linjc16/ctgov huggingface dataset:
Neuro-urological Outcome After Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
Most patients with spinal cord injury suffer from bladder dysfunction which may - especially in the long-term - impair renal function. Improved treatment during the last decades improved life expectancy and quality of life. This study evaluates the bladder function in the long-term after spinal cord injury.

Detailed Description
-----------------
Bladder dysfunction is a common consequence of spinal cord injury and depends on the completeness and the level of the lesion. Patients with suprasacral injury usually suffer from neurogenic detrusor overactivity mostly combined with detrusor sphincter dyssynergia. Without adequate treatment, this adverse combination puts the upper urinary tract at risk due to high intravesical pressure often causing vesico-ureteral reflux. Based on improved therapeutic options in the last decades, life expectancy and quality of life constantly increased in spinal cord injury patients. The investigators aim to evaluate the bladder function in the long-term after spinal cord injury.

Conditions
-----------------
Urinary Bladder Neurogenic Dysfunction

Intervention / Treatment
-----------------
* Other: Video-urodynamic examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spinal cord injury for at least 5 years Neurogenic lower urinary tract dysfunction Written informed consent Exclusion Criteria: Lower urinary tract dysfunction due to other causes than spinal cord injury

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 |
| --- | --- |
| patients with SCI for at least 5 years<br>Ages Eligibility: minimum 18 years Genders Eligibility: female and male | Other: Video-urodynamic examination<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urodynamic evaluation | Max. cystometric capacity, compliance, detrusor leak point pressure | 5 years after SCI, yearly thereafter (participants are followed until death) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary complications | recurrent tract infection, deterioration of the upper urinary tract | 5 years after SCI, yearly thereafter (participants are followed until death) | 
| imaging of the upper urinary tract | videocystography, ultrasound | 5 years after SCI, yearly thereafter (participants are followed until death) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neurogenic detrusor overactivity, detrusor sphincter dyssynergia, compliance, video urodynamic, spinal cord injury
Effects of Shoulder Edema on Intubated Tube in Patients Undergoing Shoulder Arthroscopy

Study Overview
=================
Brief Summary
-----------------
Intubation is needed in general anesthesia and appropriate cuff pressure is important to avoid trauma or postoperative sore throat and aspiration. Shoulder arthroscope uses some amount of irrigation fluid and it can influence to cuff pressure. Therefore, we will measure cuff pressure during shoulder arthroscope.

Conditions
-----------------
Arthroscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) 1,2 Age 20-65 Exclusion Criteria: emergency operation anticipated difficult intubation chronic obstructive lung disease recent upper respiratory infection

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum 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 |
| --- | --- |
| shoulder arthroscopy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Direct intracuff pressure measurement technique using manometer |  | every one hour during operarion |
Natural Cycle, Minimal Stimulation and Conventional IVF: a Registry-based Study

Study Overview
=================
Brief Summary
-----------------
International prospective registry-based study of different types of In Vitro Fertilisation (IVF) and their outcome.

Detailed Description
-----------------
One year of prospective collection of descriptive In-Vitro-Fertilisation data. The data will be collected in 13 In-Vitro-Fertilisation-centres

Official Title
-----------------
Natural Cycle, Minimal Stimulation and Conventional IVF: a Registry-based Comparison of the IVF Treatments, Their Efficacy and Pregnancy Outcomes

Conditions
-----------------
IVF

Intervention / Treatment
-----------------
* Procedure: In Vitro Fertilisation (IVF)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: In Vitro Fertilisation and signed informed consent Exclusion criteria: Medical freezing Social freezing thawed cycles
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| In Vitro Fertilisation (IVF)-Patients<br>Patients aim to do In-Vitro-Fertilisation (IVF) | Procedure: In Vitro Fertilisation (IVF)<br>* Natural Cycle In Vitro Fertilisation (IVF): without hormonal stimulation Conventional In Vitro Fertilisation (IVF): conventional hormonal stimulation Minimal Stimulation In Vitro Fertilisation (IVF): low dose of hormonal stimulation will be applied<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | pregnancy rate per transferred embryo | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes | Number of retrieved oocytes per protocol | 1 Year | 
| Clinical pregnancy rate | Pregnancy rate per transfer | 1 year | 
| Pregnancy outcome | Pregnancy complications including preeclampsia | 1 year | 
| In Vitro Fertilisation complications rates | miscarriage | 1 year |
Safety Assessment of Weekly Intravenous Infusions of SNS-595 for the Treatment of Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether SNS-595 given intravenously weekly for 3 weeks is safe.

Detailed Description
-----------------
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood) and determining the dose and dose schedule for the next phase of studies with SNS-595.

Official Title
-----------------
Phase I Open-Label, Multicenter, Dose-Escalation Clinical Study of the Safety and Pharmacokinetic Profiles of Weekly Intravenous Administrations of SNS-595 in Patients With Advanced Malignancies

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: SNS-595


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must give written informed consent 18 years of age Advanced solid malignant tumors Tumor can be measured and evaluated Blood tests are within standard limits Normal blood coagulation ECOG Performance Status equal to 0 or 1 Hemoglobin > or = to 9.0 g/dL Absolute Neutrophil Count > or = to 1,500 Platelets > or = to 100,000 Calculated or measured creatinine clearance < 50 mL/min Serum creatinine < or = 1.5 times the upper limit of normal (ULN) AST, ALT, Alkaline Phosphatase < 3 times ULN except if there is hepatic involvement then AST, ALT, and Alkaline Phosphatase < or = to 5 times ULN Total Bilirubin < or = to 2 mg/dL Exclusion Criteria: Prior exposure to SNS-595 Pregnant or breastfeeding. Women of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards. Heart attack, stroke/TIA or other blood clotting event (deep vein thrombosis or pulmonary embolus) within 6 months before the screen visit. Requires kidney dialysis (hemodialysis or peritoneal). Known bleeding disorder (i.e., hemophilia, von Willebrand Disease, coagulopathy, etc.). Received an investigational agent or prior chemotherapy or immunotherapy within 28 days before first dose of SNS-595 Receiving therapeutic anticoagulation therapy (coumadin, heparin, etc.). Currently receiving corticosteroids (inhaled steroids for breathing diseases are allowed) or seizure medications. Any medical, psychological, or social condition that, in the opinion of the Principal Investigator, would contraindicate the patient's participation in the clinical trial due to safety and or compliance with study procedures.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SNS-595|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Intravenous Magnesium on Postoperative Sore Throat After Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to investigate the effect of intravenous magnesium on postoperative throat pain after thyroidectomy. The secondary purpose of this study is to investigate the effect of intravenous magnesium on total dose of fentanyl in recovery room after thyroidectomy.

Conditions
-----------------
Thyroid Neoplasms

Intervention / Treatment
-----------------
* Drug: Magnesium Sulfate
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thyroidectomy Exclusion Criteria: Allergy to magnesium Chronic pain Chronic opioid use Chronic NSAID use Renal dysfunction Liver dysfunction Cardiac arrythmia Seizure

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium group<br>intravenous administration of Magnesium Sulfate | Drug: Magnesium Sulfate<br>* adminstration of intravenous magnesium as bolus of 50 mg/kg, followed by continuous infusion at rate of 10 mg/kg/h<br>|
| Placebo Comparator: Control group<br>intravenous administration of normal saline | Drug: Normal saline<br>* the same bolus and infusion volumes of normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Throat pain | pain assessment using visual analog scale | Up to 48 hours after surgery end | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fentanyl dose in recovery room |  | Up to 30 minutes after surgery end |
Comparative Clinical Trial of Lornoxicam to Diclofenac in Patients of Osteoarthritis of Knee Joint.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the pain relieving action of the lornoxicam and diclofenac in patients of OA knee.

Official Title
-----------------
Open, Randomized, Controlled Clinical Trial of Lornoxicam as Compared to Diclofenac in Osteoarthritis of Knee Joint in Patients of Tertiary Care Hospital of Gujarat.

Conditions
-----------------
Osteoarthritis of Knee Joint

Intervention / Treatment
-----------------
* Drug: Diclofenac
* Drug: Lornoxicam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed patient aged between 25 to 65 yrs of either gender suffering from osteoarthritis of knee according to criteria given by American College of Rheumatology Informed consent obtained from the patient. Exclusion Criteria: Patients with any other systemic llness, Patients with pregnancy and lactation, Patients taking other drugs like lithium[4], digoxin, methotrexate, anticoagulants, antidiabetics, diuretics, Patients with H/O hypersensitivity to NSAIDs, Patients who had consumed any analgesics in last 1 month

Ages Eligible for Study
-----------------
Minimum Age: 25 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diclofenac<br>Tab.Diclofenac 50 mg ,Orally, 12 hrly in morning and in evening after taking food for 3 months. | Drug: Diclofenac<br>* Tab. Diclofenac 50 mg 12 hrly, orally, in morning and in evening after taking food for 3 months.<br>|
| Experimental: Lornoxicam<br>Tab. Lornoxicam 4 mg , orally, 8 hourly after taking food in morning , in noon and evening for 3 months. | Drug: Lornoxicam<br>* Tab. Lornoxicam 4 mg , orally, 8 hourly after taking food in morning , in noon and evening for 3 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in reduction in reading of Wong Baker face pain scale and in time of 100 meters walking test |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To monitor side effects of study drugs. |  | 3 months |
A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood

Study Overview
=================
Brief Summary
-----------------
A diagnostic peripheral maternal blood test taken and the free foetal DNA is analysed and the presence of trisomies using a novel method.

Detailed Description
-----------------
A total of  2000 participants have donated blood samples used for the development and validation of the IONA non-invasive prenatal screening test for Downs, Edwards and Patau syndrome. The IONA Test was CE marked Feb 2013. We are now recruiting a further 800 participants to provide blood samples to further develop and verify the test for other chromosomal abnormalities and to improve test efficiency.

Official Title
-----------------
A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood

Conditions
-----------------
Aneuploidy, NIPT

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient/subject is willing and able to give informed consent for participation in the study. Female, aged 16 years or above. Currently pregnant at time of entry to the study. Pregnancy having been identified as 'high-risk' by screening test. Exclusion Criteria: The patient/subject may not enter the study if ANY of the following apply: The participant herself has Down's Syndrome or other chromosomal abnormality. Children under 16 Adults with learning disabilities Adults who are unconscious or very severely ill Adults who have a terminal illness Adults in emergency situations Adults suffering from a mental illness Adults with dementia Prisoners Young offenders Adults who are unable to consent for themselves Any person considered to have a particularly dependent relationship with investigators

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Controls<br> | |
| Aneuploidy<br>T13, 18, 21 and other chromosomal abnormalities yet to be determined | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of method of novel analysis for Aneuploidy | Analysis of maternal blood by a selective amplification of fetal DNA over maternal DNA within that sample. Patients to be followed up for 1 year. | 2013 Approx | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimization of existing methods for maximising ffDNA | Use of novel methods either in conjugation with existing methods or as a substitute for steps in existing methodologies- currently undergoing laboratory development that could increase the titre of fetal DNA within a given sample. Patients will be followed up for 1 year. | up to July 2019 |
Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.

Detailed Description
-----------------
This was an open-label study of 60 weeks duration in elderly patients (≥65 years) with primary hypercholesterolemia or combined dyslipidemia who completed the 12 week treatment in study NK-104-306 and who met the inclusion/exclusion criteria. Patients who qualified started open-label treatment with pitavastatin 2 mg QD. The dose of pitavastatin could be increased to 4 mg QD after at least 8 weeks of treatment at 2 mg QD, in patients who failed to attain their LDL-C target.

Official Title
-----------------
Open-Label, Long-Term (> 1 Year) Extension Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Conditions
-----------------
Hypercholesterolemia, Dyslipidemias

Intervention / Treatment
-----------------
* Drug: Pitavastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than or equal to 65 years of age Primary hypercholesterolemia Combined dyslipidemia Completed study NK-104-306 (NCT00257686) Exclusion Criteria: Failed to complete study NK-104-306(NCT00257686)

Ages Eligible for Study
-----------------
Minimum 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitavastatin 2 mg QD<br>Pitavastatin 2 mg once daily | Drug: Pitavastatin<br> <br> |
| Experimental: Pitavastatin 4 mg QD<br>Pitavastatin 4 mg once daily | Drug: Pitavastatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in LDL-C | percent change from baseline in low density lipoprotein-cholesterol (LDL-C) | Baseline to 60 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Cholesterol | Percent change from baseline in total cholesterol (TC) | Baseline to 60 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pitavastatin, hypercholesterolemia, combined dyslipidemia
Bladder Thermal Distention for Patients With Refractory Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators will evaluate the efficacy of Bladder Thermal Distention (BTD) in patients with overactive bladder syndrome who failed previous treatment of anticholinergic drugs. The investigators' hypothesis is that it will improve the storage symptoms.

Detailed Description
-----------------
Inclusion criteria: Patients with overactive bladder syndrome Detrusor Overactivity proven in urodynamic test Exclusion criteria: Mixed urinary incontinence Active urinary tract infection Urethral Stricture Outcome measures: Bladder Diaries Urgency questionnaire

Official Title
-----------------
Bladder Thermal Distention for Patients With Refractory Overactive Bladder

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

Intervention / Treatment
-----------------
* Procedure: Bladder Thermal Distention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with overactive bladder syndrome Detrusor Overactivity proven in urodynamic test Exclusion criteria: Mixed urinary incontinence Active urinary tract infection Urethral Stricture

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: Bladder Thermal Distention<br>Continuous irrigation of the bladder with warm saline (up to 45 Celsius) using a specific 3 ways catheter. The procedure will last 1 hour. Saline will be irrigated by the PelvixTT system. | Procedure: Bladder Thermal Distention<br>* Bladder Thermal Distention is an approved procedure in Europe from 2006. The treatment is hydrodistention of the bladder with a warm saline (up to 45C). The procedure lasts 1 hour. The saline is infused constantly through a 3 ways specific catheter (Unithermia 18F) by the PelvixTT system.<br>* Other names: PelvixTT - Hyperthermia Elmedical LTD, Israel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urgency Questionnaire | Patients will complete the validated USIQ questionnaire | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily frequency of micturitions on Bladder Diary | Patients will complete bladder diaries before and after the procedure. Frequencies of micturitions per day will be documented | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overactive Bladder, Bladder Distention