linjc16/ctgov huggingface dataset:
Stivarga Regulatory Post-Marketing Surveillance Study in Korea

Study Overview
=================
Brief Summary
-----------------
To investigate and collect post-marketing data on the safety of Stivarga in real world practice in its registered indication(s) as required by Health Authority.

Official Title
-----------------
Stivarga® Regulatory Post-Marketing Surveillance Study in Korea

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Drug: Regorafenib (Stivarga,BAY73-4506)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated informed consent Patients diagnosed with histologically confirmed metastatic colorectal cancer and/or metastatic or unresectable locally advanced gastrointestinal stromal tumors and/or HCC who have been previously treated with sorafenib by physician Patients who are prescribed with Stivarga tablet 40mg(Regorafenib) for the first time Exclusion Criteria: Patients participating in an investigational program with interventions outside of routine clinical practice All contra-indications according to the local marketing authorization have to be considered.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients treated by Physician with Stivarga under approved local prescriptions | Drug: Regorafenib (Stivarga,BAY73-4506)<br>* Patients treated by Physician with Stivarga under approved local prescriptions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with serious adverse events | Every 2 months (monthly safety assessment within first two cycles) | Up to 30 days after terminating treatment | 
| Percentage of patients with adverse drug reactions (ADRs) | Every 2 months (monthly safety assessment within first two cycles) | Up to 30 days after terminating treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response |  | Up to 6 years | 
| Progression free survival (PFS) |  | Up to 6 years | 
| Overall survival (OS) |  | Up to 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stivarga / Regorafenib / Metastatic Colorectal Cancer / Metastatic or unresectable locally advanced GIST (Gastrointestinal stromal tumors)
Neurological Impact of Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN Pilot Study

Study Overview
=================
Brief Summary
-----------------
Two hundred million adults worldwide have major surgery every year. A million of these patients will have an obvious stroke after their surgery. Another 10 million patients may have silent strokes. Although silent strokes are not diagnosed immediately, they are likely to reduce patients' short-term memory, concentration, and ability to function at home. However, the investigators do not know how common silent strokes are after noncardiac surgery, nor the extent to which they affect brain function. The investigators will first perform a pilot trial to determine the feasibility of the larger study that will provide the definitive answer to this question. Participating patients will be assessed by questionnaire before and after surgery, and will have a magnetic resonance imaging (MRI) study of the brain after the surgery to look for silent strokes. Combining the results of the MRI and the questionnaires will allow us to determine the frequency of silent strokes after non-cardiac surgery, and their effect on brain function. The NeuroVISION Pilot Study will determine the feasibility of a large study to examine the frequency and the impact of silent stroke in patients who undergo noncardiac surgery.

Official Title
-----------------
Neurological Impact of Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN Pilot Study

Conditions
-----------------
Perioperative Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 65, undergoing noncardiac surgery, regional or general anesthetic. Exclusion Criteria: -Patients who have a contraindication to MRI.

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| adults > 65 yrs undergoing noncardiac surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recruitment |  | 2 years |
The Effect of Osteopatic Cranial Techniques on the Audiometric and Tympanometric Values in Children Suffering From Otitis Media With Effusion.

Study Overview
=================
Brief Summary
-----------------
Children with otitis media with effusion will be treated with osteopatic cranial techniques or with a placebo treatment. Before and after the treatment audiometric and tympanometric measures will take place. This procedure will be repeated 3 times, once a week and every session will last for 30-45 minutes. The fourth week, only audiometry and tympanomtry will be done.

Official Title
-----------------
The Effect of Osteopatic Cranial Techniques on the Audiometric and Tympanometric Values in Children Suffering From Otitis Media With Effusion.

Conditions
-----------------
Otitis Media With Effusion

Intervention / Treatment
-----------------
* Procedure: treated with osteopatic cranial techniques
* Procedure: Treatment with placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children between 3 and 7 years old Bilateral otitis media with effusion Tympanogram type B Exclusion Criteria: ventilation tubes Damage of the tympanic membrane Operation of the tympanic membrane Other illness e.g. Down, craniofacial abnormalities,…

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Treatement with osteopatic cranial techniques | Procedure: treated with osteopatic cranial techniques<br>* treated with osteopatic cranial techniques<br>|
| Placebo Comparator: 2<br>Treatment with placebo | Procedure: Treatment with placebo<br>* Treatment with placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Audiometric and tympanometric results |  | directly after every session of treatment (3 times, once a week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Audiometric and tympanometric results |  | one week after the last treatment session. |
Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease

Study Overview
=================
Brief Summary
-----------------
This Phase 1/Phase 2 study will evaluate GMI-1070, a pan-selectin inhibitor, in adults with stable sickle cell disease. The study will assess safety, pharmacokinetics, and microvascular effects of intravenous GMI-1070 in the outpatient setting.

Official Title
-----------------
Phase 1/Phase 2 Study of the Safety, Pharmacokinetics, and Microvascular Effect of Titrating Doses of Intravenous GMI-1070, a Pan-Selectin Inhibitor, in Adults With Sickle Cell Disease

Conditions
-----------------
Sickle Cell Disease

Intervention / Treatment
-----------------
* Drug: GMI-1070


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 45 years Established diagnosis of SCD-SS or SCD-SB0-thal At medical baseline, with no evidence of worsening of disease over the last 3 months Available and agree to return for follow-up visits for the full duration of the study Able to cooperate with study procedures Documented and observed written informed consent Exclusion Criteria: Vaso-occlusive crisis Recent major surgery, hospitalization, infection, significant bleeding, cerebrovascular accident or seizure, or transfusion Currently receiving, or has received within the previous 4 weeks, any other investigational agent Pregnant or lactating female; or female of childbearing age unable or unwilling to comply with birth control or abstinence during the course of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GMI-1070<br> | Drug: GMI-1070<br>* Intravenous GMI-1070 given as two doses over the course of one day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as Measured by the Number of Participants With Adverse Events |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Plasma Clearance |  | 48 hours | 
| Volume of the Central Compartment |  | 48 hours | 
| Intercompartmental Clearance |  | 48 hours | 
| Volume of the Peripheral Compartment |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sickle Cell Disease
the Incidence and the Association Between Motor Subtypes and Outcome of Delirium in Ischemic Stroke Patients

Study Overview
=================
Brief Summary
-----------------
this study examines the incidence of newly developed delirium in patients who admit to university hospital stroke unit for cerebral infarction, and analyze the association between delirium motor subtypes and short-term outcome in post-stroke delirium patients.

Official Title
-----------------
the Prospective Study on the Incidence and the Association Between Motor Subtypes and Outcome of Delirium in Ischemic Stroke Patients

Conditions
-----------------
Delirium, Cerebral Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All cerebral infarction patients who admit to stroke unit Chungnam National University Hospital. Exclusion Criteria: Any patients who refuse to enroll the study. Any patients who admit to Intensive Care Unit(ICU), because ICU is well-known for precipitating delirium.
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 |
| --- | --- | --- |
| mean K-DRS-R98 score | mean score of delirium severity rating scale during follow up period. Detailed information about scale: Korean Version of the Delirium Rating Scale-Revised-98(K-DRS-R98) DRS-R98 proved to be a valid and reliable instrument for the assessment of delirium severity and distinguish patients with delirium from non-delirious patients including dementia. The scale is composed of two sections. The first section is the severity scale, which consists of 13 items that are scored from 0 to 3 according to a Likert scale that is anchored by descriptions of phe-nomenology. The second section consists of three diagnostic items that are scored from 0 to 2 or 3. These items include temporal onset of symptoms, fluctuation of symptom severity and physical disorder. The total scale is comprised of 16 items. The total score is the sum of the scores for each item and the higher the score, the greater the severity. | 3 weeks |
Effects of Dexmedetomidine on Delirium After Living Donor Renal Transplantation in Adult Patients

Study Overview
=================
Brief Summary
-----------------
Delirium, an acute change in mental status, is a serious medical complication among hospitalized patients. Syndrome of delirium involves agitation, sleep disturbance, affective disorders and cognitive disruptions. One vulnerable period for developing delirium is in the postoperative days. Postoperative delirium often initiates a cascade of adverse consequences including an increase in length of stay and hospital costs, and greater mortality. The investigators have observed that the incidence of postoperative delirium in patients after renal transplantation is about 20-30% in our hospital. Several studies have revealed that dexmedetomidine, as a widely used sedative during anesthesia, can decrease the incidence of postoperative delirium after cardiac surgery. The investigators aim to examine whether administration of dexmedetomidine can reduce postoperative delirium after living donor renal transplantation in adult patients.

Conditions
-----------------
Postoperative Delirium After Living Donor Renal Transplantation

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 17 and < 60 years; American Society of Anesthesiology (ASA) I-III; admitted for living donor renal transplantation. Exclusion Criteria: Patients with a history of drug abuse; preoperative history of schizophrenia, epilepsy, parkinsonism, use of cholinesterase inhibitor, inability to communicate in the preoperative period (coma, profound dementia, or language barrier).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Dexmedetomidine ivpump 0.2ug/kg/h during living donor renal transplantation. | Drug: Dexmedetomidine<br> <br> |
| Placebo Comparator: Saline<br>Saline ivpump 0.2ug/kg/h during living donor renal transplantation. | Drug: Saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Delirium |  | Postoperative day 1-7. |
Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy

Study Overview
=================
Brief Summary
-----------------
Prospective, longitudinal multi-center study performed in 15 participating substitution centers in Germany. Aims: - Primary objective: To compare the impact of the different substitution drugs (methadone, buprenorphine, and suboxone) on the neurocognitive, emotional, and quality-of-life-related tolerability in opioid dependent patients under HCV treatment. - Secondary objective: To investigate if IFN therapy impairs efficacy (with respect to e.g. retention rates, concomitant drug use and in particular neurocognitive function) and tolerability of agonist maintenance treatment with methadone, buprenorphine, or suboxone

Official Title
-----------------
Evaluation of Neurocognitive Performance, Quality of Life, and Emotional State in Drug Substituted Patients (Methadone, Buprenorphine, Suboxone) Under Hepatitis C Therapy (Peginterferon Alfa and Ribavirin)

Conditions
-----------------
Chronic Hepatitis C Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Opioid-dependent patients on current stable agonist maintenance therapy (for at least 6 months prior to study enrolment) with methadone, buprenorphine, or suboxone. Patients need to be infected with chronic hepatitis C and must have indication for therapy with peginterferon alfa and ribavirin. Patients with informed written consent with respect to a follow-up of psychiatric side effects and in particular neurocognitive performance. Patients with baseline monitoring of emotional state and neurocognitive performance. Exclusion Criteria: According to SPC According to legal requirements reg. drug substitution therapy (BTMVV) Insufficient knowledge of the German language or cognitive impairment (due to the indispensable application of questionnaires and the TAP, Test Battery of Attentional Performance). Age under 18 years or over 65 years coinfections such as hepatitis B virus or human immunodeficiency virus

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time course of neurocognitive performance (as assessed by the TAP - Test Battery for Attentional Performance) |  | Repeated measures design with the following evaluation timepoints: baseline, twice to four times during antiviral treatment, twice after antiviral treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis C, drug substitution, neurocognitive, patients with stable drug substitution therapy, patients with interferon-based antiviral therapy
Phase 3 Study of Acupression's Bracelets in Nausea and Vomiting Induced by FEC100 Chemotherapy's Sort.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate a betterment of the digestive symptomatology by the anti-emetic acupression's bracelets's use associated with hygiene and dietetic advices.

Official Title
-----------------
Evaluation of Acupression's Bracelets Associated to an Educational Step Versus Education Only in Nausea and Vomiting's Mastering Induced by FEC100 Chemotherapy's Sort.

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Device: Acupression's bracelet
* Behavioral: Hygiene and dietetic advices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman Age > 18 years Well-informed written consent, signed by the patient before the beginning of the study Breast cancer's diagnosis (operated or not) Forecast of a treatment by FEC100 chemotherapy's sort (D1=D21) during at least 3 cycles. Patient affiliated at a welfare or beneficiary from it Investigator estimates that the patient is able to conform with protocol's conditions and to respect them Exclusion Criteria: Operated arm's lymphedema Wrist's morphology which cannot permit the bracelet's wearing (20 cm) D1=D15 FEC100's treatment Psychic incapability to sign a well-informed consent Refusal to give a written consent Patient under tutelage or guardianship Pregnant or breast-feeding woman Any clinical trial's participation which would impose nausea and vomiting's treatment modalities

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

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

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

| Intervention/Treatment |
| --- |
|Device: Acupression's bracelet|nan|
|Behavioral: Hygiene and dietetic advices|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of 15% of stage III/IV nausea and vomiting's incidence. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Neoplasm, FEC100, Chemotherapy, acupression, bracelet, nausea, vomiting
Drug-coating Balloon Treatment in Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
Drug-coated balloon (DCB) is an alternative choice for patients with coronary artery disease (CAD). This study is to investigate the efficacy and safety of DCB treatment in patients with CAD.

Detailed Description
-----------------
This is a prospective, multi-center, registry to enroll patients undergoing DCB treatment. All subjects undergoing DCB treatment will be enrolled in this study without strict inclusion and exclusion criteria. Data and images will be collected during the index procedure, and at the clinical and angiographic follow-up.

Official Title
-----------------
Drug-coating Balloon Treatment in Coronary Artery Disease: a Prospective, Multicenter, Registry Study (ULTIMATE-DCB)

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

Intervention / Treatment
-----------------
* Device: DCB treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suitable for DCB treatment Exclusion Criteria: Pregnancy Contraindications to contrast media, antiplatelet therapy, or paclitaxel Expected life less than 12 months Cardiac shock

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 |
| --- | --- |
| DCB treatment<br>DCB (Sequent® Please) treatment will be performed for suitable patients with CAD. | Device: DCB treatment<br>* DCB (Sequent® Please) treatment for CAD patients will be enrolled. Intravascular ultrasound (Boston Scientific®) guidance is recommended.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target vessel failure (TVF) at 12 months | TVF is defined as the composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target- vessel revascularization. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parameter by quantitative coronary angiography at 7 months | Late lumen loss | 7 months | 
| Bleeding at 12 months | bleeding | 12 months | 
| Bailout drug-eluting stents (DES) implantation rate | Bailout DES implantation rate during procedure by angiographic criteria | During procedure |