linjc16/ctgov huggingface dataset:
Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies

Study Overview
=================
Brief Summary
-----------------
The purpose of this exploratory study is to determine whether memantine can provide benefits on clinical symptoms in patients with Parkinson's Disease Dementia or Dementia with Lewy Bodies.

Detailed Description
-----------------
The objective of this exploratory study is to assess the benefits of memantine compared to placebo in out-patients with a diagnosis of Parkinson's Disease Dementia or Dementia with Lewy Bodies (mild to moderate severity) over a 6-month period. This is a multinational, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study with specific cognitive (attention, executive function, visual perception and memory), behavioural, functional and global measures.

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled, 6-month Study of the Efficacy and Safety of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies

Conditions
-----------------
Parkinson's Disease Dementia, Dementia With Lewy Bodies

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study population will consist of male or female outpatients at least 50 years of age with mild to moderate disease severity (MMSE 12 to 24 inclusive) according to UKPDS and DSM IV TR criteria (for PDD patients) and the third report of the DLB consortium (for DLB patients) and who have a knowledgeable and reliable caregiver to accompany the patient to all clinic visits during the course of the study. Exclusion Criteria: Evidence of clinically significant active disease, evidence of other neurological disorders, and current treatment with AChEIs.

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Memantine<br> | Drug: Memantine<br>* 20mg once daily oral dose<br>* Other names: Ebixa®;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Daily oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Memantine, Cognition, Parkinson's Disease Dementia, Dementia With Lewy Bodies
Procedures, Complications and Follow-up of Tracheostomy in Intensive Care Units.

Study Overview
=================
Brief Summary
-----------------
Tracheostomy is worldwide used for critically ill patients. The aim of our study is to assess the mortality, quality of life, laryngeal function, procedures, early and late complications of tracheostomy performed for critically ill patients admitted in intensive care units.

Official Title
-----------------
Procedures, Complications and Follow-up of Tracheostomy in Intensive Care Units - a Prospective Study by Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI)

Conditions
-----------------
Respiratory Failure, Neurological Disease, Heart Failure, Airway Management

Intervention / Treatment
-----------------
* Procedure: Tracheostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years indications for tracheostomy Exclusion Criteria: Infection/inflammation of neck tissue Previous neck surgery causing abnormal anatomy of the site Recent surgery of cervical spine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tracheostomy<br>The investigators will enroll all the critical ill patients undergoing tracheostomy performed in intensive care units | Procedure: Tracheostomy<br>* Percutaneous and surgical tracheostomies will be performed with the procedure currently available in clinical practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at ICU discharge |  | within 2 days after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of life will be evaluated at 3, 6 and 12 months after the discharge from the intensive care unit. | within 2 days after discharge, at 3, 6 and 12 months after tracheostomy | 
| Laryngeal organ function | Laryngeal organ function will be evaluated at 3, 6 and 12 months after the discharge from intensive care unit. | within 2 days after discharge, at 3, 6 and 12 months after tracheostomy | 
| Late complications |  | from day 2 until the discharge | 
| Procedural findings of percutaneous tracheostomy |  | at the beginning and at the end of tracheostomy procedures | 
| Early complication |  | in the first 24 hours from the end of the procedure |
Efficacy of Traditional Persian Medicine Preparation Versus Artificial Saliva for Radiation Induced Xerostomia

Study Overview
=================
Brief Summary
-----------------
Head and neck cancers(HNC) is one of the most common cancers worldwide. Xerostomia is one of the most common side effect of radiation therapy among patients with HNC. Mouth dryness significantly impairs patients' quality of life (QOL). HNC.Regarding to traditional use of A. digitata and M. sylvestris in addition to known their beneficial effects in recent studies, we decided to design a randomized, controlled clinical trial to try to evaluate efficacy of the these herbs in QOL of HNC patients with radiation induced xerostomia

Conditions
-----------------
Xerostomia, Head and Neck Cancers

Intervention / Treatment
-----------------
* Drug: mixed powder of A. digitata and M. sylvestris
* Drug: Hypozalix spray (artificial saliva)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with head and neck cancer who had grade 1 and 2 xerostomia (based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0) and finished radiotherapy at least two months before the study(22). Exclusion Criteria: history of connective tissue disorder (e.g., Sjogren) other medical causes of xerostomia (such as diabetes, bowel and renal diseases), using antidepressants drugs, recurrence of cancer, end stage cancer, pregnancy, lactation history of hypersensitivity or allergy to A. digitata and M. sylvestris

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>In the control group, patients received Hypozalix (artificial saliva)spray three times per day for a period of four weeks. | Drug: Hypozalix spray (artificial saliva)<br>* Hypozalix spray (artificial saliva)<br>|
| Experimental: intervention<br>Patients in intervention group received sachets containing 4 grams of mixed powder of A. digitata and M. sylvestris (in a proportion of 1:1), three times per day for a period of four weeks | Drug: mixed powder of A. digitata and M. sylvestris<br> <br> * Other names: Traditional Persian Medicine preparation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in patients' quality of life | changes in patients' quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire|(EORTC QLQ-H&N 35) | 4 weeks |
Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine the effectiveness and safety of an annual intravenous treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will receive calcium and vitamin D supplements.

Official Title
-----------------
Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Zoledronic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, 25-85 years old Exclusion Criteria: Current users of bisphosphonates such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel ® (residronate), Skelid® (tiludronate) History of severe liver, kidney or eye disease Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 85 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: Zoledronic Acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare % change in Lumbar Spine BMD from Baseline to Month 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare % change in Lumbar Spine BMD from Baseline to Months 6 and 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations |  |  | 
| To compare % change in BMD at the Total Hip, Femoral Neck, Trochanter and Total Body, from Baseline to Months 6, 12 and 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations |  |  | 
| To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations at all study timepoints, relative to Baseline |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male Osteoporosis
Phase II Study of Epirubicin, Cisplatin and Capecitabine (ECX) Versus Cisplatin and Capecitabine (CX) for Advanced Gastric Cancer (AGC)

Study Overview
=================
Brief Summary
-----------------
Recently, 3-drug (ECX) and 2-drug (CX) combination chemotherapy involving capecitabine showed promising results in randomized clinical trials for advanced gastric cancer (AGC). The objective of the study is to evaluate the safety and activity of ECX and CX combination chemotherapy given as first-line therapy for AGC.

Official Title
-----------------
A Randomized Phase II Study of Combination Chemotherapy With Epirubicin , Cisplatin and Capecitabine (ECX) or Cisplatin and Capecitabine (CX) in Advanced Gastric Cancer

Conditions
-----------------
Advanced Gastric Cancer

Intervention / Treatment
-----------------
* Drug: Epirubicin
* Drug: Cisplatin, capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 75 years or less Adenocarcinoma of stomach Advanced, metastatic, or recurrent No prio chemotherapy for advanced disease Adequate performance status Adequate major organ functions Exclusion Criteria: Severe comorbid illness or active infections Pregnancy or lactating women GI obstruction or malabsorption syndrome

Ages Eligible for Study
-----------------
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECX<br>Epirubicin, cisplatin and capecitabine combination chemotherapy will be administered. | Drug: Epirubicin<br>* Epirubicin 50 mg/m2 iv on day 1<br>Drug: Cisplatin, capecitabine<br>* Cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Capecitabine 2000 mg/m2 on days 1 to 14.<br>|
| Active Comparator: CX<br>Cisplatin and capecitabine combination chemotherapy will be administered. | Drug: Cisplatin, capecitabine<br>* Cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Capecitabine 2000 mg/m2 on days 1 to 14.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure-free survival |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | six months |
An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on quality of sleep in children (aged 6 through 11 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in Germany. An 8-week treatment phase is followed by a 16-week extension period.

Official Title
-----------------
An Open-Label Study on Effectiveness and Tolerability of Atomoxetine as Perceived by Patients, Parents, and Physicians in Children With Attention-Deficit/Hyperactivity Disorder in Germany

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: Atomoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatients who are at least 6 years of age and who will not have reached their 12th birthday Diagnosis of ADHD Normal intelligence Exclusion Criteria: Weigh less than 20 kg or more than 60 kg at study entry Other relevant psychiatric diagnoses Are at serious suicidal risk as determined by the investigator Have a history of severe allergies Alcohol or drug abuse within the past 3 months

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 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: Atomoxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment. |  |  | 
| O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment |  |  |
International Multicenter Study One Day Prevalence Observational Study for Delirium on ICU

Study Overview
=================
Brief Summary
-----------------
An anonymous international multicenter - clinical survey, one-day observational study.

Detailed Description
-----------------
Delirium is a serious complication in postoperative and critically ill patients and is independently associated with cognitive impairment at hospital discharge and with significantly higher 6-month mortality. Furthermore, ICU delirium is associated with more days requiring mechanically ventilation, longer ICU length of stay, and longer hospital length of stay. More recently a study by Pisani and co-workers' could show an association between days of delirium and mortality; - each additional day spent in delirium is associated with a 20% increased risk of prolonged hospitalization - translating to over 10 additional days - and a 10% increased risk of death.The reported prevalence of delirium in critically ill patients ranges widely from 11% to 87%. The aim of our study is to investigate the implementation rate of routine delirium assessment in European ICUs.

Official Title
-----------------
International Multicenter Study One Day Prevalence Observational Study for Delirium on ICU

Conditions
-----------------
Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients staying in the ICU on the 25th of January (one-day prevalence study) No exclusion Criteria:
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill patients<br>Patients staying in the ICU on the 25th of January | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation rate of routine delirium assessment |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point prevalence of ICU delirium |  | 24 hours | 
| Methodology of delirium assessment (e.g. type of score, frequency of evaluation) |  | 24 hours | 
| Non-pharmacological treatment-/prevention strategies |  | 24 hours | 
| Drugs used for delirium treatment |  | 24 hours | 
| Sedation practices (e.g. scales, daily sedation goals, SBT - spontaneous breathing trials, SAT - spontaneous awakening trials) |  | 24 hours | 
| Analgesia regimes (e.g. scales) |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU, Delirium, Analgosedation, Pain, Implementation
Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the association between acid reflux and cell changes in Barrett's esophagus. Specific aim 1: To test the hypothesis that controlled acid reflux is associated with lesser degree of stromal activation. Specific aim 2: To test the hypothesis that stromal fibroblast derived growth factors drive BE epithelial proliferation.

Official Title
-----------------
Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus

Conditions
-----------------
Barrett's Esophagus

Intervention / Treatment
-----------------
* Procedure: 24 hour pH study and upper endoscopy (EGD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior histological demonstration of Barrett's esophagus that is endoscopically visible; length of visible segment >/= 1 cm Absence of dysplasia or LGD on biopsies within the past 5 years Ability to provide informed consent Age between 18 years and 90 years at study entry. Exclusion criteria: Eastern Cooperative Oncology Group performance status 3 or 4 Inability to tolerate endoscopic procedures Pregnancy: Females of child-bearing age will be screened with pregnancy test. Prior esophageal surgery, or cancer

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 |
| --- | --- |
| Those with barrett's esophagus<br>Those with barrett's esophagus: no dysplasia or low grade dysplasia | Procedure: 24 hour pH study and upper endoscopy (EGD)<br>* All subjects enrolled will undergo 24 hour pH followed by EGD.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| activated myofibroblasts | The primary end point for the study will be the proportion of patients with activated myofibroblasts (defined as positive staining for SMA and vimentin with negative staining for Desmin, in > 50% of subepithelial myofibroblasts). This primary end point will be compared between the group with controlled acid reflux and the group without acid reflux. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrett's esophagus
A Pilot Study of the Efficacy of Recombinant Alpha Interferon (IFN-A2b) and Zidovudine (AZT) in the Treatment of Progressive Multifocal Leukoencephalopathy (PML) Complicating HIV-1 Infection

Study Overview
=================
Brief Summary
-----------------
To study the effectiveness of alpha interferon (IFN-A2b) and zidovudine (AZT) in treating progressive multifocal leukoencephalopathy (PML) as a complication of HIV-1 infection.

Official Title
-----------------
A Pilot Study of the Efficacy of Recombinant Alpha Interferon (IFN-A2b) and Zidovudine (AZT) in the Treatment of Progressive Multifocal Leukoencephalopathy (PML) Complicating HIV-1 Infection

Conditions
-----------------
HIV Infections, Leukoencephalopathy, Progressive Multifocal

Intervention / Treatment
-----------------
* Drug: Interferon alfa-2b
* Drug: Zidovudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV seropositivity by both ELISA and Western blot. Biopsy proven progressive multifocal leukoencephalopathy (PML). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Intolerant to interferon. Prior or concomitant central nervous system disease (CNS) such as toxoplasmosis, multiple sclerosis (MS), or neurosyphilis. Patients with the following are excluded: Intolerant to interferon. Prior or concomitant central nervous system disease (CNS) such as toxoplasmosis, multiple sclerosis (MS), or neurosyphilis. Prior Medication: Excluded: Patients receiving interferon for other reasons.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interferon alfa-2b|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
-----------------
Leukoencephalopathy, Progressive Multifocal, Interferon Alfa-2b, Drug Evaluation, Acquired Immunodeficiency Syndrome, Zidovudine