cyrilzakka/clinical-trials huggingface dataset:
Effects of Low-level Mechanical Vibration on Bone Density in Ambulant Children Affected by Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD) is a X-linked recessive disorder due to a mutation of the dystrophin gene (Xp21). Dystrophin is a sarcolemmal protein of skeletal and cardiac muscle, and its absence causes progressive muscle degeneration and substitution with fat and connective tissue. The progressive muscle degeneration leads to loss of autonomous walking before the age of 15 years and death for cardiac and/or respiratory failure. There are no specific treatment for DMD, and the standard of care is now based on long-term corticosteroid (CS) use. The studies on bone mass in DMD are very few, but they agree in reporting the presence of a reduced bone mass and an increased rate of fractures probably due to long-term steroid therapy and disuse-osteopenia. The aim of this study, involving 20 ambulant DMD boys (age 7-10 years) has been the evaluation of the effects of low-level mechanical vibrations on bone in a group of ambulant DMD children for 1 year, with RDA-adjusted dietary calcium intake and 25OH vitamin D supplementation.

All children were instructed to have a daily intake of calcium equal to the 100% of the RDA and were supplemented with calcifediol (0.7 mcg/kg/die).

The 20 boys were randomly assigned to two groups:

group 1 (mechanical intervention group) = a mechanical device (a small platform designed to induce vertical, sinusoidal acceleration) was installed in the home of each boy of group 1.

group 2 (placebo control group) = a placebo device was installed in the home of each boy of group 2

All boys were instructed to stand on the platform for 10 minutes each day for 12 months.

Compliance was followed and stimulated through weekly telephone contacts with parents and children.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DMD
* Ability to stand up and walk (some balance assistance allowed, but full weight-bearing necessary)
* All the children must already be on glucocorticoid therapy for at least 6 months before the start of the study.

Exclusion Criteria:

* Presence of other diseases interfering with bone density and bone turnover
* The inability to regularly use the vibratory platform.
EEG Responses to Arabic Music Scales

Recent studies showed that various factors can contribute to the efficiency of a music therapy such as the type of music used, the type of instrument, the ethnicity, musical preference of the subjects and many others. Investigators noticed that most of studies and clinical trials, while acknowledging the importance of ethnicity and musical preferences, use the Western Music type in their investigations and practice. While in the Middle East, Music Therapy played a tremendous role in the 10th century since the "scales theory" of the famous Scientists El Farabi and Avicenna, very little countries of the Middle East are investing in scientific studies using Arabic Music as a therapeutic tool. This study will be an electroencephalogram (EEG)-based investigation on correlations of multiple factors that can influence the cortical responses of the subject to the music and self-reported state of emotion and anxiety.

This is the first clinical study involving Music in Qatar and the Gulf region, and the first study to explore Arab Music Scales using a combination of EEG and self-reported assessements.

Using EEG, investigators will analyze the full brain activity of brainwaves produced by up to 100 subjects in response to the audio musical stimuli. 24 different audio recordings have been designed to investigate on different acoustic cues:

* with versus without quartertones
* known music versus improvisation
* Maqam Saba (sad) versus maqam Kurd (happy)
* 3 different Middle Eastern instruments: Ney, Oud and Qanun
* Two pitches: from Re or from Sol

The presentation of the audio stimuli clips will be randomized by the SuperLab5 software and EEG brainwaves will be recorded using the Power Lab (AD instrument). Between every audio clip, recording will be paused to ask the subjects to self-report on their emotional and anxiety states using a self-evaluation questionnaire. Subjects will be randomly assigned to morning of afternoon sessions of recording.

Using bioinformatic tools, investigators will perform a correlation study between EEG results, emotional self-report from the PANAS-X questionnaire, as well as answers to another questionnaire asking for their age, gender, ethnicity, right or left handedness, musical preferences, and if the subject plays an instrument.

The outcomes will have direct applications on the development of personalized Music Therapy in the region for treatment and management of mental health conditions, neurodegenerative diseases and other conditions that are of high prevalence in the region.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 years old to or above (might include pregnant women)
2. Living in Qatar
3. Understand either English or arabic

Exclusion Criteria:

1. Individuals not meeting the inclusion criteria
2. Individuals with auditory impairments
3. Individuals with any known neurological condition (including epilepsy, Alzheimer, Parkinson, Autism etc)
4. Individuals not able to come to the site (WCMQ).
5. Adults not able to consent
Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media

The purpose of this study is to evaluate the Safety and Reduction of Ear Pain in Adults with Acute Otitis Media.


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

1. AOM diagnosis with moderate to severe bulging of the TM and recent (\< 48 hours \[h\]) onset of ear pain.
2. Moderate to severe ear pain in the affected ear(s), defined as a score of ≥ 5 (on a scale of 0 10) on the NRS 11 as evaluated by the subject at Screening.
3. Generally good health (other than AOM) as determined by evaluation of medical history and physical examination at Screening.
4. Negative urine pregnancy test at Screening for all female subjects of childbearing potential.
5. Able to read and sign written informed consent prior to study participation.

Exclusion Criteria includes but is not limited to:

1. Presence of a perforated TM at Screening or had a perforated TM within 6 months (mo) prior to Screening as determined by medical history
2. Subjects with tympanostomy tubes
3. Acute or chronic otitis externa
4. Chronic otitis media defined as confirmed presence of middle ear effusion for 12 weeks or longer
5. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg, cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
6. Clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment
7. Permanent hearing loss irrespective of otitis media
8. Subjects with medical conditions that may affect interpretation of the safety or efficacy of study drug as determined by the investigator's medical judgment
9. Subjects with craniofacial abnormalities (eg, cleft palate, Down's Syndrome)
10. Subjects with erythema of the TM without other evidence of otitis media
11. Seborrheic dermatitis involving the affected external ear canal or pinna
12. Use of medications with known vasoconstrictive properties (eg, decongestants \[Afrin®, Sudafed®\]) currently or within 2 h prior to Screening
13. Use of oral analgesics \< 2 h prior to Screening or Baseline (oral analgesics \> 2 h are permitted as long as ear pain criteria are met per Inclusion Criteria)
Cardiac Injury and Anaemia Following Surgery for Fractured Neck of Femur: An Observational Study Study Protocol: Cardiac Injury and Anaemia Following Surgery for Fractured Neck of Femur

Blood transfusion is an expensive and finite resource and optimum transfusion threshold in surgical patients is yet to be defined. Patients commonly receive blood transfusions to reduce the risk of myocardial ischaemia or improve perfusion of other organs (e.g. the kidneys), but this treatment may have important adverse effects including postoperative infection. Patients undergoing surgery for fractured neck of femur are often elderly, with co-morbidities and a high risk of postoperative complications, including MI and AKI. We propose to conduct a study with the following aims:

1. To describe the incidence of anaemia and transfusion in patients undergoing surgery for fractured neck of femur.
2. To use clinical and biochemical data to measure the incidence of perioperative cardiac and kidney injury in this group.
3. To evaluate highly sensitive serum troponin and urinary MALDI-MS as possible endpoints in a future prospective randomised trial of perioperative transfusion.

Blood transfusion is an expensive and finite resource and optimum transfusion threshold in surgical patients is yet to be defined. Patients commonly receive blood transfusions to reduce the risk of myocardial ischaemia or improve perfusion of other organs (e.g. the kidneys), but this treatment may have important adverse effects including postoperative infection. There is great interest in restrictive transfusion practices (e.g. a transfusion trigger of 70 g L-1), however patients with co-existing cardiovascular disease have been excluded from studies of restrictive versus liberal transfusion strategies. Highly sensitive troponin assays are now available, which allow clinicians to reliably detect cardiac injury in increased numbers of patients who have undergone major surgery. Troponin release after surgery is common, as high as 40% in some studies. Patients undergoing surgery for fractured neck of femur are often elderly, with co-morbidities and a high risk of postoperative complications, including MI and AKI. We propose to conduct a study with the following aims:

1. To describe the incidence of anaemia and transfusion in patients undergoing surgery for fractured neck of femur.
2. To use clinical and biochemical data to measure the incidence of perioperative cardiac and kidney injury in this group.
3. To evaluate highly sensitive serum troponin and urinary MALDI-MS as possible endpoints in a future prospective randomised trial of perioperative transfusion.

Eligibility Criteria:
Inclusion Criteria:

* Fractured Neck of Femur
* Age \>50
* Informed consent

Exclusion Criteria:

* refusal of consent
Video Feedback Intervention in Nursing Home Residents With Dementia and Severe Challenging Behavior.

The purpose of this study is to evaluate how, under what circumstances and for whom the video feedback intervention works for (the caregivers of) people with dementia and severe challenging behavior in a nursing home setting.

This mixed multiple case study focuses on the evaluation of a video feedback intervention for (the caregivers of) people with dementia and challenging behavior. The video feedback intervention focuses on understanding the person with dementia, increasing the sense of competence in caregivers and improving their communication skills when interacting with the person with dementia. This realist evaluation aims to investigate what outcomes the intervention generates, for whom and in which contexts. Participants will receive care as usual.

Eligibility Criteria:
Inclusion Criteria:

* Nursing home resident
* Dementia
* Severe challenging behavior
* Video feedback intervention is started by health care professionals as part of usual care

Exclusion Criteria:

* N/A
Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia

Fear of the dentist is a very common phenomenon which delays consultations and brings negative consequences on oral and general health. Virtual reality (VR) reduces children's pain and anxiety during dental care or oral surgery. The aim of this prospective, randomized and controlled study is to show the effectiveness of virtual reality to reduce anxiety in a sample of adults during tooth avulsions under local anesthesia. There is a group with virtual reality and a control group without virtual reality.

Patients complet the State Trait Anxiety Inventory - State - (STAI-YA) questionnaire and the visual analog anxiety scale (VAS) just before and just after the surgery by transcribing the anxiety they feel during it. The main judgement criterion is the evolution of the STAI-YA score before vs during the surgery. Secondary criteria are the relevance of the chosen metric by comparing it to the VAS, defining the factors influencing the evolution of the anxiety score, studying the side effects of VR and the wish to repeat the experience.

The virtual reality experience consisted of putting on a headset with music and a 3D helmet on the eyes that broadcast a landscape in motion (a walk).

The inclusion took place in the University Hospital of Caen between november 2021 and may 2022.

119 patients were randomized into two groups, one with VR and another one without VR. At the end, 105 patients were analyzed.

The main objective was to find a reduction in the STAI-YA score of more than 8 points between before and during the intervention. This analysis was performed in both groups.

During the initial consultation, questions were asked about the medical file and informed consent was sought. Patients were then randomised to one of two groups.

During the second consultation, a STAI-YA questionnaire and a VAS scale were completed, then the intervention was performed with or without virtual reality, depending on the group, and the STAI-YA questionnaire and the VAS scale were again completed by recalling the stress experienced during the surgery.

Eligibility Criteria:
Inclusion Criteria:

- Adults (\> 18 years old) coming for at least two dental extractions under local anesthesia

Exclusion Criteria:

* patients suffering of motion sickness,
* claustrophobia,
* uncontrolled epilepsy,
* visual impairment,
* hearing disability,
* non-French speakers,
* pregnant women,
* protected adults
* people followed by a psychiatrist whether for depression, bipolarity, schizophrenia
* The day of the intervention, patients who had consumed anxiolytics
HRQoL and Function of Adults Treated in Adolescence for Scoliosis With Physical Exercises

We attempt to investigate the influence of physiotherapy and physical activity education applied in adolescence on physical fitness, curve progression, pulmonary function, physical activity and quality of life in adulthood. Quality of life assessment includes mental and social functioning, body image, self - esteem, depression and anxiety surveillance. The follow - up period ranges from 15 to 26 years. Also a group of shorter follow - up of 9 - 13 years is available.

The null hypothesis is that scoliosis specific exercise program applied in adolescence does not influence HRQoL and functioning in adulthood.

Among conservative treatment approaches of adolescent idiopathic scoliosis (AIS), different physiotherapy methods are recommended and popular in some countries (Spain, Germany, Poland), while in others bracing and observation are standard (North America, Australia, the UK, Scandinavia. Neither of the methods have been shown to be definitely effective. Considerable evidence indicates that bracing can lead to psychological stress, poorer body image and self - esteem and reduce overall quality of life in adulthood. As to physiotherapy and physical exercises, such evidence is limited, especially long term follow up studies are not available.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of scoliosis in adolescence
* participation in exercise program in the Centre of Compensatory Gymnastics in Bielsko-Biala in adolescence
* medical records available

Exclusion Criteria:

* contraindications for pulmonary and / or exercise tests
* psychiatric disorders
* recent trauma
* recent traumatic (emotional) event
* contraindications for x-ray exposure
Standard Versus Oesophago-gastric Junction Complex Myotomy for Treatment naïve Type 2 Achalasia Patients

- Consecutive eligible patients will be randomized in a 1:1 ratio to esophagogastric complex only myotomy or standard myotomy groups. Randomization is done according to the computer-generated algorithm. A clinical research coordinator will prepare the sealed randomization envelops and will hand over to the operating endoscopists before the beginning of the procedure. Written informed consent will be obtained from all participants. In this study, the participants and the care-provider assessing the clinical response to the POEM procedure at 3months will be blinded to the allocation.

. Primary objective -

• To study the incidence of true reflux on 24 hour pH analysis with manual study.

Secondary objective -

* To analyse treatment success which is defined as Eckdart score \< 3 at follow up assessment ( 3rd month)
* To analyse the recovery of peristalsis after POEM using High resolution manometry
* To study total procedure time , intra operative adverse effects and duration of hospital stay.
* Severity of oesophagitis
* Presence of GERD symptoms based on GERD questionnaire \& Quality of life questionaire post procedure.

Eligibility Criteria:
Inclusion Criteria:

* Adult \>18 years
* Diagnosis of Type 2 Achalasia cardia based on High resolution manometry.

Exclusion Criteria:

* Patients with Type 1 \& 3 ACHALASIA CARDIA
* Patients with previous endoscopic or surgical treatment for achalasia
* Patients with standard exclusion criteria for POEM procedure such as contraindication to general anesthesia, coagulopathy (international normalized ratio \> 1.5, platelet count \< 50 000/μL), portal hypertension, pregnancy, breast feeding women, and diffuse scarring in the esophagus due to previous surgery or radiation.
The Effect of Esomeprazole and Fundoplication on Airways

Evaluate the prevalence of bronchial responsiveness (BHR) among patients with gastroesophageal reflux disease (GERD).

Investigate correlation between bronchial reactivity and the severity of GERD, and similarly investigate the correlation between exhaled nitric oxide (NO) and the severity of GERD.

Compare the effects of esomeprazole 40 mg twice daily and Nissen fundoplication on bronchial reactivity, exhaled NO, pulmonary function and quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Over 18 of age
2. Diagnosis of gastroesophageal reflux disease
3. Compliance to perform methacholine inhalation challenge (judged by the investigator)

Exclusion Criteria:

1. Known allergy to esomeprazole or any other PPI
2. Use of systemic corticosteroids within 3 weeks before any study visit
3. Pregnancy (in a written informed consent patients are asked to assure that they are not pregnant and they are also told to immediately stop the study medication if they become pregnant during the study)
4. Incapability to keep a 3-week washout with usual antireflux medication prior to the first visit
5. Regular use of PPI or H2-RA medication 3 months after fundoplication
Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis

The objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU).


Eligibility Criteria:
Inclusion Criteria:

* Have characteristics of Behcet's disease consistent with International Criteria for Behcet's disease
* Have a documented history of active uveitis with or without retinal vasculitis within the past 12 months
* Best corrected visual acuity (BCVA) \>= 20 ETDRS letters in both eyes at baseline
* Effective contraceptive measures

Exclusion Criteria:

* Infectious uveitis and masquerade syndromes
* End stage ocular disease
* History of allergic or anaphylactic reactions to monoclonal antibodies
* Active tuberculosis disease
* History of recurrent infection or predisposition to infection; active ocular infection
* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply
Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder

To evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have OAB syndrome (urgency, with or without urge incontinence, usually with frequency and nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin succinate due to lack of sufficient improvement in urgency episodes


Eligibility Criteria:
Inclusion Criteria:

* Patients with OAB who have been treated with tolterodine tartrate extended release for at least 4 weeks immediately preceding entry into the study, and wish to switch to solifenacin succinate due to lack of sufficient improvement in urgency episodes.
* Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to Screening and is continued throughout the study.
* At least 3 urinary urgency episodes/24 hours while receiving tolterodine tartrate extended release documented in a 3-day patient diary in the pre-washout assessments on tolterodine tartrate extended release with or without urge incontinence described as OAB syndrome.
* Prior to treatment with tolterodine tartrate extended release, patients must have had OAB syndrome for 3 or more months.

Exclusion Criteria:

* Previous treatment with darifenacin
* Treatment with tolterodine tartrate extended release for less than 4 weeks prior to enrollment in the study.
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator.
* Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones.
* Clinically significant outflow obstruction as determined by the Investigator
* Uncontrolled narrow angle glaucoma, urinary or gastric retention.
* All patients with severe renal or hepatic impairment will be excluded
* Patients with chronic severe constipation or history of diagnosed gastrointestinal obstructive disease.