cyrilzakka/clinical-trials huggingface dataset:
Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition

The investigators performed two case-control studies in Niger and Senegal analysing fecal microbiota to characterize the specificity of the gut microbiota alteration associated with severe acute malnutrition (SAM).

Fecal samples of cases (severe acute malnutrition (SAM) ascertained according to the WHO definition) and controls (asymptomatic healthy children ascertained by clinical and anthropometric criteria) were analysed by v3v4 16S rRNA sequencing, redox and pH measurement and using specific polymerase chain reaction targeting Methanobrevibacter smithii and Bacteroides thetaiotaomicron. Based on the literature and oxydative stress reported in SAM, the investigators tested if the proportion of aerotolerant prokaryotes is increased among gut prokaryotes enriched in SAM in comparison to prokaryotes enriched in controls. The investigators further linked this to fecal redox potential and assessed the total number of bacteria in feces by flux cytometry.

Eligibility Criteria:
Inclusion criteria:

* Children aged 0-59 months of varying nutritional status from Niamey (Niger) and Dakar (Senegal).

Exclusion Criteria:

* Absence of parent or patient consent, antibiotic administration \<2 months before stool collection and insufficient fecal amount. Exclusion criteria for controls included any form of malnutrition, presence of fever, acute respiratory infection (cough), acute or chronic diarrhea in the previous 4 weeks. Symptoms and complications of malnutrition (cough, fever, diarrhoea, vomiting) nor other form of malnutrition (moderate to severe stunting and underweight) were not a reason of exclusion for cases since they are considered as direct consequence and part of severe acute malnutrition.
Complications From Left Atrial Appendage Occluder

The following case reported a rare complication of left atrial appendage perforation complicated by cardiac tamponade during LAAO device deployment and its corresponding surgical management


Eligibility Criteria:
Inclusion Criteria:

* 73-year-old woman with CHA2DS2-VASc score 4

Exclusion Criteria:

* nil
Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma

This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.


Eligibility Criteria:
Inclusion Criteria:

Severe persistent asthma with the following characteristics:

* Uncontrolled according to Global Initiative for Asthma (GINA) 2007 guidelines and at least 2 exacerbations having required systemic corticosteroid and/or at least 1 hospitalization or emergency room visit in the past year.
* Treated with high-dose inhaled corticosteroid (i.e. \> 1,000 µg beclometasone dipropionate equivalent per day) plus inhaled long-acting β2 agonist (with or without maintenance oral corticosteroid).
* Non-atopic, i.e. negative blood multiallergic testing and negative Aspergillus-specific IgE-radio allergosorbent blood test and negative skin prick tests to a battery of common aeroallergens

Exclusion Criteria:

* Current smokers or smoking history stopped for less than 3 years or \> 10 pack years.
* Asthma exacerbation during the 4 weeks prior to randomization.
* Active lung disease other than non-atopic asthma.
* Patients with an active cancer, a suspicion of cancer or any history of cancer with less than 5 disease free years.
* Pregnant or nursing (lactating) women.
* Treatment with omalizumab.

Other protocol-defined inclusion/exclusion criteria may apply
Immunophenotyping of Acute b Cell Lymphoblstic Leukemia

To study the immunophenotyping pattern of acute B lymphoblastic leukemia in south Egypt Cancer Institute iand its correlation with disease outcome

study the immunophenotyping pattern of acute B lymphoblastic leukemia in south Egypt Cancer Institute from 2009 -2019 and its correlation with disease outcome

Eligibility Criteria:
Inclusion Criteria:

* New cases admitted to SECI Who didn't receive treatment.Age above 1 years old.

Exclusion Criteria:

* Cases who received treatment Patients below 1 years old.Patients diagnosed as AML or T-ALL
Multifocal Neuromodulation in Motor and Cognitive Function of People With Parkinson's Disease

People with Parkinson's disease (PD) experience various motor and nonmotor symptoms throughout its evolution. It is characterized mainly by the presence of tremor, stiffness, bradykinesia and postural instability, leading to progressive functional limitation and impairment in the performance of usual activities of daily living. In addition, patients may have cognitive disorders, memory deficits, problems related to visuospatial dysfunction, difficulties in performing sequential or repetitive movements, freezing, and slow psychological responses. Previous studies analyzed by systematic reviews suggest the efficacy of Transcranial Direct Current Stimulation (tDCS) to improve the motor and non-motor symptoms of PD, depending on the area of stimulation. However, most of these focus only on one specific area. Therefore, the overall objective of this study is to investigate the effects of multifocal neuromodulation on the motor and cognitive function of people with Parkinson's disease.

For this, a randomized, triple-blind clinical trial will be conducted with 60 people with PD, recruited from the reference centers in neurology and physiotherapy in João Pessoa. After recruitment of participants, they will be randomized into three groups: Group 1 - tDCS over Primary motor cortex (M1) + Dorsolateral prefrontal cortex (DLPFC); Group 2 - tDCS over Primary motor cortex + Frontal polar area (FPA); Group 3 - tDCS over Primary motor cortex. In each condition, an initial baseline assessment (T0) will be performed after 15 treatment sessions (T1) and 30 days after the end of the protocol (Follow-up Assessment - T2), during which time participants will not receive any type of treatment. The outcomes evaluated will be: Motor and cognitive function, executive functions, attention and planning, balance, gait speed an quality of life. For all analyzes, the statistical software SPSS (SPSS Inc, Chicago IL, USA) for Windows, version 20.0, will be used and considered significant, an alpha value of 5% (p \<0.05 ).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic PD, issued by a neurologist specializing in movement disorders;
* Disease staging between I and III, according to the modified Hoehn and Yahr scale;
* Be using antiparkinsonian medication regularly;
* Score higher than 24 or 18 (for participants with low education), verified through the Mini Mental State Examination.

Exclusion Criteria:

* Diagnosis of atypical parkinsonism;
* Neurological comorbidities;
* History of epilepsy, neurosurgery (including metal clip implantation) and pacemaker implantation;
* Previous surgical intervention for PD (DBS implantation - deep brain stimulation);
* Presence of severe freezing episodes.
Evaluation of Left Ventricular Volumes by Real-Time 3-Dimensional Echocardiography

Quantitative measurements of left ventricular volume and ejection fraction are useful in the management of patients with heart disease. Several imaging methods exist, but are limited by cost, invasiveness, or exposure to radio-isotopes. Conventional echocardiography is a noninvasive method that allows estimation of left ventricular size and function; however, quantitative measurements of volume are not widely used due to lack of reproducibility and inaccurate measurements. Real-time three-dimensional echocardiography is a new technique that can be used to derive volume measurements from a single image acquisition. We hypothesize that real-time three-dimensional echocardiography is an accurate method for making left ventricular volume measurements. We therefore propose to measure left ventricular volumes using real-time three-dimensional echocardiography in human subjects and correlate these measurements with magnetic resonance imaging, a more accurate noninvasive method for obtaining these measurements.

Quantitative measurements of left ventricular volume and ejection fraction are useful in the management of patients with heart disease. Several imaging methods exist, but are limited by cost, invasiveness, or exposure to radio-isotopes. Conventional echocardiography is a noninvasive method that allows estimation of left ventricular size and function; however, quantitative measurements of volume are not widely used due to lack of reproducibility and inaccurate measurements. Real-time three-dimensional echocardiography is a new technique that can be used to derive volume measurements from a single image acquisition. We hypothesize that real-time three-dimensional echocardiography is an accurate method for making left ventricular volume measurements. We therefore propose to measure left ventricular volumes using real-time three-dimensional echocardiography in human subjects and correlate these measurements with magnetic resonance imaging, a more accurate noninvasive method for obtaining these measurements.

Eligibility Criteria:
Normal volunteers and patients with any form of heart disease who agree to undergo MRI and echocardiographic examination studies.

Adults older than the age of 18 years.

No pregnancy, atrial fibrillation, unstable angina, recent myocardial infarction (less than 5 days), or other acute medical illness.

No pacemaker, aneurysm clip, neural stimulator, ear implant, and metallic foreign body such as shrapnel or bullets.
Comparison of the Perception of Non-technical Skills

Clinical simulation has recently acquired great importance in the health sciences. It is a pedagogical methodology that is increasingly used in health science degrees, since it is very useful for the acquisition of both technical and non-technical skills (leadership, teamwork and effective communication, among others).

However, if the investigators focus on physical therapy, the use of clinical simulation is a novel field and therefore requires a great deal of research. Researchers in this field do not yet have the consistency and experience as in other health branches such as medicine or nursing, where the participants have been using high-fidelity simulators for years for the learning of all their students.

Clinical simulation allows students to achieve these competencies without the need to practice on real patients. For all these reasons, and because of the situation of need generated in recent years, in which internships in hospitals and clinical centers were completely suppressed, the need for our research is justified.


Eligibility Criteria:
Inclusion Criteria:

* Second year students of the Physiotherapy Degree
* They do not have clinical experience with real patients.
* Subject teachers

Exclusion Criteria:

* Not wanting to sign to participate in the study.
* Not signing the informed consent
* Teachers who do not have experience in clinical simulation
Mechanisms of the Nicotine Metabolism Effect on Tobacco Dependence

The purpose of the study is to learn more about tobacco dependence and nicotine metabolism in African-Americans and whites, by studying to see if how fast a person metabolizes nicotine (how the body breaks down nicotine into inactive compounds) affects how dependent they are on smoking cigarettes. The investigators believe that people with a faster rate of metabolism may have more severe nicotine withdrawal symptoms and also may have a harder time trying to quit smoking.

Our studies will use the nicotine metabolite ratio (NMR) (the ratio between the nicotine metabolites 3'hydroxycotinine and cotinine)as a simple and clinically feasible biomarker for the rate of nicotine metabolism. The investigators hypothesize that a faster rate of metabolism leads to faster elimination of nicotine from the body and a more rapid dissipation of brain tolerance to nicotine in the interval between cigarettes, leading in turn to (1) more severe nicotine withdrawal symptoms and (2) greater subjective reward from the cigarette smoked following deprivation. These effects would help to explain why smokers with faster rates of nicotine metabolism have a poorer response to smoking cessation therapy when compared to those with slower rates of metabolism.

The investigators will explore the relationship of the NMR to the endophenotypes of withdrawal, craving and reward, with the assumption that these factors are likely intermediaries for the mechanism linking nicotine metabolism to tobacco dependence and smoking cessation rates with pharmacotherapy. Our study design uses a brief (6 hour) interval of smoking abstinence followed by a "reward" cigarette to elicit the subjective responses relating to withdrawal and reward. Because smoking behavior and severity of nicotine dependence vary by race and sex the investigators will also compare the relationship between NMR and withdrawal and reward in African American vs white smokers and in men vs women.

Secondary analyses will examine whether nicotine half-life mediates the observed effects of NMR on primary response measures.

Eligibility Criteria:
Inclusion Criteria:

* African-American or Caucasian
* Age 18-70 years
* Regular smoker of 5 or more cigarettes per day
* Saliva cotinine of 100 ng/ml or greater

Exclusion Criteria:

* Obese (BMI \> 38) or underweight (BMI \< 17)
* Major systemic or psychiatric condition
* Medications that are inducers of CYP2A6
* History of alcohol abuse
* Positive drug urine tox test
* Pregnancy or breast feeding
Effect of Virtual Reality and Progressive Muscle Relaxation on Anxiety and Attention Among Cardiac Care Unit Patients

This study aims to:

Assess the effect of virtual reality and modified progressive muscle relaxation distraction techniques on anxiety, attention and getting distracted from the external environment among cardiac care unit patients.

Research hypotheses:

H1: Patients who receive VR intervention have lower Hamilton Anxiety Rating (HAM-A) scores than those who receive modified PMR intervention.

H2: Patients who receive VR intervention exhibit improvement in their physiological parameters than those who receive modified PMR intervention.

H3: Patients who receive VR intervention have lower Attention/Distraction scores than those who receive modified PMR intervention.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to CCU for at least 3 days after stability, so they would have experienced CCU routines in all shifts.
* Diagnosed with cardiac disease.
* Aged from 18 to 60 years, from both genders.
* Patients who are conscious and stable condition.
* Patients without a history of neurological impairment such as motor, visual and auditory disabilities and psychological disorders.

Exclusion Criteria:

* Patients staying in the CCU for less than 3 days.
* Who is unconscious or unstable condition.
* Sedated or refuse to participate.
* Have psychiatric diseases and receive psychological drugs.
99mTc-ABH2 SPECT/CT in Breast Cancer

This prospective study will investigate the potential usefulness of 99mTc-ABH2 SPECT/CT in the diagnostic performance and evaluation efficacy of breast cancer.

This study aims to assess the diagnostic performance of 99mTc-ABH2 SPECT/CT for the detection of HER2-positive primary breast cancer and possible metastases. Visual and semiquantitative methods will be utilized to evaluate the acquired SPECT/CT images. A comparative analysis of tumor imaging data and HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples will further be conducted. Results of HER2 expression imaging may have potential significance in screening and monitoring individuals for targeted therapy with monoclonal antibodies, like Trastuzumab.

Eligibility Criteria:
Inclusion Criteria:

* clinically suspected primary breast cancer by mammography or ultrasonography and being able to sign the written informed consent form

Exclusion Criteria:

* pregnancy or lactation, impaired liver or kidney failure, and undergoing any preceding local or systemic therapies that might interfere HER2 binding
MDRS for Prevention of Nocturnal Hypoglycemia

The investigators have developed a unique Remote \& Safety diabetes management system (MDRS) that offers real-time remote monitoring and control of glucose levels. The system allows the supervising personal to alarm the patient and intervene in cases such as pending hypoglycemia, long standing hyperglycemia or technical faults.The aim of this feasibility study is to evaluate the efficacy of the MDRS system in preventing nocturnal hypoglycemia in children and young adults with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes diagnosed at least 1 year prior to study entry
* Continuous subcutaneous insulin infusion pump for at least 3 month prior to study entry
* Use of continuous glucose measurement device for at least one month prior to study entry
* Age: 4-24 years old
* HbA1c \< =8.5%
* No more than one severe hypoglycemia or an episode diabetic ketoacidosis within the year prior to study entry, and none within the month prior to study entry.
* Capable of reading a pump screen in English
* Capable of operating the MDRS software
* A patient older than 18 years- leaving routinely with at least one more adult(age above 18 years) capable of connecting the C\&C center and properly reacting to the instructions given by the attending personal.
* A patient younger than 18 years- leaving routinely with at least two adults (age above 18 years) capable of connecting the C\&C center and properly reacting to the instructions given by the attending personal.
* All participants must provide an adult independent contact person, leaving near by the participant, capable of connecting the C\&C center and properly reacting to the instructions given by the attending personal. This person will be called into action in emergency cases in which the participant or his household members can not be reached.
* Capable of completing the hypoglycemia the relevant surveys
* Able to understand and sign an informed consent forms

Exclusion Criteria:

* Any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator are likely to effect subject compliance or the subjects ability to complete the study.
* Patients participating in other device or drug studies
* Known dermal hypersensitivity to trial products or those that contain medical adhesive
* Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication for participation in the study.
* Inability to understand/complete the hypoglycemia fear survey
* Female subject who is pregnant or planning to become pregnant within the planned study duration
Rhythmic Auditory Stimulation on Upper-limb Movements in PD Patients

The goal of this clinical trial is to examine effects of training involving rhythmic auditory stimulation (RAS) on upper-limb movements and functions in patients with Parkinson's disease (PD).

This study employed a 21-day randomized controlled trial design to evaluate the efficacy of upper-limb training involving RAS on upper-limb function and neural activity in PD patients. The RAS group showed sustained improvements at one-month follow-up.

This study employed a randomized controlled trial design. We randomly assigned PD patients into either the RAS group (experimental) or the noRAS group (control). Both groups underwent a 21-day training program (40 minutes per session, one session daily), with the only difference being the presence or absence of RAS. Assessments were conducted at five time points: baseline (T1), day 8 (T2), day 15 (T3), post-intervention (T4), and one-month follow-up (T5). Behavioral assessments were performed at all time points, while EEG recordings were only conducted at baseline (T1) and post-intervention (T4). All assessments and training sessions were scheduled during participants' medication 'on' state (1-2 hours after medication intake) to ensure consistency and optimal motor function.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic PD diagnosed by a neurologist based on the Movement Disorders Society clinical diagnostic criteria;
* the Hoehn and Yahr stage is 2 or 3, meaning that bilateral movement problems or combination with mild postural instability;
* a score of Montreal Cognitive Assessment is equal to or higher than 21 to ensure that they understand experimental instructions;
* a score of Edinburgh Handedness Inventory is above 60 to ensure that they are right-handed;
* types and doses of medications remain unchanged in the past month right before participation.

Exclusion Criteria:

* the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.
A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients

This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus, Type 2
* Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening)
* Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%
* Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m\^2
* Capable and willing to follow the protocol
* Give written consent

Exclusion Criteria:

* Are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)
* Have a history of severe hypoglycemia in the past 6 months
* Are pregnant or may become pregnant
* Women who are breastfeeding
* Have significant cardiac disease
* Have significant renal or liver disease
* Undergoing therapy for a malignancy
* Contraindications to the study medications
* Have an irregular sleep/wake cycle
* Have a serious disease or any condition considered by the investigator to be exclusionary