cyrilzakka/clinical-trials huggingface dataset:
Effect of Life Kinetik Training on Lower Limb Coordination in Ataxic Patients

Coordination is essential for the performance of most daily motor activities. Coordination problems are common in MS patients. One of the most commonly reported symptoms is dysmetria (limb ataxia). Ataxia is thought to occur in about 80% of MS patients. It leads to limitations in daily life activities. Aim of Study: to investigate the effect of life kinetik training on lower limb coordination in MS patients with ataxia.

Methods: Thirty remitting relapsing Multiple Sclerosis (RRMS) patients from both sexes with ataxic symptoms, will be recruited from multiple sclerosis specialized clinic in the Neurology department, Faculty of Medicine, Cairo University with EDSS score will be ranged from 2 to 4 and SARA score will be ranged from 1 to 10. Lower Extremity Motor Coordination Test (LEMOCOT) will be used to assess lower limb motor coordination. They will be randomly assigned into two equal groups; control group (GI) will receive selected physical therapy program and study group (GII) will receive same program of (GI) in addition to life kinetik training.

Eligibility Criteria:
Inclusion Criteria:

* MS from both sexes
* Patients' age will be ranged from 20 to 45 years
* Expanded disability scale (EDSS) score ranging from "two" to "four"

Exclusion Criteria:

* Patients with Ataxia caused by other cause rather than MS
* Patients with other neurological disease or orthopedic deformities may affect movement
* Patients with cardiovascular and pulmonary diseases that make exercise unsafe
* Patients with cognitive impairment or psychiatric disorders
Long COVID Symptoms in SARS-CoV-2-positive Children in China

The goal of this observational study is to learn about in children aged 6-18 years, after the acute phase of SARS-CoV-2 infection, the COVID symptoms or Long COVID symptoms to impact their daily activities. We aimed to investigate the prevalence of long-lasting symptoms, the duration and intensity of symptoms, quality of life, number of sick days or absences from school, and psychological and social outcomes. The participants will be asked to fill in Long COVID symptom burden questionnaires who had been infected with SARS-CoV-2 as self-reported PRC test or antigen test positive.

The goal of this observational study is to learn about in children aged 6-18 years, after the acute phase of SARS-CoV-2 infection, the COVID symptoms or Long COVID symptoms to impact their daily activities. We aimed to investigate the prevalence of long-lasting symptoms, the duration and intensity of symptoms, quality of life, number of sick days or absences from school, and psychological and social outcomes.

The participants will be asked to fill in SBQ-Long COVID symptom burden survey questionnaires who had been infected with SARS-CoV-2 as self-reported PRC test or antigen test positive.

The survey questionnaires will be filled every two weeks after the participants have been tested SARS-CoV-2 positive.

Eligibility Criteria:
Inclusion Criteria:

infected with SARS-CoV-2 as self-reported PRC test or antigen test positive or have symptoms, but without Covid-19 test.

Exclusion Criteria:

aged below 6 years or above 18 years
Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation Phantom Limb Pain

Investigators will evaluate preamputation cryoanalgesia on pain, mobility, opioid use and general physical and emotional disability using a pilot randomized trial design, to explore the amount and variability of improvement on those outcomes and to investigate the potentiality of conducting a future larger randomized controlled trial, which the investigators will assess quantitatively the benefits of cryoanalgesia.

Primary Aim: To determine preoperative cryoneurolysis improves phantom limb pain compared with no cryoneurolysis. Estimate the standard deviation of phantom limb pain score at baseline and post-treatment (Day 0), Days 1 and 2; Weeks 1, 2, 3, and Months 1, 2 and 3. The investigators will consider using the upper limit of the 75% confidence interval to plan the sample size of future larger trial.

Hypothesis 1: Preoperative cryoneurolysis reduces phantom limb pain over 3 month after surgical leg amputation compared with no cryoneurolysis.

Secondary Aim 1: To determine if preoperative cryoneurolysis improves mobility after lower limb amputation compared with no cryoneurolysis.

Hypothesis 1: Preoperative cryoneurolysis improves mobilization (as measured with accelerometer) over 3 the month after surgical leg amputation compared with no cryoneurolysis.

Secondary Aim 2: To determine if preoperative cryoneurolysis improves general physical and emotional disability after lower limb amputation compared with no cryoneurolysis.

Hypothesis 2: Preoperative cryoneurolysis reduces general physical and emotional disability (as measured with the World Health Organization Disability Assessment) over the 3 month after surgical leg amputation compared with no cryoneurolysis.

Secondary Aim 3: To determine if preoperative cryoneurolysis decreases opioid use after lower limb amputation compared with no cryoneurolysis.

Hypothesis 3: Preoperative cryoneurolysis reduces opioid consumption over the 3 month after surgical leg amputation compared with no cryoneurolysis.

Exploratory Aims:

Hypothesis 1: Preoperative cryoneurolysis reduces residual limb pain over the 3 months after surgical leg amputation compared with no cryoneurolysis.

Eligibility Criteria:
Inclusion Criteria:

* Adults at least 18 years of age.
* Scheduled for a unilateral lower limb amputation distal to the femoral head and including at least one metatarsal bone.

Exclusion Criteria:

* Pregnancy
* Incarceration
* Morbid obesity (body mass index greater than 40 kg/m2
* Contraindication specific to cryoneurolysis such as a localized infection at the treatment site, cryoglobulinemia, cold urticaria, or Reynaud's syndrome.
* Investigator opinion that the potential subject is a poor candidate for this trial.
PET MRI in Coronary Artery Disease

This study will assess the use of position emission tomography/magnetic resonance imaging (PET/MRI) using ultra-small-superparamagnetic particles of iron oxide (USPIO) as a contrast agent in patients with coronary artery disease.

Positron emission tomography/magnetic resonance imaging (PET/MRI) has the potential to provide detailed information on coronary artery anatomy, the presence of coronary artery stenosis, the composition of atherosclerotic plaque using MRI tissue characterisation and information about the underlying biological processes using targeted PET tracers. Ultra-small-superparamagnetic particles of iron oxide (USPIO) have a long blood pool half-life so are an ideal contrast agent for PET/MRI imaging.

This study will assess the use of PET/MRI with USPIO in patients with stable coronary artery disease and recent acute myocardial infarction.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers to undergo MRI imaging will be over the age of 18 years and able to provide informed consent.
* Patients with coronary artery disease to undergo PET/MRI will have multi-vessel disease (≥2 vessel coronary artery disease with ≥ 50% cross-sectional luminal stenosis).
* able to provide informed consent
* over the age of 40 years

Exclusion Criteria:

* inability or unwillingness to undergo magnetic resonance imaging or positron emission tomography
* renal failure (Serum creatinine \>200 umol/L or estimated glomerular filtration rate \<30 mL/min
* hepatic failure
* pregnancy
* inability to provide informed consent
* contraindications to undergoing MRI scanning
* contraindications to contrast agents not included above including evidence of iron overload, known allergy to constituents of the contrast agents, and anaemia not caused by iron deficiency
Effectiveness of an Ultrasonic Denture Hygiene Intervention Program Among Community-dwelling Elders

Objectives: The objective of this study was to assess prospectively the effectiveness of ultrasonic denture hygiene interventions in improving denture cleanliness among community-dwelling elders. Methods: A randomized clinical trial was conducted among community-dwelling elders, in which a total of 66 subjects who received upper metal framework removable partial dentures in the past five years were recruited randomly from a computerized database. They were randomly allocated into three denture hygiene intervention groups: group 1 (mechanical cleaning with a toothbrush and ultrasonic cleaning with cetylpyridinium chloride mouthrinse), group 2 (mechanical cleaning with a toothbrush and ultrasonic cleaning with distilled water) and control (mechanical cleaning with a toothbrush only). Denture cleanliness was assessed at baseline and one month review using: i) Denture Cleanliness Index (DCI) scores; ii) plaque coverage percentage; and (iii) microbiological tests. Results: There were significantly greater reductions in mean DCI scores and mean percentage of plaque coverage area in group 1 and group 2 compared to the control group for both CoCr and acrylic fitting surfaces (p\<0.001). Group 1 had significant reductions in the viable counts of bacteria (CoCr and acrylic) and yeast (CoCr only) (p\<0.05), while only significant reductions in bacterial viable counts (CoCr and acrylic) (p\<0.05) were documented in Group 2. No significant differences were detected between groups 1 and 2 with regards to all clinical and microbiological outcomes. When comparing these parameters for CoCr and acrylic surfaces, no significant differences were observed following the intervention period. Conclusions: The ultrasonic cleaner was significantly more effective than the control in the reduction of biofilm coverage on metal framework removable partial dentures during the one month intervention period. The adjunctive use of cetylpyridinium chloride with ultrasonic cleaning did not yield improved outcomes compared to water.


Eligibility Criteria:
Inclusion Criteria:

* previously provided with cobalt chromium metal framework removable partial dentures (RPDs) within the past five years at Prince Philip Dental Hospital

Exclusion Criteria:

-
Treatment Resistant Depression and Obstructive Sleep Apnea, Effect of Continuous Positive Airway Pressure (CPAP)

The purpose of the study is to determine the effect on mood and anxiety symptoms of adding CPAP to the psychiatric treatment of patients with TRD (treatment resistant depression) and associated OSA (obstructive sleep apnea).

Primary objective:

What is the effect on mood and anxiety symptoms of adding CPAP to the psychiatric treatment of patients with TRD and associated OSA?

Secondary objectives:

1. How common is co-morbid OSA in patients with treatment resistant unipolar depression referred to a tertiary Mood Disorders Clinic?
2. Is there a difference in daytime functioning (severity of depressive and anxiety symptoms, cognitive function, daytime sleepiness) and sleep quality between patients with TRD diagnosed with OSA compared with patients with TRD who have no OSA?
3. What is the association between sleep fragmentation and hypoxemia and the severity of depression in patients with TRD?

Eligibility Criteria:
Inclusion Criteria:

* Patients with TRD.
* Males and females between the ages of 18 and 65 years who agree to take part and sign the Informed Consent will be invited to participate in the study.
* Patients with co-morbid Dysthymic Disorder, Generalized Anxiety Disorder or Social Anxiety Disorder may be included in the study.

Exclusion Criteria:

* Patients with uncontrolled medical illnesses will not be permitted to participate.
* Patients with a history of current or Bipolar Disorder, Schizophrenia, Panic Disorder, Obsessive-Compulsive Disorder or Anorexia Nervosa.
* Head injury patients resulting in loss of consciousness for more than 10 minutes.
* Patients with epilepsy or severe personality disorders who, at the judgment of the investigators, are not appropriate candidates for the study, will be excluded.
* Patients who do not have the mental or physical capacity to apply the CPAP interface and to plug in and switch on an auto CPAP unit at home will be excluded.
* Blind and/or deaf patients will be excluded.
* Patients who initially decline an offer of CPAP treatment for OSA, and those who prefer conservative treatment options (weight loss, avoidance of alcohol and sedatives) will be excluded.
* Patients with severe claustrophobia, who cannot tolerate any CPAP interface, will be excluded.
The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux

The purpose of this study is to investigate the relationship between ear fullness, pressure, and/or pain and laryngopharyngeal reflux, in order to focus medical therapy and improve therapeutic outcomes in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* They complain of symptoms of ear fullness, ear pain, and/or ear pressure, either unilateral or bilateral
* They are willing to participate in the study.
* They are between the ages of 18 to 80

Exclusion Criteria:

* They have had major ear surgery (not including tympanostomy tubes)
* They have a medical condition that is another possible etiology of ear pain or acid reflux and may require additional medical or surgical intervention such as: Acute or chronic otitis externa, Chronic otitis media, Temporomandibular joint dysfunction, Upper aerodigestive track neoplasm, History of head/neck radiation therapy.
* They are pregnant. Proton pump inhibitors are a Category C drug with unknown pregnancy risks.
* They do not wish to participate in the study
* They are \<18 or \>80.
Virtual Reality to Reduce Labor Pain

Background and Goal of Study Labor pain remains an area where different analgesia options are looked for, more specifically non-pharmacological remedies are popular. Hypnosis and virtual reality (VR) have been studied with encouraging results. However, until now, the combination of VR and hypnosis (VRH) has not been assessed during labor, although it has shown promising results in other acute pain areas. The VRH4L study will evaluate the efficacy of Virtual Reality Hypnosis (VRH) in reducing pain during labor. Hypnosis is delivered as a standardized therapeutic intervention through virtual reality, using a digital sedation software (AQUA ®, Oncomfort SA).

For this prospective, interventional parallel group, monocentric randomized controlled trial full term women who were planned for an induction of labor at the St-Jean Hospital in Brussels from March to May 2021 were included. Women with complicated pregnancies and patients with contraindications to VR were excluded.

Patients were randomized in two arms. In the VRH group the patients received a 30-minute session of virtual reality hypnosis when in active labor and had access to standard care. Patients in the control group received only standard care.

Primary outcome was the difference in post intervention pain score between the two arms. Secondary outcomes were the difference in pain score 30 minutes after the intervention, vital signs correlated to pain, satisfaction of the experience, interaction with the midwife and prevalence of side effects. Data was analyzed using the student's T test.


Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥ 18 and ≤ 45 years
2. Pregnant with term gestation
3. Willing to adhere to the rules linked to the use of the VRH headset: turning off mobile phone, visit bathroom in advance, no new visitors and no interference of the partner other than when the woman would ask him so
4. Provision of written informed consent
5. Induced labor

Exclusion Criteria:

1. Complicated pregnancy ( HELLP,...)
2. Scheduled caesarian delivery
3. Receipt of epidural analgesia or opioid painkillers before start active labor phase
4. Low auditory acuity that precludes use of the device
5. Low visual acuity that precludes use of the device
6. Head or face wounds precluding use of the device
7. Schizophrenia
8. Epilepsy
9. Dizziness
10. Non-proficiency in French and/or Dutch (research language)
Assessement of the Peal Force Needed to Peel New Adhesives From the Skin

This study investigates the adhesion of new adhesives to the skin.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have intact skin on the area used in the investigation

Exclusion Criteria:

1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
2. Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Have dermatological problems in the abdominal area (assessed by investigator)
Preventive Physical Activity Intervention in Head and Neck Cancer

The study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+/- chemotherapy). The patients will be randomized into either an intervention group (performing a preventive physical activity protocol before and during radiotherapy) or a control group not performing a specified physical exercise protocol. All patients will be in contact with with a speech language pathologist or a physical therapist weekly during radiotherapy. The study is expected to improve physical function and quality of life during and after oncologic treatment


Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx)
* Receiving radiohterapy (+/- chemotherapy) with curative intent

Exclusion Criteria:

* Surgery due to head and neck cancer
* Previous treatment for head and neck cancer
* Tracheostomized patients
* Inability to perform exercise intervention
* Inability to perform part of 6-minute walking test
* Inability to independently fill out questionnaires in Swedish
* Previous neurologic or neuromuscular disease
Functional Neuroanatomy and Regional Metabolism Before and After Treatment With Duloxetine

The findings may guide future investigations on novel therapeutic targets in depressive subjects. Based on the depicted link between personality traits and altered brain metabolism and function, the latter might be used as supporting objective measures and possible biomarkers for increased depression risk.

Interoceptive awareness (IA) is the awareness of bodily signals and has been highlighted as important in many early theories of emotion. William James was one of the first to present a psychological theory linking viscero-afferent feedback to emotional experience. The processing of bodily and thus interoceptive stimuli may be a crucial component in yielding empathy, since affective states are often assumed to involve awareness of one´s own bodily state. The assumption of a close relationship between interceptive awareness and empathy is further supported when considering the regions recruited during both processes, like the insula and the anterior cingulate cortex. Although especially the affective component may implicate interoception and interoceptive awareness, the impact of interoception on empathy has never been evaluated behaviorally or neurophysiologically.

Also associated with altered insula and anterior cingulate cortex (ACC) function is Alexithymia. Alexithymia, a personality trait, is marked by cognitive and affective features including difficulties in identifying and describing feelings as well as in distinguishing feelings from bodily sensations of emotional arousal. Recent studies found a negative correlation between prefrontal glutamate (Glu) and mental perspective taking as well as extraversion. Even though several functional imaging studies investigated the neuronal signatures of interoceptive awareness and the personality trait alexithymia, little is known about the functional relevance of neurotransmitter concentrations

Eligibility Criteria:
Inclusion Criteria:

* acute depressive episode

Exclusion Criteria:

* major medical illness
* history of seizures, head trauma with loss of consciousness
* abnormal clinical laboratory test result, and pregnancy
* atypical forms of depression
* suicidal ideation
* any additional psychiatric disorder
* history of substance abuse or dependence
* electroconvulsive therapy in the previous 6 months

Healthy subjects without any psychiatric, neurologic, or medical illness
The Jules Bordet Institute Molecular Profiling Program Feasibility Trial

Prior to the use of genomic tests for patient inclusion in clinical trials, it is essential for the Jules Bordet Institute (JBI) to pilot the logistical and technical aspects by examining the feasibility and turnaround time of performing and obtaining data from a few key molecular assays.

Patients with metastatic colorectal cancer, non-small cell lung cancer or melanoma will be enrolled. Biopsie from metastatic lesions will be performed. A targeted cancer gene screen assay will be performed using DNA sequencing.

Results will be discussed during a molecular screening tumor board.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent for all study procedures according to local regulatory requirements prior to enrollment into the study.
* Age ≥ 18 years.
* Histologically proven metastatic or locally recurrent CRC, NSCLC or melanoma.
* Tumor tissue (FFPE and frozen) from recurrent or metastatic lesions available for research purposes.

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status \>2.
* The biopsy procedure is estimated to be too risky for the patient.
* Any anti-VEGF or anti-VEGFR treatment administered less than 3 weeks before new biopsy procedure.
* No appropriate washout period for patients on anticoagulation therapy.
Rehabilitation Following Laparoscopic Colonic Surgery

The standard procedure for treating colonic cancer is changing from open surgery to laparoscopic surgery. Following open colonic surgery patients are fatigued and loss body mass and have a reduction in physical function, but the investigators do not know if this is also the case following laparoscopic surgery.

This study examines how fatigue, quality of life, physical function, and body composition changes following laparoscopic colonic surgery.

Patients are examined preoperatively and postoperative day 10 and 30.


Eligibility Criteria:
Inclusion Criteria:

* elective colonic cancer surgery
* hemicolectomy or sigmoid resection
* informed consent

Exclusion Criteria:

* disseminated cancer
* contraindications for laparoscopic surgery
* dementia or serious psychiatric disease
* diseases or other aspects that prohibit participation