cyrilzakka/clinical-trials huggingface dataset:
Foot Abnormalities in Diabetic CKD Patients

1. To find the correlation between different stages of CKD and type and severity of foot abnormalities in diabetic patients with CKD.
2. To assess factors that may aggravate foot abnormalities in diabetic patients with CKD by measuring serum calcium, phosphorus, parathyroid hormone, albumin, uric acid...etc.

Chronic kidney disease is an important contributor to morbidity and mortality, the global prevalence of CKD was 9.1% (697.5 million cases) in 2017(1). Diabetes is a leading cause of end stage renal disease worldwide. (2) Foot abnormalities and amputation are major health concerns as they diminish health-related quality of life and cause financial burden (3).

KDIGO 2020 defines Chronic Kidney Disease (CKD) as persistently elevated urine albumin excretion (≥30 mg/g \[3mg/mmol\] creatinine), persistently reduced estimated glomerular filtration rate (eGFR \<60 ml/min per 1.73 m2), or both, for greater than 3 months. (4) Diabetic foot is defined as either diabetic peripheral neuropathy, peripheral arterial disease, infection, ulceration, or Charcot osteoarthropathy, or a combination of these abnormalities, in a person diagnosed with diabetes mellitus, according to the guidelines of International Working Group of Diabetic Foot 2020 (IWGDF). (5) There is a much higher incidence of diabetic foot disorder in those with renal disease and outcomes are generally poorer (2) as CKD patients are sharing three main risk factors of foot ulceration and amputation: neuropathy, peripheral arterial disease and increased susceptibility to infection with impaired wound healing. (6)

this research is conducted as little is known about the potential relationship between chronic kidney disease and diabetic foot. This research evaluates the true burden of different diabetic foot lesions in CKD patients, assesses the severity of diabetic foot in different stages of CKD and the factors that may aggravate it in CKD, for future need to modify our clinical policies in management of diabetic foot in CKD patients to provide better prognosis and prevent long term disabilities.

Eligibility Criteria:
Inclusion Criteria:

1. Diabetic CKD patients classified according to estimated GFR into 5 stages according to KIDGO 2012 classification:

   Stage 1 CKD: eGFR 90 or Greater Stage 2 CKD: eGFR Between 60 and 89 Stage 3 CKD: eGFR Between 30 and 59 Stage 4 CKD: eGFR Between 15 and 29 Stage 5 CKD: eGFR Less than 15 etheir on dialysis ( satge 5 D) or not (stage 5 non D)
2. Age more than ≥18 years

Exclusion Criteria:

1. Patients administer drugs causing neuropathy as:amiodarone, chemotherapy, oxazolidinone linezolid, isoniazid, metronidazole, nitrofurantoin ,immunosuppressants, nucleoside reverse transcriptase inhibitors, levodopa and antifungal drugs.
2. Patients with other causes of CKD.
3. Patients have other causes of PVD.
4. Age less than ˂18 years.
5. Patients' refusal to participate in the study.
Effects of Virtual Reality and Cyclic Training on Balance

Stroke is the third leading cause of functional disability and death in the world. It leads to many problems that affect gait, upper extremity function and balance. In stroke patients balance dysfunction leads to impaired postural control and walking. Because of poor balance fall rate increases in stroke patients. Balance is an important predictor of outcome in stroke rehabilitation. After stroke difficulties in balance control may be caused by multiple factors such as muscle weakness, impaired proprioception, and asymmetry in weight wearing, spasticity and impaired motor control. Different means are used to treat stroke, some conventional treatments along with new adjunct therapies are usual practice for the rehabilitation of the stroke.

Virtual Reality is choice of adjunct therapy now a days and can be used in different ways for the rehabilitation. Virtual Reality or active video gaming proved their role as vital part of the treatment program in pediatric rehabilitation as well as adult rehabilitation program. These programs help the patient to achieve goals for functional and activities of daily living skills.

This study will be a randomized control trial, used to compare the effectiveness of virtual reality and cyclic training on balance in sub-acute stroke patients. Subjects with sub-acute stroke meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique. Assessment will be done by using berg balance scale (BBS) and time up and go test. Subjects in one group will be treated with Virtual reality and Conventional therapy and in other group Cyclic training and Conventional therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Sub-acute stroke
2. Able to stand for 5 minutes
3. The score of mini mental state examination (MMSE) \> 19
4. Male and Females (both genders)
5. Verbal instructions can follow

Exclusion Criteria:

1. Visual and auditory problem unable to hear and see feedback from the video game and problem of vestibular system
2. Spasticity of lower limb
3. Any other medical condition that could affect movement and balance
4. Use of pacemaker, apraxia, epilepsy
5. Psychiatric disorders
External Stressors Prior to Traumatic Knee Injury in Youth Athletes.

The aim of this study is to evaluate different aspects of mental stress aspects and its role as a potential risk factor for traumatic knee injury in youth athletes. Approximately 300 athletes (age 16-19) 50% women) who are involved in high risk sports (soccer, handball and floorball) will be included. The athletes will record his/hers traumatic knee injury together with information about training regimes and some details on injury mechanism on a web-based form. The form also includes questions about mental stressors, such as club exchange, changed game system in addition to conflict within and outside the family, etc, prior to injury.

The present study will contribute new knowledge on levels of muscle function and different aspects of mental stress factors that may be related to traumatic knee injury in young athletes.


Eligibility Criteria:
Inclusion Criteria:

Male and female sport high school athletes Aged 15-19 years Participating and competing in soccer, handball, or floorball

Exclusion Criteria:

Traumatic knee injury prior to sport high school.

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NOsocomial Dissemination Risk of SARS-Cov2

To date, in France, in the context of the SARS Cov2 pandemic,both the number of affected subjects and the number of severe forms requiring hospital care are increasing.

Several nosocomial transmission clusters have already been identified in hospitals (both pediatric and adult) but there is still limited data on the nosocomial spread of SARS-Cov2.

This nosocomial transmission affects both patients and caregivers. It is important to understand the spread of the virus within the hospital. This will help to optimize procedures to prevent transmission to caregivers and hospitalizedpatients not infected with SARS Cov2, and more generally this will contribute to control the spread of SARS Cov2 in the community

It is an observational study without any risk. Every participating service will be investigated for 2 consecutive days .

* At each staff rotation, an individualsensorwill be provided toall thestaff(caregivers, administrative, students etc...) to be worn duringtheirworking hours. Also a sensor will be placed at each patient's bedside.
* In addition, epidemiological data relating to socio-demographic characteristics, profession, protective measures will be collectedfrom hospitalstaff. Also, some data from the 'entrepot des données de santé" regarding individual carepathways in the hospitalwill be extracted.
* A map of the unit, specifying the location of each patient will be made.

Eligibility Criteria:
Inclusion Criteria for patients:

* Informed of the purpose of the study and having expressed his non-opposition or of a relative (if the patient's state of health does not allow it)
* Hospitalized in one of the participating departments

Inclusion criteria for hospital staff:

* Informed of the objective of the study and having expressed his no opposition
* Having daily contact with patients hospitalized in participating departments

Inclusion criteria for patient visitors

* Informed of the purpose of the study and having expressed his non-opposition
* Having daily contacts with patients hospitalized in the participating departments

Exclusion Criteria for evryone (patient, hospital staff and patients visitors) :

* Refuse to participate
Study Mild Intermittent Asthma to Assess the Topical Safety and Tolerability of Albuterol Sulfate Acu-30™ DPI

This open label single blind study will determine the safety of albuterol sulfate dry powder in a novel inhaler by observing for the potential occurrence of reflex bronchial constriction after inhalation of increasing doses of the compound.

This is a single blind (investigator unblinded), open label, single exposure, non-randomized, single center, outpatient, stepwise, rising dose study in male subjects with mild intermittent asthma to assess topical safety and tolerability of Albuterol Sulfate Acu-30™ DPI, compared with Placebo Acu-30™ DPI. Increasing doses of each drug will be administered in a sequential fashion in 4 steps to 3 different subjects at each step (a total of 12 subjects) with mild intermittent asthma in each step.

Eligibility Criteria:
Inclusion Criteria

* Mild intermittent asthma (meeting GINA specifications - www.ginasthma.com)
* Medically normal subjects with no significant abnormal findings
* No tobacco (nicotine products) use for at least 2 years before the study starts
* Normal (or abnormal and clinically insignificant) laboratory values at screening (potassium or glucose levels)
* No significant medical or surgical conditions (COPD, cystic fibrosis, severe allergic rhinitis)

Exclusion Criteria:

* Past or present history of experiencing any allergic reaction to the medications/formulations administered in this study, or in the opinion of the Principal Investigator, suggests an increased potential for an adverse hypersensitivity
* Subject with abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Patients With Rheumatoid Arthritis

A drug interaction study to evaluate the effect of ASP015K (twice daily) on the pharmacokinetics (PK) of once weekly oral methotrexate (MTX).

Patients check in on day -1 and remain confined until all the exit procedures are performed on the morning of day 10. Patients to return for 1 post-treatment follow-up visit on day 13.

Patients receive a single dose of methotrexate on day 1 and day 8 and ASP015K (twice daily) on days 3 through 8 plus the morning of day 9.

Eligibility Criteria:
Inclusion Criteria:

1. If female, subject must be at least 2 years post menopausal or is surgically sterile per documentation provided by a medical professional and the subject is not pregnant as documented by a negative serum pregnancy test at Screening and negative urine pregnancy test at check-in
2. If male, subject must agree to sexual abstinence and/or to use a highly effective method of birth control during the study period and for 60 days after the last dose of study drug
3. Subject must have a clinical diagnosis of Rheumatoid Arthritis (RA) at least 6 months prior to Screening
4. Subject must be on a stable 15 - 25 mg dose of methotrexate \> 28 days prior to Screening
5. If subject is on a non-biologic disease modifying anti-rheumatic drug (DMARDs) therapy, the dose must be stable \> 28 days prior to Screening
6. Subject must be willing and able to comply with the study requirements

Exclusion Criteria:

1. Subject has a previous history of any clinically significant neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that would preclude participation in the study
2. Subject has a known history of positive test for hepatitis B surface antigen (HbsAg) or hepatitis C antibody or history of a positive test for human immunodeficiency virus (HIV) infection
3. Subject has received live virus vaccination within the last 30 days prior to study drug administration
4. Subject has a Body Mass Index (BMI) \> 35 (kg/m2)
5. Subject is on biologic disease modifying anti-rheumatic drug (DMARDs) therapy
6. Subject has a current history of anemia as defined by hemoglobin of less than 12 g/dL
7. Subject has a recent history (within the last 6 months) of drug or alcohol abuse or a positive urine screen for alcohol or drugs of abuse/illegal drugs at Screening or check-in
8. Subject has received any investigational agent within 30 days of screening
Coronary Artery Disease and Exercise Adherence

This study aims to determine the factors affecting exercise adherence in patients with coronary artery disease (CAD). For this purpose, the following measurement tools will be used respectively: (1) "Patient Information Form" including sociodemographic characteristics of the patients and medical information related to the disease, (2) the Exercise Adherence Rating Scale (EARS), (3) Exercise Self-Efficacy Scale (ESE) and, (4) Turkish-Health Literacy Survey Europe-Q12 (HLS-EU-19-12Q-TR). Statistical analyses will be carried out by descriptive statistics (number, percentage, mean, standard deviation, etc.), correlation analysis and regression analysis.

Coronary Artery Disease (CAD) is the most common form of cardiovascular disease in the world and is one of the leading causes of mortality and morbidity in Turkey and worldwide. Exercise training is very important in the treatment of CAD because of its various cardiovascular benefits. However, most patients have been shown to have low to moderate adherence rates to the recommended exercise prescription. The results of a limited number of studies show that the factors affecting exercise adherence in patients with CAD need to be supported by new studies. This study aims to determine the factors affecting exercise adherence in patients with coronary artery disease (CAD). The study will be conducted with CAD patients followed up in the cardiology clinics of a tertiary care hospital in northern Turkey. A cohen's d will be calculated using preliminary data from 20 patients using Exercise Adherence Rating Scale (EARS), and an adequate sample size will be determined with a 95% confidence interval, a bias level of 0.05, and 80% power. Patients with a diagnosis of CAD confirmed by a physician at least one year ago, who have been recommended any exercise/physical activity by a physician according to article 1 of EARS, who are ≥18 years old and \<75 years old, and who have the ability to understand and speak Turkish will be included in the study. The data will be collected using the following measurement tools respectively: (1) "Patient Information Form" including sociodemographic characteristics of the patients and medical information related to the disease, (2) the Exercise Adherence Rating Scale (EARS), (3) Exercise Self-Efficacy Scale (ESE) and, (4) Turkish-Health Literacy Survey Europe-Q12 (HLS-EU-19-12Q-TR). Statistical analyses will be carried out by descriptive statistics (number, percentage, mean, standard deviation, etc.), correlation analysis and regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of CAD confirmed by a physician at least one year ago,
* Individuals who have been recommended any exercise/physical activity by a physician according to item 1 of the EARS,
* Turkish comprehension and speaking skills.

Exclusion Criteria:

* Presence of serious physical and mental health problems,
Examining the Role of Pain in the Link Between Early Childhood Adversity and Psychopathology

The goal of this study is to investigate the role of physical pain in the link between childhood adversity and later psychopathology. Children who are participating in a larger longitudinal study will be asked to submerge their hand in cold water and hold it in the cold water as long as possible. Participants will do this twice, once alone and once holding the hand of their parent, to examine the role of parental support in pain development. The study will examine self-report of pain and salivary cortisol response to pain. It is hypothesized that children who have been exposed to more adversity will experience increased pain response and increased psychopathology symptoms. It is expected that higher social support in the family will decrease this relationship.

This study will initiate a program of prospective research, linking early life adversity to both pain and psychopathology symptoms in the pre-adolescent period. This study will examine these links using an existing longitudinal sample of 6.5-9.5 year-old children experiencing familial stress. The project will examine the relationship between dysregulation and pain sensitivity from the behavioral perspective, but also through HPA axis dysregulation. Finally, the project will probe parental support as a moderator on the relationship between dysregulation and pain and psychopathology symptoms. The project will use a novel adaptation of the cold pressor test to examine experimental pain sensitivity as a function of parental support by including a condition in which the child holds the hand of their parent during the task. The project will also examine the neural basis of social support through parent-child brain synchronization. Support for the proposed model may indicate that interventions that increase parental support might decrease both pain and psychopathology.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have been enrolled in our ongoing CARE study

Exclusion Criteria:

* Subjects who have not participated in the CARE study
Gastric Venous Reconstruction After Total Pancreatectomy

Total pancreatoduodenectomy (TP) is the standard surgical approach for treatment of extended pancreas tumors. If the gastric coronary vein has to be sacrificed for oncologic or for technical reasons in total pancreatectomy with splenectomy, gastric venous congestion (GVC) may result because all major venous draining routes are terminated. In the sequelae of GVC, gastric venous infarction ultimately leads to gastric perforation with abdominal sepsis. To avoid gastric venous infarction, partial or even total gastrectomy is usually performed in the event of GVC after TP. However, this significantly impacts the patient's quality of life.

Reconstruction of gastric venous outflow represents a technical approach to overcome GVC and to avoid gastric venous infarction making (partial) gastrectomy unnecessary. The current study aims to assess the role of gastric venous outflow reconstruction in GVC after TP to prevent (partial) gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Provide written informed consent
* Elective total pancreatectomy for malignant or benign pancreatic lesions or chronic pancreatitis with splenectomy
* Intraoperative ligation of coronary vein

Exclusion Criteria:

* Gastric resection due to malignant infiltration
* Non-reconstructable gastric venous drainage
* Previous pancreas surgery
Evaluation of a Novel Method for Hematocrit Level Determination

The hematocrit level is defined as the ratio of plasma volume and red blood cell mass. Determination of this level is important for the diagnosis and follow-up of various hematological and renal disorders. In clinical practice, automated hematology analyzers are commonly used.

Recently, a new method for hematocrit level determination has been introduced which employs layered resonant piezoelectric sensors. In the present study this technique will be applied in blood samples of healthy subjects and compared to a standard laboratory method.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 80 years
* Men and women will be included in equal parts
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Symptoms of a clinically relevant illness in the 3 weeks before the study day
* Systemic treatment with anticoagulants
* Intake of any medication that could lead to spurious hematocrit values
* Presence of any medical condition that could lead to spurious hematocrit values
* Blood or plasma donation during the previous 3 weeks
Supervised Exercise as a Therapeutic Strategy for Interstitial Cystitis/Bladder Pain Syndrome

In this study, the efficacy of exercise to improve interstitial cystitis/bladder pain syndrome symptoms and quality of life will be investigated.

Effective treatment for symptoms associated with interstitial cystitis/bladder pain syndrome is a significant clinical challenge due to the lack of insight into disease etiology/pathophysiology, costly and potentially invasive procedures, and a lack of research into potential therapeutics. The primary objective of this study is to determine if a supervised exercise program by a trained exercise physiologist can relieve pain and improve urinary and bladder symptoms in patients with interstitial cystitis/bladder pain syndrome. This has the potential to open enormous future avenues of research, save both patients and the healthcare system cost, and most importantly improve patients' lives. A second objective of this study is to determine if exercise alters depressive symptoms, often a comorbid diagnosis, in patients with interstitial cystitis/bladder pain syndrome. A third objective of this study is to examine urinary markers of inflammation before and after exercise in patients with interstitial cystitis/bladder pain syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Adult females (\>18 years and \<80 years) with a previously established clinical diagnosis of Interstitial cystitis/bladder pain syndrome (IC/BPS) will be eligible to participate
* Must speak English
* The clinical diagnosis of IC/BPS will be based on the recently published American Urological Association Guidelines definition: "An unpleasant sensation (pain, pressure, or discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms for more than six weeks duration, in the absence of infection or other identifiable causes"
* The diagnosis will be confirmed by a urologist who specializes in the treatment of patients with IC/BPS

Exclusion Criteria:

* Study participants must be fully ambulatory without the use of a cane, walker, or wheelchair
* Study participants must be able to tolerate moderate aerobic exercise. It will also be required that a physician clear any subjects entering the exercise program who have signs and symptoms suggestive of cardiovascular, cerebrovascular, metabolic, or renal disease and have been active 3 days per week for 30 minutes each day
* Any history of bladder cancer, uterine cancer, ovarian cancer, vaginal cancer, the current placement of a catheter, urethral diverticulum, spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida, cyclophosphamide treatment, radiation cystitis, bladder tuberculosis, or are experiencing an active genital herpes episode
* Pregnant women are not eligible for this study