cyrilzakka/clinical-trials huggingface dataset:
Nasal Expiratory Positive Airway Pressure for the Treatment of Pediatric Obstructive Sleep Apnea Syndrome

This study will evaluate effectiveness and adherence of the nasal expiratory positive airway pressure (NEPAP) device as an an alternate therapy for children with Obstructive Sleep Apnea Syndrome (OSAS). NEPAP is currently approved for use only in adults.

The nasal expiratory positive airway pressure (NEPAP) device has been used to treat OSAS in adults. A disposable device is placed in each nostril at night and attached with adhesive. The device acts as a one-way valve, during inspiration the valve opens, with negligible resistance to flow. During expiration, the valve closes and airflow is directed through small air channels, increasing resistance. The increased resistance helps to maintain the upper airway pressure during the critical end-expiratory period when the upper airway has been found to be most narrow in the breaths preceding an apnea event. In contrast to Continuous Positive Airway Pressure (CPAP) which provides positive pressure during both inspiration and expiration, NEPAP creates pressure during expiration. NEPAP is a potential alternative therapy which is less cumbersome than CPAP and may increase adherence.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects age 5-16 years (note: Due to the size of the devices, it is expected that most children will be at least 8 years old, but a few may be younger. Subjects will be evaluated in clinic to fit for size and habituate to the device)
2. OSAS (AHI \> 5/hr)
3. Subject has had adenotonsillectomy or is not a candidate for adenotonsillectomy
4. Subject is non-adherent to CPAP or is seeking an alternative therapy
5. Tolerance of NEPAP device during a daytime session
6. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

1. Severe developmental delay thought to involve a high risk of aspiration
2. Family does not understand English well enough to perform the standardized, validated questionnaires.
3. Age \>16 years since results may be similar to adult studies in these older patients.
4. Severe breathing disorder (including respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum)
5. Severe heart disease (including heart failure)
6. An acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection or perforation of the ear drum

Subjects that do not meet all of the enrollment criteria will not be enrolled. Any violations of these criteria will be reported in accordance with Institutional Review Board (IRB) Policies and Procedures.

Study members will not recruit females who are known to be pregnant. However, if a subject becomes pregnant during the study, we will continue to use the device. Pregnancy is not an exclusion criterion as positive airway pressure therapy does not harm the pregnant woman or fetus.
Virtual Occupational Therapy Application

Virtual Occupational Therapy Application (VOTA) combines low-cost human motion tracking, commercial game engine technology, and evidence-based Occupational Therapy (OT) practice in a computer-based virtual world in which stroke patients practice activities of daily living (ADLs). The protocol investigates the efficacy of VOTA therapy for Upper Extremity (UE) motor recovery and assesses system usability and user acceptance.


Eligibility Criteria:
Inclusion Criteria:

* Participant is a hemiparetic stroke survivor;
* Time since last stroke at least 3 months;
* Participant has antigravity strength at the elbow to at least 45 degrees of active flexion in the stroke affected arm;
* Participant has antigravity shoulder strength to at least 30 degrees each in active flexion, abduction/adduction, and 15 degrees in active rotation from an upright seated position in the stroke affected arm;
* Participant has visual acuity with corrective lenses of 20/50 or better;

Exclusion Criteria:

* Existing participation in an upper extremity stroke rehabilitation program or planned participation during the study period;
* Inability to understand and follow verbal directions;
* Determination that participation would result in over exertion or significant discomfort or pain;
* Determination that participation would result in significant agitation or elevated stress;
* Withholding or withdrawal of consent by the participant;
* Visual field deficit in either eye that impairs the ability to view the computer monitor;
* Hemispatial neglect that impairs the ability process and perceive visual stimuli provided through the computer monitor;
Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study

To assess pelvic floor symptoms and quality of life in elderly women.

The aim is to assess pelvic floor symptoms and quality of life in elderly women. The study is conducted as population-based in 100-130 women at the age of 64-66 years. All study objects are examined gynecologically and with vaginal ultrasound. Subjective symptoms are evaluated with validated questionnaires concerning pelvic floor symptoms, sexual symptoms and quality of life. This is a pilot study before a larger scale population-based study.

Eligibility Criteria:
Inclusion Criteria:

* All women in one municipality aged 64-66 years who are willing to participate in the study.

Exclusion Criteria:

* Persons under guardianship or who does not understand the used questionnaires.
Utility of a Survey Instrument to Predict Benefit From a Novel Treatment for Vertical Heterophoria

Patients with acute exacerbation of chronic headache disorder present frequently to the Emergency Department (ED) for pain management. A novel etiology of headaches is Vertical Heterophoria (VH), a poorly understood and little recognized binocular vision malady that when treated with realigning prismatic spectacle lenses results in marked reduction in headache and other associated VH symptoms.

This study aims to determine the accuracy of the Vertical Heterophoria Symptom Questionnaire (VHSQ) in identifying a ED headache patients who will experience significant reduction in VH symptoms with use of realigning prismatic spectacle lenses. This study's secondary purpose is to determine if VH is a common cause of chronic headache disorders in ED headache patients.

To achieve these goals, a prospective observational study will be performed on ED headache patients \> 18 years old. All will be given the VHSQ, and all will be assessed for a diagnosis of VH by an optometrist who will utilize a novel VH testing method. High and low score groups on the VHSQ will then be compared to each other to determine the prevalence of VH in each.


Eligibility Criteria:
Initially include all patients presenting to Emergency Department with chief complaints of Headache, Head Pain, Face Pain and/or Migraine.

Inclusion Criteria:

* Greater than or equal to 18 years old
* Ability to speak and read English
* Chronic headache disorder as defined by physician diagnosis, or greater than three months of headaches requiring symptom relief with medication more than once every two weeks, or having headaches so severe that previous Emergency Department evaluation or treatment was necessary

Exclusion Criteria:

* Symptoms directly caused by trauma within the last three months
* Known TMJ disorder and presenting with TMJ pain
* Suspected infectious sinusitis or meningitis
* Pain originating from ear
* Pain originating from dental source
* Patient not willing or able to travel to study optometrist for follow-up
* Known history of cerebral aneurysm
* Known history of brain tumor
* Without previous CT, MRI, or other imaging to assess patient's headache disorder
* Patient a prisoner
* Patient under temporary or permanent custodianship
* Patient currently with questionable state of mental competence
* Treating physician or study investigator believes patient to be inappropriate for study participation
The Red Blood Cells Based Blood Test for Lung Cancer EARLY Detection

This study plan to enroll 852 patients with pulmonary nodules smaller than 3 cm in diameter, whose DNA and RNA will be extracted from mature red blood cells isolated from peripheral blood. The DNA 5-methylcytosine(5-mC) and RNA 2'-O-methylation information will be acquired by NGS and Nm Judge Universally sequencing (NJU-Seq), which will be used to establish models to distinguish patients with benign and malignant nodule in the training group and further evaluated in the validation group. The pathological results will be acquired after surgery or biopsy as standard in the study.

This is a prospective, multi-center, observational, cohort study and seeks to enroll 852 participants with pulmonary nodules smaller than 3 cm in diameter from 4 hospitals in China.

Each participant pulmonary nodule is ≤30mm as assessed by CT scanning, nodule is suspected to be malignant, and plan to use biopsy or surgery for diagnosis or treatment within 60 days.Their blood samples, CT scan data, and clinical data will be collected at each visit and tissues will be collected when participants who receive pneumonectomy or percutaneous lung biopsy.

Each subject will analysis DNA and RNA methylation in nucleic acids extracted from mature red blood cells isolated from peripheral blood by next-generation sequencing (NGS) . A proprietary algorithm will be used to identify the modification sites and pattern for differentiating the benign and malignant pulmonary nodules. Sensitivity and specificity of the different methylation panels will be to evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Pulmonary nodule is ≤3cm;
2. Subjects suspected of lung cancer;
3. Diagnosis or treatment by biopsy or surgery within 60 days;
4. Signed informed consent.

Exclusion Criteria:

1. History of malignant tumors;
2. Received anti-tumor therapy;
3. Can't collect the histopathological results or the pathological results are metastatic cancer;
4. Can't obtain detection information of red blood cells;
5. Pregnancy or lactating female；
6. Other situations not suitable for the study.
Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome

The purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain in subjects with Carpal Tunnel Syndrome. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent to participate in the study
2. Subjects between 18 to 80 years old
3. Having symptomatic CTS spreading within or beyond the median nerve distribution (demonstrating 'extra-median spread'), involving at least 1 wrist, with chronic pain as defined by International Association for the Study of Pain (existing pain for at least 6 months and having pain on at least half the days in the past 6 months with an average of at least a 3 on a 0-10 VAS scale).
4. Pain resistant to first line therapies of chronic pain (pain still present at lower levels most of the time following therapy)
5. Must have the ability to feel pain as self-reported.

Exclusion Criteria:

1. Subject is pregnant
2. Contraindications to tDCS+TUS:

   1. intracranial metal implant
   2. implanted brain medical devices
3. History of alcohol or drug abuse within the past 6 months as self-reported
4. Use of carbamazepine within the past 6 months as self-reported
5. Suffering from major depression (with a PHQ-9 score of ≥20)
6. History of neurological disorders involving stroke, brain tumors, or epilepsy with residual neurological symptoms as self-reported (note patients will also be evaluated via EEG at baseline about 1 week prior to stimulation and any patient showing abnormal EEG activity will be removed))
7. History of unexplained fainting spells as self-reported
8. History of head injury resulting in more than a momentary loss of consciousness as self-reported and with current neurological deficits
9. History of intracranial neurosurgery as self-reported
Deep Learning Image Reconstruction for Abdominal CT of Hepatocellular Carcinoma Compared With 3-TESLA MRI

New algorithms for processing CT acquisitions, based on artificial intelligence, have been reported to improve acquisition quality. Thats' why it's possible to imagine that new scan post-processing algorithms enable better detection and characterization of hepatocellular carcinoma lesions than with standard reconstructions. DLIR reconstructions could even match with MRI detection.

The aim of the study is to compare the detection and characterization of hepatic lesions according to the LI-RADS classification in CT with DLIR artificial intelligence reconstruction, compared with ASIR-V reconstruction and the gold standard of MRI.


Eligibility Criteria:
Inclusion Criteria:

* undergoing CT and MRI scans in the same week, with protocols dedicated to the detection of HCC lesions

Exclusion Criteria:

* imaging with radiological artefact
Endometrial Tissues and Mononuclear Cells Receptivity in Pathogenesis of Endometrial Proliferative Processes

A prospective observational study of endometrial tissue and peripheral blood mononuclear cells receptivity to sex steroid hormones in postmenopausal patients with endometrial proliferative processes

Endometrial cancer is in third place among cancer diseases in female population of Russia. The peak morbidity occurs during the postmenopausal period. In this regard, early diagnosis of previous endometrial proliferative processes and effective methods for their treatment are relevant. However, failures with hormonal therapy are often observed. This may be due to the low receptivity of the pathological tissue. It is also known that the functional activity of immunocompetent cells is controlled by the immune system, however, studies of the receptivity of peripheral blood mononuclear cells to sex steroid hormones were carried out in healthy blood donors. Changes in mononuclear cells receptivity may be one of the pathogenetic links in the development of endometrial proliferative processes and endometrial cancer. This may also influence the effectiveness of their treatment. In this regard, the purpose of the study is to evaluate the role of the expression of estradiol and progesterone receptor genes in endometrial tissue and peripheral blood mononuclear cells in the occurrence of endometrial proliferative processes in postmenopausal patients with a pathogenetic justification for the choice of treatment method. To achieve this goal, the investigators investigated the expression level of estrogen and progesterone receptors (ERa, ERb, GPER, PRA, PRB, mPR, PGRmC1) by RT-PCR in pathological endometrial tissue and peripheral blood mononuclear cells. GABDH was used as a comparison gene. The data obtained made it possible to determine the significance of mononuclear cell receptivity in the pathogenesis of endometrial proliferative processes.

Eligibility Criteria:
Inclusion Criteria:

* endometrial polyps
* endometrial hyperplasia
* atypical endometrial hyperplasia
* endometrial cancer

Exclusion Criteria:

* hormonal treatment (estrogen-progestogens, gestagens, gonadotropin-releasing hormone agonists, menopausal hormone therapy and tamoxifen) for 6 months before the study
* uterine fibroids, larger than 6-7 pregnancy weeks
* pathology of the uterine appendages according to ultrasound pelvis
* inflammatory diseases of various localization at the time of taking the material
Effect of PRP as Therapy for Shoulder Osteoarthritis

Patients with shoulder osteoarthritis are suffering from pain and disabilities which lead to difficulties in life. The presence of platelet-rich plasma as regenerative therapy which helps in healing of damaged tissues like ligaments and joint might be of great benefit in managing such conditions.

Primary and secondary osteoarthritis of the shoulder occurs due to destruction of the articular surface of the humeral head and glenoid , Patient mainly presented with pain and decreases in the range of motion .

Treatment of shoulder osteoarthritis is often controversial and is typically based on the patient's age, the severity of symptoms, and level of activity, radiographic findings, and medical comorbidities.

The new era of management include regenerative therapy ,Platelet-rich plasma (PRP) is one of the regenerative therapy that prove its effect as injections of a concentration of a patient's own platelets to accelerate the healing of injured tendons, ligaments, muscles and joints.

Eligibility Criteria:
Inclusion Criteria:

* Patient's age: From 21 years.
* Acute symptoms on a background of at least a 3-month history of chronic pain or swelling of the shoulder joint with radiological confirmed (X-ray or MRI)
* Mild or moderate osteoarthritis of the shoulder joint according to The Samilson-Prieto classification.
* Numerical Rating Scale for pain scores greater than five on a 10 scale

Exclusion Criteria:

* Under 21 years of age
* Severe osteoarthritis according to The Samilson-Prieto classification. (Figure 1)
* Neuropsychiatric disorders.
* Immunocompromised patients.
* Active infection or malignancy at the joint.
* Pregnancy and breastfeeding.
* Patients may have thrombocytopenia, bleeding disorders, or on anticoagulant therapy.
* Shoulder surgery within 3 months or inflammatory arthritis; previous infection of the shoulder joint.
Outcomes of Perforation After Colorectal Endoscopic Submucosal Dissection

Endoscopic resection of superficial colorectal neoplasms decrease risk of colorectal cancer. En bloc resection is necessary for large superficial lesions with risk of superficial submucosal cancer and is advised if feasible for all lesions. Endoscopic submucosal dissection (ESD) allows en bloc resection of large superficial colorectal neoplasms, increasing curative resection rate and decreasing local recurrence risk. However, the risk of perprocedural or delayed perforation is higher compared to wild field piece meal endoscopic mucosal resection. Endoscoping clipping and closing methods mostly allow conservative treatment, but some case still necessitate surgery. The aim of our study is to describe and ananalyse outcomes after perprocedural or delayed perforation in all patients undergoing ESD and analyse the need for surgical intervention.


Eligibility Criteria:
Inclusion Criteria:

* patients from the FECCO (NCT04592003) cohort experiencing perprocedural or delayed perforation
* age over 18 years old

Exclusion Criteria:

* patients refusing exploitations of health datas
* patient treated with endoscopic mucosal resection
Phase III Trial to Evaluate the Elortinib vs Gefitinib in Advanced NSCLC With EGFR Exon 19 or 21 Mutations

This is a randomized controlled trial to compare efficacy and safety between erlotinib and gefitinib in advanced NSCLC harboring EGFR exon 19 or 21 mutations.Eligible patients were randomized to receive erlotinib or gefitinib in any line settings.The primary endpoint was progression-free survival (PFS).

Patients with stage IV NSCLC who have EGFR exon 19 or 21 mutations will randomized to received oral erlotinib 150mg or gefitinib 250mg once daily until disease progression or unacceptable toxicity. Method of direct DNA sequencing of tumor tissue is used to analysis EGFR mutation status of exons 18-21. The response will be evaluated by RECIST criteria first month,second month and then repeat every 3 months after the beginning of the treatment weeks.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage IIIB (wet) or IV NSCLC.
* Patients with positive EGFR exon19 or exon21 mutation as confirmed by direct sequencing histologically.
* Signing the informed consent form.
* The vital organ functions are tolerant to therapy.
* Have recovered to CTCAE2 grade below from toxicity of previous chemotherapy and radiotherapy
* PS 0-2 scores.
* Functional reserve of bone marrow is adequate, e.g. white blood cell count ≥3.0×109/L, planet count ≥90×109/L, and HB≥80×109/L.
* Serum bilirubin is 2 times less than the upper limit of normal (ULN), ALT and AST are 3 times less than ULN; for liver metastases, ALT and AST need to be 5 times less than ULN; creatinine should be 2 times less than ULN.

Exclusion Criteria:

* Informed consent is not provided.
* Women of pregnancy or breastfeeding.
* Have difficulty in swallowing.
Project ALIVE (A Lifestyle Intervention Via Email)

The objective of this study is to test the effectiveness of an email-based diet and physical activity intervention on increasing physical activity and fruit and vegetable consumption and decreasing intake of saturated and trans fats and added sugars.


Eligibility Criteria:
Inclusion Criteria:

* regional Northern California KP employees

Exclusion Criteria:

* none
Correlation Between Trans Esophageal Pressure and Non-invasive Respiratory Support Failure in Patients With Acute Hypoxic Respiratory Failure

This study aims at assessing the correlation between trans esophageal pressure and related respiratory mechanics (including, among others, nasal pressure-Pnose) and non-invasive respiratory support failure in patients with acute hypoxic respiratory failure of different etiology (including COVID-19).


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Acute hypoxic respiratory failure (P/F \< 200)

Exclusion Criteria:

* Acute pulmonary edema
* Chest wall deformities
* Immediate need for Mechanical Ventilation
* Pregnancy
* Hypercapnic RF
Assertive Community Treatment in Copenhagen

The aim of the study is to evaluate the effect of assertive community treatment in Copenhagen in two regions compared with two regions where this treatment was not implemented. The effect on user satisfaction, use of bed days, social network, global assessment of functioning, substance misuse will be evaluated.

In area where assertive community treatment was implemented 100 patients had filled in a form regarding their social situation. They were interviewed after one year and asked about user satisfaction and followed up in Danish registers. Register information was extracted concerning vital status, cause of death, use of psychiatric services and criminal record. The same procedure was carried out for a comparison group, carefully matched, from other regions in Copenhagen, where assertive community treatment was not implemented.

Eligibility Criteria:
Inclusion Criteria:

* User of bed days exceeded 40 days last two years; or
* 4+ admissions during last two years; or
* A second diagnosis of substance misuse; or
* Non compliance with medication or outpatient visits in usual settings; or
* Being unable to use other existing services

Exclusion Criteria:

* Forensic patient with a sentence to stay in hospital
Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy

This trial aims to determine if intra-operative use of human dehydrated amnion chorion allograft improves post-operative patient healing outcomes.

This study is to determine if intra-operative use of Amnio-Fix improves post-operative patient healing outcomes after laryngectomy and/or pharyngectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is scheduled to undergo laryngectomy and/or pharyngectomy procedure due to oncological indication
2. Subject is age 18 or older
3. Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study

Exclusion Criteria:

1. Subjects currently enrolled in or planning to enroll in another clinical trial
2. Subjects with a known history of poor compliance with medical treatments
3. Subjects that are using or have used an investigational drug, device, or biologic within the 12 weeks prior to treatment
4. Subjects that have any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
5. Subject has undergone previous pharyngeal reconstructive surgery
6. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)