cyrilzakka/clinical-trials huggingface dataset:
US Phase III Study of APD421 in PONV

A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 18 years of age
* Patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure and expected to require at least one overnight stay in hospital

Exclusion Criteria:

* Patients scheduled for outpatient/day case surgery
* Patients scheduled to undergo intra-thoracic, transplant or central nervous system surgery
* Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block
* Patients who are expected to remain ventilated for a period after surgery
* Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed
The Effect of Refractive Errors on Central Corneal Thickness by Using Pentacam and IOL Master

To evaluate the impact of refractive errors on the central corneal thickness obtained by Pentacam and intraocular lenses (IOL) master in eyes with different refractive errors.

Central corneal thickness (CCT) is a key indicator of corneal health status and helps to assess corneal diseases. The normal corneal thickness is about 540 μm and mainly consists of the stroma, which is estimated at 450 μm in the center. The stroma provides vital structural integrity and plays a key role in helping maintain transparency. It has been reported, however, that CCT follows a diurnal pattern being 10 μm thicker in the morning due to reduced evaporation of water from underneath the closed eyelids

Eligibility Criteria:
Inclusion Criteria:

* Subjects included in this study aged between20 and 41 years, asked for refractive surgery

Exclusion Criteria:

* patients with corneal scarrig or opacification.

  * Patients with corneal dystrophies.
  * Patients with keratoconus.
  * Previous ocular or refractive surgery.
  * Ocular trauma.
  * Uveitis patients.
  * Patients with history of recent contact lens wear.
To Investigate the Effect of PEMF for Knee OA Patients

Health care costs are increasing alarmingly, which will impose an overwhelming economic burden to an aging society like that of Hong Kong. For example, degenerative musculoskeletal disorders such as osteoarthritis (OA) present a grand challenge with its high prevalence (\>40% in the elderly suffered from knee OA). Knee osteoarthritis (OA) is the most common form of arthritis, and around 2 million population worldwide suffer from this disorder. OA is a debilitating progressive disease with typical pathological progress such as cartilage degeneration, inflammation, joint width narrowing and developing osteophytes. The main system of knee OA is acute pain leading to loss of mobility. There is no effective treatment to cure or stop the progression of OA. For now, the main method is to alleviate the pain and symptoms, including control weight, exercise, physical treatment and intake of NSAIDs/ paracetamol.

Pulsed electromagnetic field (PEMF) treatment has shown to enhance cell activity related to tissue healing, delay bone and cartilage degeneration and give beneficial effects such as relief in pain, anti-inflammation and reduce swelling. In clinic, PEMF treatment has been reported to be safe, and has been proved to reduce the usage of NSAIDs and pain in patients with knee OA.

This study aims to investigate the effectiveness of PEMF therapy on for patients with knee OA.


Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of knee
* VAS score ≥ 4
* Grade 2 and 3 osteoarthritis (Kellgren-Lawrence criteria)
* No alleviation of symptoms after ≥ 3 months of nonsurgical treatment
* No acute knee injuries in both limbs in the past 3 months
* No muscle strain in both limbs in the past 3 months
* Voluntarily agreed to participate and signed the informed consent form

Exclusion Criteria:

* Skin diseases around the target knee joint
* Severe pain in other areas affects the diagnosis of function and symptoms of knee joints
* Injection in target knee within 3 months of enrolment
* Inflammatory joint disease (e.g., rheumatic inflammation)
* Infectious joint disease (e.g., septic arthritis)
* Pregnant or breastfeeding
* Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent, an insulin pump
* Physical inability to undertake testing procedures
* Inability to give informed consent
Minimally Invasive Surgery (MIS) Database for the Purpose of Research

The Minimally Invasive Surgery Team (MIST) are establishing a separate research database to find out more about patient's undergoing minimally invasive surgery (laparoscopic , open and robot assisted) procedures at UCSD. The hope is that collection of this information will give physicians a better knowledge and understanding of the benefits of minimally invasive surgery and possibly assist physicians to better manage future patients.

Minimally invasive surgery has become the gold standard in surgical treatment for many indications, such as treatment of gallstones and acute appendicitis. For many other indications, the potential for minimally invasive approaches exist, but the data does not yet exist to establish it as the gold standard. In addition, there are certain patient factors such as age or weight that may influence the success of a minimally invasive procedure.

While there are numerous articles in the literature reporting outcomes for minimally invasive therapies, these series are often notable for small patient populations and varying definitions of treatment success from study to study. Due to the lack of uniformity in reporting patient outcomes, an opportunity exists to establish a standardized database of a large number of patients undergoing these procedures.

A standardized database will facilitate conducting prospective research of the risk factors and benefits of minimally invasive surgery. This analysis will not only enhance the care provided to these patients, it will reduce the use of ineffective therapy, thus promoting improved efficiency while increasing the quality of care provided within the UCSD system.

This is our initial application. Several other departments at UCSD have developed similar databases. There are numerous examples of prospective databases used for similar purposes in the literature. Smithers, et al, used a prospective database of 446 patients undergoing esophagectomy to compare open to laparoscopic outcomes. Nesset, et al, maintained a database of bariatric surgery patients for two decades and was able to draw conclusions from a data set of 1584 patients. Even at smaller numbers, a prospective database is useful. Andrew, et al, described the improvement in outcomes over the learning curve in the first 201 patients undergoing laparoscopic roux-en-Y gastric bypass using such a database. Though labor intensive, Clemmesen, et al, found maintaining a database allowed them to improve care for their patients.

Eligibility Criteria:
Inclusion Criteria:

Gastric Banding Group:

* For gastric banding subjects to qualify for study inclusion, subjects have to have a BMI ranging from 33-40. Currently a BMI of 33 is our lower level of acceptable for bypass.

Control Group:

* All adult subjects 18 years or greater being seen in the minimally invasive surgery clinic for elective laparoscopic surgery will also be screened.

Exclusion Criteria:

* Subjects with a BMI\>40 will be excluded because their fat cells are very large and therefore fragile and unsuitable for research use.
Telerehabilitation-Based Action Observation Treatment in Children with Hemiparetic Cerebral Palsy

The aim of this study is to evaluate the effectiveness of action observation therapy applied using two different telerehabilitation techniques (synchronous and asynchronous) to children with hemiparetic cerebral palsy.

Action observation treatment (AOT) is a new rehabilitation technique. AOT involves the observation of purposeful actions, presented through a video-clip or performed by an operator, in order to imitate and then perform them. In this study, AOT will be applied by observing actions to be presented via video-clips. 36 children with hemiparetic cerebral palsy who meet the inclusion criteria and agree to participate in the study will be included. The participants will be randomly divided into three groups. The groups are: a) the synchronous telerehabilitation group, where AOT will be applied under the supervision of a physiotherapist via videoconferencing; b) the asynchronous telerehabilitation group, where AOT will be applied under parental supervision; and c) control group. Both the synchronous telerehabilitation group and the asynchronous telerehabilitation group will receive AOT 5 days a week for 3 weeks, for a total of 15 sessions, in addition to conventional physiotherapy. The control group will only receive conventional physiotherapy. A total of three evaluations will be made at baseline (T0), at the end of treatment (T1), and at two months of follow-up (T2).

Eligibility Criteria:
Inclusion Criteria:

* Presence of confirmed hemiparetic cerebral palsy
* Manual Ability Classification System ≤ 3
* Age between 6 and 12
* Absence of major visual and/or auditory deficits
* Sufficient cooperation to comprehend and complete the test procedure and participate in treatment
* House Functional Classification Score ≥4
* Grade ≤2 on the Modified Ashworth Scale

Exclusion Criteria:

* Seizures uncontrolled by therapy
* Surgery and/or botulinum toxin-A injections in the upper limb within 6 months prior to the baseline assessment
* Having a disabling behavioral disorder to treatment
HOme PElvic Floor Improvement Trainer Trial

This study will gauge the efficacy of a home biofeedback treatment device for pelvic floor dysfunction/voiding dysfunction and pelvic pain. Investigators will test the utility of this device as a treatment alternative and/or temporary treatment for a patient's symptoms prior to or perhaps in lieu of their physical therapy appointment.

This study aims to determine if a special device can help children with pelvic floor problems. The pelvic floor issues under investigation include difficulty controlling urination and ongoing pain in the lower belly. The study will explore whether the device helps children gain better control over urination.

It will also investigate if the device contributes to the reduction of pelvic pain experienced by children. Furthermore, the study will analyze if the device leads to improvement in how the body functions during urination. The consistency with which children use the device and adhere to instructions will be monitored. Finally, the study includes an assessment of whether children find the device acceptable for use.

Eligibility Criteria:
Inclusion Criteria:

* Dysfunctional voiding symptoms without chronic pelvic pain.
* Chronic pelvic pain with or without dysfunctional voiding symptoms.
* Daytime enuresis, nocturnal enuresis, frequency, urgency, dysuria
* 8 years - 18 years, no one under 8 and no one over 18.

Exclusion Criteria:

- Has seen a physical therapist for traditional physical therapy of the pelvic floor due to urinary symptoms or chronic pelvic pain within the last 12 months.

Note: This would include patients who begin physical therapy for their pelvic floor outside of the study while enrolled in the study.

-All patients with the following conditions: severe developmental delay such as CP or wheelchair bound, cannot eat by mouth, mechanical ventilation dependence, etc.

* Nonverbal or unable to effectively communicate needs and preferences.
* Within the voiding dysfunction group, a diagnosis of a congenital GU anomaly (bladder exstrophy, cloacal anomaly, spina bifida, etc.)
* No initial medication usage will be excluded; however, if the patient begins a new medication or treatment regimen during the study, the patient will be excluded.
Prospective, Randomized Study of 2 Different Wound Dressings

The primary objective of this investigation is to evaluate the performance of a self-adhesive absorbent post-operative dressing coated with a soft silicone layer in minimize the risk of the development of blistering in subjects after hip or knee arthroplasty or spinal surgery in comparison to a standard wound dressing The secondary objectives are to evaluate:

* the performance of the dressing
* the comfort, conformability and the acceptability of the dressing
* pain before, during and after dressing removal
* the overall cost regarding dressing wear time, time to do dressing change and personal resources needed

A monocentre, post CE-mark, randomized clinical trial will be conducted at the University of Cologne, Department of Orthopedics and Trauma Surgery.

Male or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an expected hospital stay for 4 days or more will be included in the trial. Individual trial duration will be for 7 days (follow-up).

Two hundred subjects will be included in the trial, i.e. 100 subjects per arm. The treatment arm (either new or standard wound dressing) will be assigned by randomization stratified by type of surgery (i.e. hip, knee or spine).

AEs/ADEs/unexpected events with the device may be documented by relevant photos at time. All photos shall include a sticker marked with subject code, visit number/date and time.

Outcome Measures

Primary variable:

• Development of blistering from day 0 to day 6 post surgery Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee (CEC).

Secondary variables:

* Other wound complications (i.e. leakage, inflammation, infection)
* Number of dressing changes
* Pain before, during and after dressing removal (VA scale)
* Performance and acceptability of the dressing (4 point rating scale)

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18years
2. Have an expected total length of stay of 4 or more days
3. Undergoing elective primary arthroplasty of the hip or knee or spinal surgery
4. Undergoing hip surgery with a standard access
5. Give their written informed consent to participate

Exclusion Criteria:

1. Dressing size does not fit the incision area
2. Known allergy/hypersensitivity to any of the components of the dressing
3. Multi-trauma
4. Undergoing arthroplasty or spine surgery due to tumour or infection?
5. Fractures
6. Wound at the surgical site prior to surgery
7. Neurological deficit of operated side (hemiplegia, etc.)
8. Subject has documented skin disease at time of enrolment, as judged by the investigator
Transcranial Magnetic Stimulation (TMS) for Primary Progressive Apraxia of Speech (PPAOS)

The purpose of this study is to assess the influence of transcranial magnetic stimulation (TMS) on speech performance in individuals with primary progressive apraxia of speech.

Apraxia of speech (AOS) is a motor speech disorder affecting the programming of motor speech production. It is characterized by the impaired ability to coordinate the sequential, articulatory movements necessary to produce speech sound. It can result from insult to the brain, such as in stroke, or as the presenting sign/symptom of another neurodegenerative disease.

TMS is a neurostimulation technique which has been shown to modulate cortical excitability in a non-invasive manner, and has been associated with positive outcomes in a variety of neurological and psychological disorders.There is evidence to support the role of TMS in individuals with primary progressive aphasias. In addition, there is a a case report suggesting an improvement in speech following TMS in an individual with primary progressive AOS. This study is being undertaken to further examine the role of TMS in primary progressive AOS.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18 and above who are able to consent
* Diagnosis of primary progressive apraxia of speech based on neurological evaluation

Exclusion Criteria:

* Any uncontrolled medical condition expected to limit life expectancy or interfere with participation in the trial (i.e. unstable cancer, severe depression or anxiety by DSM-IV criteria)
* Abnormal stress test, as determined by the treating physician (unless cardiology clearance provided)
* Active substance abuse or alcohol dependence
* Uncorrected vision or hearing deficits that would preclude administration of the cognitive measures
* Unwilling or unable to provide written informed consent
* History of fainting spells of unknown or undetermined etiology that might constitute seizures
* History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or family history of treatment resistant epilepsy
* No medication is an absolute exclusion from TMS. Medications will be reviewed by the responsible MD and a decision about inclusion will be made based on the following:

  * The subject's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other CNS active drugs.
  * The published TMS guidelines review medications to be considered with TMS
* Any metal in the brain, skull or elsewhere unless approved by the responsible MD
* Any medical devices (i.e. Cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
* Substance abuse or dependence within the past six months
* Absence of corticospinal functional integrity
Treatment of AA Amyloidosis

The purpose of this study is to assess the safety and efficacy of a subcutaneous injection of nL-SAA1-01in a patient with AA Amyloidosis.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven AA amyloidosis
* Measurable disease
* Ability to travel to the study site and adhere to study-related follow-up examinations and/or procedures and provide access to participant's medical records

Exclusion Criteria:

* Participant has any condition that in the opinion of the site investigator, would ultimately prevent the completion of study procedures
Feasibility and Preliminary Efficacy of Hatha Yoga in Head and Neck Cancer Survivors

Treatment for head and neck cancer can result in marked musculo-skeletal impairment (MSI). This study will examine the effects of Hatha Yoga as a therapeutic modality to address MSI.

The use of aggressive treatment for head and neck cancer (HNC) particularly combined modality treatment regimens has resulted in an increase in survival. Unfortunately, this improvement has come with a marked increase in acute and late-effects. Acute HNC treatment-related toxicities have been clearly and extensively documented; however, data pertaining to adverse late-effects, those most likely to impact the survivor's long term symptom burden, functionality, and overall quality of life (QOL), are limited. This pilot study will be conducted to examine the feasibility of tailored Hatha Yoga as a therapeutic modality to address MSI in patients who have survived HNC.

Eligibility Criteria:
Inclusion Criteria:

* \>/= 18 years of age
* \>3 months post-treatment of HNC
* no active cancer
* ability to understand English in order to complete questionnaires
* willing to participate in the guided and home Yoga practice
* willing to drive to the study site
* willing and able to provide informed consent
* completed medically indicated physical therapy
* medical clearance by study medical oncologist

Exclusion Criteria:

* a prior cancer diagnosis within the past three years (except basal cell, surgically treated squamous cell skin cancer, early prostate cancer under observation)
* have received radiation therapy or chemotherapy for any condition other than primary HNC
* medical conditions that would prohibit the safe implementation of a Yoga practice (e.g., vertigo, dementia)
* active Yoga practice within the past 6 months
Evaluation of the Effectiveness of Self-hypnosis on Anxiety and Burnout of Nursing Staff

Its a prospective, non-interventional, single-center study, involving the human person evaluating the impact of self-hypnosis training on anxiety level and burn out in nursing and medical staff

Like other pandemics, that of Covid-19 had a significant psychological impact on the general population. However, this impact turned out to be even more acute among healthcare workers, in connection with repeated exposure to the risk of infection, the reorganization of care and their specific positioning (...) Psychotraumatic, anxiety and depression symptoms has been observed worldwide. The staff of CHR Metz-Thionville were not spared. From the first wave, the caregivers exposed directly to SARS-CoV-2 (emergency, resuscitation, cohorting sector) requested the hypnosis referent doctor of the structure, in order to benefit from hypnosis sessions in order to better manage their anxiety during the sanitary crisis.

The main demand from caregivers was learning stress management tools and a desire for empowerment without psychological support. For information, the support platform set up by the psychiatry service recorded very few calls (39 caregivers from March 24, 2020 to June 26, 2020). Faced with the influx of hypnotherapy requests, the training unit was asked to set up on-site self-hypnosis training.

It seemed important to measure the effect of this learning on the mental health of caregivers using psychometric scales.

This training was initially offered to front-line caregivers in the fight against the covid-19 pandemic and by extension to all caregivers wishing to be trained in this practice.

It is obvious that this pandemic may have worsened a general ill-being of caregivers already present before the current health crisis.

There are many studies on the management of anxiety and pain in patients with a history of chronic disease, and some have focused specifically on learning self-hypnosis techniques. Even if the protocols for learning self-hypnosis techniques are very heterogeneous in these various pathologies, there is a common observation : "studies show positive results on self-esteem, catastrophism, depression, quality of sleep , the somatizations, the anxiety of the patients (and of their parents for the children), mood ".

To date, and to our knowledge, there are no methodologically rigorous studies measuring the effects of hypnosis or self-hypnosis on the mental health of caregivers.

Publications are often limited to clinical cases or positions related to the use of hypnosis and / or self-hypnosis for the well-being of caregivers.

Eligibility Criteria:
Inclusion Criteria:

* Nursing staff of the CHR Metz-Thionville: doctors, nurses or nursing assistants
* Over 18 years old
* Not objecting to participating in the study
* Affiliated to a social security scheme

Exclusion Criteria:

Hospital staff

* Not speaking and/or not understanding the French language.
* Having disorders of higher functions.
* With known history of schizophrenia.
* Deaf or hard of hearing.
* already trained in hypnosis.