cyrilzakka/clinical-trials huggingface dataset:
Impact of Muscle Training Device on Non-Severe OSA

The goal of this clinical trial is to test for the efficacy of the newly invented device #DidgeriTU with non-severe obstructive sleep apnea. The main question it aims to answer is:

• Can DidgeriTU reduce apnea events in patients with non-severe obstructive sleep apnea? Researchers will compare DidgeriTU with a sham device to see how the apnea event has changed.

Participants will:

* Use DidgeriTU or sham device for 3 month
* Do an online questionnaire once a month during the study
* Home sleep test, lung function test, and tongue strength test at the start and end of the study

Previously, in Switzerland, an aboriginal musical instrument, the Didgeridoo, was taught to patients with OSA. It has been proven to be effective in reducing apnea events.

Our newly invented instrument, DidgeriTU, adopts the Didgeridoo principle for expiratory muscle exercise to reduce apnea events.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with mild to moderate obstructive sleep apnea.
* Age 18 years or older.
* Patients voluntarily consent to provide information for research purposes.

Exclusion Criteria:

* Patients with an average apnea-hypopnea index (AHI) of \<4 or \>29 events per hour after repeated diagnosis using a home sleep apnea test.
* Patients who refused to cease using CPAP during the study process
* Patients with a history of chronic lung disease.
* Elderly patients with neurological conditions that impair cognitive function, such as dementia, stroke, or psychiatric disorders.
* Patients taking medications that may affect muscle function within 3 months before the start of the study.
* Patients with hypothyroidism or other conditions that may affect muscle function.
* Patients who consume alcohol at a moderate level or higher
Neurobiological Responses in Alcoholism and Early Trauma

Alcohol use disorder (AUD) accompanied by early trauma presents clinical challenges, including elevated rates of comorbid emotional symptoms and relapse. To better understand this co-occurring condition, this study investigates the neurobiological responses associated with AUD and early trauma. Using a multimodal neuroimaging approach, including functional magnetic resonance imaging (fMRI), the study concurrently measures brain activity and stress hormone responses in individuals with AUD and control participants, both with and without early trauma. The primary goal is to examine neurobiological responses and relapse patterns following treatment in individuals with AUD, with and without a history of early trauma. Conventional alcohol treatments often fail to specifically address the emotional complications in AUD individuals with early trauma. Therefore, this study also explores whether incorporating stress regulation into alcohol relapse prevention can improve outcomes for this population. Following baseline assessments that included multimodal neuroimaging, all participants with AUD received an 8-week outpatient treatment program integrating cognitive-behavioral methods focused on emotion regulation with stress reduction techniques, particularly self-regulated breathing strategies.

The study recruited four demographically matched groups (age, sex ratio): individuals with AUD with and without a history of early trauma, and moderate drinkers with and without early trauma. Study procedures involved functional magnetic resonance imaging (fMRI), an eight-week outpatient treatment program, and a 90-day follow-up period. During fMRI sessions, participants engaged in a validated emotion provocation task, viewing stress, alcohol-cue, and neutral images while concurrent brain and stress hormone data are collected. Individuals with AUD completed baseline assessments, including multimodal neuroimaging, and then participated in an 8-week treatment program consisting of two sessions per week. This program integrated cognitive-behavioral techniques focused on emotion regulation with breathing-based stress management. Control participants completed baseline assessments including multimodal neuroimaging but did not receive any treatment. Following the treatment, participants with AUD were prospectively followed for 90 days, with remote follow-up interviews conducted at 14, 30, 90 days via video communication.

Eligibility Criteria:
AUD inclusion Criteria:

* Alcohol use disorder
* Either low or high early trauma (based on the Childhood Trauma Questionnaire)
* Body mass index (BMI) up to 35 (due to weight limitations of the MRI scanner)

AUD exclusion Criteria:

* Current or past substance use disorder other than alcohol; excluding caffeine and nicotine
* Psychiatric disorders except for mood and anxiety disorders
* Any significant current medical conditions
* Women who are peri- and post- menopausal, pregnant or lactating
* MRI specific exclusion criteria (e.g., claustrophobia, implanted metal in the body)
Primary Prevention Long-term Registry Study in OSA and Hypertension. Survival Analysis 2010-2022

Hypertension and obstructive sleep apnea (OSA) are both common conditions that independently increase the risk cardiovascular disease including atrial fibrillation, ischemic heart disease, heart failure and stroke. OSA is also an independent promoter of hypertension development and poorly controlled hypertension is overrepresented in OSA. Finally, HT and OSA share many risk factors including obesity, and several lifestyle factors. Altogether, these links contribute to a high prevalence of patients with both disorders.

The investigators suspect participants with HT and OSA are at even higher CV risk and may get their first CV event earlier in life. Comparison between HT and OSA participants vs HT alone, OSA alone or healthy controls has not previously been investigated in large studies.

Thus, the investigators aim to investigate long-term risk of major cardiovascular events (MACE) or death comparing these groups in registry data between 2010-2022 in Sweden. The investigators will also investigate the protecting effect of positive airway pressure (PAP) on the OSA related CV risk increase and how many hours/night of PAP use is needed to get any protective effects.

Please see attached analysis plan

Eligibility Criteria:
Inclusion Criteria:

* Adult patients starting PAP treatment for OSA in the swedevox registry between 2010-2021 with and without hypertension. Randomly selected controls with and without hypertension from the general population.

Exclusion Criteria:

* Patients with manifest cardiovascular disease (stroke, ischemic heart disease, cardiac failure or atrial fibrillation at baseline).
* Patients with kidney failure at baseline.
* Patients with malignant cancer at baseline.
* Subjects with missing data on any of the main variables in the fitted models.
The SITE Study - Dexamethasone Ophthalmic Insert In OR on Day of Surgery Versus In-office Post-Op Day 1

To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op.

This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op.

There will be approximately 50 eyes with two groups:

Group 1 (up to 10 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.

Group 2 (up to 40 eyes) will receive the insert in the lower punctum on the day after surgery in the HOPD.

Each subject's participation is expected to last for approximately 1 month and will be required to complete five scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 7 and Day 30.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be eligible for study participation if they:

Are an adult subject aged 65 years or older Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes Are willing and able to comply with clinic visits and study related procedures Are willing and able to sign the informed consent form

Exclusion Criteria:

* Subjects are not eligible for study participation if they:

Have active infectious systemic disease Have active infectious ocular or extraocular disease Have unobstructed nasolacrimal duct in the study eye(s) Have known hypersensitivity to dexamethasone or are a known steroid responder Have a history of ocular inflammation or macular edema Are currently being treated with immunomodulating agents in the study eye(s) Are currently being treated with immunosuppressants and/or oral steroids Are currently being treated with corticosteroid implant (i.e. Ozurdex) Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye Have a history of complete punctal occlusion in one or both punctum Currently use topical ophthalmic steroid medications Are unwilling or unable to comply with the study protocol Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment
Posttraumatic Stress Disorder in Parents and Children After Discharge From the Pediatric Intensive Care Unit

Background: If disorders that occur immediately after a trauma are not treated, they may become chronic and turn into severe health problems.

Objectives: This study was conducted with children who had spent time in an intensive care unit and their parents to examine the development of posttraumatic stress disorder (PTSD) in both children and parents.

Methods: The study was a cross-sectional study. A total of 110 children, 98 mothers and 80 fathers were included in the study.

Background: If disorders that occur immediately after a trauma are not treated, they may become chronic and turn into severe health problems.

Objectives: This study was conducted with children who had spent time in an intensive care unit and their parents to examine the development of posttraumatic stress disorder (PTSD) in both children and parents.

Methods: The research was carried out in the intensive care unit of a children's hospital in Turkey. Children between the ages of 8-12 who had spent time in the PICU over the period January 1 - March 1, 2019, who had been discharged from the PICU or transferred into another unit during this time, and who met the research criteria were included in the study. Between these dates, the total number of children discharged from intensive care or transferred into another unit was 166. Of these children, 138 were between the ages of 8-12. During this period, three children who died, two children whose general condition meant they were unable to participate in the study, and 23 children for whom parental consent could not be obtained were excluded from the study. The study was ultimately completed with 110 children. In addition, the parents of the children in the sample group (98 mothers and 80 fathers) who were alive, reachable, and who agreed to participate were included in the study.

Results: A total of 110 children, 98 mothers and 80 fathers who agreed to participate in the study, met the sample selection criteria, and were available throughout were included in the study.

Eligibility Criteria:
Inclusion Criteria:

* The child was between 8-12 years old,
* The child had an accompanying adult present,
* The child was conscious and/or able to communicate verbally,
* The child did not have any intellectual disability,
* There were no challenges in communicating with the family and/or the child (i.e., they spoke Turkish, were able to communicate),
* The child's stay at the PICU was no longer than 29 days,
* The child and their family volunteered to participate in the study.

Exclusion Criteria:

* All participants who do not meet the inclusion criteria
Preemptive Erector Spinae Plane Block Versus Serratus Anterior Plane Block in MRM

Modified radical mastectomy (MRM) is one of the most performed surgeries for breast cancer. MRM is associated with significant pain during the immediate postoperative period.

Modified radical mastectomy (MRM) is one of the most performed surgeries for breast cancer. MRM is associated with significant pain during the immediate postoperative period.

Inadequate pain management has both psychological and physiological repercussions.

Various local or regional nerve blocks like thoracic epidural, interscalene brachial plexus, paravertebral, pectoral nerve blocks, and erector spinae plane blocks are performed in MRM to provide analgesia.

Ultrasound-guided Erector spinae plane block (USG-ESPB) is one of the novel and effective regional techniques where local anaesthetic is deposited deep into the erector spinae muscle, blocking the ventral and dorsal rami of multiple spinal nerves, and is technically simple, with fewer hemodynamic side effects and with minimal complications

Eligibility Criteria:
Inclusion Criteria:

* female patients
* aged from 18 to 70 years
* with a body mass index ≤ 30 kg/ m2
* American Society of Anesthesiologists (ASA) physical status I-II,
* who were scheduled for MRM for breast cancer

Exclusion Criteria:

* history of drug allergy,
* psychiatric illness, substance abuse,
* severe cardiovascular or respiratory disease,
* any pre-existing liver disease, metabolic or neurological syndrome, c
TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass

Patients will be randomized into 2 groups:

* TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia
* IV: Patients receiving only intravenous Acetaminophen analgesia

Postoperative pain 24 hours after surgery will be evaluated.

Patients will be randomized into 2 groups:

* TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia (1g/6h)
* IV: Patients receiving only intravenous Acetaminophen analgesia (1g/6h)

Postoperative pain 24 hours after surgery will be evaluated, by a Visual Analogic Scale (VAS), ranging from 0 to 100mm.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing One-anastomosis gastric bypass (OAGB) as primary bariatric procedure

Exclusion Criteria:

* Patients undergoing OAGB as revisional procedure
* Patients undergoing other bariatric procedures
* Patients undergoing additional surgical procedures during the same surgical act (band removal, cholecystectomy, hernioplasty, or hiatal hernia treatment)
* Patients with history of allegy to local anesthetic drugs
Promoting Appropriate Weight Gain Pregnant Women

The purpose of this study is to learn if engaging in group based phone counseling (GBPC) and an interactive physical activity monitoring system can help pregnant women gain an appropriate amount of weight during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* 12-16 weeks pregnant
* Pre-pregnancy BMI between 22 kg/m2 to 45 kg/m2

Exclusion Criteria:

* Diabetes
* Pre-eclampsia
* Hypertension
* Other metabolic abnormalities
Validation/Evaluation of Multimodal Imaging Combining 3D Ultrasound and Stress Myocardial Scintigraphy in the Diagnosis of Coronary Artery Disease

Our primary goal is to validate a new diagnostic tool for functional coronary artery stenosis that uses multimodal imaging (combining stress echocardiography and stress scintigraphy) in patients with known coronary chest pain.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient has a documented coronaropathy
* The patient needs a new coronarography following symptoms indicating a change in his/her coronary disease state

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* Patients with arrhythmias, left bundle branch block on the electrocardiogram which would complicate the interpretation of examinations
* Unstable, acute coronary syndromes unstable needing emergency coronary angiography
* Patient with contraindication for conducting a stress test:
* poorly controlled hypertension
* pre-existing severe arrhythmia
* aortic stenosis
* and obstructive hypertrophic cardiomyopathy
* Patient has contraindication for atropine
* History of prostate adenoma
* Glaucoma
Effectiveness of Mindfulness-based Cognitive Therapy Undergoing Post Stroke Rehabilitation

The goal of this clinical trial is to investigate the efficacy of mindfulness-based cognitive therapy compared to usual care for stroke survivors undergoing inpatient rehabilitation.

It was hypothesized that group-based MBCT would lead to improving mood, mindfulness, social support, physical, and neurocognitive function; and that these improvements would be maintained over the 3-month follow-up period. Participants in the control group received only usual care, the intervention group were involved in MBCT intervention in addition to usual care. MBCT intervention was designed to consist of eight 1.5-hour group sessions over 6 consecutive weeks.

Eligibility Criteria:
Inclusion Criteria:

* stroke patients with functional impairments
* confirmation of stroke by CT or MRI scan
* age between 18-90 years
* had adequate communication skills, cognitive and physical capacity to participate in study activities
* competence to provide informed consent

Exclusion Criteria:

* severe cognitive impairment according to the Word List Learning Instrument (total score \<7)
* severe depression according to the Beck Depression Inventory (BDI) (total score\>25)
* history of severe mental illness (psychotic disorder, schizophrenia, severe depression, bipolar disorder, PTSD, suicidal tendencies)
* the current change in the antidepressant therapy.
Study of an Anti-TLR4 mAb in Rheumatoid Arthritis

This is a Phase 2, PoC, randomized, placebo-controlled, double blind, international multicentre study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis

The study foresees the randomization of at least 81 moderate to severe, ACPA positive, RA patients who are inadequate responders to MTX, in two double blind arms (NI-0101:placebo, with a ratio of 2:1). Patients will receive NI-0101 or placebo infusions up to a maximum of 6 administrations (every two weeks for 12 weeks). All patients will continue receiving a stable dose of MTX. After 12 weeks, patients will enter the follow up period with monthly visits for a minimum of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* Age \>= 18 years old
* BMI: \< 30 and \> 18
* Diagnosis of RA according to 2010 ACR/EULAR criteria and with a disease duration of at least 6 months since diagnosis
* Patient must present with active RA, characterized by at least 6 swollen joints out of 66 assessed and 6 tender joints out of 68 assessed and by the presence of synovitis (measured by ultrasound) in at least one of the 6 swollen joints
* C-reactive protein (CRP) level \> 0.7 mg/dL or if the CRP level is between 0.3 mg/dL and 0.7 mg/dL (included) then patient must also present an ESR \> 30mm/hr
* Patients must have received MTX treatment for at least 3 months and have been on a stable dose of MTX for at least 6 weeks prior to start of screening
* ACPA-positive RA patients
* Women must be postmenopausal (\> 12 months without menses) or surgically sterile or using two effective contraception methods for at least 4 weeks prior to the randomization date and agree to continue contraception for the duration of their participation in the study (until the end of follow up period)
* Sexually active male patients must use a barrier method of contraception during the course of the study (and until the end of the follow up period)
* Patients must give written informed consent for study participation

Exclusion Criteria:

* A documented history of an autoimmune disease other than RA by ACR classification, or Sjögren syndrome
* Administration of cytotoxic drugs and immune suppressants (other than MTX) within 3 months prior to screening
* Previous multiple administrations of any biological DMARD or targeted synthetic DMARD
* Known primary immunodeficiency
* Pregnant or breastfeeding women
* Suspicion of active or latent tuberculosis
* HIV, HCV, HBV infection
* Infection reported during screening not recovered 72h prior to first dose
* History of anaphylactic reactions to any protein therapeutics or excipients
* Any history of malignancy, excluding cured basal or squamous cell carcinoma of the skin, or cervical in situ carcinoma
* Clinically significant cardiac disease requiring medication, such as congestive heart failure, unstable angina, myocardial infarction within 6 months prior to randomization
* Moderate to severe renal insufficiency, clinically relevant liver function test abnormalities or pancytopenia
* Major psychiatric or neurological disorder
Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth

Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product applied to see if they become sensitized to repeated applications.

For the Irritation Study (30 subjects), patches containing CHG, vehicle, saline, CHG comparator or sodium lauryl sulfate (a product that is expected to produce a slight skin irritation) will be placed on the same spot of your skin every day for 21 days. The skin will be examined every day.

The Sensitization Study (200 total subjects) place patches containing CHG, vehicle, saline, CHG comparator on the skin 3 times a week for 3 weeks. Following a two-week rest period the patches will be reapplied for 48 hours and assessed out to 72 hours thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Free of skin disorders
* Signed consent

Exclusion Criteria:

* Allergies to latex
* Topical or systemic steroids, antihistamines, antiinflammatory agents 7 days prior or during testing
* severe illness
* Pregnant (females)
Real-life Clinical Outcomes of Direct Oral Anticoagulants (MACACOD)

MACACOD is a clinical record in the usual clinical practice of direct oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban). Design: single-center, observational, prospective, uncontrolled study of anticoagulated patients with any direct oral anticoagulant (DOAC) with atrial fibrillation or venous thromboembolism to determine the incidence of serious complications (thromboembolic or hemorrhagic) in real life

Population: Patients over 18 years of age, with recurrent atrial fibrillation or venous thromboembolism, already anticoagulated with any DOAC or patients who initiate therapy with DOAC and who give their consent. Upon entering the study, demographic data, previous anticoagulant treatments, previous serious complications, comorbidities and baseline analytical results are recorded. The risk scores CHA2DS2-Vasc, HAS-BLED and Charlson comorbidity index (CCI) are calculated. The type of health education received in relation to anticoagulant therapy is also recorded. During the follow-up, complications and clinical changes and the analytical results of coagulation, renal and hepatic function will be recorded. The risk scores will be updated at each visit. In case of serious complications, the associated costs will be estimated.

Eligibility Criteria:
Inclusion Criteria:

· Patients older than 18 years.

* With atrial fibrillation or recurrent venous thrombosis.
* In chronic treatment with any DOAC type drug.
* Patients who sign the informed consent

Exclusion Criteria:

* Patients who do not guarantee collaboration.
* Patients with advanced cognitive impairment and not supervised.
* Patients with alcoholism.
* Patients with psychiatric disorder and not supervised