cyrilzakka/clinical-trials huggingface dataset:
Factors and Consequences Associated With Diabetic Foot Problems Among Diabetic Patients in Jordan

Purpose: To assess diabetic foot ulcers (DFU)-related risk factors and complications among diabetes mellitus (DM) patients in Northern Jordan. Also, to analyze the impact of educational intervention on their behavior.

Methods: The study consisted of two phases. Phase one was a prospective cross-sectional study of 200 DM patients, including 94 with a history of DFU, where demographic and clinical data were collected to assess diabetic foot-associated risk factors and complications. Phase two was a randomized clinical trial with 105 DM patients: 52 in the control group received standard care, while 53 in the intervention group received standard care supplemented with formal educational session and ongoing foot care education via mobile health by a clinical pharmacist. Foot care practices and medication adherence were evaluated at baseline and after 8 weeks of follow-up.

Background: Diabetes mellitus (DM) is a common chronic metabolic condition with numerous consequences, including diabetic foot ulcers. diabetic foot ulcer (DFU) is the major cause of non-traumatic lower extremity amputations. DFU is linked to several risk factors, including a lack of information and inadequate foot care practices. In Jordan, statistics on diabetic foot are few, with no evidence of the impact of patient education on disease outcomes.

Aims: To assess DFU-related risk factors and complications among DM patients in Northern Jordan. Also, analyze the impact of educational intervention on their behavior.

Methods: A prospective cross-sectional sample of 200 DM patients, including 94 with a history of DFU was initially selected. Subsequently, a smaller cohort of 105 patients was randomized into either a control group or an intervention group after providing written informed consent. The control group received standard care, while the intervention group received standard care supplemented with formal educational session followed by ongoing education on foot care using mobile health by a clinical pharmacist. Diabetic foot-associated risk factors and complications were assessed. Foot care practices and medication adherence were evaluated for both the control and intervention groups at baseline and again after 8 weeks of follow-up. Binary logistic regression was employed to assess factors associated with DFU. The Chi-square test and independent sample t-test were used to compare the behavior between the two groups before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults DM (1 year)

Have a mobile phone

Exclusion Criteria:

* Cognitive impairment
Postoperative Use Of Pump Blood İn Cardiopulmonary Bypass Surgery

In our study, the impact of administering autologous blood remaining in the cardiopulmonary bypass system during coronary artery bypass surgeries will be evaluated using the ROTEM device to assess its effect on coagulation parameters. Additionally, the influence of this autologous blood on the need for erythrocyte suspension will be examined, providing insight into its potential role in reducing transfusion requirements in the postoperative period.

Material and Method: The study included 60 patients scheduled for coronary artery bypass graft surgery who met the inclusion criteria. These patients were randomly assigned into two groups: 30 in the study group and 30 in the control group. Following the surgery, all patients were transferred to the intensive care unit under continuous monitoring. In the control group, ROTEM analysis was performed during the first postoperative hour. For the study group, blood from the oxygenator and tubing set was collected into a 1000 cc Ringer lactate bag, originally used as the pump's priming solution, under sterile conditions using a roller pump. The hematocrit levels and the total volume of the collected blood were measured and recorded in milliliters. The study group patients received a 30-minute infusion of this blood at the 1st postoperative hour. ROTEM was performed on the study group after the infusion had concluded.

Postoperative monitoring was carried out at four specific time points: the 4th hour, 24th hour, 48th hour, and upon discharge from the intensive care unit. During this period, the patients' drainage volumes, hemoglobin, hematocrit, leukocyte, and platelet counts were documented. In addition, fluid balance, BUN, and creatinine levels were tracked, along with mechanical ventilator duration and associated parameters. The study concluded with postoperative follow-up, and all collected data were analyzed statistically to assess outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Elective cardiopulmonary bypass surgery
2. Ages 18-70

Exclusion Criteria:

1. Patients not accepting to be included in the study
2. Having kidney disease
3. Having hematological disease
4. Having peripheral artery disease

3- Ejection Fraction \< 45% 4- Anticoagulants usage
MSG and Gastrointestinal Motility

The purpose of this study is to clarify the physiological function of sodium glutamate by measuring its effect on upper GI motility ( gastric emptying).

Amino acids such as monosodium glutamate are known to stimulate both endocrine and exocrine secretion. In addition, there is a report that oral intake of glutamate evokes the activation of vagal afferent nerves in the rat. Thus, such amino acids are thought to be influential in the process of digestion and absorption.

. To investigate the effect of monosodium glutamate on gastrointestinal motility, we planned a single-blind randomized study. The participants will take either monosodium glutamate or sodium chloride before the first examination of upper GI motility and the other agent before the second examination. The order of intake will be randomized by the envelope method.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Must not have digestive symptoms
* Must not eat within six hours of study participation

Exclusion Criteria:

* Regular medications for the gastrointestinal tract
* Previous Helicobacter pylori infection
* Previous abdominal surgery
Sevice-learning in Physiotherapy and Heart Transplantation and Acute Coronary Syndrome

A service-learning programme in physiotherapy students will be performed. 30 physiotherapy students will be randomly assigned to an intervention group (n=16) or to a control group (n=16). Intervention group will perform a service-learning program with real patients with heart transplantation, and will have to perform a physical therapy program adapted to a real patient. Two meetings will be performed in order to establish groups, explain the project and search information based on evidence in scientific databases. In addition, three meetings with patients will be stated in order to establish the adapted program based on the real patient's needs and characteristics. The control group will have to perform a physiotherapy program without meeting real patients.

This study aims at determining the effect of a Service-Learning program on knowledge, ethical sensitivity and acquired transversal competences. On the other hand, we aim at evaluating the service performed, the skills acquired, the participation, the degree of participatory evaluation and the level of satisfaction of the intervention group. All variables will be measured with validated scales or questionnaires.

Both groups will have to describe the specific characteristics of the program, different phases of the process, types of exercises recommended, contraindications, safety ranges with respect to the intensity of the exercise, ways of calculating the intensity and self-control. Likewise, they will have to defend the usefulness and duration of the final product through an oral presentation of the program to the patients themselves. Finally, the possible doubts that should exist will be solved.

Eligibility Criteria:
Inclusion Criteria:

* Physiotherapy students

Exclusion Criteria:

* Prior courses on cardiac rehabilitation
Ceftobiprole in Hospital Acquired Pneumonia

The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the water-soluble prodrug \[form\] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia.

Ceftobiprole medocaril (the water-soluble prodrug \[form\] of ceftobiprole), referred to as ceftobiprole is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole is not yet approved for the treatment of nosocomial (hospital-acquired) pneumonia. This is a randomized, double-blind, multicenter study of ceftobiprole versus a comparator (linezolid plus ceftazidime) to assess the effectiveness and safety of ceftobiprole in patients with nosocomial pneumonia. The patients will be randomized to receive ceftobiprole plus placebo or the comparator. The primary endpoint is the clinical cure rate of ceftobiprole at the test-of-cure visit. The patients will receive either ceftobiprole plus placebo or the comparator for 7 to 14 days (unless extended at discretion of medical monitor). Patient safety will be monitored throughout the study. In December 2006, this study (BAP00307) and another similar study (BAP00248, see NCT00229008) were amended (changed) to create 1 study (BAP00248/307).Therefore, the results reported for this study will be combined with the results reported for study BAP00248. Patients will receive either ceftobiprole plus placebo or a comparator by intravenous infusion for 7 to 14 days (unless extended at discretion of medical monitor).

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from nosocomial pneumonia or ventilator-associated pneumonia
* Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control, before entry and throughout the study, and have a negative serum or urine pregnancy test at the screening

Exclusion Criteria:

* Known or suspected hypersensitivity to any related antibiotic medications
* Any known or suspected condition or concurrent treatment that would be contraindicated by the prescribing information
* Treatment with any investigational drug within 30 days before enrollment
* Prior enrollment to this study
Cognitive Impairment and Affective Mood Disorders in Patients With IBD

The aim is to evaluate the presence of mild cognitive impairment (MCI) in patients with inflammatory bowel disease (IBD). This will be done by cognitive tests. Along them, screening for depression, anxiety and stress will be done. A blood sample for determining serum values of homocysteine, protein S100-B, amyloid and BDNF will be stored. Patients will be followed-up for 2 years.

The aim is to evaluate the presence of mild cognitive impairment (MCI) in patients with inflammatory bowel disease (IBD). This will be done by cognitive tests. Along them, screening for depression, anxiety and stress will be done. A blood sample for determining serum values of homocysteine, protein S100-B, amyloid and BDNF will be stored. Patients will be followed-up for 2 years.

Study has 3 phases: inclusion, 1 year visit and 2 year visit. Inclusion: consent signing, checking exclusion and inclusion criteria, cognitive testing, blood sample storing, questionnaires for screening.

1. year visit: cognitive testing.
2. year visit: cognitive testing.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of IBD for IBD group.
2. No diagnosis of IBD for healthy controls group.
3. Obtainment of signed informed consent.

Exclusion Criteria:

1. No consent form signed.
2. Pregnancy.
3. Severe organ insufficiency (cardiac, renal, respiratory, liver).
4. Prior severe head trauma.
5. Neoplasia.
6. Prior neurodegenerative disease.
7. Prior diagnosis of cognitive impairment or dementia.
8. Prior cardiac arrest.
9. Use of B9 and B12 vitamin supplements.
10. Involvement in other clinical trials.
11. Unclear diagnosis.
12. Prior psychiatric disorders.
13. Prior use of neuroleptics.
14. Proven history of familiar Alzheimer disease.
15. Alcohol and drugs abuse.
16. Prior stroke.
17. Prior myocardial infarction.
To Investigate the Effect of Montelukast on Behavior Problems in Children With Asthma

The purpose of the study to investigate whether montelukast lead to behavior problems in children with asthma.


Eligibility Criteria:
Inclusion Criteria:

* To have asthmatic children aged 18-60 months
* To have that receive prophylactic treatment for asthma
* Healthy children will be enrolled among those being brought for routine controls

Exclusion Criteria:

* Children with other chronic disease
* Children with chronic drug use (except for the treatment of asthma)
A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis

This is a double-blind, randomized, active-controlled, parallel group, Phase 1/3 study to compare efficacy, PK, PD and overall safety of CT-P53 with Ocrevus in patients with Relapsing-remitting Multiple Sclerosis.

CT-P53, containing the active ingredient ocrelizumab, is a humanized monoclonal antibody that is being developed as a proposed biosimilar medicinal product to Ocrevus. The purpose of this study is to demonstrate similar efficacy, PK, PD and safety of CT-P53 and Ocrevus in patients with Relpasing-remitting Multiple Screlosis.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed as multiple sclerosis (MS) in accordance with the revised McDonald criteria.
* Patient has evidence of recent MS activity as defined in the study protocol
* Patient has neurological stability for ≥30 days.
* Patient with 0 to 6.0 (both inclusive) on the EDSS score.

Exclusion Criteria:

* Patient diagnosed with primary or secondary progressive MS.
* Patient diagnosed with MS for more than 15 years duration with an EDSS score ≤2.0 at Screening.
* Patient unable to complete or has a contraindication to an MRI
* Patient with contraindications and/or severe hypersensitivity to corticosteroids including methylprednisolone or any of the excipients of study drug or etcs defined in the study protocol.
* Patient who has currently or history of any of medical conditions described in the study protocol.
* Patients who have received or going to receive any of prohibited medications or treatments defined in the study protocol.
Life-style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy

Takotsubo cardiomyopathy presents like a heart attack and is typically triggered by intense emotional or physical stress. Recovery of this condition varies and many patients continue to suffer from symptoms such as fatigue and breathlessness for a protracted period after their event. The purpose of this study is to establish whether following a structured exercise program or a mental wellbeing program compared to usual care for 12 weeks after an episode of Takotsubo will result in significant improvement in the brain activity, general and mental wellbeing of patients.

Takotsubo cardiomyopathy is characterised by sudden onset left ventricular dysfunction precipitated by major stress. This neuro-cardiac condition has a 5-year morbidity and mortality comparable with acute myocardial infarction and no current therapies exist. The psycho-somatic basis of Takotsubo suggests that its neuro-biology could be amenable to modulation. Here, the investigators propose a mechanistic three-arm pilot feasibility trial of standardised physical exercise training, cognitive behavioural therapy and current standard of care in patients who suffered a very recent episode of takotsubo cardiomyopathy.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with takotsubo cardiomyopathy in the previous three weeks
* Participant who is willing and able to give informed consent for participation in the study.
* Participant who is willing to travel to Aberdeen Royal Infirmary for the study visits.
* Healthy volunteers (for blood and saliva samples only) willing to give informed consent for participation in the study. Healthy volunteers should not be on any medication.
* For influenza T-Cell testing: healthy volunteers who have recently received their annual flu vaccination.
* Myocardial Infarction (MI) comparators: patients with type 1 acute MI (diagnosed within the last three weeks)

Exclusion Criteria:

* Any patient whose takotsubo cardiomyopathy was triggered by a physical illness that would preclude them from taking part in a physical exercise training program
* Any patient who is not able or willing to travel to the cardiovascular research facility for their study visits
* Any patient who is not able to commit to a 12 week supervised training program
* Inability to exercise on a cycle ergometer or a treadmill (e.g. use of walking aids or prosthetic limbs or advanced frailty)
* Unwillingness to participate
* Contraindication to MRI scanning such as implantable cardiac devices.
* Pregnancy
* Healthy volunteers taking medication
Extended-Release Melatonin in Patients With Rapid Eye Movement Sleep Behavior Disorder

The purpose of this research is to compare the efficacy of immediate versus extended-release melatonin as a supplement affecting the sleep cycle in patients with Parkinson disease and Rapid Eye Movement Sleep Behavior Disorder.

Enrolled patients with Parkinson disease and previously diagnosed rapid eye movement sleep behavior disorder, who are being treated at Mayo Clinic in Florida, will be randomized to receive either immediate-release melatonin or extended-release melatonin and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of 4 weeks separated by a washout period of 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Parkinson's disease and rapid eye movement sleep behavior disorder.
* Patient registered to Parkinson's disease database of Mayo Clinic Florida.

Exclusion Criteria:

* Patients who are using other sleep aids or medications (Clonazepam).
* Patients who are not willing to undertake 1 week of washout period.
* Patients who do not sign a consent for research.
Supplementation of n-3 PUFA in the Modulation of Lean Mass in Patients With Lung Cancer Receiving a High-protein Diet

This study is conducted to test the hypothesis that patients with lung cancer undergoing treatment with immunotherapy, chemotherapy and tyrosine Kinase Inhibitors receiving a high protein diet and supplemented with fish oil will improve muscle mass, therapeutic response and modulate the intestinal microbiota within a 4 month period.

Lung cancer (PC) is the most prevalent tumor. The loss of muscle mass, myosteatosis and changes in body composition have been associated with inflammation in cancer and PUFA n-3 have been shown to be an important modulator of the inflammatory response and epigenetic mechanisms. Additionally, the intestinal microbiome has received prominence with the use of immunotherapy, as it is demonstrating that resistance to this therapy can be attributed to the abnormal composition of the intestinal microbiome. Aims: The purpose of this study is to assess the effects of fish oil supplementation in the modulation of lean mass and intestinal microbiome in patients with lung cancer undergoing treatment with immunotherapy, chemotherapy and Tyrosine Kinase Inhibitors receiving a high-protein diet. Methods: Fifty patients will be randomly allocated either to treatment with fish oil or to placebo for 4 months. The following assessments will be made: lean mass, myosteatosis, sarcopenia, adipose compartment, inflammation, micro RNA, food consumption, membrane phospholipid composition, composition of the intestinal microbiota, toxicity, response to antineoplastic treatment and survival.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-small cell lung cancer, both sexes, ECOG performance status (0-2) eligible for treatment with immunotherapy, chemotherapy and tyrosine Kinase Inhibitors.

Exclusion Criteria:

* supplementation of PUFA n-3 in the last 6 months; weight loss\> 10% in 6 months, chronic liver disease, previous chronic kidney disease, anorexia, decompensated diabetes mellitus and dementia.
Afamin in Gestational Diabetes Mellitus

This study includes pregnancies in 11 to 14 th gestational weeks. Investigators will sample maternal plasma in the first trimester and analyze maternal plasma afamin values. All these women will then be screened by two step OGTT. Investigators will compare afamin levels in GDM and control groups.

Background Gestational diabetes mellitus (GDM) is an endocrinopathy that occurs during pregnancy, and presents several clinical findings together with increased blood glucose levels. The frequency of GDM differs, while the incidence of the disease in Turkey is reported to be 7%. Most of the societies recommend screening all women with or without any risk factors in terms of GDM. The definitive diagnosis is made via oral glucose challenge test (OGTT). Early diagnosis and treatment are the key points to improve maternal and fetal outcomes. Different biomarkers are studied regarding GDM diagnosis starting from first trimester. However, there is not a worldwide accepted biomarker for defining the high risk group to the date. Afamin is known as an important indicator of oxidative stress. Moreover, oxidative stress itself is strongly associated with insulin resistance and obesity which are responsible from GDM pathogenesis.

Objective To investigate the association between first trimester maternal plasma afamin levels and GDM. Also, investigators aimed to understand the role of afamin for the prediction of GDM in this study.

Methods This is an observational prospective cohort study conducted in Department of Perinatology, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital, University of Health Sciences, Ankara, Turkey. During 11 and 14 weeks of gestational, maternal blood will be obtained from eligible pregnant women, and samples will be stored at -80 oC. Informed written consent will be obtained from participants. Between 24th and 28th gestational weeks, all these women will be screened by two step OGTT. Then, afamin levels will be compared in GDM and control groups. Exclusion criteria are; multiple pregnancy, fetal anomalies, pregestational diabetes, underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders), age \<18 or \> 35 years, fasting glucose level \> 105 mg/dL or random glucose level \> 200 mg/dL.

Eligibility Criteria:
Inclusion criteria:

* singleton pregnancy,
* having no fetal anomalies
* having no pregestational diabetes
* having no underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders)
* age \>18 or \< 35 years
* fasting glucose level \< 105 mg/dL

Exclusion Criteria:

* multiple pregnancy
* fetal anomalies
* pregestational diabetes
* underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders)
* age \<18 or \> 35 years
* fasting glucose level \> 105 mg/dL or random glucose level \> 200 mg/dL