cyrilzakka/clinical-trials huggingface dataset:
Determining Clinical Profile of Parkinson's Disease Among Egyptian Population

Parkinson's disease is the second most common neurodegenerative disease affecting about 1-3% of population above 60 years. Recently, non-motor symptoms are getting more attention in PD management. The pattern of PD onset and clinical course differ from one population to another. Many studies have been conducted to determine the clinical profile of PD in populations worldwide. However, no similar studies have been conducted in Egypt. Therefore, the investigators will conduct a nation-wide, collaborative, cross sectional study to determine the pattern of Parkinson's disease onset, clinical course, and non-motor symptoms among Egyptian population.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the Parkinson's disease criteria of United Kingdom Brain Bank within the study centres.

Exclusion Criteria:

* Patients with vascular Parkinsonism (history of stroke)
* Patients with treatment induced Parkinsonism
* Patients with history of dopaminergic neurotoxin (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine)
Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants

Pediatric patients, especially infants undergoing open heart surgery have a predictable fall in cardiac index 6 to 18 hours after surgery, the so-called low cardiac output syndrome (LCOS). Patients, who have LCOS require more monitoring, more medication and a longer stay in intensive care unit. To prevent LCOS the phosphodiesterase inhibitor milrinone is routinely used during the first 24 hours after surgery. Levosimendan, a calcium- sensitizer improves cardiac muscle contractile force, vascular smooth muscle relaxation and coronary blood flow through calcium sensitization of the myocardial contractile filaments and opening of potassium channels without increasing oxygen consumption of the heart muscle cells. As the myocardium of infants is more calcium dependent than in later life, levosimendan should be of special benefit in this age group. The purpose of this study is to investigate whether levosimendan is superior to milrinone in preventing LCOS in infants after corrective open heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age younger than one year
* corrective open heart surgery with biventricular repair, except tetralogy of fallot

Exclusion Criteria:

* Missing written consent of parents
* Weight less than 3 kg
* preoperative LCOS
* gestational age less than 36 weeks
* preexisting renal failure
* preexisting thrombopenia
* preoperative cardiopulmonary resuscitation
* preoperative use of milrinone or levosimendan
Failure Analysis of Patellofemoral Arthroplasty

The purpose of the retrospective cohort study is 1) to determine preoperative risk factors for revision af patellofemoral arthroplasty, and 2) to provide a detailed description of indications for revision after patellofemoral arthroplasty. All patients operated with patellofemoral arthroplasty in Denmark from January 1, 2008 to December 31, 2015, will be included in the cohort.

Approx. 11,000 operations with the insertion of a knee arthroplasty (knee prosthesis) are performed annually DK. The durability and quality of the treatment are assessed with prosthesis survival, that expresses the proportion of prostheses that are still functional after a given number of years (eg the 10-year prosthesis survival for all types of knee prostheses in DK is approximately 94%).

Unicompartmental implants are increasingly used, so that only the worn part of the knee is replaced. Especially for osteoarthritis between the patella and the femur, a patellofemoral prosthesis (PFA - patellofemoral alloplasty) can be inserted, which is much smaller than the traditional full prosthesis (TKA - total knee arthroplasty).

PFA operations are controversial. A recently published Danish study (double-blind RCT) comparing TKA and PFA has shown that PFA patients achieve greater satisfaction, better knee function and greater quality of life than TKA patients. A recent study has also demonstrated that the cost of a PFA procedure is less than that of a TKA. As a paradox to this clear RCT finding, all national implant registers (Sweden, England, New Zealand, Denmark, etc.) show a significantly poorer prosthesis survival for PFA compared with TKA.

It is important for the future treatment of patients with severe osteoarthritis between the patella and femur to understand the cause of the discrepancy between RCT and registry results. The discrepancy gives rise to a number of questions regarding. indications, techniques, competences, postoperative regimens etc.

The divergence between the RCT and registry studies can only be clarified by a study that 1) examines the influence of preperative factors (patient history, physical findings, radiology etc.) on outcome, and that 2) attempts a causal analysis for each reoperation. The investigators intend to do this though a cohort study including all cases of patellofemoral arthroplasty performed in Denmark from January 1, 2008 until December 31, 2015.

The purpose is to determine preoperative risk factors for revision after PFA and to provide a detailed description of indications for revision after PFA.

Eligibility Criteria:
Inclusion Criteria:

* Patellofemoral arthroplasty
* Primary procedure performed between Jan 1 2008 and Dec 31 2015
* Primary procedure performed in Denmark

Exclusion Criteria:

* Patella-nail syndrome
* Dislocating tendon following patellectomy.
Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of moderate to severe hidradenitis suppurativa.

Hidradenitis suppurativa (HS) is a chronic devastating skin disorder affecting areas rich in apocrine glands. HS is diagnosed by its clinical features and its chronicity. It is recognized by the presence of recurrent, painful, deep-seated, rounded nodules usually ending in abscesses and sinus tracts with suppuration and hypertrophic scarring. As complement C5a is involved in the underlying acute inflammatory responses, this study is set up based on the hypothesis that IFX-1 might be able to block C5a induced pro-inflammatory effects such as neutrophil activation and cytokine generation, potentially contributing to the local skin inflammation and tissue damage.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, ≥ 18 years of age
* Written informed consent obtained from subject
* Diagnosis of HS for at least 1 year
* Moderate or severe HS, as indicated by HS lesions in at least 2 distinct areas, 1 of which must be at least Hurley Stage II or Stage III
* Inadequate response to at least 3 months of oral antibiotics, or intolerance to antibiotics
* Total abscess and inflammatory nodule (AN) count of ≥ 3

Exclusion Criteria:

* Prior treatment with adalimumab or another biologic product during the 24 weeks before Screening
* Subjects on permitted oral antibiotic treatment for HS (doxycycline or minocycline only) who have not been on a stable dose during the 28 days before Screening
* Subject received systemic non-biologic therapy for HS with potential therapeutic impact for HS during the 28 days before Screening (other than permitted oral antibiotics)
* Prior treatment with any of the following medications during the 28 days before Screening:

  * Any other systemic therapy for HS
  * Any iv anti-infective therapy
  * Phototherapy (ultraviolet B or psoralen and ultraviolet A)
* History of heart disease or malignancy
French Observatory of Congenital Ventricular Septal Defect With Pulmonary Overload

Ventricular septal defects (VSD) are the most common cardiac congenital heart defect (about 1/3 of patients with congenital heart disease). VSD management is related to hemodynamics and anatomical localization and the occurrence of complications. Small perimembranous VSD without pulmonary hypertension and without significant left to right shunting are tolerated, whereas large VSD with pulmonary hypertension require early surgical management in the first months of life. The management uncertainties concern the medium-sized perimembranous VSD causing a significant left-right shunt but without pulmonary hypertension, which are of variable treatment (surgical correction, percutaneous treatment, medical or abstention). There are no recommendations or consensus on the preferred indication of a therapeutic attitude.

The Pediatric and Congenital Cardiology Subsidiary, within the French Society of Cardiology, set up an observatory of perimembranous VSD with significant shunting, without pulmonary hypertension the objectives of this study are:

* To study the incidence of cardiovascular events in perimembranous VSD and search for predictive anatomical markers of events.
* To study the evolution of echocardiographic and functional data of patients having percutaneous or surgical closure compared to patient managed medically.

This observatory will provide a better understanding of the therapeutic algorithm in the management of VSD with pulmonary overload without pulmonary hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patient at least 1 year old
* Having a perimembranous VSD with pulmonary overload defined by "a left-right shunt and a z-score of the left ventricular end-diastolic diameter\> = 2".
* Consent for inclusion in the study was signed by the parents or legal guardian for minors, by the patient for the adults.

Exclusion Criteria:

* Congenital heart disease associated with membranous VSD
* Stenosis of the left ventricular outflow tract (average gradient ≥20 mmHg)
* Aortic insufficiency
* sub-pulmonary stenosis (mean gradient ≥20 mmHg)
* Tricuspid insufficiency ≥ 2/4
* History of cardiac surgery or cardiac interventional catheterization
* Shunt right-left through the VSD
* Pulmonary Arterial Hypertension defined on the data of a catheterization by PAPM\> = 25 mmHg and pulmonary vascular resistance\> = 3 UW.m²
* Active infectious endocarditis
* Cardiac insufficiency according to the "ESC 2016" criteria, other than a symptomatology of pulmonary hyper flow during the first year of life. Heart failure is defined by the presence of clinical signs of heart failure associated with a structural or cardiac functional abnormality resulting in a decrease in cardiac output and / or an increase in filling pressures.
* History of persistent or chronic atrial arrhythmia (atrial flutter, atrial tachycardia or chronic atrial fibrillation or requiring electrical cardioversion, drug therapy or endocavitary ablation)
* History of sustained ventricular arrhythmia (duration\> = 30 seconds)
* Complete BAV
* Refusal of the patient or guardian to participate in the study
Advance Health Mobile APP for the Self Management of Diabetes Type2

Digital health using mobile health (mHealth) tools, such as telehealth and text messaging, and or mobile Apps can improve blood glucose levels in patients with type 2 diabetes. This intervention is designed to improve self-management of diabetes and blood glucose levels in diabetic patients.

Patients with type 2 diabetes may experience improvements in their blood glucose levels thanks to mHealth technologies like mobile apps and telehealth text messaging. The goal of this intervention is to help diabetic people better control their blood glucose levels and diabetes. The intervention arm will employ a smartphone application designed specifically for individuals with Type 2 diabetes, with the goal of improving their self-management behaviors. Features of the app include real-time health monitoring, appointment scheduling, medication tracking, patient data storage, treatment and follow-up recommendations, and health education and promotion.

Eligibility Criteria:
Inclusion Criteria:

* The presence of T2D and at least 1 recorded HbA1c level of 8.0% or higher in the past 6 months
* Age between ages 21 and 85 years,
* Receiving primary care at the clinical site
* Having fluency in English/ Urdu in reading and writing
* Having a smartphone
* Agreeing to take part in the study

Exclusion Criteria:

* Planning to move away from the study site
* Being pregnant or in lactation, (6) being unable to send or read text messages on a mobile phone,
* Having a history of receiving or planning surgery.
Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis to Adapt Treatment

This study compares different methods of clinical evaluation (C) and/or ultrasound (B or D) concerning the rheumatoid arthritis in order to monitore the treatment. This study will provide the exact number of patients in remission according the 3 methods.

It could allow to assess the concordance between the 3 evaluated methods. This study will permit to define the best method which limit the evolution of structural damages ( principal criteria).

The aim of this study is to evaluate the Xrays evolution at 1 year ( at least one new erosion versus no erosion with the Sharp modified by van der Heijde) of patients affected by rheumatoid arthritis (ACR/EULAR 2010). The first approach is the assessment of remission defined by modified SDAI in order to evaluate in all cases the same number of joints \[Simplified Disease Activity Index algebric sum of 5 parametres : number of painful joints (28 joints) , number of synovitis (38 joints), global evaluation of patient and and practitioner with VAS, and PCR ≤ 3.3mg/l\] (mode C). The second one is a combined approach: clinical-ultrasound (same criteria but with MTPs and shoulders in B mode so a 26 joints evaluation with clinical examination and 12 joints evaluation in B mode) (mode B). The last one is an ultrasound approach (remission defined as the absence of power Doppler on 38 joints (28 of SDAI plus 10 MTPs joints) (mode D) in a pragmatical context (study assessed by private rheumatologists and hospital rheumatologists).

This trial is a National randomized multicentre trial that compares three modes of follow to adjust the therapeutic adaptation in Rheumatoid Artritis.

Eligibility Criteria:
* Inclusion Criteria:

  * Both gender patients aged 18 -to 80 years old
  * Patients will be eligible if they fulfill ACR/EULAR 2010 rheumatoid arthritis
  * All the treatment recommended for rheumatoïd arthritis (anti-inflammatory drugs, steroids, hydroxychloroquine, salazopyrine, methotrexate, ARAVA or biologics treatment: Enbrel, humira, remicade, cimzia, tocilizumab, rituximab, abatacept, simponi) would be in stable posology since at least 12 weeks before inclusion
  * Patients would be able to understand and be agree with the protocole
  * Patients would be able to consent
* Exclusion Criteria:

  * Patient unable to cooperate patient and who refuse to sign consent form
  * Patient unable to understand the study,under administrative supervision or legal guardianship
  * Signs and symptoms of uncontroled or severe progressive pathology at the level of renal, hepatic, hematological, endocrine, lung, cardiac, neurological or cerebral
  * Scheduled surgery procedure during the study on the estimated joint.
  * Patient non-affiliated to social security
  * Pregnant and nursing mothers
Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism

Autism Spectrum Disorders (ASD) include Autistic disorder, Asperger's syndrome and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). These are developmental disorders beginning prior to three years of age. Recent Centers for Disease Control (CDC) estimates suggest that ASD affects up to 1 in 100 individuals and up to 1 in 50 boys. There are very substantial costs associated with caring for patients with ASD, and ASD has the highest Caregiver Burden Scores of any condition. There are three core symptom domains of ASD, including social deficits, repetitive behaviors and language deficits. Patients can also have associated symptoms of attentional deficits, disruptive behaviors and intellectual disability. There is currently no Food and Drug administration (FDA) approved treatment for the core symptoms of autism, but risperidone and aripiprazole have FDA approval for disruptive behaviors associated with autism.

This is a 12 week randomized double blind placebo controlled trial of Milnacipran in adults with ASD or Aspergers Syndrome. Milnacipran is said to play a role in the activation and normalization of the locus coeruleus-noradrenergic system, of which is hypothesized to play a role in behavior adaptations and performance.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female patients
* Aged 18-50 years
* Diagnosis of Autism Spectrum Disorder
* intelligence quotient greater than 70

Exclusion Criteria:

* Pregnant subjects
* Patients deemed by comprehensive psychiatric interview to have a significant risk of suicide
Minimal Invasive Treatment of Inguinal Hernia in Neonates

In this study, preoperative physical examination findings, peroperative findings and data, and postoperative follow-up results of newborns who underwent inguinal hernia repair with PIRS ("Percutaneous Internal Ring Suturing") method will be evaluated retrospectively.

Congenital inguinal hernia is one of the most common surgical pathologies of childhood. Its treatment includes high ligation of the patent processus vaginalis by open or laparoscopic method. There are many described minimally invasive/laparoscopic repair techniques of inguinal hernias in children. One of them is "percutaneous internal ring suturing" or "Percutaneous Inner Ring Suturing".

There are many studies on the PIRS method in children. Two of these studies are prospective clinical studies published previously by the investigators of this study: in the first, the PIRS method was shown to be a safe and effective method for minimally invasive repair of inguinal hernia in children, and in the second, the use of subparalytic laryngeal masks in anesthesia of patients who underwent PIRS was shown to be sufficient for airway protection and anesthesia management in children undergoing laparoscopy.

Although there are many studies on the repair of inguinal hernia in children with PIRS or other minimally invasive methods in the last decade, there are very limited studies on the use of these methods in newborns, a special group of childhood patients. In the literature, there is no study examining only newborn patients. In this context, the study will be a first in the literature.

Eligibility Criteria:
Inclusion Criteria:

1. Having undergone PIRS surgery at the study institute between October 1, 2015 and January 1, 2023
2. Age between 0-28 days

Exclusion Criteria:

1. Age \> 28 days
2. Having had surgery with open surgery
3. Having another surgical procedure performed in the same session
Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Fit2ThriveMB

This study will test the feasibility and acceptability of increasing PA in metastatic breast cancer (MBC) patients using a smartphone app, fitbit and coaching.

The primary purpose of the present study is to pilot test the feasibility and acceptability of a 12 week mHealth intervention to increase PA in metastatic breast cancer (MBC) patients using a two-arm randomized control trial (RCT). We will also examine the effects of the intervention on symptom burden, quality of life, and functional performance. Inactive MBC patients will be assigned to Fit2ThriveMB or education control. Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls. Participants in the education control will be asked to download the app cancer.net from the American Society of Clinical Oncology, will receive educational materials and calls during the intervention period and the Fitbit following completion of 12 week assessments.

Eligibility Criteria:
Inclusion Criteria:

* Female; ≥18 years of age
* Diagnosed with metastatic breast cancer or locally advanced disease not amenable to surgical resection (Metastases to the auxiliary lymph nodes, and nowhere else in the body, do not qualify).
* Fluent in spoken and written English
* Own a smartphone
* Have access to the internet to complete assessments
* Self-report engaging in \<150 minutes of moderate to vigorous PA per week.

Exclusion Criteria:

* Untreated brain metastases
* Uncontrolled cardiovascular disease or other major contraindications (i.e. non- ambulatory, severe cognitive or functional limitations) to PA participation
* Current enrollment in another dietary or PA trial
Masseter Thickness, Bruxism, and Oral Behaviors in Chronic Neck Pain

A total of 30 patients aged 18-65 years who present with chronic non-specific neck pain and 30 healthy volunteers will be included in the study. Patients with symptoms persisting for at least 3 months will be eligible for inclusion. Necessary information will be provided to all participants, and informed consent will be obtained.

To assess pain severity before treatment, participants will be asked to rate their complaints using the Visual Analog Scale (VAS), a linear scale for pain assessment. The Neck Disability Index will be used to determine the level of disability.

The Jaw Functional Limitation Scale-20 (JFLS-20), Patient Health Questionnaire-9 (PHQ-9), Patient Health Questionnaire-15: Physical Symptoms, Generalized Anxiety Disorder-7 (GAD-7), and the Oral Behaviors Checklist-included in Axis 2 of the DC/TMD form developed for evaluating temporomandibular joint dysfunction-will be used to assess patients' psychosocial characteristics and parafunctional habits.

Additionally, masseter muscle thickness will be evaluated using ultrasonographic measurement.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic non-specific neck pain
* Aged between 18-65 years
* Symptoms persisting for at least 3 months

Exclusion Criteria:

* Pregnancy
* Presence of psychiatric or neurological diseases
* Use of psychiatric medications
* Cognitive impairment
* History of neck injection or surgery within the last 6 months
* Presence of rheumatic diseases
* Spinal stenosis
* Cervical disc herniation
* Advanced degeneration detected in radiological imaging
* History of fracture or surgery in the temporomandibular joint
* Presence of inflammatory, rheumatologic diseases, or malignancy affecting the t--emporomandibular joint
Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice

Can genetic markers be used to predict anti-TNF response? A cohort was established to identify SNPs associated with anti-TNF therapy in patients with inflammatory bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* CD or UC, treated with anti-TNF

Exclusion Criteria:

* Missing data
Reducing Delay of Vaccination in Children Study

This trial will assess the effectiveness of a tailored message intervention on decreasing infant undervaccination.

This intervention is based on the concept of "message tailoring," whereby each mother is provided with individually customized vaccine- related information that addresses their unique concerns, values, questions and logistical barriers. Message tailoring is an evidence-based health messaging strategy that has been shown to improve compliance with a wide variety of preventive health care behaviors among diverse patient populations.

In this three-armed trial the investigator will examine how providing mothers with multiple "doses" of a tailored versus untailored version of our intervention compares with "usual care" for the impact on infant under-vaccination. Secondary outcomes will include maternal vaccine-related attitudes (including level of vaccine hesitancy), alignment of maternal values with provider recommendations, and self-efficacy for overcoming logistical barriers to vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled at Kaiser Permanente Colorado, Pregnant in the 3rd trimester, and plan to use Kaiser Permanente Colorado for the child's medical care received.

Exclusion Criteria:

* less then 18 years of age, non-english speaking and an inability to consent