linjc16/ctgov huggingface dataset:
A Multicenter Trial to Investigate Fesoterodine Sustained Release in Overactive Bladder Syndrome

Study Overview
=================
Brief Summary
-----------------
The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2 week Safety Follow-Up period. Subjects were randomized to one of 4 treatment arms receiving either fesoterodine (SPM 907) 4mg, fesoterodine 8mg, active control (tolterodine SR 4mg) or placebo during the Double-Blind Treatment Period. Two primary efficacy variables will be assessed for submission in the United States: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. For the submissions in the European Union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment. The most important safety variables included the assessment of adverse events, laboratory parameters, changes in ECG, physical exams and measurement of residual urine.

Official Title
-----------------
A Phase 3, Parallel Group, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled Multicenter Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome

Conditions
-----------------
Overactive Bladder Syndrome

Intervention / Treatment
-----------------
* Drug: SPM 907


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overactive Bladder Syndrome Exclusion Criteria: less than 8 micturitions in 24 hours

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SPM 907|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to assess the MTD and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers.

Official Title
-----------------
An Open, Dose Escalation, Single Dose Study to Assess Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

Conditions
-----------------
Rheumatic Diseases

Intervention / Treatment
-----------------
* Drug: T0001，10mg
* Drug: T0001，20mg
* Drug: T0001，35mg
* Drug: T0001，50mg
* Drug: T0001，65mg
* Drug: T0001，75mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult volunteers, able to give written informed consent for participation in the trial; Men or women 50% each , aged 18-45 years old; Subjects must have physical examination required and prove medical fitness in 7 days before the clinical starts. BMI should be between 19-24, similar BMI among subjects enrolled at the same time; Exclusion Criteria: Acute or chronic infection, or history of active tuberculosis; History of diseases of central nervous system, cardiovascular system, kidney, liver ( specified liver function index), digestive system, respiratory system , metabolism system; Subjects who use 5 Unit doses tuberculin skin test are positive( 48-72 hour scleroma reading≥5mm); Subjects with a history of mental problems; Pregnant and lactating women or women who plan to be pregnant in 3 months; Occurence of clinical significant abnormal laboratory examination value during the screening; Subjects that lack of understanding ,communication or collaboration, and can't comply with the protocols; Subjects that the researchers considered to be not appropriate to participate the trial due to other reasons;

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

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

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

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: T0001<br> | Drug: T0001，10mg<br> <br> Drug: T0001，20mg<br> <br> Drug: T0001，35mg<br> <br> Drug: T0001，50mg<br> <br> Drug: T0001，65mg<br> <br> Drug: T0001，75mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerance Dose |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 3 weeks | 
| pharmacokinetics parameter(Cmax, AUC, t1/2, CL, etc） |  | Pre-dose，2、4、12、24、36、48、60、72、84、96、120、144、168、216、264、312、384 and 480hours after the start of subcutaneous injection |
Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj

Study Overview
=================
Brief Summary
-----------------
Observational Study to evaluate the safety of FURESTEM-RA lnj. in moderate to severe rheumatoid arthritis patients who participated in phase 1 clinical trial of FURESTEM-RA lnj.

Detailed Description
-----------------
This is a observational study, single center, open label, study of safety of FURESTEM-RA Inj. in subjects with moderate to severe rheumatoid arthritis. Subjects participating in this observational study originally participated in study FURESTEM-RA Inj. [NCT02221258]

Official Title
-----------------
Observational Study to Evaluate the Safety of FURESTEM-RA Inj. in Moderate to Severe Rheumatoid Arthritis Patients Who Participated in Phase 1 Clinical Trial of FURESTEM-RA Inj

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

Intervention / Treatment
-----------------
* Drug: FURESTEM-RA Inj.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258] Subject who understands and voluntarily sign an informed consent form Exclusion Criteria: In case follow-up is not possible from end of clinical trial Phase 1 to end of this study period

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 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 |
| --- | --- |
| Non-Interventional Study<br>Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258] | Drug: FURESTEM-RA Inj.<br>* Non-interventional observational study<br>* Other names: Not applicable-observational study;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of FURESTEM-RA Inj. | Evaluate the number of adverse events Safety of FURESTEM-RA Inj. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FURESTEM-RA
NAT2 in Re-challenge of INH in Patients With Hepatitis

Study Overview
=================
Brief Summary
-----------------
Apply the information of NAT2 genotyping into the re-challenge protocol of INH titration in patients with anti-TB medication induced hepatitis.

Detailed Description
-----------------
adjusting INH dose according to NAT2 genotyping and serum concentration of INH.

Official Title
-----------------
The Application of the N-acetyltransferase 2 (NAT2) Genotyping in Re-challenge Protocol of Isoniazid (INH) Titration in Patients With Anti-TB Medications-induced Hepatitis

Conditions
-----------------
Tuberculosis, Hepatotoxicity

Intervention / Treatment
-----------------
* Drug: Isoniazid (Rifinah)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years-old Taken INH for more than 1 week Abnormal liver function Exclusion criteria: Rule out the INH induced liver abnormality Existing reasons to cause liver abnormality other than TB-medication Taking drugs which interact with INH

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INA dose adjustment, NAT2<br>The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient. | Drug: Isoniazid (Rifinah)<br>* The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.<br>* Other names: Rifinah;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease the events of hepatotoxicity when patients are re-challenged with INH |  | 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| economics evaluation of performing pharmacogenetics screening in practice |  | 6-12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tuberculosis, isoniazid, Arylamine N-acetyl transferase, genotyping, hepatotoxicity, pharmacogenetics
ASSURE Study - Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICD Implantations

Study Overview
=================
Brief Summary
-----------------
The ASSURE Study will evaluate shock conversion performance when programming the first shock of an implantable cardioverter-defibrillation (ICD) is based on an implant test consisting of either 1) a single induction of ventricular fibrillation (VF) and subsequent demonstration conversion success at 14 J or 2) an upper limit of vulnerability (ULV) test at 14 J.

Official Title
-----------------
Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICDs Study

Conditions
-----------------
Tachyarrhythmia

Intervention / Treatment
-----------------
* Device: ICD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who meet current indications for an ICD including cardiac resynchronization therapy (CRT) devices Patients who sign and date a Patient Informed Consent form prior to the implant visit Patients who remain in the clinical care of the enrolling physician in approved centers Patients who receive only left-sided pectoral implantations with the ICD lead placed in the right ventricular apex Patients who have a minimum R wave of at least 7 mV; or for ICD replacement, patients who have a minimum chronic R wave of at least 5 mV Exclusion Criteria: Patients who are involved in Non-Invasive Programming Stimulation (NIPS) studies Patients who undergo lead repositioning Patients who are expected to receive a heart transplant during the duration of the study Patients who have or who are likely to receive a tricuspid valve prosthesis Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study Patients who are younger than 18 years of age Patients who are pregnant or plan to become pregnant during the study Patients whose life expectancy is less than 12 months Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ICD|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Urinary NGAL Acute Kidney Injury After Stored Red Blood Cells Transfusion in Critically Ill Patients.

Study Overview
=================
Brief Summary
-----------------
The study aims to explore the association of the novel urinary bio marker NGAL with the age of PRBCs(packed red blood cells) transfusion in critically ill patients.

Detailed Description
-----------------
The investigators will measure the urinary NGAL in all patients who received blood transfusion in the intensive care unit during the study period. The age of PRBCs transfusion will be correlated with the incidence of AKI. The rise of NGAL and serum creatinine will be used to diagnose AKI (Acute Kidney Injury).

Official Title
-----------------
The Association of NGAL With the Development of Acute Kidney Injury After Stored Red Blood Cells Transfusion in Critically Ill Patients.

Conditions
-----------------
Anemia, Acute Kidney Injury

Intervention / Treatment
-----------------
* Diagnostic Test: urinary NGAL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patients admitted to the intensive care unit. Exclusion Criteria: patients who have established AKI at the time of recruitment

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 |
| --- | --- |
| Stored blood transfusion<br>measurement of urinary NGAL | Diagnostic Test: urinary NGAL<br>* measurement urinary NGAL using the ARCHITECT technique<br>|
| Fresh blood transfusion<br>measurement of urinary NGAL | Diagnostic Test: urinary NGAL<br>* measurement urinary NGAL using the ARCHITECT technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AKI | Diagnosis of AKI by rise of serum creatinine | within 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarkers
Effects of Forskolin on Intraocular Pressure in Glaucomatous Patients Under Maximum Tolerated Medical Therapy

Study Overview
=================
Brief Summary
-----------------
Elevated intraocular pressure is still the main risk factor for development and progression of glaucoma. Several drugs exist on the market that may decrease IOP in glaucomatous patients. However, some patients cannot reach the target pressure despite a multitherapy with a combination of drugs, and are therefore addressed to surgical treatments. Forskolin is a natural compound that is a receptor-independent adenyl-cyclase activator, that increases intracellular cAMP. It has been shown to be able to decrease IOP after topical application, by a mechanism that is not used by the other drugs. Aim of the present study is to see whether a food supplement containing forskolin (KRONEK) has any effect on the IOP of POAG patients that cannot reach their target pressure, and are therefore on the waiting list for surgical intervention.

Official Title
-----------------
Effects of the Oral Administration of an Association of Forskolin With Rutin and Vitamins B on Intraocular Pressure (IOP) in Patients Affected by Primary Open Angle Glaucoma (POAG) Under Maximun Tolerated Medical Therapy (MTMT)

Conditions
-----------------
Primary Open Angle Glaucoma, Intraocular Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 30-70 Years Sex: both Pathology: POAG Characteristics: Target pressure not achieved with current treatments Exclusion Criteria: Concomitant ocular pathologies Previous ocular surgery Known hypersensitivity to any of the components in the KRONEK tablets Concomitant participation in other trials

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Intraocular pressure |  | Enrollment, 1, 2, 3, 4 weeks after initiation of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure fluctuations during the day |  | Enrollment, 1, 2, 3, 4 weeks after initiation of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
POAG, IOP, Forskolin, Food supplement
HRQoL Among Patients Amputated Due to Peripheral Arterial Disease

Study Overview
=================
Brief Summary
-----------------
A prospective cohort study over the prosthetic use among patients amputated after vascular disease and the impact of their HRQoL.

Official Title
-----------------
Health-related Quality of Life Among Patients Amputated Due to Peripheral Arterial Disease

Conditions
-----------------
Quality of Life, Amputation, Peripheral Arterial Disease, Prosthesis User

Intervention / Treatment
-----------------
* Procedure: Amputation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients amputated at femoral, knee or tibial level due to peripheral arterial disease Exclusion Criteria: Patients not able to provide informed consent Patients not able to verbally express their experience of the amputation. Patients that not speak Swedish

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 |
| --- |
|Procedure: Amputation|Major amputation defined as at or above ankle|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health related quality of life according to EQ-5D | The change in HRQoL between baseline and after 1 year. Measured with EQ-5D-3L | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients using prosthesis | Prosthesis use after a major amputation is measured with Stanmore mobility grade | 1 year after the amputation |
Combination of Rectal Indomethacin and Pancreatic Duct Stenting Versus Indomethacin Alone in Preventing PEP

Study Overview
=================
Brief Summary
-----------------
Rectal indomethacin and pancreatic duct (PD) stenting (PDS) are recommended for the prevention of post-ERCP pancreatitis (PEP). However, the effects of the combination of the two methods on preventing PEP are controversial. We hypothesized that some group of patients with difficult cannulation might benefit from the combination of indomethacin plus PDS (IP) compared with indomethacin alone (IN).

Official Title
-----------------
Combination of Rectal Indomethacin and Pancreatic Duct Stenting Versus Indomethacin Alone in Preventing Post-ERCP Pancreatitis in Patients With Difficult Cannulation

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

Intervention / Treatment
-----------------
* Device: Pancreatic duct stenting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients underwent diagnostic or therapeutic ERCP With native papilla With difficult cannulation (cannulation time >10min or cannulation attempts >5 times or inadvertently PD cannulation ≥1) Receiving post-ERCP rectal indomethacin Exclusion Criteria: Patients with indications of PD cannulation No attempt of cannulation due to inaccessible papilla Non-difficult cannulation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| IP group<br>All patients recevied pancreatic duct stent during ERCP and one single dose of 100mg rectal indomethacin after ERCP. | Device: Pancreatic duct stenting<br>* A stent placed in the pancreatic duct to reduce PEP possibly by relieving pancreatic ductal hypertension that develops because of transient procedure-induced edema and stenosis of the pancreatic orifice<br>|
| IN group<br>All patients received one single dose of 100mg rectal indomethacin after ERCP. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall PEP | PEP was diagnosed if there was a worsening or new onset of pain in the upper abdomen, an elevation in serum amylase of at least three times of the upper limit of the normal range 24h after the procedure and requiring at least two nights of hospitalization. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall ERCP related complication |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Indomethacin, Double-guidewire technique, Adverse events, PEP, PD stenting