linjc16/ctgov huggingface dataset:
Assessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation

Study Overview
=================
Brief Summary
-----------------
To determine whether UK-390,957 is an effective and safe treatment for premature ejaculation.

Official Title
-----------------
A Phase 2b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Dose Response Study to Assess the Efficacy and Safety of Oral UK-390,957 in Men With Premature Ejaculation

Conditions
-----------------
Ejaculation

Intervention / Treatment
-----------------
* Drug: UK-390,957


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature ejaculation as defined by DSM-IV Exclusion Criteria: History of erectile dysfunction

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: UK-390,957|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of efficacy and safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Quality of Sexual Life |  |  |
Topotecan and Cisplatin Versus Etoposide and Carboplatin in 1st Line Treatment of Patients With Small Cell Lung Cancer and Extensive Disease (SCLC-ED)

Study Overview
=================
Brief Summary
-----------------
Randomised trial comparing standard chemotherapy with carboplatin and etoposide with a combination of topotecan and cisplatin in patients with inoperable lung cancer of small cell type.

Detailed Description
-----------------
Fase III, multicenter randomised trial comparing up to six cycles of carboplatin and etoposide with up to six cycles of topotecan and cisplatin in patients with extensive stage small cell lung cancer and PS 0-3

Official Title
-----------------
Randomized Phase III Trial of Topotecan and Cisplatin Versus Etoposide and Carboplatin in the Treatment of Patients With Previously Untreated Small Cell Lung Cancer and Extensive Disease

Conditions
-----------------
First-Line, Extensive Disease, Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: topotecan + cisplatin
* Drug: Etoposide + carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed SCLC Extensive stage No prior chemotherapy WHO PS 0-3 Adequate organ function (liver, kidney) Adequate hematology (bone marrow) Informed consent Exclusion Criteria: PS 4 Inadequate organ function Uncontrolled infection Concomitant major medical contraindications

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Topotecan + cisplatin | Drug: topotecan + cisplatin<br>* topotecan IV 2 mg/sqm d1-3 + cisplatin IV 50 mg/sqm d3 q3W<br>|
| Active Comparator: B<br>Etoposide + carboplatin | Drug: Etoposide + carboplatin<br>* Etoposide 120 mg/sqm IV d 1-3 + carboplatin AUC 5 d1 q3W<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 years survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rates |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SCLC, Extensive disease, topotecan
Tomographic Analysis of Anterior, Posterior, Total Corneal Refractive Power Changes After Laser-assisted Keratotomy

Study Overview
=================
Brief Summary
-----------------
To analyze the effect of femtolaser-assisted keratotomy on corneal astigmatism (anterior, posterior and Total corneal refractive power) measured by Scheimpflug tomography after laser lens surgery.

Detailed Description
-----------------
This study investigated patients' eyes with low to moderate total corneal refractive power determined with Scheimpflug tomography (Pentacam HR) after penetrating femtosecond laser-assisted keratotomy (pFLAK) and laser lens surgery. The anterior corneal astigmatism, posterior corneal astigmatism and total corneal refractive power were determined before, 1 month and 3 months after lens surgery. Vector analysis according to the Alpins' method was used to calculate surgically induced astigmatism (SIA).

Official Title
-----------------
Tomographic Analysis of Anterior, Posterior and Total Corneal Refractive Power Changes After Femtosecond Laser-assisted Keratotomy After Laser Lens Surgery

Conditions
-----------------
Corneal Astigmatism

Intervention / Treatment
-----------------
* Procedure: Laser keratotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients who received penetrating femtosecond laser-assisted lens surgery with low to moderate corneal astigmatism Exclusion Criteria: Eyes with irregular corneal astigmatism such as keratoconus, previous corneal surgery, acute or chronic ophthalmic diseases of the anterior segment and intraoperative complications were not included in this study.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Laser keratotomy|Penetrating femtosecond laser assisted keratotomy to treat preexisting corneal astigmatism during lens surgery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Total corneal refractive power at 3 months | Total corneal astigmatism (anterior and posterior astigmatism) | Before and 3 months after lens surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Anterior corneal astigmatism at 3 months | Anterior corneal astigmatism | Before and 3 months after lens surgery | 
| Change from Baseline Posterior corneal astigmatism at 3 months | Posterior corneal astigmatism | Before and 3 months after lens surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laser-assisted keratotomy, anterior astigmatism, posterior astigmatism, total corneal refractive power, nomogram
Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome

Study Overview
=================
Brief Summary
-----------------
This surveillance's objectives are Unknown adverse reactions Incidences of adverse drug reaction Efficacy during long-term administration Factors considered to have effect to safety and effectiveness Incidences of status epileptics, skin disorders and hyper sensitivity reaction, and central nervous system-related adverse events(ataxia , somnolence and/or dizzy, etc.)

Conditions
-----------------
Lennox-Gastaut Syndrome

Intervention / Treatment
-----------------
* Drug: Rufinamide


Participation Criteria
=================
Eligibility Criteria
-----------------
All patients with Lennox-Gastaut syndrome and administrated Inovelon
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| E2080<br>Children ages >= 4 years: Patients weighing 15.0-30.0 kg: oral daily dose of 200 mg in two divided doses after meals for the first 2 days. The dose will be increased by up to 200 mg/day every two days. The maintenance dose should be 1000 mg/day in two divided doses after meals. The dose can be increased or decreased within a range not exceeding 1000 mg/day, and should be increased by up to 200 mg/day at intervals not less than 2 days. Patients weighing >= 30.1 kg: Adults: oral daily dose of 400 mg in two divided doses after meals for the first 2 days, then increased by up to 400 mg/day every two days. The maintenance dose should be 1800 mg/day for patients weighing 30.1-50.0 kg, 2400 mg/day for patients weighing 50.1-70.0 kg, and 3200 mg/day for patients weighing 70.1 kg or over in two divided doses after meals. Dose can be increased or decreased within a range not exceeding the above maintenance dose, and should be increased by up to 400 mg/day at intervals not less than 2 days. | Drug: Rufinamide<br>* Administration of Inovelon 100mg or 200mg Tablets<br>* Other names: Inovelon Tablet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigations on adverse events and adverse drug reactions |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of attacks |  | 12 weeks and every 6 months up to 2years | 
| Overall assessments of the improvement in the seriousness of seizures |  | 12 weeks and every 6 months up to 2years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epileptic encephalopathy, Lennox-Gastaut type
Retinal Pigment Epithelial Characteristics in Eyes With Neovascular Age-related Macular Degeneration Following Long-term Treatment With Anti Neovascular Endothelial Growth Factor

Study Overview
=================
Brief Summary
-----------------
Purpose: To assess retinal pigment epithelial (RPE) and retinal structural changes in eyes with neovascular age-related macular degeneration (AMD) treated with anti-vascular endothelial growth factor (anti-VEGF) during long-term follow-up and to evaluate morphological markers potentially influencing prognosis. Methods: 18 patients (18 eyes) with neovascular AMD were recruited subsequent to completion the Avastin Versus Lucentis in Age Related Macular Degeneration (MANTA) study following a mean period of 84 months (range: 69-93 months). After receiving a loading dose of 3 intravitreal anti-VEGF injections subsequent to baseline of the MANTA study, patients were treated as-needed [pro re nata (PRN)]. Functional and morphological changes were assessed using spectral domain optical coherence tomography (SD-OCT).

Official Title
-----------------
Retinal Pigment Epithelial Characteristics in Eyes With Neovascular Age-related Macular Degeneration Following Long-term Treatment With Anti Neovascular Endothelial Growth Factor

Conditions
-----------------
Neovascular Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Device: OCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion and exclusion criteria corresponded to the criteria of the MANTA study Exclusion Criteria: Inclusion and exclusion criteria corresponded to the criteria of the MANTA study

Ages Eligible for Study
-----------------
Minimum Age: 66 Years
Maximum Age: 98 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OCT|Patients were recruited, visual acuity and optical coherence tomography Pictures were taken|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | visual acuity testing was performed | 93 months |
A Pharmacokinetic and Pharmacogenetic Study in Patients Receiving Sulfamethoxazole-trimethoprim Therapy

Study Overview
=================
Brief Summary
-----------------
In this study, we aim to investigate the incidence of the adverse reactions, the effectiveness and the gene polymorphism associated with the plasma level of sulfamethoxazole-trimethoprim and their metabolites (including N4-acetyl-sulfamethoxazole, sulfamethoxazole hydroxylamine and sulfamethoxazole-nitroso). And we also aim to investigate the factors associated with the sulfamethoxazole-trimethoprim induced acute psychosis.

Official Title
-----------------
A Pharmacokinetic and Pharmacogenetic Study in Patients Receiving Sulfamethoxazole-trimethoprim Therapy

Conditions
-----------------
Pneumocystis Jirovecii Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and females aged 20 years or older using oral or intravenous form of sulfamethoxazole-trimethoprim Exclusion Criteria: patients who are under 20 years of age

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Sulfamethoxazole-trimethoprim treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High performance liquid chromatography for drug plasma concentration | The plasma concentration will not be measured until the patient's treatment course completed. | Participants will be followed for the duration of the treatment course, an expected average of 21 days |
Radiological Findings in Primary Intestinal Ischaemia

Study Overview
=================
Brief Summary
-----------------
To investigate which findings on a non-specific CT scan that predict acute primary intestinal ischaemia.

Detailed Description
-----------------
48 patients with primary intestinal ischemia admitted in 4 consecutive years (2006-2009) in Department of Gastrointestinal Surgery, Aalborg University Hospital. Control group consists of 82 patients operated in the same department and in the same time range. Abdominal CT scans are described with respect to intestinal diameter, changes in intestinal wall, extra intestinal changes and vessel pathology.

Official Title
-----------------
Preoperative Findings on Non-specific CT in Patients With Primary Acute Intestinal Ischaemia; a Case-control Study

Conditions
-----------------
Acute Intestinal Ischemia

Intervention / Treatment
-----------------
* Radiation: Computerized tomography scan of the abdomen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary acute intestinal ischaemia in an abdominal operation. CT-scan within 48 hours preoperative. Exclusion Criteria: Secondary intestinal ischaemia Intestinal ischaemia isolated intestinal mucosa. No CT-scan within 48 hours preoperative

Ages Eligible for Study
-----------------
Maximum Age: 120 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 |
| --- | --- |
| Acute intestinal ischaemia<br>Abdominal CT scan within 48 hours preoperative. | Radiation: Computerized tomography scan of the abdomen<br>* Non-specific abdominal ct´s with different phases and contrast +/-.<br>|
| Controls<br>Abdominal CT scan within 48 hours preoperative. | Radiation: Computerized tomography scan of the abdomen<br>* Non-specific abdominal ct´s with different phases and contrast +/-.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal wall pathology | Incidense of CT findings in the radiological main group called Intestinal wall pathology | 48 hours | 
| Gastrointestinal vessel pathology | Incidense of CT findings in the radiological main group called Gastrointestinal vessel pathologypathology | 48 hours | 
| Intestinal diameter | Incidense of CT findings in the radiological main group called Intestinal diameter | 48 hours | 
| Extraintestinal pathology | Incidense of CT findings in the radiological main group called Extraintestinal pathology | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnoses Disease
Evaluation of NT-proBNP in Chronic Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
NT-proBNP is a major diagnostic and prognostic marker in cardiology, but it is also a new marker for biological inflammation, especially in rheumatology. Its evaluation in chronic inflammatory bowel disease was carried out in a preliminary study, the OPERA study where in a population of 12 patients showed an increase in NT-proBNP correlated with the biological and endoscopic activity of the disease. This larger study is therefore a pilot study that could see NTproBNP as a new biomarker of inflammation in MICI.

Official Title
-----------------
Evaluation of NT-proBNP in Chronic Inflammatory Bowel Disease

Conditions
-----------------
Inflammatory Bowel Diseases, NT-pro-BNP

Intervention / Treatment
-----------------
* Other: Evaluate the blood level of NTproBNP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects (age 18 years) MICI Group: Patients monitored for probable HC or MC Control group: Patients referred for consultation in gastroenterology with a clinical and endoscopic picture eading to the diagnosis of TF I Person who agreed to participate in the study Patient covered by social insurance Exclusion Criteria: Causes of increased concentrations of natriuretic peptides: acute heart failure, acute or chronic pulmonary disease with right ventricular repercussion, valvulopathies, primary or secondary HVG, atrial fibrillation cardiac arrhythmia, chronic systolic dysfunction, hyperthyroidism, Addison's disease, hyperaldosteronism Primary, diabetes, cirrhosis with ascites, cancers, chronic renal insufficiency. Inflammatory and autoimmune diseases (excluding MC and RCH), chronic inflammatory syndrome Ongoing treatment that may affect the concentration of natriuretic peptides: ACE inhibitor, angiotensin II receptor antagonists, diuretics Patient deprived of liberty or protected major (under guardianship or curatorship)

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with CD or RCH<br> | Other: Evaluate the blood level of NTproBNP<br>* Evaluate the blood level of NTproBNP in patients with MICI compared to a healthy control population.<br>|
| Other: The control population<br> | Other: Evaluate the blood level of NTproBNP<br>* Evaluate the blood level of NTproBNP in patients with MICI compared to a healthy control population.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood level of NTproBNP. |  | 1 month |
Breast Feeding Practice in High Risk Pregnant Women

Study Overview
=================
Brief Summary
-----------------
The American Academy of Paediatrics recognizes multiple benefits of breastfeeding to both the term and premature newborn, particularly with regard to protection from infectious agents. Studies have demonstrated decreased rates of bacteraemia, meningitis, respiratory and urinary tract infections, necrotizing enterocolitis, and otitis media among breastfed infants

Official Title
-----------------
Breast Feeding Practice in High Risk Pregnant Women

Conditions
-----------------
Breast Feeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus. Cardiac disease. Essential hypertension. Chronic chest disease, and/or chronic TB infection. Chronic hepatitis. Neurologic disease. Anaemia (Hemoglobin <10 gm/dL). Thyroid disease. Multiple pregnancy. Exclusion Criteria: pregnant women < 34 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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 |
| --- | --- |
| Low risk pregnant women<br>evaluation of the efficacy of breastfeeding Low risk pregnant women | |
| high risk pregnant women<br>evaluation of the efficacy of breastfeeding high risk pregnant women | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of breast feeding women during pregnancy |  | 6 months |
Oral Gemifloxacin Versus Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis

Study Overview
=================
Brief Summary
-----------------
oral Gemifloxacin versus intravenous Cefotaxime in treatment of spontaneous bacterial peritonitis

Detailed Description
-----------------
Comparative Study between the Efficacy of oral Gemifloxacin and intravenous Cefotaxime in treatment of spontaneous bacterial peritonitis

Official Title
-----------------
Comparative Study Between the Efficacy of Oral Gemifloxacin and Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis

Conditions
-----------------
Spontaneous Bacterial Peritonitis

Intervention / Treatment
-----------------
* Drug: Cefotaxime
* Drug: Gemifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with spontaneous bacterial peritonitis Exclusion Criteria: secondary peritonitis

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cefotaxime<br>Cefotaxime intravenous | Drug: Cefotaxime<br>* Cefotaxime IV<br>* Other names: cefotax, claforan;|
| Active Comparator: Gemifloxacin<br>Oral Gemifloxacin | Drug: Gemifloxacin<br>* Gemifloxacin oral<br>* Other names: gemiflox;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with resolution of infection | the total number of patients with resolution of infection | 6 months |