linjc16/ctgov huggingface dataset:
How Diabetic Patient Are Taken Care in Cardiology Service Actually?

Study Overview
=================
Brief Summary
-----------------
Care of the diabetes is multidisciplinary with the involvment either private and hospital specialist

Official Title
-----------------
How Diabetic Patient Are Taken Care in Cardiology Service Actually?

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: evey patient admitted in cardiology department more than 24 hours 18 years old and above accepted to participate patient treated by insuline and/or with oral antidiabetic treatment Type 2 diabetes Exclusion Criteria: Type 1 diabetes patient admitted for angiography iatrogenic hyperglycaemia

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined endpoint of diabetic hospitalized patients | Combined endpoint are glycemia dosage, glycosylated hémoglobin,insulinotherapy, | During hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiology diabetes
A Trial of Grazax in Subjects With Hayfever

Study Overview
=================
Brief Summary
-----------------
The trial is performed to evaluate the efficacy and safety of specific immunotherapy with Grazax for treatment of grass pollen induced allergy.

Official Title
-----------------
A Phase III Trial Assessing the Efficacy and Safety of Grazax in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Drug: Grazax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of grass pollen allergy Positive skin prick test to grass Positive specific IgE to grass Exclusion Criteria FEV1 <70% of predicted value

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Grazax<br>* Tablets 75,000 SQT and matching placebo. One tablet daily.<br>|
| Placebo Comparator: 2<br> | Drug: Grazax<br>* Tablets 75,000 SQT and matching placebo. One tablet daily.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording of allergy symptoms |  | Grass pollen season 2007 |
Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches

Study Overview
=================
Brief Summary
-----------------
The RA patients receiving leflunomide for more than one month, and not receiving other DMARDs (except hydroxychloroquine), will be enrolled to assess their disease activity. Blood samples will be collected for genetic studies and pharmacokinetic assay of the blood levels of the drug and its active metabolite.

Official Title
-----------------
Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Leflunomide 20Mg Tab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid arthritis patients already receiving leflunomide with or without Hydroxychloroquine but without other Disease modifying agents Exclusion Criteria: Those diagnosed with other rheumatic diseases or Rheumatoid patients receiving disease modifying agents other than leflunomide

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 |
| --- | --- |
| leflunomide responsive vs non-responsive<br> | Drug: Leflunomide 20Mg Tab<br>* blood samples of rheumatoid patients will be collected for SNPs detection and drug assay<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of single nucleotide polymorphisms associated with response to the drug | SNPs associated with the response or adverse drug reactions will be detected and correlated with the ratio of leflunomide to its active metabolite | one -two years |
Keloid Radiation Registry

Study Overview
=================
Brief Summary
-----------------
Radiation therapy has been, and is being used in treatment of patients with keloid. Radiation is typically used as an adjunct to surgery in order to reduce the recurrence rate of keloid. Radiation therapy is not free of long term side effects. Radiation Therapy is known to cause secondary cancers. The investigators also do not have a good understanding as to how effective radiation therapy is in preventing recurrence of keloid. Purposes of this study are to determine the long term safety as well as efficacy of radiation therapy when used for treatment of keloid.

Detailed Description
-----------------
The Keloid-Radiation project is a clinical registry of patients with keloid who have been treated with Radiation Therapy. This registry aims to monitor the at least 1,000 keloid patients who received radiation therapy to their keloid and to collect epidemiological and clinical data about these patients in order to assess the long term safety and effectiveness of radiation therapy. Radiation is currently being used in the treatment of keloid, thus enabling the epidemiological characteristics of patients, analysis of treatment response, modeling the influence of risk factors on patients´ risk of developing long term complications such as a cancer, as well as the detailed analysis of the dose delivered, equipment used and radiation planning. This study intends to gather data about the long term efficacy and safety of radiation therapy and rate of developing secondary cancers in patients who have received radiation therapy for treatment of their keloid.

Official Title
-----------------
Keloid Radiation Registry

Conditions
-----------------
Keloid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically confirmed diagnosis of keloid History of radiation therapy for treatment of keloid All Ages Signed informed consent form ( by parent or legal guardian if patient is under the age of 18) Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keloid, Radiation Therapy, Hypertrophic Scar
A Multi-Center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

Study Overview
=================
Brief Summary
-----------------
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.

Official Title
-----------------
A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIb)

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Drug: PEP005 (Ingenol Mebutate) gel, 0.015%
* Drug: Vehicle Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is male or female and at least 18 years of age Female patients must be of either: Non-childbearing potential, post-menopausal Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy Exclusion Criteria: Cosmetic or therapeutic procedures within 2 weeks and 2cm of the selected treatment area Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and 2 cm of the selected treatment area

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEP005 (Ingenol Mebutate) gel<br> | Drug: PEP005 (Ingenol Mebutate) gel, 0.015%<br>* once daily for 3 consecutive days<br>|
| Placebo Comparator: Vehicle gel<br> | Drug: Vehicle Gel<br>* once daily for 3 consecutive days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Clearance of Actinic Keratoses (AK) Lesions | Complete clearance of the treatment field | baseline and 57 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial Clearance of Actinic Keratoses (AK) | Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area | baseline and 57 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peplin, Actinic keratosis, PEP005
A Pilot Study to Develop Predictive Biomarkers for the Response to Immunotherapy in Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Several immune checkpoint inhibitors targeting the PD-1 pathway have been developed with clinical trials showing an approximately 20% durable response in unselected patients with advanced non-small cell lung cancer (NSCLC). At the moment, no clear biomarker exists to accurately predict anti-PD1/PDL1 tumor responsiveness. The goal of this study is to broadly discover and evaluate the utility of blood based biomarkers for use in measuring and predicting response to immunotherapy in patients with lung cancer.

Official Title
-----------------
A Pilot Study to Develop Predictive Biomarkers for the Response to Immunotherapy in Lung Cancer

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Other: Blood and Urine Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced Metastatic NSCLC Scheduled to initiate an immune checkpoint inhibitor Age >= 18 years Able to provide informed consent Exclusion Criteria: Other, unrelated, concomitant active, invasive malignancy

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

| Intervention/Treatment |
| --- |
|Other: Blood and Urine Collection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the correlation between markers identified in the blood and in the primary tumor. |  | 5 years |
Study of the Efficacy of an Investigational Drug in Adult Patients With Non Small-Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
The primary goal of the study is to evaluate an investigational drug's effectiveness as a treatment for Non small-cell lung cancer (NSCLC)

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

Intervention / Treatment
-----------------
* Drug: Investigational drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary. Inclusion Criteria: Eligible patients must be at least 18 years of age with a diagnosis of NSCLC that has gotten worse during or after treatment with platinum-based chemotherapy. Patients must have at least one tumor that can be evaluated by the doctor during the investigational drug treatment. Any side-effects from prior chemotherapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function. Exclusion Criteria: Any of the following will exclude patients from study participation: receipt of more than 1 prior regimen of chemotherapy for NSCLC (repeat of the same chemotherapy at different points in time count as 1 regimen). Irradiation to 25% or more of bone marrow, prior high dose chemotherapy with bone marrow or stem cell support, current participation in other clinical trials, pregnant or breast-feeding women, known HIV-positive or AIDS-related illness.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Investigational drug|nan|

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
-----------------
Pharmacia
Fasting Study of Olanzapine Tablets 20 mg and Zyprexa® Tablets 20 mg

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to investigate the bioequivalence of Mylan olanzapine 20 mg tablets to Eli Lilly Zyprexa® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions.

Official Title
-----------------
Single-Dose Fasting In Vivo Bioequivalence Study of Olanzapine Tablets (20 mg; Mylan) and Zyprexa® Tablets (20 mg; Eli Lilly) in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Olanzapine Tablets 20 mg
* Drug: Zyprexa® Tablets 20 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, adult subjects, 18 years and older able to swallow medication Exclusion Criteria: institutionalized subjects history of any significant disease use of any prescription or OTC medications within 14 days of start of study received any investigational products within 30 days prior to start of study

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Olanzapine Tablets 20 mg | Drug: Olanzapine Tablets 20 mg<br>* 20mg, single dose fasting<br>|
| Active Comparator: 2<br>Zyprexa® Tablets 20 mg | Drug: Zyprexa® Tablets 20 mg<br>* 20mg, single dose fasting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. |  | blood collections through 144 hours |
TandemHeart to Reduce Infarct Size (TRIS Trial)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a device known as the TandemHeart® System (TandemHeart) can help limit heart damage and reduce serious complications after a certain type of heart attack (acute ST elevation anterior wall myocardial infarction [STEMI]) by evaluating the use of the TandemHeart system prior to a procedure called percutaneous coronary intervention (PCI)

Official Title
-----------------
A Randomized Controlled Multicenter Study on the Use of the TandemHeart to Reduce Infarct Size

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Device: TandemHeart System
* Procedure: Percutaneous coronary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA The following is a list of general inclusion criteria. More detailed information can be found in the study protocol. ≥ 18 years of age Presents within 6 hours of acute MI symptoms Evidence of ST elevation First myocardial infarction Written informed consent EXCLUSION CRITERIA The following is a list of general exclusion criteria. More detailed information can be found in the study protocol. Contraindications to antiplatelet/anticoagulation therapy History of blood disorders or active bleeding Renal dysfunction or failure Neurologic damage Cardiogenic shock History of cerebrovascular disease History of transfusion reaction Prior coronary artery bypass surgery Participation in another trial with an investigational drug or device Pregnant

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: TandemHeart System + PCI<br>TandemHeart System prior to percutaneous coronary intervention | Device: TandemHeart System<br> <br> Procedure: Percutaneous coronary intervention<br> <br> * Other names: PCI;|
| Active Comparator: PCI<br>Percutaneous coronary intervention | Procedure: Percutaneous coronary intervention<br> <br> * Other names: PCI;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety | Major Adverse Cardiac or Cerebrovascular Events (MACCE): Death, all cause Stroke Reinfarction Major vascular complications | 30 days post-procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial infarction, STEMI, ST elevation MI, Acute MI
Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)?

Study Overview
=================
Brief Summary
-----------------
The investigators evaluate if intravenously applied THC (Cannabis) reduces postoperative Nausea and vomiting. THC will be given during anesthesia before emergence. We measure how long and how effective it reduces PONV

Official Title
-----------------
Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)?

Conditions
-----------------
Nausea, Vomiting

Intervention / Treatment
-----------------
* Drug: THC 9-d-tetra hydro cannabinol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III elective open and laparoscopic surgery >1hour Exclusion Criteria: ambulatory surgery pregnancy, breast feeding >ASA III BMI >35 antipsychotic, antiemetic, cytostatic therapy major cardiovascular, renal, hepatic, central nervous system disease current chronic cannabis consumption and hard drug abuse schizophrenia preoperative nausea and vomiting, vestibular disease not speaking german or french refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Receives 0.125mg/kg THC before emergence | Drug: THC 9-d-tetra hydro cannabinol<br>* 0.125mg/kg iv one time<br>|
| Placebo Comparator: 2<br>Receives NaCl before emergence | Drug: THC 9-d-tetra hydro cannabinol<br>* 0.125mg/kg iv one time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of postoperative Nausea and Vomiting |  | 0-24h after Operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological and physiological data after ingestion of THC Analgetics required |  | 0-24h after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesia, THC, Postoperative Nausea
An Epidemiological Survey of Cancer-related Fatigue Among Taiwanese Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the prevalence, severity, impacts and managements of CRF among Taiwanese cancer patients.

Detailed Description
-----------------
The cross-sectional survey is conducted at oncology inpatients unit and outpatients clinics of hospitals in Taiwan. Furthermore, the results will elucidate not only the epidemiology of CRF in Taiwan, but will supply physicians with more understanding about CRF, and help them to enhance the quality on cancer care to being perfected in the future.

Official Title
-----------------
An Epidemiological Survey of Cancer-related Fatigue Among Taiwanese Cancer Patients

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Patients who signed the informed consent form (2) The age of eligible patients should be > 20 years old. (3) Inpatients or outpatients who have been given a diagnosis of cancer (4) Able to communicate verbally and completely fill out the questionnaires Exclusion Criteria: Patients who have been given a diagnosis of cognitive impairment are unable to complete the questionnaires

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-related fatigue evaluation | ICD-10 Fatigue Criteria,Brief Fatigue Inventory-Taiwan Form | 30 minuts | 
| Symptoms and Quality of Life Assessments | FACT-G7 | 15 minutes |