cyrilzakka/clinical-trials huggingface dataset:
This Study is About the Efficacy of Repetitive Peripheral Magnetic Stimulation on the Treatment of Shoulder Subluxation in Subacute Stroke Patients.

The goal of this clinical trial is to study the efficacy of repetitive peripheral magnetic stimulation (rPMS) on shoulder subluxation in subacute stroke patients. The main questions it aims to answer are Could rPMS reduce shoulder subluxation and improve upper-limb motor recovery in subacute stroke patients?

Researchers will compare real rPMS to sham rPMS to see if rPMS works to improve shoulder subluxation and upper-limb motor recovery in subacute stroke patients.

Participants will:

* Get real rPMS or sham rPMS for 20 minutes, 5 days a week for 2 weeks
* Get conventional rehabilitation program 5 days a week for 2 weeks
* Follow-up at 2-, 4-, 8- and 12-weeks after first day of treatment


Eligibility Criteria:
Inclusion Criteria:

* Subacute phase (seven days to six months) and first time of stroke patients
* Shoulder subluxation that measured half of a fingerbreadth or more
* Meet the criteria for admission to a comprehensive rehabilitation program
* Medically stable
* Intact skin on the hemiparetic arm

Exclusion Criteria:

* Patients with contraindication for magnetic stimulation; cardiac pacemakers, magnetic materials near the intended stimulation site
* Patients with pregnancy
* Patients with severe aphasia or severe cognitive impairment
* Patients with previous shoulder pathology or limit shoulder function before stroke
* Patients with unstable vital signs
Trial of Leptin Replacement Therapy in Patients With Lipodystrophy

Lipodystrophies represent a therapeutic challenge with regards to insulin resistance, hypertriglyceridemia and fatty liver which often is coupled with significant adipose tissue loss. The purpose of the study is to examine the safety and efficacy of Leptin on subjects with lipodystrophy.

The mechanism by which leptin improves glucose and lipid control is not clear. We will examine the possible mechanisms of leptin action by studying the effects of leptin administration on food intake, insulin resistance, insulin secretory response, hepatic and intramuscular triglyceride stores in a large sample of patients with lipodystrophy.

Hypothesis: Leptin replacement in patients with generalized and partial lipodystrophy and hypoleptinemia will be safe and efficacious in improving the metabolic abnormalities associated with insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* age \> 6 years
* Partial and generalized lipodystrophy
* Serum leptin levels less than the 7th percentile of normal values reported by the 3rd National Health and Nutrition Examination survey (less than 7.0 ng/mL in females and less than 3/0 ng/mL in males)
* Presence of at least one of the following metabolic abnormalities:

  1. Type 2 Diabetes Mellitus
  2. Fasting serum insulin \>20 uU/mL
  3. Fasting serum triglycerides \> 300 mg/dL
  4. Previous participation in leptin trial (Amgen 991265, GCRC 660) - for Part B of the Study.

Exclusion Criteria:

* Known liver disease due to causes other than non-alcoholic steatohepatitis.
* Hematocrit of less than 30%.
* Current alcohol or substance abuse.
* Use of anorexigenic drugs, anabolic steroids, GH and thiazolidinediones
* Active tuberculosis
* Psychiatric disorder impeding competence or compliance
* Malignancies
* HIV infection
* Subjects who have a known hypersensitivity to E. Coli derived proteins
* Other condition, which in the opinion of the clinical investigators would impede completion of the study.
Standardization of Ambulance Equipment

The aim of the research is to find out what effect the standardization of ambulance equipment has on the speed of performing specific medical procedures.

The aim of the research is to find out what effect the standardization of ambulance equipment has on the speed of performing specific medical procedures. In two simulated scenarios, the times from the decision to execution of medical procedures will be measured. In the first scenario, the equipment is located in the standard way and the research participants know where it is located. In the second scenario, the equipment is placed elsewhere and participants do not have the opportunity to check the equipment before the scenario. For the statistical comparison the Student's T-test and Wilcoxon signed-rank test will be used. For analysis of variance will be used the ANOVA test and for more than two dependent selections the Friedman's ANOVA test will be used.

Eligibility Criteria:
Inclusion Criteria:

* consent to participate
* times of all procedures recorded
* all procedures provided in a correct way - in meaning of quality of the procedure

Exclusion Criteria:

* disagreement with participation
* not all procedures provided or not provided correctly
Fluorescence Endoscopy of Esophageal Carcinoma

For locally advanced esophageal cancer (EC), neoadjuvant chemoradiotherapy (nCRT) for 5 weeks followed by esophagectomy and lymphadenectomy, if necessary, is standard of care. It is reported that the pathological complete response (pCR) rate after nCRT ranges from 16% to 43%, with a median of 26.5%. According to current clinical guidelines, patients who achieved pCR still go for surgery even though those patients who achieved pCR may not benefit from surgery. Besides, about 50% of EC patients may have post-operative complications including pneumonia, anastomotic leakage, recurrent laryngeal nerve paralysis, which lead to low health-related quality of life (HQoL).

The golden standard to test the pathological response is by pathological assessment of the surgical specimen and thus after surgery. Theoretically, if pCR after nCRT can be predicted accurately before surgery by advanced imaging techniques, patients could have a wait-and-see. The wait-and-see procedure includes regular follow-up and salvage surgery if recurrence is present. Therefore, molecular fluorescence endoscopy (FME) using near-infrared fluorescence (NIRF) tracer bevacizumab-800CW targeting vascular endothelial growth factor combined with high-definition white light (HD-WL) endoscopy is expected to be a promising technique to monitor pCR and fill the gap.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced esophageal carcinoma (cT1b-4a N0-3 M0) in multi-disciplinary esophageal oncology meeting agreed on long course neoadjuvant chemoradiotherapy, followed by esophagectomy;
* Age ≥ 18 years;
* Written informed consent.

Exclusion Criteria:

* Patients with psychological diseases or medical issues who are not able to sign informed consent form;

  * Concurrent uncontrolled medical conditions;
  * Pregnancy or breast feeding. A negative pregnancy test must be available for women of childbearing potential (i.e. premenopausal women with intact reproductive organs and women less than two years after menopause);
  * Irradical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of primary tumor prior to start of neoadjuvant chemoradiotherapy
  * Received a different investigational drug within 30 days prior to the dose of bevacizumab-800CW;
  * History of infusion reactions to bevacizumab or other monoclonal antibodies;
Impact of the Choice of Gastric Tube Placement Sites on the Incidence of Ventilator Associated Pneumonia

In intensive care, many gastric tubes are inserted on a regular basis. There are different practices in terms of the location of the gastric tube. In some cases, the tube is inserted through the nose and in others, it is inserted through the mouth.

In the literature and in practice, these gastric tubes create discomfort and complications that have an impact not only on the patient, but also on the treatments and the length of the patient's stay in hospital.

Nosocomial Ventilator Associated Pneumonia is the most serious common complication for patients intubated with a gastric tube. It is possible that placement site may have an impact on the risk of developing Ventilator Associated Pneumonia, particularly by increasing the risk of bacterial pullulation opposite the sinuses when the tube is placed via the nasal route.

Investigator hypothesises that placing the gastric tube orally will reduce the rate of ventilator-associated pneumonia compared with the nasal route in mechanically ventilated intensive care patients.


Eligibility Criteria:
Inclusion Criteria:

* patient in intensive care, intubated, ventilated
* Adult
* Requiring a gastric tube
* With an expected duration of mechanical ventilation of more than 48 hours
* Affiliated to social security
* Patient or relative consent or, failing that, emergency inclusion of the patient

Exclusion Criteria:

* Pregnant, breast-feeding or parturient women
* Patients under legal protection: curatorship and guardianship
* Contraindication to placing a gastric tube through the nose or mouth
* Patients who already have a gastric tube when they enter the service
* Patient intubated for more than 24 hours
* Patient intubated via the nasotracheal route
Pilot Study to Assess Lung Shunting of Yttrium-90 Microspheres Using PET/CT

This pilot clinical trial studies positron emission tomography (PET)/computed tomography (CT) in finding beads after Yttrium-90 bead therapy in patients with primary liver cancer or cancer that has spread to the liver (metastatic) that can not be removed by surgery. Imaging procedures, such as PET/CT after Yttrium-90 bead therapy, may help see if the beads are present in the lung and compare the results with the pre-therapy imaging.

PRIMARY OBJECTIVES:

I. To estimate the absolute difference in post-therapy Yttrium-90 microsphere hepatopulmonary shunt fraction and the pre-therapy Technetium-99m macroaggregated albumin hepatopulmonary shunt fraction in patients with unresectable primary hepatic malignancy and hepatic metastatic disease.

SECONDARY OBJECTIVES:

I. To quantify and compare the pre-therapy Technetium-99m macroaggregated albumin particle sizes and post-therapy Yttrium-90 microsphere sizes.

OUTLINE:

Patients receive routine pre-therapy Technetium-99m macroaggregated albumin. Patients then undergo routine radioembolization with Yttrium-90 microspheres. Within 36 hours after radioembolization, patients undergo PET/CT imaging.

Available imaging, clinical, interventional and surgical follow-up data for 2 years after completion of enrollment in the study will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo intra-arterial hepatic 99mTc MAA evaluation in anticipation of 90Y microsphere radioembolization

Exclusion Criteria:

* Patients who are unable to give consent
* Prisoners
Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.

This study evaluates the effect in artery stiffness of enalapril maleate in Rheumatoid Arthritis women patients. Half of participants will receive 5 mg enalapril maleate every 12 hrs, while the other half will receive a placebo.

Rheumatoid Arthritis (RA) is a chronic inflammatory systemic disease considered as an independent cardiovascular risk factor that is associated with cumulative inflammatory load with an elevation of circulating levels of cytokines, which mediate the mechanism of endothelial cells activation by increasing the angiotensin converting enzyme (ACE) function and generation of vasoconstriction. Enalapril maleate is a prodrug that is hydrolyzed by hepatic esterases in enalaprilat, which is a potent inhibitor of ACE. ACE inhibition decreases vascular systemic resistance and mean, diastolic and systolic blood pressures in several hypertensive states, independently of the mechanism, ACE inhibitors have a widespread clinic use for cardiovascular diseases. Therefore, the researchers considered that there could be an association between the use of enalapril and the decrease in arterial stiffness.

Eligibility Criteria:
Inclusion Criteria:

* Patients classified with RA according to the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) 2010
* Patients treated in the outpatient service of the Rheumatology Service of the Hospital Civil de Guadalajara "Dr. Juan I Menchaca".
* Sign an Informed Consent Letter
* Under treatment with conventional Disease-Modifying Antirheumatic Drugs (DMARDS)

Exclusion Criteria:

* Patients with a previous diagnosis of diabetes mellitus, systemic hypertension, thyroid, kidney or liver disease
* History of acute myocardial infarction, cardiac arrhythmias, cerebral vascular event or heart failure
* Smoking active patients in the last 6 months
* Patients with a desire for close conception, pregnant or breastfeeding.
* Patients with blood pressure \<90/60 mmHg
* Patients who do not accept to participate in the study
* Patients with a BMI greater than ≥40 Kg / m2
* Non-palpable carotid and femoral pulses
* Unstable psychological state
Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis

The purpose of this trial is to demonstrate that the bleeding time of suture holes after construction of arterial bypass anastomosis is shorter after treatment with Lyostypt® than with Surgicel®

Hemostasis in peripheral vascular surgery is made more difficult by the need for direct arterial and arterial graft suturing as well as by systemic anticoagulation to prevent thrombosis during periods of vascular occlusion. Polytetrafluorethylene (PTFE) is one of the most frequently used graft materials for vascular replacement or bypass in the case when no autologous venae are available (1). However, the insufficient elasticity of PTFE and its porosity promote the development of suture hole bleeding (2,3) which can cause considerable loss of blood and prolongation of operations (2).

This study is designed to demonstrate the superiority of Lyostypt® to oxidized cellulose (Surgicel®) for hemostasis of suture hole bleeding in arterial bypass anastomoses after vascular reconstruction. Lyostypt® is an absorbable, wet stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII. Therefore collagen is very effective in hemostasis. Collagen is cell-friendly whereas other hemostats significantly disturb cell growth. Advantages of collagen fleece are fast induction of hemostasis, low tissue reaction and fast absorption (15). Furthermore, collagen was shown to be the best overall hemostatic agent in microvascular surgery. Authors concluded that collagen fleece establish faster hemostasis than oxidized cellulose and that it was resorbed faster than oxidized cellulose (15).

Eligibility Criteria:
Inclusion Criteria:

* Patients with an indication for a peripheral vascular reconstruction due to peripheral vascular disease (PVD) including femoro-femoral, femoro-popliteal and femoro-crural reconstructions or the need of a crossover including femoro-femoral or ilaco-femoro reconstruction.
* suture hole bleeding of peripheral arterial bypass anastomosis using PTFE graft prosthesis
* Written informed consent

Exclusion Criteria:

* Emergency surgery
* Patients with coagulopathy or uremia
* Reoperation within one month at the same location
* Pregnant and Breastfeeding Women
* Known or suspected allergies or hypersensitivity to any of the used devices (e.g. to material of bovine origin)
* Severe comorbidity (ASA ≥ 4)
* Life expectancy less than 12 months
* Current immunosuppressive therapy (more than 40 mg of corticoid per day or ezathioprin)
* Chemotherapy within last 4 weeks
* Radiotherapy on the treated region within the last 2 months
* Severe psychiatric or neurologic diseases
* Lack of compliance
The Role of Nebulized Budesonide in the Treatment of Acute Exacerbations of COPD

This study was designed to evaluate the hypothesis that nebulized budesonide) might be an alternative to systemic corticosteroids (SC) in the treatment of patients with acute exacerbations of COPD (AECOPD).

Patients, hospitalized with AECOPD, were randomized into three groups. Group I received only bronchodilator treatment (BDT), Group II received SC (40 mg prednisolon) plus BDT, and Group III received nebulized budesonide (NB)(1500 mcg qid) plus BDT. Improvement rates in multiple parameters during 10-day hospitalization, and acute exacerbation and re-hospitalization rates within one-month after discharge were compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients who were admitted to our pulmonary department for an acute exacerbation were prospectively enrolled in the study

Exclusion Criteria:

* COPD patients hospitalized with specific reasons like pneumonia, pulmonary emboli, congestive heart failure, pneumothorax etc. as the cause of acute exacerbation, or patients with risk of imminent respiratory failure requiring mechanical ventilation or direct admission to the ICU were excluded.
Exercise in Sjogren, Myositis and Takayasu's Arteritis

Exercise may improve physical capacity and health parameters in Primary Syndrome´s Sjogren, Myositis and Takayasu's Arteritis.

Therefore, this study aims to investigate the role of an exercise training program in patients with Primary Syndrome´s Sjogren, Myositis and Takayasu's Arteritis.


Eligibility Criteria:
Inclusion Criteria:

* Physically inactive
* Stable drugs regime for at least three months

Exclusion Criteria:

* Other rheumatic diseases
* Physical disability that prevent the patient to perform the physical tests
* Severe pulmonary disease
Incidence of Iron Deficiency Anemia in Toddlers

The frequency of iron deficiency anemia was extensively studied in infants on the first year of life. There is not enough information about the frequency of iron deficiency during the second and third years of life. In a previous study performed in Israel and published in Pediatrics 2006 the incidence of anemia does not decrease towards age 18 months. Then there is reasonable to study the iron deficiency frequency beyond this age.

The purpose of this study is to analyze the frequency of Iron deficiency anemia in a group of 400 toddles from age 18 months to 36 months.

Two groups of children will be included, 200 children from Jewish origin and 200 from non Jewish origin, mostly Arabs.

A questionnaire that included demographic characteristics, nutrition and iron supplementation in the first year, growth status, and laboratory results will be filled for each patient.

The laboratory analysis will include complete blood count and serum ferritin analysis.

Children that were previously diagnosed suffering from iron deficiency, children suffering from chronic diseases or were born premature will not be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children that attend the pediatric community clinics.

Exclusion Criteria:

* Children that were previously diagnosed suffering from iron deficiency.
* Children suffering from chronic diseases or were born premature will not be included in the study.
Pre-meal Planning and Expected Satiety

Obesity is considered to be caused by an imbalance between energy expenditure and energy intake. A major determinant of our daily energy intake is the size of the meals that we consume. It has been suggested that decisions about portion sizes are often made in advance, before a meal begins. This pre-meal planning is considered to especially depend on the estimated 'expected satiety' and 'expected satiation' of different foods. Further, also factors like weight concern and palatability of the food might have their influence on meal size selection. In general, it is not clear how these factors are integrated during pre-meal planning and which brain networks are involved in these decisions/this process. Thus, the investigators plan to study pre-meal planning in healthy, normal-weight and overweight/obese individuals with functional magnetic resonance imaging under different cognitive instructions including pleasure, expected satiety and self-control in terms of health consequences. The investigators will explore the neural networks involved in pre-meal planning and expect them to be modulated by the before mentioned factors. Further, the investigators plan to explore gender differences and expect that female subjects will select smaller portion sizes especially in the self-control condition as they are often more concerned about their weight/health. Finally, the investigators will explore differences between lean and overweight subjects to elucidate factors that might lead to increased meal sizes in overweight subjects.


Eligibility Criteria:
Inclusion Criteria:

* body mass index: 18-25 kg/m²; 25-35 kg/m²,
* right-handed,
* age: 18-35 years.

Exclusion Criteria:

* functional magnetic resonance imaging contraindications,
* claustrophobia,
* self-reported eating disorders,
* vegan or vegetarian diet, food allergies,
* intake of antidepressants,
* metabolic disorders.
A Prospective Multicenter Clinical Trial of MRD-based Treatment Strategy in Children and Young Adults With AML

Minimal-residual disease (MRD) will be measured either by flow cytometry, or polymerase chain reaction (PCR) methods, in 3 check-points and it will be one of the decision-making control parameter for the optimal therapy tactics.

Patients with initially high-risk group and those with high MRD after 2 initial courses of chemotherapy will be assigned to the allogenic transplantation of the hematopoietic stem cells from Human Leucocyte Antigen (HLA) matched or haploidentical family donors.

Genetic alterations in acute myeloid leukemia (AML) clone are well known prognostic risk factors of AML relapse. Standard risk group includes favorable t (15;17) (q22; q21) and inv (16)/t (16;16). High-risk patients have a complex karyotype rearrangement (3 and more), inversion of the long arm in 3rd chromosome and EVI1 gene rearrangement, monosomy 5 and 7, translocations involving KMT2A gene and several rare translocations. All other genotype alterations attributed to the moderate risk group.

Besides genetic factors, detection of the minimal residual disease (MRD) after initial chemotherapy and its decrease rate after 1st postremission chemotherapy with high dose Cytarabine and anthracyclines, plays a crucial role in the development of the morphologic relapse. Patients with PCR-MRD\<0,1% after 2 courses of chemotherapy have a 30% or less risk of relapse, while PCR-MRD\>0,1% - over 70%. In the clinical trial investigators are planning to measure MRD either by immune-phenotype, or PCR methods, in 3 check-points and it will be one of decision-making control parameter for the optimal therapy tactics.

Patients with initially high-risk group and those with high MRD after 2 initial courses of chemotherapy will be assigned to the allogenic transplantation of the hematopoietic stem cells from HLA- matched or haploidentical family donors.

Eligibility Criteria:
Inclusion Criteria:

1. de novo acute myeloid leukemia
2. signed informed consent

Exclusion Criteria:

diagnosis of: Fanconi anemia, acute promyelocytic leukemia, MDS, JMML, AML as secondary malignancy, Dawn syndrome.
Study Evaluating the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects

To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and ECG.
* Nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined by history.

Exclusion Criteria:

* A family history of long QT syndrome and/or cardiac death.
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematological, neurological, or psychiatric disease.