linjc16/ctgov huggingface dataset:
Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of ONO-2506PO in patients with Parkinson's Disease

Official Title
-----------------
Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: ONO-2506PO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Parkinson's disease Stage 2 - Stage 4 of revised Hoehn & Yahr severity score Taking L-dopa/DCI without changing dose and regimen Having motor complication Other inclusion criteria as specified in the study protocol Exclusion Criteria: Previous participation in ONO-2506PO or ONO-2506 protocol Previous brain surgery for Parkinson's disease Presence or history of serious cardiac disease Other exclusion criteria as specified in the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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

| Intervention/Treatment |
| --- |
|Drug: ONO-2506PO|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's disease rating scale (Part III) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's disease rating scale (Part I, II, IV and total), revised Hoehn & Yahr severity score and off time |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-2506PO, Parkinson's disease
Alpha-1 Foundation DNA and Tissue Bank

Study Overview
=================
Brief Summary
-----------------
This is a long-term follow-up banking protocol that collects medical information and tissue (blood, liver and lung) samples for future research; use of data and samples for research purposes is overseen by the Tissue Bank Advisory Committee; the purpose of the Bank is to further research on alpha-1 antitrypsin deficiency.

Detailed Description
-----------------
Subject participation includes completion of informed consent, medical questionnaire, and email authorization. Subjects may provide a blood sample for alpha-1 antitrypsin genotype, phenotype and level. Lung and liver tissue may also be provided if available. Subjects may be contacted no more often than annually for updated information. This project has a certificate of confidentiality from NIH.

Official Title
-----------------
Alpha-1 Foundation DNA and Tissue Bank

Conditions
-----------------
Alpha 1 Antitrypsin Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all interested individuals may enroll Exclusion Criteria: there are no exclusion criteria
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 |
| --- | --- | --- |
| Data and tissue samples | At the end of 15 years the tissue and data sample usage will be analyzed to determine continuation of the project. Each year the investigator provides a summary to the Alpha-1 Foundation. | The total number of tissue samples received and used for research are tracked annually. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tissue banking, research
Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Population in study will be selected from students and staff of the University of Pisa. Right carotid artery contour wave analysis will be performed during the application of different PEEP levels (from 0 cmH2O to 10 cmH2O) with applanation tonometry technique.

Official Title
-----------------
Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Other: progressive increasing of PEEP level.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 40, absence of any chronic diseases, no smoke, no drugs assumptions, no use of caffeine the day of the exam Exclusion Criteria: pregnancy, chronic diseases, smokers, and intake of caffeine the day of the exam.

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: progressive increasing of PEEP level<br>four-step measurements of central artery blood pressure evaluating contour wave analysis during a progressive increasing of PEEP level. | Other: progressive increasing of PEEP level.<br>* four-step measurements of central artery blood pressure evaluating contour wave analysis during a progressive increasing of PEEP level First step (Baseline) Subjects spontaneously breathe in air at atmospheric pressure during applanation tonometry. Second step (PEEP=5 cm H2O) Applanation tonometry was performed during the application of PEEP = 5 cmH2O (Oxygen flow = 8lt.- Air flow = 10 lt.). Third step (PEEP= 10 cm H2O) Applanation tonometry was performed during the application of PEEP = 10 cmH2O (Oxygen flow = 15lt.- Air flow = 20 lt.). Fourth step (Recovery) Subjects spontaneously rebreathe air at atmospheric pressure during applanation tonometry.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic variations in wave reflection induced by the application of increasing levels of PEEP in healthy subjects. | Mean blood pressure | at rest and after 5 minutes |
Analgesia aNd caNcer recUrrence Lung cAncer Resection

Study Overview
=================
Brief Summary
-----------------
The choice of analgesia after cancer surgery may play a role in the onset of recurrence, particularly opioids seem to play a role in the immune system by promoting cancer cell proliferation and migration. Based on this consideration, our aim was to assess the impact of perioperative analgesia's choice on cancer recurrence after curative surgery for Stage I Non-Small Cell Lung Cancer. The investigators retrospectively reviewed the records of patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012. Patients received analgesia either by peridural (PERI group) or, in case of patient refusal or failure in catheter positioning, intravenous analgesia with opioids (EV group). Follow-up was concluded in August 2019. The five-year cumulative incidence of recurrence and the overall survival were evaluated and adjusted with a propensity score matching methodology.

Official Title
-----------------
Impact of Analgesia on Cancer Recurrence and Mortality Within Five Years After Stage I Non-Small Cell Lung Cancer Resection

Conditions
-----------------
Recurrence Tumor, Opioid Use, Unspecified, Analgesia, Thoracic Surgery

Intervention / Treatment
-----------------
* Procedure: Peridural analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 yrs Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012 Exclusion Criteria: Age<18aa Pregnancy Day hospital patients

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| PERI group<br> | Procedure: Peridural analgesia<br>* We attempted to evaluate the effectiveness of peridural analgesia through cancer survival and recurrence outcomes.<br>|
| EV group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative incidence of recurrence and the overall survival |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Recurrence tumor, Opioid use, Analgesia, thoracic surgery
Evaluation of A Novel Methodology in the Assessment of Urethral Function Using [S,S]-Reboxetine in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
[S,S]-Reboxetine will be used to evaluate pharmacodynamic changes in urethral function in healthy volunteers using a novel methodology

Official Title
-----------------
Measurement Of Urethral Function In Healthy Female Volunteers - Evaluation Of The Sensitivity of Urethral Reflectometry Compared To Urethral Pressure Profilometry, Using [S,S]-Reboxetine.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: [S,S]-Reboxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female subjects, aged 18-65 years. Subjects must be non-pregnant and non-lactating, and be either post menopausal (greater than 1 year without menses), surgically sterilized, or using another acceptable form of contraception. Subjects of child bearing potential must have confirmed negative pregnancy tests at screening and prior to commencing all study periods. Exclusion Criteria: Evidence or history of clinically significant disease (including drug allergies, but excluding untreated, asymptomatic,seasonal allergies at time of dosing). Subjects with any clinically significant abnormality following review of laboratory data, urinalysis and physical examination.

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: [S,S]-Reboxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflectometry measurements at visit 2, 3, 4 , 5, 6 and 7. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urethral pressure profile measurements at visit 2, 3, 4, 5, 6 and 7 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Equipment, Supplies
Balancing of Patients Treated by Vitamin K Antagonists (VKAS) in General Medicine

Study Overview
=================
Brief Summary
-----------------
Despite the rise in prescriptions for direct oral anticoagulants,Vitamin K antagonists(VKA) remains the most prescribed treatment for treating and preventing long-term thromboembolic events. They remain the most important drugs of iatrogenic accidents despite the means deployed by the health authorities. The balance of the patients under VKA can be appreciated thanks to the time spent in the therapeutic zone or TTR which is correlated with the risk of occurrence of haemorrhagic or thrombotic events.

Detailed Description
-----------------
Despite the rise in prescriptions for direct oral anticoagulants, Vitamin K antagonists (VKA) remains the most prescribed treatment for treating and preventing long-term thromboembolic events. They remain the most important drugs of iatrogenic accidents despite the means deployed by the health authorities. The balance of the patients under VKA can be appreciated thanks to the time spent in the therapeutic zone or TTR which is correlated with the risk of occurrence of haemorrhagic or thrombotic events. The management of VKA in France seems hardly comparable to that of the neighboring countries in front of: A TTR estimated at 60%. Majority management of anticoagulant treatments by general practitioners. The weak development of clinics anticoagulants. The takeoff of direct oral anticoagulant prescriptions. Preponderance of fluindione prescriptions among the various oral anticoagulants. It therefore seems interesting to study a cohort of French patients under VKA. Through the calculation of the TTR, the investigators will be able to draw a picture of the balance of the anticoagulant treatment and try to identify factors that can influence it.

Official Title
-----------------
Balancing of Patients Treated by Vitamin K Antagonists (VKAS) in General Medicine : Study ok Variables Influencing the Time Paid in the Therapeutic Target

Conditions
-----------------
Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient treated with VKA. Realization of INR in one of the labs of the territory of LaboSud Oc biology between 1 September 2015 and 13 January 2016. Exclusion Criteria: Less than 3 INR during the data collection period (TTR calculation not possible). Time greater than 56 days between two INRs (calculation of the invalid TTR). Interrupted treatment (calculation of invalid TTR). Lack of information about the patient

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time spent in the therapeutic range (TTR) | calculating their time spent in the therapeutic range (TTR). | 1 day |
The Effect of Cognitive Behavior Intervention on Psychological Distress of Cancer Patients and Their Family Members

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the effect of cognitive behavior group intervention with cancer patients and their family members. Around 80 cancer patients and their family members will participate in group intervention and will be compared with 80 controls.

Detailed Description
-----------------
The aim of the study is to evaluate the effect of cognitive behavior group intervention with cancer patients and their family members. Around 80 cancer patients and their family members will participate in group intervention and will be compared with 80 controls (randomized control study). Brief Symptom Inventory,Fatigue inventory, Mini Sleep Questionnaire and repression-sensitization questionnaire will be answered by the participants pre-, post-intervention and after four months.

Official Title
-----------------
Evaluation of the Effect of Cognitive Behavior Intervention on Psychological Distress of Cancer Patients and Their Family Members

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: cognitive-behavior groups


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hebrew speaking Exclusion Criteria: psychiatric condition

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

| Intervention/Treatment |
| --- |
|Behavioral: cognitive-behavior groups|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in psychological distress, level of fatigue and sleep problems |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer patients, family, cognitive behavior, distress
Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to receive either a continuous infusion of propofol or a continuous infusion combination of fentanyl and midazolam preceded by a loading dose. Sedative doses may be reduced if necessary. Treatment is continued until sedation is no longer needed, any other sedative therapy is administered, or unacceptable toxicity is experienced. Patients are assessed after extubation, just prior to hospital discharge, and then every 2 months for 6 months after hospital discharge.

Conditions
-----------------
Respiration Disorders

Intervention / Treatment
-----------------
* Drug: fentanyl
* Drug: Midazolam
* Drug: propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients admitted to the Rainbow Babies and Children's Hospital Pediatric Intensive Care Unit who require mechanical ventilation and sedation therapy Mean COMFORT score must be greater than 26 after 3 consecutive scores are obtained at 2 minute intervals over 6 minutes No other concurrent sedative therapy

Ages Eligible for Study
-----------------
Maximum 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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fentanyl|nan|
|Drug: Midazolam|nan|
|Drug: propofol|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
-----------------
disease-related problem/condition, oncologic disorders, pulmonary complications, rare disease, Respiration, Artificial
Does LMA Instead of ET Tube Affect Incidence of Postoperative Vomiting in Children Undergoing Strabismus Correction?

Study Overview
=================
Brief Summary
-----------------
The effect of airway management on vomiting after strabismus surgery is unknown. The purpose of this study is to find out whether the use of different airway devices, such as LMA, which is a special mask placed in the throat or Endotracheal tube (ET tube), which is a soft tube placed in the wind pipe, affects the incidence of vomiting after surgery. Two hundred six children between the ages of 2 and 12 years are expected to take part in this study.

Detailed Description
-----------------
The child will be checked by the study doctor to determine if he/she qualifies to be part of the study. The study doctor may not want the child to take part in this study if he/she is currently in another research study; or if the child has been in any other research study within the last 30 days, or if the child is extremely obese, or has reflux or another GI problem. If the child qualifies for the study, he/she will receive routine general anesthesia. For airway management, the child will have either a LMA or ET tube. The child has an equal chance of receiving either one of these airways devices, much like the coin flip. After surgery, the child will be transferred to the recovery room (PACU). If the child vomits in PACU, he/she will receive rescue medication, which can be repeated if the need arises. A research coordinator will call the parents the following day to find out whether the child vomited after leaving the hospital, in the car or at home, for any complications and receiving any medications.

Official Title
-----------------
Does Using Laryngeal Mask Airway (LMA) Instead of an Endotracheal Tube (ET Tube) Affect the Incidence of Postoperative Vomiting in Children Undergoing Strabismus Correction? - An Observational Study

Conditions
-----------------
Strabismus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Elective Uni- or Bilateral Strabismus repair Exclusion Criteria: ASA >2 History of Prematurity History of Reflux History of Neurological Disease Difficult Airway Obesity

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 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 |
| --- | --- |
| LMA group<br>Patients in which laryngeal mask airway (LMA) is used. | |
| ET group<br>Patients in which endotracheal tube (ET) is used. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of the patients that will develop postoperative vomiting in children undergoing strabismus correction |  | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Strabismus, LMA, ET Tube, POV