cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Aquatic Therapy in Children With Duchenne and Becker Muscular Dystrophy

The purpose of this study is ; to evaluate the effects of aquatic therapy applied in addition to conventional physical therapy on balance, functionality and quality of life in children with Duchenne and Becker muscular dystrophy.

Duchenne and Becker muscular dystrophy is the most common type of muscular dystrophy in childhood caused by a mutation of the DMD gene. Progressive muscle weakness is the main symptom, as muscle fiber degeneration is the primary pathological process.

Weakness selectively affects the proximal before the distal limb muscles and the lower before the upper limbs. The affected child therefore has difficulty running, jumping, and walking up steps.

Although there is currently no treatment method that eliminates the disease, exercise practices significantly improve the quality of life of children.

There are not enough studies in the literature evaluating whether the addition of aquatic therapy to conventional physical therapy helps to improve balance skills, functionality and quality of life in children with muscular dystrophy.

The purpose of this study is ; to evaluate the effects of aquatic therapy applied in addition to conventional physical therapy on balance, functionality and quality of life in children with Duchenne and Becker muscular dystrophy.

Our study will include children aged 5-18 years and complete a 10 -m walk without assistance/support who are diagnosed with Duchenne or Becker muscular dystrophy by a neurologist and followed up in the Muscular Diseases Unit of Gaziosmanpaşa Training and Research Hospital In follow-ups, patients who are planned to receive aquatic therapy will be listed according to their application dates.

In addition to the exercises home programme, patients at the top of the list will receive aquatic treatment 3 days a week for a total of 5 weeks with a physiotherapist.

Patients at the bottom of the list will form the control group and will receive home programme exercise while waiting in line for aquatic therapy After 5 weeks, the initial assessments will be repeated and recorded

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Duchenne Muscular Dystrophy or Becker Muscular Dystrophy by a neurologist
* Between the ages of 5-18, with ongoing ambulation
* Co-operating with the physiotherapist's practices

Exclusion Criteria:

* Those who will not be able to perform the evaluation parameters
* Have a serious systemic disease that may interfere with exercise
* Injury and/or surgery in the last 6 months
* Receive gene therapy
* In the presence of contraindications to aquatic therapy such as excessive fear of water, behavioral problems, shortness of breath at rest, infection, incontinence, known chlorine allergy, open wound, acute systemic disease, epilepsy, tracheotomy, permanent drain, immunodeficiency
The Effect of Synching Prescription Refills on Adherence

To determine the effect of synchronizing a patient's prescription refill schedule on medication adherence. The targeted population is Humana members who are currently taking 2 or more Stars medications (hypertension, hypercholesterolemia, diabetes) and are current customers of RightSource. Participants will be randomized to one of two groups. Group one will be usual care and group two will be the Rx synchronization group.


Eligibility Criteria:
Inclusion Criteria:

* Humana members who are currently taking 2 or more Stars medications (hypertension, hypercholesterolemia, diabetes) and are current customers of RightSource.

Exclusion Criteria:

* under 18 years of age
Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal

The purpose of this study is to evaluate the efficacy of tattoo removal using topical imiquimod, 5% cream in conjunction with the 1064nm Nd:YAG laser. This procedure for tattoo removal will be compared to a laser removal alone.

Inclusion criteria includes: patients of both genders with Fitzpatrick skin types I-IV who are 18-65 years of age and who has 2 tattoos from 2 to 10 cm in diameter, of similar age which contains black and/or blue ink in areas that can be covered. Exclusion criteria includes: tattoos in chronically sun exposed areas, larger than 25 cm2,pregnancy,breast feeding state, immunosuppressed patients, history of autoimmune or connective tissue disorders, hypersensitivity to imiquimod, active sunburn, current tan, use of coumadin, aspirin , vitamin E or non-steroidal anti-inflammatory agents for the past 10 days.

Eligibility Criteria:
Inclusion Criteria:

* 2 tattoos no larger than 25cm2, professionally made, with approximately the same age, containing blue/black ink.

Exclusion Criteria:

* Hypersensitivity to imiquimod
* Current sun tan
* Use of vitamin E, non-steroid anti-inflammatory drugs, coumadin or aspirin for the past 10 days
* Amateur tattoos
* Pregnancy
* Breast-feeding status
* Immunosuppression
* Auto-immune diseases.
Safety Study of 3D Printing Personalized Biodegradable Implant for Breast Reconstruction

Scope of tumor resection was simulated according to the MR imaging data. After meticulous design, the investigators created the personalized porous biodegradable scaffold and printed by 3D printer, using porous PCL biomaterials. During operation, the biodegradable scaffold was implanted into the defective cavity after tumor resection. Safety indicator, cosmetic outcome and autologous compatibility were evaluated.

3D image reconstruction and printing Magnetic model images data were firstly produced by Siemens Trio Tim 3. 0 T MRI. The relative scanning parameters were adjusted as follows: layer thickness 0.9mm; pixel pitch 0.625 mm. In general, the thicker the layer thickness and pixel pitch, the better resolution and the more similar reconstructed model the investigators will get. The MRI data were then imported into Mimics 17.0® \[Materialise, Leuven, Belgium\] for 3D reconstruction of the targeted area. In this software, the investigators can adjust threshold value to acclimatize to segment tumor area. After that, 3D models were calculated and output as .stl files. According to the requirements of surgical planning, the scope of tumor resection was created after 2 cm expansion of the tumor area, that is, the filling scope of the implant. Next, the investigators designed the personalized porous degradable scaffold. In order to guarantee no significant differences and deformation of the implanted scaffold, the investigators used the contour of tumor resection as the boundary of the scaffold, with flexible porous structure as the units of the scaffold. Boolean operation can help to achieve this target. Finally, the printing of the personalized porous biodegradable scaffold was carried out. Biologically active material PCL was selected and the deformation and degradation time were set for 2 years by adjusting the molecular weight of PCL. Theoretically, PCL with the molecular weight above 65,000 can stably exist for 2 years in vivo, and then it will gradually degrade into H2O and CO2.The PCL material was put into the 3D printer, which was developed by the State key laboratory for mechanical manufacturing systems engineering of Xi'an Jiaotong university. The personalized porous biodegradable scaffold was completed after printing and removing supports.

Procedure In this study,the investigators produced the bio-implant at least 10 days before surgery. Before surgery, the printed bio-implant has been prepared and obtained full sterilization. Simply, under general anaesthesia, lumpectomy and sentinel-lymph-node biopsy was performed firstly, followed by 3D-printing scaffold transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients
* Tumor sized 3 cm to 6 cm
* ECOG score 1-2
* Multiple diffuse lesions in one quadrant
* Written informed consent

Exclusion Criteria:

* Triple negative breast cancer patients
* Participant in another clinical study
* Pregnancy and breastfeeding
* Patients with nipple infringement
* Inflammatory breast carcinoma
* Paget's disease
* Serious operative contraindication
* Contraindication for MRI
Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study

Hypoxic-ischaemic brain injury (HIBI) is the main cause of death in patients who are comatose after resuscitation from cardiac arrest. Current guidelines recommend to target a mean arterial pressure (MAP) above 65 mmHg to achieve an adequate organ perfusion. Moreover, after cardiac arrest, cerebral autoregulation is dysregulated and cerebral blood flow (CBF) depends on the MAP. A higher blood pressure target could improve cerebral perfusion and HIBI. Transcranial Doppler (TCD) is a non-invasive method to study CBF and its variations induced by MAP.

The aim of this study is to test the feasibility of an early-goal directed hemodynamic management with TCD during the first 12 hours after return of spontaneous circulation (ROSC).


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in the Intensive Care Unit (ICU) under mechanical ventilation with a Glasgow Coma Scale ≤ 8/15 after in- or out-of-hospital cardiac arrest
* Mean arterial pressure between 65 and 85 mmHg with or without vasopressor support

Exclusion Criteria:

* Age \< 18 years old
* No flow (time between cardiac arrest and the beginning of cardiac massage) \> 15 minutes or unknown
* Low flow ((time between cardiac arrest and ROSC: return of spontaneous circulation)\> 60 minutes
* Time between ROSC and inclusion \> 12 hours
* Transcranial doppler unavailable
* Cardiac arrythmia
* Patient under extracorporeal life support before inclusion or at risk of being referred for assistance due to cardiogenic shock with high dose of vasopressors before inclusion (MAP \< 65 mmHg with norepinephrine or epinephrine \> 1 µg/kg/min or dobutamine \> 10 µg/kg/min)
* Severe cardiac dysfunction defined by left ventricular ejection fraction \< 20% or aortic Velocity Time Integral (VTI: measured with trans-thoracic echocardiography) \< 14 cm with dobutamine \> 10µg/kg/min
* Patient under Extracorporeal Membrane Oxygenation (ECMO) for Acute Respiratory Distress Syndrome (ARDS) before inclusion
* Cardiac arrest secondary to brain injury such as stroke, subarachnoid hemorrhage or traumatic brain injury
* Hemorrhagic shock
* Any acute pathology that requires strict blood pressure control (aortic dissection, stroke, cardiogenic pulmonary edema with high blood pressure)
* Decision of withdrawing or withholding life sustaining treatment before inclusion or considered during the first 12 hours of ICU management
* Patient with a modified Rankin scale (MRS) 4 or 5 prior to resuscitation
* Pregnancy or lactation
* Patients already enrolled in another clinical study on cardiac arrest
* Patients with judicial protection
* No social security coverage
Eye Gaze Strategies During Facial Emotion Recognition in Neurodegenerative Diseases: Links With Neuropsychiatric Disorders (EYE-ToM Study)

It is commonly admitted that social cognition impairment, like deficit in facial emotion recognition or misinterpretation of others' intentions (Theory of Mind), are associated with social behavior disorders.

This kind of disorders are observed in Fronto-Temporal Dementia (FTD), Alzheimer's Dementia (AD) and Parkinson's Disease (PD), with severe deficits in FTD and lighter deficits in AD and PD.

One explanation might be that patients apply inappropriate visual exploration strategies to decode emotions and intentions of others.

This study aims to test this hypothesis and further to analyse whether different patterns emerge from these pathologies.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized or coming to perform a consultation, for whom an Eye-Tracking examination is indicated as part of routine care.
* Sufficient written and oral expression in French.
* Written informed consent signed by the patient.
* For the control group: No cognitive impairment (non pathological MMSE (according to age, gender and socio-cultural level), no neurological history, and no psychiatric history (especially anxiety and depressive disorders).
* For the FTD group: Patient diagnosed according to revised Rascovsky et al. 2011., no neurological history (excepted diagnosed FTD), and no psychiatric history (excepted those related to diagnosed FTD).
* For the AD group: Patient diagnosed according to DSM-IV-TR criteria, no neurological history (excepted diagnosed AD), and no psychiatric history (excepted those related to diagnosed AD).
* For the PD group: Patient diagnosed according to NINDS criteria, no neurological history (excepted diagnosed PD), and no psychiatric history (excepted those related to diagnosed PD).

Exclusion Criteria:

* General anaesthesia within 3 months.
* Ophthalmological problems preventing a video-oculography examination.
* Oculomotor disorders such as "fixation disorders" or "ocular tracking disorders".
* Cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia.
* History of stroke.
* History of alcohol or drug abuse.
Effects of Cryotherapy on Joint Function and Pressure Pain Threshold in Patients With Subacromial Impingement Syndrome.

Background: Subacromial impingement syndrome (SIS) is a chronic and disabling disease, characterized by compression and mechanical abrasion of the tendons of the rotator cuff muscles, subacromial bursa and tendon of the long head of the biceps against the anterior surface of the acromion, coracoacromial ligament or the acromioclavicular joint during arm elevation movement. After the trauma, inflammatory processes initiate and may lead to loss of function when untreated. This inflammation leads the release of cytokines (IL-6, IL-10, IL-1β and TNF-α) whose acts as inflammatory mediators. Physical therapy works in treating SIS with the goal of reducing pain and inflammatory process. Cryotherapy is widely used in physical therapy by anti-inflammatory and analgesic effects, low cost, effectiveness and easy application. Objective: The aim of the study is to evaluate the effects of a cryotherapy protocol, applied on shoulder of subjects with SIS, on serum inflammatory mediators (cytokines) and local pressure pain threshold. Possible changes in function and pain will also be evaluated. Materials and Methods: 30 subjects will be selected and share in two groups, 15 healthy subjects and 15 subjects with SIS. Function assessments and quality of life will be held using the DASH and WORC questionnaires. Cryotherapy will be applied for 4 consecutive days, lasting 20 minutes without interruption through ice pack over the shoulder of SIS carriers. For the blood samples, 20ml of blood will be collected at the first and last day of the intervention, and then stored at -80 ° C.


Eligibility Criteria:
Definition: The participants will be selected from population in general and will be screened by the inclusion and exclusion criteria below:

Inclusion Criteria:

* The diagnosis for SIS will be based on a clinical examination and self-reported orthopaedic history. at least 3 positive tests of: Neer impingement test, Hawkins impingement test, Jobe test, Speed test or Gerber test, pain with passive or isometric resisted shoulder lateral rotation, pain with active shoulder elevation and pain with palpation of rotator cuff tendons.

Exclusion Criteria:

* Fracture, osteoporosis, malignancy, infection, and active inflammatory process, pregnancy, systemic illnesses, physical therapy or manual therapy treatment within 6 months prior to the evaluation, signs of complete rotator cuff tear or acute inflammation, cervicothoracic spine-related symptoms (positive cervical compression test and excessive kyphosis), scoliosis, glenohumeral instability (positive apprehension, anterior drawer, or sulcus tests), or previous upper extremity fracture or shoulder surgery.
Monitoring Brain Waves in Response to Visual and/or Auditory Stimulation in Parkinson's Disease Patients

Voltage fluctuation as a result of brain activity will be recorded into the computer using an EEG device.

Patients with Parkinson's disease may have gait disturbances including freezing of gait. Visual and auditory stimuli may improve gait. Investigators will analyze brain wave during walking while giving the subject different stimuli.

The voltage fluctuation (in hundreds of microvolts) will be recorded using the EEG cap and amplifier into a computer.

Eligibility Criteria:
Inclusion Criteria:

• Patients with Parkinson's disease that are ambulatory and can sign a written informed consent

Exclusion Criteria:

* Patients with Parkinson's disease who are not ambulatory
* Patients with dementia
* Patients that are blind
* Patients that have severe hearing impairment
Laser Atherectomy Versus Angioplasty for the Treatment of Critical Limb Ischemia

The reason the investigators are doing this study is to compare the results of laser atherectomy versus angioplasty with or without the placement of a stent in the artery. A stent is a metal tube used to open up narrow arteries in the body.

People with peripheral artery disease that has severely reduced blood flow in their lower leg are usually treated with surgical bypass. This condition is known as Critical Limb Ischemia or CLI. Over the last decade, advances in techniques and tools have allowed surgeons to more aggressively treat complex cases. Studies have shown successful treatment of CLI with endovascular techniques (less invasive surgical procedures through a small incision for the treatment of vascular disease), including laser atherectomy and angioplasty. Surgical guidelines are not clear as to the best procedure to use for CLI. To the best of our knowledge, a study comparing laser atherectomy and angioplasty has not been done. Laser atherectomy works by releasing ultraviolet light which is absorbed by the plaque in the arteries. This will then get rid of the plaque. Angioplasty is a procedure used to open blocked or narrowed arteries. Currently, it is not known if laser atherectomy has better results than angioplasty.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Male or female (non-pregnant females)
* Patients with peripheral artery disease that has progressed to critical limb ischemia (CLI)
* Patients undergoing angiography with possible intervention for Rutherford Class 4-6 limb ischemia that may benefit from revascularization
Studying An Investigational Drug Crizotinib (PF-02341066) In Non Non-Small Cell Lung Cancer Tumors That Are Positive For Anaplastic Lymphoma Kinase (ALK)

This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for ALK.


Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically proven diagnosis of malignancy other than NSCLC
* positive for translocation or inversion event involving the ALK gene locus
* positive for ALK amplification events
* positive for ALK activating point mutations

Exclusion Criteria:

* mutations of amplifications involving the c-Met gene but not the ALK gene
* concurrent treatment on another therapeutic clinical trial
* prior therapy specifically directed against ALK
Intravenous Immunoglobulins in Complex-regional Pain Syndrome

The purpose of this study is to determine whether intravenous immunoglobulins are effective in the treatment of complex-regional pain syndrome.

CRPS, a chronic pain syndrome associated with trophic disturbances is a frequent complication after limb trauma. More than one third of the CRPS will continue to chronic disease including loss of function in one limb. Some reports implicate an autoimmune pathogenesis of CRPS. Especially the finding of autoantibodies against peripheral neurons and successful treatment in single cases provide evidence for a possible successful treatment of CRPS with intravenous immunoglobulins (IvIg). Therefore IvIg may be an important anti-inflammatory treatment to prevent severe chronification of CRPS. Since IvIg is mainly effective in B-cell-mediated autoimmune diseases, autoantibodies against autonomic neurons and the concentration of B-cell activating factors BAFF and APRIL will be measured in the course of the study.

Eligibility Criteria:
Inclusion Criteria:

* CRPS 1 (according to the IASP criteria) between 6 weeks and 6 months after diagnosis
* skin temperature of the affected side equal or higher than on non-affected side
* no change of the analgetic or co-analgetic medication within the last 10 days

Exclusion Criteria:

* Immunosuppressive or immunomodulatory treatment within the last three months
* CRPS previously treated with sympathetic block, lidocaine patch, local DMSO, spinal cord stimulation, intrathecal drug administration
* Known immune-mediated neuropathy (CIDP, MMN, MADSAM)
* Selective IgA-deficiency
* Severe heart disease
* Tumour disease in the last 5 years
* Allergy against Gamunex 10%
* Chronic renal disease Vaccination with live vaccine within the last three months
* Member of another clinical trial within the last 3 months
Fall Prevention in Older Adults With OAB

Though OAB treatment may improve physical activity, there is a lack of easily administered instruments for measuring physical activity in older adults. Aim is to validate instruments to measure physical activity and preference for medication, and to determine the effect of preference for anti-cholinergic medication on adherence, physical activity, and falls risk. It's plan a prospective cohort study of adults aged 65 or older with OAB undergoing treatment with anti-cholinergic medication.

Older adults with overactive bladder (OAB) have reduced physical activity and are at increased risk for falls. Though recent studies suggest that treatment of OAB may improve physical activity, there is a lack of easily administered instruments for measuring physical activity in older adults. Furthermore, physical activity outcomes in older adults with OAB are affected by treatment preference and potential neurocognitive dysfunction caused by anti-cholinergic medication. The aims of the present proposal are 1) to validate an instrument to measure physical activity 2) to validate an instrument to measure preference for medication and 3) to determine the effect of preference for anti-cholinergic medication on adherence, physical activity, and falls risk. Plan: a prospective cohort study of adults aged 65 or older with OAB undergoing treatment with anti-cholinergic medication. The primary outcome will be physical activity measured using a self-reported instrument and accelerometer at baseline and 8 weeks after treatment. Secondary outcomes will be fall risk defined by changes in neurocognitive testing, urinary symptoms, and medication adherence at 8 weeks after treatment. The findings of this study could provide a paradigm shift in the management of older adults with OAB and at increased risk for falls.

Eligibility Criteria:
Inclusion Criteria:

adults aged 65 or older, urinary urgency of quite a bit severity or more on the Overactive Bladder Questionnaire-Short Form (OABq-SF), eligible for pharmacologic therapy for overactive bladder

Exclusion Criteria:

predominant stress incontinence (on UDI-6), current/recent use (6 m) or contraindication to anti-cholinergic medication, severe voiding difficulties, men on 5-alpha reductase inhibitors, severe neurologic disease, recent anti-incontinence or prolapse surgery, other urinary tract conditions such as calculus or recurrent UTI.