linjc16/ctgov huggingface dataset:
The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)

Study Overview
=================
Brief Summary
-----------------
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the seal/mask.

Detailed Description
-----------------
A minimum of 15 OSA participants who currently use a Full face mask will be recruited for the trial. Participant will be on the trial for 1 week- The participant will use the trial seal in-home for 1 week. An additional 5 Participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.

Official Title
-----------------
The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea (OSA)

Conditions
-----------------
Sleep Disordered Breathing, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: F&P Mask Seal
* Device: F&P Mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (18+ years of age) Able to give consent Apnea hypopnea Index (AHI)≥ 5 on diagnostic night Prescribed PAP for OSA Existing oro-nasal mask user Exclusion Criteria: Inability to give consent Patients who are in a coma or a decreased level of consciousness Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure) Commercial drivers who are investigated by New Zealand Transport Agency Current diagnosis of carbon dioxide (CO2) retention Pregnant or may think they are pregnant

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F&P Mask Seal<br>Participants to use trial seal in-home for 1 week | Device: F&P Mask Seal<br>* Investigative Mask Seal to be used for OSA therapy<br>|
| Experimental: F&P Mask<br>Participants to use trial mask in-home for 2 weeks | Device: F&P Mask<br>* Investigative Mask to be used for OSA therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use | Subjective questionnaire | 1 week in home | 
| Acceptability | Subjective questionnaire | 1 week in home | 
| Ease of use | Subjective questionnaire | 2 weeks in home | 
| Acceptability | Subjective questionnaire | 2 weeks in home | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective leak data | Obtained from participants' device | 1 week in home |
Physical Activity on Prescription in Overweight Older Adults

Study Overview
=================
Brief Summary
-----------------
This randomized controlled study evaluates the effect of individualized physical activity on prescription (PAP) in older overweight adults. The primary hypothesis is that an individualized prescription of physical activity increases physical activity level in overweight older adults after 6 months. Secondary hypothesis are that the increased physical activity level will improve cardio metabolic risk factors and quality of life. 200 women and men, aged 65 with low physical activity level, overweight, and abdominal obesity, will be randomized to an intervention group or a control group. The control group receives general information about physical activity and registration of physical activity level for one week. The intervention group receives in addition an individualized physical activity on prescription with patient-centered counseling. After six months both groups go through the same health check-up as at baseline and follow-ups take place after 12 and 24 months.

Official Title
-----------------
Physical Activity in Prevention and Treatment of Overweight, Central Obesity and the Metabolic Syndrome - a Randomised Controlled Study in Overweight 65 Year Old Women and Men

Conditions
-----------------
Low Physical Activity Level, Central Obesity, Metabolic Syndrome

Intervention / Treatment
-----------------
* Behavioral: Physical activity on prescription


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 25 and 40 waist circumference over 88 cm for women and 102 cm for men basically healthy mostly sedentary in their leisure time Exclusion Criteria: current heart disease tablet or insulin treated diabetes type 2 cancer other chronic serious illness

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 69 Years

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity on prescription<br> | Behavioral: Physical activity on prescription<br> <br> |
| No Intervention: Ordinary care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity level |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiometabolic risk factors |  | 6 months |
A Study of RO6807952 in Patients With Diabetes Mellitus Type 2

Study Overview
=================
Brief Summary
-----------------
This randomized, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6807952. Patients will receive multiple weekly subcutaneous doses of RO6870952. The anticipated time on study treatment is 8 weeks.

Official Title
-----------------
A Randomized, Placebo-Controlled, Sequential, Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MAR701/RO6807952 in Type 2 Diabetic Patients

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

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: RO6807952


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, 18 to 70 years of age, inclusive Diagnosis of type 2 diabetes >/=3 months and </=10 years prior to screening Fasting plasma glucose >/=110 mg/dL and </=240 mg/dL Patients on a stable dose of metformin for at least 2 months prior to screening Hemoglobin HbA1c >/=6.5% and </=10.5% Body mass index >/=25 kg/m2 and </=42 kg/m2 Systolic blood pressure <155 mmHg and diastolic blood pressure <95 mmHg Exclusion Criteria: Patients with type 1 diabetes History of significant renal and hepatic diseases History of metabolic acidosis and diabetic gastroparesis History of pancreatitis History of coagulation disorders or unexplained excessive bleeding History of clinically significant cardiovascular disease or severe symptomatic hypoglycemia within 6 months of screening

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RO6807952<br>* Escalating subcutaneous dose<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo to RO6807952<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood concentrations of RO6807952 |  | 8 weeks | 
| Effect of RO6807952 on Hemoglobin HbA1c level |  | 8 weeks | 
| Effect of RO6807952 on glucose level |  | 8 weeks | 
| Change in meal tolerance test |  | 8 weeks |
Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients

Study Overview
=================
Brief Summary
-----------------
This study evaluates the impact of highly active antiretroviral therapy on the size of the latent viral reservoirs in resting CD4+ T cells and monocytes in HIV positive patients. The activation state of the cells will be assessed, by measuring the activation of Akt, to determine its influence on the size of the viral reservoirs.

Official Title
-----------------
Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients: EURECA (ERANET to Unravel New Roads to Eradication and a Cure for AIDS) Study

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Other: additional blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected patients under Highly Active Anti-Retroviral Therapy (HAART) or Naïve from treatment Exclusion Criteria: Age limits Pregnancy Legal restrictions to consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: blood sample<br> | Other: additional blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the integrated viral reservoir size | Measure by Alu-PCR. Results are given in number of integrated proviral DNA copies per 1 million cells. | day 1 | 
| Measure of the proviral reservoir size | Measure by Total Proviral HIV DNA detection kit. Results are given in number of total proviral DNA copies per 1 million cells. | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Akt activation | Measure of Akt activation in live cells by flow cytometry | day 1 |
Rehabilitation After Rotator Cuff Repair

Study Overview
=================
Brief Summary
-----------------
A new postoperative regimen with a new bandage technique after surgery results in a better shoulder function and quality of life after surgery - than traditional postoperative regimen with shoulder lock and abductor cushion.

Detailed Description
-----------------
A new postoperative regimen , with a new bandage technique with shorter immobilization time and without shoulder lock, is supposed to results in a better shoulder function 6 and 12 months after surgery. Function is measured by Constant score, pain with VAS and quality of life with EQ5D, 3 and 12 months after surgery. The two treatment groups are compared.

Official Title
-----------------
Rehabilitation After Rotator Cuff Repair a Randomised Controlled Study

Conditions
-----------------
Rotator Cuff Injury

Intervention / Treatment
-----------------
* Other: Early mobilization
* Other: Post surgery shoulder lock


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned shoulder surgery, rotator cuff repair Exclusion Criteria: not swedish speaking reoperation

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early mobilization<br>Intervention is early mobilization, four weeks immobilization postsurgery with collar´n cuff only. | Other: Early mobilization<br>* Early mobilization, collar´n cuff 4 weeks post surgery and after this light exercises start and no further bandage.<br>* Other names: Collar´n cuff 4 weeks post surgery and early mobilization;|
| Other: Post surgery shoulder lock<br>Post surgery shoulder lock with abduction cushion 3 weeks and after this period collar´n cuff 3 weeks | Other: Post surgery shoulder lock<br>* Post surgery: Shoulder lock with abduction cushion, additionally 3 weeks with collar´n cuff, and after this period light exercises are allowed and nu further bandage.<br>* Other names: Shoulder lock three weeks post surgery;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder function | Shoulder function is assessed by Constant score | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Visual analogue scale | 6 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shoulder surgery, rotator cuff injury, rehabilitation, function, pain, quality of life
Comparison of Different Screening Score for Hypoxemic OSA (Obstructive Sleep Apnea) With the Results of a Polysomnography (PSG)

Study Overview
=================
Brief Summary
-----------------
Comparison of different screening score for hypoxemic OSA (Obstructive Sleep Apnea) with the results of a polysomnography (PSG). The different screening score studied are: STOP-BANG, DES-OSA, P-SAP and OSA50.

Detailed Description
-----------------
The investigators should compare the four screening scores (STOP-BANG, DES-OSA, P-SAP and OSA50) with the results of the PSG (and in particular the number of apnea and hypopnea index and the probability of hypoxemia).

Official Title
-----------------
Comparison of Different Screening Score for Hypoxemic OSA

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

Intervention / Treatment
-----------------
* Other: All patients incoming in the sleep study centre for a PSG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults patients (> 18 years) Exclusion Criteria: None

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients for PSG at SLBO<br>All patients incoming in the sleep study centre for a PSG. At the arrival the screening score will be recorder. AHI will be recorded next morning after analysis of the PSG. | Other: All patients incoming in the sleep study centre for a PSG<br>* All patients incoming in the sleep study centre for a PSG. Comparison between screening score and AHI derived from PSG.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the DES-OSA score with previously described scores. | Comparison of the DES-OSA score with the results of previously described scores (STOP-BANG, P-SAP and OSA50). | The day before the PSG (PolySomnoGraphy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the four screening scores with results of the PSG. | Comparison of the four screening scores collected past day (before PSG - PolySomnoGraphy) with the results of the PSG (especially the AHI: Apnea Hypopnea Index) | The day after the polysomnography |
Global Blood-Brain Barrier Disruption and Post-Stroke Cognitive Decline

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to gain a better understanding of why some individuals who have suffered a stroke experience post-stroke cognitive decline. Specifically this study is testing whether global disruption of the blood-brain barrier detected at the time of the stroke is informative about the risk of post-stroke cognitive decline over the next 3 years.

Detailed Description
-----------------
It is well known that ischemic stroke is a risk factor for developing dementia. Prior studies have shown that after a stroke, there can be a change in the trajectory of cognitive performance with acceleration of decline. The mechanism of this phenomenon has not been established. It is known that vascular changes in the brain, referred to as cerebral small vessel disease, are associated with cognitive decline and dementia. Cerebral small vessel disease is readily seen on MRI scans of the brain, and the larger the burden of these findings, the higher the risk of cognitive deficits. Disruption of the blood-brain barrier has been implicated in the development of the changes seen on MRI. Acute stroke has been shown to disrupt the blood-brain barrier, even in parts of the brain not directly affect by the stroke. The investigators hypothesize that when there is diffuse blood-brain barrier disruption in response to an acute stroke it sets off a cascade of changes in the brain that lead to post-stroke cognitive decline.

Official Title
-----------------
Global Blood-Brain Barrier Disruption and Post-Stroke Cognitive Decline

Conditions
-----------------
Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute ischemic stroke demonstrated on an MRI scan that includes perfusion imaging with an exogenous contrast agent Exclusion Criteria: Inability to perform telephone-based cognitive 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognition (Cognitive Decline) | Serial telephone-based cognitive assessments will be performed to detect cognitive changes (cognitive decline). | Assessments occur every 6 months for 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood-brain barrier, post-stroke cognitive impairment and dementia, vascular cognitive impairment and dementia, Alzheimer's disease and related dementias, stroke
Osteoporosis Associated Vertebral Fractures - Medical and Socio-economic Aspects in Austria

Study Overview
=================
Brief Summary
-----------------
The purposes of this study were to analyse demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures.

Conditions
-----------------
Osteoporotic Fractures

Intervention / Treatment
-----------------
* Procedure: Operation
* Procedure: Non-operative treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -patients older than 50 years of age with vertebral fractures at the thoracic or lumbar spine caused by a low-energy trauma or without any trauma, or with vertebral fractures at the thoracic or lumbar spine with typical osteoporotic deformity of the vertebrae (wedge, fish, or flat) Exclusion Criteria: patients younger than 50 years of age vertebral fractures at the cervical spine vertebral fractures at the thoracic or lumbar spine caused by a high-energy trauma (motor-vehicle accident, sports-related accident, fall from a considerable height) patients suffering from a malignancy, making a pathological fracture presumably, patients with vertebral fractures, whose dataset of follow-up monitoring was lacking, to make an evaluation of osteoporotic involvement impossible

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| osteoporosis associated vertebral fractures<br>Analyzation of demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures. | Procedure: Operation<br>* Analyzation of demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures treated with operation.<br>Procedure: Non-operative treatment<br>* Analyzation of demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures treated with non-operative treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| demographic aspects | demographic aspects (age, social status) of osteoporosis associated vertebral fractures treated with either operation or non operative treatment | at least two year follow up | 
| gender aspects | gender aspects (sex) of osteoporosis associated vertebral fractures treated with either operation or non operative treatment | at least two year follow up | 
| socio economic aspects | socio-economic aspects (cost ratio) of osteoporosis associated vertebral fractures treated with either operation or non operative treatment | at least two year follow up |