cyrilzakka/clinical-trials huggingface dataset:
Mechanism Investigation of Selinexor Combined With Lenalidomide and Rituximab in the Treatment of Diffuse Large B-cell Lymphoma

This is a retrospective observational study of the therapeutic mechanism and resistance mechanism of the treatment of Selinexor combined with lenalidomide and rituximab in diffuse large B-cell lymphoma patients. By detecting the immune cells in peripheral blood and tumor tissues of patients before and after treatment, the key immune cell subsets and immune molecules linked to the action and resistance of the treatment of Selinexor combined with lenalidomide and rituximab, so as to provide the basis for the optimization of the treatment or the combination of other immunotherapies.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old.
2. Histopathologically confirmed diffuse large B-cell lymphoma according to World Health Organization (WHO) classification criteria 2016.
3. There is evidence of relapsed or refractory disease.
4. Treatment with Selinexor combined with lenalidomide and rituximab.

Exclusion Criteria:

* No
Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers

This is a long-term follow-up of the persistence of immune response in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644) . No vaccination was administered during the present long-term follow-up study.

Primary Objective:

* To describe the yearly persistence of humoral immune response to Japanese encephalitis after a single dose of JE-CV

Persistence of immune response will be determined in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644). No vaccination will be given in this study.

Eligibility Criteria:
Inclusion Criteria :

* Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations.
* Participant who was vaccinated with JE-CV in JEC02 trial and had a pre-vaccination blood sample at baseline in JEC02 trial.
* Participant and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.

Exclusion Criteria :

* Receipt of any JE vaccine other than JE-CV during JEC02 trial and during the period up to inclusion in JEC05 trial.
* Planned participation in another clinical trial up to the first year of the follow-up in the present trial.
How Active Breathing Training Improves Dysphagia in Elderly People

The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.

The investigators have designed a simple and user-friendly training method called "Active Breathing Exercises" based on commonly used swallowing training techniques in the department of rehabilitation medicine and the prevalent pathological causes of swallowing disorders in the elderly. The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.

Eligibility Criteria:
Inclusion Criteria:

* Age over 60 years old.
* No hospitalization within the past six months.
* With clear consciousness and able to cooperate with questionnaires and training.
* The elderly people who voluntarily participate and agree to adhere until the end of the study.

Exclusion Criteria:

* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Physical disability.
* Difficulty in mobility.
Development of Eye-tracking Based Markers for Autism in Young Children

The main aim of the present study is to examine eye-tracking based markers for social processing deficits in children with autism spectrum disorder (ASD). To this end a battery of five eye-tracking paradigms will be administered to young children with ASD and typically developing children. To additionally evaluate the specificity of the eye-tracking markers a group of children with disorders of delayed development other than ASD will be included.

During an initial screening session all participants will undergo the Autism Diagnostic Observation Schedule (ADOS). ASD-related symptomatology and levels of impairments will be further characterized using the Social Responsibilities Scale 2 (SRS 2), Caregiver Strain Questionnaire (CSQ), Aberrant Behavior Checklist (ABC), Social Communication Questionnaire (SCQ), and Repetitive Behaviour Scale Revised (RBS-R).

Subsequently all participants will be administered the following eye-tracking paradigms: (1) dynamic social and non-social visual preference paradigm during which dynamic geometric images (DGI) and dynamic social images (DSI) will be presented, (2) non-biological versus biological motion paradigm, (3) social attention and sharing of enjoyment paradigm, (4) preference for real versus schematic emotional face stimuli paradigm during which photographs of human faces and emoticons will be presented, (5) shared social attention and gaze direction paradigm.

Eligibility Criteria:
Exclusion criteria for all participants:

* visual, auditory or motor impairments
* use of medication

Inclusion criteria for all participants:

* written informed consent from parents / caregiver
* age: 1-10 years

Additional inclusion criterion for the ASD group:

- diagnosis of Autism Spectrum Disorder according to DSM-5

Additional inclusion criteria for typically developing children in the control group:

* no symptoms of developmental disorders
* no current or history of psychological disorder

Additional inclusion criterion for the unspecific disorder of delayed development children in the additional control group:

- disorder of delayed development other than ASD
Validating the Hum Test

The sensitivity and specificity of the Hum Test is being investigated in it's ability to detect conductive hearing loss. The hum test is simply elicited by asking the subject to hum to him or herself for a few seconds at both a high and low pitch that is comfortable for the subject. The subject is then asked if the hum was heard on one side more than the other (left or right), or if the sound was equal on both sides. To simulate conductive hearing loss, ear plugs will be placed in one of the subject's ears. We will elicit the hum test as well as the standard Weber test and audiogram across two conditions, with an ear plug and without an ear plug. From this, it is hoped to assess how the Hum Test compares to the audiogram (gold standard) in detecting conductive hearing loss as well as how it compares to the standard Weber test. If the Hum Test demonstrates strong sensitivity and specificity in detecting conductive hearing loss, it could have application as being utilized as an alternative to the standard Weber test, or in a setting where a formal physical examination may not yet be possible but where the etiology of a patient's hearing change could be quickly assessed remotely and thus the urgency of intervention/ consultation could then be determined.

It is presumed that the Hum Test works similarly to the Weber Test, where bone conduction of the skull is elicited to determine if a change in hearing is conductive or sensorineural in nature. Because the hum test is frequently employed in clinical practice yet its validation has yet to be demonstrated, investigation is warranted.

To examine and compare the Hum Test, Weber Test, and audiogram in their ability to detect and identify hearing loss, hearing loss will be simulated with the use of ear plugs (mimicking conductive hearing loss). Subjects will serve as their own control as these tests will be conducted with and without ear plugs.

Study data will be maintained using an online, password protected storage system. No identifiable information will be collected or stored (i.e. name, DOB, etc.). Limited demographic information will be collected for analysis purposes such as age and gender.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-35
* Subjective normal hearing and no previous complaints or history of hearing problems or otologic disorders
* Subjects will be NYU medical students, NYU resident physicians, or patients from the Long Island Cochlear Implant Center

Exclusion Criteria:

* Has not had a URI (assessed by asking patient if they have had fever, cough, sore throat, nasal congestion, or runny nose) within one month of study session
Immediate Effects of Myofascial Release Techniques on Balance in Young Adults With Pes Planus

The plantar fascia is a thick, multi-layered, non-elastic fibrous tissue band that extends along the plantar surface of the foot.The configuration of the plantar fascia is generally considered as a dense, longitudinally arranged fiber band divided into medial, central, and lateral components. The most significant functional role of the plantar fascia is to maintain the arch structure of the foot, providing a stable support base while standing and absorbing dynamic reaction forces during walking.Pes planus is a rather general term with many definitions. Staheli described pes planus as a "foot with a broad base of support," commonly known as flatfoot in layman's terms. In a study involving 80 female participants aged 65 and older, 90% of foot deformities observed while standing were identified as pes planus. Generally, pes planus is a condition characterized by excessive pronation of the rear part of the foot and a lowering of the medial longitudinal arch. During the push-off phase of walking, the pronation moment generated by the ground reaction force flattens the arch as the subtalar joint rotation combines. The shift in position in the talus bone causes the navicular bone to drop. The plantar calcaneonavicular ligament tightens, and the tibialis posterior muscle lengthens. Abnormalities in the bones of the foot, dysfunction of the tibialis posterior muscle, Achilles tendon shortening, or muscle weakness can contribute to pes planus. Individuals with pes planus may experience foot and leg pain with exercise, physical activity, and prolonged walking, which can limit their level of physical activity. Research has examined the relationship between pes planus and various physical parameters, and it has been found that one of these parameters, balance, is negatively affected by the presence of pes planus.

Participant information, including age, gender, height, body weight, and body mass index, was recorded using a general form. Dynamic and static balance was assessed before and after the interventions in the study groups. Three specialist physiotherapists conducted measurements and evaluations (navicular drop, static and dynamic balance). The assessing physiotherapist remained consistent throughout, and they were unaware of the participant groups. An expert in manual therapy administered the MRTs. Statistical analysis was performed by a separate researcher uninvolved in the practical aspects of the study.

Eligibility Criteria:
Inclusion Criteria:

* volunteering for study participation,
* being between the ages of 18-25
* presence of pes planus.

Exclusion Criteria:

* Presence of orthopedic conditions other than pes planus,
* having a history of lower extremity surgery
* presence of neurological or rheumatological disorders,
* having a problem with vision or hearing
* participating in regular physical activity (\>150 min/week)
Intramuscular Ketorolac at Two Single-Dose Regimens

The purpose of this study was to evaluate a single 15 mg intramuscular (IM) dose of ketorolac for analgesic non-inferiority versus a single 60 mg IM dose for the treatment of acute MSK pain in a military emergency department (ED) that services Department of Defense (DoD), Department of Veteran Affairs (VA), and foreign military beneficiaries

The primary purpose of this study is to evaluate a single 15 mg IM dose of ketorolac for analgesic non-inferiority versus a single 60 mg IM dose for the treatment of acute MSK pain in a military ED that services Department of Defense (DoD), Department of Veteran Affairs (VA), and foreign military beneficiaries. The authors chose to evaluate 15 mg rather than the previously identified 10 mg dose for ease of administration as ketorolac is manufactured in 15 mg/mL, 30 mg/mL, and 60 mg/2mL vials in the U.S. The dose of ketorolac served as the primary independent variable for the study and the change in Visual Analog Scale (VAS) score served as the dependent variable. Prescribing the minimally effective doses of NSAIDs is pertinent to prevent and reduce the number of adverse events. Thus, the secondary outcome assessed for the dose-dependence of subjective and objective adverse events with ketorolac.

Eligibility Criteria:
Inclusion Criteria:

* Tricare beneficiaries between 18-55 years of age
* Triaged as Emergency Severity Index 4 or 5
* Presenting to the William Beaumont Army Medical Center Emergency Department with a chief complaint of acute MSK pain (i.e., general muscular, neck, back, shoulder, arm, forearm, elbow, wrist, finger, hip, knee, thigh, leg, ankle, foot, or digits)
* Pain intensity of 20 mm or greater on a standard 100 mm visual analog scale
* Who the attending provider concurred with ketorolac IM administration for analgesia.

Exclusion Criteria:

* Body weight less than 50 kg (110 lbs.)
* Younger than 18 or older than 55 years
* Pregnant or breast feeding
* History of: confirmed, unconfirmed, known, unknown, or suspected peptic ulcer disease, intestinal hemorrhage, renal insufficiency, hepatic insufficiency, cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, dark stools, bright red blood per rectum, hemoptysis, easy bruising, or high risk of bleeding
* Unable to confidently convey or unknown medical history
* Allergy or hypersensitivity to nonsteroidal anti-inflammatory drugs or aspirin
* Systolic blood pressure \<90 or \>180 mmHg
* Pulse rate \<50 or \>150 beats/min
* Any over-the-counter or prescribed opioid and/or non-opioid analgesic medication (oral, per rectum, topical or parenteral) taken within 12 hours of ED presentation
* Advised by any medical provider to not receive NSAIDs for any reason
* Pain duration greater than 30 days (including acute on chronic pain)
* Refusal to remain in the WBAMC ED for up to 60 minutes after injection of ketorolac
* Patients currently taking anticoagulant medications
* Concurrent use of medications which are contraindicated with concomitant NSAID use (drugs include aspirin, probenecid and pentoxifylline).
Interest of Immersive Virtual Reality on Stress During Botulinum Toxin Injections in Spasticity (RVTOX)

The main objective of the study is to investigate the effect of exposure to a virtual reality session during botulinum toxin injections on injection-induced stress.

The secondary objectives are to study the effect of exposure to a virtual reality session during botulinum toxin injections, on the pain induced by the injection. And study the evolution of the effects of virtual reality with the repetition of the sessions.

Botulinum toxin injections is very frequently used in the treatment of spasticity after central neurological damage (stroke, multiple sclerosis, spinal cord injury, head trauma). The injections may be painful and the tolerance of the injections varies from one patient to another. The pain felt during the injection causes in most patients great stress during the injection.

Virtual reality is a video technique with 360 ° vision simulating the physical presence of the patient in an "existing" environment outside the hospital setting. This technique has been used in painful procedures but only one publication, in pediatrics, has shown a decrease in pain and agitation during botulinum toxin injections.

The hypothesis of this research is that an immersive virtual reality system can, in adults, reduce stress and the painful experience of botulinum toxin injections.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient, male or female, suffering from spasticity of neurological origin (multiple sclerosis, stroke, head trauma, etc.) and eligible for treatment by botulinum toxin injection
* Able to give an informed consent to participate in research
* Affiliation to Social Security.

Exclusion Criteria:

* Contraindication to virtual reality (epilepsy, schizophrenia, strabismus, amblyopia, anisometropia, local contraindication to wearing a helmet (lesion of the face or the skull)
* Major cognitive disorders
* Any medical condition deemed by the investigator to be incompatible with the research.
* Indication of sedation by MEOPA during botulinum toxin injection sessions.
* Patients who have already experienced virtual reality
* Drug treatment or medical condition that may affect heart rate variability
* Pregnant or breastfeeding women
* Patients under safeguard of justice
* Refusal of participation.
A New Prenatal Blood Test for Down Syndrome

The study will examine the sensitivity and specificity of a circulating cell-free nucleic acid test (DNA/RNA) to identify Down syndrome between about 10 weeks and 21 weeks 6 days gestation. In addition, the new test may be used to identify trisomy 13 and 18 as part of a more complete laboratory developed test. We hypothesize that the new circulating cell-free fetal NA-based test will accurately and precisely measure specific fetal markers in maternal circulation and that measurement will lead to the ability to noninvasively identify with high sensitivity and specificity, fetal chromosome abnormalities, such as Down syndrome.

The RNA study is an observational trial whose primary aim is to document the performance (sensitivity and specificity) of one or more laboratory developed test (LDT) using circulating cell-free fetal nucleic acids from maternal plasma to identify Down syndrome. Multiple test modalities are being pursued, including massively parallel sequencing and those utilizing differential methylation. The population being studied is women already having a diagnostic test (e.g., amniocentesis, CVS) between 10 weeks and 21 weeks 6 days gestation, and whose pregnancy is at high risk for having Down syndrome. The women provide informed consent. The karyotype will provide the gold standard against which the LDT test is judged. Samples and karyotypes will be collected from up to 25 prenatal diagnostic centers around the world and tested in several laboratories in the United States. The secondary aim is to develop a nucleic acid sample bank to allow documentation of subsequent improvements or new methodologies to identify fetal aneuploidy using circulating cell-free fetal nucleic acids.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between about 10 weeks and 21 weeks 6 days gestation who are undergoing a diagnostic procedure (i.e., chorionic villus sampling or amniocentesis) for karyotype analysis who have, on average, a high prevalence of Down syndrome (about 1:30 to 1:50).
* Three main sources are pregnancies screen positive for:

  1. the combined test at 10 to 13 weeks (NT, PAPP-A and hCG)
  2. the second trimester quadruple test at 15 to 18 weeks gestation
  3. integrated screening (PAPP-A and the quadruple test, with or without NT).
* Variations of the integrated test such as sequential testing will also be acceptable.
* Other, less common high risk groups would be women having diagnostic testing because of maternal age of 38 years or older at delivery, pregnancies with an abnormal ultrasound highly suggestive of a chromosome abnormality (e.g., major heart defect, clenched fist), and women with an inherited form of Down syndrome (Robertsonian translocation).

Exclusion Criteria:

* Nonpregnant women and women at relatively low risk for a Down syndrome baby.
Feasibility Testing of a Novel Endoscope for Reflectance Confocal Microscopy of Normal Oral Tissue In Vivo

The purpose of this study is to obtain images (pictures) of normal oral tissue, which occur inside the mouth, using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. The technology is called "reflectance confocal microscopy."


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Ability to sign informed consent
* Age ≥ 18 years.

Exclusion Criteria:

* Inability to give informed consent.
* Previously known oral disease