cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Feasibility of Screening Relatives of Patients Affected by Non-Syndromic Thoracic Aortic Diseases

The primary hypothesis is that a tailored programme of genetic and imaging screening of first- and second-degree relatives of patients affected by non-syndromic forms of thoracic aortic diseases will identify individuals at risk of death from these conditions. These individuals would constitute specific population of patients, requiring dedicated imaging surveillance and/or earlier prophylactic aortic surgery.

Diseases involving the thoracic aorta (the major artery in the body) are a major health problem affecting an increasing number of people worldwide.

In particular, a group of these conditions termed Non-Syndromic Aortic Diseases (NS-TAD), can develop without any obvious symptoms or external features which prevents early identification. Unfortunately, if not treated, the aorta may enlarge and lead to dissection, a life-threatening medical emergency. For this reason, the investigators believe it might be helpful to investigate relatives of patients undergoing surgery for thoracic aortic disease to understand if there are tests that could help identify and treat this condition at the right time.

Therefore the investigators propose to conduct a feasibility study to identify the practical issues and challenges that would need to be overcome in order to perform a successful tailored genetic (by collecting a small blood sample) and imaging (with exams such as echocardiography and MRI) screening in such population of individuals.

Moreover, all participants will receive two questionnaires to ask their opinion about the study and to measure their levels of anxiety and depression, to judge whether and how this study has affected their emotional status.

The study will be carried out at the Department of Cardiovascular Sciences Glenfield Hospital, University Hospitals of Leicester NHS Trust.

Eligibility Criteria:
Inclusion Criteria:

1. NS-TAD probands operated on (n=16).
2. FDR and SDR, aged 16 and above:

   1. At least two relatives willing to participate in the screening programme.
   2. Relatives able to understand English.

Exclusion Criteria:

1. Probands with syndromic aortopathies, including Marfan Syndrome, Loeys-Dietz Syndrome, Ehlers-Danlos Syndrome, Shprintzen-Goldberg syndrome, aneurysm-osteoarthritis syndrome, arterial tortuosity syndrome, and cutis laxa syndrome.
2. Probands with aortic lesions associated with trauma and infections.
3. Probands/relatives unable to give informed consent
Belgian Pulmonary Function Study

Pulmonary function tests including spirometry, lung volumes, measurements of resistance and diffusing capacity are essential in the diagnosis of several pulmonary diseases. These tests are an integral part of the diagnosis and treatment of lung diseases, but until now there is no clear evidence for the use of many of the pulmonary function tests because of a lack of adequate studies. The obscurity largely pertains to the conditions under which combinations of the various tests are indicated. Therefore the Belgian Thoracic Society, assembling all pulmonologists and the pneumology LOK/GLEM"s, will investigate this matter.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age between 18 and 75 years old
* New outpatients with respiratory symptoms as dyspnoea, cough, sputum, but without firm diagnosis
* Results of the tests are available and acceptable
* Standardized list of complaints
* Capability of patient for doing pulmonary function tests
* Seen by a Pneumologist
* Written informed consent

Exclusion Criteria:

* Patients with diagnosed respiratory disease
* Younger than 18 and older than 75 years old
* Recent heart attack
* Pneumothorax
* hemoptoic
* Suspicion of Tuberculosis
* Not capable to do pulmonary function tests
Asthma and Quantifying Delivery Of Radio Labeled Aerosol

Introduction: Inhalation therapy has been established as an efficient route to treat asthma exacerbations, but coupled to noninvasive ventilation (NIV) remains quite challenging.

Objectives: The aim of this study were to compare radiaoaerosol pulmonary index and radioaerosol mass balance in the different compartments (pulmonary and extrapulmonary) using vibrating mesh nebulizers (VMN) and jet nebulizer (JN) coupled to noninvasive ventilation (NIV).

Material and methods: The investigators assessed 10 stable moderate to severe asthmatics in a crossover study. Patients was randomly assigned to participate in both phases of the study: Phase 1(NIV+MN) and phase 2(NIV+JN). DTPA-Tc99m with radioactivity of 25 miC was used to inhaler using JN positioned in the circuit using a "T" piece, particle size generation in a five micron range and oxygen flow tritated at eight L/min and MN was positioned in the mask, particle size generation in a one range and connected to electrical energy. NIV was used a bilevel pressure through a face mask attached with straps and pressure adjusted were 12 cmH2O and 5 cmH2O as inspiratory and expiratory pressures, respectively. After, radioactivity counts were performed using a gama camera and regions of interest were delimited. To calculate aerosol mass balance the investigators considered the amount of radioaerosol deposited into the lungs, upper airways, stomach, nebulizer, circuit, inspiratory and expiratory filters, and mask divided for each of these compartments and represented as a percentage.


Eligibility Criteria:
Inclusion Criteria:

* stable moderate to severe asthma (FEV1 \> 60% and \> 80% and PEF with a variation of 30% from the predicted values to moderate and FVE1 \> 60% and );
* More than one year elapsed since the diagnosis of asthma;
* None exacerbation in the last six months;
* Age between 18 - 60 years, from both sexes,
* Able to understand verbal commands
* Consent to participate in this protocol.

Exclusion Criteria:

* presence of dyspnea;
* smoking history;
* cardiopulmonary diseases (chronic obstructive pulmonary disease, pneumonia, cardiac failure, myocardial infarction, pneumothorax);
* hyperthermia;
* hemodynamic instability (heart rate \> 150 bpm and systolic blood pressure \< 90 mmHg);
* arrhythmia absence;
* pregnancy
* contraindications for use of noninvasive ventilation
Rate of Malignant Transformation and Clinical Characteristics Among an Oral Lichen Planus Cohort: a Retrospective Center Experience

The main objective of this paper will be to evaluate the rate of malignant transformation among a cohort of patients affected by oral lichen planus with long-term follow-up. Secondary aims will be to study and describe the characteristics of these patients to identify potential risk factors for malignant transformation, and to evaluate the therapeutic effects and features to OLP drgus.

Oral Lichen Planus (OLP) is a chronic inflammatory mucocutaneous disease of unknown etiology, primarily affecting the oral mucosa. Global prevalence ranges from 1.01% to 3%, with an estimated 1.43% prevalence in Europe. Although OLP can affect the scalp, nails, and skin, it most commonly manifests in the oral cavity. The disease primarily involves the stratified squamous epithelium of the mouth, and while its precise cause remains unclear, it is thought to result from a T-cell-mediated autoimmune response, triggered by microbial agents, chemicals, stress, or viral infections. T cells directly attack keratinocytes, causing epithelial damage, with both specific (T-cell activity) and nonspecific mechanisms (MMPs, chemokines, and mast cells) contributing to disease progression. CD8+ and CD4+ T cells and Langerhans cells play key roles in antigen presentation, while Matrix Metalloproteinases (MMPs) and their inhibitors (TIMPs) are involved in the breakdown of the basement membrane, leading to keratinocyte destruction.

The main objective of this paper will be to evaluate the rate of malignant transformation among a cohort of patients affected by oral lichen planus with long-term follow-up. Secondary aims will be to study and describe the characteristics of these patients to identify potential risk factors for malignant transformation, and to evaluate the therapeutic effects and features to OLP drgus.

Eligibility Criteria:
Inclusion Criteria:

* Clinical-histological diagnosis of Oral lichen planus
* Patients who gave consensus to personal data treatment
* Minimum 6 months follow-up

Exclusion Criteria:

* Patients who did not give consensus to personal data treatment
* Oral lichenoid lesions
* Patients with anamnesis of hematopoietic stem cells transplant
* Patients with a OSCC at the first histological examination (i.e., namely: also OSCC patients with a OLP background were excluded)
Surgery and Convergence Insufficiency Intermittent Exotropia

This trial aims to determine which treatment modality is better for treatment of the convergence insufficiency subtype of intermittent exotropia.

Surgery can give better results,

Eligibility Criteria:
Inclusion Criteria:Convergence Insufficiency Type Intermittent Exotropia

* No stereopsis
* Good visual acuity

Exclusion Criteria:

* Amblyopia
* Anisometropia \> 2.5D
* Vertical deviations
A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)

The main purpose of this study is to determine the efficacy and safety of insulin efsitora alfa (LY3209590) administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of T2D according to the World Health Organization criteria.
* Have an HbA1c of 7.0% to 10.0%, inclusive, at screening.
* Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study.
* Are insulin naive

Exceptions:

* short-term insulin treatment for a maximum of 14 days, prior to screening, and
* prior insulin treatment for gestational diabetes.

Exclusion Criteria:

* Have a diagnosis of type 1 diabetes (T1D), latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes.
* Have a history of \>1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.
* Have had severe hypoglycemia episodes within 6 months prior to screening.
* Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
* Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening
* acute myocardial infarction
* cerebrovascular accident (stroke), or
* coronary bypass surgery.
* Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
* Have had significant weight gain or loss within 3 months prior to screening, for example, ≥5%.
Adaprev in Digital Flexor Tendon Repair

This study is being undertaken to verify the safety and performance of Adaprev™, a Class III medical device, when administered as a short term implant into the tendon sheath at the time of surgery, on the post-operative function of severed digital tendons. Subjects are randomised to either Adaprev or standard care and attend visits for 26 weeks following surgery. This clinical investigation will recruit 44 subjects in the UK at up to 10 clinical trial sites.


Eligibility Criteria:
Inclusion Criteria:

- Subjects aged 18 years and above with complete division of the Flexor Digitorum Profundus (FDP) tendon in Zone II.

Exclusion Criteria:

* Subjects with additional complicated injuries
* Subjects whose flexor tendon repair involves a finger with less than full tendon function prior to the injury requiring repair
* Subjects who are undergoing surgical repair of the severed tendon(s) more than four days after the injury occurred.
* Subjects with a history of clinical significant hypersensitivity to any of the devices, drugs or surgical dressings to be used in this trial.
* Subjects with conditions which may delay healing.
* Subjects who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
* Females who are pregnant
Hyperbaric Oxygen Treatment (HBOT) During Methadone Tapering

The aims of this study are to 1) explore the efficacy of hyperbaric oxygen therapy (HBOT) applied at two different pressures compared to sham treatment in relieving signs and symptoms (both physical and psychological) of opioid withdrawal in human subjects associated with methadone dose reductions; and 2): explore whether HBOT can increase the odds of successful methadone dose reduction in patients who are interested in tapering their opioid dose. The investigators aim to explore, through qualitative methods, individual's experiences with treatment for opioid use disorder (OUD).

The investigators will conduct a prospective, randomized, sham treatment-controlled trial to examine the efficacy of HBOT for improving signs and symptoms of opioid withdrawal in methadone-maintained OUD patients as they undergo two planned methadone dose reductions spaced two weeks apart.

A participant sample size of 24 was chosen based on power analysis guided by the investigators' earlier study that indicate that clinically meaningful results can be found with a minimum of 8 per group related to variables of highest interest i.e., pain and withdrawal symptoms.

Additionally to this trial, participants will be asked to partake in a semi-structured interview in which they will be asked to discuss (1) Beginning Treatment, (2) Life in Recovery, and (3) HBOT \& Further Treatment.

Edited 11/23/24: An additional study arm was added to better address the question about the level of HBOT needed for effects. The new participant sample size of 36 was chosen based on power analysis guided by our earlier study that indicate that clinically meaningful results can be found with a minimum of 8 per group related to variables of highest interest i.e., pain and withdrawal symptoms. Participants will be randomized into one of three trial arms: (active arm of n = 12 in HBOT 100% oxygen and 2.0 ATA, partial active arm of n = 12 in HBOT 100% oxygen and 1.3 ATA, and sham arm of n = 12 in HBOT 21% oxygen and 1.3 ATA). All groups will be receiving standard of care for addiction withdrawal symptoms, as managed and provided by their clinic physician and neither the full or sub-therapeutic HBOT dose are expected to affect their ongoing treatment.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in a supervised opioid treatment program at the Spokane Regional Health District
* Age greater than 18 years
* Ability to read, speak, and write English
* Ability to provide written informed consent.

Exclusion Criteria:

* Pregnancy
* Any other medical or psychiatric condition that the PI, Co-PI (physician of record) or the Spokane Hyperbaric Center medical director determine might compromise safe study participation in the HBOT clinic (including but not limited to active psychosis, history of frequent psychiatric hospitalizations, severe anxiety with claustrophobia, aggression)
* Upper respiratory infection
* Emphysema
* Air cysts in the lung
* History of thoracic or ear surgery
* Taking the medication Antabuse for alcohol addiction
* High fever.
Closed Loop Vagal Nerve Stimulation for Patients With Posttraumatic Stress Disorder

The tasks of the project are to map the potency and kinetics of the neurologic, autonomic peripheral, inflammatory, and behavioral responses to vagal nerve stimulation (VNS) vs. sham treatment, at baseline and in response to stressful traumatic scripts related to personal traumatic events, as well as a series of other stressors.

The purpose of this project is to develop the fundamental physiological understanding of feedback controlled vagal nerve stimulation (VNS) using positron emission tomography (PET) brain imaging and blood biomarker measurement with stress in healthy individuals and individuals with PTSD. Healthy human subjects with a history of psychological trauma but without the diagnosis of a psychiatric disorder (Phase 1), and human subjects with a history of PTSD (Phase 2), undergo PET imaging of the brain in conjunction with VNS or a sham treatment during exposure to neutral scripts and scripts of personal traumatic events. Blood is drawn simultaneously for measurement of a variety of stress responsive biomarkers, including inflammatory markers and neurohormones. A second PET scan with biomarkers assesses the delayed effects of VNS. On two other days subjects undergo exposure to random stressors with VNS or sham in conjunction with measurement of stress biomarkers.

Eligibility Criteria:
Inclusion Criteria:

Phase 1:

* Do not meet criteria for post traumatic stress disorder (PTSD) or other major mental disorder as determined by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5 SCID) interview for PTSD
* Have a history of psychological trauma as defined by DSM-5.

Phase 2:

- Meet criteria for PTSD as determined by the Structured Clinical Interview for DSM-5 (SCID) interview for PTSD.

Exclusion Criteria:

* Positive pregnancy test
* Meningitis
* Traumatic brain injury
* Neurological disorder or organic mental disorder
* History of loss of consciousness greater than one minute
* Alcohol abuse or substance abuse or dependence based on the SCID within the past 12 months
* Positive toxicology screen
* Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia, based on the SCID
* A history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness
* Evidence of a major medical or neurological illness on physical examination or as a result of laboratory studies (complete blood count (CBC), blood urea nitrogen (BUN), creatinine, blood sugar, electrolytes, liver and thyroid function tests, urinalysis, and EKG)
* Active implantable device (i.e. pacemaker)
* Carotid atherosclerosis
* Cervical vagotomy
Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy

Study design:

A prospective phase II, non-randomized observational study of dose-escalated pencil beam proton therapy re-irradiation for pelvic recurrences from rectal cancer.

Re-irradiation is either a part of neo-adjuvant treatment or as a definitive treatment strategy for un-resectable recurrences.


Eligibility Criteria:
Inclusion Criteria:

* • Locally recurrent rectal cancer.

  * Bioptically verified (adenocarcinoma )
  * Available dose plan from primary radiotherapy
  * Previous pelvic RT (\>30Gy EQD2)
  * Evaluated in MDT-conferences (Herlev, Aarhus)
  * Age\>18 years
  * PS 0-2
  * Adequate organ function
  * Informed consent

Exclusion Criteria:

* Non-resectable distant metastases (PET-CT)
* Unable to undergo MRI, PET-CT
* Inability to attend full course radiotherapy and follow up in the out patient clinic.
Single Patient Room Versus Open Bay in NICU

The NICU at the IWK Health Center in Halifax, Nova Scotia is embarking on a redevelopment project that will see its current open bay design converted to a single room care environment. There will be a period during the redevelopment when new single room care unit will coexist with one open bay unit. This provides a unique opportunity to explore the effect of the two different environmental designs on both short and long-term outcomes. Preterm infants (under 31 weeks gestational age) and very low birth weight infants (under 1500 grams) will be randomized to either the open bay unit or the single patient room unit, at 36 months corrected age neurodevelopmental outcomes will be assessed.

Do very preterm infants (\< 31 weeks gestational age) and very low birth weight infants (\< 1500 grams) admitted to a single patient room in the NICU have improved long-term neurodevelopmental outcomes when compared to very preterm infants admitted to an open bay in the NICU?

Babies who will be admitted to NICU will be randomized to either the open-bay unit or single room care. The randomization will be achieved through the use of the WANNNT (Winnipeg Assessment of Neonatal Nurses Need Tool) and current patient census; this involves taking 1/3 of the fraction of the patient census on each team and adding it to 2/3 of the fraction of the WANNNT. This methodology was reviewed by several IWK Committees including Ethics, Family Leadership Council, Neonatal care Committee and the Family Centered Care Committee. This randomization is designed to ensure fairness and an equitable workload between the two units.

Eligible study infants are also enrolled in the Perinatal Follow-Up Program (PFU) as a standard of care at the IWK Health Center. The baby's legal guardian signs a consent to be enrolled in the PFU Program and to allow collection and use of data for their child as long as their child cannot be identified from the use of the data. All families of infants admitted to NICU, whether or not they have been enrolled in the PFU Program will receive an information package explaining the single patient room NICU compared with the open bay NICU.

At three years of corrected gestational age, all eligible infants will have the Bayley Scales of Infant and Toddler Development - version 3 assessment completed which evaluates cognitive, language and motor skills. These infants will also be examined for the presence or absence of cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

* All very preterm infants born less than 31 weeks gestational age or birth weight less than or equal to 1500 grams
* age less than 14 days
* Multiples will be randomized to the same arm.

Exclusion Criteria:

* Babies with major anomalies
* Babies admitted for palliative care only