cyrilzakka/clinical-trials huggingface dataset:
Predictors of De-novo Development of Obstructive Sleep Apnea in Pregnancy

This study seeks to understand the physical, physiologic and biologic features that predispose a woman to the development of obstructive sleep apnea once they are exposed to the cardiopulmonary and metabolic physiological changes of pregnancy. Knowing these specific predictive factors can help identify a population at risk and guide clinicians to develop suitable targeting screening strategies.

Patients will be recruited from multiple community and hospital-based practices that care for pregnant women. Subjects will have:

1. measurements of body composition
2. anthropometric measures
3. sleep and mood questionnaires
4. Home sleep studies
5. blood testing for biological markers
6. salivary testing for hormonal markers
7. pulmonary function tests and upper airway patency measurements

Women without sleep apnea at enrollment will then be followed longitudinally for the development of obstructive sleep apnea during pregnancy with repeat assessment during their third trimester. Women diagnosed with sleep apnea at enrollment will have no further assessment in late pregnancy.

Monetary incentives will also be issued at data collection points. Subjects will receive small gift incentives such as baby-related items.

Eligibility Criteria:
Inclusion Criteria:

* \<13 completed weeks of gestation
* BMI \>30 kg/m2 at recruitment
* \>18 years of age
* Ability to give informed consent

Exclusion Criteria:

* Unable to meet inclusion criteria
* Twin pregnancies
Aerobic Exercise and Cognitive Training in Patients With Stroke

The goal of this clinical trial is to test the effects of aerobic exercise and BDNF on patients with ischemic and hemorrhagic stroke during a computerized cognitive training.

The main questions it aims to answer are:

1. Does a moderate intensity aerobic exercise, prior to a cognitive training, allow a better performance?
2. Is it possible to exploit the timing of rehabilitation interventions to obtain greater effects? Participants will be divided in 2 groups. The experimental group will first perform 20 minutes of pedaling as a moderate intensity aerobic exercise. It will then participate in one-hour cognitive training sessions, with the aim of training attentional, working memory and executive functions. The control group will carry out the same interventions but in reverse order.

The researchers will compare the results of the cognitive training in the two groups to verify if the order of the interventions influences the results themselves.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of stroke, both ischemic and haemorrhagic.
* Patients admitted to the Specialist Rehabilitation Unit 1 of the "E. Spalenza - Don Gnocchi "of Rovato.
* Overall score in the MoCA test ³ 26
* In case of a diagnosis of aphasia, a test of verbal comprehension ("Token Test") with score in the norm, P.E. \> 1
* Hypertonic and spasticity picture compatible with the performance of motor activity of pedaling expected in the EA session.
* Tolerance of physical exercise
* Incoming electrocardiogram normal and free of anomalies

Exclusion Criteria:

* Overall score in the MoCA test \<26
* In case of a diagnosis of aphasia, a test of verbal comprehension ("Token Test") with pathological or borderline score, P.E. £ 1.
* Documented diagnosis of neurodegenerative diseases with impact on performance cognitive.
* Severe acquired brain injury
* Illiteracy
* Status of hypertonus and spasticity not compatible with the performance of motor training
* Excessive fatigue: the patient does not tolerate moderate intensity physical activity and accuses excessive fatigue during the preliminary test
* Electrocardiogram at entrance with anomalies and / or altered
* Ischemic heart disease
* Cardiac disorders that are contraindications for aerobic activity of moderate intensity
The NACHO Trial (Nut Allergy Children OIT)

Most food allergies that begin in early childhood are mild and resolve by school age, but nut allergies persist in about 80-90% of individuals into adulthood. The consumption of nuts, particularly cashew nuts, has increased dramatically in Finland in the 21st century, leading to a rise in severe allergic reactions to cashew nuts among young children. Of the food anaphylaxis cases reported in the Finnish Anaphylaxis Registry between 2015-2020, 49% were caused by nuts, with cashew nuts being the most common trigger. The standard treatment for nut allergies is strict avoidance of nuts and symptom management with emergency medications.

Oral immunotherapy (OIT) is a food allergy treatment that increases tolerance, and it has primarily been studied in school-aged children, with desensitization achieved in about 80% of cases. Permanent tolerance, depending on the allergen, develops in 30-50% of cases within five years. International guidelines recommend peanut OIT for children over the age of 4 who have severe peanut allergies. The likelihood of achieving tolerance, especially permanent tolerance, appears to improve the earlier the treatment is started. To date, only one study (NUIT CRACKER) has been published on cashew nut desensitization in children over 4 years old, involving 50 children, where 88% achieved desensitization to both cashew nuts and pistachios.

The aim of this study is to develop a cashew nut desensitization protocol and investigate its effectiveness in achieving tolerance and permanent desensitization in children aged 1-17 years, compared to cashew nut avoidance. The study will assess the safety of cashew nut desensitization and its impact on the quality of life of patients and their families.


Eligibility Criteria:
Inclusion Criteria:

1. Age 6 months - 17 years
2. Sensitization to cashew nut (allergen-specific IgE or positive skin PRICK test)
3. Positive oral food challenge for cashew nut

Exclusion Criteria:

1. Poor adherence
2. Uncontrolled or severe asthma
3. Uncontrolled active or severe or atopic dermatitis
4. Chronic urticaria
5. Eosinophilic esophagitis or other gastrointestinal eosinophilic disorders
6. Active malignant neoplasia
7. Active systemic, autoimmune disease
8. Diabetes treated with insulin
9. Severe systemic illness or severe medical conditions such as cardiovascular or lung diseases
10. Medication with beta blockers
11. Medication with ACE-inhibitors
12. Mastocytosis
13. Pregnancy or breastfeeding
14. Language barriers (not fluent Finnish or Swedish)
Qualitative Evaluation of Therapeutic Alliance in Adolescent Psychiatry

Context: Psychiatric disorders (anorexia nervosa, depression, anxiety based school refusal) are a major public health concern in adolescence. Their treatment is a challenge for the families, the health care system and society. The treatment is complex and non-standardized. In clinical practice, the relational dimension between the stakeholders is recognized by all. Nevertheless no study has ever crossed their perspectives about therapeutic alliance in adolescent psychiatry.

Objective: to explore, within a qualitative approach, how a therapeutic alliance is established in three different clinical situations according to the adolescents, their parents and their physicians by crossing their perspectives.

Methods: This is a national (France) multi-center qualitative study based on 180 semi-structured interviews. Participants (purposively selected until data saturation) came from three different sub-samples: (i) adolescents with anorexia nervosa (N =20) plus their parents (N=20) and their physicians (N=20), (ii) adolescents with depressions (N=20) plus their parents (N=20) and their physicians (N=20), and (iii) adolescents with anxiety-based school refusal (N=20) plus their parents (N=20) and their physicians (N=20). Data are collected through open ended semi structured interviews and independently analyzed with NVivo V.11 software by three researchers according to the principles of Interpretative Phenomenological Analysis.


Eligibility Criteria:
Inclusion Criteria:

* adolescents, boys and girls, aged 12 to 18 years, speaking fluent French, with (i) anorexia nervosa according to DSM 5 criteria (ii) depressive disorders (dysthymia, depressive episode) according to DSM 5 criteria (iii) anxiety-based school refusal according to four criteria:

  1. refusal to attend school (to operationalize this first criterion, adolescents were included if they had not attended school at all for at least one month before starting treatment); (2) presence of a DSM-5 anxiety disorder (except obsessive-compulsive or post-traumatic stress disorders) with emotional upset at the prospect of attending school; (3) absence of a DSM-5 conduct disorder; and (4) parental knowledge of the adolescent's whereabouts during the period of non-attendance.

     that led to treatment that had begun at least six months earlier and clinically determined to be well enough to participate in a research interview.
* receiving treatment for at least 6 months
* one parent at least agrees to participate

Exclusion Criteria:

* acute symptoms and serious somatic and/or psychiatric co-morbidities
The Role of Short Course of Palliative Radiation in Metastatic Cancer Rectum

Short-course radiotherapy (SCRT), which allows the delivery of 25 Gy in five daily fractions, has emerged as an attractive strategy for rectal cancer treatment. Surgery can safely be deferred after SCRT, allowing an opportunity to deliver chemotherapy (ChT) preoperatively rather than postoperatively. In cases of metastatic disease, this represents an effective treatment option to improve local control and avoid colostomy in a subset of patients.

All patients will be under go complete history and physical examination, proctoscopy and biopsy, followed by metastatic work up include chest X ray, pelvic abdominal CT.

Radiotherapy:

Target volume: all the gross primary disease and gross nodal involved plus 2 cm safety margin will be included. not involved node will not be included.

Dosage: total dose of 25 Gy over 5 fractions through 1 weak will be given. Time: Radiotherapy will be given first and chemotherapy will be given after 1 weak rest to avoid the over lapping toxicity.

Chemo therapy:

To be started after 1 weak rest after radiotherapy. CAPOX (oxaliplatin given intravenously at 130 mg/m2 on day 1, followed by oral capecitabine 1000 mg/m2 twice daily on days 1-14, in a 3-week cycle). or folfox (leucovorin calcium (IV 200 mg/m2 on day 1,2,15,16 ) + 5 fluorouracil (IV 600 mg/m2 on day 1,2,15,16)+ oxaliplatin (IV 85 mg/m2 on day 1, 15) plus target agent according to RAS status if wild for bevacizumab ( IV 5 ml/kg on day 1, 15) or cetiximab (IV 250 mg/m2 on day 1,8,15, 22) or vectibex (IV 6mg/kg on day 1,15)

Surgery:

Surgery if complete bowel obstruction as palliation or as treatment if controlled metastatic sites and primary

Follow up:

CT pelvi-abdomen will be done after 3 cycle of chemotherapy to assess the response then after end of CTH every 3 month in first year. Toxicity of RTH will be collected before and after RTH.

Eligibility Criteria:
Inclusion Criteria:

1. Adenocarcinoma pathological evidence in rectal carcinoma.
2. Metastatic unresectable rectal cancer.
3. Symptomatic disease for at least one of the following signs: bleeding, pain, tenesmus, obstruction,

Exclusion Criteria:

1. Previous radiotherapy.
2. Concomitant chemotherapy.
3. Previously created stoma.
Evaluation of the Effectiveness of Eliquis ® (Apixaban) Risk Minimization Tools in European Economic Area (EEA) Countries

The main purpose is to evaluate the effectiveness of the Eliquis® (apixaban) Prescriber Guide and Patient Alert Card in terms knowledge of the important identified risk of bleeding associated with Eliquis treatment communicated by the RM tools.

Observational Model, Other- This is a non-interventional, cross-sectional study in the EEA involving representative samples of HCPs who treat patients with Eliquis, as well as patients treated with Eliquis. This study will be facilitated via web-based surveys used to evaluate the effectiveness of the Eliquis Prescribe Guide and Patient Alert Card as risk management tools.

Enrollment: 384 Health Care Professions (HCPs) and 192 Patients

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults (VTEt)

Prevention of VTE in adult patients knee replacement surgery (VTEp)

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* HCP must have been involved in the treatment of at least one patient with Eliquis for any approved indication
* Patients must have taken Eliquis for any approved indication
CT (Computerized Tomography) for Late EndovasculAr Reperfusion

The objective of this multicenter, retrospective, cross-sectional, chart review study is to compare outcomes (disability, complications and mortality) of patients with large vessel occlusion stroke presenting at late time window selected by either Non-Contrast CT (NCCT) only, advanced imaging with CTP (Computed Tomography Perfusion), MRI (Magnetic Resonance Imaging), or medical management.

Boston Medical Center (BMC) will serve as the main data coordinating site. Fifteen additional sites will seek local IRB approval or ethics approval. The aggregated de-identified data will be analyzed comparing types of interventions and outcomes by type of imaging or medical management.

Additional subgroup analysis that are planned include:

1. Futile Reperfusion in the Extended Window.

   We will evaluate clinical, imaging and time metric factors associated with successful reperfusion yet poor outcomes (modified Rankin 3-6) in the 6-24 hour window.

   An evaluation of factors associated with symptomatic intracranial hemorrhage and mortality will be conducted.
2. Pre-Stroke disability.

   1. EVT patients treated in the extended window compared to Medical Management
   2. EVT patients treated in the extended window with pre-existing disability vs. those without pre-existing disability
3. Intravenous Thrombolysis in the Extended Window

   We aim to compare the safety and outcomes of bridging IVT in patients with acute ischemic stroke due to large vessel occlusion (LVO) who underwent EVT 6 to 24 hours after time-last-known-well.
4. Medical Management vs CT selected Patients

   We hypothesize that in patients with large vessel occlusion in the anterior circulation presenting in the 6 to 24 hour window, patients who are selected by non-contrast CT and treated with endovascular therapy have more favorable outcomes (ordinal mRS shift) as compared to patients who are medically managed.
5. Sex differences in the Extended Window

   In this study we aim to asses whether there are sex differences in clinical outcomes and safety of EVT in patients presenting in the 6-24 hour time window.
6. Transfer Analysis

It is not well established whether transfer patients presenting in the extended window should have repeat imaging upon receipt at the endovascular center after an interim time window.

We hypothesize that within a 0 to 2, or 2 to 4 hour delay between images of the primary stroke center to receiving endovascular center, transferred patients in the extended window, who undergo thrombectomy with successful reperfusion will have similar outcomes in patients with or without repeat imaging at the receiving center.

We aim to compare the safety and outcomes of late-window bridging IVT vs. direct EVT for LVO acute ischemic stroke in the 6-24 hour time window.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting 6-24 hours from last known well with large vessel occlusion stroke
* ASPECTS score 5 or greater from last known well
* January 1, 2014 to May 1, 2022

Exclusion Criteria:

-Time last seen well to treatment \<6 hours from last known well
Flexible Laryngeal Mask Airway Versus Tracheal Intubation in Nasal Bone Fracture

In surgery under general anesthesia due to nasal bone fracture, laryngeal mask airway or tracheal intubation has been used. However, it has not been investigated that the difference of recovery profiles according to use of laryngeal mask airway or tracheal intubation in nasal bone fracture surgery. The aim of study is to evaluate the efficacy of the laryngeal mask airway regarding recovery profiles and airway complications, compared to tracheal intubation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiologists classification 1 or 2 who receive general anesthesia due to nasal bone fracture

Exclusion Criteria:

* Patients with high risk of aspiration, patients who anticipated difficult airway
Hemostatic Activity Following LAAO

The primary objective of this study is to prospectively investigate hemostatic activity following transcatheter left atrial appendage occlusion (LAAO).

This is a prospective cohort study of patients undergoing transcatheter LAAO at Aarhus University Hospital. Hemostatic consequences following device implantation will be evaluated using blood samples collected pre- and post-procedurally, and serially during three months follow-up in 135 LAAO patients. Platelet function and characteristics, overall activation of the extrinsic coagulation pathway and the intrinsic contact activation pathway, as well as endothelial response to implantation, will be assessed through a wide range of biochemical analyses. Patients will serve as their own controls, with a final control blood sample collected at three-months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Atrial fibrillation (paroxysmal, persistent, or permanent)
* Admitted and eligible for LAAO
* Signed written consent

Exclusion Criteria:

* Known hereditary bleeding disorders (i.e. Hemophilia A and B, Von Willebrand disease)
* Platelet count \< 75 x 109/ml
Investigating Genetic Status in Patients Presenting to Clinic

The causes of neurodegenerative dementias such as Frontotemporal Dementia, Lewy Body Disease and Alzheimer's disease are still largely unknown. While the contribution of some genetic mutations and polymorphisms is associated with autosomal dominant patterns of inheritance of these dementias, in many cases, the specific causative mutation in these families is not yet identified. Further, in many patients, polygenic risk is thought to give rise to pathophysiologic changes, but which specific genes affect risk are largely yet unknown. By examining genotypes in patients that present to our Cognitive Neurology and Alzheimer's Research Clinic with suspected or confirmed neurodegenerative dementia, or have a history of a familial dementia, we aim to help identify and characterize genetic mutations or polymorphisms that give rise to neurodegenerative diseases.


Eligibility Criteria:
Inclusion Criteria:

* Persons presenting to the cognitive clinic with a neurodegenerative disorder (for example, AD, FTD, LBD, ALSP, and related conditions);
* Biological family members of someone diagnosed with a neurodegenerative disorder, presenting to clinic;
* Age 18+ years old;
* Consenting to a blood draw.

Exclusion Criteria:

• Persons declining / unwilling / not able to have a blood draw.
Effects of Caffeine in Tinnitus

Caffeine intake is reported by many authors to enhance the perception of tinnitus. The aim of this study is to determine the effects of 1 month caffeine intake reduction in the scores of validated questionnaire Tinnitus Handicap Inventory (THI) and in a visual-analog scale (VAS).

A group of 50 patients who takes more than 3 small cups (50 ml) of caffeine daily and have tinnitus will be asked to reduce caffeine intake for 1 month. Scores of THI and VAS will be taken before and after this period.

Eligibility Criteria:
Inclusion Criteria:

* tinnitus for more than 6 months
* THI \> 38
* no central acting drugs in the last 6 months
* tympanogram type A-n
* daily intake of caffeine greater than 150 ml

Exclusion Criteria:

* vascular and muscular tinnitus
* concomitant TMJ disorders
* abnormal otoscopy
* mixed and conductive hearing losses
* Ménière disease
Using a Cold Atmospheric Plasma Device to Treat Skin Disorders

This study examines the efficacy of a non-thermal, atmospheric plasma device in the treatment of skin disorders

The study uses non-thermal atmospheric pressure plasma to treat target conditions. The patients are monitored at set intervals for efficacy and adverse effects using investigator's assessment and imaging techniques

Eligibility Criteria:
Inclusion Criteria:

* diagnoses of target conditions
* ability to complete study protocol

Exclusion Criteria:

* based on specific condition
Poly-omic Predictors of Symptom Duration and Recovery for Adolescent Concussion

The purpose of this study is to identify changes in salivary micro ribonucleic acid (miRNA) levels that are predictive of symptom duration and character following mild traumatic brain injury (mTBI) in children.

The objective of this multi-center study is to refine and validate a saliva RNA assessment for adolescent concussion, yielding a non-invasive test that predicts duration and character of symptoms, and helps guide clinical decisions. To accomplish this goal, the study will enroll 750 adolescents with mTBI. Saliva RNA levels and symptoms will be assessed at \<48 hours, 7 days, and 30 days post-injury. Aim 1 will assess the ability of saliva RNA dynamics (Δ from \<48 hours to day 7) to predict PPCS 30 days after mTBI (defined by persistence of ≥3 symptoms on day 30, compared with pre-injury state on the Post-Concussion Symptom Inventory; PCSI). RNA accuracy will be compared to a validated clinical prediction tool (5p tool). Aim 2 will assess the ability of saliva RNA dynamics (Δ from \<48 hours to day 30) to identify recovered participants on day 30. RNA accuracy will be compared to change in composite score on a standardized reaction time test (from \<48hrs to day 30). Completion of these aims will yield an objective biologic test that can be used for prognosis at the time of mTBI, and to aid clinical decisions regarding return-to-learn or return-to-play.

Eligibility Criteria:
Inclusion Criteria:

* Presence of mTBI: defined by criteria from the Berlin Consensus Statement and WHO. Assessment for mTBI status be performed by a licensed clinician per the 2018 CDC guidelines.
* Age at enrollment: 13-18 years of age (inclusive).

Exclusion Criteria:

* \> 48 hours after initial mTBI
* Glasgow Coma Scale score of 13 or less
* Previous moderate-to-severe TBI requiring overnight hospitalization
* Unresolved symptoms from previous concussion, or any concussion within the last 3 months
* Abbreviated Injury Scale (AIS) score \> 3 (to reduce confounding from poly-trauma)
* Psychiatric illness requiring previous hospitalization;
* Neurological condition (e.g. epilepsy, hydrocephalus) or abnormality on neuroimaging (if performed)
* Intellectual disability that prevents ability to provide informed assent
* Pregnancy
* Active substance use/dependence
* Previous neurosurgery
* Non-fluency in English
* Upper respiratory infection
* Periodontal infection
* Injury to the oropharynx
* Previously enrolled in the same study
* Inability to complete follow-up assessments