linjc16/ctgov huggingface dataset:
Adverse Drug Reactions With Fatal Outcome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the incidence of drug-related deaths in a university hospital during the year 2015

Detailed Description
-----------------
The investigators aimed to determine the incidence of drug-related mortality of admitted patients in a university hospital during the year 2015

Official Title
-----------------
Adverse Drug Reactions With Fatal Outcome

Conditions
-----------------
Adverse Drug Reaction

Intervention / Treatment
-----------------
* Drug: adverse drug reaction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inpatients deaths and drug-related deaths. Exclusion Criteria: death patients in the emergency room, patients with a death diagnosis not available, and dead patients due to other causes non-drug related.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Drug-related deaths<br>fatal adverse drug reactions | Drug: adverse drug reaction<br>* drug-related death<br>* Other names: side effect;|
| non drug-related deaths<br>deaths for other causes different as drugs | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of drug-related deaths of all hospital admissions |  | during the year 2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of drug-related deaths with the suspected drug started the previous week |  | during the year 2015 | 
| Number of drug-related deaths with drug interactions between suspected drugs |  | during the year 2015 | 
| Number of preventable drug-related deaths assessed by Schumock criteria |  | during the year 2015 | 
| Number of drug-related deaths with polypharmacy | Polypharmacy: when patient received >10 drugs | during the year 2015 | 
| Number of drug-related deaths with autopsy |  | during the year 2015 | 
| Number of drug-related deaths in which the suspected drug had a contributive role |  | during the year 2015 | 
| Number of drug-related deaths with certain or probable categories assessed by World Health Organization (WHO) criteria and Naranjo algorithm |  | during the year 2015 | 
| Number of drug-related deaths presented during hospitalization |  | during the year 2015 | 
| Risk factors of drug-related deaths | risk factors assessed: age, sex, Charlson score, and hospitalization length | during the year 2015 | 
| Incidence of drug-related deaths of all inpatients deaths |  | during the year 2015. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adverse drug reaction, hospital mortality, incidence
Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine.

Conditions
-----------------
Malignant Melanoma

Intervention / Treatment
-----------------
* Biological: CYT004-MelQbG10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide written informed consent. Able and willing to complete all protocol requirements. Age: 18 years and older. Histological confirmed stage III or IV melanoma. At least one confirmed detectable target lesion HLA-A*0201 haplotype Expected survival of at least 6 months. Full recovery from surgery. Able to undergo either CT scan or MRI scan for tumor assessment. Wash-out period of 4 weeks after chemotherapy All AEs form prior anticancer therapy have resolved to ≤ Grade 1. Sexually active males should use adequate contraception throughout the study period and 3 months thereafter. Females of child bearing potential should use adequate contraception throughout the study period and 3 months thereafter, that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom), and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine. Exclusion Criteria: Pregnant or nursing. Use of an investigational drug within 30 days before enrolment. Known or suspected brain metastases. Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, neurological or bone marrow function disorders Serum tests positive for HIV, HBV, HCV. Active autoimmune diseases or severe allergies. Current diagnosis or history of relevant and severe psychiatric disorder that compromises the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study. Abuse of alcohol or other recreational drugs. Previous vaccination with a Melan-A analog peptide.

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: CYT004-MelQbG10|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Color Doppler Analysıs Of Uterin And Intraovarian Blood Flow Before And After Treatment Wıth Cabergoline In Hyperprolactinemic Patients

Study Overview
=================
Brief Summary
-----------------
the investigators examined the hypothesis that hyperprolactinemia may alter uterin, endometrial and intraovarian blood flow and may contribute to increased infertility by another way.

Conditions
-----------------
Adverse Reaction to Other Drugs and Medicines

Intervention / Treatment
-----------------
* Drug: cabergoline treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who had blood prolactin level higher than 25ng/dl Exclusion Criteria: Pregnancy Use of drugs effecting vasculature such as hormonal therapy, oral contraceptives, antihypertensives Diseases like pelvic inflammatory disease and systemic hypertension Women with clinically overt or treated cardiovascular disease Concurrent illness other than hyperprolactinemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: pretreatment group<br>doppler evaluation at pretreatment period | |
| Experimental: posttreatment group<br>doppler evaluatıon in normoprolactinemia women who given cabergoline treatment | Drug: cabergoline treatment<br>* cabergoline treatment for hyperprolactinemia group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| th effect of prolactin vascular flow and resistance |  | the effect of prolactin in vascular resistance at 2 weeks after treatment |
Local Treatment by Thermic Destruction of Primitive Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser

Official Title
-----------------
Local Treatment by Thermic Destruction of Primitive Breast Cancer. Phase II: Feasibility and Effectiveness, Standardization of Procedures.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Thermic destruction of tissue by Laser using the Novilase device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Noninflammatory unilateral and unifocal breast cancer Size </= 20mm (ultrasound measure) Histological confirmation of cancer by biopsy grade status hormone and HER2. Good delineation of the lesion on ultrasound. Minimum distance of 5 mm between the tumor and the skin between the tumor and muscle. Age between 18 and 80 ECOG performance status 0 or 1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with breast cancer smaller than 20mm<br> | Procedure: Thermic destruction of tissue by Laser using the Novilase device<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of laser treatment | Destruction of the carcinoma will be assess by histological analysis of the specimen. If more than 10% of viables cancerous cells are remaining in the volume treated by laser, the procedure would be a fail | 28 days after initial diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life quality | Life quality will be assess using the questionnaire QLQ-C30 breast module BR23-version 3 | D-0 and before the surgery |
Dexlansoprazole MR in Nonerosive Reflux Disease

Study Overview
=================
Brief Summary
-----------------
This study aim is to compare the efficacy of Dexlansoprazole MR intake before and after breakfast in patients with nonerosive reflux disease.

Conditions
-----------------
Nonerosive Reflux Disease

Intervention / Treatment
-----------------
* Drug: Dexlansoprazole MR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NERD confirmed by gastroscopy Exclusion Criteria: PPI medication within 2 weeks before enrollment

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 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: Exprerimental group<br>medication after diet | Drug: Dexlansoprazole MR<br>* Administration of drug after or before diet<br>|
| Active Comparator: control group<br>medication before diet | Drug: Dexlansoprazole MR<br>* Administration of drug after or before diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage (%) of patients free of reflux symptoms |  | 4 weeks |
Evaluation of a Patient Education Program for Ankylosing Spondylitis

Study Overview
=================
Brief Summary
-----------------
Long term disease management is essential for Ankylosing Spondylitis (AS), a chronic progressive systemic inflammatory disease of the axial skeleton. Extensive information about the disease is a necessary first step. An education program for AS was implemented to improve inpatient medical rehabilitation. In a controlled quasi-experimental multicentric study the efficacy of this program was analysed.

Official Title
-----------------
Evaluation of a Patient Education Program for Ankylosing Spondylitis

Conditions
-----------------
Ankylosing Spondylitis, Spondyloarthritis

Intervention / Treatment
-----------------
* Behavioral: patient education
* Behavioral: Standard Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ankylosing Spondylitis (AS) according to modified New York Criteria Early diagnosis criteria for AS ESSG Criteria for Spondyloarthritis Exclusion Criteria: History of malignant disease during past five years Secondary fibromyalgia syndrome Group integration deficiencies Seminar repeaters

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 |
| --- | --- |
| Experimental: IG<br>Patient education | Behavioral: patient education<br>* complex individual antiinflammatory rehabilitation program during inpatient rehabilitation (physiotherapy, physical therapy, occupational therapy, health-promoting measures and more) and additionally Patient education 6 x 90 Minutes<br>|
| Other: CG<br>without patient education | Behavioral: Standard Care<br>* complex individual antiinflammatory rehabilitation program during inpatient complex individual medical rehabilitation (physiotherapy, physical therapy, occupational therapy, health-promoting measures and more) and additionally further 6 treatments from available disciplines(e.g. massage, electrotherapy, bath)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa

Study Overview
=================
Brief Summary
-----------------
Study to look at the effectiveness, tolerability and safety of two doses of Study Medication in Early Parkinson's Disease (PD) Patients who have not been treated with Levodopa.

Official Title
-----------------
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Clinical Trial For The Efficacy, Tolerability And Safety Of Two Doses Of Rasagiline Mesylate In Early Parkinson's Disease (PD) Patients Not Treated With Levodopa

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Rasagiline Mesylate
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women with Parkinson's disease (PD) whose diagnosis is confirmed by at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) being present, without other known or suspected cause of parkinsonism. Subjects must be age 35 years or older. Subjects not taking or requiring anti-parkinsonian medications, except for anticholinergics. Exclusion Criteria: Subjects with unstable systemic medical problems or clinically significant malignancy, with particular attention to clinically significant or unstable vascular disease

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Rasagiline treatment | Drug: Rasagiline Mesylate<br>* tablet, 1 or 2 mg, daily, 58 weeks<br>|
| Placebo Comparator: B<br>placebo arm | Drug: placebo<br>* tablet, once daily, 58 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to assess the safety and efficacy of rasagiline in PD subjects, not receiving or requiring carbidopa/levodopa therapy. The primary efficacy measure will be the change in total UPDRS score, calculated from baseline to 26 weeks. |  | 58 weeks |
Study to Improve the Treatment of Patients With Heart Failure by General Practitioners

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether it is possible to improve the care of general practitioners for patients with heart failure. The investigators try to reach that goal by training the GP's for 90 minutes in uptitrating the recommended medication according the guidelines. After 6 month the investigators ask the patients to fill out a questionary. The investigators ask them about their quality of live.

Official Title
-----------------
Therapy OPtimization Heart Failure Utrecht

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Behavioral: GP's treating HF according the dutch guidelines


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Do have a general practitioners diagnosis heart failure mentioned twice in the electronical medical file. Exclusion Criteria: Incapacitated patients with a life expectancy of less than 2 months Seniles Patients who do not speak the Dutch language

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Training of the GP's, intervention<br>General practitioners are trained to diagnose and treat heart failure according the recommendations of the NHG-standard. | Behavioral: GP's treating HF according the dutch guidelines<br> <br> |
| Active Comparator: Controle<br>General practitioners giving care as usual to their heart failure patients. | Behavioral: GP's treating HF according the dutch guidelines<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion recommended medication for patients with heart failure | the proportion patient who got at the end of the study the tree medicaments which should be prescribed to a patient with heart failure. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL | Measurement of quality of live six months after uptitration of the recommended medication. | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, general practitioner, medical therapy, quality of live
Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone

Study Overview
=================
Brief Summary
-----------------
Study to examine the concentration of the study drug, tigecycline, in human bone samples following the administration of multiple doses.

Official Title
-----------------
An Open-Label, Multiple-Dose Study of the Pharmacokinetics of Tigecycline in Human Bone

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Tigecycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Men and nonlactating and nonpregnant women greater than or equal to 18 years of age. Healthy as determined by the investigator on the basis of medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG). Have a high probability for compliance with and completion of the study. Exclusion: Subjects with chronic osteomyelitis. Subjects who have known or suspected hypersensitivity to tigecycline or other tetracyclines. Involvement in other investigational studies of any type within 30 days before test article administration.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tigecycline|Each subject will receive 3 IV doses of tigecycline, as 30-minute infusions: Dose 1 = 100 mgDose 2 = 50 mgDose 3 = 50 mg The doses of tigecycline will be administered to the subjects at approximately 12-hour intervals.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine both the bone and corresponding serum concentration of tigecycline at selected time points following adminstration. |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, human bone
Evaluation of the Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents (GBCA)

Study Overview
=================
Brief Summary
-----------------
The objective of this long term study is to prospectively evaluate the incidence of NSF in patients with severe CKD or kidney failure including patients undergoing dialysis (stages 4 and 5 i.e., with an eGFR below 30)who have not had exposure to a GBCA within 10 years prior to enrollment.

Official Title
-----------------
A Prospective Study Evaluating the Incidence of Nephrogenic Systemic Fibrosis in Patients With Stages 4 to 5 Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents Within the Past 10 Years

Conditions
-----------------
Renal Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has CKD with an eGFR below 30 mL/min/1.73m2 and/or undergoing dialysis as calculated from a serum creatinine (SCr) value obtained from the local laboratory within 24 hours prior to signing the informed consent; Provides written informed consent and is willing to comply with protocol requirements Exclusion Criteria: Has received a GBCA within the past 10 years prior to inclusion in this study including the administration of a GBCA for something other than an MRI (e.g., CT or DSA); Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives; Has ever been suspected of, or diagnosed with, NSF; Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy and laboratory/other diagnostic evaluations should development of NSF be suspected.
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 |
| --- | --- | --- |
| To estimate the incidence of NSF in patients that have not been exposed to GBCA within the last 10 years with severe CKD including those undergoing dialysis observed during the follow-up time period over the total number of eligible patients. |  | 1,3,6,12,18,24 months |