cyrilzakka/clinical-trials huggingface dataset:
PHIL in the Treatment of Intracranial dAVF.

This study is a prospective, multicenter, single-arm study. Patients with Dural Arteriovenous Fistulas (dAVF) have a few choice for safe treatment. In this study, all patients with qualifying dAVFs will be treated with PHIL® Liquid Embolic material.


Eligibility Criteria:
Inclusion Criteria:

* Age 22 - 80 years.
* Subject is willing and capable of complying with all study protocol requirements, including specified follow-up period.
* Subject or authorized legal representative must provide written informed consent prior to initiation of any study procedures.
* Subject has an intracranial dAVF

Exclusion Criteria:

* Subject having multiple dAVFs to be treated.
* Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated).
* Subject has known allergies to dimethylsulfoxide, iodine.
* Subject is currently participating in another clinical study
* Female subject is currently pregnant.
* Subject has co-morbid conditions that may limit survival to less than 24 months.
OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

The purpose of this study is to describe the safety and tolerability of two dose levels of OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.


Eligibility Criteria:
Inclusion Criteria includes, but is not limited to:

* Subject is a male or female aged 6 months to 12 years, inclusive
* Subject has a clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement
* Subject's caregiver is willing to comply with the protocol and attend all study visits

Exclusion Criteria includes, but is not limited to:

* Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement
* Subject has a history of sensorineural hearing loss
* Subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the study
DOD Regulating Together Intervention

Our long-term goal is to validate Regulating Together (emotion regulation intervention) and improve psychosocial outcomes for youth with autism spectrum disorder and emotion dysregulation.

144 children ages 8-12 years old with autism spectrum disorder will be enrolled in the study and randomized to Regulating Together (RT) or Achieving Independence and Mastery in School (AIMS) groups. Participants will complete assessments at five time points: Screen (T1) Week 0 - where they will complete consent; Baseline (T2); Week 7: Post Active Treatment (includes semi-structured interviews) (T3); Week 16: Post Generalization (T4); Week 29: Final outcome visit (T5). Participants will receive 5 weeks of intervention, twice per week, following the T2 visit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autism spectrum disorder (ASD)
* A Full Scale IQ score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II) or other previous Weschler IQ test
* Concern of emotion dysregulation (ED) as measured by a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R).
* Caregivers and child are fluent in speaking English
* Child functional verbal communication, confirmed via appropriateness for an Autism Diagnostic Observation Schedule (ADOS-2) Module 3.
* Family willing to keep prescribed medication and outside interventions stable
* willing to participate in twice weekly 90-minute sessions of either Regulating Together (RT) or Achieving Independence and Mastery in School (AIMS).
* The guardian must provide written informed consent on behalf of the participant and the participants ages 11-12 years old must provide written informed assent to participate.

Exclusion Criteria:

* Initiation of new psychosocial intervention within 30 days prior to randomization/first day of treatment.
* any physical aggression toward other children outside the home in the past 2 weeks that resulted in serious injury
* Presence of comorbid major neuropsychiatric illness warranting other treatment approaches.
* Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
Fatigability and Physical Performance: Effects of Resistance Training Variables Manipulation

This study evaluate whether resistance training variables modulate the fatigability (power-duration relationship) and physical performance in adults and older adults

The resistance training variables manipulation is utilized for maximize the results of resistance training. However it is unclear whether the resistance training variables manipulation modulates the fatigability (i.e. power-duration relationship) and whether this explains the improvement on physical performance (i.e. gait speed, sit-to-stand and timed up and go tests).

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (\>12 months amenorrhea) with age above or equal 50 years old.
* No hormone therapy or phytoestrogens

Exclusion Criteria:

* No-drinker alcohol (no alcohol intake whatsoever in their diet);
* Non- smokers;
* Hypertensive with uncontrolled blood pressure values;
* Diabetic with uncontrolled glycemia;
* Presence of arthropathies;
* Presence of myopathies;
* Skeletal musculotendinous disorder.
Effectiveness Verification of Using Hydrogen Inhalation to Improve Fatigue, Pain and Quality of Life in Cancer Patients

There are two recruitment methods for this study, which are mainly based on the Co-Principal Investigator Dr. Chih-Jen Huang recommendation of eligible subjects and poster recruitment methods.

When the subjects return to the outpatient clinic, those who meet the conditions for admission will be recommended by Dr. Chih-Jen Huang. If they agree to participate in the trial, they will sign the informed consent form, and instruct the subjects to use their mobile phones to scan the QR code of the relevant introduction of the trial first, and complete the test. The first questionnaire measurement before hydrogen inhalation; if the subjects are recruited by the poster, they can contact the host of Tongtong through the QR code on the poster or the contact number, and sign the consent form for the first time during the return visit. Questionnaire measurement.

This study is a randomized controlled trial, and an experimental group and a waiting list group will be used to verify the interventional effect of hydrogen. For patients diagnosed with head and neck cancer who received radiation therapy or combined chemotherapy (CCRT) and met the inclusion criteria, the study was included after the study description and the consent of the trial were obtained. Investigators will be included, and the subjects will be numbered by the research executor (Co-Principal Investigator), and the number will be handed over to the project host, who will assign the subjects to the experimental group or the control group according to the random case allocation table generated in advance. The manufacturer will install a hydrogen inhalation machine (hydrogen inhalation or air inhalation) at the subject's home and explain the relevant operation methods. The research executor will pay attention to the LINE group on the first day of installation, and obtain the pre-test basic value data through the google form After (baseline data), continuous hydrogen inhalation was performed daily, and four post-test evaluations were performed before the inhalation and on the 1st, 3rd, 7th, and 14th days after the inhalation was started. The control group was inhaled with the same machine, but the gas was only ordinary air, which was used as a placebo control; after the experiment was over, if the moderator of the air inhalation group explained the plan, hydrogen inhalation would be given in the follow-up month for 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 20
* Pathological diagnosed with head and neck cancer
* Received radiation therapy or combined chemotherapy
* Can use Mandarin or Taiwanese to communicate and have normal cognition

Exclusion Criteria:

* With chronic obstructive pulmonary disease
* Having contraindications to use of low flow oxygen
* Feeling uncomfortable using nasal cannula for inhalation
Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin

Study Purpose: The purpose of this study is to determine the optimal method for induction of labor in multiparous women who present with an unfavorable cervix.

Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in place will result in more rapid labor courses, without increasing morbidity or increasing the need for operative delivery.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Gestational age \> 34 + 0/7 weeks
* Prior spontaneous vaginal delivery
* Clinical or U/S EFW of \<4500 grams
* Singleton gestation
* Cervical dilation \<2 cm

Exclusion Criteria:

* Any contraindication to cervical ripening balloon, pitocin, or vaginal delivery
* Placenta within 2 cm of cervical os
* Placental abruption, chorioamninoitis, or systemic infection prior to induction
* Rupture of membranes prior to induction -\>1 prior C/S
Rehabilitation in SOD1 ALS Treated With Tofersen

The primary objective of this study is to document and describe the effects of a personalized rehabilitation program for patients with SOD1 ALS participating in the tofersen expanded access program. Participants currently receiving tofersen treatment will be referred to outpatient physical and/or occupational therapy. Participants will have an initial assessment performed and an individualized rehabilitation program will be prescribed. Each participant is encouraged to follow the prescribed recommendations that will include scheduled outpatient therapy sessions, functional assessments, and/or a home-based rehabilitation program. Functional assessments will be done at a minimum of every three months.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of ALS with an SOD1 mutation
* Current enrollment in the tofersen expanded access program
* Age greater than 18 years
* Medically able to participate in outpatient physical therapy and/or home-based rehabilitation, as determined by the treating health care provider

Exclusion Criteria:

* Any comorbidities or conditions that, in the opinion of the treating healthcare provider, would unacceptably increase the risk of participation in outpatient physical therapy and/or home-based rehabilitation
Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study

Clinical performance of the device will be evaluated in a fully-crossed, multiple-reader multiple-case (MRMC) study. This study will be used to determine the impact of the device on reader performance in identifying suspicious radiographic findings in fetal heart ultrasound video clips recorded during 2nd trimester anatomic ultrasound examinations conducted during the second trimester of the pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* ultrasound examinations conducted during the second trimester of the pregnancy
* fetus between 18 and 24 weeks of gestational age
* mothers 18 years old or older

Exclusion Criteria:

* exams corresponding to multiple pregnancy
* fetal heterotaxy
* exams not containing video clips with interpretable 4-chamber (4C), Left Ventricular Outflow Tract (LVOT) or Right Ventricular Outflow Tract (RVOT) standard views
Therapeutic Study of ONO-4819CD for Ulcerative Colitis

The purpose of this study is to investigate whether ONO-4819CD is safe and effective in the treatment of mild to moderate ulcerative colitis.

Ulcerative colitis is a relapsing disease of unknown cause characterized by bloody diarrhea. Therapy usually involves 5-aminosalicylates, corticosteroids and immunosuppressants. However, steroid resistance and dependency can become problematic. Immunosuppressive drugs, such as azathioprine, are beneficial but may have serious side effects. Therefore, new therapeutic approach is needed.

Prostaglandin E2 is one of the prostanoids, which is involved with innate immunity. PGE2 induces oral tolerance to specific antigen in the small intestine and downregulates the production and release of proinflammatory cytokines by macrophages and neutrophils. Accordingly, PGE2 is considered to be the mediator of mucosal protection.

Recently, it was elucidated that disruption of EP4 gene, which is one of PGE receptors, caused severe colitis in mice. Moreover, EP4-selective agonist (AE1-734) was also revealed to ameliorate severe dextran sodium sulfate-induced colitis in mice. We therefore examined the effects of 2 weeks intravenous EP4-selective agonist therapy for patients with mild to moderate ulcerative colitis.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of ulcerative colitis
2. Mild to moderate ulcerative colitis refractory to 5-aminosalicylates therapy.
3. 20 years and above
4. Must obtain written informed consent

Exclusion Criteria:

1. Corticosteroids therapy within two weeks before enrollment
2. Immunosuppressive therapy within three months before enrollment
3. Leukocytapheresis therapy within one month before enrollment
4. Blood transfusion within two weeks before enrollment
5. Impaired renal function
6. Impaired hepatic function
7. Uncontrolled hypertension/hypotension
8. Uncontrolled arrhythmia
9. Impaired cardiac function
10. Cancer
11. Uncontrolled diabetes
12. Interstitial pneumonia
13. Glaucoma
14. History of colon resection
15. Infectious diseases needing medical treatments
16. Drug allergy
17. Pregnancy
Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)

During end-stage kidney disease, clinical guidelines suggest reducing elevated phosphate levels in the blood. However, the effect of lowering blood phosphate levels on important patient-centred outcomes has never been tested. This trial will evaluate whether compared to high levels, lowering blood phosphate levels would reduce death or major events due to heart disease, improve physical health, and be cost-effective.

Hyperphosphataemia is highly prevalent in patients with end-stage kidney disease (ESKD) and associated with increased mortality risk. The Clinical Practice Guidelines suggest lowering elevated phosphate levels towards the normal range (level 2C suggestion). However, trial data demonstrating that treatments that lower serum phosphate will improve patient-centred outcomes are lacking.

The primary objective is to test the hypothesis that compared to a liberal serum phosphate concentration target of 2.0 to 2.5 mmol/L, intensive lowering of serum phosphate towards the normal level (≤1.50 mmol/L) with phosphate binders reduces the risk of fatal or non-fatal major cardiovascular events in ESKD patients receiving dialysis. The secondary objectives are to test the hypothesis that intensive lowering of serum phosphate towards the normal level with phosphate binders would improve physical health, fatigue, health-related quality of life, patient satisfaction, and pruritus; and be cost-effective.

In this pragmatic, multinational, randomised controlled large simple trial, a total of 3600 adult ESKD patients receiving dialysis will be randomised either to intensive (≤1.50 mmol/L) or liberalized (2.0-2.5 mmol/L) serum phosphate target. The choice and dose of phosphate binders will be at the treating physician's discretion and local practice to achieve and maintain serum phosphate concentration within the required target range according to randomisation. The primary endpoint is the composite endpoint of cardiovascular death, non-fatal major cardiovascular or peripheral arterial events. The secondary outcome measures will be individual components of the primary composite endpoint, all-cause death, and utility-based quality of life EQ5D-5L.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥45 years, or Age ≥18 years with diabetes,
2. ESKD on haemodialysis or peritoneal dialysis, for at least 3 months,
3. Currently prescribed at least one phosphate-lowering medication at any dose
4. Able to provide informed consent

Exclusion Criteria:

1. Elective kidney transplantation scheduled,
2. Concomitant major illness / comorbidity that may result in death in the next 6 months in the view of the treating physician,
3. Participation in an interventional study that is likely to affect serum phosphate concentration.
Test Semiquantitative Prostate Specific Antigen (PSA)

The aim of the study is to compare the diagnostic performances of a simple and rapid PSA assay on whole blood to the standard plasma PSA assay.

Screening and surveillance of prostate cancer typically involves sensitive laboratory techniques for the quantification of plasma prostate specific antigen (PSA). In this study, we determine the sensitivity and specificity of a simple test strip based PSA assay using only a few drops of whole blood as compared to a standard plasma PSA assay. Blood samples will be taken from hundred patients who are followed for a prostatic disease needing PSA surveillance. Before decantation of the samples, a few drops of blood will serve for the rapid test on strips. Plasma PSA levels will be determined with the TRACE ("Time Resolved Amplified Cryptate Emission") technology in homogeneous liquid phase. The results from the rapid test can then be compared to the plasma levels obtained by TRACE.

Eligibility Criteria:
Inclusion Criteria:

* Patients followed for prostate cancer or symptomatic benign prostatic disease, and for who a PSA assay is indicated.
* Patients must have given informed consent.

Exclusion Criteria:

* Patients followed for a disease other than prostatic.
A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for children with Attention-Deficit/Hyperactivity Disorder or ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Have voluntarily signed an informed consent form
* Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with parent(s)
* First grade or higher in a school setting 3 days/week
* Subject is generally in good health based on medical history, physical examination, clinical lab tests, and ECG
* Subject weighs at least 37 pounds (17 kg)
* Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements
* Subject and parents have been judged by the study doctor to be reliable to keep required appointments for clinic visits and all tests, including blood draws, and examinations

Exclusion Criteria:

* Subject is not functioning at an age-appropriate level intellectually
* Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger's syndrome, or pervasive developmental disorder
* Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind
* Subject has a history of significant allergic reaction to any drug
* Subject requires ongoing treatment with any psychiatric medication
* Subject has a serious medical condition, seizure disorder (except febrile seizures as an infant), or history of substance abuse or dependence
Proof of Concept Study Concerning Vestibular Stimulation Using a New Method of Dynamic Posturography.

Falls in the elderly population are a major public health problem because of their frequency and their consequences, notably in terms of dependence their cost to society. In most cases, balance disorders related to an impaired vestibular system are blamed, even though there is no formal evidence that this is the case.

Vestibular tests in routine otoneurological practice are based on the exploration of vestibulo-ocular or even vestibulo-cortical reflexes. They are not particularly suitable to screen for vestibular disorders in falls.

A prototype rocking chair has been developed to test psycho-vestibular pathways, defined as the pathways via which vestibular afferents are transported to the subject's conscience. Thanks to this apparatus, a stimulus of body movement will be generated, but with limited tactile, visual and proprioceptive afferents, in such a way that the vestibular system alone is able to indicate to subjects their position in space. The subject will be required to detect oscillatory movement, and then to distinguish between a vestibular stimulus and a pulsed auditory stimulus.

The study hypothesis is that the movement stimulation generated by our prototype will be sufficient to stimulate the vestibular system, which will manifest itself as a conscious sensation of movement and by a vestibulo-ocular reflex causing oculomotor manifestations.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* National health insurance cover
* Written consent
* Subjects able to understand simple instructions and packaging information and to provide informed consent

Exclusion Criteria:

* Vertigo, consciousness disorders, nausea or pain before the tests
* Bilateral deafness
* History of neurological, rheumatic or orthopaedic disease likely by itself to trigger a fall
* Psychiatric disorder likely to compromise participation.
* Personal history of falls of undetermined cause.
* Présence de saccades et/ou nystagmus en position statique
* Femme enceinte
Transcutaneous Measurement of Carbon Dioxide Versus Current Sedation Practices in Sedated Patients

Does transcutaneous carbon dioxide partial pressure (TcCO2) monitoring detect hypoventilation prior to current sedation monitoring practices in order to prevent hypoxemia in sedated patients undergoing colonoscopies?


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring sedation for colonoscopy

Exclusion Criteria:

* Patient refusal