cyrilzakka/clinical-trials huggingface dataset:
The Application of Virtual Reality Exposure Versus Relaxation Training in Music Performance Anxiety

The aim of the study is to investigate the effect of exposure treatment using virtual reality (VR) in musicians with performance anxiety compared to a relaxation technique on anxiety symptoms and corresponding cardiovascular parameters. The prospective, randomized clinical trial will include 46 musicians with musical performance anxiety (MPA). The experimental group will receive four exposure sessions in VR and the control group will receive four progressive muscle relaxation (PMR) sessions. Anxiety symptoms will be measured using a german version of the Performance Anxiety Questionnaire and a behavioral assessment test (BAT) before, after the treatment, and at 6-month follow-up. The cardiovascular reactivity will be assessed measuring the heart rate variability (HRV) throughout the BAT and the blood pressure before and after the BAT. Furthermore, blood and saliva samples will be collected before and after the BAT to assess endocrine stress parameters and epigenetic markers. The following hypotheses are derived: 1) Significant and lasting reduction of subjective MPA symptoms for the experimental group receiving VRET at T1 (post/ shortly after treatment) and T2 (follow-up/ 6 months after treatment) compared to T0 (pre/ before treatment). 2) Significant better reduction of subjective MPA symptoms for the experimental group receiving VRET compared to the control group receiving PMR at T1 (post/shortly after treatment) and T2 (follow-up/ 6 months after treatment) compared to T0 (pre/ before treatment). 3) The postulated effects in hypotheses 1 and 2 go along with a significantly higher HRV representing less cardiac stress during the BAT in case of a successful reduction of anxiety symptoms at T1 (post/ shortly after treatment) and T2 (follow-up/ 6 months after treatment) compared to T0 (pre/ before treatment).


Eligibility Criteria:
Inclusion Criteria:

* Music performance anxiety (MPA)

  * Reporting anxiety and/or avoidance of musical performance situations
  * Reporting psychological distress and/or impaired functioning due to the MPA
* Sufficient knowledge of the German language (to understand questionnaires and the therapy manual)
* Compliance with the covid-19-regulations for local study appointments
* Written informed consent

Exclusion Criteria:

* Substance use disorder
* Physiological contraindications for an exposure therapy (i.e. epilepsy, serious disorder of the cardiovascular system)
* Psychological contraindications for an exposure therapy (i.e. psychotic disorder, substance dependence, borderline personality disorder, acute suicidality)
* Use of sedative medication or tranquilizers (i.e. beta-blockers) for the therapy appointments
* Claustrophobia
* Blood-injection-injury type phobia
* Instrument not portable, too big or not playable while standing (i.e. piano, drums, harp, double bass)
* Not able to play the instrument blindfold
* Current psychotherapy because of the MPA
* Recent (\< 6 months ago) psychotherapy because of the MPA
Serum Ghrelin in Polycystic Ovary Syndrome

measuring serum gherlin in polycystic ovary syndrome patients and compare it to healthy levels

two groups one healthy and other with pco measure ghrelin level in both of them to find relation between pco and ghrelin

Eligibility Criteria:
Inclusion Criteria:pco women

* At least 12 months of infertility.
* Patients with polycystic ovarian syndrome according to Rotterdam criteria:

Exclusion Criteria:

* Patients with hyperprolactinemia
* Patients with Cushing's syndrome
* Patients with Congenital or non-classical adrenal hyperplasia
* Patients with hormone secreting tumors.
* Patients with hormonal treatment in the last 3 months.
Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses

This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month dispensing study

The aim of this study is to determine if adapted contact lens wearers enfilcon A toric lenses can be confidently refit into fanfilcon A toric lenses and can be successful after one month of daily wear.

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported eye exam in the last two years
* Is a habitual soft toric lens wearer
* Can be successfully fit with study lenses (≥ grade 2 fit acceptance)
* Has a contact lens spherical prescription between -1.00 to -6.00D with a cylinder between -0.75 and -1.75D (Diopters) (inclusive)
* Has a spectacle cylinder of at least 0.75D in each eye.
* Can achieve best corrected spectacle refraction distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter
* Has a contact lens refraction that fits within the available parameters of the study lenses
* Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so)
* Is willing to comply with the visit schedule.

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; \> 8 hours/day)
* Presents with clinically significant anterior segment abnormalities
* Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear
* Presents with slit lamp findings that would contraindicate contact lens wear such as:

  * Pathological dry eye or associated findings
  * Significant pterygium, pinguecula, or corneal scars within the visual axis
  * Neovascularization \> 0.75 mm in from of the limbus
  * Anterior uveitis or iritis (or history in past year)
  * Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
  * History of corneal ulcers or fungal infections
  * Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea.
* Has presbyopia or has dependence on spectacles for near work over the contact lenses.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.
* Is frequently using rewetting/ lubricating eye drops (more than once per day)
Daily Dystonia Practice - A Trial to Investigate NT 201, the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Cervical Dystonia

The aim of this study is to confirm efficacy and safety of NT 201 (Xeomin®, also known as IncobotulinumtoxinA) after one injection session and to determine the efficacy and safety profile and the duration of treatment effect of NT 201 in long-term treatment with repeated injection sessions.


Eligibility Criteria:
Inclusion Criteria:

* Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - total score at baseline \> / = 25 with TWSTRS - severity score \> / = 10 and TWSTRS - disability score \> / = 3
* Patients must be on a stable dose of other medications
* For pre-treated patients only: Source documentation of the last two consecutive injection sessions with botulinum neurotoxin type A and stable treatment response directly prior to trial entry
* For pre-treated patients only: At least 10 weeks must have passed between the last injection session of botulinum neurotoxin type A for cervical dystonia and the time of the baseline visit.
* For pre-treated patients only: The most recent injection session with botulinum neurotoxin for cervical dystonia must have been at a dose of ≤ 300 units of Botox® or Xeomin®, or ≤ 1,200 units Dysport®.
* Age \> / = 18 and \< 76 years
Characterization of Executive Functions and Patterns of Eye Movements in Children With Developmental Disabilities

The purpose of this study is to characterize the profile of executive functions and eye movements in several populations of children with developmental disabilities.

Abnormal Executive function (EF) profile was considered a major characteristic of Attention deficit / hyperactivity disorder (ADHD) and autism, and is frequently implicated in Developmental coordination disorder (DCD) children as well. The scientific literature implies that the EF profile among these three groups share some common abnormalities, but differ significantly in specific features. Abnormal EF profile may be a core feature of the developmental trajectory of each syndrome.

The fine measurement of eye movements may shed light on the underlying mechanisms of specific disorders, and point to abnormal attention, information processing, or motor organization. Gaze is an important component of social interaction. Eye contact and recognition of other's gaze direction are crucial to empathy assessment.

The current study will embark in the assessment of a wide range of EF in these populations and in a matched control group, as well as their relation to other important parameters such as daily function skills and comorbid neurobehavioral characteristics. It will also assess the pattern of eye movements in response to various visual stimuli in these populations. The main purpose is to characterize the similarities and differences of each of these populations, in terms of EF and eye movements.

Assessment methods:

Clinical parameters:

* Intelligence tests (according to the child's age)
* Communication: DSM-IV, ADOS, Stony Brook questionnaire
* Motor / Coordination: Movement Advanced Battery for Children (M-ABC)
* Attention: Conners Rating Scales - Revised (CRS-R 3rd ed.)
* Sleep: Sleep habits questionnaire

Executive functions will be assessed using the following methods:

* NEPSI-II
* BRIEF questionnaire
* Wisconsin Card Sorting Test
* Tower of Hanoi

Eye movements will be measured using an infra-red video camera produced by ISCAN inc. the following visual stimuli will be presented:

* Human faces presenting various emotions
* Various objects
* Saccade and anti-saccade tasks

Eligibility Criteria:
Inclusion Criteria:

* Age of 4-10 years
* A medical diagnosis according to the relevant study group
* Normal vision without glasses or contact lens.

Exclusion Criteria - clinical groups:

* Intelligence Quotient below 70
* A known brain damage
* A known hearing impairment
* Regular use of medications (except for psychostimulants)
* Evidence for a known genetic syndrome
* History of fetal CMV infection, birth asphyxia, major head injury or epilepsy

Exclusion Criteria - control group:

* Intelligence Quotient below 70
* Regular use of medications
* Evidence for a neurological / psychiatric disorder, birth injury, developmental delay, head injury, or other medical disorders that affect the central nervous system
* Family History - first degree) of autism, DCD, ADHD or other neurological/psychiatric disorder
Students' Hand Hygiene Beliefs, Practices and Skills

ABSTRACT This study was conducted to determine the effect of hand hygiene training given to home patient care students with different methods on their hand hygiene beliefs, practices and skills. This study was a randomized controlled trial. The population of the study consisted of 123 students. After the removals, the study was completed with 75 students in the video, paint and control groups. In the intervention of the study, lecture, discussion, question and answer, demonstration, coloring and video methods were used.

Hand hygiene is the most important strategy to prevent the transmission of microorganisms between patients, healthcare personnel and the healthcare environment. This study was conducted to determine the effect of hand hygiene training given to home patient care students with different methods on their hand hygiene beliefs, practices and skills. This study was a randomized controlled trial. The population of the study consisted of 123 students. After the removals, the study was completed with 75 students in the video (n=25), paint (n=25) and control (n=25) groups. In the intervention of the study, lecture, discussion, question and answer, demonstration, coloring and video methods were used.

Eligibility Criteria:
Inclusion Criteria:

* No previous training in a health field,
* First time students taking the Care Principles and Practices Lecture
* Students who agreed to participate in the study

Exclusion Criteria:

* Previous education in one of the health fields,
* Repeatedly taking the Care Principles and Practices Lecture
* Students who refused to participate in the study
A Registered Cohort Study on Duchenne Muscular Dystrophy

Dystrophinopathy is a term of X-linked recessive genetic disease, including Duchenne Muscular Dystrophy, Becker Muscular Dystrophy, and the X-linked dilated cardiomyopathy. The aim of this study is to determine the clinical spectrum and natural progression of dystrophinopathy in a prospective multicenter natural history study, to assess the clinical, genetic of patients with dystrophinopathy to optimize clinical management.


Eligibility Criteria:
Inclusion Criteria:

* Beyond 2 years old
* Diagnosis with Duchenne Muscular Dystrophy, and female carriers, genotypically confirmed
* Diagnosis should be supported by muscle biopsy, if no genetic confirmation.

Exclusion Criteria:

* Presence of other clinically significant illness
Impact of Marking Surgical Incision on Patient's Abdomen

This is a study looking at patient's satisfaction with incision site and location after undergoing minimally invasive gynecologic surgery. (Laparoscopy) The study group will have the anticipated incision marked with a washable marker on their abdomen. The control group will have preoperative counselling as usual. After surgery, will assess patient's satisfaction with the incision scar.

This study is a prospective, randomized controlled trial examining the impact of marking the patient abdomen at the time of the preoperative visit on patient's satisfaction with scar appearance and symptoms, and pain at the incision site after undergoing minimally invasive gynecologic surgery for benign conditions.

We hypothesize that preoperative marking and instruction about incision expectations will improve patient's postoperative satisfaction with scar appearance and symptoms as well as decrease incision site pain compared to traditional preoperative counseling.

Patients that will undergo laparoscopic surgical intervention will be identified. The patient will be randomized into two groups: preoperative marking the abdomen versus conventional preoperative counseling.

If the patient is randomized to the marking the abdomen group (study group) she will then have the anticipated incision needed to place the trocars during her surgery marked on her abdomen by the surgeon attending physician involved in the patient care during the preoperative counseling visit. If she is randomized to the control group, then she will undergo traditional preoperative counseling by the same team without marking the abdomen.

After completed the surgery, information regarding type of surgery, reason for the procedure, estimated blood loss, surgical length, complications, location and size of abdominal incisions made on the patient's abdomen will be collected. Then at the 6 weeks post op visit, patient's satisfaction with the incision scar will be evaluated with a validated patient scar assessment questionnaire form and by one 5 point Likert scale question used in previous studies. The pain at rest at the incision site will be evaluated by a Visual Analog Pain Scale (VAS). Patients will also be asked to evaluate their generalized pain using a modified McGill Present Pain Intensity Scale.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 89
2. Diagnosed with a benign surgical pathology
3. Patient scheduled for elective minimally invasive gynecologic surgery

Exclusion Criteria:

1. Have a diagnosis of gynecologic cancer
2. History of prior laparoscopic surgery
3. Emergency surgery
4. Inability to provide informed consent
5. Unable to follow up in the office for post operative visits
6. Skin hypersensitivity or allergy to marker dye
7. Positive pregnancy test
Resistance Training as an Aid to Smoking Cessation Treatment

The purpose of this study is to determine whether resistance training can aid smoking cessation.


Eligibility Criteria:
Inclusion Criteria:

Age 18 or older, smoke five or more cigarettes a day for at least the past 12 months

Exclusion Criteria:

Participating in any type of exercise for \>60 minutes/week over the past 3 months, current smokeless tobacco use, participation in an ongoing effort to quit smoking, current or planned pregnancy, any serious medical condition that would make exercise unsafe
Confirmatory Study of PRGN-2012 in Patients with RRP

The purpose of this confirmatory study is to provide further demonstration of the efficacy of PRGN-2012 for the treatment of RRP in adults.

This is a single-arm, open-label confirmatory study of PRGN-2012 in RRP patients with a history of repeated surgical debulking for the management of their disease. Patients will be treated with PRGN-2012 and followed for at least 12 months to evaluate for efficacy and safety endpoints.

Eligibility Criteria:
Key Inclusion Criteria:

* Age 18 years and older
* Clinical diagnosis of RRP requiring surgical intervention
* Performance status of ECOG of 0-1
* Sexually active participants (men and women) of reproductive potential must agree to use contraception.
* All participants must have the ability to understand and willingness to sign a written informed consent

Key Exclusion Criteria:

* Severe acute or chronic medical or psychiatric conditions that, in the opinion of the investigators, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results and in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Participants receiving any prohibited medications including immunosuppressive medications and other treatments for RRP.
* Participants who had received any other investigational agents within the past 30 days.
* Pregnant women are excluded from this study
Whole-body Electrostimulation on Functional Mobility and Quality of Life in the Elderly

Elderly people experience reduced strength, mass and muscle function throughout the aging process, and this negatively affects the functionality and quality of life of these individuals. A randomized clinical trial will be carried out with 30 volunteers who will be allocated into two groups (whole-body electrical stimulation or control). Whole-body electrical stimulation (WBS) sessions will take place twice a week, for 8 weeks, totaling 16 sessions. The primary outcomes of this study are functional mobility (Timed Up and Go test) and quality of life (EQ-5D questionnaire). Functional mobility will be assessed at baseline, after 4 and 8 weeks of treatment or follow-up. Quality of life will be assessed only at the beginning and end of 8 weeks.

Elderly people experience reduced strength, mass and muscle function throughout the aging process, and this negatively affects the functionality and quality of life of these individuals. Rehabilitation strategies similar to conventional exercise that minimize the damage caused by aging and improve subjects' adherence need to be studied. A randomized clinical trial will be carried out with 30 volunteers who will be allocated into two groups (whole-body electrical stimulation or control). Whole-body electrical stimulation (WBS) sessions will take place twice a week, for 8 weeks, totaling 16 sessions. Simultaneously with the WBS, the elderly will perform exercises for the upper, lower limbs and trunk. The following assessments will be carried out at baseline and 8 weeks to verify the effect of therapy: assessment of functional mobility; quality of life (EQ-5D); isometric muscle strength of the quadriceps muscles, biceps brachii and handgrip strength; lower limb muscle strength; assessment of body composition; assessment of cellular senescence; the inflammatory profile; well-being; measurement of muscle damage and pain; assessment of therapy safety and assessment of sleep quality. Assessments of functional mobility, lower limb muscle strength, cellular senescence; the inflammatory profile; well-being; and muscle damage will also be carried out in 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Elderly people aged between 60 and 85 years;
* Both sexes;
* To have the ability to walk.

Exclusion Criteria:

* Cognitive dysfunction;
* Intolerance to electrical stimulator and/or changes in skin sensitivity;
* Skin injuries or burns where the electrodes are positioned;
* Sequelae of stroke;
* Recent acute myocardial infarction;
* Uncontrolled hypertension;
* Grade IV heart failure or decompensated;
* Unstable angina or arrhythmia;
* Peripheral vascular changes in the lower limbs such as venous thrombosis deep;
* Disabling osteoarticular or musculoskeletal disease;
* Uncontrolled diabetes;
* Cancer;
* Autoimmune disease;
* Pacemaker;
* Epilepsy;
* Hemophilia;
* Chronic obstructive pulmonary disease;
* Liver and kidney diseases;
* Grade II obesity (BMI≥35).
Safety and Immunogenicity Study of SCB-1019T in Children

This phase 1 study in Australia will evaluate the safety, reactogenicity and immunogenicity of the Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) in children 2-\<6 years of age.

This Phase 1 randomized, placebo-controlled, observer-blind study will evaluate the safety, reactogenicity and immunogenicity of different formulations of SCB-1019T vaccine in children 2-\<6 years of age. A placebo is used as a control in the study because there is no licensed RSV comparator vaccine available for young children globally.

Eligibility Criteria:
Inclusion Criteria:

• Male and female participants 2 to \<6 years of age at Visit 1. • Parents/guardians of participants willing and able to provide written informed consent and comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures. • Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator.

For full inclusion criteria, please refer to full protocol.

Exclusion Criteria:

* Acute disease or fever (≥38°C) at time of vaccination. For participants with minor illness and/or fever at the time of vaccination, Visit 1 may be rescheduled.
* Evidence of chronic diseases including hepatitis, bleeding disorders, metabolic diseases, autoimmune diseases, neurological conditions that impair respiratory functions, genetic disorders that increase the risk of severe respiratory diseases, major congenital malformations, cardiac and lung diseases or reactive airway diseases.

For full Exclusion criteria, please refer to full protocol