cyrilzakka/clinical-trials huggingface dataset:
Sonodynamic Therapy in the Treatment of Carotid Atherosclerosis

Sonodynamic therapy (SDT) is a new treatment for carotid atherosclerotic plaque. The purpose of this study is to evaluate the safety and initial effectiveness of this technique.

Carotid atherosclerotic plaque is an important cause of ischemic stroke. Treatments for patients with carotid plaque include lifestyle changes, medical management(such as control of hyperlipidemia, hypertension, and diabetes) and carotid revascularization(carotid endarterectomy or carotid artery stenting). Studies have suggested that plaque morphology and composition are important determinants of plaque stability, using serial MR imaging of the carotid artery allowed observation of changes in plaque composition. Contrast enhanced ultrasound (CEUS) is a well accepted technique for detection of intraplaque neovascularization(IPN) in carotid atherosclerotic disease. The purpose of this trial is to evaluate the safety and initial effectiveness of SDT. The SDT can induce macrophage elimination and inhibit matrix degradation, which will promote plaque lipid depletion, inflammation level decrease and changes in other plaque tissue components, leading to plaque stabilization and reduction.

Eligibility Criteria:
Inclusion Criteria:

* Age 18- 80 years
* Carotid artery with 30%\~70% stenosis by ultrasound and plaque thickness\>2.5mm
* Patients without transient ischemic attack, minor stroke or amaurosis fugax within 6 months
* Patients' LDL-c level below 100 mg/dL(2.6mmol/L), well-controlled blood pressure(systolic BP\<140 and diastolic BP\<90 under resting conditions) and diabetes(HbA1c\<7%)
* Written informed consent

Exclusion Criteria:

* Non-atherosclerotic carotid artery stenosis
* Contraindication to MRI( uses pacemaker, has metallic implants, claustrophobia)
* Acute MI, acute coronary syndrome or stroke within 4 weeks prior to visit
* Severe cerebral artery stenosis, atrial fibrillation or MRI detected thrombosis that would cause stroke
* Previous significant adverse reaction to a statin
* Systemic disorders such as hepatic, renal, hematologic, and malignant disease
* Medical history that might limit the individual's ability to take trial treatments for the duration of the study
* Allergic to DVDMS or sonovue
* Diagnosis of porphyria
* Pregnant women and nursing mothers
* History of bilateral carotid endarterectomy or has immediate plans for carotid endarterectomy
* Patient who is attending other clinical trial
In Vivo Kinematics for Subjects With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA

The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs.

The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs. The Journey II BCS Knee System was designed to resect and replicate both the PCL and ACL, the Journey II CR System retains the posterior cruciate ligament, while the Journey II XR System retains the cruciate and collateral ligaments so they remain intact.

Eligibility Criteria:
Inclusion Criteria:

1. Patients in the age range of 18 years to 85 years (both inclusive)
2. Patients who have a BMI less than 35
3. Patients who do not have previous surgery on the implanted knee that might restrict their movement
4. Patient who are at least 6 months post-operative
5. Patients who do not experience any pain or other post-operative complications
6. Patients who have a stable TKA and can perform a deep knee bend activity
7. Patients who are willing to participate in this study and are willing to sign appropriate HIPAA and informed consent forms
8. Subjects will have a Journey II, either the BCS or XR, knee system

Exclusion Criteria:

1. Pregnant, potentially pregnant, or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
2. Patients who have currently enrolled in a fluoroscopic study within the past year.
3. Patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims.
4. Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
5. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability
6. Subjects who are unable to perform a deep knee bend.
7. Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
8. Subjects without the required type of knee implant.
German Translation and Cross-cultural Adaptation of the Headache Screening Questionnaire (HSQ) Followed by a Test-retest Reliability Study.

The goal of this study is to learn more about the Headache Screening Questionnaire in people with Headache. The main question is:

Does the lower limit of a 95% confidence interval of the HSQ in physiotherapy during a period of 2 to 4 weeks reach at least 0.4?

Data are collected using the REDCap web application (https://redcap.zhaw.ch/). REDCap is designed for the creation and administration of online surveys. Respondents can access the survey directly via a QR code or link and complete the screening questionnaire via smartphone or computer. In a first step, the participating persons are included or excluded based on the criteria mentioned (chapter: Proband:innen). Once eligibility has been confirmed, the HSQ is completed online for the first time in a second step. After that, the test persons will receive a reminder e-mail after 2 weeks to complete the retest online. After the reminder email the test persons have 2 weeks to complete the retest. Those who participate later will be excluded and not included in the data analysis. In addition, the retest asks whether the headaches have changed compared to the test due to the physiotherapeutic treatment. This is asked with a three Likert scale (not changed, slightly changed, strongly changed). The severely changed headaches are not included in the analysis.

Translated with www.DeepL.com/Translator (free version)

Eligibility Criteria:
Inclusion Criteria:

* Individuals who are older than 18 years,
* live in Switzerland
* speak and understand German
* have had multiple headache episodes of the same or similar type

Exclusion Criteria:

* individuals with other known neurological conditions,
* known cognitive impairment
* known secondary headache types
Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices

This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different formulations of indacaterol, one administered via the Concept1 device and one administered via the Simoon device. The study aimed to determine whether the novel formulation (Simoon) had a similar profile to that of the established formulation (Concept1).

This study was double-blind with regards to the Concept1, where placebo for the lactose-blended indacaterol was available. However, with regards to the Simoon, neither the subject nor the investigator was blinded due to lack of a placebo to the PulmoSphere formulation. Hence, the overall designation of the study was partially-blind.

Eligibility Criteria:
Inclusion criteria:

* Patients with persistent asthma with a forced expiratory volume in 1 second (FEV1) ≥ 50%
* Patients using inhaled corticosteroid (with or without long-acting beta agonist)

Exclusion criteria:

* Asthma exacerbations in previous 6 months
* Chronic obstructive pulmonary disease (COPD) or other pulmonary disease
* Excessive use of short-acting beta agonists

Other protocol-defined inclusion/exclusion criteria applied to the study.
Efficacy of a Combined Linguistic/Communication Therapy in Acute Aphasia After Stroke

Linguistic training is traditionally the gold standard for rehabilitation of aphasia after stroke and efficacy criteria count early stage, intensity as well as personalized treatment. To date, no clear evidence showed a specific effect of any therapy in the acute phase of aphasia after stroke. This study aims to compare the effect of a combined therapy (linguistic/communication) versus a linguistic therapy on communication performance in patients in the acute phase of aphasia after a first stroke.

Twenty to 25% of strokes cause aphasia. Speech and language therapy is the well-known standard treatment of aphasia after stroke although it is based on weak scientific evidence. To date, the efficacy criteria of aphasia rehabilitation are early stage, intensity as well as personalized treatment. Usually these patients receive in acute phase a linguistic training focused on the linguistic impairment. This approach is based on the cerebral plasticity postulate. However the superiority of this practice compared to other methods has never been shown. Moreover the benefit of the combination gathering linguistic treatment with communication treatment has to our knowledge never been studied.

In the present study investigators propose to compare the effect of a combined linguistic/communication rehabilitation versus a linguistic treatment. To do so, investigators will recruit patients with aphasia after a first stroke, in the acute phase. After a allocation to the " combined " and " linguistic " groups, all the patients will have a comprehensive language and neuropsychological assessment before and after 3 months of rehabilitation, and finally 6 months after the onset.

The "linguistic" group will have a rehabilitation only focused on linguistic processes whereas the "combined" group will have a linguistic training as well as communication training. The therapy will be personalized and the therapists will exclusively use standardized linguistic and/or communication toolboxes of rehabilitation containing dedicated activities.

Eligibility Criteria:
Inclusion Criteria:

* First stroke
* Inclusion at the acute phase (\< 7 days)
* Patient registered at the social security system
* French as usual language
* Aphasia severity score measured by the Boston Diagnostic Aphasia Examination (BDAE) scale ≥ 1 and ≤ 4
* Consent signed by the patient or if not, by the caregiver

Exclusion Criteria:

* Cognitive impairment before the onset (IQCode \> 3.4)
* Alcohol or drug addiction
* Untreated psychiatric disease,
* Uncorrected sensory impairment
* Evolutive pathology
* Adults protected by Law
* Participation to another research
VR Training for Nurses' Delirium Management: An RCT

Background:

Delirium is an acute mental status change characterized by confusion, fluctuating symptoms, and inattention. It affects 11%-40% of hospitalized elderly patients and over 80% of mechanically ventilated ICU patients. Early detection and intervention are crucial in preventing adverse outcomes. The Confusion Assessment Method for the ICU (CAM-ICU) has been widely adopted in Taiwan for delirium screening. However, nurses' knowledge and skills in delirium assessment remain insufficient.

Objective:

This study aims to evaluate the effectiveness of a spherical video-based virtual reality (SVVR) training system in improving nurses' delirium assessment and management skills.

Methods:

A parallel-group randomized controlled trial will be conducted. Participants (nurses aged 20-65) will be recruited via social media and screened for eligibility. They will be randomly assigned to:

Intervention group: SVVR-based delirium training using a head-mounted display. Control group: Standard video-based training via YouTube. Pre- and post-intervention assessments will measure delirium knowledge, attitudes, assessment skills, learning motivation, and technology acceptance. Quantitative data will be analyzed using SPSS (Version 25) with t-tests, ANOVA, and chi-square tests. Qualitative data will be analyzed using thematic analysis.

Expected Outcome:

This study will determine whether immersive VR training enhances nurses' delirium management skills more effectively than conventional video training.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 20 and 65 years.
* Currently a licensed nurse and practicing.
* Willing to participate in this study and comply with the related procedures.
* Completed and signed the written informed consent form.

Exclusion Criteria:

* Nurse managers or nurses who do not directly care for patients, or nurses working in outpatient or community settings.
* Individuals with epilepsy, heart disease, or dizziness.
* Individuals with anxiety, panic disorder, or claustrophobia.
* Individuals with myopia greater than 600 degrees or those who have previously undergone eye surgery.
Acupuncture in Emergency Delirium After Tonsillectomy

Emergence delirium (ED) (also called emergence agitation) can be defined as a "dissociated state of consciousness in which the child is irritable, uncompromising, uncooperative, incoherent and inconsolable crying, moaning, kicking or thrashing".

Tonsillectomy (with or without adenoidectomy) is a routinely performed operation. Emergence agitation is a frequent phenomenon in children recovering from general anesthesia for tonsillectomy, and increases risk of self-injury. It's not unusual for the post-anesthesia care unit (PACU) staff look that a child, who was asleep just minutes before, starts screaming, pulling out his intravenous line, looks like he's about to fall out of his bed. This condition requires sedatives that may cause undesirable side effects. The cause of emergence delirium and the mechanism of agitation following general anesthesia is unknown. Probably the volatile agents work on some pathways, possibly in the locus coeruleus or amygdala, in the setting of a specific neurodevelopmental stage of the brain.

While emergence delirium can be seen into adulthood, its peak incidence is in younger children (2-7 years of age). The incidence of ED is unclear: anywhere from 2-80%, but when confounders like pain, nausea etc. are controlled, the incidence is probably around 20-30%.

Limited data suggest that acupuncture may be a safe, nonpharmacological treatment for the reduction of pain and agitation in term and preterm infants and that may be an alternative method for preventing ED. In particular a prospective, randomized, double-bind controlled study demonstrated a reduction of the ED in many surgeries, after the electrical stimulation of the heart 7 acupuncture site.

Nearly 400 acupuncture points are known on the body surface and they belong to 14 meridians, running along the human body. After the needle peeling, the nervous free terminations release some polypeptid (the most important is the substantia P) and it increases the excitability of the near nervous free terminations which cause vasodilatation. It has a myorelaxant effect, decreases the level for pain tolerance and make stronger the inhibitor effect of descendent fibers, with production of endogenous endorphins. This is the reason why acupuncture is considered valid in prevention and control of ED.


Eligibility Criteria:
Inclusion criteria

1. Children scheduled to undergo tonsillectomy with or without adenoidectomy
2. American Society of Anesthesiologist (ASA) physical status I or II

Exclusion criteria

1. Coagulation disorders (pro-hemorrhagic status)
2. Neurological disorders (development delay)
Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-01)

The purpose of the study was to determine safety and efficacy of WELT-IP in adult insomnia patients. WELT-IP is a cognitive behavioral therapy for insomnia (CBT-I) based digital therapeutics.

This was a randomized, double-blinded, sham-controlled trial. Overall, 52 subjects were randomized into the following groups:

* WELT-IP group: WELT-IP (insomnia digital therapeutics) use
* Control group: sham app use Subjects in both groups continued to receive their clinician-directed standard-of-care treatment for insomnia, if applicable, including pharmacotherapy. Subjects were randomized and in WELT-IP group used WELT-IP and subjects in control group used a sham for a period of 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* DSM-5 insomnia patient
* ISI of 8 or above
* for 7 days before baseline visit (Visit 2), completing sleep diary for more than 4 days in the guidelines
* capable of using mobile device and application

Exclusion Criteria:

* currently on non-pharmacological treatment for insomnia (ex. CBT-I, light therapy, oriental therapy for insomnia)
* sleep disorders diagnosis other than insomnia (ex. Obstructive sleep apnea, sleep behavior problem, restless leg syndrome)
* progressive and active medical conditions
* received continuous psychotherapy such as CBT, motivational enhancement therapy, psychotherapy, and psychoanalysis in the past 3 months
* major psychiatric illness as assessed through MINI
* suicide risk as assessed through C-SSRS
* having occupational risk due to sleep restriction
* shift workers
Testing the Effects of the Caregiver Interaction Profile Training on the Interactive Skills of Daycare Providers

The goal of this clinical trial is to test the Caregiver Interaction Profile (CIP) training program (Helmerhorst et al., 2017) promoting the relational quality between professional caregivers and children in daycare. The main questions it aims to answer are:

* Does the CIP training program, compared to no training, improve the relational quality between daycare providers and children in daycare?
* Does the CIP training program, compared to no training, foster children's social, emotional, and language development? Daycare providers assigned to the "training group" will participate in the CIP training program, which uses video-recorded interactions between the daycare providers and children in daycare to give feedback on the relational quality as observed in the videos. Daycare providers assigned to the "waiting list control group" will initially not take part in the training program but will receive the training after the study is finished. All daycare providers' daily interactions with the children in daycare will be filmed before and after the training in order to see if there has been a change in relational quality for the daycare providers in the training group (compared to the control group). Daycare providers in the training and control groups will also fill out questionnaires about the social, emotional, and language development of the children in their care.

Researchers will compare daycare providers (and the children in their care) in the "training group" to daycare providers (and the children in their care) in the "control group" to see if the relational quality in the training group improves more than that in the control group as a result of the CIP training, and how that impacts the social, emotional, and language development of children.


Eligibility Criteria:
Inclusion Criteria:

* currently working as a professional daycare provider in a daycare center

Exclusion Criteria:

* temporary staff in daycare on short-term contracts
Evaluation of Changes in Consumption of Drugs and Substances After Incarceration

To improve the management and risk reduction, it is essential to understand the evolution of the consumption of psychoactive substances, medicated or not in detention; it does not have at present no data on this subject. This work has as main objective to evaluate the development of substance use terms (goods and consumption practices) by the inmates between the period preceding their incarceration and their fifth month in detention.


Eligibility Criteria:
Inclusion Criteria:

* Major subject
* Subject in the fourth or fifth month of incarceration
* Held about agreeing to participate in the study

Exclusion Criteria:

* Patient refusing to participate
* Patient unable to respond to the questionnaire (major difficulties understanding of the French language)
Monitoring System for the Wearing of Orthodontic Elastics

The aim of the study is to validate a novel sensor intended to measure the wearing time of orthodontic elastics in patients with multibracket appliances. The newly developped sensor will be tested in 42 patients over a period of 6 months

Fixed multibracket appliances are used to correct tooth and jaw malocclusions. Usually, elastics are inserted between the upper and lower jaws to adjust the position of the jaws in relation to each other. The wearing time of the elastics determines the duration of the treatment and the quality of the treatment results. While micro-sensors are increasingly used for removable appliances to monitor patient compliance, there is still no such possibility for fixed appliances. This gap is to be closed with the planned 'OrthoKontrol' (intraoral mini-sensor). This is intended to measure and record the wearing time of the elastics.

Eligibility Criteria:
Inclusion Criteria:

* Multibracket appliances (fixed braces) in both jaws
* Need for intermaxillary elastics on at least one side
* Minimum motor skills

Exclusion Criteria:

* Patients with general diseases
* Patients with inflammatory oral diseases
* Patients with physical disabilities, which make it impossible to cooperate
* Independent insertion of the elastics is not possible
* Patients with impaired judgment Pregnant women
Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients

To evaluate the effect and safety of KHK7791 in combination with phosphate binders to treat Hyperphosphatemia in ptatients on HD.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stable chronic renal failure who have undergone hemodialysis three times per week for at least 12 weeks until screening examination.
* Dialysis conditions (dialysate, dialyzer, frequency of dialysis per week, dialysis duration, blood flow rate, and dialysate and substitution fluid flow rates), excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
* Taking phosphate binders three times per day. The prescribed drug and dosage regimen should have been unchanged during the last 2 weeks before screening examination.
* Serum phosphorus levels should be in the range of ≥6.1 and ≤10.0 mg/dL at screening examination.
* If on any vitamin D or calcimimetics regimen, then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.

Exclusion Criteria:

* iPTH \>600 pg/mL (should be based on the most recent value from the patients' medical records, etc. before pre-enrollment)
* Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome
* History of gastrectomy or enterectomy (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination.
* Having concurrent severe heart disease \[including congestive heart failure, defined as New York Heart Association (NYHA) cardiac functional classification of class III or IV, and cardiovascular disease requiring hospitalization, such as myocardial infarction\] or hepatic impairment (including AST/ALT ≥100 U/L at screening examination, or cirrhosis).
* Developed cerebrovascular disease (such as cerebral infarction and hemorrhage) or cardiovascular disease (such as myocardial infarction and unstable angina) requiring hospitalization within 6 months before screening examination.
* Uncontrollable hypertension or diabetes.
* Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis, or change in the dialysis center (relocate to another hospital/clinic) during the study period.
* Any diagnosis of and treatment of malignancy within 5 years before screening examination (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix).