cyrilzakka/clinical-trials huggingface dataset:
Development of Bone-vestibular Evoked Myogenic Potential

This study aims to evaluate the effects of different masking conditions on cervical vestibular evoked myogenic potential (cVEMP) responses. Vertical-axis vibrations (VAVs) of 500-Hz short-tone bursts (STB500) and 750-Hz short-tone bursts (STB750) were used to elicit cVEMP responses. These stimuli were delivered through a Mini-Shaker placed at the vertex (Cz) under three masking conditions: no masking (NOM), speech noise masking (SNM), and random interstimulus-interval tone bursts (rISITB). The study focused on testing protocols that can potentially improve unilateral VEMP testing and explore its clinical applicability.

Participants and Ethics:

The study recruited 20 healthy adults (10 males and 10 females, aged 20-37 years), all of whom had normal otoscopic findings and no history of hearing issues. Ethical approval was obtained, and all participants provided informed consent.

Bone Conduction Vibrations (BCV):

Bone-conducted vibrations were generated using a SmartEP system and delivered via a Mini-Shaker transducer. Stimuli included 500 Hz and 750 Hz short-tone bursts (STB500 and STB750), calibrated to appropriate levels, with specific rise, plateau, and fall times.

Masking Conditions:

Masking sounds included speech noise (250-1000 Hz, calibrated at 100 dB SPL) and random interstimulus-interval tone bursts (rISITB, 500 Hz, 100 dB SPL).

Testing Procedure:

Vertical-axis BCV was delivered to the vertex (Cz) while participants maintained steady neck muscle tension in specified head positions. Electrodes were placed using a standard montage for cVEMP recording. Each side was tested under three masking conditions (NOM, SNM, rISITB) with a 24-hour interval between tests. Responses were recorded bilaterally and repeated for reproducibility.

Study Focus:

The study investigates the effects of different masking conditions on response characteristics, including latencies, amplitudes, and asymmetry ratios. The aim is to refine VEMP testing protocols, explore its potential for unilateral testing, and evaluate its applicability for specific vestibular organ assessments.

Eligibility Criteria:
Inclusion Criteria:

* 20y-40y adult

Exclusion Criteria:

* Having history of hearing loss or dizziness
* failed hearing screening test
* Having history of head or neck surgery
Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss

Idiopathic sudden sensorineural hearing loss (ISSNHL) refers to idiopathic sensorineural hearing loss of at least 30 dB over at least three test frequencies occurring over a 72-hour period. Vertigo has been considered a risk factor of poor prognosis in patients with ISSNHL. However, the clinical outcome and development of vestibular function in these patients have not been reported yet. We'd like to conduct a study on the problem whether these patients resulted in a complete recovery of the peripheral vestibular functions or compensation of the central vestibular system. If the answer is the former one, these cases might be supportive evidence of regeneration of hair cells in vestibular disorders.

This study is designed as a prospective cohort study with only one cohort. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The primary measurement is the vestibular function tests including SOT, the caloric reflex test, vHIT, VEMP (cVEMP and oVEMP). The secondary measurements included PTA, DHI, and VAS. The sample size was set at 60 patients. The continuous variables were expressed as means ± standard deviation (SD) whereas categorical variables were expressed as frequency and percentage for data description. P \<0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* 16 to 70 years old.
* Diagnosed as ISSNHL.
* Present with vertigo.
* At least 1 abnormal result in vestibular function tests(SOT, vHIT, caloric reflex test, and VEMP).
* The onset of the disease was within 30 days.

Exclusion Criteria:

* Unwilling to sign informed consent.
* The cause of sudden hearing loss has been identified, such as trauma, vasogenic disease, et al.
* Bilateral hearing loss.
* Patients with coexisting vestibular disorders, including Meniere disease, vestibular neuritis, labyrinthitis, and peripheral vestibular loss et al.
* Patients not suitable to receiving vestibular function tests, such as those with severe cervical spine disease, cardiovascular disease, or pregnancy et al.
* Cognitive impairment;
* Other conditions that the investigator evaluated the patients as not appropriate for this study.
Somatostatin Receptor Imaging in Cardiac Sarcoidosis

The purpose of the trial is to determine the accuracy of Cu-64 labelled DOTATATE for diagnosing cardiac sarcoidosis using PET/CT or PET/MRI.


Eligibility Criteria:
Inclusion Criteria:

Group A: Suspected cardiac sarcoidosis Group B: Known cardiac sarcoidosis, clinical follow-up Group C: Myocarditis or dilated cardiomyopathy (Non-cardiac sarcoidosis)

Exclusion Criteria:

Infection Pregnancy Severe claustrophobia Weight \>140 kg
The Impact of an Instructional Web-based Healthcare App for Relieving Back Pain From Spinal Compression Fractures

With the expected rise of patients with osteoporosis-induced fractures, it has become increasingly urgent to design and use specialized health education materials aimed at easing pain and improving bodily functions

This study designed web-based dynamic pain relief instructions for women with spinal compression fractures. We collected patients' pain rating data the day before, one month after, and three months after providing the instructions.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women

Exclusion Criteria:

* postmenopausal women
Comparing Population Cessation Services

If the treatment combining Motivation Enhancement, Reduction Counseling, Nicotine Replacement Therapy and Transtheoretical tailored interventions produces an increasing treatment trajectory, it will produce unprecedented impacts with unmotivated smokers specifically and population cessation generally. These recruitment and intervention strategies require limited resources from health care providers and could be readily disseminable to other health care systems for application with populations of smokers, especially unmotivated smokers who have been understudied and underserved.

This proposal addresses major gaps in research for nicotine addiction treatments for entire populations of smokers and for the 80% who are not motivated to quit. Nicotine addiction is just like other drug addictions in terms of breaking the addiction cycle. Researchers and providers differ on whether treatment emphasis should be on clinician-based counseling, biologically-based medications, computer-based tailored communications or a combination of these. There is a lack of comparative research on population treatments to compare effectiveness, cost-effectiveness and enhancement of quality of life. Such comparative research would provide health care systems and providers with evidence on how to best serve entire populations of smokers, especially unmotivated smokers who are seriously underserved. This research will compare the four most highly recommended treatments: 1. Motivation Enhancement Therapy (MET) plus NRT; 2.Tailored communications based on the Transtheoretical Model (TTM), and 3. The combination of these treatments.

Eligibility Criteria:
Inclusion Criteria:

* smoker

Exclusion Criteria:

* pregnancy
Testing the Feasibility of Computer-based Cognitive Training in Individuals with Multiple Sclerosis Living in the Community

Cognitive impairments are common in multiple sclerosis (MS) diagnosed both at the onset and throughout the disease course. Poor cognitive abilities have been associated with poor outcomes such as higher levels of unemployment, poor quality of life, driving difficulties among others. Learning and memory are a common cognitive deficit. This computer-based cognitive training is a 10-session treatment proven to be effective in ameliorating learning and memory in individuals with MS across 3 realms of functioning: objective cognitive performance, daily life activities and neuroimaging. Despite this strong efficacy, as well as the recent clinical application of this computer-based cognitive training across the world, recent in-person studies have highlighted that transportation to the clinic to complete treatment sessions is a significant obstacle to clinical use of this effective treatment. To address this limitation, the proposed pilot study will test the efficacy of the computer-based cognitive training administered remotely via zoom health in persons with multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* English as primary language
* Diagnosis of multiple sclerosis

Exclusion Criteria:

* Most recent exacerbation within one month
* Other Neurological History: head injury, stroke, seizures, or any other significant neurological history will not be included in the study
* Individuals with an active diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II will be excluded from the study.
* Poor Visual Acuity (corrected vision in worse eye \&amp;lt; 20/60), diplopia, or nystagmus
* Inability to understand directions and following one, two, and three step commands
* Intact New Learning and Memory: Only individuals that show impaired performance on a memory test will be included in the study
Using the Arms to Drive the Legs During Walking

This study aims to understand and compare the metabolic and mechanical demands placed on the body while walking normally and walking with the use of an apparatus that drives leg swing through the use of the arms. This information will help the investigators identify how arm swing mechanics helps minimize energy demands and to use this knowledge to design walking rehabilitation interventions in the future.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy and free from neurological disease and/or body related injury
* Community-dwelling young men and women 18-36 yrs
* Use and be contacted by telephone
* Speak, read, understand, and complete a questionnaire in English
* Body mass index \< 30 kg/m2

Exclusion Criteria:

* not of the specified age range or Body Mass Index
* inadequate aerobic fitness training
* answering "no" to question #3 on Screening Form ("Is participant in good general health?")
* answering "yes" to:
* question #4 ("any difficulty with mobility?")
* question #5 ("problems with balance/dizziness?")
* question #6 ("lingering symptoms/pain from injury?")
* question #7 ("chest pain/shortness of breath?")
* question #8 ("high blood pressure/hypertension?"), or
* questions #9, 10, 11 ("first degree family history of heart attack?")
* question #12 ("smoke cigarettes?")
* question #13 ("diabetes?")
* question #14 ("high cholesterol?")
* question #15 ("Is participant pregnant?")
Continuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II Trial

This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer(patients with HER2 negative and PD-L1 CPS≥5).Patiens will recevie Serplulimab plus chemotherapy ((oxaliplatin+capecitabine) as first-line treatment. After PD，patients will randomly 2：1 assigned to treatment：one group will receive Serpluimab with Paclitaxel,Apatinib；another group will receive Paclitaxel with or without Ramucirumab.All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent

stage one ：Serplulimab 3mg/kg,d1,q2w or 4.5mg/kg,d1,q3w+oxaliplatin130mg/m2 iv.gtt d1+capecitabine 1000mg/m2 p.o.b.i.d d1\~d14,q3w

stage two:Serplulimab 3mg/kg,d1,q2w or 4.5mg/kg,d1,q3w+Apatinib 250mg/qd+Paclitaxel 135\~175mg/m2 iv.gtt,d1,q3w

Paclitaxel 135\~175mg/m2 iv.gtt,d1,q3w±Ramucirumab 8mg/kg,d1,q2w

Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
2. Age ≥ 18 years and ≤ 75 years when ICF is signed;
3. Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;
4. never received systemic anti-tumor drug therapy before；
5. HER2 negative and PD-L1 CPS≥5;
6. Measurable lesion according to RECIST v1.1 by IRRC;
7. ECOG score 0-1;

Exclusion Criteria:

1. Has other active malignancies within 5 years before the first administration of the study drug;
2. Plan to or have previously received organ or bone marrow transplantation;
3. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
4. Have received any research drugs within 14 days before the first use of the study drugs.
The Effect of FES on Children With Spinal Cord Injury

Regular exercise is strongly recommended to help maintain a healthy lifestyle. Unfortunately, children and young adults with damaged spinal cords may not be able to exercise regularly. However, there is an exercise bike specially designed for persons with damaged spinal cords that enables them to pedal by directly stimulating the muscles in their legs. Our study is designed to determine the benefits of exercise for Spinal Cord Injured (SCI) patients using this bike.

The inability to walk due to spinal cord dysfunction has profound effects on patients, both physiologically and psychologically. Complications associated with walking upright include loss of muscle mass from atrophy, reduction in bone mineral density (osteoporosis), compromised cardiovascular endurance, loss of sense of well-being, etc. Functional Electrical Stimulation (FES) of the lower extremities has been found to reverse many of these complications. We propose to examine the use of FES in children who have suffered from spinal cord injury (SCI). We plan to examine the effect of FES bike therapy on bone mineral density and psychological well-being.

Eligibility Criteria:
Inclusion Criteria:

* Age 4-21
* Paralysis/lack of sensation in lower extremities due to spinal cord injury.

Exclusion criteria:

* Diseases known to affect bone metabolism
* A history of hip or knee dislocation or subluxation
* The presence of pressure sores in the areas of treatment
* The presence of metallic hardware in the femur
* A history of peripheral nerve injury, lower motor neuron disease, or chronic corticosteroid use; or a seizure disorder requiring pharmacological antiepileptic therapy that can affect bone mineral density.
* Individuals with pacemaker devices or unhealed fractures also were excluded.
Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis

This is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study, conducted in subjects with moderate-to-severe atopic dermatitis.

This phase 2 study is designed to explore the efficacy and safety, as well as pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of dose-ranging AK120 compared to placebo, which will generate information regarding the selection of dosing regimens with AK120 monotherapy treatment in adult subjects with moderate-to-severe AD.

Primary Objectives:

• To evaluate the efficacy of AK120 in the treatment of adult subjects with moderate-to-severe Atopic Dermatitis (AD).

Secondary Objectives:

* To evaluate the safety of AK120 in the treatment of adult subjects with moderate-to-severe AD.
* To evaluate the Pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AK120 in adult subjects with moderate-to-severe AD.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female, over the age of 18
2. Chronic atopic dermatitis (AD) diagnosed at least 1 year.
3. Subject with EASI score ≥16, IGA ≥ 3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe), ≥ 10% body surface area (BSA) of AD involvement.
4. Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months.

Key Exclusion Criteria:

1. Inadequate washout period for prior drug therapy (eg. corticosteroids, immunosuppressive/ immunomodulating, biologics, phototherapy, Chinese traditional medicine, anti-infective agents).
2. History of exposure to active TB, and/or history or current evidence of TB infection.
3. Positive serology results at Screening for hepatitis B, hepatitis C or HIV.
4. Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit.
5. History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit
6. Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with participation in the study, or interfere with the interpretation of study results.
ISSUE3: International Study on Syncope of Uncertain Etiology 3

ISSUE 3 is a multi-center, prospective, randomised controlled double-blind study aimed to assess the effectiveness of pacemaker therapy for prevention of asystolic neurally-mediated syncope.

In asystolic neurally-mediated syncope (NMS) documented by Implantable Loop recorder (ILR), ISSUE-2, an observational trial, showed that pacemaker was effective in reducing the 1-year first syncope recurrence rate from 33% rate before implant (ILR phase 1) to 5% rate after implant (phase 2). Moreover, the control non-asystolic group still continued to have a 41% recurrence rate after the first recurrence of syncope, thus supporting the conclusion that the reduction with pacemaker was due to the beneficial effect of pacemaker itself and not to other factors. However a formal controlled trial is needed to confirm these findings.

Eligibility Criteria:
Inclusion Criteria:

* Suspected or certain neurally-mediated syncope, based on the Guidelines recently published by the Task Force on Syncope of the European Society of Cardiology 2,3 (Appendix 1);
* More than 3 syncope episodes in the last 2 years;
* Clinical presentation of syncope of sufficient severity requiring treatment initiation in the physician's and patient's judgement.
* Age \> 40 years.
* Negative carotid sinus massage.
* Patients accept to have an ILR implantation.

Exclusion criteria:

* Carotid sinus hypersensitivity
* Suspected or certain heart disease and high likelihood of cardiac syncope:
* Symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement;
* Loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic, drop-attack, TIA, intoxication, cataplexy);
* Subclavian steal syndrome;
* Psychologically or physically (due to any other illness) or cognitively unfit for participation in the study according to the opinion of the investigator;
* Patient compliance doubtful;
* Patient geographically or otherwise inaccessible for follow-up;
* Patient unwilling or unable to give informed consent;
* Life expectancy \<1 year.
Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus

To evaluate the efficacy of mid-stromal implantation of an isolated Bowman layer graft, to reduce and stabilize ectasia in eyes with advanced keratoconus


Eligibility Criteria:
Inclusion Criteria:

•Advanced keratoconus

Exclusion Criteria:

* Further ophthalmic diseases
* History of ocular surgery
* Pregnancy, brest feeding
Investigational Study With the BD PosiFlush™ SafeScrub on NADs

This study is an investigational study to evaluate the safety and performance of the BD PosiFlush™ SafeScrub on needleless access devices.

This study is being conducted to generate clinical data to support the performance and safety of BD PosiFlush™ SafeScrub. The study data will be used for regulatory submission in EU.

Eligibility Criteria:
Inclusion Criteria:

1. Any patient (≥18 years of age) in a high acuity hospital medical or surgical unit regardless of gender, with an eligible in-situ vascular access device and with a needleless access device (NAD). This includes patients who have a current VAD, whether it is newly placed or long-term access as part of their routine medical care. Eligible in-situ vascular access devices are peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs) and implanted venous access ports. Eligible NADs are stopcocks, Y-sites, and needle-free connectors.
2. Expected to be available until 2 accesses are completed and for any periodic observation upto 15 min after each access.
3. Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant.

Exclusion Criteria:

Any patient in whom observation might interfere with medical care or create undue hardship as determined by the patients care team.

* Patients under the age of 18.
* Patients suffering hypernatremia and fluid retention, when the administration of sodium or chloride could be clinically detrimental as determined by the study investigator.
* Patients with a known allergy to any of the followings as determined by the study investigator:
* Any of the components or materials of BD PosiFlush™ SafeScrub device or BD PosiFlush™ SP Syringe, or
* 0.9% sodium chloride solution
* Pregnant or breastfeeding women
* Urine pregnancy test will be required for all women of childbearing age who want to participate in the study
A Study to Investigate the Ileo Neo Rectal Anastomosis Compared to the Ileo Pouch Anal Anastomosis for Patients With Ulcerative Colitis

For patients with ulcerative colitis, eligible for surgical treatment, which restorative surgical procedure: the standard ileo pouch anal anastomosis or the alternative ileo neo rectal anastomosis is the best in terms of complications, functional outcome and health status and quality of life.

This research is designed to answer questions from the medical profession and patients´ community (Crohn en Colitis Ulcerosa Society, the Netherlands) whether the new INRA technique needs further development on a broader scale or not.

The research project will be conducted in the two institutes where INRA procedures have been carried out and in the UMCN to recruit matched control IPAA patients. There is a large experience with the IPAA procedure in this latter institute. The University of Tilburg will participate to work on health status and quality of life aspects. They have a large experience with quality of life research in general and have participated in QOL research in this topic before.

The aim of this historical cohort study is to establish the value of INRA, compared to IPAA, for patients with ulcerative colitis.

Eligibility Criteria:
Inclusion Criteria:

* UC patients with INRA procedure
* Age, sex and disease specific matched group of UC-IPAA patients with temporary diverting ileostomy from the same period
* Written informed consent

Exclusion criteria

* Pregnancy
* Malignancy (apart from basalioma or carcinoma-in-situ of cervix)
* Psychiatric disease or inability to assess follow up