Title
-----------------
Pain Management of Children With Appendicitis in the Emergency Department (ER)

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: Determination of pain management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with appendicitis Exclusion Criteria: -

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 |
| --- | --- |
| Children with appendicitis<br>All children who came to the ER with appendicitis | Other: Determination of pain management<br>* Determine of pain management given to children with appendicitis in ER according to their medical records<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of children given pain medication | Percentage of children given pain medication will be determined according to the data found in their medical records | One year |
A Randomized Clinical Study Comparing a Fully-Coated Cementless Stem Versus a Cemented Stem for Total Hip Replacements

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to answer the question as to whether or not a fully coated cementless stem is equal to or better than a cemented stem in patients over 72 years with good bone quality.

Official Title
-----------------
A Randomized Clinical Study Comparing a Fully-Coated Cementless Stem Versus a Cemented Stem for Total Hip Replacements

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: Fully coated Prodigy stem
* Device: Cemented Endurance Stem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients undergoing surgery for total hip replacements, including diagnosis of osteoarthritis, rheumatoid arthritis, traumatic and post-traumatic arthritis, avascular necrosis and congenital dislocation of the hip. Congenital dislocation of the hip will be included where small but anatomical acetabuli are present, ie., the acetabuli located near the tear-drop Revisions of failed osteotomies may be included Bone quality felt to be acceptable to the surgeon for cementless arthroplasty preoperatively in patients > 72 years of age Exclusion Criteria: Patients with active infection Revision cemented total hip replacement Charcot joints Patients with primary or secondary bone tumors in the vicinity of the joint to be replaced C.D.H. with abnormally placed acetabuli or femoral canals Fibromyalgia patients

Ages Eligible for Study
-----------------
Minimum Age: 72 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fully Coated Prodigy Stem (AML)<br>Total hip arthroplasty with fully coated prodigy stem (AML) | Device: Fully coated Prodigy stem<br>* Total hip arthroplasty with fully coated Prodigy stem<br>|
| Active Comparator: Cemented Endurance Hip Stem<br>Total hip arthroplasty with cemented Endurance hip stem component | Device: Cemented Endurance Stem<br>* total hip arthroplasty with cemented endurance stem<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Womac |  |  | 
| SF-12 |  |  |
Blockade Efficacy of Buprenorphine/Naloxone For Opioid Dependence

Study Overview
=================
Brief Summary
-----------------
Buprenorphine, a treatment for opioid dependence, can be mixed with naloxone, to limit abuse potential. The purpose of this study is to examine the effectiveness of buprenorphine/naloxone that is given at less than daily intervals, in order to prevent withdrawal symptoms associated with stopping opioid abuse.

Detailed Description
-----------------
Buprenorphine and naloxone are often combined to decrease withdrawal symptoms in opioid dependent individuals. Buprenorphine/naloxone is usually given daily to individuals who are attempting to stop opioid abuse; however, research suggests that individuals may be more inclined to take medication if it is given in less than daily intervals. The purpose of this study is to examine the opioid blockade effects of buprenorphine/naloxone that is administered in less than daily doses to opioid dependent individuals. This study will last 11 weeks. Participants will stay in a residential research unit for the duration of the study. Participants will be randomly assigned to receive different doses of daily, sublingual buprenorphine/naloxone. After a minimum of 2 weeks on each dose, participants will undergo challenge sessions on each weekday for 1 week (Monday through Friday). Challenge sessions will consist of increasing doses of intramuscular hydromorphone. During the challenge session week, buprenorphine/naloxone will be given only on Monday; a placebo will be given the rest of the week. Challenge sessions will examine the blockade effects of buprenorphine/naloxone at 2, 26, 50, 74, and 98 hours after the last active dose of buprenorphine/naloxone.

Official Title
-----------------
The Acute and Protracted Blockade Efficacy of Buprenorphine/Naloxone

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine/naloxone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets diagnostic criteria for opioid dependence Qualifies for opioid substitution treatment (e.g., methadone) Exclusion Criteria: Significant psychiatric or physical disorder

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

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine/naloxone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological effects |  | up to one day | 
| drug effects (measured at Week 11) |  | up to one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opioid Dependence
Naltrexone in Treatment of Cocaine Dependence - 5

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of naltrexone in the treatment of cocaine dependence as measured by: 1) decreased urine benzoylecgonine (BE) levels, 2) decreased cocaine use by self-report, 3) decreased cocaine craving, and 4) retention in treatment.

Detailed Description
-----------------
Double-blind, placebo controlled study of the safety and efficacy of naltrexone in treating cocaine dependence in a patient sample that initiated the study while in an inpatient setting and were then followed-up for 3 months as outpatients.

Official Title
-----------------
Naltrexone in Treatment of Cocaine Dependence

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Naltrexone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet DSM-III-R criteria for cocaine dependency, 18 to 65 years of age, capable of understanding the study, voluntarily signed consent, male or non-pregnant female using approved form of birth control. Exclusion Criteria: abnormal liver function tests (SGOT, SGPT, or GGT greater than twice the normal values), opioid use within the last 7 days, use of neuroleptics, having a severe acute medical problem, unable to complete psychiatric rating scales, or judged by the investigator to be unlikely to comply with the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention |  |  | 
| Cocaine use |  |  | 
| Depression |  |  | 
| Anxiety |  |  | 
| Addiction severity |  |  | 
| Global improvement |  |  | 
| Psychopathology |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma

Study Overview
=================
Brief Summary
-----------------
Phase II study of selective intra-arterial infusion of chemotherapy for intraocular retinoblastoma

Official Title
-----------------
Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma

Conditions
-----------------
Retinoblastoma, Eye Cancer

Intervention / Treatment
-----------------
* Procedure: Intra-arterial infusion of chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with advanced intraocular retinoblastoma (International Retinoblastoma Classification group D or E*). Patients with tumor recurrence or vitreous seeding following completion of systemic chemotherapy or previous radiation therapy. Exclusion Criteria: Congenital brain anomaly identified on MRI. History of systemic coagulopathy. Evidence of extra ocular retinoblastoma on clinical examination or neuroimaging.

Ages Eligible for Study
-----------------
Maximum 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

| Intervention/Treatment |
| --- |
|Procedure: Intra-arterial infusion of chemotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response: Globe salvage rate (Eyes saved/Eyes treated). This will be determined by clinical ocular examination. |  | Follow-up will be performed for one year from treatment date. |
A Study Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease (0653-023)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This purpose of this study is to determine if the administration of ezetimibe and simvastatin together is more effective than simvastatin alone in lowering LDL-C levels to a goal of <100 mg/dL in patients at risk for Heart Disease.

Official Title
-----------------
A Comparison of Treatment With Ezetimibe (SCH 58235) and Simvastatin Coadministration Versus Simvastatin in Attaining the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III Coronary Heart Disease (CHD) or CHD Risk Equivalent Strata Low-Density Lipoprotein Cholesterol (LDL-c)

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Drug: MK0653, ezetimibe / Duration of Treatment: 27 Weeks
* Drug: MK0733, simvastatin / Duration of Treatment: 27 Weeks
* Drug: Comparator: simvastatin / Duration of Treatment: 27 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged 18 to 80 at risk for Heart Disease who have LDL-C levels greater than or equal to 130 mg/dL and triglyceride level less than or equal to 350 mg/dL Patients must be able to maintain the National Cholesterol Education Program diet throughout the course of the study Exclusion Criteria: Patients are excluded from the study if their weight is less than 50% of ideal body weight, if they are pregnant or lactating, have congestive heart failure, uncontrolled heart rhythm problems or a recent heart attack, coronary artery bypass surgery, or angioplasty. Additionally, patients with poorly controlled Type 1 or 2 diabetes mellitus, kidney disease, uncontrolled endocrine or metabolic disease, are known HIV positive, and uncontrolled high blood pressure

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0653, ezetimibe / Duration of Treatment: 27 Weeks|nan|
|Drug: MK0733, simvastatin / Duration of Treatment: 27 Weeks|nan|
|Drug: Comparator: simvastatin / Duration of Treatment: 27 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C measurement (target goal = <100 mg/dL) |  | 27 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well tolerated in patients |  | 27 Weeks |
Rectal Washout in Transanal Total Mesorectal Excision and Presence of Intraluminal Malignant Cells

Study Overview
=================
Brief Summary
-----------------
The study aims to assess the existence of intraluminal malignant cells and the appropriate fluid volume needed to perform rectal washout during transanal total mesorectal excision (taTME) for rectal cancer.

Detailed Description
-----------------
Twenty patients undergoing taTME for rectal cancer is included. Following the closure of the rectal lumen by a purse string suture, rectal washout is performed with a total of 500 ml sterile water. Fluid samples are collected after every 100 ml by instilling 50 ml of saline after each washout. A sixth sample is collected from the presacral cavity. Each sample is cytologically examined by a pathologist and labelled either malignant or non-malignant.

Official Title
-----------------
Rectal Washout in Transanal Total Mesorectal Excision and Presence of Intraluminal Malignant Cells

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: Rectal washout


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgery at Slagelse Hospital for rectal cancer with transanal mesorectal excision Consent to participate in the study Exclusion Criteria: No consent to participate No 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 |
| --- | --- |
| Patients undergoing rectal washout in transanal mesorectal excision<br>Patients undergoing rectal washout in transanal mesorectal excision for rectal cancer. | Procedure: Rectal washout<br>* Rectal washout is performed intraoperatively before transection and means irrigation of the rectum following the closure of the rectal lumen below the tumour with a purse string suture. Rectal washout is performed with a total of 500 ml sterile water. Fluid samples are collected after every 100 ml by instilling 50 ml of saline after each washout. A sixth sample is collected from the presacral cavity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Existence of intraluminal malignant cells in fluid samples from rectal washout | Positive/negative cytology | Intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid volume needed to perform rectal washout during transanal total mesorectal excision to eliminate intraluminal malignant cells | Positive/negative cytology | Intraoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rectal washout, transanal total mesorectal excision, rectal cancer
Sleep Deprivation and Advancement of Sleep Period as Treatment for Bipolar Depression.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if sleep deprivation and sleep phase advancement is effective treatment of bipolar patients in a depressive phase.

Detailed Description
-----------------
Background: The onset of therapeutic action for most anti-depressive treatments is usually two weeks. During this period patients suffer from great symptomatic distress. Treatment options that are effective in this period is therefore of interest for psychiatric wards. Aim: To explore if sleep deprivation and three days sleep phase advancement is effective treatment for inpatients with bipolar disorder in a depressive phase. Method: A randomized controlled trial with 24 patients diagnosed with bipolar disorder. Patients will be randomized to treatment as usual in an psychiatric ward, or sleep deprivation and three days sleep phase advancement. Patients in the treatment as usual group will be offered treatment with sleep deprivation and sleep phase advancement after five weeks if they still meet inclusion criteria.

Official Title
-----------------
Sleep Deprivation and Three Days Sleep Phase Advancement as Treatment for Bipolar Depression.

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Behavioral: Sleep deprivation and sleep phase advancement
* Other: usual treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bipolar disorder, depressive phase Exclusion Criteria: substance abuse, psychotic symptoms, suicidal intentions, active mania/hypomania.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep deprivation<br>Sleep deprivation and sleep phase advancement | Behavioral: Sleep deprivation and sleep phase advancement<br>* Total sleep deprivation from 0800 to 1700 next day, and three day sleep phase advancement following sleep deprivation.<br>|
| Active Comparator: usual treatment<br> | Other: usual treatment<br>* Treatment as usual in the psychiatric ward. Patients in this group will be offered treatment with sleep deprivation and sleep phase advancement after five weeks if they still meet inclusion criteria<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on rating scales for depression and symptom severity. |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on rating scales for anxiety, mania, cognitive processing, and sleep quality. |  | one month |
Energy Dense Oleic Acid Formula to Geriatric Patients

Study Overview
=================
Brief Summary
-----------------
Background and aims: Old patients seldom reach energy requirements. The effects of an oleic-acid rich formula on energy intake and appetite were studied. Methods: Recently admitted geriatric patients (n=71), likely to stay more than 1 week were randomised to receive a fat emulsion (Calogen, intervention group (IG)) or to standard care (control group (CG)). Thirty ml of the emulsion were given 3 times daily, i.e. 420 kcal, and was distributed at the regular medication rounds. Food intake and self-rated appetite were registered 2-3 days after admission and on day 8 or the day prior to discharge. Nutritional risk screening (NRS) 2002 and serum lipids and fatty acid profiles were analysed.

Official Title
-----------------
Energy Dense Oleic Acid Rich Formula to Newly Admitted Geriatric Patients - Feasibility and Effects on Energy Intake

Conditions
-----------------
Nutritional Intervention

Intervention / Treatment
-----------------
* Other: Calogen® - an energy dense oleic acid based formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria were: likely to stay at the ward more than one week, >65 years old and able to give informed consent. Exclusion Criteria: Exclusion criteria were: pancreatitis, fat malabsorption, overweight (BMI >30) and non-consent for participation.

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Intervention with energy dense formula<br>Patients were randomised to intervention with the energy dense formula Calogen. | Other: Calogen® - an energy dense oleic acid based formula<br>* A daily dose of 3 x 30 ml of Calogen®, strawberry flavour, distributed at the same time as the pharmaceutical prescriptions, i.e. at 7.00, 14.00 and 20.00.<br>* Other names: Nutricia Nordica AB, Sweden;|
| No Intervention: Control group<br>The patients that were randomised to control group were assigned to ordinary treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To detect a significant difference in energy intake of 48kJ/200 kcal between the groups at 5% significance level and with 80% power. |  | 5 days to 3 weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on serum lipids and appetite |  | 5 days to 3 weeks treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nutrition, geriatric, supplement, energy