cyrilzakka/clinical-trials huggingface dataset:
Effect of Visual Feedback From the SpiroGym Mobile Application

The previous pilot study showed that two weeks of intensive expiratory muscle strength training (EMST) coupled with SpiroGym were sufficient to significantly improve the participants' voluntary peak cough flow (PCF). The improvement was quantitatively comparable to the results of other intensive EMST studies with longer durations. When interpreting such rapid improvement, the impact of SpiroGym's visual feedback was considered. It was assumed that visual feedback increased training effort compared to regular training without immediate control.

The aim of this study is to evaluate the effect of visual feedback provided by the SpiroGym mobile application on performance during expiratory muscle strength training in patients with Parkinson's disease.

The study will be conducted as a prospective crossover experimental design. Patients with Parkinson's disease will complete two EMST sessions (at 75% of maximum expiratory pressure), separated by a two-week period. One EMST session will include feedback via the SpiroGym mobile application, while the other will be conducted without such feedback. The order of these conditions will be randomly assigned.

Primary hypothesis

Visual feedback provided by the SpiroGym application during expiratory training will result in higher muscle activation, as measured by surface electromyography (sEMG), compared to training without visual feedback.

Secondary hypothesis

1. Participants using visual feedback during expiratory training will demonstrate greater expiratory performance, reflected by higher noise intensity recorded by the SpiroGym application, than participants training without visual feedback.
2. Participants will report lower perceived difficulty and higher motivation to perform expiratory training exercises when visual feedback is provided, compared to when it is absent.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinsons disease
* Stable dopaminergic medication (stable dose for at least 1 month)

Exclusion Criteria:

* Other neurological disorders
* Significant cognitive impairment
* Major psychiatric disorder
* History of head or neck cancer or previous surgical interventions in the neck region.
* Illness during the study period
Fat Grafts With Adipose-derived Regenerative Cells for Soft Tissue Reconstruction in Children

Although first reports of the clinical use of adipose-derived regenerative cells (ADRC) suggest that this approach may be feasible and effective for soft tissue augmentation, there is a lack of randomized, controlled clinical trials in the literature. Hence, this study aimed to investigate whether a novel protocol for isolation of ADRC and their use in combination with fat tissue improve the long-term retention of the grafts in paediatric patients with craniofacial microsomia.

To overcome problems associated with fat grafting, such as unpredictable clinical results and a low rate of graft survival, many innovative efforts and refinements of surgical techniques have been reported. For example, condensation of living tissue and removal of unnecessary components have been performed by centrifugation, filtration or gravity sedimentation; external mechanical force has been used to expand the recipient tissue as well as the overlying skin envelope; and a recent experimental study has suggested that repeated local injections of erythropoietin might enhance retention of grafted fat.

Based on the finding that aspirated fat tissue contains a much smaller number of adipose-derived regenerative cells (ADRC) compared with intact tissue and that these cells play pivotal roles in the adipose tissue remodeling after lipoinjection, the supplementation of fat grafts with stromal vascular fraction isolated from adipose portion of liposuction aspirates has been proposed as a method to compensate its relative deficiency of ADRC.

In the literature, there are at least three experimental studies demonstrating that supplementation of adipose progenitor cells enhances the volume or weight of surviving adipose tissue, and first reports of the clinical use of ADRC suggest that this approach may be feasible and effective for soft tissue augmentation.

However, since these studies represent level of evidence IV, which correspond to the publication of case series, there is a lack of randomized, controlled clinical trials comparing this method to current standard techniques.

Hence, this study aimed to fill this gap by investigating whether a novel protocol for isolation of ADRC and their use in combination with fat tissue improve the long-term retention of the grafts in paediatric patients with craniofacial microsomia.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral craniofacial microsomia
* 10 to 18 years old
* Phenotype: (M0, M1 or M2) and (S1 or S2) according to the OMENS-Plus classification

Exclusion Criteria:

* Previous facial soft tissue surgery
* Absence of fat donor site
Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal

To evaluate the feasibility of a 6-month multidisciplinary program to reverse type 2 diabetes using the Mediterranean diet, intermittent fasting and exercise.

The morbidities associated with type 2 diabetes (Db2) are major, including cardiovascular and renal complications, but also cognitive impairment. Providing interventions targeting Db2 reversal has shown great potential to improve healthy aging.

A Db2 reversal clinic has been established at the Montreal Heart Institute's ÉPIC Center, with an approach based on the Mediterranean diet and exercise. First-year results showed a 0.6% decrease in Hb1Ac and an average weight loss at 3 months of 4.5 kg in diabetic patients. This improvement was maintained at 6 and 12 months. Although these results are encouraging, the literature in Db2 remission shows that a weight loss of 10 kg is the ideal goal.

Therefore, to offer the possibility of further metabolic improvement at 6 months, three interventions are proposed as additions to the current program: targeting ultra-processed food reduction, motivational coaching and intermittent fasting. The main objective of our pilot study is to determine the feasibility of this improved program in type 2 diabetic patients, aged 18 to 80 years.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Ability to give written consent, to use a smartphone application or complete an adherence/compliance diary, and use a blood glucose and blood pressure machine at home.

Exclusion Criteria:

* All types of diabetes other than type 2
* Taking the following glucose-lowering agents: insulin, sulfonylureas
* BMI \< 18,5 kg/m2
* Unintentional weight loss of more than 10 kg in the past year
* Moderate to severe retinopathy
* Pregnant or nursing woman
* Severe organ failure
* Pathologies predisposing to gastrointestinal bleeding, untreated
* Recent cholecystitis (3 months)
* Antibiotic use in the past 3 months, or untreated active infection
* Known impaired nutrient absorption
* Uninvestigated new anemia or Hb \< 110 g/100 mL
* Currently following an intermittent or prolonged fasting protocol
* Currently following a specific diet (vegan, celiac/gluten free, ketogenic)
* Active diagnoses of psychiatric or neurological illness not controlled for at least 6 months
* Taking, stopping or adjusting a medication in the last 3 months resulting in an active weight change.
Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus

The purpose of this study is to compare glucose control, quality of life and number of hypoglycemias in preschool children before and after using a real-time glucosensor. Nocturnal hypoglycemia can be missed even when the parents check their children's blood glucose several times at night. The investigators hypothesise that nocturnal hypoglycemia can be prevented by using the sensor in this age group. As a consequence, quality of life of the families will improve. The investigators also hypothesise that diabetes control will improve at 3-6 months from the beginning of the study.


Eligibility Criteria:
Inclusion Criteria:

* Duration of diabetes for more than 6 months
* Use of insulin pump for more than 3 months
Power Toothbrush Use in Nursing Homes to Eliminate Mouth and Body Inflammation

The purpose of this study is to investigate whether brushing the teeth of nursing home residents with a power toothbrush as compared with standard care typically provided in nursing homes, will increase caregiver compliance with the provision of daily oral care as well as lower oral and systemic inflammation.

It is well recognized worldwide that residents of nursing homes have poor oral health primarily due to caregiver resistance in the provision of daily oral hygiene care. Fear of being bitten or assaulted by the resident as well as lack of time and discomfort with working in the mouth, are reasons cited for this resistance. It is also now recognized that inflammation in the mouth can raise overall inflammation within the body potentially leading to serious health consequences. Numerous studies involving periodic professional interventions as well as education and training of caregivers in oral care provision have not met with a great deal of success. Caregivers in some studies have indicated preference to power toothbrushes as they are bulkier and longer eliminating the need for insertion of fingers into the mouth and subsequently alleviating fears of being bitten. This study hypothesizes that caregiver utilization of a power toothbrush may increase their compliance with daily oral care provision and could potentially result in elimination of oral and systemic inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Residents of Nursing Home
* Presence of any natural teeth
* Non-aggressive behavior
* Presence of Periodontal inflammation

Exclusion Criteria:

* Smoking
* Comatose
* On a ventilator
* Aggressive behavior
* Presence of communicable disease
* On antibiotics
Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer

The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory breast cancer. The study will include patients who have and have not failed prior trastuzumab treatment.


Eligibility Criteria:
Inclusion criteria:

1. Female patients \>=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
2. Locally advanced or metastatic disease
3. Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1)
4. For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment
5. Investigator-confirmed diagnosis of Inflammatory Breast Cancer
6. Must have biopsiable disease

Exclusion criteria:

1. Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population)
2. Must not have received prior vinorelbine treatment
Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture

prospective randomized trial including adukt patients scheduled for hip fracture surgery, Randomization into 2 groups: Group A: Hydroxizin peroperatively Group B: Melatonin pre operatively

prospective randomized trial including adukt patients scheduled for hip fracture surgery, Randomization into 2 groups: Group A: Hydroxizin peroperatively Group B: Melatonin pre operatively

Non inclusion criteria: patients with severe cognitive impairement Primary outcome pre operative anxiety assessed with Amsterdam preoperative anxiety and information scale

Eligibility Criteria:
Inclusion Criteria:

* All adult patients scheduled for hip fracture surgery

Exclusion Criteria:

* Patients with contraindications for hydroxizine or Melatonin Patients with severe cognitive impairement
Modifiable Factors and Glaucoma - RCT

There is growing awareness that environmental factors, behaviors and diet are intimately related to patient health and may play a role in the pathogenesis and progression of glaucoma. Evidence from recent years has shown that some behaviors and environmental factors can affect the intraocular pressure, the primary risk factor for glaucoma. This study aims to investigate whether simple and common lifestyle inteventions such as sleeping with a head elevation, a high fiber diet, moderate aerobic exercise and moderation in caffeine intake could affect intraocular pressure and other outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with glaucoma.

Exclusion Criteria:

* Not able to attend follow-up
* Contraindication for treatment or follow-up
ImmunoTEP With 68-Ga in Metastatic Colo Rectal Cancer

Evaluation of the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68 for imaging potential candidate patients for surgery of local resection of one or more metastases at diagnosis or during relapse CCR expressing CEA.

Injection of a bispecific anti-CEA x anti-HSG antibody TF2 (120 nmoles) and 30 hours later IMP-288 peptide labeled with gallium-68 (3 to 6 nmoles/150 MBq). A TEP imaging acquisition is plannified 60 min after the 68-Ga injection.

Eligibility Criteria:
Inclusion Criteria:

* Existence of one or more metastases of of colorectal cancer (CRC) expressing the CEA , potentially accessible by surgical or thermo resection at the moment of the diagnosis or at relapse.

OR

* Isolated and progressive elevation of plasma CEA during the monitoring of CRC with high metastatic risk
* More than 18 years
* Negative pregnancy test for women of childbearing age. Women of childbearing age should take effective continuous contraception for 3 months.
* At least 4 weeks after the last treatment and after recovery of potential toxicity
* Karnofsky more than 70 or ECOG 0-1
* Life expectancy of at least 6 months
* CEA positive immunohistochemistry or plasma CEA supperior or equal to the normal level
* Creatinin less or equal 200 micromol/L
* Signed informed consent
* geographical proximity

Exclusion Criteria:

* Pregnancy or breastfeeding
* Serious illness or comorbidity assessed risk
* History of other cancer within 5 years, with the exception of skin carcinomas other than melanomas or in-situ carcinoma of the cervix
* Anti-antibody presence in patients who have already received antibody
* Hypersensitivity to antibodies or proteins
* Intellectual inability to sign the informed consent
* Insulin-dependent diabetic patient or non-insulin dependent
Teamwork Makes the Dream Work

Exploring the effect of team-based ARTAS intervention in an inpatient setting on HIV linkage to care and hospital readmission rates.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater
* newly diagnosed HIV
* Known diagnosis of HIV not on ART within 30 days of admission
* Known HIV and not virally suppressed based on interview
* Known HIV and has not been under the care of an HIV specialist within the past 6 months

Exclusion Criteria:

* All three criteria must be present for exclusion:
* virally suppressed
* actively taking ART
* are under active care of an HIV specialist within the last 6 months
* Less than 18 years of age (stand alone exclusion)
Prediction of PACU Delirium Using EEG - German Validation Study

Aim of this observational study is to investigate whether frontal electroencephalogram analysis is able to predict increased risk for PACU delirium.

Delirium in the postoperative anaesthesia care unit (PACU), a special of form of postoperative delirium, is associated with increased hospital stay and an elevated hospital re-admission rate. First studies investigating the patients' electroencephalogram (EEG) on emergence from anaesthesia were able to show that an abrupt change of predominant EEG-rhythm is associated with an increased rate of PACU delirium. Therefore, it seems possible to use frontal EEG in order to identify patients being at elevated risk for PACU delirium.

Aim of this observational study is to validate the results of an international collaboration in a German population of patients undergoing general anaesthesia. EEG in these patients is recorded from start of anaesthesia until emergence. Rate of PACU delirium is assessed using the CAM-ICU score 15 and 60 minutes after emergence in the recovery room.

In a pilot study in 626 patients from 2013 to 2015 in 5 international study centres the rate of PACU delirium was 20%. As it is planned to investigate 5 co-factors using regression analysis 50 cases of delirium will be necessary for a sufficient analysis. Therefore, in total 250 patients will be included.

Due to an additional study centre that included 50 patients enrolment of the german validation group was completed after 200 patients.

Eligibility Criteria:
Inclusion Criteria:

* age: 18 years or older
* surgery in general anaesthesia

Exclusion Criteria:

* emergency surgery
* general anaesthesia within 30 days before
Smart Capnography Respiratory Index in Post Anesthesia Patients

The smart capnography respiratory index is a software tool that constitutes a representation of 4 parameters: End Tidal CO2, respiratory rate, O2 saturation and heart rate already displayed on a monitor in the form of a single respiratory index integer value ranging from 1 to 10 with trend information. The index is to be used to identify and display status and changes in patient respiratory status in a simple manner based on the summary of changes in the 4-above mentioned parameters. the respiratory index is to be used in varied clinical environments and is intended for use in adult and pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult or pediatric patients after surgery and anesthesia, monitored in the PACU

Exclusion Criteria:

* none
Musculoskeletal Changes After Physiotherapeutic Intervention in Podiatric Subjects

The recurrence of diabetic foot ulcers (DFU) is a key problem in podiatric care. It is very often given by biomechanical abnormalities frequently present in those patients. The aim of our randomized controlled study is to find possible changes as of plantar pressures as of biomechanics of the ankle and small joints in patients with type 2 diabetes mellitus with different degrees of neuropathy. During this project, investigators will examine the possible impact of 12-week lasting intervention program on the distribution of plantar pressures, joint mobility and muscle strength of lower limbs. The incidence of ulcerations / reulcerations and changes of psychosocial characteristics will be evaluated during the study period.

Approximately 60 patients with Type 2 diabetes mellitus will be included into the study. These patients will be randomized into 3 study groups - patients with type 2 DM with mild form of peripheral sensory neuropathy (20 subjects), patient with severe peripheral neuropathy (20 subjects) and those with diabetic foot syndrome, without active lesion (20 subjects). All patients will undergo 12 week lasting active intervention program consisting of recommendations by a physiotherapist focusing on the improvement of physical fitness, muscle strength and foot joint improvement. Control group will be consisted of 20 patients with healed diabetic foot.

The outcomes of this project will try to objectively verify in the randomized controlled trial the impact of exercise on lower limb biomechanics, mobility, self-sufficiency, quality of life in patients with type 2 diabetes mellitus at risk or already developed diabetic foot syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* sensoric neuropathy (mild - based on VPV 15-30 V or EMG results, severe - based on VPT above 50 V or EMG results)
* diabetic foot with healed diabetic foot ulcers, inactive Charcot foot

Exclusion Criteria:

* impossibility to exercise
* amaurosis
* non-compliance
* critical limb ischemia
* active ulcer, surgical wound
* active Charcot foot
* active carcinoma
* recent stroke (last 8 weeks)
* recent myocardial infarction (last 8 weeks)
* recent PTA, PCI, bypass (last 8 weeks)
* myopathy
* rheumatoid arthritis
* cox-, gonartrosis of 3rd -4th grade.
Use of High Intensity Interval Training as a Strategy to Minimize the Insulin Resistance Observed in Sleep Deprivation

Sleep is an essential biological process for life and great value to functions such as learning, memory processing , cell and brain repair. Recently, new evidence points to the relationship between lack of sleep and carbohydrate metabolism , establishing a framework for insulin resistance observed in studies with restriction and sleep deprivation on several nights and in a single night . To reverse this process , one of the most effective strategies is physical exercise and part listed in the literature as a non-pharmacological tool for prevention and health promotion , as well as in the treatment of some diseases . However , the pace of modern society causes people to practice less physical exercise , lack of time being the main reason . In this scenario, the High Intensity Interval Training ( HIIT ) emerges as a powerful strategy that induces major changes optimizing the time spent on such activity. Considering the benefits of this mode , the purpose of this study is to investigate the effects of high-intensity interval training in the context of insulin resistance observed during sleep deprivation. Will be recruited 20 male volunteers, aged between 18 and 35 years old, healthy, with normal sleep duration equivalent to 7-8 hours / night, not smoking and regular eating habits. They will be submitted to a protocol of 6 sessions of high-intensity interval training for two weeks, and since the end period, sleep normally, or be deprived of sleep for 24 hours. Biochemical (thyroid hormones, cortisol, glucagon, free fatty acid, cholesterol, glucose and insulin) will be undertaken as well as evaluation of body composition by plethysmography, basal metabolic rate by indirect calorimetry and insulin sensitivity through Oral Glucose Tolerance Test (OGTT) before and after the training period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Recreationally Active
* Eutrophic
* Sleep Duration about 7-8 hours

Exclusion Criteria:

* No Smoking
* Without Sleep disorders
* Nondiabetic