linjc16/ctgov huggingface dataset:
Effectiveness of Duloxetine in the Treatment of Stress Urinary Incontinence(Uncontrolled Leakage of Urine)

Study Overview
=================
Brief Summary
-----------------
The study evaluates the effectiveness of duloxetine in reducing urinary incontinence occurrences in women due to physical stress(e.g. stomach pressure on bladder). Incontinence is the inability to control bladder function with leakage of urine.

Official Title
-----------------
The Effectiveness of Duloxetine Compared With Placebo in the Treatment of Predominant Stress Urinary Incontinence

Conditions
-----------------
Urinary Incontinence, Stress

Intervention / Treatment
-----------------
* Drug: duloxetine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female outpatients > or = 18 years of age experience episodes of stress urinary incontinence must have an educational level and degree of understanding English are free of urinary tract infections can use the toilet independently Exclusion Criteria: any in or outpatient surgery in the last six months suffer from severe constipation extension of any internal organs beyond vaginal opening currently breastfeeding any nervous diseases affecting normal urinary function

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: duloxetine|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare duloxetine 40 mg BID with placebo in the reduction of incontinence episode frequency(IEF). Study visits occur every two weeks in therapy phase. |  |  | 
| Evaluate the effects of different regimens of dose escalation and tapering effects on incidence of most prevalent adverse events. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of overall patient safety. |  |  | 
| Reduction of IEFs using standardized instruments. |  |  |
Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy of soy/isoflavone supplementation on hot flashes in men who are being treated with luteinizing hormone-releasing hormone (LHRH) agonist therapy for control of advanced prostate cancer

Detailed Description
-----------------
Literature has shown that low dose estrogens can control hot flashes in men on androgen deprivation but with a high risk of thromboembolic events. Soy derivatives that contain isoflavones, a type of phytoestrogen, have been evaluated in peri-menopausal women as a possible safer alternative to synthetic estrogens but there has not been a similar study performed on their effect in men on androgen deprivation therapy for prostate cancer.

Official Title
-----------------
A Prospective Trial of Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Flav-ein capsules
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven adenocarcinoma of prostate with treatment of prostate cancer (radical prostatectomy, radiation therapy, etc.) had biochemical/clinical relapse and started on antiandrogens have documented history of hot flashes Exclusion Criteria: History of MI, DVT, CVA peanut allergy untreated hypothyroidism must be off other medical treatment for hot flashes for 2 weeks before enrollment in this study

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

Sexes Eligible for Study
-----------------
Male

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>Subjects receive supplement | Dietary Supplement: Flav-ein capsules<br>* Soy/isoflavone supplementation<br>|
| Placebo Comparator: 2<br>Subjects will receive placebo | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens |  | 16 Weeks |
Long-term Follow-up of Anxiety and Depression in Patients With Malignant Tumors

Study Overview
=================
Brief Summary
-----------------
This study was a single-center prospective, real-world observational study with plans to enroll all eligible patients. The basic information, anxiety and depression, treatment and prognosis of these patients were collected.

Detailed Description
-----------------
A total of 200 patients with malignant tumors will be enrolled in Henan Cancer Hospital. This study is a single-center prospective real-world observational study, and all eligible patients are planned to be enrolled. The basic information, anxiety and depression, treatment and prognosis of these patients were collected.

Official Title
-----------------
A Single-center, Real-world Prospective Observational Study of the Incidence and Development of Anxiety and Depression in Patients With Malignant Tumors

Conditions
-----------------
Malignant Tumor, Anxiety, Depression

Intervention / Treatment
-----------------
* Other: Hospital Anxiety and Depression Scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women of all ages are welcome. Pathological diagnosis of malignant tumor in our hospital. Received at least one hospitalization at this hospital. The expected survival time is greater than 1 year. Exclusion Criteria: 1.There was no pathological report of malignancy.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Hospital Anxiety and Depression Scale|The basic information, anxiety and depression, treatment and prognosis of these patients were collected.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety Depression Scale | Confirmed in 1 day | Confirmed in 1 day | 
| Hospital Anxiety Depression Scale | End of the treatment | End of the treatment | 
| Hospital Anxiety Depression Scale | The treatment ended 3 months later | The treatment ended 3 months later | 
| Hospital Anxiety Depression Scale | The treatment ended 6 months later | The treatment ended 6 months later | 
| Hospital Anxiety Depression Scale | The treatment ended one year later | The treatment ended one year later | 
| Hospital Anxiety Depression Scale | The treatment ended 2 years ago | The treatment ended 2 years ago |
Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

Study Overview
=================
Brief Summary
-----------------
In newborn infants submitted to surgical procedures, tramadol may provide an effective analgesia and decrease the time on mechanical ventilation support and the time to achieve full enteral feeding.

Official Title
-----------------
Post-Operatory Analgesia in Newborn Infants: a Comparative Study of Fentanyl Versus Tramadol

Conditions
-----------------
Pain, Neonatal Infections, Analgesia

Intervention / Treatment
-----------------
* Drug: FentanyL
* Drug: Tramadol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant 0-28 days of life with indication of large or medium surgical procedure (definition according to the American College of Cardiology, American Heart Association - 2002) Exclusion Criteria: Death or hospital discharge until 72 hours after surgical procedure New surgery until 72 hours after the studied surgical procedure Proved bacterial infection before surgery Ambiguous genitalia Chromosomal syndromes

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: F<br>Patients that received continued infusion of fentanyl at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop | Drug: FentanyL<br>* Fentanyl: 1 µg/kg/h for preterm infants and 2 µg/kg/h for term infants for 48 hours and than gradually decrease until interruption of the drug.<br>|
| Experimental: T<br>Patients that received continued infusion of tramadol at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop | Drug: Tramadol<br>* Tramadol: 0.1 mg/kg/h for preterm infants and 0.2 mg/kg/h for term infants for 48 hours and than gradually decrease until interruption of the drug.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment wuth CRIES and NFCS pain scales during the first 72 hours after surgical procedure |  | Every 2-4h during the first 72 hours after surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time between surgical procedure and successful extubation |  | Hospital stay | 
| Time between surgical procedure and achievement of 100 mL/kg of enteral feeding |  | hospital stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Analgesia, Newborn Infant, Opioids, Side-effects, Intensive care, Postoperative
Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is not being conducted in the United States. Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to that of gliclazide in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

Official Title
-----------------
Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: vildagliptin
* Drug: Gliclazide
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: On a stable dose of metformin as defined by the protocol Blood glucose criteria must be met Body mass index (BMI) in the range 22-45 Exclusion Criteria: Pregnancy or lactation Type 1 diabetes Evidence of significant diabetic complications Evidence of serious cardiovascular complications Laboratory value abnormalities as defined by the protocol Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br> | Drug: vildagliptin<br> <br> Drug: Metformin<br> <br> |
| Active Comparator: Gliclazide<br> | Drug: Gliclazide<br> <br> Drug: Metformin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 52 weeks |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event profile after 52 weeks of treatment |  | 52 weeks | 
| Change from baseline in fasting plasma glucose at 52 weeks |  | 52 weeks | 
| Patients with endpoint HbA1c <7% at 52 weeks |  | 52 weeks | 
| Patients with reduction in HbA1c >/= 0.7% after 52 weeks |  | 52 weeks | 
| Patients with reduction in HbA1c >/= 0.5% after 52 weeks |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, vildagliptin
The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle

Study Overview
=================
Brief Summary
-----------------
The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.

Detailed Description
-----------------
Currently available methods of emergency contraception (EC) only work during a very narrow time period prior to the hormonal trigger for ovulation or the release of an egg. Women having unprotected sex outside this window receive no benefits from this emergency therapy. Prostaglandins are critical before, during, and after ovulation, thus their inhibition may cause an EC effect that works over a longer time period. We wanted to determine if celecoxib might work as an EC with a wider window of action.

Official Title
-----------------
The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle.

Conditions
-----------------
Ovulation (Follicular Rupture Yes/no), Menstrual Cycles (Total Length, Bleeding Days), Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)

Intervention / Treatment
-----------------
* Drug: Celebrex
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-35 Normal menstrual periods (24-35 days) Good general health Willing to use a non-hormonal form of contraception for the entire study (Acceptable forms of contraception include condoms, spermicide, sexual contact with a sterilized partner, subject is surgically sterile, same-sex partner, Copper IUD and abstinence) Willing and able to return to clinic for bi-weekly blood tests Exclusion Criteria: Pregnant or breast feeding Polycystic ovarian disease Gastrointestinal conditions (i.e.gastric ulcer) Currently using birth control Known allergy to aspirin, non-steroidal anti-inflammatory drugs (NSAIDS) or Sulfa-drugs Diabetes Cardiac disease or hypertension Moderate to severe heartburn (GERD) Obesity (BMI greater than 30)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Celebrex<br>* One 400mg tablet daily.<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* One tablet daily.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstrual Cycle Length | Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Celebrex, prostaglandin inhibitor, ovulation, menstrual cycles
An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy

Study Overview
=================
Brief Summary
-----------------
Purpose: The purpose of the correlative studies is to evaluate levels of serum factors of circulating VEGF and soluble VEGFR, circulating tumor cells and circulating endothelial cells assayed at baseline and over the course of initial treatment in order to explore relationships with baseline patient factors, measurable disease response and clinical progression. Hypothesis soluble markers of angiogenic growth factors and receptors, and circulating endothelial and tumor cells can serve as markers for biologic activity of temsirolimus and/or sorafenib.

Detailed Description
-----------------
It is recognized that the measurable disease RECIST criteria response rate with mTOR inhibition is likely to be low and that the benefit of such therapy will also include effects on disease stabilization. Disease stabilization is difficult to interpret in the phase II setting. Thus, it is desirable to develop biomarkers which will provide additional information on novel treatment effects and how they might relate to disease progression

Official Title
-----------------
An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy

Conditions
-----------------
Carcinoma, Renal Cell

Intervention / Treatment
-----------------
* Other: Not applicable - blood tests/tissue specimen tests will be undertaken


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients enrolled from Canadian centres for the Wyeth Pharmaceuticals sponsored multicenter, open-label phase III study evaluating second line therapy with either temsirolimus or sorafenib in patients progressing after sunitinib therapy, are eligible for this correlative studies protocol. Patients must provide written informed consent.

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 |
| --- | --- |
| Biomarker<br> | Other: Not applicable - blood tests/tissue specimen tests will be undertaken<br>* Not applicable - blood tests/tissue specimen tests will be undertaken<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This is an exploratory study. Correlations between biomarkers and baseline factors and treatment outcomes will be made |  | Not available as study withdrawn on November 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Renal Cell Carcinoma, Biomarkers, Biomarkers in patients with Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy
An Interocular Comparative Study of Unilateral Cataract

Study Overview
=================
Brief Summary
-----------------
The purpose of this cross-sectional study is to compare bilateral anterior segment parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric cataract extraction with primary IOL implantation to explore any possible interocular differences and their possible relationships.

Detailed Description
-----------------
Great advances have been made in managing pediatric cataracts during the last several decades; these advances have contributed to a decrease in the incidence of postoperative complications and improvement in visual outcomes.Early cataract removal and replacement with an intraocular lens (IOL) represent the most appropriate treatments to avoid irreversible amblyopia.Although screening and timely surgical intervention play a key role in improved best corrected visual acuity (BCVA) among pediatric patients with cataracts, determining the prognosis for an individual remains difficult, particularly for unilateral cataract. Few studies have focused on the interocular differences in ocular anatomic parameters other than axial length in unilateral pediatric cataract after surgery, the significance of which for the possible interocular visual functional difference remains unclear. Therefore, the investigators conducted this cross-sectional study to compare bilateral anterior segment parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric cataract extraction with primary IOL implantation to explore any possible interocular differences and their possible relationships.

Official Title
-----------------
Interocular Anatomical and Visual Functional Differences in Pediatric Patients With Unilateral Cataracts at 3 Months Post-surgery: A Cross-sectional Study

Conditions
-----------------
Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with uncomplicated surgeries Children who were younger than 10 years old Children with unilateral total cataract Exclusion Criteria: Premature birth Microphthalmia Micro-or Megalocornea Keratoconus Glaucoma Traumatic or complicated cataracts Vitreous and retinal diseases Any previous surgeries

Ages Eligible for Study
-----------------
Maximum Age: 10 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 |
| --- | --- | --- |
| Interocular anatomical parameters in pediatric unilateral cataract patients measured by pentacam | The Parameters are measured by pentacam (Oculus Inc., Wetzlar, Germany), a rotating Scheimpflug camera. | Baseline | 
| Visual function in pediatric unilateral cataract patients measured by Teller Acuity Cards | The visual function is measured by Teller Acuity Cards (Stereo Optical Company, Inc., IL, USA). | Baseline |