linjc16/ctgov huggingface dataset:
Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the activity of 4 escalating doses of AVE0657 in comparison to placebo in patients with Obstructive Sleep Apnea Hypopnea Syndrome.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled, Study of the Safety and Activity of Four Escalating Single Doses of AVE0657 in Patients Suffering From Obstructive Sleep Apnea Hypopnea Syndrome

Conditions
-----------------
Sleep Apnea, Obstructive

Intervention / Treatment
-----------------
* Drug: AVE0657
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects diagnosed with Obstructive Sleep Apnea Hypopnea Syndrome based on International Classification of Sleep Disorders Exclusion Criteria: Subjects having been treated by Continuous Positive Airway Pressure, oral appliance during 4-weeks prior to randomization Chronic respiratory disease or inadequate respiratory parameters Body Mass Index (BMI) of ≤20 kg/m² or ≥35 kg/m² Surgical procedure to correct apnea within the last three months. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Dose Level 1<br> | Drug: AVE0657<br>* capsules once a day at bedtime<br>|
| Experimental: Dose Level 2<br> | Drug: AVE0657<br>* capsules once a day at bedtime<br>|
| Experimental: Dose Level 3<br> | Drug: AVE0657<br>* capsules once a day at bedtime<br>|
| Experimental: Dose Level 4<br> | Drug: AVE0657<br>* capsules once a day at bedtime<br>|
| Placebo Comparator: Placebo<br>12 subjects: 3 subjects per dose level | Drug: placebo<br>* capsules once a day at bedtime<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Apnea Hypopnea Index (AHI) |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive sleep apnea
Harnessing Placebo Effects: Non-Deceptive Use of Placebo in Irritable Bowel Syndrome (IBS)

Study Overview
=================
Brief Summary
-----------------
Irritable bowel syndrome patients will be given either placebo pill or no treatment for a period of 3 weeks.

Detailed Description
-----------------
Seventy patients with irritable bowel syndrome (IBS) will be randomized to either 1) placebo pill or 2) no treatment and followed for 3 weeks. The study will involve three visits: baseline, midpoint and end point. At baseline all patients will physical examination, be evaluated for IBS and be administered standardized IBS questionnaires including: IBS adequate relief questionnaire, IBS global symptom improvement scale, IBS quality of life and IBS symptom severity scale. At midpoint and endpoint the same questionnaires will be administered. Patients on no treatment will be offered education on managing IBS at the end of the study.

Official Title
-----------------
Pilot Randomized Controlled Trial

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Other: Sugar pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Irritable bowel syndrome. Exclusion Criteria: Any signs of organic bowel disease such as rectal bleeding. No other major illnesses.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cellulose pill<br>The active intervention is a sugar pill. | Other: Sugar pill<br> <br> |
| No Intervention: No treatment<br>The control arm is wait list control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS Global Improvement Scale |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS Adequate Relief |  | 3 weeks | 
| IBS quality of life (QoL) |  | 3 weeks | 
| IBS Symptom Severity Scale |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
irritable bowel syndrome, no organic digestive disease
Patient Perception of Visual Quality and Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the visual quality and function of pseudophakic patients.

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

Intervention / Treatment
-----------------
* Other: Administration of patient self-assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum 22 years of age Pseudophakic patients who have been bilaterally implanted with the same type of intraocular lenses in both eyes Ability to understand, read and write English to give consent and complete the study questionnaires Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization Other protocol-defined inclusion criteria might apply Exclusion Criteria: Any ocular pathology of clinical significance, as determined by the investigator, that may affect visual outcomes or influence subjective ocular/visual symptoms Patient is pregnant or is lactating Concurrent participation or participation within 30 days prior in any other clinical trial Other protocol-defined exclusion criteria might apply

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pseudophakic<br> | Other: Administration of patient self-assessment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery | Patients will be assessed at a baseline visit and a visit 1 week later to determine their use of corrective visual aids (i.e., spectacles, contact lenses) post Intraocular Lens (IOL) surgery. | Baseline and 1 week |
COVID-19 Vaccines and the Development of New LUTS

Study Overview
=================
Brief Summary
-----------------
This study was conducted to check whether coronavirus disease 2019 (COVID) vaccines have a relationship with LUTS or not in a healthy and mostly medically free population.

Official Title
-----------------
Relationship Between the Coronavirus 2019 Disease (COVID-19) Vaccines and the Development of New Lower Urinary Tract Symptoms: A Cross-sectional Study on Medical Students.

Conditions
-----------------
COVID-19 Vaccine Adverse Reaction, Lower Urinary Tract Symptoms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical Student Having had a COVID-19 Vaccine Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New Lower Urinary Tract Symptoms | Only after having had any COVID -19 vaccine | 2-3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19 Vaccines, LUTS, Medical students
CSAPG Early Warning Score

Study Overview
=================
Brief Summary
-----------------
The Early Warning Score (EWS) has been shown in previous studies to be correlated with mortality and mean hospital stay, but it is unknown whether the implementation of the scale improves mortality and mean hospital stay. This trial aims to study whether the implantation of the EWS in a regional hospital reduces the mean hospital stay (primary objective), mortality and complications (secondary objectives). For this, an open clinical trial will be carried out in which the hospitalization floors of the hospital will be administratively divided into two sections (two study branches); the EWS scale will be implemented in the computer equipment of one of the sections of each floor, acting the another section as a control branch. All the patients admitted to the participating hospital floors during one year will be included in the study. The mean stay, mortality and complications will be compared between study branches.

Official Title
-----------------
CSAPG Early Warning Score

Conditions
-----------------
Complication

Intervention / Treatment
-----------------
* Diagnostic Test: EWS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted during study period to the participant hospital units. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EWS<br>Early Warning Score will be implemented in the computer system of the nursing station | Diagnostic Test: EWS<br>* Early Warning Score will be implemented in the computer system of the nursing station. When the nurses enter the vital signs of the patients into the system, the EWS will be automatically calculated and an alarm will be displayed if an intervention is necessary, which is protocolized.<br>|
| No Intervention: Control<br>Nursing supervision will be carried out in the usual way. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | Average days of hospital admission | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Percentage of patients deceased during hospital admission | 1 year | 
| Complications | Percentage of patients who develop health complications during hospital admission | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hospital Stay, Mortality, Complication
Endoscopic Submucosal Dissection (ESD) and Endoscopic Mucosal Band Ligation (EMBL) for Early Cancer

Study Overview
=================
Brief Summary
-----------------
To compare the treatment methods of endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer.

Conditions
-----------------
Early Cancer

Intervention / Treatment
-----------------
* Procedure: endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with early neoplasm in the gastrointestinal tract Exclusion Criteria: Patients who can not meet the surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| ESD<br>endoscopic submucosal dissection (ESD)for early cancer | Procedure: endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer<br> <br> |
| EMBL<br>endoscopic mucosal band ligation (EMBL) for early cancer | Procedure: endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year overall survival |  | 5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopic submucosal dissection (ESD), endoscopic mucosal band ligation (EMBL)
Long-term Observation PMS for Afatinib

Study Overview
=================
Brief Summary
-----------------
In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a new substance, results of PMS need to be submitted as a part of reexamination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).

Official Title
-----------------
Post Marketing Surveillance on Long Term Drug Use of GIOTRIF Tablets in Patients With Epidermal Growth Factor Receptor Mutation-positive Inoperable or Recurrent Non-small Cell Lung Cancer.

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: Afatinib dimaleate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC)will be included. Exclusion criteria: - None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Afatinib<br> | Drug: Afatinib dimaleate<br>* 20mg - 50mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Drug Reactions (ADRs) | This outcome measure presents incidence of adverse drug reactions (ADRs). An ADR was defined as an AE if either the investigator or the sponsor (or both) assessed the causal relationship to GIOTRIF® Tablets either as Yes, Probably yes or Can't be denied. The number of patients with Adverse Drug Reactions (ADRs): Malignant progression reported as ADRs were included. | From first drug administration until 28 days after the last drug administration, up to 52 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Overall Response Based on Physician's Assessment [According to RECIST Version 1.1] | Objective overall response based on investigator's assessment (according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target lesions and assessed by MRI: complete response (CR) is the disappearance of all target lesions, a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesion and stable disease (SD) is defined as fitting the criteria neither for progressive disease (PD) nor a PR. The population included the Tyrosine Kinase Inhibitor [TKI]-naïve patients and the TKI pre-treated patients. Overall response was calculated with 95% Clopper-Pearson confidence interval. OR = (CR+PR)/(CR+PR+SD+PD+Unknown)*100. | 52 weeks. |
Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology

Study Overview
=================
Brief Summary
-----------------
The primary objective is to investigate the pharmacokinetics (PK) of 2 doses of alfuzosin (given as a solution or tablets depending on age) in children and adolescents 2 to 16 years of age with elevated detrusor Leak Point Pressure (LPP) (≥40 cm H2O) of neuropathic etiology stratified into 2 age groups (2 to 7 years and 8 to 16 years). The secondary objectives are to investigate the safety and tolerability of the 2 dose regimens and to determine the effect of the 2 dose regimens on detrusor LPP.

Official Title
-----------------
Four-week, Open-label, Multicenter, Randomized, Parallel-group Study to Investigate the Pharmacokinetics, Safety, Tolerability and the Effects on Leak Point Pressure of Two Oral Doses of Alfuzosin (0.1 mg/kg/Day; 0.2 mg/kg/Day) in Children and Adolescents 2 to 16 Years-of-age With Elevated Detrusor Leak-point Pressure of Neuropathic Etiology

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

Intervention / Treatment
-----------------
* Drug: alfuzosin (SL770499)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and adolescents of either gender 2-16 years of age with elevated detrusor LPP of neuropathic etiology.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 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: alfuzosin (SL770499)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elevated detrusor leak point pressure
Dexamethasone-implant for the Treatment of RVO

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of a dexamethasone-implant alone or in combination with bevacizumab. 64 eyes are prospectively investigated. Group 1 (22 CRVO and 16 BRVO) is treated with dexamethasone-implant alone, Group 2 (14 CRVO 12 BRVO) with three consecutive bevacizumab injections followed by a dexamethasone-implant. Recurrences are treated with dexamethasone-implant only. Patients are seen preoperatively and thereafter in monthly intervals. The primary endpoint was BCVA at twelve months.

Official Title
-----------------
Twelve Months Experience With a Dexamethasone-implant for the Treatment of Macular Edema Associated With Retinal Vein Occlusion

Conditions
-----------------
Macular Edema Caused by Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Drug: Dexamethasone implant
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: maximum duration of symptoms of four months and no known history of glaucoma or corticosteroid response in the past - Exclusion Criteria: Glaucoma, Diabetic Retinopathy, prior IVOM, Uveitis -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone-implant (Group 1)<br>Group 1 included 38 patients (22 with CRVO and 16 with BRVO) and was treated with a dexamethasone-implant injection from the beginning. | Drug: Dexamethasone implant<br> <br> |
| Active Comparator: Bevacizumab/Dexamethasone-implant (Group 2)<br>Group 2 included 26 patients (14 CRVO, 12 BRVO) and was treated with three consecutive injections of bevacizumab at a monthly interval, followed by a dexamethasone-implant injection four weeks after the last bevacizumab injection. | Drug: Dexamethasone implant<br> <br> Drug: Bevacizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central retinal thickness |  | 12 months | 
| Lens opacity |  | 12 months | 
| Saftey of procedure |  | 12 months |