linjc16/ctgov huggingface dataset:
Insulin Treatment in Cancer Cachexia

Study Overview
=================
Brief Summary
-----------------
The study is designed to evaluate whether daily insulin treatment to weight losing cancer patients attenuates progression of cancer cachexia and improves metabolism.

Detailed Description
-----------------
Randomized study with long-term follow-up based on survival, health related quality of life, food intake, resting energy expenditure, body composition, exercise capacity and measurement of metabolic efficiency.

Official Title
-----------------
Insulin Treatment in Cancer Cachexia: Effects on Survival, Metabolism and Physical Functioning. A Randomized Prospective Study.

Conditions
-----------------
Cancer Cachexia

Intervention / Treatment
-----------------
* Drug: Insulatard, flexpen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight loss Systemic solid cancer Exclusion Criteria: Diabetes Brain metastases Expectant survival of less than 6 months Serum creatinine above 200 umol/l Persistent of recurrent fever Cholestasis

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 85 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

| Intervention/Treatment |
| --- |
|Drug: Insulatard, flexpen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life, |  |  | 
| food intake, |  |  | 
| resting energy expenditure, |  |  | 
| body composition, |  |  | 
| metabolic efficiency, |  |  | 
| spontaneous physical activity, |  |  | 
| blood and hormonal tests |  |  | 
| serum tumor markers |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer cachexia, Tumor host metabolism
An Intervention to Reduce Inappropriate Prescriptions of Antibiotics for Respiratory Infections in General Practice

Study Overview
=================
Brief Summary
-----------------
This study will explore the possible effect of a tailored educational intervention towards general practitioners, in order to improve antibiotic prescriptions for respiratory infections.

Official Title
-----------------
Can Antibiotic Prescriptions in Respiratory Tract Infections be Improved? A Cluster Randomized Educational Intervention in General Practice

Conditions
-----------------
Respiratory Tract Infections, Anti-Bacterial Agents

Intervention / Treatment
-----------------
* Behavioral: Educational intervention
* Behavioral: Educational intervention program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General practitioner Specialist in general practice
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Educational intervention|Educational outreach visits to the CME-groups, work-shops, audit and feedback|
|Behavioral: Educational intervention program|The 433 recruited GPs had a total of 1336 717 office consultations of which 171 679 (12.8%) were RTIs encounters for 118 621 different patients. The GPs participated in peer continuing medical education (CME) groups in southern Norway. A multifaceted intervention was tailored, where key components were educational outreach visits to the CME-groups, work-shops, audit and feedback. Prescription Peer Academic Detailers conducted the educational outreach visits. During these visits, evidence-based recommendations of antibiotic prescriptions for RTIs were presented and software handed out for installation in participants PCs, enabling collection of prescription data. These data was linked to corresponding data from the Norwegian Prescription Database (NorPD). Main outcomes are baseline proportion of inappropriate antibiotic prescriptions for RTIs and change in prescription patterns compared to baseline one year after the initiation of the tailored pedagogic intervention.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in antibiotic prescription patterns for respiratory infections | From the 1.336.717 office consultations, main outcomes data (baseline proportion of inappropriate antibiotic prescriptions for RTIs and change in prescription patterns compared to baseline) was measured 1 year after the initiation of the tailored pedagogic intervention. | 1 year |
Relationship Between Heat Wave and Hyponatremia

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to explore the relationship between moderate to severe hyponatremia and heat.

Detailed Description
-----------------
We will explore the relationship between heat wave and moderate and severe hyponatremia in a population of adult patients admitted in the emergency department of a primary and tertiary care teaching urban hospital. We will compare the prevalence of hyponatremia between summer and winter periods. We will describe the types of observed hyponatremia and describe the characteristics of the patients suffering of moderate to severe hyponatremia.

Official Title
-----------------
Relationship Between Heat Wave and Moderate to Severe Hyponatremia in the Emergency Departement of Primary and Tertiary Care Teaching Hospital.

Conditions
-----------------
Hyponatremia

Intervention / Treatment
-----------------
* Other: Seasonality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all adults (> 16 y) with blood natremia measured Exclusion Criteria: Patients without measure of natremia in the emergency department

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Hyponatremia, seasonality<br>Summer months = June, July, August Winter months = December, January, February | Other: Seasonality<br>* The impact of high temperature during summer months on the prevalence of hyponatremia will be explores.<br>* Other names: Winter = December, January, February;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with moderate to severe hyponatremia | Moderate to severe hyponatremia is defined as Sodium blood levels < 125 mmol/L | Natremia measured at admission in the ED | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | December 2011 to August 2013 | 
| Hospital length of stay |  | December 2011 to August 2013 |
GutMe!: IBS and Collagen Protein Powder an Interventional Study

Study Overview
=================
Brief Summary
-----------------
In this study we would like to understand how or if a food-based supplement affects gut symptoms such as bloating, stomach cramps and irregular bowel habits. Through using a digital symptom tracking app for a few weeks, you may just learn more about exactly what is triggering your symptoms!

Official Title
-----------------
GutMe!: IBS and Collagen Protein Powder an Interventional Study

Conditions
-----------------
Irritable Bowel Syndrome, Irritable Bowel, Irrit

Intervention / Treatment
-----------------
* Dietary Supplement: Collagen Protien Powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: US based self report bloating Exclusion Criteria: vegan or vegetarian diet suffering from any skin disorders kidney disease treated medical issues glutamine sensitivity

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm interventional study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Single arm study. Receives collagen protein powder. | Dietary Supplement: Collagen Protien Powder<br>* Collegen Protein Powser<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported IBS symptoms |  | Baseline, Week 4 and Week 10 |
Prenatal PCB Exposure

Study Overview
=================
Brief Summary
-----------------
This project is designed to investigate the association between prenatal exposure to environmental contaminants on cognitive development of school-age children

Official Title
-----------------
Prenatal PCB Exposure and Cognitive Development

Conditions
-----------------
Maternal Exposure

Participation Criteria
=================
Eligibility Criteria
-----------------
Pregnant mothers carrying full-term infants between 1991 and 1994. No longer recruiting. This is not a clinical trial. This is an epidemiological study.

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

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

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
-----------------
Cognitive development, Prenatal exposure, PCBs
Retrospective Study on Colorectal Robotic Surgery Results Obtained Using a New Robotic Platform

Study Overview
=================
Brief Summary
-----------------
The ALF-X (Advanced Laparoscopy through Force reflection) Robotic Surgery System is a medical device that is available for distribution in the EU (European Union) under CE Mark for use in general surgery, thoracic surgery, gynecological surgery and urological surgery. The main research question is to assess, from a retrospective poit of view, the safety and feasibility of this new robotic platform in the colorectal surgery.

Detailed Description
-----------------
The rationale of this study is to investigate the perioperative and the short term perioperative outcomes of this new robotic Platform in minimally invasive colorectal surgery. Tha ALF-X utilizes fully reusable along with haptic feedback and an innovative vision control system.

Official Title
-----------------
Retrospective Study on Colorectal Robotic Surgery Results Obtained Using a New Robotic Platform

Conditions
-----------------
Colorectal Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients affected by colorectal disease (benign or malignant) having undergone surgery using ALF-X platform Exclusion Criteria: none

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 |
| --- | --- |
| ALF-X<br>all patient underwent robotic colorectal surgery using ALF-X system | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation adverse events | Adverse events occurred during the surgery and during the 30 days after the surgery evaluated using Clavien-Dindo Classification, conversion rate to traditional laparoscopy or open surgery | from the surgery up to 30 days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalisation | Duration of hospitalisation | from surgery to hospital discharge, up to 30 days | 
| Duration of surgery | Duration of surgery | from to the start to the end of the surgery | 
| Setup for surgery - collision rate | Registration and calculation of the collision rate | from to the start to the end of the surgery | 
| Setup for surgery - reduced mobility | Registration and calculation of the reduced mobility of the tools | from to the start to the end of the surgery | 
| Adverse events | Number of adverse events | Up to 30 days post-surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
robotic, colorectal, surgery
Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis

Study Overview
=================
Brief Summary
-----------------
Epistaxis is a common problem among people of all ages and backgrounds. However, occasionally epistaxis can be severe enough to require emergency room admission. Among the treatment options for epistaxis, nasal packing is the most common approach. This approach requires a return visit to the clinic for removal of the packing. Additionally, there is a great deal of pain during the insertion and removal of this packing. This study aims to justify the further investigation of thrombin as a potential treatment approach for these patients. Thrombin could provide a treatment approach that reduces pain and eliminates the need for a return visit to the clinic.

Official Title
-----------------
A Randomized Controlled Trial Comparing Outcomes in Patients Treated With Merocel Packing or Thrombin-JMI for Anterior Epistaxis

Conditions
-----------------
Epistaxis

Intervention / Treatment
-----------------
* Drug: Thrombin-JMI
* Drug: Merocel pack


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking adults that have failed first line therapy for anterior epistaxis in the ER or the hospital Exclusion Criteria: Non-english speaking patients Patients with bleeding disorders Known pregnant women or women that think they may be pregnant Patients with a know presence of antibodies to bovine thrombin preparations Patients that currently have or are known to have a history of systemic skin condition or rash such as eczema or psoriasis Patients found to have posterior epistaxis Patients requiring a surrogate for medical decisions

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 |
| --- | --- |
| Experimental: 1<br>Thrombin-JMI | Drug: Thrombin-JMI<br>* 5,000 IU, to nasal mucosa via syringe spray applicator<br>|
| Active Comparator: 2<br>Merocel pack | Drug: Merocel pack<br>* 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cessation of Epistaxis |  | baseline, day 4-6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epistaxis
Feasibility Study of a New Fistula Pouching System

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigation is to carry out a clinical evaluation of a newly developed fistula pouching system's ability to function as a good pouch for fistulas, with the opening on the skin of the stomach or in a wound on the skin of the stomach.

Official Title
-----------------
Pouching of Fistula - a Non-comparative, Multi-center Investigation

Conditions
-----------------
Cutaneous Fistula

Intervention / Treatment
-----------------
* Device: Fistula Pouching System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Capable of giving informed consent Have to be hospitalized Have a fistula with the opening on the skin in the abdominal area Exclusion Criteria: Pregnant and/or breast-feeding Receiving radiation- or chemotherapy during the investigation period

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Fistula Pouching System|3 different sizes of fistula pounching system|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nurse's preference to use the test product in the future |  | Up to 18 days |
Efficacy of Preoperative Intravenous Dexamethasone in Primary Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
To determine efficacy of preoperative IV dexamethasone for postoperative pain control after TKA.

Detailed Description
-----------------
Preoperative intravenous over 0.1 mg/kg of dexamethasone could be reduced pain after primary TKA.

Official Title
-----------------
Efficacy of Preoperative Intravenous Dexamethasone in Controlling Postoperative Pain After Primary Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty 50-85 years old ASA class 1-3 Exclusion Criteria: Unable to perform spinal anaesthesia History of drug allergies: steroids Renal impairment (CrCl <30 mL/min) Liver impairment Cognitive function disorders Poor controlled DM (HA1C > 7.5) Morning DTX at operative day > 180 mg% Received corticosteroids within 3 months before surgery

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>Preoperative dexamethasone 0.15mg/Kg mixed with NSS to 50 mL IV slowly push over 5 minutes | Drug: Dexamethasone<br>* Dexamethasone 0.15mg/kg mixed with NSS up to 50 mL IV slowly push over 5 minutes<br>|
| Placebo Comparator: Placebo<br>Preoperative intravenous normal saline 50 mL slowly push over 5 minutes | Drug: Normal saline<br>* NSS 50 mL IV slowly push over 5 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative pain | measured with VAS for pain, drugs for relief pain | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional knee score | measured with WOMAC, KSS | 3 month | 
| post-operative nausea and vomiting | measured with amount of nausea/vomiting and drugs requiring for fixed its. | 48 hours | 
| complication of preoperative dexamethasone | measured with wound complication, blood sugar level | 2 weeks | 
| inflammatory level | CRP level | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total knee arthroplasty, pain control, dexamethasone, steroids
Opioid vs. Opioid-free Anesthesia for Hip Arthroscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether an infusion of lidocaine/ketamine compared to fentanyl is equivalent in anesthesia effectiveness and can help reduce the incidence of postoperative nausea and vomiting in patients undergoing elective hip arthroscopy surgery.

Official Title
-----------------
Fentanyl vs. Lidocaine/Ketamine Infusion for Hip Arthroscopy

Conditions
-----------------
Opioid Free Anaesthesia, Postoperative Analgesia

Intervention / Treatment
-----------------
* Drug: Lidocaine/ ketamine
* Drug: Fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old ASA I-II Undergoing elective hip arthroscopy Exclusion Criteria: Known allergies to study drugs Opioid use 1 month prior to surgery BMI >30 Unable to comprehend visual analog scale

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine/ ketamine infusion<br>lidocaine 1mg/Kg bolus, followed by continuous infusion 1 mg/kg/h AND ketamine 1mg/Kg bolus followed by continuous infusion 1 mg/kg/h | Drug: Lidocaine/ ketamine<br> <br> |
| Active Comparator: fentanyl<br>iv fentanyl, 3ug/kg bolus | Drug: Fentanyl<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative nausea and vomiting in the recovery room |  | first 3 postoperative hours | 
| morphine consumption in the recovery room |  | first 3 postopeartive hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative nausea and vomiting on day 1 |  | 1st postoperative day | 
| Anesthestic gas consumption |  | intraoperative |