cyrilzakka/clinical-trials huggingface dataset:
Characterizing Occupational Therapy Intervention for Children With Autism Spectrum Disorders

This pilot study aims to identify behavioral and neural measures of sensory processing and attention associated with routine occupational therapy intervention for children with autism spectrum disorders. Specifically, the investigator will examine the impact of a child's level of engagement during therapy using standardized behavioral and electroencephalography (EEG) measures of sensory processing.

Occupational therapy is one of the most frequently requested and highly utilized interventions for children with autism spectrum disorders (autism) and therapists have consistently reported using the sensory integration framework as a dominant theory guiding practice. A key component of sensory integration theory is the child's active engagement during therapy, which is assumed to improve neural function, behavior, and participation. However, no studies have examined the neural mechanisms associated with occupational therapy interventions among children with autism.

This pilot feasibility study will examine behavioral and electroencephalography (EEG) measures of attention and sensory processing before and following 6-8 weeks of routine occupational therapy at community outpatient centers among 30 children with autism aged 6 - 13 years. The primary aim is to determine the feasibility, sensitivity, and validity of EEG measures of auditory processing as a response biomarker following routine occupational therapy intervention. Another aim is to examine the contribution of a child's engagement during therapy as a key predictor of change using behavioral and EEG outcome measures. The occupational therapy intervention consists of one-hour weekly sessions of usual care at Nationwide Children's Hospital outpatient centers.

Results from this grant will provide valuable proof-of-concept data establishing engagement during therapy as an active ingredient in occupational therapy intervention using neurophysiological and behavioral measures. These results will also establish the validity of EEG measures as sensitive to a child's level of engagement and neuroplastic changes following occupational therapy intervention.

Eligibility Criteria:
Inclusion Criteria:

For children with autism:

* a medical diagnosis of Autism
* between 8 - 13 years
* must be verbal
* have normal or corrected vision/hearing
* enrollment in the 8-week OT treatment plan with a therapist enrolled in the study.

For typically developing children:

• No history of neurological injuries, disabilities, and family history of mental health disorders on parent report

Exclusion Criteria:

* history of a definitive neurologic disorder including seizures (except for uncomplicated brief febrile seizures), tumor, severe head injury, stroke, lesion, or disease
* presence of a severe chronic medical disorder
* presence of a major visual impairment
* history of alcohol/substance abuse or dependency.
Exhaled Nitric Oxide and Airway Caliber in Children With Asthma

The purpose of this study is to assess if in steroid naïve asthmatic children with elevated baseline exhaled nitric oxide, treatment with inhaled steroid and normalization of exhaled nitric oxide level results in restoration of the bronchodilator response to deep inhalation.

Previous studies have shown that a deep inhalation (DI) would increase airway caliber in normal subjects. Whereas in asthmatics with spontaneous bronchoconstriction (obstruction of the airway), DI was shown to worsen airway obstruction. The mechanism for this variability in response to DI is not well-understood, but seems to be a key in understanding the pathophysiology of the disease, and possibly in the development of an effective therapy. Air way inflammation resulting in airway wall thickening and peribronchial edema is thought to play a role how the airway responds to deep inhalation. This study assess if reduction in airway inflammation (as measured by level of exhaled NO)results in optimization of the bronchodilator response to deep inhalation

Eligibility Criteria:
Inclusion Criteria:

* Age: \> 6 years at age of screening.
* Physician diagnosed asthma
* Elevated exhaled NO at initial evaluation (\>25ppb)
* Be able to reproducibly perform DI maneuvers and all other pulmonary function testing
* Be clinically stable for at least 2 weeks prior to screening with no evidence of acute upper or lower respiratory infection or current pulmonary exacerbation.
* Has not been on inhaled or oral steroid for at least 4 weeks prior to enrollment in the study.
* Parent/child willingness to enroll in the study and provide written informed consent.
* Be able to present for the required study visits.

Exclusion Criteria:

* Chest wall or spinal column deformity; known cardiac, neuromuscular, or other chronic diseases
* Use of beta agonist, theophylline, leukotriene receptor antagonists, or caffeine-containing soft drinks 12 hr prior to the study.
* Use of inhaled steroid in the past 4 weeks.
* Respiratory infection or asthma exacerbation in the previous 2 weeks
AI-assisted Colonoscopy Report System In Improving Reporting Quality

In this study, the investigators proposed a prospective study about the effectiveness of speech and image recognition-based system in improving reporting quality during colonoscopy for colonoscopy report quality in endoscopists. The participants would be divided into two groups. For the collected colonoscopy videos, group A would record their observations with the assistance of the artificial intelligence system. The artificial intelligence assistant system can automatically capture bowel segment images and prompt abnormal lesions. Group B would complete the endoscopy report without special prompts. After a period of washout period, the two groups switched, that is, group A without AI assistance and group B with AI assistance to complete the colonoscopy report. Then, the completeness of the colonoscopy report, the completeness of capturing anatomical landmarks and detected lesions, the completeness of structured description, the accuracy of lesion reporting, the time for reporting and the satisfaction with the reporting system are compared with or without AI assistance.


Eligibility Criteria:
Inclusion Criteria:

Patients:

1. Male or female ≥18 years old;
2. Able to read, understand and sign an informed consent;
3. The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures;
4. Patients requiring colonoscopy.

Doctors:

1. Males or females who are over 18 years old;
2. After qualified medical education and obtaining the Physician's Practice License.

Exclusion Criteria:

Patients:

1. Have drug or alcohol abuse or mental disorder in the last 5 years;
2. Pregnant or lactating women;
3. Patients with known multiple polyp syndrome;
4. patients with known inflammatory bowel disease;
5. known intestinal stenosis or space-occupying tumor;
6. known colon obstruction or perforation;
7. patients with a history of colorectal surgery;
8. Patients with a previous history of allergy to pre-used spasmolysis;
9. Unable to perform biopsy due to coagulation disorders or oral anticoagulants;
10. High-risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.

Doctors:

1. The researcher believes that the subjects are not suitable for participating in clinical trials.
Microcirculation During Haemodialysis

* SDF is validated by measuring changes in microcirculation in sepsis patients with MOF (Boerma studies).
* SDF is validated by measuring changes in microcirculation in stable chronic hemodialysis patients (NDT 2009 Bemelmans).
* Ultrafiltration in stable chronic hemodialysis leads to a decrease in sublingual microcirculatory flow (NDT 2009 Bemelmans).
* Trendelenburg position improves the sublingual microcirculatory flow at the end of hemodialysis treatment (NDT 2009 Bemelmans).
* Hemodialysis with ultrafiltration leads to a significant reduction of myocardial perfusion and cardiac output (NDT 2009 Dasselaar)
* Cardiac output measurement during dialysis is not practical.
* BVM is a validated method for hypotension due to ultrafiltration to prevent the amount of ultrafiltration online change based on the measured haemoconcentration (ref Dasselaar et al NDT 2005).
* BCM is a validated measurement to the dry weight in hemodialysis patients measured by a bioimpedance technique (NDT Passauer et al 2009).

The search for an optimal method of ultrafiltration with minimal hypoperfusion of vital organs.

* Stabile hemodialysis patients with dialysis dependancy for more than 3 months, with adequate access
* Study duration 3 weeks
* Number of hemodialysis treatment for purposes of study: 3
* Timing hemodialysis treatments for Study session Monday or Tuesday after the weekend (randomized design in the sessions)

  * session a: 5 hours total duration: 4 hours HD without UF followed by 1 hour GUF
  * Session b: 4 hours total duration: 4 hours HD with UF
  * session c: 4 hours total duration: 4 hours HD with UF and BVM
* UF is determined by actual target weight.
* Measurements during sessions:

  * In each session in advance: blood pressure, pulse, weight, BCM, laboratory tests (Hb, Hct, Na, K, urea, creatinine, calcium, albumin, phosphate, nt-proBNP, troponin T, CRP)
  * During each session at t = 0, t = 1 hour, t =2 hours and t = 4 hours: SDF, blood pressure, pulse, UF at that time, UF rate at that time
  * End each session: blood pressure, pulse, weight, BCM, laboratory tests (Hb, Hct, Na, K, urea, creatinine, calcium, albumin, phosphate, nt-proBNP, troponin T, CRP)

Eligibility Criteria:
Inclusion Criteria:

* dialysis patient
* age \> 18
* informed consent

Exclusion Criteria:

* no adequate access
* instable hemodynamics
Battlefield Acupuncture Following Shoulder Surgery

The purpose of this randomized clinical trial is to determine the effectiveness of Battlefield Acupuncture (BFA) in addition to standard post-surgical shoulder physical therapy compared to a standard shoulder rehabilitation program in reducing medication use and pain in patients who have undergone shoulder surgery. Measurements of medication (opioid, NSAID, acetaminophen, etc.) use (daily number of pills consumed), pain rating, patient specific functional scale and global rating of change will be taken at 48-hours (baseline), 72-hours, 1-week, and 4-weeks post-surgery. It is hypothesized that the inclusion of Battlefield Acupuncture will result in a decrease in post-surgical pain levels, reduced opioid medication use, and improved patient mood when compared to rehabilitation alone.


Eligibility Criteria:
Inclusion Criteria:

* Age 17-55 Department of Defense beneficiaries (17 only if an emancipated cadet at the U.S. Military Academy)
* Prior to or within 48 hours post shoulder stabilization surgery
* Prior to or within 48 hours post rotator cuff repair surgery

Exclusion Criteria:

* Self-reported pregnancy
* History of blood borne pathogens, infectious disease, or active infection
* History of metal allergy
* History of bleeding disorders or currently taking anti-coagulant medications
* Participants who are not fluent in English
Evaluation of a Three Dimensional Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer

The purpose of the study is to assess the effectiveness of MIRA in classifying women with dense breast tissue for supplemental breast MRI. To assess the effectiveness of MIRA for correctly classifying women with breast cancer and to evaluate the safety of the device.

In women above 30 years old who are undergoing MRI or are scheduled for image-guided needle biopsy due to lesions detected by other imaging modalities.


Eligibility Criteria:
Inclusion Criteria:

* Women who are between 30 to 70 years of age and who are asymptomatic and scheduled to undergo routine breast cancer screening (MRI and/or mammography) OR
* Women who are between 30 to 79 years of age and scheduled for image-guided needle biopsy as a result of findings obtained during standard of care imaging modalities (mammography, ultrasound and/or MRI) performed at the clinical site that participates in the study.

Exclusion Criteria:

1. Contraindication to bilateral mammography or MRI.
2. Subjects who are unable to read, understand and execute the informed consent procedure.
3. Subjects who have had mammography, ultrasound or MRI examination performed on the day of the study prior to MIRA scan.
4. Subjects who have significant existing breast trauma.
5. Subjects who have undergone lumpectomy/mastectomy.
6. Subjects who have undergone breast reduction or breast augmentation.
7. Subjects who have undergone any other type of breast surgery.
8. Subjects who have large breast scar / Breast deformation.
9. Subjects who have undergone a breast needle biopsy within the 6-month period prior to their intended enrollment into the study.
10. Subjects who have a temperature \> 37.8C degrees on the day of the MIRA imaging.
11. Subjects who are pregnant or lactating.
12. Subjects who have had placement of an internal breast marker.
13. Subjects with known Raynaud's Disease.
14. Subjects that are claustrophobic or have physical limitations that do not allow them to sit in the system chair for the required imaging session.
15. Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices.
16. Inmates or mentally disabled individuals.
17. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy).
18. Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase.
19. Subjects currently participating in another investigational clinical study.
20. Subjects undergoing breast MR for pre-staging.
21. Subjects with known Mastitis
ENDOMETRIOSIS - MRI

Endometriosis is a frequent pathology with an estimated prevalence of 10% of women of childbearing age. There is no exact correspondence between the symptoms described by the patients and the severity of the lesions, which makes clinical diagnosis difficult. It therefore seems important to improve the complementary examinations available to make the diagnosis more precise and to better study the effectiveness of the treatments implemented. The clinical examination and per-surgical findings of patients with deep pelvic endometriosis show a clear decrease in the mobility of the pelvic organs in relation to each other, but few studies have looked at this mobility, which could however have an implication in explaining the pathophysiology of the disease and the symptomatology of the patients, as well as in the detection of lesions preoperatively. The persistence of hypo-mobility could also help to understand treatment failures.


Eligibility Criteria:
Inclusion Criteria:

* Patient referred for suspected pelvic endometriosis requiring pelvic MRI
* Female, nulliparous,
* patient with signed written consent, patient with health insurance,
* patient willing to comply with all study procedures and duration

Exclusion Criteria:

* BMI \> 35,
* history of hereditary collagen and elastic tissue disease,
* history of pelviperitonitis,
* history of major pelvic surgery,
* inability to receive informed information,
* inability to participate in the entire study,
* lack of social security coverage,
* refusal to sign consent
The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation

Mortality associated with difficult airway in anesthesia is up to 30%. So, it is urgent to find a safe and effective method for intubation. Awake tracheal intubation which is used to retain spontaneous breathing is one of the important measures to ensure the safety of the patients with difficult airway in anesthesia.

Sufentanil is used to provide good analgesia and can effectively inhibit the reaction of awake tracheal intubation, however, the outstanding problem is serious respiratory depression after intravenous sufentanil injection. Few study showed that dezocine is a kappa opioid antagonist related to mild respiratory depression and can prevents sufentanil-induced cough during general anesthesia induction.It is necessary to carry out large-scale, multi-center, randomized, controlled clinical study to determine whether dezocine prevents sufentanil-induced respiratory depression and whether dezocine combined sufentanil is a safe and effective method for awake tracheal intubation.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent；
2. Selective surgery and general anesthesia patients；
3. Age 18-65 yrs；
4. Anesthesia Society of American (ASA) Scale I\~II；

Exclusion Criteria:

1. Mallampatis Ⅲ-Ⅳ；
2. Heat rate \< 50 beats/minutes；
3. II-III Atrioventricular block；
4. Use of alpha agonist or antagonist within two weeks；
5. Use of opioid within 24 hours；
6. Serious heart, liver, kidney disease and cerebrovascular disease；
7. Allergic to the trial drug and other anesthesia drug contraindication；
8. Factors existed that affect language communication；
9. Any respiratory disease；
10. Unsuccessful intubation for 3 times or drop out during intubation.
Reverse Prediction of Ion Channel Remodeling in Patients With Atrial Fibrillation Utilizing Monophasic Action Potential and Mathematical Modeling

Atrial fibrillation(AF) is the most common sustained arrhythmia in humans. The loss of rate-dependent action potential duration(APD) adaptation is one of the characteristics of atrial fibrillation, but detailed understanding of mechanism is limited. Thus, we propose to utilize the monophasic action potential recording data from human patients in three groups, control, paroxysmal and persistent atrial fibrillation, and apply reverse engineering method to quantify the extent of electrical remodeling of ionic channel parameters using a mathematical model of atrial cell. Our approach will be useful in developing drug targets for ion channels in atrial fibrillation patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients agreement of consent
* AF patient age 19-75
* Patients who undergoing catheter ablation of atrial fibrillation or supraventricular tachycardia
* Patient agreement of consent who admission for catheter ablation

Exclusion Criteria:

* Patients who do not agree with study inclusion
* Permanent AF refractory to electrical cardioversion
* AF with rheumatic valvular disease
* Patients with left atrial diameter greater than 60mm
* Patients with age less than 19 or more 75
Transcranial Magnetic Stimulation (TMS) for Motor Symptoms in Psychiatric Disorders

Psychomotor slowing may occur in major psychiatric disorders, such as major depressive disorders or schizophrenia spectrum disorders. It refers to slowing of fine motor skills, motor planning and gross motor behavior. In major depression and schizophrenia, psychomotor slowing is associated with alterations of premotor cortex, dorsolateral prefrontal cortex and basal ganglia. This randomized, sham-controlled, prospective trial will test, whether 15 sessions of repetitive transcranial magnetic stimulation (rTMS) may ameliorate psychomotor slowing in schizophrenia or major depression.

Psychomotor slowing may occur in major psychiatric disorders, such as major depressive disorders or schizophrenia spectrum disorders. It refers to slowing of fine motor skills, motor planning and gross motor behavior. In major depression and schizophrenia, psychomotor slowing is associated with alterations of premotor cortex, dorsolateral prefrontal cortex and basal ganglia. This randomized, sham-controlled, prospective trial will test, whether 15 sessions of rTMS in 3 weeks may ameliorate psychomotor slowing in schizophrenia or major depression.

Eligible participants will be randomized to one of four arms:

Eligibility Criteria:
Inclusion Criteria:

* suffering from major depressive disorder or schizophrenia spectrum disorder according to DSM-5 criteria
* right handedness
* normal or corrected-to-normal vision and hearing

Exclusion Criteria:

* epilepsy
* history of severe head trauma
* current abuse of drugs or alcohol; past addiction to drugs or alcohol
* pregnancy
* incompatibility to cerebral MRI
Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial

Hypoxia/bradycardia are common symptoms after vaccination of preterm infants. Adults show diurnal variations in vaccination response, due to circadian regulation of the immune system. The investigators plan to investigate whether preterm infants also show differences in hypoxia/bradycardia rate upon morning vs. evening vaccination.

Hypoxia/bradycardia is recorded by pulse oximetry starting 24 hours before until 48 hours after vaccination; parents also kept a sleep-diary. 24 hours after vaccination interleukin-6, interleukin-1β and C-reactive protein get determined. To control vaccination response, pertussis- and haemophilus-titers are determined before vaccination and at 4 months corrected age.

Intervention: First hexavalent vaccination given to very preterm infants either in the evening or in the morning.

Primary outcome: rate of desaturations (SpO2 \<80%) and bradycardias (Pulse rate \<100/min) in first 24 h following vaccination in evening vs. morning vaccination group Secondary outcomes: cytokine levels (IL 6, IL 1ß, CRP) measured 24 h after vaccination, pertussis- and haemophilus-titers as measured before and after vaccination, i.e. at 4 months corrected age, in evening vs. morning vaccination group

Eligibility Criteria:
Inclusion Criteria:

* gestational Age: 26+0 to 30+6 Weeks of gestational age

Exclusion Criteria:

* bronchopulmonary dysplasia
* periventricular leukomalacia
* intraventricular hemorrhage \>°2
* congenital malformations
Multi-academic Center Study of Xofigo Patients

The study will be conducted from a real-world perspective to describe treatment sequences involving radium-223 and chemotherapy in patients with metastatic castrate resistant prostate cancer (mCRPC) and assess overall survival (OS) associated with treatment sequences involving radium-223 and chemotherapy. While clinical trials of radium-223 has demonstrated a survival benefit in the treatment of mCRPC, both pre and post- docetaxel, study lacked exposure to second generation androgens and hence could not assess outcomes pre or post abiraterone or enzalutamide.

The specific objective of this study is to describe and compare the clinical outcomes between treatment sequences for patients with mCRPC where 1) radium-223 is used (alone or in combination with abiraterone or enzalutamide) prior to chemotherapy versus 2) radium-223 used after chemotherapy in the treatment of mCRPC. The secondary objectives are to describe the safety patterns of docetaxel use among mCRPC patients who received chemotherapy post radium-223.


Eligibility Criteria:
Inclusion Criteria:

* Received at least one dose of radium-223 after mCRPC diagnosis
* Received at least one prescription or dose of chemotherapy for treatment of mCRPC

Exclusion Criteria:

- No documented visceral metastasis at initiation of radium-223