cyrilzakka/clinical-trials huggingface dataset:
Benchmark Ear Impression Techniques

The purpose of this study is to determine the scan quality of the direct ear scanner concerning consistency, accuracy and reliability and to compare the data to common silicone ear impressions by benchmarking the outcome of each impression technique on custom product dummies on participants.

Today's standard for ear impression techniques is the impression taking process with silicone impression material. To use the silicone impression for a hearing aid manufacturing process the geometry of the impression is needed. Modern processes scan the silicone ear impression with specific scanners. Afterwards the digitalized ear impression is uploaded in the modeling software for further proceed. A new ear impression technique is now provided with the direct ear scanner technology. The direct ear scanner can create a digital scan of the outer ear and ear canal. The scan than can directly transferred to the modeling software. The research question of this study is to determine the scan quality of the direct ear scanner concerning consistency, accuracy and reliability and to compare the data to common silicone ear impressions.

Eligibility Criteria:
Inclusion Criteria:

* Only adult participants ≥ 18 years
* Informed consent form as documented by signature
* Ability to fill in a questionnaire conscientious
* Healthy outer ear (Pinna and ear canal, w/o previous surgical procedures)

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formula (RIF)

The investigators design a multicenter randomized controlled trial to prove that RIF plus ATRA is possibly superior to ATO plus ATRA as consolidation and maintenance treatment for the patients with non-high-risk APL.

Acute promyelocytic leukemia (APL) is a unique subtype of acute myeloid leukemia (AML) which accounts for 10-15% of acute myeloid leukemia. It is characterized by the PML-RARA fusion gene generated by the t(15;17)(q22;q21) chromosomal translocation. The application of ATRA and ATO, make APL from highly fatal to highly curable. APL0406 study proves that ATRA plus arsenic trioxide is at least not inferior and may be superior to ATRA plus chemotherapy in the treatment of patients with non-high-risk APL. Now, the arsenic trioxide has already became the based regimen as targeted first-line treatment without chemotherapy. A study shows that oral RIF plus ATRA is not inferior to intravenous ATO plus ATRA as maintenance treatment of APL. The investigators design a multicenter randomized controlled trial to prove that RIF plus ATRA is possibly superior to ATO plus ATRA as consolidation and maintenance treatment for the patients with non-high-risk APL. Application of oral RIF decrease the total hospitalization days.

Eligibility Criteria:
Inclusion Criteria:

* age 14 to 70 years
* Newly diagnosed APL with t(15;17)(q22;q12)
* Before treatment the Peripheral blood white blood cell count≤10×109/L
* Patients who can complete the entire treatment process
* Patients or their families signed written informed consent

Exclusion Criteria:

* Be allergic to the drug ingredient, the supplementary material or the allergic constitution person
* Cardiac insufficiency, renal insufficiency, significant arrhythmias, EKG abnormalities or other important organ dysfunction
* Combined with other malignant tumors
* Pregnant and lactating women
* Participants in other drug trials in the last 3 months
* Suffering from mental illness or other circumstances which unable to carry out the plan
* Other patients who were not suitable for the study
Women and Risk of Type 2 Diabetes

This is a follow-up survey of women, 10-12 years after they were included in the population-based Stork Groruddalen study of pregnant women, primarily set up to study gestational diabetes and related health issues in pregnancy in a multiethnic population. The investigators will now update the information about the health status of these women to study the development of risk factors for type 2 diabetes and cardiovascular diseases.

The STORK-Groruddalen is a cohort study of 823 pregnant women. Participation rate was high due to facilitation for ethnic minorities and data collection at the local Health Centres, set up to study ethnic differences in health to inform prevention strategies to reduce these differences. The investigators have published many papers from this well charatertized cohort, about gestational diabetes and related health issues in pregnancy. Participants have agreed to be contacted for subsequent follow-up surveys.

The inivestigators are now planning a follow-up study of these woman during 2019-2022, to study trajectories for risk factors for type 2 diabetes and cardiovascular diseases such as BMI, blood pressure, lipids, behavioural factors, physical activity and mental health and other health issues. The investigators will collect selfreported information through questionnaires, perform clinical measurements and take blood samples and buccal swabs. Collecting updated information about a range of health outcomes for women in this cohort will, together with already collected data, enable us to study the development of risk factors for type 2 diabetes and cardiovascular diseases in a life course perspective.

Eligibility Criteria:
Inclusion Criteria:

* Previous participants in the STORK G study still living in Norway

Exclusion Criteria:

* Moved out of Norway
Single Dose of Atorvastatin and Circulating Endothelial Microparticles

Healthy subjects take single dose of 80mg atorvastatin, then measured their circulating endothelial microparticles and flow-mediated vasodilation in the brachial artery by ultrasound at different time points.


Eligibility Criteria:
Inclusion Criteria:

* healthy youth

Exclusion Criteria:

* acute pathologies
* familial history of cardiovascular disease
* smoking or drinking alcohol
Calcium DXA: Impact of Calcium Supplements on Lumbar Spine Bone Mineral Density

We, the investigators at the University of Wisconsin, hypothesized that ingesting calcium tablets prior to a spine bone density scan will not affect the bone mineral density as measured by dual energy x-ray absorptiometry (DXA).

We hypothesized that ingesting calcium tablets prior to a spine bone density scan will not affect the bone mineral density as measured by DXA. To test this, 36 subjects ingested various calcium supplements after a spine DXA scan and were then scanned again 15, 30 and 45 minutes after ingestion. Subsequently a subset of 15 subjects had three spine scans performed for instrument precision and subsequently ingested a calcium tablet with scans 15 and 30 minute intervals after ingestion.

Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 years or older

Exclusion Criteria:

* Internal spinal hardware
Two-staged Approach in Positioning Endobronchial Blockers Without Fiberoptic Guidance

The purpose of this study is to find a novel method for placing endobronchial blockers without fiberoptic guidance to provide one-lung isolation during anesthesia for thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for lung resection

Exclusion Criteria:

* refuse to enroll
* patients with lesions involving mainstem bronchi
* patients with anomalies in tracheobronchial tree
RollOut -Pre-Rolled TachoSil in Laparoscopic Utilisation. A Non-Interventional Study

The purpose of this study is to describe ease of use and satisfaction with application of the pre-rolled TachoSil in laparoscopic procedures within approved therapeutic indication as per Summary of Product Characteristics (SmPC).

The drug being observed in this study is called Tachosil. Tachosil is being used in open invasive surgery for use as a local haemostatic and tissue sealing. This study will look at the application and an overview on the ease of use of pre-rolled form of Tachosil in minimal invasive (laparoscopic) surgery, cost analysis along with the evaluation of participant's satisfaction with the product.

The study will enroll approximately 131 participants who will be inpatients. A participant can be included in the study when the physician has decided to use pre-rolled TachoSil according to the local SmPC and after obtaining informed consent from the participant. Participants will be analyzed in a routine setting after surgery.

Data from all participants will be collected from their files as well as study specific questions answered by the treating physician.

This multi-center trial will be conducted in 7 Austrian centers. The overall recruitment period is expected for 1 year and six months. Participants will be analyzed from the date of surgery till their discharge from hospital.

Eligibility Criteria:
Inclusion Criteria:

1- Inpatients planned for laparoscopic surgery, in the field of gynecology, urology and abdominal surgery where pre-rolled TachoSil was applied, 18 years or older.

Exclusion Criteria:

1. Has contraindications, such as hypersensitivity to the active pharmaceutical ingredients or to other components of pre-rolled TachoSil according to the current SmPC.
2. Is participating in another clinical trial.
Evaluation of the Castor Single Branch Stent Graft in Treatment of Acute Aortic Syndrome

The objective of this study to evaluate the safety and effectiveness of the Castor single branch stent graft for endovascular repair of acute aortic syndrome patients without an inadequate proximal landing zone (\<15mm)

The goal of this observational, ambispective, and multicenter cohort study is to evaluate efficacy and safety of the Castor single branch stent graft.

205 patients who received thoracic endovascular aortic repair by meant of the Castor single branch stent graft from June 2018 to June 2022 were enrolled in our study. All enrolled patients have an inadequate proximal landing zone (\<15mm) , and they underwent routine follow-up after thoracic endovascular aortic repair at 1-month, 6-months, and 1-year for the following, but not limited to assessment: physical examination, laboratory test and the CT angiography.

Meanwhile, the enrolled patients will come for continuous follow-up at 2-years, 3-years, and annually to 10-years post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute Stanford type B aortic syndrome who received thoracic endovascular aortic repair by meant of Castor single branch stent graft from June 2018 to June 2022

Exclusion Criteria:

* Patients with acute type B aortic syndrome with an adequate proximal landing zone (≥15mm)
* Previous endovascular repair of the aorta
* Patients with missing data and loss of follow-up
Role of AT1-receptor Blockers in Insulin-induced Vasodilation.

In this study we hypothesize that blocking the angiotensin II AT1-receptor improves the insulin-induced microvascular dilatation. Objectives: 1. Does blockade of the angiotensin II AT1-receptor improve the insulin-induced microvascular effects in hypertensive patients. 2. Does blockade of the angiotensin II AT1-receptor impair the insulin-induced microvascular effects in normotensive control subjects?


Eligibility Criteria:
Inclusion Criteria:

hypertensive subjects:

1. 18-60 years
2. Caucasian
3. untreated hypertension \>140/90mmHg.

normotensive subjects:

1. 18-60 years
2. Caucasian
3. Blood pressure \<140/90 mmHg.

Exclusion Criteria:

1. Obesity (BMI\>27kg/m2)
2. Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)
3. Impaired glucose tolerance or diabetes mellitus according to the criteria of the ADA
4. Smoking
5. Alcohol use \>4U/day
6. Use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, NNSAIDs)
7. Pregnancy
8. Wearing contact lenses
Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.

To determine the relationship between the result of amniotic fluid optical density between 26 and 36 6/7 weeks of pregnancy and the risk of developing neonatal respiratory distress syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy between 26 and 36 6/7 weeks.

Exclusion Criteria:

* Problems in the handling of the amniotic fluid sample that prevented the calculation of the optical density.
Study on the Ability of Virtual Reality Glasses in Anxiety and Pain Reduction in 50 Women Undergoing Amniocentesis or Feticide

Both amniocenteses and especially feticide are procedures that incorporate both anxiety and pain. As anxiety and pain can be reduced when using a distraction, The investigators speculate that the use of virtual reality glasses during these procedures will elevate both anxiety and pain.

The investigators will examine this hypothesis by comparing two groups of participants who undergo amniocentesis or feticide, one group will undergo the procedure while using virtual reality glasses and the other without the use of the glasses.


Eligibility Criteria:
Inclusion Criteria: Pregnant women undergoing amniocentesis/foeticide who will sign an informed consent form

-

Exclusion Criteria:

* Women younger than 18 years
* Twin pregnancies
* Women with vertigo
Out of Plane Approach for Interscalene

Study aims to examine the influence of out of plane interscalene approach to a brachial plexus block on the effect of phrenic nerve blockade.

Studies have proven that there is 100% blockade of the phrenic nerve with the in-plane approach to the interscalene brachial plexus block. The patient population with pulmonary comorbidities with poor reserve cannot afford to have a further deterioration of their pulmonary status due to phrenic nerve blockade. These patients are not ideal candidates for increased opiate therapy for intraoperative and post-surgical pain as well due to further depression of their respiratory function. To optimize their pain control as well as avoid any respiratory-related morbidity and mortality, it is ideal to develop a technique which can provide appropriate brachial plexus block at the interscalene level while completely avoiding any local anesthetic spread to the phrenic nerve.

The study aims to examine the influence of out of plane interscalene approach to a brachial plexus block on the effect of phrenic nerve blockade. Practitioner preference and institutional norms often influence the in plane approach for the above-mentioned block. The most common practice at our institution is the in plane approach to the brachial plexus block.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients(18-85 years old)
* Scheduled for elective shoulder surgery who would benefit from a preoperative interscalene approach to the brachial plexus block for intraoperative and postoperative pain relief.

Exclusion Criteria:

* Patients with any distorted anatomy for whom the block cannot be performed accurately, such as scars, surgical fixtures at the site, active infection, any open wound or drains at the site.
* Patients who request benzodiazepine anxiolytics such as midazolam for premedication before the procedure. Also patients who request narcotic medications as premedication before the procedure
* Non-English and Non-Spanish speaking patients
* Inadequate or failed blocks and inadvertently intrathecal or intravascular injection will be dropped from the study
* Incarcerated patients
* Expected heavy bleeding on multiple anticoagulants with markedly elevated PT ( Prothrombin time ), INR (International Normalized Ratio ), PTT ( Partial Thromboplastin Time ) levels and markedly reduced platelet counts
FamilyLink and Breastfeeding

The central hypothesis guiding this project is that having mothers view live video of their babies while they are pumping increases milk volume, caloric density, and maternal pumping experience.


Eligibility Criteria:
Inclusion Criteria:

* Mothers of 30 preterm infants (born before 34 weeks gestational age) admitted to the University of California, Davis neonatal intensive care unit (NICU)
* Mother is pumping breastmilk
* Delivery at least 7 days prior
* Mother not an inpatient,

Exclusion Criteria:

* Mother has HIV
* Mother without access to a computer, smartphone, or tablet to access FamilyLink
* Infant delivered via surrogacy
* Maternal age outside limit of 18 to 50
Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-003)

The purpose of this phase III study is to determine the safety and efficacy of difluprednate in the management of inflammation following ocular surgery.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for unilateral ocular surgery.

Exclusion Criteria:

* Systemic administration of any corticosteroid or immunosuppressive drug in the 2 weeks prior to study enrollment.
Yearly Strain Variation Study, 2010/2011

The purpose of the study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2010/2011 season for yearly licensing application.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 to 59 years of age, inclusive, at the time of screening (for Stratum A only)
* Subject is 60 years of age or older, inclusive, at the time of screening (for Stratum B only)
* Subject has given written informed consent prior to study entry
* Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice
* Subject agrees to keep a daily record of symptoms for the duration of the study
* If subject is of childbearing potential, subject presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
* Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

* Subject has a history of severe allergic reaction or anaphylaxis
* Subject has an oral temperature of \>= 37.5°C on the day of vaccination in this study.
* Subject has a rash or dermatologic condition or tattoos, which may interfere with injection site reaction rating
* Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry
* Subject has received a seasonal influenza vaccine within 6 months of study entry
* Subject currently has or had a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
* Subject has any inherited or acquired immunodeficiency
* Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (\>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs.
* Subject has a functional or surgical asplenia
* Subject has a known or suspected problem with alcohol or drug abuse
* Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study.
* Subject is pregnant or lactating at the time of enrollment
* Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
Tickle Stimulation in Disorders of Consciousness (DoC)

The aim of this project is to investigate whether tickling stimulations can have a short-term effect on the responsiveness of patients with Disorders of Consciousness due to Severe Acquired Brain Injury and to compare this effect with that of neutral tactile stimulations that do not induce tickling.

During the experimental session, patients will undergo the CRS-R and the Nociception Coma Scale-Revised (NCS-R) to ensure that any responses to tickling are not influenced by pain sensations. Subsequently, fNIRS detection optodes will be placed using a non-invasive frontal headband. A 10-minute resting-state recording will be performed. Next, patients will be subjected to tickling: they will be tickled bilaterally in the three most ticklish areas identified in a pilot study with healthy subjects-namely, the soles of the feet, the armpits, and the ribs-plus a control area, the forehead. The stimulation will be manual and will be performed by rubbing the targeted body part while opening and closing fingers in pairs in an arched motion. Additionally, patients will also receive a neutral stimulation (in the same body areas), which consists of simply touching the area without inducing tickling. The order of stimulations will follow a randomized list. Each stimulation will last for 5 seconds, followed by 5 seconds of rest, repeated twice. In total, patients will be stimulated for 10 seconds plus 5 seconds of rest (15 seconds in total) for each body area. There will be a 1-minute pause between each area. Afterward, an additional 10 minute resting-state fNIRS recording will be conducted. During the experimental session, patients will be filmed so that the videos can be analyzed by two different experimenters, who will assess differences between stimulations based on facial expressions, verbalizations/vocalizations, body movements, and changes in emotional state (e.g., crying, smiling, grimacing). At the end of the protocol, the fNIRS optodes will be removed. In total, the experiment will last approximately one hour and fifteen minutes: 30 minutes for CRS-R/NCS-R and 45 minutes for the tickling protocol and fNIRS recording.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of disorders of consciousness (DoC) based on the CRS-R scale;
* Age ≥18 years;
* Time since the event ≥ 28 days

Exclusion Criteria:

* Large craniectomy that may interfere with fNIRS recording; Unstable clinical conditions (e.g., respiratory failure, fever, status epilepticus, etc.);
* Fractures, paralysis, injuries, or muscular dystrophy that prevent proper stimulation of the aforementioned body parts;
* Lack of informed consent from the legal representative.