linjc16/ctgov huggingface dataset:
Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation

Study Overview
=================
Brief Summary
-----------------
Efficacy and Safety from a high-dosed sublingual grass pollen preparation

Official Title
-----------------
A Multicentre, Multinational, Placebo-controlled, Double-blind, Randomized Study to Evaluate Efficacy and Safety of a Perennial, Sublingual, Specific Immunotherapy in Patients With Rhinoconjunctivitis With/Without Controlled Asthma Caused by Grass Pollen

Conditions
-----------------
Allergy, Rhinitis, Conjunctivitis

Intervention / Treatment
-----------------
* Biological: Allerslit forte
* Biological: Allerslit forte


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allergic rhinoconjunctivitis attributable to grass pollen Positive SPT Positive EAST Positive provocation Test Exclusion Criteria: Serious chronic disease other perennial allergies

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>sublingual placebo preparation | Biological: Allerslit forte<br>* sublingual placebo preparation, daily<br>|
| Experimental: 2<br>Sublingual preparation, 40 micro grams Phl p 5 maintenance dose | Biological: Allerslit forte<br>* Sublingual preparation, 40 micro grams Phl p 5 maintenance dose,daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom and Medication Score |  | Grass pollen season 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sublingual grass pollen preparation, IgE-mediated Allergic Disease attributed to grass pollen
Investigation of Low-intensity Focused Ultrasound Parameters

Study Overview
=================
Brief Summary
-----------------
This project examines the effects of different brain stimulation settings on muscle contractions. The investigators believe this study will help to better understand noninvasive brain stimulation techniques that may have the potential to aid in addiction, pain, and mental health issues. Participants undergo structural imaging, an fMRI and CT. These images are used to align the low-intensity focused ultrasound (LIFU) and transcranial magnetic stimulation (TMS) devices to temporarily change brain activity. Electromyography (EMG) will be used to record muscle contractions on the hand.

Official Title
-----------------
Investigation of Low-intensity Focused Ultrasound Parameters

Conditions
-----------------
Development of LIFU for Clinical Purposes

Intervention / Treatment
-----------------
* Device: Low-intensity Focused Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above criteria and must understand and speak English. Exclusion Criteria: Contraindications to MRI, CT, or TMS Claustrophobia Pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants. Pregnancy Active medical disorder or treatment with potential CNS effects History of neurologic disorder History of head injury resulting in loss of consciousness for >10 minutes History of alcohol or drug dependence Failure to provide a social security number or tax ID number. This is required for tax purposes or payment cannot be processed.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Multi-visit study, testing various LIFU parameters per session
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parameter Trials<br>Approximately 36 parameter combinations will be tested per study session, expected 6 sessions of trials. Response recorded using TMS and EMG. | Device: Low-intensity Focused Ultrasound<br>* LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waveforms | Changes in waveform peak will be observed per each variable application of LIFU | Outcome measured throughout study participation - an average of 4 weeks per participant. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low-intensity focused ultrasound, transcranial magnetic stimulation
Characteristics and Outcome of Patients With COVID-19 in ICUs in South Tyrol

Study Overview
=================
Brief Summary
-----------------
The investigators retrospectively investigate the epidemiology, clinical characteristics and therapeutic interventions of patients with COVID-19 associated respiratory failure admitted to the intensive care units in South Tyrol, Italy.

Detailed Description
-----------------
In this observational, retrospective study the epidemiology, characteristics, therapeutic interventions and outcome of patients with COVID-19 associated respiratory failure admitted to the intensive care units in South Tyrol, Italy, are assessed. Data extracted from the medical patients' records include type and duration of respiratory support (high-flow nasal oxygen, non-invasive ventilation, invasive ventilation), need for tracheostomy, vasopressor needs, antibiotic therapy, corticosteroid treatment, laboratory values (interleukin-6, C-reactive protein, procalcitonin, D-dimer, lymphocyte count), lengths of stay in the ICU and mortality.

Official Title
-----------------
Characteristics and Outcome of Patients With COVID-19 Associated Respiratory Failure Treated in South Tyrol, Italy

Conditions
-----------------
COVID-19, COVID-19 Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted to the intensive care units in South Tyrol due to COVID-19 associated respiratory failure Exclusion Criteria: SARS-CoV-2 patients admitted to the intensive care units in South Tyrol for other pathologies (i.e., not respiratory failure)

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality (dead/alive) at discharge from the ICU is defined as primary outcome | Through study completion, an average of 1 year |
Influence of Nevirapine on HCV Viral Load

Study Overview
=================
Brief Summary
-----------------
Nevirapine-based antiretroviral therapy is associated with lower plasma HCV viral load in HIV/HCV-coinfected individuals.

Official Title
-----------------
Influence of Nevirapine on HCV Viral Load Among HIV/HCV-coinfected Patients

Conditions
-----------------
HCV Infection., HCV Viral Load.

Intervention / Treatment
-----------------
* Drug: Nevirapine
* Drug: efavirenz, protease inhibitors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infection. Older than 18 years. Chronic hepatitis C. Undetectable HIV viral load during one year before starting study. To have not received HCV therapy during one year before starting study. To have not started efavirenz or protease inhibitors o nucleoside analogs during 6 months before starting study. Non contraindications for drugs included in this study. To change an antiretroviral regimen including efavirenz or protease inhibitors by nevirapine due to side effects, interactions or pregnancy (NVP group) To continue with a antiretroviral regimen including efavirenz or protease inhibitors (non-NVP group) Both groups will be matched according to these variables: Liver stiffness. HCV genotype. Hospital. Time from starting antiretroviral therapy. Previous third drug (EFV or PI) to introduction of NVP. Exclusion Criteria: HCV therapy during follow-up

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nevirapine<br> | Drug: Nevirapine<br>* nevirapine: 400 mg a day.<br>Drug: efavirenz, protease inhibitors<br>* efavirenz: 600 mg a day<br>|
| Active Comparator: Non-nevirapine<br> | Drug: Nevirapine<br>* nevirapine: 400 mg a day.<br>Drug: efavirenz, protease inhibitors<br>* efavirenz: 600 mg a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HCV viral load |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCV, HIV, Nevirapine, HCV viral load, Efavirenz, Protease inhibitors
Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView

Study Overview
=================
Brief Summary
-----------------
This study is designed as a prospective observational, non-controlled, non-interventional study. The aim of this study is to obtain a broad user perspective of the aScope™ 4 Broncho, focusing on the device functionalities within regular clinical practice and therapeutic use of flexible bronchoscopes in the OR and ICU. The study will include a minimum of 100 adult patients admitted to the operating room (OR) or Intensive Care Unit (ICU) undergoing at least one bronchoscopy procedure. The inclusion will stop when 100 fully evaluable patients or a maximum of 150 patients have been enrolled. The involved sites will include patients during a five months' period, from September 2017 to January 2018.

Detailed Description
-----------------
Refer to brief description

Official Title
-----------------
Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView

Conditions
-----------------
Bronchoscopy, Anesthesia

Intervention / Treatment
-----------------
* Device: aScope 4 Broncho


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient's ≥18 years Clinical indication and eligible for an airway procedure involving a bronchoscopy procedure, as judged by the Investigator Patients being admitted in the OR or ICU at the investigational site Exclusion Criteria: - None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| aScope 4 Broncho<br>The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho | Device: aScope 4 Broncho<br>* Investigator is asked: In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure Patients will not be asked to consent to participate in this study, as no patient data are obtained and the CE-marked aScope™ 4 Broncho is used within its intended use<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Preference of Scope | This non-interventional study compared the clinical performance of the Ambu aScope 4TM Bron-cho with the standard bronchoscope (reusable or single-use) normally used at each of the study centers based on the investigators memory of the standard bronchoscope. | Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit |
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total hip replacement surgery.

Official Title
-----------------
Phase II/III Study of YM150 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients Undergoing Elective Total Hip Replacement Surgery

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: YM150
* Drug: Placebo
* Drug: Enoxaparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects is scheduled for elective primary total hip replacement surgery Written informed consent obtained before screening Exclusion Criteria: Subject has history of deep vein thrombosis and/or pulmonary embolism Subject has a hemorrhagic disorder and/or coagulation disorder Subject has had clinically important bleeding occurred within 90 days prior to the screening visit Subject has an acute bacterial endocarditis, retinopathy, hypertension, or thrombocytopenia Subject is receiving anticoagulants/antiplatelet agents

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YM150 group-1<br>YM150 low dose group | Drug: YM150<br>* oral<br>|
| Experimental: YM150 group-2<br>YM150 high dose group | Drug: YM150<br>* oral<br>|
| Placebo Comparator: Placebo group<br> | Drug: Placebo<br>* oral<br>|
| Active Comparator: Enoxaparin group<br> | Drug: Enoxaparin<br>* injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall incidence of venous thromboembolism |  | For 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of individual venous thromboembolism |  | For 2 weeks | 
| Incidence of bleeding events |  | For 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
YM150, FXa inhibitor, Thrombosis, Anticoagulant, Venous thromboembolism, Arthroplasty, replacement, hip
The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a four-week treatment period.

Conditions
-----------------
Blepharitis

Intervention / Treatment
-----------------
* Drug: Azithromycin ophthalmic solution, 1%
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have best corrected visual acuity in both eyes of at least +0.7 or better If female, are non-pregnant or non-lactating Have a current diagnosis of blepharitis in one or both eyes Exclusion Criteria: Have lid structural abnormalities Have suspected ocular fungal or viral infection Have practiced warm compress therapy within 14 days prior to Visit 2 Unable to withhold the use of contact lenses during the treatment or follow-up periods Unable to withhold the use of ocular cosmetic products within 24 hours prior to study visits Have had penetrating intraocular surgery within 90 days prior to Visit 2 Have had ocular surface surgery within the past year prior to Visit 2 Have a serious medical condition which could confound study assessments

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: 1<br> | Drug: Azithromycin ophthalmic solution, 1%<br>* One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eyelid margin erythema |  | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs and symptoms of Blepharitis |  | One week, two weeks, three weeks, four weeks, six weeks, eight weeks |
Pilot Cohort Study of Rb-82 Myocardial PET Imaging to Evaluate Coronary Microvascular Dysfunction in Men With Prostate Cancer Receiving Androgen-Deprivation Therapy

Study Overview
=================
Brief Summary
-----------------
To determine the feasibility of using myocardial PET imaging as a means to assess cardiovascular risk in men with prostate cancer planned for androgen- deprivation therapy with external beam radiation therapy.

Official Title
-----------------
Pilot Cohort Study of Rb-82 Myocardial PET Imaging to Evaluate Coronary Microvascular Dysfunction in Men With Prostate Cancer Receiving Androgen-Deprivation Therapy

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

Intervention / Treatment
-----------------
* Device: myocardial PET imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Either clinically localized prostate cancer or biochemically-recurrent prostate cancer patients who are planned for at least 6 months ADT with a GnRH agonist and curative-intent radiation therapy per their oncologic providers. Over 50 years of age. Calculated 10-year Framingham General Cardiovascular Risk Score of ≥10% at the time of planned initiation of ADT. Patients must be able to read and understand English. Participants must sign the informed consent form. Exclusion Criteria: Prior treatment with GnRH agonist therapy. History of active asthma or other reactive airway disease. Ischemic cardiac event (myocardial infarction, unstable angina) within the preceding 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 51 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>To determine the feasibility of using myocardial PET imaging | Device: myocardial PET imaging<br>* using myocardial PET imaging as a means to assess cardiovascular risk in men with prostate cancer planned for androgen-deprivation therapy with external beam radiation therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of subjects who successfully complete Rb-82 myocardial PET Imaging assessments |  | 12-18 months |
Total Joint Arthroplasty and Sleep

Study Overview
=================
Brief Summary
-----------------
To compare non-prescription sleep aids (low-dose diphenhydramine and melatonin) to sleep hygiene education for improving postoperative sleep quality after total joint arthroplasty.

Official Title
-----------------
Postoperative Sleep Quality Following Total Joint Arthroplasty: A Prospective, Randomized, Controlled Trial of Diphenhydramine and Melatonin Versus Sleep Skills Training

Conditions
-----------------
Primary Total Hip Arthroplasty, Primary Total Knee Arthroplasty

Intervention / Treatment
-----------------
* Drug: Diphenhydramine (Benadryl)
* Dietary Supplement: Melatonin
* Behavioral: Sleep Hygiene Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing elective primary total hip or knee arthroplasty Exclusion Criteria: History of substance abuse Workman's compensation patients Revision joint replacement History of prescription or over-the- counter sleep aid use

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group (Usual Care)<br>Usual care | |
| Active Comparator: Sleep Hygiene Education<br>Sleep Hygiene Education | Behavioral: Sleep Hygiene Education<br>* Brochure containing information about getting a good night's sleep.<br>|
| Active Comparator: Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin)<br>Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin) and Sleep Hygiene Education | Drug: Diphenhydramine (Benadryl)<br>* Oral Diphenhydramine (Benadryl), 25 mg<br>Dietary Supplement: Melatonin<br>* Oral Melatonin, 3 mg<br>Behavioral: Sleep Hygiene Education<br>* Brochure containing information about getting a good night's sleep.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epworth Sleepiness Scale (ESS) | Patient Reported Outcome Measure - assess the daytime sleepiness of the patient Scale: 0-3. 0 being never dozing, 3 being high chance of dozing | 12 weeks post-op | 
| Pittsburgh Sleep Quality Index (PSQI) | Patient Reported Outcome Measure - measure the quality and patterns of sleep in the older adult Scale: 0-3. 0 no trouble sleeping in the past month/very good sleep, 3 three or more times having trouble sleeping in the past month/very bad sleep | 12 weeks post-op | 
| Visual Analogue Scale (VAS) for pain | Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain | 12 weeks post-op |