linjc16/ctgov huggingface dataset:
Post-Authorization Long-term Safety Surveillance on Antihypertensive Treatment With Kanarb® (Fimasartan)

Study Overview
=================
Brief Summary
-----------------
Evaluated the incidence and characteristics of adverse events during the treatment for Kanarb tablet.

Detailed Description
-----------------
This study is designed to evaluate the incidence and characteristics (profile, relationship to the study drug, severity, and outcome) of adverse events (AEs) observed during 1-year treatment with Kanarb tablet® (fimasartan)

Official Title
-----------------
A Prospective, Observational, Post-Authorization Long-term Safety Surveillance on Antihypertensive Treatment With Kanarb® (Fimasartan) During 1 Year Among 20 and Older Diagnosed With Essential Hypertension

Conditions
-----------------
Essential Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with essential hypertension Taking Kanarb tablet® (fimasartan) as prescribed previously (within 1 month) or newly Male and female adults aged 20 years or older Voluntarily provided a written consent to participate in the study Exclusion Criteria: Patients with hypersensitivity to this drug or the ingredients of this drug Pregnant or breast-feeding women Patients on renal dialysis Patients with moderate to severe hepatic impairment Patients with biliary atresia Genetic disorders such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption Patients considered inappropriate for taking Kanarb tablet® (fimasartan) by investigator Clinically significant abnormal liver function (AST, ALT ≥2 x upper limit of normal (ULN); TB ≥1.5 ULN)

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 |
| --- | --- | --- |
| Number of Participants Experiencing AEs or ADRs | Number of participants experiencing AEs (or ADRs) during the study | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Persistence Rate of Fimasartan | Treatment persistence rate of Kanarb tablet® (fimasartan) until the end of 1-year study | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Fimasartan
Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke

Study Overview
=================
Brief Summary
-----------------
This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.

Official Title
-----------------
SAINT (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke

Conditions
-----------------
Cerebral Stroke, Stroke, Acute, Cerebrovascular Stroke, Ischemic Attack, Transient

Intervention / Treatment
-----------------
* Drug: NXY-059


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females Acute ischemic stroke with limb weakness Onset of symptoms within 6 hours Full functional independence prior to the present stroke Exclusion Criteria: Unconsciousness Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition. Severe illness with life expectancy less than 6 months. Known severe kidney disorder. Current known alcohol or illicit drug abuse or dependence. Pregnant or breast-feeding. Treatment with acetazolamide and methotrexate is not permitted during the infusion Participation in a previous clinical study within 30 days. Meets all other exclusion criteria.

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: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NXY-059|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global disability on modified Rankin scale at 90 days. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH stroke scale |  |  | 
| Barthel Index |  |  | 
| Stroke Impact Scale |  |  | 
| EQ-5D all at 90 days |  |  | 
| Safety outcomes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, cerebral vascular accident, CVA, Ischemia, Hemorrhage, TIA, Transient Ischemic Attack, Brain Attack, Cataplexy
Study of RNS60 on Pain and Function After Hip Labral Repair

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if use of RNS60 during hip labral repair surgery decreases pain and improves functional capacity post-operation.

Official Title
-----------------
Study of RNS60 on Post-operative Pain and Function in Patients Undergoing Hip Labral Repair or Reconstruction Surgery

Conditions
-----------------
Hip Labral Tear

Intervention / Treatment
-----------------
* Drug: RNS60
* Drug: Saline


Participation Criteria
=================

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: RNS60<br> | Drug: RNS60<br> <br> |
| Placebo Comparator: Saline<br> | Drug: Saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of post-operative pain | Comparison of scores from validated pain scales from post-surgery to one week. | 1 week |
International Validation of a Delirium Prediction Model for ICU Patients

Study Overview
=================
Brief Summary
-----------------
Recently our ICU research group developed and validated a delirium prediction model in the NetherlandsThis. This model has a high predictive value. We want to examine what the predictive value is in ICUs of other European countries.

Detailed Description
-----------------
Delirium is a serious and common disorder in ICU patients. It is increasingly recognized that screening of ICU patients is a valuable tool for early detection and treatment of delirium, which may reduce its incidence, severity and duration. Apart from treatment of delirium, delirium prevention (pharmacological and nursing interventions)is an important issue. However, it is time consuming to take preventive measures in all ICU patients. The recently developed prediction model facilitates the conduct of preventive measures focused on high risk groups. This prediction model is developed and validated in the Netherlands. The aim of our study is to investigate the predictive value of the model in ICUs in other countries.

Official Title
-----------------
International Validation of a Delirium Prediction Model for ICU Patients (PRE-DELIRIC) in ICUs; a Multicentre Trial.

Conditions
-----------------
Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients 18 years or older Exclusion Criteria: delirious state within the first 24hours after ICU admission sustained comatose during complete ICU stay admission duration less than twelve hours; serious auditory or visual disorders unable to understand the language of the included centre severely mentally disabled serious receptive aphasia or if there are missing or incomplete delirium screenings during admission to the ICU

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 |
| --- | --- |
| delirious patients<br>The cohort is divided in delirious and non-delirious patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delirium | Delirium is defined as at minimum one positive CAM-ICU screening during the complete ICU stay | during admission at the critical care |
Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of ixabepilone in Japanese patients with solid tumors.

Official Title
-----------------
Phase I Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: Ixabepilone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 years or older Histologically or cytologically confirmed diagnosis of adenocarcinoma Solid tumors Exclusion Criteria: Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: Ixabepilone<br> | Drug: Ixabepilone<br>* Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, At least 1 cycle, (21 days)<br>* Other names: BMS-247550;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the maximum tolerated dose (MTD), and a recommended Phase II dose of Ixabepilone when administered every three weeks by assessing status of treatment, dose intensity, and dose-limiting toxicities (DLT) |  | 3-week treatment cycles until unacceptable toxicity | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety by assessing adverse events. Toxicity will be evaluated according to the Common Toxicity Criteria Version 3.0 (CTC). Response will be evaluated according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria |  | 3-week treatment cycles | 
| To evaluate the plasma pharmacokinetics of Ixabepilone according to the following parameters: Cmax, AUC(INF), Tmax, t1/2, MRT(INF), Vss, Cltot |  | Cycle 1 (first 3 weeks of study therapy) | 
| To describe any preliminary evidence of anti-tumor activity (response), assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) |  | 3-week treatment cycles until unacceptable toxicity |
Clove In The Treatment Of Relapsed Or Resistant Acute Leukemia In Children

Study Overview
=================
Brief Summary
-----------------
Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is able to induce remission in resistant/refractory acute leukemias in pediatric. Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) entered the study and received the association of clofarabine (40 mg/m2/day) in combination with etoposide (100 mg/m2/day) and Cyclophosphamide (440 mg/m2/day) in 1 or 2 induction cycles End point were complete remission (CR)or CR without platelet recovery (CRp) and toxicity

Official Title
-----------------
Clofarabine, Cyclophosfamide, And Etoposide For The Treatment Of Relapsed Or Resistant Acute Leukemia In Pediatric Patients

Conditions
-----------------
Acute Leukemia

Intervention / Treatment
-----------------
* Drug: Clofarabine VP 16 ciclophospahamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of > 25% of blast in bone marrow treatment with second line therapies patients with resistant disease i.e. with >25% of blasts 21 days after the last cytostatic agent administration children with persistent high MRD level (> 10-3) after first or further line chemotherapy, were considered eligible to the treatment Relapsed after > months after SCT Karnofsky score >50 a Forced Espiratory Volume >30% sufficient hepatic and renal function defined as creatinine levels <2 × ULN, bilirubin <1.5 × ULN aspartate and alanine aminotransferases <10 × ULN. Exclusion Criteria: isolated extra-medullary relapse, and active infections

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 20 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: children with advanced leukemia<br> | Drug: Clofarabine VP 16 ciclophospahamide<br>* Clofarabine intravenously 2-hour infusion,dose 40 mg/m2, followed by Etoposide (VP 16)100 mg/m2 i.v. over 2 hours and Cyclophosphamide 440 mg/m2 i.v. over 1 hour<br>* Other names: Endoxan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response to treatment |  | after an expected average of 3 weeks after the first dose of each chemotherapy course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with toxicity as a measure of safety and tolerability | Grade of toxicity defined according to the National Cancer's Inst. Common terminology Criteria (NCI CTCAE v3.0) | at an expected average of 4 weeks after the first dose of each chemotherapy course |
Knee-Hip-Spine Harmony: The Relationship Between Sagittal Spinal Alignment in Total Hip/Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Concomitant osteoarthritis of hip/knee joint and lumbar spinal degeneration is commonly seen in elderly population. These degeneration changes of spine would change sagittal or coronal alignment and spinal flexibility in varies degrees. Total hip and knee arthroplasty (THA/TKA) are among the most successful orthopedic operations performed, aiming at the alleviation of osteoarthritic pain. Normal alignment of the spine and pelvis in the sagittal plane is critical to maintain an upright standing position with minimal energy consumption. However, there is a scarcity of studies on how THA or TKA influences the parameters of the spine and the pelvis. Compared with the balance of coronal plane, more attention is paid to the balance of sagittal plane. The objectives of this study are to investigate changes in the truncal parameters after THA or TKA and assess whether these parameters are improved or deteriorated after these operations.

Official Title
-----------------
Knee-Hip-Spine Harmony: The Relationship Between Sagittal Spinal Alignment in Total Hip/Knee Arthroplasty

Conditions
-----------------
Cases Who Received TKA/THA

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary degenerative arthritis of the knee or hip Those who have undergone artificial knee or hip replacement surgery Follow up surgery for at least 1 year Track the whole trunk lower limb sagittal plane coronal aligament before and after surgery Exclusion Criteria: Previous hip surgery Previous spine surgery Contracture after hip fusion surgery Scoliosis over 10 degrees combined with neuropathy Patients with flexion contracture after knee joint surgery Rheumatoid arthritis lesions
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 |
| --- | --- | --- |
| The Forgotten Joint Score-12 (FJS-12) | The Forgotten Joint Score-12 (FJS-12) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total hip arthroplasty (THA). The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities (Rosinsky et al., 2019). | Post-operative at 24th month | 
| EQ-5D | EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. | Post-operative at 24th month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total hip/knee arthroplasty
A National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy

Study Overview
=================
Brief Summary
-----------------
This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in hypertensive patients uncontrolled by monotherapy.

Official Title
-----------------
An 8 Weeks Open Label National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy

Conditions
-----------------
Primary Hypertension

Intervention / Treatment
-----------------
* Drug: valsartan/amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient uncontrolled by mono-therapy for at least 8 weeks, having B.P.>/= 140/90 mmHg in non diabetics or >/= 130/80 mmHg in diabetics Exclusion Criteria: Patient having B.P.>= 180/110 mmHg in non diabetics or >= 160/100 mmHg in diabetics Type 1 Diabetes or uncontrolled type 2 Diabetes. PCI in last 12 months. Concomitant unstable angina. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>valsartan/amlodipine | Drug: valsartan/amlodipine<br>* 160/10 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypertension in patients that will be controlled on each concentration and those that will switch to the higher concentration (160/10) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypertension of patients that were previously controlled on (160/5) and those that were uncontrolled and switched to the higher concentration (160/10) after 4 weeks on (160/5) concentration. |  | 8 weeks | 
| Safety and Tolerability of the Trial Medication |  | 8 weeks | 
| The incidence of Edema |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Valsartan/Amlodipine,
Actigraphy Sleep Parameters in Obstructive Sleep Apnea Patient's

Study Overview
=================
Brief Summary
-----------------
Those patient's that come to the sleep unit and that accept to participate in the study will undergo a polysomnography with the extra of an actigraphy placed in their no dominant arm wrist. The outcomes that will be analyzed are: Time in bed, assumed sleep time, wake time, sleep efficiency, sleep latency, light's on/light's off

Official Title
-----------------
Comparison of Actigraphy Sleep Parameters vs Polysomnography Sleep Parameters in OSA Patient's

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Polysomnography
* Device: Actigraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient's with OSA suspicion undergoing a PSG in the sleep unit Exclusion Criteria: Neurologic disorders Severe comorbidities Other sleep disorders, such as insomnia No informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Polysomnography and actigraphy<br>Polysomnography and actigraphy | Device: Polysomnography<br>* Patient's undergo a polysomnography<br>Device: Actigraphy<br>* Patient's wear an actigraphy while doing the polysomnography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep time (min) | To compare the outcomes acquired with the actigraphy with those acquired by the Polysomnography | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep efficiency | To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy. | 3 months | 
| Wake time | To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy. | 3 months | 
| sleep latency | To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Actigraphy, Polysomnography, Obstructive Sleep Apnea