linjc16/ctgov huggingface dataset:
Treatment of the Overactive Bladder Syndrome: A Delphi Study

Study Overview
=================
Brief Summary
-----------------
Idiopathic overactive bladder syndrome (iOAB) is a prevalent condition in urological practice. The variability in management between specialists and between centers remains high. Even guidelines are not always clear on the treatment management of drug therapy resistant OAB. Standardization in OAB treatment is needed.

Detailed Description
-----------------
Guidelines on the overactive bladder syndrome (European Association of Urology, American Urology Association and International Consultation on Incontinence) are comparable but remain vague mainly on the level between conservative and major surgery. They do not specify combinations of medications and do not distinguish between intradetrusor botulinum toxin injections (BTX) and sacral neuromodulation (SNM) because of lack of evidence. To reduce the variability in the treatment management of OAB, standardization is needed. By use of a Delphi technique, the current perception of Belgian urologists towards the most appropriate treatment approach for idiopathic OAB (iOAB) was explored. Based on these results a practical treatment algorithm for its use in daily clinical practice could be developed.

Official Title
-----------------
Development of a Flowchart Reflecting the Current Attitude and Approach Towards the Idiopathic Overactive Bladder Treatment in Belgium: A Delphi Study

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

Intervention / Treatment
-----------------
* Other: Delphi questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Profession: MD, Urologist Member of the working group of Functional Urology Exclusion Criteria: Retirement Non-operative as an urologist.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Delphi panel<br>Urologists of the Belgian Working group of Functional Urology willing to participate on the Delphi project. | Other: Delphi questionnaire<br>* Statements on OAB topics, rated along their level of appropriateness on a scale from 1 to 9. Multiple rounds are organised to reach consensus on a topic.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of consensus on the level of appropriateness | No consensus, trend towards consensus or consensus | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overactive bladder Syndrome, Delphi study, Treatment algorithm
Latest Imaging SPECT System Evaluation Phase 1

Study Overview
=================
Brief Summary
-----------------
Monocentric study for the evaluation of a whole body CZT scintigraphy system.

Detailed Description
-----------------
Monocentric evaluation of performances and clinical interest of a whole body scintigraphic acquisition system with CZT digital detectors. Comparison of image quality and resolution of the new system compared to a reference one, on phantoms and during the acquisition of a wide variety of examinations.

Official Title
-----------------
Latest Imaging SPECT System Evaluation Phase 1

Conditions
-----------------
Rheumatic Disease, Neoplasms, Parathyroid Diseases, Pulmonary Embolism, Heart Diseases, Thyroid Diseases, Kidney Diseases, Dementia, Parkinsonian Disorders

Intervention / Treatment
-----------------
* Radiation: Scintigraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to our Nuclear Medicine department for bone, cardiac, pulmonary, thyroid, parathyroid, renal or cerebral perfusion scintigraphy or to DaTSCAN. Exclusion Criteria: Under 18 years old patients. Pregnant women or at risk of pregnancy. Patients under guardianship Painful patient (EVA>4) Patients in whom a standard examination is not feasible (agitation).

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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: All patients will undergo scintigraphy on 2 distinct devices and the images obtained will be compared.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scintigraphy acquisitions<br>All patients will undergo scintigraphy on 2 distinct devices and the images obtained will be compared. | Radiation: Scintigraphy<br>* The scintigraphy of the patients will be carried out on 2 distinct devices and the images obtained will be compared.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of images with a score greater than or equal to 4 | Rate of images obtaining a score greater than or equal to 4 in visual image quality analysis on a 5-point LIKERT scale. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| collimator performance | Physical measurements of collimator performance on test object. | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gamma camera, whole body scan, scintigraphy
Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)

Study Overview
=================
Brief Summary
-----------------
Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset. The purpose of this study is to compare the effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given with stavudine (d4T) plus nelfinavir (NLF).

Detailed Description
-----------------
Patients are randomized to 1 of 2 open-label treatment groups. Group 1 receives ddI EC plus d4T plus NLF for 48 weeks. Group 2 receives ddI plus d4T plus NLF for 48 weeks. Both forms of ddI are administered orally once daily. Antiviral activity is determined by the magnitude and the duration of reduction of plasma HIV RNA from baseline through Week 24.

Official Title
-----------------
Comparison of HIV RNA Suppression Produced by Triple Regimens Containing Either Didanosine Enteric Coated or Didanosine Formulations Each Administered Once Daily

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Nelfinavir mesylate
* Drug: Stavudine
* Drug: Didanosine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Are at least 18 years old. Have a viral load of at least 5,000 copies/ml and a CD4 count of at least 100 cells/mm3. Exclusion Criteria You will not be eligible for this study if you: Have received more than 4 weeks of treatment with nucleoside anti-HIV medications (NRTIs), or more than 1 week with protease inhibitors. (All anti-HIV treatments other than study medications must be stopped at least 14 days prior to study entry.) Have severe diarrhea. Are pregnant or breast-feeding. Have a history of pancreatic disease or any other serious condition. Have hepatitis within 30 days prior to study entry. Cannot take medications by mouth. Have received certain medications.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nelfinavir mesylate|nan|
|Drug: Stavudine|nan|
|Drug: Didanosine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Didanosine, Drug Therapy, Combination, Drug Administration Schedule, Stavudine, HIV Protease Inhibitors, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Prevention of Iron Deficiency in Breastfed Infants

Study Overview
=================
Brief Summary
-----------------
With early screening and appropriate iron supplementation, iron deficiency in the first year of life can be prevented in breastfed infants.

Detailed Description
-----------------
Infants with low ferritin at 1 month are at high risk of iron deficiency. They will receive iron drops starting at 2 months. All other infants are at low risk of iron deficiency. All infants will receive iron-fortified cereal starting at 4 months of age.

Official Title
-----------------
Prevention of Iron Deficiency in Breastfed Infants

Conditions
-----------------
Iron Deficiency, Anemia

Intervention / Treatment
-----------------
* Dietary Supplement: Fer-in-Sol
* Other: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term infants gestational age 37-42 weeks birth weight > 2500 g exclusively breastfed at 28 d of age intend to breast feed until 9 mo of age Exclusion Criteria: supplemental formula before 4 mo of age

Ages Eligible for Study
-----------------
Minimum Age: 4 Weeks
Maximum Age: 9 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Fer-in-Sol drops and iron-fortified cereal | Dietary Supplement: Fer-in-Sol<br>* Fer-in-Sol drops providing 7.5 mg iron in 0.3 ml per day given from 84 to 168 d of age and iron-fortified cereal<br>|
| Other: Control<br>No intervention | Other: control<br>* No dietary supplements<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron deficiency anemia will be prevented in all infants before 5.5 mo of age | Iron deficiency anemia will be defined as plasma ferritin less than 10 ug/L and hemoglobin less than 105 g/L. The expected outcome is there will be no infants with iron deficiency anemia before 5.5 mo of age. | 5.5 mo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the number of infants with iron deficiency between 5.5 and 9 mo of age | Iron deficiency will be determined as plasma ferritin less than 10 ug/L. We will determine the number of infants with iron deficiency between 5.5 and 9 mo of age | 9 mo | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iron deficiency, anemia
Clinical Utility of Caduet in Achieving Blood Pressure and Lipid Endpoints in a Specific Patient Population

Study Overview
=================
Brief Summary
-----------------
The purpose is to demonstrate the utility of Caduet (amlodipine/atorvastatin) in the African American population

Official Title
-----------------
Clinical Utility Of Caduet In Simultaneously Achieving Blood Pressure And Lipid Endpoints In A Specific Patient Population (CAPABLE)

Conditions
-----------------
Hypertension, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Amlodipine/Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African American men and women with concurrent hypertension and dyslipidemia that is either treated or untreated Subjects must satisfy the blood pressure and LDL-C inclusion criteria for their respective Cardiovascular Risk group determined at screening Exclusion Criteria: Subjects currently being treated with concomitant amlodipine and atorvastatin therapy, including Caduet Subjects with blood pressure at goal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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: Amlodipine/Atorvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of Caduet therapy by assessing the percentage of intent-to-treat subjects achieving both BP and lipid treatment goals (JNC VII and NCEP ATP III) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the percentage of subjects achieving treatment goals(JNC VII and NCEP) stratified by the final BP and lipid therapy doses, respectively, the change from baseline in lipid profile, SBP and DBP |  |  |
Trial of Folic Acid Effect on Hcy and cIMT After Kidney Tx

Study Overview
=================
Brief Summary
-----------------
To see the effect of Folic acid supplementation after kidney transplantation on plasma total homocysteine level and carotid intimal-media thickness

Official Title
-----------------
Clinical Trial of Effectiveness of Folic Acid Therapy on Homocysteine Level and Carotid Intima-Media Thickness After Kidney Transplantation

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Folic acid
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having hyperhomocysteinemia(tHcy>12.5 µmol/L in men and 11.5 µmol/L in women ) No evident history of CVD 4. no evidence of cigarette smoking not participating in other clinical studies on evaluation of cardiac diseases and not taking any lipid lowering treatment not being pregnant or breast feeding a baby(women) Having HIV or viral hepatitis infections. Exclusion Criteria: unstable condition of the transplanted kidney (Cr> 3 mg/dl, BUN > 50 mg/dl) Cyclosporine (CsA) intoxication New onset of any severe disease ( such as MI, stroke, DM, etc.).

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Folic acid supplementation | Drug: Folic acid<br>* Folic acid 5 mg/day<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo similar to the folic acid tablets, 1/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma level of total homocysteine (tHcy) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carotid intima-media thickness (cIMT) |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Folic Acid, Homocysteine, intima-media thickness
Study to Evaluate a Pharmacokinetic Drug Interaction Between Eperisone Hydrochloride and Aceclofenac in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
A randomized, open label, single-dose, 6-sequence, 3-period, crossover study to evaluate a pharmacokinetic drug interaction between eperisone hydrochloride and aceclofenac in healthy male subjects.

Conditions
-----------------
Acute Low Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI : 20.0 - 28.0 kg/m2 willingness to sign the written informed consent form(ICF) Exclusion Criteria: Evidence of clinically relevant pathology within 30 days prior to drug administration History of relevant drug and/or food allergies

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eperisone<br> | |
| Aceclofenac<br> | |
| Eperisone hydrochloride, Aceclofenac<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see whether it is better to take delavirdine (DLV) plus indinavir (IDV) plus zidovudine (ZDV) twice a day or three times a day.

Detailed Description
-----------------
Patients are divided into 2 treatment groups; the groups are balanced with respect to viral load. Group A receives ZDV, DLV, and IDV 3 times daily. Group B receives ZDV, DLV, and IDV 2 times daily. Patients are evaluated for changes from baseline in viral load and CD4 cell count.

Official Title
-----------------
An Open-Label, Parallel Group, Pilot Study of Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of BID and TID Regimens of Delavirdine Mesylate, Zidovudine, and Indinavir Sulfate in HIV-1 Infected Individuals

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Indinavir sulfate
* Drug: Delavirdine mesylate
* Drug: Zidovudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have a viral load (level of HIV in the blood) of at least 20,000 copies/ml. Have a CD4 cell count of at least 50 cells/mm3. Are at least 14 years old (consent of parent or guardian is required if under 18). Exclusion Criteria You will not be eligible for this study if you: Have ever taken an anti-HIV drug other than ZDV. Have taken ZDV for more than 1 month.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Delavirdine mesylate|nan|
|Drug: Zidovudine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug Therapy, Combination, Zidovudine, Drug Administration Schedule, HIV Protease Inhibitors, CD4 Lymphocyte Count, Indinavir, Delavirdine, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.

Study Overview
=================
Brief Summary
-----------------
This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/day over 52 weeks in patients who completed the 3-week double-blind study CLIC477D2301.

Detailed Description
-----------------
A 52-week, open-label extension study to evaluate the safety and tolerability of licarbazepine 750- 2000 mg/day in the treatment of manic episodes of bipolar I disorder

Official Title
-----------------
A 52-week, Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750- 2000 mg/Day in the Treatment of Manic Episodes of Bipolar I Disorder

Conditions
-----------------
Bipolar I Disorder

Intervention / Treatment
-----------------
* Drug: Licarbazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent provided prior to participation in the extension study successful completion of study CLIC477D2301 willingness and ability to comply with all study requirements Exclusion Criteria: premature discontinuation from study CLIC477D2301 failure to comply with the study CLIC477D2301 protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Licarbazepine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar disorder, manic episode/treatment/licarbazepine