linjc16/ctgov huggingface dataset:
Lung Deposition Via Different Inhalation Devices

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the deposition of budesonide to the lung after inhalation with 5 different devices and to relate the findings to in vitro properties of inhaled budesonide.

Official Title
-----------------
A Phase I, Randomized, Open-label, 5-way Crossover, Single Centre Study in Healthy Subjects to Assess the Lung Deposition of Inhaled Budesonide Delivered Via Different Inhalation Devices

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Pulmicort pMDI HFA
* Drug: Budesonide pMDI HFA
* Drug: Pulmicort Repulses
* Drug: Pulmicort Turbohaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent prior to any study specific procedures BMI between 18 and 30 kg/m2 Non-smokers/non-snuffers Exclusion Criteria: Pregnant and/or lactating women Use of oral contraceptives or hormonal implants Known or suspected hypersensitivity to glucocorticosteroids, inhaled lactose, or other excipients in study drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Pulmicort pMDI | Drug: Pulmicort pMDI HFA<br>* Inhalation aerosol, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations<br>|
| Experimental: 2<br>Budesonide pMDI | Drug: Budesonide pMDI HFA<br>* Inhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations<br>|
| Experimental: 3<br>Budesonide pMDI + Aerochamber Zero-stat spacer | Drug: Budesonide pMDI HFA<br>* Inhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations<br>|
| Experimental: 4<br>Pulmicort repulses via Spira Nebuliser | Drug: Pulmicort Repulses<br>* Suspension for nebulisation, 0.5 mg/mL. Each subject receive a single dose from 100 inhalations<br>|
| Experimental: 5<br>Pulmicort Turbohaler | Drug: Pulmicort Turbohaler<br>* Inhaled powder, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung deposition of budesonide (AUC) |  | Before dose and repeatadly during the 8-hour period after dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inhalation, lung deposition
Clinical Outcome in Uveitis

Study Overview
=================
Brief Summary
-----------------
This study is aimed at investigating the long term clinical outcome of patients with uveitis.

Detailed Description
-----------------
Patients will be included if they are treated for uveitis and have had repeat follow-up. Data will be gathered from the entire length of the patients follow-up. The main outcome measures will be: Change from baseline of Best corrected visual acuity (BCVA)at 10 years Causes of vision loss (≤6/15, VL) and severe vision loss (≤6/60, SVL) at 10 years Number of clinical visits at 10 years.

Official Title
-----------------
Clinical Outcome and Causes of Visual Loss in Uveitis

Conditions
-----------------
Uveitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical Diagnosis of Uveitis. Exclusion Criteria: No follow-up data.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Uveitis<br>Patient with a clinical diagnosis of Uveitis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity | Recorded repeat best corrected visual acuity at intervals throughout the length of follow-up. | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Causes of visual loss | Record any ocular changes related to permanent visual loss under 6/12 and severe visual loss under 6/60. | First follow-up, years 1,2,5,10, Final follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uveitis, Vision Loss
Long Term Safety of Aliskiren Alone or With the Optional Addition of Hydrochlorothiazide in Patients With Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
Assess the long-term safety and tolerability of aliskiren, with the optional addition of HCTZ, in patients with essential hypertension, to ensure long term blood pressure control and protect against end organ damage.

Official Title
-----------------
A 12 Month, Randomized, Open-label, Multicenter, Study to Assess the Long Term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential Hypertension.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients with essential hypertension. Patients who are eligible and able to participate in the study. Exclusion Criteria Severe hypertension. History or evidence of a secondary form of hypertension. History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply.

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aliskiren|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, laboratory abnormalities, serious adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean sitting diastolic blood pressure after 12 months |  |  | 
| Change from baseline in mean sitting systolic blood pressure after 12 months |  |  | 
| Change from baseline in standing systolic blood and diastolic pressure after 12 months |  |  | 
| Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline |  |  | 
| Blood pressure less than 140/90 mmHg |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, blood pressure, aliskiren
Individualized Perioperative Open Lung Ventilatory Approach in Emergency Abdominal Laparotomy. A Prospective Multicenter Randomized Controlled Trial.

Study Overview
=================
Brief Summary
-----------------
Prospective multicenter randomized controlled trial. Individualized perioperative open lung ventilatory approach in emergency abdominal laparotomy.

Official Title
-----------------
Individualized Perioperative Open Lung Ventilatory Approach in Emergency Abdominal Laparotomy. A Prospective Multicenter Randomized Controlled Trial.

Conditions
-----------------
Ventilator Lung

Intervention / Treatment
-----------------
* Procedure: STD-02
* Procedure: iOLA-iHFNC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult men and women ≥18 years of age who underwent emergency laparotomy with the presence of post-induction positive air-test (SpO2 <97% after a maximum of 15 minutes at FIO2 of 0.21). A SpO2 <97% at any FIO2 would also be considered a positive air-test. Exclusion Criteria: 1) Pregnancy or breast feeding, 2) Moderate or severe ARDS defined, 3) refractory shock, 4) diagnosis or suspected intracranial hypertension (>15mmHg), 5) mechanical ventilation in the last 15 days (including CPAP), 6) presence of pneumothorax or giant bullae in a chest radiograph or computed tomography (CT), 7) patients participating in another intervention study with the same or similar primary outcome variable.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: STD-02<br>Conventional standardized lung protective ventilation. | Procedure: STD-02<br>* Conventional standardized ventilatory approach.<br>|
| Experimental: iOLA-iHFNC<br>Individualized ventilatory strategy that mantains an open lung condition. | Procedure: iOLA-iHFNC<br>* Indivudualized perioperative open lung ventilatory approach.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe postoperative pulmonary complications | A composite of severe postoperative pulmonary complications appearing during the first 7 postoperative days. Postoperative pulmonary complication will include any of the following: 1) Respiratory failure, 2) Pneumothorax, 3) Weaning failure, 4) Acute respiratory distress syndrome (ARDS), 5) Pulmonary infection. | 7 days |
Assessment of Dolutegravir Removed by Hemodialysis in HIV-infected Patients With End-stage Renal Disease

Study Overview
=================
Brief Summary
-----------------
Data on the capacity of hemodialysis to remove dolutegravir (DTG) from plasma in patients with end-stage renal disease (ESRD) on hemodialysis (HD) are lacking. If DTG was removed from plasma by HD, it would be possible to have subtherapeutic drug concentrations at the end of HD sessions.

Detailed Description
-----------------
The prevalence of chronic renal disease and end-stage renal disease (ESRD) is increasing in the HIV-positive population. This means that an increasing number of HIV-infected patients will need renal replacement therapy.However, little is known about DTG removal from plasma by HD in patients with ESRD. Objective: to evaluate the effect of HD on DTG clearance as well as on DTG plasma concentrations at steady state in HIV-infected patients with ESRD undergoing HD.

Official Title
-----------------
Removal of Dolutegravir by Hemodialysis in HIV-infected Patients With End-stage Renal Disease

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Drug: Dolutegravir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age 1 years old or older. HIV documented infection (western blot) ESRD undergoing routine hemodialysis Stable antiretroviral treatment (no changes within the prior 2 weeks) Signature of informed consent Exclusion Criteria: Inadequate adherence to antiretroviral treatment (<90% in the week prior to inclusion). Clinical evidence or suspicion that the patient will not be able to comply with the study protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dolutegravir 50mg/day per 5 days<br>Dolutegravir 50mg/day per 5 days | Drug: Dolutegravir<br>* Dolutegravir 50mg/day per 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodialysis extraction ratio of dolutegravir |  | Day 5 | 
| hemodialysis clearance of dolutegravir |  | Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients presenting adverse events related to dolutegravir |  | From Baseline to day 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, HIV-infection
Compliance of Diabetic Patients Treated With Metformin

Study Overview
=================
Brief Summary
-----------------
Metformin is the 1st line treatment in all subjects with type 2 diabetes without a contraindication to its use. The compliance with the use of metformin is not optimal mainly owing to relatively frequent gastrointestinal side effects. However, hard data about the real compliance are currently not available. In this trial we aim at assessing the compliance with metformin intake using a combination of serum metformin measurement and a specific questionnaire. We will further evaluate the impact of different pharmacological forms of metformin (standard vs. XR - extended release) on its compliance and try to identify common characteristics associated with reduced compliance.

Official Title
-----------------
Compliance of Diabetic Patients Treated With Metformin

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Diagnostic Test: Measurement of plasma metformin levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus on metformin therapy for at least 3 months Exclusion Criteria: -

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Measurement of plasma metformin levels|Subjects on chronic metformin therapy will have their plasma metformin levels measured during a regular check-up with glycated hemoglobin assessment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma metformin levels |  | At the time of measurement |
Volumetric Bone Mineral Density and it's Relationship With Osteoporotic Fractures in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Idiopathic Parkinson's disease (IPD) is the second most frequent neurodegenerative disease. Its association with osteroporosis and fragility fracture is now clearly demonstrated, but the determinants of this osteoporosis are yet to be explained. Our aim was to study factors associated with volumetric bone mineral density (vBMD) and bone microstructure at the tibia and radius in IPD.

Official Title
-----------------
Determinants of Volumetric Bone Mineral Density at the Tibia and Radius and it's Relationship With Osteoporotic Fractures in Idiopathic Parkinson's Disease

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

Intervention / Treatment
-----------------
* Other: High resolution peripheral scanner (HRpQCT).


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with idiopathic Parkinson's disease according to the criteria of the UKPDBB. Parkinson's disease of moderate severity (Index HOEHN and Yahr <5) Patient can respond to questionnaires, with or without help Exclusion Criteria: Patients with active psychiatric illness preventing the realization of examinations Severe Parkinson's disease (Index HOEHN and Yahr ≥5 ) Heavy-morbidity including heart failure NYHA> 3 or chronic respiratory failure, terminal or severe renal impairment known dialyzed Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Idiopathic Parkinson's Disease patients<br>High resolution peripheral scanner (HRpQCT). | Other: High resolution peripheral scanner (HRpQCT).<br>* radius and tibia osteodensitometry measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of volumetric bone mineral density at the tibia and radius | Measurement performed by High Resolution peripheral Quantitative Computed Tomography (HRpQCT) | 0 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, Parkinson, HR-pQCT, bone microstructure, fracture risk
Prospective Robotic-assisted Revisional Bariatric Study

Study Overview
=================
Brief Summary
-----------------
Very few studies have compared robotic-assisted (RRBS) versus laparoscopic revisional bariatric surgeries (LRBS). To date, there has not been a prospective study comparing the perioperative outcomes of patients undergoing robotic-assisted and laparoscopic revisional bariatric surgery. This study aims to enroll patients undergoing RRBS and LRBS and evaluate the outcomes through 45 days, including the perioperative period. We hypothesize that RRBS may be associated with lower rates of perioperative outcomes.

Official Title
-----------------
A Prospective Multicenter Study to Evaluate the Perioperative Outcomes of Robotic-assisted Revisional Bariatric Surgery

Conditions
-----------------
Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Procedure: Revisional bariatric surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18 years or older at the time of consent Subject has a history of prior bariatric surgery Subject's revisional procedure will be either laparoscopic revisional bariatric surgery (LRBS) or robotic-assisted revisional bariatric surgery (RRBS) Subject undergoes revisional bariatric surgery that is applicable to study Exclusion Criteria: Subject is undergoing a primary bariatric procedure Subject has undergone more than one previous bariatric procedure Subject's revisional bariatric procedure is an emergent procedure Subject is contraindicated for general anesthesia or surgery Subject is unable to comply with the follow-up visit schedule Subject is pregnant or suspects pregnancy Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent Subject belonging to other vulnerable population, e.g, prisoner or ward of the state

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 |
| --- | --- |
| Robotic-assisted revisional bariatric surgery<br>Subjects who undergo robotic-assisted revisional bariatric surgery | Procedure: Revisional bariatric surgery<br>* Subjects who undergo revisional bariatric surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of conversions | Conversions is defined as RRBS to LRBS or open revisional bariatric surgery, and LRBS to open revisional bariatric surgery | During the surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative rate of anastomotic leak | Anastomotic leak is defined as a leak of luminal contents from a surgical join | 45 days after date of procedure |
Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect

Study Overview
=================
Brief Summary
-----------------
With this observational study we want to examine if the intensity of agitation, the intensity of psychotic symptoms and the presence of sleeping disorder predict the success of the treatment with a atypical antipsychotic after 12 weeks of treatment with patients with a psychotic and/or manic episode. In this study it will be examined what the percentage of patients with a 2-point improvement at the CGI-scale is. Of these group, the responders, retrospective the profile of the responders will be analysed (key-factors and confounders). PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect

Conditions
-----------------
Mania, Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a manic episode or patients diagnosed with schizophrenia (psychotic episode) Patients who start a treatment with an atypical antipsychotic : quetiapine, olanzapine or risperidone Patients who are prepared to consent to make the coded data available to AstraZeneca Patients with a CGI ≥ 4 Exclusion Criteria: Patients with a serious underlying disease (including renal or hepatic insufficiency, cancer, cardiovascular diseases and suchlike). Contra-indications for quetiapine, olanzapine or risperidone according to the SmPC for these products Patients unable to give informed consent according to the attending physician

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 |
| --- | --- |
| Quetiapine<br> | |
| Olanzapine<br> | |
| Risperidone<br> | |

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
-----------------
Patients with a manic episode, Patients diagnosed w/schizophrenia, who start a treatment with an atypical antipsychotic & who are at least scored as moderately ill on the CGI at baseline