linjc16/ctgov huggingface dataset:
Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the safety of ipilimumab and dasatinib combination therapy in patients with CML

Official Title
-----------------
Phase Ib Study Evaluating the Safety and Exploring the Molecular and Cytogenetic Response of Combination Therapy With Dasatinib and Ipilimumab in Patients With Chronic or Accelerated Phase Chronic Myeloid Leukemia

Conditions
-----------------
Leukemia, Myeloid, Chronic

Intervention / Treatment
-----------------
* Biological: Ipilimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ph+ CML on dasatinib therapy Loss of cytogenetic or molecular response while on dasatinib therapy On stable dose of dasatinib for a minimum of 12 weeks and with < 14 day interruption of treatment Exclusion Criteria: Blast crisis CML Autoimmune disease Uncontrolled or significant cardiovascular disease

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 and Group 2<br> | Biological: Ipilimumab<br>* IV Solution, IV, 10 mg/kg, (if dose reduction necessary at 3 mg/kg), Every three weeks for the first 10 weeks, with a booster at week 22, Up to 38 weeks depending on response<br>* Other names: MDX-010;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of ipilimumab in combination with dasatinib in CML patients with a loss of previously achieved major molecular response or a loss of previously achieved cytogenetic response to dasatinib |  | At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the frequency of molecular response, complete cytogenetic response and an overall efficacy signal response rate |  | At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38 | 
| To explore the immunologic responses to combination therapy with ipilimumab and dasatinib |  | At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38 | 
| To explore whether molecular responses to combination therapy with ipilimumab and dasatinib correlate with immunologic responses |  | At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38 |
Interest of Drug Reconciliation to Ensure the Continuity of the Treatment at Discharge

Study Overview
=================
Brief Summary
-----------------
From a regulatory point of view, medication reconciliation is a necessary process to ensure safe medication management for patients. According to national studies and the international scientific literature, the information received by patients and health professionals at discharge from hospital is insufficient. Medication reconciliation at discharge reduces medication errors and rehospitalisation, but few studies have been conducted on the impact of a coordinated and reliable care pathway on medication continuity. The iCoCon study will enable a new healthcare organisation to be set up in order to improve the quality of the patient pathway and the patient's medication management. This new organisation is part of the policy of continuous improvement of the quality and safety of care

Official Title
-----------------
Nterest of Drug Reconciliation to Ensure the Continuity of the Treatment at Discharge

Conditions
-----------------
Hospitalized Patient

Intervention / Treatment
-----------------
* Other: Drug reconciliation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalized patient Patient with a drug treatment with a particular mode of supply Paediatric patient or an adult patient. First inpatient stay over the inclusion period from late 2021 to late 2022 Exclusion Criteria: Patient under curatorship or guardianship Patient residing abroad No free, informed and written consent obtained
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug reconciliation<br>Drug reconciliation and transmission to pharmacist | Other: Drug reconciliation<br>* Drug reconciliation information transmission to pharmacist interview with the patient<br>|
| No Intervention: standard<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of a coordinated and reliable pathway when patients are discharged from the institution via drug reconciliation to ensure the continuity of patients' treatment | Value of coordinated pathway is evaluated by number of days of treatment interruption between patient discharge and provision of treatment to the patient | 1 month after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medication reconciliation, Continuity, Town-hospital network
Serotonin/Dopamine Antagonism of Cocaine Effect: 2 - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study measures incorporate an appropriate integration of behavioral and neurobiological indices.

Detailed Description
-----------------
Risperidone in low doses is compared with placebo in a 6-week randomized trial. Subjects also receive supportive counseling. Outcome measure include rating of behavior, mood, drug abuse, global function, and urine toxicology.

Official Title
-----------------
Serotonin/Dopamine Antagonism of Cocaine Effect

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

Intervention / Treatment
-----------------
* Drug: Risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cocaine abuse or dependence Exclusion Criteria: Dependence on other drugs. Major psychiatric illness

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine toxicology for cocaine |  |  | 
| Analog mood scales |  |  | 
| POMS |  |  | 
| EPS sx |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Subcutaneous Aspart Insulin to Treat Diabetic Ketoacidosis (DKA) and Beta-Hydroxybutyrate Testing in DKA

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether insulin administered by a subcutaneous injection is effective in the treatment of a diabetic crisis and to determine if beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis.

Official Title
-----------------
Subcutaneous Aspart Insulin and Point of Care Beta Hydroxybutyrate Testing: A New Paradigm for the Management of Diabetic Ketoacidosis

Conditions
-----------------
Diabetic Ketoacidosis

Intervention / Treatment
-----------------
* Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 or older venous pH < 7.3 or arterial < 7.35 at least 2 of the following 3: serum HCO3 < 18/anion gap > 16 serum glucose > 300 mg/dl serum acetone positive Exclusion Criteria: pregnant less than age 18

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 |
| --- | --- |
| Active Comparator: Subcutaneous Insulin<br>Aspart Insulin administered subcutaneously 0.2 units/kg/sq every 2 hours | Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)<br>* Aspart Insulin 0.2units/sq q 2 hours Regular Insulin 0.1units/kg/hr intravenous Aspart Insulin 0.1 units/kg/hr intravenous<br>|
| Active Comparator: IV Regular Insulin<br>Intravenous Regular Insulin 0.1 units/kg/hour | Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)<br>* Aspart Insulin 0.2units/sq q 2 hours Regular Insulin 0.1units/kg/hr intravenous Aspart Insulin 0.1 units/kg/hr intravenous<br>|
| Active Comparator: Intravenous Novolog Insulin<br>Intravenous Novolog Insulin 0.1 units/kg/hour | Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)<br>* Aspart Insulin 0.2units/sq q 2 hours Regular Insulin 0.1units/kg/hr intravenous Aspart Insulin 0.1 units/kg/hr intravenous<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6 |  | q 2 hours | 
| Hours to achieve blood glucose less than 200mg/dl |  | q 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DKA
Effectiveness of Interventions for Hospital Medical Thromboprophylaxis: a Bicentric Swiss Quality-improvement Study

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate and compare the short-term and medicum-term effectiveness of 2 types of interventions in 2 different hospitals to improve the adequacy of hospital thromboprophylaxis among acute medical inpatients.

Official Title
-----------------
Effectiveness of Interventions for Hospital Medical Thromboprophylaxis: a Bicentric Swiss Quality-improvement Study

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Other: Comprehensive electronic tool in the electronic medical chart
* Other: Educative sessions
* Other: Pocket card


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute medical inpatients hospitalized at the Geneva University Hospitals or the Lugano Regional Hospitals Exclusion Criteria: patients already on therapeutic anticoagulation patients with an estimated life expectancy of <3 months pregnancy patients hospitalized for COVID-19

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implementation of an electronic tool for risk stratification and thromboprophylaxis prescription<br> | Other: Comprehensive electronic tool in the electronic medical chart<br>* Use of a comprehensive electronic tool in the electronic medical chart to help the stratification of risk of VTE and the subsequent prescription of an adequate thromboprophylaxis<br>Other: Educative sessions<br>* Educative sessions on thromboprophylaxis<br>|
| Experimental: Implementation of educative sessions and pocket cards for thromboprophylaxis<br> | Other: Educative sessions<br>* Educative sessions on thromboprophylaxis<br>Other: Pocket card<br>* Pocket card (guide for thromboprophylaxis)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with an adequate thromboprophylaxis |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of venous thromboembolism |  | 90 days | 
| Incidence of major bleeding |  | 90 days |
Role of Wound Irrigation After Appendectomy

Study Overview
=================
Brief Summary
-----------------
Surgical site infection is a common problem after open appendectomy. Irrigation of the surgical wound by topical antibiotics has been devised as a measure to reduce the incidence of wound infection. The present trial aims to assess the efficacy of layer-by-layer wound irrigation with gentamicin-saline solution in prevention of superficial surgical site infection after open appendectomy for acute uncomplicated appendicitis.

Official Title
-----------------
A Randomized Trial on Wound Irrigation in Prevention of Surgical Site Infection After Appendectomy

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Procedure: Irrigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients of both genders aging between 18 and 65 years who present with acute appendicitis. Patients with perforated appendicitis will be also included. Exclusion Criteria: Patients with appendicular mass, appendicular abscess, generalized peritonitis. Patients with other causes of acute abdomen as revealed intraoperatively. Patients taking long course of steroid therapy or immunosuppressive treatment, Patients unwilling to participate in the trial.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Irrigation<br>Layer by layer irrigation of the surgical wound with gentamicin-saline solution | Procedure: Irrigation<br>* upon closure of the peritoneum gentamicin-saline solution (160 mg of gentamicin in 400 ml of normal saline 0.9%) will be used for irrigation of every layer of the wound before its closure<br>|
| No Intervention: Control<br>The surgical wound is closed layer by layer without irrigation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | The incidence of superficial site infection as detected by clinical examination on follow-up | 2 months after surgery |
Online Self-help for Depressed Patients Awaiting Psychotherapy

Study Overview
=================
Brief Summary
-----------------
Patients with major depression who are on a waiting list for psychotherapy usually suffer from considerable symptoms. Online self-help is one potential way to alleviate this suffering. The investigators want to study if patients awaiting psychotherapy benefit from online-self help. The investigators therefore randomly assign patients to either online self-help or no intervention and assess their depressive symptoms on a regular basis. The investigators hypothesize that online self-help will be superior to no intervention in alleviating depressive symptoms in depressed patients awaiting psychotherapy.

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Other: Online self-help


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Depressive Disorder stable medication 18yrs. or older Exclusion Criteria: current psychotherapy acute suicidality unavailability of internet connection

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online self-help<br>Provision of online self-help while waiting for psychotherapy | Other: Online self-help<br>* Provision of online self-help<br>|
| No Intervention: Waiting list alone<br>Waiting for psychotherapy alone | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Symptomatology |  | up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Symptomatology |  | 6 weeks, up to 10 months |
The Clinical Significance of Minimal Change in Reflux Esophagitis Based on the Gastroesophageal Reflux Disease Questionnaire

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define the endoscopic findings of minimal change that is significant to clinical significant reflux esophagitis. Through this, the investigators want to estimate the applicability of minimal change findings of reflux esophagitis to the clinic.

Official Title
-----------------
Non-interventional, Cross-sectional, Multi-center Study to Establish The Clinical Significance of Minimal Change in Reflux Esophagitis Based on the Gastroesophageal Reflux Disease Questionnaire (GerdQ)

Conditions
-----------------
Gastroesophageal Reflux Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 20 years old patients who consent to revealing their medical information and be able to respond to questionnaires regarding the symptom. Patients who had shown the reflux esophageal minimal change in the endoscopic finding: the reflux esophagitis Exclusion Criteria: Patients who had shown the mucosal break or barrett esophagus at gastric mucosal barrier or lower oesophagus in endoscopic findings Patient with a diagnosis of gastroesophageal reflux disease and who have received medication treatment Patient who had received H2-receptor antagonists, prostaglandin, PPI, NSAIDs or aspirin, high dose steroid and anticoagulants for at least 5 consecutive days in the 4-week period immediately preceding the diagnostic endoscopy Patients with a history of operation due to gastrointestinal disease, malignancy, alcoholism, pregnancy (in female), breast feeding (in female) or systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| 1<br>Reflux esophageal minimal change in the endoscopic finding | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate significant minimal change endoscopic finding of reflux esophagitis diagnosis |  | Significant minimal change endoscopic finding for gastroesophageal reflux disease diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the probability model of diagnosing gastroesophageal reflux disease based on minimal change endoscopic findings through definition of significant minimal change endoscopic findings of gastroesophageal reflux disease diagnosis. |  | at baseline -->this is a cross-sectional study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minimal Change, GERD, GERDQ
Predictors of Response to Iron and Erythropoietin Stimulating Agents

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to identify predictors of treatment response. This involves collected baseline clinical parameters and bloods for biochemical parameters prior to administering the study treatment. A positive outcome following treatment was defined as an uptitration of haemoglobin by greater than 5g/l within 2 months. The study evaluated the participants response to treatment against the clinical and biochemical information collected prior to treatment being received.

Official Title
-----------------
Predictors of Response to Iron and Erythropoietin Stimulating Agents

Conditions
-----------------
Renal Failure Chronic, Anemia

Intervention / Treatment
-----------------
* Drug: Iron Sucrose Solution for Injection
* Drug: Epoetin Beta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All prevalent haemodialysis patients, established for greater than 3 months Exclusion Criteria: Inability to consent Bone marrow disorder Transfusion dependence Active bleeding Active infection Active malignancy Frail with either frequent hospital admissions or unable to follow trial protocol due to differing target haemoglobin

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EPO group<br> | Drug: Epoetin Beta<br>* Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000<br>* Other names: Neorecormon;|
| Active Comparator: Iron group<br> | Drug: Iron Sucrose Solution for Injection<br>* 200mg iron sucrose given on 5 successive haemodialysis sessions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Incrementation | Incrementation of haemoglobin of 5g/l following treatment | Within 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis