linjc16/ctgov huggingface dataset:
Aptus at Home: Co-design of a Home-based Monitoring System for Anaemia

Study Overview
=================
Brief Summary
-----------------
Co-design of a home-based anaemia monitoring system with participants who have previous diagnosis of anaemia.

Detailed Description
-----------------
The device/ monitoring system being developed is called Aptus home. Aptus home measures the haemoglobin and haematocrit levels in blood from a single drop of blood. By measuring these blood parameters, participants are able to monitor anaemia in participants' homes. The use of the device will take place in the participant's home to simulate what the investigators believe will be the ideal location for people who would prefer to self-manage their condition. This study is a unique opportunity to gain feedback on the future design and development of a home-based monitoring system through user evaluation. As this is an adaptive/ iterative study design, this will give the Sponsor the opportunity to make changes to the user interface and user platform based on the feedback received from the end user.

Official Title
-----------------
Aptus at Home: Co-design of a Home-based Monitoring System for Anaemia

Conditions
-----------------
Anemia, Iron Deficiency Anemia

Intervention / Treatment
-----------------
* Device: Blood measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior diagnosis of anaemia Commitment to perform finger pricking to use the device every two weeks and complete 2 monthly questionnaires Participant's willingness to participate in 1 to 1 interviews and, or focus groups Understands and has a good level of spoken and written English Exclusion Criteria: No prior diagnosis of anaemia Not committed to perform two weekly finger pricks to use device and complete 2 monthly questionnaires Unwilling to attend interviews and focus groups Doesn't have a good level of written and spoken English

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

| Intervention/Treatment |
| --- |
|Device: Blood measurement|Single fingerprick to measure haemoglobin and haematocrit measurements using the Aptus Home, anaemia home monitoring system.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative capture of user feedback- Questionnaires | User feedback gathered from participants using the anaemia monitoring device in participants' homes will be used to inform the changes necessary to develop a successful home-based anaemia monitoring system. | 14 months | 
| Qualitative capture of user feedback- focus groups | User feedback gathered from participants using the anaemia monitoring device in participants' homes will be used to inform the changes necessary to develop a successful home-based anaemia monitoring system. | 14 months |
A Medical Device to Treat Brain Aneurysms

Study Overview
=================
Brief Summary
-----------------
An aneurysm is a bulge in a blood vessel caused by a weakness in the blood vessel wall, usually where it branches. As blood passes through the weakened blood vessel, the blood pressure causes a small area to bulge outwards like a balloon. Most brain aneurysms only cause noticeable symptoms if they burst (rupture). This leads to an extremely serious condition known as a subarachnoid hemorrhage, where bleeding caused by the ruptured aneurysm can cause extensive brain damage and symptoms. The study aims to evaluate the safety and effectiveness of a medical device to treat brain aneurysms.

Detailed Description
-----------------
Patients will be treated with the Nautilus, then will be followed up for up to 6 months.

Official Title
-----------------
Treatment of Ruptured and Unruptured Wide-Neck Aneurysms With Nautilus™ Device Assisted Occlusion (TORNADO)

Conditions
-----------------
Cerebral Aneurysm

Intervention / Treatment
-----------------
* Device: Nautilus endovascular device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: * Patients who present with intracranial aneurysm Exclusion Criteria: * Unstable neurological deficit

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients treated with the device<br>Patients treated with the Nautilus will be followed up | Device: Nautilus endovascular device<br>* Patients will be treated with the Nautilus Endovascular device followed by treatment follow up for up to 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events | The rate of participants experiencing death or stroke in treated vascular territory measured using the NIH stroke scale within 3- 6 months follow-up | 3-6 months | 
| Probable benefit | Rate of stable, successful aneurysm occlusion measured using the Raymond Roy Occlusion Classification at 3-6 months follow-up | 3-6 months |
Upper Limit for TSH of First and Second Trimester Pregnancy in Turkey

Study Overview
=================
Brief Summary
-----------------
Physiological changes necessitate the use of pregnancy-specific reference ranges for TSH and FT4 to diagnose thyroid dysfunction during pregnancy. Although many centers use fixed upper limits for TSH of 2.5 or 3.0 mU/L, this may lead to overdiagnosis or even overtreatment. The new guidelines of the American Thyroid Association have considerably changed recommendations regarding thyroid function reference ranges in pregnancy accordingly. Any hospital or physician that is still using the 2.5 or 3.0 mU/l cut-off for TSH during pregnancy should evaluate their own lab-specific cut-offs. The investigator's objective is to establish a rational reference range of serum TSH for diagnosis of subclinical hypothyroidism in the first and second trimester of pregnant women in west Black Sea region in Turkey.

Detailed Description
-----------------
Serum thyroid function tests (including T3, T4, TSH, Anti-TPO) will be obtained from the singleton pregnancies in first and second trimester to determine the local specific normal ranges.

Official Title
-----------------
What is the Rational Upper Limit for TSH and T4 During First and Second Trimester Pregnancy in West Black Sea Region of Turkey

Conditions
-----------------
Thyroid, Thyroid Dysfunction, Hypothyroidism, Pregnancy Early

Intervention / Treatment
-----------------
* Diagnostic Test: Serum thyroid functions tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy Free of pre-existing thyroid disease That do not use thyroid interfering medication That did not undergo IVF treatment TPOAb negative Exclusion Criteria: Adolescent pregnancy

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnants<br>400 pregnant women with a singleton pregnancy, free of pre-existing thyroid disease, that do not use thyroid interfering medication, that did not undergo IVF treatment and are TPOAb negative. Serum thyroid functions tests will be obtained on the first visit. | Diagnostic Test: Serum thyroid functions tests<br>* Serum TSH, fT3, fT4 and anti-TPO<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TSH | Serum TSH (mU/I) | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TSH
Comparison of Upper and Lower Body Air Warming in Patients Undergoing Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
This study is conducted to evaluate the effectiveness of forced air warming using upper and lower body blankets by measuring core body temperature in patients undergoing video-assisted thoracic surgery in the lateral decubitus position over 2 hours of general anesthesia.

Conditions
-----------------
Core Body Temperature

Intervention / Treatment
-----------------
* Device: Bair Hugger


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing video-assisted thoracic surgery over 2 hours ASA I, II and III age over 18 years Exclusion Criteria: refuse to enroll patients with fever or hypothermia before surgery patients who required changes of position during surgery

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: upper body<br>warming with upper body blankets | Device: Bair Hugger<br>* forced air warming with Bair Hugger air warmer<br>|
| Experimental: lower body<br>warming with lower body blankets | Device: Bair Hugger<br>* forced air warming with Bair Hugger air warmer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative incidence of hypothermia |  | through surgery completion, up to 4 hours |
Pupil Response in Patients on Opioids.

Study Overview
=================
Brief Summary
-----------------
Evaluation of pupillary reflex in patients on high-dose opioids. Clinical assessment of pain intensity, sedation score, and other side effects of opioids. Measurements of the concentration of opioids and their active metabolites in blood.

Detailed Description
-----------------
Pupil size reflects the balance between sympathetic and parasympathetic systems. Pupil size and reaction are also influenced by drugs, where opioids result in miosis, an effect that is not considered to be influenced by opioid tolerance. However, cancer patients on high-dose opioids do not always present small pupil size. We want to perform a dynamic assessment of pupillary reflex in patients on high-dose opioids. In addition to pupil size measurements under standard room light conditions, two pupil size reflexes will by assessed: the pupillary light reflex when the pupil is exposed to light, and the reflex dilation during a standardized noxious stimulus. On the same time we will assess pain intensity, sedation score, and other side effects of opioids while measuring the concentration of opioids and their active metabolites in blood. In addition we will register all concomitant medication that also might influence pupil size and reaction. Patients on more than 60 morphine equivalents pr day will be included.

Official Title
-----------------
Dynamic Assessment of Pupillary Reflex in Patients on High-dose Opioids

Conditions
-----------------
Chronic Pain, Impaired Pupillary Reflex, Opioid-Related Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In-patients and out-patients at Oslo University Hospital with cancer pain who have use opioids (morphine, oxycodone, fentanyl or methadone or a combination of these drugs) at least for periods of 4 weeks, and use opioids corresponding to at least 60 mg oral morphine equivalents pr day Exclusion Criteria: Patients who have undergone eye-surgery that may influence pupillary reflexes Patients on local medication that may influence pupillary reflexes Patients with amyloidosis, multiple sclerosis, Horner's syndrome, or ongoing migraine attack Patients with brain tumor

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 |
| --- | --- | --- |
| Pupillary reflexes | Dynamic pupillometry | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid and metabolite concentration |  | One year |
Blood Glucose Monitoring Systems: Discounter Versus Brand

Study Overview
=================
Brief Summary
-----------------
This study assesses the system accuracy of 5 blood glucose monitoring systems pursuant to ISO 15197 under the aspect of the system's prospected costs for the user.

Official Title
-----------------
Cheap Equals Bad? Comparative System Accuracy of POCT Blood Glucose Monitoring Systems Under the Aspect of Aspect of Pricing: Discounter Versus Brand

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Diagnostic Test: blood glucose measurement: POCT
* Diagnostic Test: blood glucose measurement: reference


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, with clinical indication for blood glucose measurement Signed informed consent form Minimum age of 18 years Subjects are legally competent and capable to understand character, meaning and consequences of the study. Exclusion Criteria: Pregnancy or lactation period Severe acute disease (at the study physician's discretion) Severe chronic disease with inherent risk of aggravation by the procedure (at the study physician's discretion) Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion) A current constitution that does not allow participating in the study (e.g. hematocrit out of BGM specifications, medication known to influence blood glucose measurements; see Appendix A of ISO 15197) Being unable to give informed consent < 18 years Legally incompetent

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subject POCT glucometer measurement<br>Blood glucose measurement POCT glucometer | Diagnostic Test: blood glucose measurement: POCT<br>* measurement of blood glucose concentration using 5 different POCT glucometer<br>Diagnostic Test: blood glucose measurement: reference<br>* measurement of blood glucose concentration using 2 different laboratory analyzer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of system accuracy based on DIN EN ISO 15197 | Assessment of the analytical measurement performance of 5 blood glucose montoring systems based on procedures defined in DIN EN ISO 15197 | day 1 |
Australia and New Zealand Adult Extracorporeal Membrane Oxygenation (ECMO) Audit 2005

Study Overview
=================
Brief Summary
-----------------
Extracorporeal membrane oxygenation (ECMO) is a means of artificially performing the function of the human lung and/or heart outside the body. Its use is escalating in a wide range of clinical settings in the adult population without evidence or guidelines to support this practice. This study involves a nationwide questionnaire which has two components. The initial pilot survey will attempt to identify all institutions currently practicing ECMO or those intending to do so in the future, and are willing to participate in prospective data collection. The second phase will involve a monthly survey of these centres regarding the extent of ECMO use, practice details implemented, and outcome data. It is hoped that the collection of this information will later assist in the development of guidelines for this expensive and presently unsubstantiated practice, together with the construction of appropriate training programs for staff.

Conditions
-----------------
Respiratory Distress Syndrome, Adult, Respiratory Insufficiency, Shock, Cardiogenic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving ECMO in Australia and New Zealand

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Transplantation, Heart Transplantation
Effects of Gastrostomy on Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
Results about effects of symptomatic treatment on QoL appears conflicting in ALS patients. Moreover no clear effects of gastrotomy have be shown on survival. Prospective study on effect of tube feeding, QoL and survival is performed in 17 teaching hospitals in France (observational study)

Detailed Description
-----------------
Following data have been recorded each three months: QoL (MOS-SF 36 and ALSAQ), bodily mass index, testing and ALS-FRS scale, functional respiratory measures, impedance analysis, and the time for tube feeding procedure, the conditions of the acceptance and side-effects of gastrotomy

Official Title
-----------------
Effects of Gastrostomy on Quality of Life and Survival in Patients With Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients > 18 years-old ALS certain or probable vital capacity (respiratory) > 70 % under riluzole Exclusion Criteria: ALS in family other conditions affected survival and QoL cognitive impairment

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastrostomy, Quality of life
Impact of Pre-surgical Nasal Bacterial Reduction on Postoperative Surgical Site Infections / Standard Care Change

Study Overview
=================
Brief Summary
-----------------
Patients presenting in the Emergency Department or admitted to the hospital with displaced hip fractures who require hemiarthroplasty or open reduction internal fixation or with spinal instability/fractures in need of urgent surgical intervention will receive treatment to reduce the number of microorganisms in their nose prior to surgery. After surgery, the subjects will be observed for any surgical site infections.

Detailed Description
-----------------
Infection rate study.

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Drug: 3M Skin and Nasal Antiseptic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting in the Emergency Department or admitted to the hospital with displaced hip fractures who require hemiarthroplasty or open reduction internal fixation or with spinal instability/fractures in need of urgent surgical intervention will be enrolled in the study.

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| Single<br>3M Skin and Nasal Antiseptic | Drug: 3M Skin and Nasal Antiseptic<br>* Intra-nasal dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infection |  | 1 year after surgery |
Study of Clinical, Biological Characteristics and Quality of Life of Patients With Hereditary or Acquired Non Drug-induced Bradykinin-mediated Angioedema, Monitored in Besançon's Partner Site Reference Center for Studies of Kinin-mediated Angioedema (CREAK)

Study Overview
=================
Brief Summary
-----------------
This study aims to describe quality of life in hereditary or acquired non drug-related bradykinin-mediated angioedema patients, using validated questionnaires

Conditions
-----------------
Angioedema

Intervention / Treatment
-----------------
* Other: Quality of life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically documented angioedema due to C1 inhibitor deficiency, hereditary (type I et II) or acquired Clinically documented angioedema with normal C1 inhibitor activity (hereditary type III) Exclusion Criteria: Acquired angioedema with normal C1 inhibitor activity (former drug-induced) Minor subjects Vulnerable subjects (under guardianship/curatorship/tutorship) Pregnant women

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 |
| --- | --- |
| Quality of life questionnaires<br>Data will be collected retrospectively and prospectively. | Other: Quality of life<br>* Dermatology Life Quality Index, Angioedema Quality of Life Questionnaire, Angioedema Activity Score<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatology Life Quality Index (DLQI) | Description of Quality of Life (QoL) using DLQI | 6 months | 
| Angioedema Quality of Life (AE-QoL) Questionnaire | Description of QoL using AE-QOL questionnnaire | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bradykinin-mediated angiodema, quality of life