cyrilzakka/clinical-trials huggingface dataset:
Fexofenadine in Pruritic Skin Disease

Primary objective:

* To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease

Secondary objective:

* To evaluate patient's satisfaction of Allegra treatment


Eligibility Criteria:
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

* All patients diagnosed with atopic dermatitis, contact dermatitis

Exclusion Criteria:

* Other skin disease except atopic dermatitis, contact dermatitis.
* Subjects taken steroid within 4 weeks and antihistamine within 1 week before screening day.
* Pruritus localized only head and face
* Subjects with severe hepatic, renal, heart dysfunction.
* Subjects with history of alcohol and drug abuse.
* Pregnant and lactating women.
Validity and Reliability of the Turkish Version of the McMaster University Head and Neck Radiotherapy Questionnaire

More than half of the patients with head and neck cancer are locally advanced patients. Radiotherapy is the primary treatment option for many patients with stage III and stage IV diagnosed with head and neck cancer. Radiation often causes tissue reactions by increasing local symptoms of the tumor and adding new symptoms to them. The acute effects of radiation are pain and burns associated with mucosal irritations and skin irritations, the root smell of the necrotic tumor and damaged normal tissues, dry skin, skin irritation, pain and dryness of mucosal membranes, decreased appetite, loss of chewing and swallowing skills, and hoarseness. The aim of this study is to make the validity, reliability and cultural adaptation of McMaster University Head and Neck Radiotherapy Inventory in Turkish.

Although there are various surveys in the literature that evaluate the quality of life of head and neck cancer patients, apart from the "McMaster University Head and Neck Radiotherapy Questionnaire", there is no other questionnaire designed specifically for local advanced stage III and stage IV head and neck cancer and treatment of specific morbidity at a certain time. Patients in these stages often have difficulties in oral communication, nutritional disorders and loss of chewing and swallowing skills leading to dehydration, bad mouth odors, appearance problems affecting social and family life, and often significant morbidity including severe pain symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily accepting to participate in the study
* Patients whose native language is Turkish
* Undergoing or receiving radiotherapy treatment
* At least 3 weeks have passed since the beginning of radiotherapy

Exclusion Criteria:

* The patient does not have sufficient functions of bone marrow, liver and kidney
* To have scored less than 70 from Karnofsky Performance Scale
Comparison of the Effects of Two Different Exercise Programs in Obese Adolescents

Obesity is one of the most important health problems of developed and developing countries. Especially in children and adolescents, the prevalence of obesity is increasing at an alarming rate. In obese individuals, the effects of postural control and balance have been reported to cause musculoskeletal problems, and motor control skills have been found to decrease. The aim of this study is to compare the effects of balance exercises and strengthening exercises on balance, posture and lower extremity functions in obese adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 12-18 Body Mass Index to be 95 and above according to percentile values No exercise program in the past 6 months

Exclusion Criteria:

* Having a medical condition that prevents exercise Having a disease of neuromuscular origin Presence of psychiatric or neurological diseases affecting cooperative and cognitive functions Equilibrium effect due to another disease
Intra- Versus Extraarticular Injection of Ropivacaine in Total Knee Arthroplasty

The purpose of this study is to evaluate the optimal site for application of local anesthetics in total knee arthroplasty surgery. The hypothesis is, that improved pain relief is obtained when administering local anesthetics in the tissues sourrounding the knee joint compared to the knee joint itself.


Eligibility Criteria:
Inclusion Criteria:

* eligible for elective total knee arthroplasty
* able to speak and understand Danish
* able to give informed consent

Exclusion Criteria:

* alocohol or medical abuse
* allergies to local anesthetics
* age \< 18 yrs.
* intolerance to opioids
Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics

This neuroimaging study is a clinical trial investigating the effectiveness of intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) in reducing suicide risk in patients with major depressive episode (MDE) or borderline personality disorder (BPD).

This neuroimaging study aims to determine the effectiveness of iTBS-TMS to the IPL in reducing suicide risk in patients with MDE or BPD. This study also aims to identify the structural and functional circuit properties that characterized the suicidal brain and the signatures that explain the clinical severity of suicidal risk. Moreover, this study aims to determine biological and dimensional predictors of anti-suicidal response to iTBS-TMS and its mechanism of action.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Diagnosed with BPD or MDE
* Chief complaint of suicidal thoughts and behaviors

Exclusion Criteria:

* Neurological conditions with known structural brain lesion
* Prior neurosurgical procedure
* Metal in the body that is ferromagnetic or metal injury to the eyes
* Epilepsy
* Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt
* Psychopathology not appropriate for the treatment (e.g., manic episode or psychosis)
* Current alcohol dependence or active symptoms of non-alcohol psychoactive substance use withdrawal, as indicated by self-report
* Inability to meet the safety criteria for MRI scanning according to the protocols of the MGH Department of Radiology
* Current pregnancy
Cognition And Neocortical Volume After Stroke

Stroke and dementia are two of the most common and disabling conditions worldwide, responsible for an enormous and growing burden of disease. There is increasing awareness that the two conditions are linked, with cognitive impairment and dementia common after stroke, vascular dementia accounting for about one-fifth of all dementia cases and recent evidence on the contribution of vascular risk factors to Alzheimer's disease. Yet little is known about whether brain volume loss - a hallmark of dementia - occurs after stroke, and whether such atrophy is related to cognitive decline. The aim of this research is to establish whether stroke patients have reductions in brain volume in the first three years post-stroke compared to control subjects, and whether regional and global brain volume change is associated with post-stroke dementia in order to elucidate potential causal mechanisms (including genetic markers, amyloid deposition and vascular risk factors). The hypotheses are that stroke patients will exhibit greater brain volume loss than comparable cohorts of stroke-free controls, and further, that stroke patients who develop dementia will exhibit greater global and regional brain volume loss than those who do not dement. An understanding of whether stroke is neurodegenerative, and in which patients, may be used to help guide the early delivery of disease-modifying therapies.

Our primary outcome measure was total brain volume (TBV) change between the 3-month and 3-year time-points compared between stroke patients and controls.

Secondary outcome 1 was TBV change between 3-months and 3-years comparing CN and CI stroke participants. TBV at 3-months will be adjusted for CCI scores, and years of education; the latter as it is correlated with cognitive performance and post-stroke dementia risk, but not for stroke lesion volume as no conclusive evidence for an effect has been demonstrated previously.

Secondary outcome 2 was hippocampal volume (HV) change between 3-months and 3-years in stroke patients and controls with adjustments identical to primary outcome.

Secondary outcome 3 was the comparison of HV change between 3-months and 3-years comparing CN and CI stroke participants with adjustments identical to secondary outcome 1.

See published protocol and uploaded statistical analysis plan for detailed description.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical stroke
2. Aged greater than 18 years;
3. Able to have cognitive testing and MRI scan; and
4. Able to give informed consent

Exclusion Criteria:

1. Significant medical comorbidities precluding participation in cognitive testing, or making survival for three years unlikely;
2. Normal exclusion criteria for MRI; e.g., implanted metal, severe claustrophobia;
3. Pre-existing dementia
4. Pregnancy, as a precaution to prevent exposing them to multiple MRI scans in a 12-month period
5. People in existing dependent or unequal relationships with any member of the research team, to protect against coercion
The Effects of Gum Chewing on Energy Intake and Expenditure

The purpose of this study is to determine if chewing gum increases energy expenditure and decreases food intake.


Eligibility Criteria:
Inclusion Criteria:

* BMI 27-37, between the ages of 18 and 38

Exclusion Criteria:

* History of chronic disease (e.g. liver, kidney, or heart disease, or diabetes)
* Medications that affect energy expenditure, appetite, or body composition (e.g. antidepressants, beta blockers, antipsychotic, or weight loss medications)
* A history of irregular menstrual cycles in women (indication of onset of menopause or other metabolic disturbances such as polycystic ovary syndrome)
* A history of phenylketonuria (PKU)
* Symptoms of depression
* A history of eating disorders
* Concurrent participation in a weight loss program
* Cigarette smoking or other tobacco use
* Jaw problems such as temporomandibular joint disorder (TMJ)
* Allergies to any of the common components in gum (sweeteners, mint flavors, etc)
* Heavy gum chewing prior to study ( \> 3 times per week)
* Pregnancy or lactation.
Clinical and Radiomic Model of COVID-19

To develop and validate a machine-learning model based on clinical, laboratory, and radiological characteristics alone or combination of COVID-19 patients to facilitate risk Assessment before and after symptoms and triage (home, hospitalization inward or ICU).

In December 2019, a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; earlier named as 2019-nCoV), emerged in Wuhan, China. The diseases caused by SARS-CoV-2 is COVID-19. As of March 8, 2020, more than 100 000 COVID-19 patients have been reported globally (more than 80 000 cases in China, more than 20 000 in other countries), and 3 600 patients (3 100 in China, 500 outside of China) have died. The outbreak of COVID-19 constitutes a Public Health Emergency of International Concern.

Among COVID-19 patients, around 80% are mild (non-severe) illness patients, who usually heal within two weeks. However, another 20% of patients may aggravate into a severe or critical illness which results in a longer hospital stay, and the mortality rate for such patients is 13.4%. Therefore, inchoate identification of the high-risk severe patients is extremely important for patient management and medical resource allocation. General quarantine and symptomatic treatment can be used for most non-severe patients, while a higher level of care and green channel to the intensive care unit (ICU) are helpful for severe patients. Previous studies have summarized the clinical and radiological characteristics of severe COVID-19 patients, while which factors are important predictors is still unclear.

Machine learning is a branch of artificial intelligence that enables us to learn knowledge and potential laws from the given data and to build a model for solving problems as human needs. In recent years, machine learning has been developed as a novel tool to analyze large amounts of data from medical records or images. Previous modeling studies focused on forecasting the potential international spread of COVID-19.

Therefore, our purpose is to develop and validate a machine-learning model based on clinical, laboratory, and radiological characteristics alone or combination of COVID-19 patients in the early stage without severe illness from multiple centers for the prediction of severe (or critical) illness in the following hospitalization to facilitate risk Assessment before and after symptoms and triage (home, hospitalization inward or ICU).

Eligibility Criteria:
Inclusion Criteria:

* confirmed COVID-19 patients by high-throughput sequencing or real-time reverse-transcriptase polymerase-chain-reaction (RT-PCR) assay for nasal and pharyngeal swab specimens.

Exclusion Criteria:

1. patients with severe illness when admitted;
2. time interval \> 2 days between the admission and examinations;
3. absent data or delayed results
Evaluation of Dexterity in Prevalent Peritoneal Dialysis Patients

The objective of the study is to measure the manual dexterity of patients treated by peritoneal dialysis - transversal study

All peritoneal dialysis patients from Peritoneal Dialysis unit will, after information and consent, have to realise four tests, one time each, to quantify their manual dexterity. The tests are already used to measure dexterity: Purdue Pegboard, Jebsen test, JAMAR, Pinch test. These tests will be performed during an in-hospital visit.

Eligibility Criteria:
Inclusion Criteria:

* patients treated by peritoneal dialysis in Caen University Hospital

Exclusion Criteria:

* refusal to participate
Comparison Between One-stage Hybrid Ablation and Thoracoscopic Surgical Ablation for Intractable Atrial Fibrillation

Previous evidence indicated that the outcomes of both video-assisted thoracoscopic surgical ablation and percutaneous radiofrequency ablation therapy for persistent atrial fibrillation (AF) were unsatisfied. Recently, hybrid ablation therapy for AF had encouraging outcomes. However, there were no randomized, controlled clinical studies to prove the effectiveness of this new strategy. This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.

This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least one anti-arrhythmic drugs
* Persistent AF lasting more than 1 year or with a left atrial diameter\>50mm

Exclusion Criteria:

* Previous percutaneous catheter ablation or surgical ablation
* Presence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease)
* Left atrial diameter\>60mm
* Previous thoracic or lung operation
* Left atrial thrombosis or left atrial appendage thrombosis
* Chronic obstructive pulmonary disease (COPD) (Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC)\<70%、FEV1\<50% anticipated value)
* Bilateral carotid artery stenosis\>80%
* Refuse to participate in this study
Effects of Fascial Distortion Model With and Without Neuromuscular Inhibition in Patients With Piriformis Syndrome

The aim of study will be to find the effects of fascial distortion model (FDM) with and without the Integrated neuromuscular inhibition technique (INIT) in piriformis syndrome.

Piriformis syndrome is a misdiagnosed cause of sciatica leg or buttock pain and disability. The male and female incidence ratio of PS is 6.1. The fascial distortion model is a targeted manual technique and decodes categorized manual gestures (pain-related body language) to 6 pathophysiological mechanisms involved in the etiology of pain. Integrated neuromuscular inhibition technique(INIT) is a combination of muscle energy technique(MET) and positional release technique(PRT).

All previous studies in which integrated neuromuscular inhibition technique(INIT) and fascial distortion model(FDM) has been performed on different muscles of the body has shown greater improvement as compared to other techniques. Comparative effects of fascial distortion model with integrated neuromuscular inhibition technique and fascial distortion model on Piriformis Syndrome has not been addressed yet. There is very limited data available on this protocol. Therefore, this study aims to compare the effects of facial distortion model with and without integrated neuromuscular inhibition technique.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral buttock pain and radiculopathy due to spasms of the piriformis muscle or sciatic nerve compression.
* Aggravate buttock pain in sitting and limited SLR.
* Patient with Freiberg test positive.
* Patient with FAIR test positive.
* Patient with positive Pace test.
* Patient with positive Beatty's maneuver.

Exclusion Criteria:

* Lumbar spinal pathology and recent injury around the hip, sacroiliac joint, or lumbar spine.
* Patient with a positive Faber test
* SIJ Pathology like SIJ dysfunction, innominate anterior or posterior rotation dysfunction, etc.
* Deep gluteal syndrome.
* Recent surgery like hip arthroplasty, surgical emplacement of a gluteal implant (buttock prosthesis); lip sculpture (fat transfer and liposuction); and body contouring (surgery and lip sculpture).
Aortoiliac Stenosis in Kidney Transplantation

The impact of aortoiliac stenosis on kidney transplant patients remains unclear. This study aims to investigate the safety and efficacy of kidney transplantation in patients with aortoiliac stenosis.

Kidney transplantation is the optimal treatment for end-stage renal disease (ESRD). Unfortunately, not all ESRD patients are eligible for kidney transplantation. Aortoiliac stenosis, an increasingly common type of peripheral arterial disease in ESRD patients, is considered as relative contra-indication for kidney transplantation. There are several reasons for concern, such as the complexity of the vascular anastomosis and inferior life expectancy. Consequently, it is still debated whether patients with aortoiliac stenosis would benefit from kidney transplantation.

This study aimed to supplement current literature on the safety and efficacy of kidney transplantation in patients with aortoiliac stenosis. To achieve this, all patients undergoing kidney transplantation in Erasmus Medical Center between January 2010 and December 2020 were enrolled, and propensity score matching was used to minimize confounding factors. Additionally, long-term graft function was investigated to evaluate the impact of stenosis on graft function.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020

Exclusion Criteria:

* Patients who were under 18 years at transplantation
* Patients who underwent combined organ transplantation
* Patients who had no follow-up
Prospective Follow-up Study of the Aortic Diameter in Patients With Giant Cell Arteritis

Giant cell arteritis (GCA) is the most frequent vasculitis in patients above 50 years of age. The disease has limited mortality, mostly due to the development of aortic aneurysms, leading to dissection and rupture. The probability to develop this complication is 17 x higher at the level of the thoracic aorta and 2,4 x at the level of the abdominal aorta in patients with GCA when compared with a control group. Therefore, follow-up of the aortic diameter in patients with GCA is part of good clinical practice. Previous retrospective research showed a link between FDG-uptake at the level of the thoracic aorta, on positron-emission-tomography (PET) at the time of diagnosis, and the increase of diameter and volume of the thoracic aorta during follow-up (on computed tomography (CT)).

The purpose of this prospective study is to follow-up on the aortic diameter, and to correlate these measures with FDG-PET uptake at diagnosis. Ideally, this would allow us to define a group of patients at high risk to develop an aortic aneurysm, already at the time of diagnosis.

As standard care, all patients with a suspicion of GCA undergo a biopsy of the temporal artery and a PET scintigraphy to evaluate the presence of large vessel vasculitis. Patients with proven GCA on biopsy and/or scintigraphy undergo a computed tomography (CT) of the aorta without the administration of contrast, at diagnosis and yearly thereafter (every 12 +/- 3 months) for 10 years.

Measurements include the diameter of the ascending aorta, aortic arch, descending aorta, suprarenal, juxtarenal and infrarenal aorta, and the volume of the thoracic and the abdominal aorta. These measurements are correlated with FDG-uptake at the level of the aorta on PET-scintigraphy at the time of diagnosis. All patients will be treated according to accepted guidelines and standard care in our center (methylprednisolone started at 32 mg/day, with slowly declining doses until stop after 1 to 1,5 years of treatment).

Eligibility Criteria:
Inclusion Criteria:

* patients with a first episode of biopsy and/or scintigraphy proven giant cell arteritis
* patients with a previous diagnosis of giant cell arteritis, in whom a yearly computed tomography of the aorta is available can opt to participate in this study
* informed consent form has to be signed by all patients

Exclusion Criteria:

* patients already treated with steroids before performance of PET-scintigraphy
* earlier episodes of giant cell arteritis, without documentation of the aortic diameter at that moment