cyrilzakka/clinical-trials huggingface dataset:
Technical Feasibility Study of a Novel Wearable Capnograph (MARIE) in an Emergency Care Environment, Part 1

You have been assessed by paramedics as needing to go to the emergency department. During transport, the paramedics will monitor you by, for example, measuring your blood pressure and checking your pulse.

In healthcare, we are constantly working to improve and optimize the degree of monitoring during ambulance transports and through this also be able to start adequate treatment earlier. In this case, we are working to understand whether exhaled carbon dioxide levels can be used to monitor important processes in the body during ambulance transport. Therefore, we offer you to participate in a project that deals with whether we can use a new equipment to measure and monitor exhaled carbon dioxide during the journey to hospital.

This clinical trial is being conducted in Region Uppsala in collaboration with Oxlantic Medical AB. The main responsible and Sponsor for the trial is Oxlantic Medical AB. The research lead for the trial is Region Uppsala and Uppsala University.

This clinical trial has been subject to ethical review and approved by the Ethics Review Authority.


Eligibility Criteria:
Inclusion Criteria:

* 20 healthy volunteers 18-84 years
* 30 patients between 18-84 years being transported by ambulance

Exclusion Criteria:

* Priority 1 ambulance transports
* Patients needing oxygen supply
* Known pregnancy
* Patients unable to provide informed consent
Evaluation of Patients With Covid-19 Infection in Terms of Severity of Osteoprosis

Osteoporosis is a condition characterized by decreased bone strength and an increased risk of fracture. Age, gender, body mass index, fragility fracture history, corticosteroid use, immobilization, smoking and alcohol use, endocrine pathologies besides inflammatory and infectious pathologies can also be effective in the development of osteoporosis. The aim of the study is to evaluate the effect of Covid-19 infection on the development of osteoporosis.

In this study, bone mineral density (BMD) measurements of patients with Covid-19 infection were examined. For this, dual-energy x-ray absorptiometry (DEXA) measurement was used. A total of 55 patients were included in the study and data such as age, height, weight, comorbidities, drugs used, and treatment methods were recorded. Results showed that the time spent in the intensive care unit was associated with the femoral neck T score in DEXA measurements of patients with Covid-19 infection. The use of drugs such as alendronate, zolendronate, denosumab or teriparatide during the treatment process did not have a statistically significant effect on the lumbar and femur T scores.


Eligibility Criteria:
Inclusion Criteria:

* Female patients over the age of 18 who had dexa measurements twice before and after covid, with at least one year between two dexa measurements, and at least one month after covid infection were included in the study.

Exclusion Criteria:

* Under the age of 18, male patients, patients with a diagnosis other than Covid-19 infection that will affect bone metabolism between the two dexa shooting dates before and after covid, patients who use another drug other than covid treatment that will affect bone metabolism between the two dexa shooting dates before and after covid not included in the study
Combined Exercise Training in Patients With Multiple Sclerosis

It is stated that the affected cognitive functions in Multiple Sclerosis are learning, memory, attention, speed of information processing, visuospatial skills, and executive functions. The speed of information processing, visual learning and memory are the most frequently affected components in MS. For this reason, approaches to increase cognitive functions by activating neuroprotective mechanisms such as exercise in patients with MS are needed.

The purpose of this study is to examine the effect of combined exercise training on cognitive functions in patients with MS.

The study was designed as a randomized, controlled, single-blind trial. This study will include patients with MS who 0-5.5 according to the Extended Disability Status Scale (EDSS) and between 18-65 years. The patient will be randomized into a combined training group and a control group. The patients in the control group will not apply an exercise training. The combined exercise training group will be given combined exercise training, consisting of Pilates and aerobic exercise, three times during 8 weeks. Both groups will be reevaluated 8 weeks after the initial assessment.

Statistical analyses will be performed using the SPSS software version 15 (SPSS Inc. Chicago, IL, USA). The pre-training and post-training measurements of groups will be compared with the Wilcoxon Test. The significance level was set at p\< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory
* Stable phase of the disease without relapses in the last 3 month
* EDSS between 2-5,5.

Exclusion Criteria:

* Orthopedic, vision, hearing, or perception problems
* Any cardiovascular or pulmonary disease in which exercise is contraindicated
Enteral Feeding and Early Gut Colonization of Preterm Infants

The aim of this study is to evaluate the potential role of the enteral feeding systems on the bacterial colonization of premature infants during their NICU admittance and its evolution after 2 years, which is the age when the infant's gut starts to contain an adult-like microbiota.

First spontaneously evacuated meconium and fecal samples were collected by the medical staff of the Hospital weekly from the diapers of the infants during their stay at the Neonatal Intensive Care Unit.

To evaluate the potential role of the enteral feeding systems as a site for colonization by nosocomial bacteria, and, its impact on early gut colonization of preterm neonates, mother's own milk, donor milk and preterm formula samples were obtained after passing through the external part of the enteral feeding tubes and cultured.

Later, when the infants reached 2 years of age, parents were contacted by phone to provide an additional fecal sample if their infants had not taken antibiotics within the previous 2 months.

Eligibility Criteria:
Inclusion Criteria:

* gestational age of less than 32 weeks or with birth weight of less than 1,200 g

Exclusion Criteria:

* any malformation or suffering from any genetic metabolic disorder
Development and Validation of the Prediction Model for Functional Mitral Regurgitation Regression in Heart Failure Patients Taking Guideline-directed Medical Therapy

This observational study is to develop and validate the prediction model for functional mitral regurgitation regression in heart failure patients taking GDMT. The patients diagnosed ≥2+ functional mitral regurgitation by ultrasonic cardiogram are enrolled in this study and would be clinically followed by at least one year (clinical visit at 3 months, 6 months, and 12 months), and then by when the endpoints are reached.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years old
* ≥2+ FMR
* Receiving GDMT

Exclusion Criteria:

* degenerative mitral regurgitation
* myocardial infarction, percutaneous coronary intervention, coronary bypass grafting surgery, cardiac resynchronization therapy, or stroke within three months prior to this study
* ≥2+ aortic stenosis or regurgitation
* previous surgical mitral valve repair or replacement
* restrictive cardiomyopthy, hypertrophic cardiomyopathy, or constrictive pericarditis
* severe heart failure (NYHA class IV) or left ventricular ejection fraction \< 20%
* symptomatic hypotension affecting GDMT prescription
* severe hepatic or renal insufficiency
* life expectancy \< 12 months
* Pregnancy
Impact of Hesperetin in Combination With Sucrose on Energy Metabolism

The aim of this cross-over intervention study is to investigate the influence of the sweet-modulating substance hesperetin in combination with sucrose in comparison to an equally sweet-tasting sucrose-only solution on markers of energy metabolism.

The study is designed as a randomised cross-over intervention study with two arms. The aim is to investigate the influence of a 10% sucrose solution, corresponding to the sugar content of a conventional soft drink, compared to an equally sweet-tasting 7% sucrose solution in combination with 50 mg/L of the polyphenol hesperetin, on time-dependent blood glucose fluctuations and ad libitum energy intake in metabolically healthy male volunteers.

To investigate the underlying mechanisms, the individual appetite score, metabolic and hormonal responses to the interventions and circulating extracellular vesicles and their miRNA composition will be measured. In addition, the participants' individual thresholds for sweet taste, preference and consumption for sweet-tasting foods such as sugar and sweeteners, and their body composition will be recorded as potential influencing factors.

Eligibility Criteria:
Inclusion Criteria:

* male
* healthy
* non-smoking
* normal taste responses towards sweet taste

Exclusion Criteria:

* female
* regular smokers
* disturbed glucose and/or lipid metabolism
* regular intake of medication
* known allergies against one of the test compounds
* ageusia
* alcohol or drug addiction
* intake of antibiotics within the past 2 months
Future Optimal Research and Care Evaluation - Aortic Stenosis

In the past decade the treatment of aortic valve stenosis has rapidly changed. At first, transcatheter aortic valve implantation (TAVI) was a last resort option for inoperable patients. Nowadays, it more and more becomes an alternative to surgical aortic valve replacement (SAVR) - also in younger and lower risk patients. This poses important questions to clinical practise regarding the optimal life-time management of each individual patient. Which involves (durability of) treatment modality (surgical vs. transcatheter vs. conservative treatment) as well as the duration and type of the required antithrombotic treatment.

Objective: to evaluate the effect of treatment modality (surgical vs. transcatheter vs. conservative treatment) and its complications on quality of life and survival in AoS patients.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years of age
* Severe or moderate aortic stenosis

No exclusion criteria are applicable to this registry
6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis

Multicenter, independent study of Synolis VA 80/160 over a period of 6 months


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age,
* Patient with osteoarthritis of the hip. The diagnosis is based on the following criteria:
* Treated hip pain: Oxford score ≥ 21/60,
* Kellgren-Lawrence positive X-ray stage: II - III (inclusion radiograph dated no more than 6 months before the inclusion visit),
* Symptoms related to osteoarthritis of the hip for at least 2 months,
* Failure of treatments (i.e., inadequate or ineffective response to analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids (leaving an OXFORD score ≥ 21/60),
* Informed consent form signed by the patient,
* The patient has never had a visco supplement injection or corticosteroid injection in the hip to be treated (or more than 6 months old).

Exclusion Criteria:

* Pregnancy,
* Participation in another clinical trial,
* Skin lesion near the injection site,
* Recent or old infection of the affected joint,
* Patient with a programmed arthroplasty,
* Patient with a pathology that makes decision-making impossible,
* The patient must not have undergone non-prosthetic hip-conserving surgery such as osteotomy or arthroscopy less than 12 months old.
Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging

Acute heart allograft rejection is a common complication after orthotopic heart transplantation. Primary objective of this study is to assess cardiac MRI as a tool for acute heart graft rejection screening, by detecting changes in myocardium structure especially extracellular volume.

Acute heart allograft rejection is a common complication after orthotopic heart transplantation. It can lead to multiple cardiac injuries and sometimes to patient's death. Currently, acute heart graft rejection screening is based on invasive strategies. Gold standard is represented by endomyocardial biopsies which provide side effects risk, rare but potentially fatal for the recipient. Cardiac MRI is an imaging tool recently used in cardiology. It is a non-invasive without any X-Ray exposition method well adapted to assess cardiac function and cardiac muscle composition. Cardiac MRI is probably a great tool to help the screening of acute heart allograft rejection, by detecting changes in myocardium structure. MRI validation as a screening tool for heart allograft rejection detection could help to reduce endomyocardial biopsies realised after orthotopic heart transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Orthotopic heart transplantation patients
* Endomyocardial biopsies \< 72h
* Estimated glomerular filtration ratio \>30ml/min (calculated by Cockcroft formula for patients age \< 65 yo or MDRD for patients age \>65 ans)
* Patients affiliated to French national health insurance
* For pre-menopausal female patients, negative pregnancy test
* Patient's consent form signature
* Patient with correct French writing and speaking comprehension

Exclusion Criteria:

* Endomyocardial biopsies showing acute cellular rejection grade 1R or antibodies mediated rejection pAMR1
* Patient in need of renal dialysis
* Past history of allergic reaction or side effects after gadolinium infusion
* Hemodynamical instability
* MRI contra-indication (claustrophobia, ocular metallic objects, non MRI compatible cardiac device, neurological non RMI compatible device, osteosynthesis prosthesis older than 1980)
* Pregnant or breast feeding woman
* Patient participating to another clinical trial
Efficacy Study of Pre-operative IPH2201 in Patients With Squamous Cell Carcinoma of the Oral Cavity

The primary objective of this open label Phase Ib/II trial is to evaluate the clinical and pharmacological activity of IPH2201 as a single-agent in treatment-naïve pre-operative patients with operable Squamous Cell Carcinoma of the Oral Cavity .

43 patients are planned to be enrolled. The first 6 patients will receive IPH2201 at a dose of 4 mg/kg q2w x 4. Subsequent patients will be treated at a dose of 10 mg/kg q2w x 4. Standard loco-regional treatment with surgery followed by adjuvant therapy will be initiated after the last administration of IPH2201.


Eligibility Criteria:
Inclusion criteria:

* Histologically confirmed, primary, previously untreated, resectable squamous cell carcinoma of the oral cavity considered clinically and radiologically as intermediate or high risk, classified II ( with large (≥ 3 cm and ≤ 4cm) cT2cN0cM0 tumors or any cT2cN0cM0 tumor invading neighboring structures) III or IVa according to the American Joint Committee on Cancer
* Adequate liver and renal function

Exclusion criteria:

* Other malignancy
* Abnormal cardiac status
* Autoimmune disease
* Serious concurrent uncontrolled medical disorder
* Systemic treatment with corticosteroids or other immunosuppressive agents within 30 days prior to IPH2201 first administration.
Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol® Extend

This study will evaluate the pharmacokinetic profiles of experimental formulations of paracetamol.


Eligibility Criteria:
Inclusion Criteria:

* Good health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination

Exclusion Criteria:

* Current (within 14 days of screening) or regular use of any prescription, over the counter (OTC) drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism, excluding prescription birth control, if applicable.
A Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury

The study population will consist of 3 mutually-exclusive sets of patients and subjects:

* TBI patients with intracranial bleeding
* TBI patients without intracranial bleeding
* Control subjects with normal brain health.

Research subjects between the ages of 22 to 50 will be enrolled. All TBI patients must have a diagnostic head CT scan within 24 hours of the injury. TBI patients without intracranial bleeding based on the CT scan must have a Glasgow Coma Scale (GCS) score at enrollment of ≤ 14. Total maximum duration of active monitoring with the device in this study is 48 hours with a clinical follow-up at day 7 after enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet all of the following inclusion criteria will be considered candidates for study enrollment:

  * Male or female subjects age 22 to 50
  * Patients with TBI who have a diagnostic head CT scan within 24 hours of the injury.
  * For patients with TBI without intracranial hemorrhage, Glasgow Coma Scale score at enrollment of ≤ 14.
  * For patients with TBI, intended clinical monitoring in the hospital setting for at least 6 hours from study enrollment.
  * Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian.
  * Willingness and ability to comply with schedule for study procedures.
  * Control subjects with normal brain health.

Exclusion Criteria:

* All subjects meeting any of the following criteria will be excluded from this study:

  * Female patients who are pregnant or lactating.
  * Known history of seizure or clinical seizure prior to initiating SENSE monitoring.
  * Open skull fracture.
  * Metallic intracranial clip, coil, or device (such as metallic ICP monitor).
  * Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the SENSE device monitoring or study participation or may confound the outcome of the study.
  * Planned placement of an intraventricular catheter after the diagnostic (pre-enrollment) CT.
  * Planned withdrawal of care within 24 hours of enrollment.
  * Planned intracranial surgery within 24 hours of enrollment.
  * Current participation in a medical or surgical interventional clinical trial.
  * Planned or current use of continuous EEG monitoring.
  * Control subjects with normal brain health will have no known history of seizure, stroke, brain tumor, TBI
Epilepsy Self-Management for Spanish Speakers: HOBSCOTCH - ESPANOL

The goal of this pilot study is to assess the feasibility of translating and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with epilepsy whose primary language is Spanish.

The main questions it aims to answer are:

1. Can the current HOBSCOTCH program be successfully translated for Spanish speaking people with epilepsy?
2. Will people with epilepsy who speak Spanish experience improved quality of life similar to that found in people with epilepsy who received the HOBSCOTCH program in English?

Participants will be asked to:

* attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-SPANISH sessions with a one-on-one certified bilingual HOBSCOTCH coach
* complete a brief clinical questionnaire about their diagnosis of epilepsy
* complete two questionnaires before and after the HOBSCOTCH sessions about their quality of life and about memory and thinking processes
* keep a short daily diary about their seizures, symptoms and use of the self-management strategies taught in the HOBSCOTCH program
* complete a brief Satisfaction Survey and a 3 question survey about shared decision making after the entire HOBSCOTCH program


Eligibility Criteria:
Inclusion Criteria:

* Adult (18 + years)
* Self-reported epilepsy with controlled or uncontrolled seizures
* Spanish as primary language
* Literate in Spanish (per bilingual Cognitive Coach)
* Access to the internet and/or a telephone

Exclusion Criteria:

* Self-report of a dementing illness, a dementing illness appearing in their medical record if available or in the judgment of the Principal Investigator or Bilingual Coach
* Severe mental disability or estimated IQ less than 70 per clinical judgement of the Principal Investigator or Bilingual Coach
* Significant visual impairment precluding reading or writing
* No reliable telephone or internet access
* No self-reported diagnosis of epilepsy
A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-eluting Stent Implantation

DES are preferred over BMS for most patients, however prolonged dual antiplatelet therapy is required for patients treated with DES for prevention of late or very late stent thrombosis. which increases a risk of major bleeding. BioFreedom is a Biolimus A9-coated stent that consists of a stainless steel stent platform with a textured abluminal surface without use of any polymer in the coating. Biolimus A9 rapid release and polymer-free property may give BioFreedom the advantages of both DES and BMS that may require less duration of DAPT. BioMatrix Flex, Biolimus-eluting stent with biodegradable polymer, also demonstrated safety and efficacy. We will compare these two difference types of Biolimus A9-eluting stents with different duration of DAPT. With proven adequate and safe duration, we will compare between one versus more than six months of dual antiplatelet therapy after Biolimus A9-eluting stents implantation using different properties of BioFreedom and BioMatrix Flex.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 19 years old
* Patients with ischemic heart disease who are considered for coronary revascularization with PCI
* Significant coronary de novo lesion

Exclusion Criteria:

* Acute myocardial infarction
* Complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesion
* Need to use of dual antiplatelet therapy more than 1 month because of other medical conditions
* Cardiogenic shock or experience of cardiopulmonary resuscitation
* Contraindication or hypersensitivity to Biolimus A9, stainless steel, heparin, antiplatelet agents or contrast media
* History of documented prior cerebrovascular attack within 6 months
* Treated with any stent within 3 months
* Reference vessel diameter \<2.25 mm or \>4.0 mm
* Pregnant women or women with potential childbearing
* Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
* Inability to understand or read the informed content
Development and Efficacy Evaluation of Integrated Chronic Care and Health Promotion Model for Patients With Coronary Artery Disease in Taiwan

The hypothesis of this project is to examine whether the integrated health care program as the intervention group can reduce the recurrence and mortality of coronary artery-related diseases than the traditional one as the comparison group.


Eligibility Criteria:
Inclusion Criteria:

* patients who suffered from acute myocardial infarction or stable angina with intervention (CABG or PTCA)

Exclusion Criteria:

1. Age \> 85 yrs old.
2. Worse short-term prognosis (e.g.cancer, congestive heart failure NYHA IV)
3. Any systemic disease which will limit the exercise program (e.g. bed-ridden stroke)
4. Unable to participate in the trial due to any logic reasons