cyrilzakka/clinical-trials huggingface dataset:
An Observational Study to Evaluate Effectiveness and Safety of Amosartan Q Tablet

This study was to evaluate the therapeutic effect and safety of amosartan Q tablet administration in adult patients with hypertension and dyslipidemia.

During the routine medical visit, Amosartan Q tablets were administered to patients in need of blood pressure/LDL-C control according to the investigator's judgment. In this study, effectiveness and safety information of treatment of Amosartan Q tablets was followed for 6 months (up to 12 months), and observation of the target patients was terminated after collecting relevant data.

As this study was a non-interventional observational study, all patients received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.

This study was a multicenter, prospective, non-interventional, observational study of factors affecting blood pressure and blood lipids after treatment with Amosartan Q tablet in hypertension patients with dyslipidemia.

Data was collected from patients receiving routine treatment at hospitals in South Korea. Each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Amosartan Q tablet.

This study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertension and dyslipidemia
* Those who have already decided to administer Amosartan Q tablet under the medical judgment of the researcher
* Those who voluntarily decided to participate in this study and consented in writing to the consent form

Exclusion Criteria:

* Patients for whom use of Amosartan Q tablet is prohibited
Zinc and Iron in Children With Short Stature

Short stature is defined as height below 3rd centile or less than two standard deviations below the median height for that age and sex according to the population standard zinc and iron have important role in growth for children

Short stature is defined as height below 3rd centile or less than two standard deviations below the median height for that age and sex according to the population standard.

Approximately 3% children in any population will be short, amongst which half will be physiological (familial or constitutional) and half will be pathological.

It is estimated that approximately 60%-80% of all short children at or below 2standerd deviation fit the definition of idiopathic short stature.

The growth and development of human require an adequate supply of many different nutritional factors. Nutritional deficiencies causing short stature include: those associated with stunting as: protein and zinc, nutrient associated with rickts as :vitamin D, and those with bone abnormalities as: cupper,zin,and vitamin c Insufficient nutrition tends to lead to short stature with a delayed pattern of growth. Under-nutrition can be isolated (eg, caused by inadequate food supply or self-imposed restriction, such as fear of obesity), or it may be a component of an underlying systemic disease that interferes with food intake or absorption, or increases energy needs. The hallmark of under-nutrition is low weight-for-height .

Trace elements are dietary mineral that are present in very minute quantities (less than 0.01%),they divided into three groups (WHO classification): Essential elements such as iodine and zinc ,Probably essential elements such as manganese and silicon , Potentially toxic elements such as fluoride,lead,cadmium, mercury, \& Lithium.

Trace elements play significant functions as growth,oregulation of gene expression, immunity,the endocrine system, brain development, and the cell protection system. An adequate micronutrient intake is crucial for health, particularly in infants, children and adolescents ,deficiency in micronutrients can affect growth and development, particularly during periods of rapid growth.

Eligibility Criteria:
Inclusion Criteria:

* • children of both sexes.

  * Age range: 4-18 years.
  * patients fulfilling criteria of short stature.
* height is 2 standard deviations below normal .
* initial height below the third percentile on Egyptian growth chart. • Number of patients: will include 50 cases

Exclusion Criteria:

* Skeletal dysplasia.
* Chromosomal anomalies
Prevalence of Wound Healing Disturbances in Geriatric Inpatients (WONDER Study)

In geriatric patients, there is a plethora of nutritional and illness-related parameters, resulting in a complex situation which hampers identification of risk factors.In the planned prospective study, the point and period prevalence of wound healing disorders (WHD) is examined at admission and at discharge in a cohort of 517 male and female geriatric patients. As the investigators are also interested to study the occurrence of WHD in patients with malnutrition (and other geriatric phenomena) compared to the prevalence of WHD in patients with a good nutritional Status.

The investigators will determine the prevalence of impaired wound healing upon admission to the hospital as well as the incidence of new wound healing disorders during hospital stay with specific focus on malnutrition and other important nutritional parameters in geriatric patients. Therefore the investigators intend to study consecutively admitted patients both at admission and at discharge and monitor them during hospital stay.

The investigators will investigate the associations between the individual nutritional status and body composition parameters (such as sarcopenia) and WHD in geriatric patients, taking both medical variables and the frailty syndrome into account.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Informed written consent
* Normal cognitive status according to Mini-Mental State Examination (MMSE ≥ 24 points)
* Life expectancy of \> 3 months according to treating doctor
* Proficient in German

Exclusion Criteria:

* Lack or incapacity of informed consent
* MMSE \< 24
* Life expectancy \< 3 months according to assessment by the attending physician
* Short term patients (\< 3 days of hospital stay)
* Lack of German language
QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE

AIMS The aims were 1) to describe the quality of life (QoL) of a cohort of children born very preterm (\<28 weeks of gestation) aged 7 to 9 years; 2) to compare children's QoL to the QoL reported by a French general population of reference. 3) to determine whether socio-demographic factors, neonatal features and neurocognitive status were impacting their QoL.

METHODS:

* Multi-centre study: 6 French level three perinatal care units (Marseille, Montpellier, Nantes, Nîmes, Nice and Rouen).
* Inclusion criteria: all infants born before 28 weeks of gestation between January 2005 and December 2007, from 7 to 9 years old of age at the time of evaluation.
* Written agreement to participate: collected from parents.
* Data collection: reports of children's QoL by children and their parents (using standardized validated questionnaires); clinical information about the children, obtained through a medical examination; children neurocognitive profile.
* Duration of inclusion: over 24 months.
* Population: of the six structures, approximately 300 children will be evaluated consistent with the active files of the participating centres and an attrition rate of 30%.

PERSPECTIVES This is one of the first studies to collect self-reported data on quality of life of school-age children (7-9 years) born before 28 weeks of gestation. A better understanding of demographic and clinical determinants of QOL of school-age very preterm children may help clinicians involved in the care of these children in their ethical and medical considerations.


Eligibility Criteria:
Inclusion Criteria:

* Child been born between 01/01/2005 and the inclusive 31/12/2007,
* Extreme premature born Child before 28 weeks of amenorrhea,
* Child hospitalized after the birth in a level maternity 3 (been born " inborn " or " outborn ")
* Not dead Child,
* Child not presenting a cerebral palsy,
* Child capable of answering a questionnaire in French language,
* Child among whom the parents(relatives) or the legal representatives accepted the principle of the participation in this study, and having signed a consent,
* Child granting to participate in the study.

Exclusion Criteria:

* Child died between the birth and dates her(it) evaluation,
* Child presenting a cerebral palsy
* Child among whom the parents(relatives) or the legal representatives refused that their child participates in this study
Working Memory in Overweight Children With and Without Loss of Control Eating

Loss of control (LOC) eating in children is associated with multiple physical and mental health impairments, including obesity and eating disorders. Little is known about the developmental neurobiology of LOC, which is crucial to specifying its pathophysiology and the development of effective preventive interventions. Individual differences in working memory (WM) appear to be related to LOC eating and excess weight status in youth, but the specificity and neural correlates of these individual differences are unclear. Failure to adequately understand the nature of associations between WM and eating behavior in children with overweight/obesity limits the development of appropriately-targeted, neuro-developmentally informed interventions addressing problematic eating and related weight gain in youth. To close this clinical research gap, the current study proposes to investigate the context-dependence of WM impairment and its neural correlates in children with concomitant overweight/ obesity and LOC eating as compared to their overweight/obese peers.

Specific aims are to investigate:

1)WM performance in youth with LOC eating relative to overweight/obese controls during recalls in the context of food-related versus neutral distractors; and 2) neural activation patterns during WM performance across both food-related and neutral stimuli. We hypothesize that, relative to their overweight/obese peers, youth with LOC eating will show 1) more errors and slower response times during recalls involving food-related vs. neutral distractors, and fewer errors and faster response times during recalls involving food-related vs. neutral targets; 2) increased activation in prefrontal regions during WM performance across stimuli types relative to overweight/obese controls, and 3) even greater activation in the context of food-related versus neutral distractors.

The proposed study is the first to use state-of-the-science neuroimaging methodology to clarify the relations between WM and LOC eating, with strong potential to advance understanding of the associations among executive functioning, excess weight status, and eating pathology, and inform the development of interventions (e.g., WM training) to alleviate their cumulative personal and societal burden.


Eligibility Criteria:
Inclusion Criteria:

* Overweight/Obese (\>85% expected body mass)
* Right-handed

Exclusion Criteria:

* Currently taking any medications known to affect their weight/appetite
* Report current or past medical or psychiatric conditions known to significantly affect eating or weight (e.g., diabetes, bulimia nervosa), with the exception of binge eating disorder
* Have an intelligence quotient (IQ) in the borderline range or lower, or any condition affecting executive functioning (e.g., recent concussion, history of traumatic brain injury)
* Are unable to read or comprehend study materials
* Are receiving concurrent treatment for overweight/obesity
* Have metallic foreign bodies, face or neck tattoos, or other conditions that would prohibit fMRI scanning
tDCS in Chronic Migraine With Medication Overuse (Edisom)

Transcranial direct current stimulation (tDCS) was suggested to provide beneficial effects in chronic migraine (CM), a condition often associated with medication overuse (MO) for which no long-term therapy is available.

We conducted a randomized controlled trial to assess long-term efficacy of tDCS. Adults diagnosed with CM and MO were assigned to receive in a 1:1:1 ratio anodal, cathodal, or sham tDCS daily for five consecutive days, along with standardized drug withdrawal protocol with intravenous administration of dexamethasone 4 mg and ademetionine 200 mg in saline solution, and oral bromazepam 1.5 mg three times daily.

Primary outcome was 50% reduction of days of headache per month at 12 months. Co-secondary outcomes were 50% reduction of days of headache per month at 6 months, reduction of analgesic intake per month, and change in disability and quality of life, catastrophizing, depression, state and trait anxiety, dependence attitude and allodynia intensity. Patients were not allowed to take any migraine prophylaxis drug for the entire study period.

Eligibility Criteria:
Inclusion Criteria:

* chronic migraine with medication overuse according to the International Headache Society criteria. Diagnosis was confirmed on the basis of a daily headache diary that all eligible patients filled out in the last month prior to the enrollment. Patients should have failed at least two prophylaxis therapies. Written informed consent.

Exclusion Criteria:

* known diagnosis of major depression or other major psychiatric disorders identified after psychiatric consultation, cardiac pace maker, clips for previous head surgery, cochlear implant, history of epilepsy, known idiopathic intracranial hypertension, harmful alcohol consumption, pregnancy.
Detection of Helicobacter Pylori Infection by High Resolution Endoscopy

Although endoscopic findings of H. pylori have been reported in the literature, there is still some debate over whether H. pylori-related gastritis can be diagnosed via endoscopic features alone. Most studies concluded that it is not possible to diagnose H. pylori-related gastritis on the basis of endoscopic findings. However, the resolution power of endoscopy has greatly improved in recent years and the exact examination of gastric mucosa was possible.

Our study aimed to achieve the following: (1) describe the H. pylori-related mucosal pattern in the gastric corpus using high-definition endoscopy; (2) evaluate the diagnostic accuracy for H. pylori detection; (3) find the optimal biopsy site for rapid urease test (RUT); (4) validate the inter- and intraobserver agreement in the assessment of endoscopic patterns.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent upper endoscopy

Exclusion Criteria:

* Age \< 20 or \> 70
* Severe systemic disease or advanced chronic liver disease
* Medication history of NSAID, PPI, H2 blockers or antibiotics
* History of H. pylori eradication therapy
* History of gastric surgery
* Recent history of upper GI bleeding
* Gastric or duodenal ulcer (including old scar change) during endoscopy
* Anemia (Hemoglobin level \< 10mg/dL)
* Pangastritis
Novel Biomarkers in Chronic Airway Diseases

The purpose of this study is:

* To define The differences of bio-chemical phenotypes in chronic airway inflammatory diseases.
* To identify novel biomarkers in chronic airway inflammatory diseases as a screening, diagnostic, or monitoring marker.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years olds
* Both sexes
* Asthma or COPD was diagnosed according to the criteria of the American Thoracic Society, GINA, GOLD guideline
* Acute exacerbation was defined by the criteria of the American Thoracic Society, GINA, GOLD guideline
* For stable disease, none of the subjects had received inhaled or oral corticosteroids or any other anti-inflammatory drugs, had an exacerbation history in the previous 6 months
Music vs Midazolam During Preop Nerve Block Placement

The purpose of this study is to determine if there are differences in anxiety scores, heart rate, blood pressure, and oxygen status when using sedation medication versus music while undergoing a peripheral nerve block before your surgery.

The general flow of the study will be conducted as follows:

1. Research coordinator will call or approach patients who are scheduled for a surgical procedure that is planning for a peripheral nerve block either for the primary anesthetic or for postoperative pain control to be placed in the preoperative bay in the ambulatory surgical center.
2. Research coordinator will discuss the purpose of our study and explain the study in detail for the patient. If a patient agrees to participate, then we will have the patient sign the informed consent for the study. If patient is on the phone and decides to participate, the patient will sign the informed consent upon arriving to Penn Medicine University City (PMUC).
3. Once the patient signs the informed consent for the peripheral nerve block by anesthesia team. The patient randomized will be revealed to either music or IV midazolam. The pre-procedure anxiety score will then be obtained using the STAI-6 validated tool.
4. The golden moment will be conducted between the patient, provider, and nursing staff. Once this golden moment is completed, the anxiolytic intervention will start (music or IV midazolam)\*
5. The preoperative nerve block will be conducted by the regional anesthesia block team.
6. Once the nerve block is complete, we will obtain the post-procedure anxiety score using the STAI-6 validated tool.
7. Once the post-procedure anxiety score has been obtained, we will also obtain the patient satisfaction score, the provider satisfaction score, and the evaluation of any difficulties in communication between the provider and patient. After these questions have been obtained, the study is complete.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are \>18 years of age, who will give informed consent in receiving a peripheral nerve block in the preoperative bay for their primary anesthetic and/or for their postoperative pain control.

Exclusion Criteria:

* significant psychiatric disorder such as generalized anxiety disorder, panic disorder, depression, psychosis, bipolar disorder; individuals who were incompetent to give informed consent; pregnant and/or breast feeding patients; any underlying coagulopathy, infection or other factors which would be a contraindication to receiving a peripheral nerve block; hypersensitivity to midazolam; and history of renal impairment. Patients who were extremely anxious (scores 50 and greater on the State Trait Anxiety Inventory-6 (STAI-6) tool) were also excluded from the study.
Validation and Standardisation of a "Neuralix" Digital Ecological Battery

The management of head trauma patients requires the assessment of cognitive disorders using standardized neuropsychological tests and questionnaires. However, the evaluation tools currently available present well-identified limitations limiting the accuracy of the measurements (in a non-exhaustive manner, let us cite for example the absence of control of the rate of "false positives" or even the impossibility of measuring the improvement or decline in performance over time). In order to overcome these limitations, the Neuralix battery was created with particular attention to the assessment of memory and executive functions largely impacted after head trauma. The Neuralix battery comes in the form of a digital application accessible online and allowing a global assessment of cognitive functions in adults. In addition, the processing of results includes the operationalization of decision criteria taking into account the limitations cited above in order to improve the sensitivity of the evaluation.

The VANOLIX study proposes the validation of the Neuralix cognitive battery with head trauma patients of moderate to severe intensity as well as its standardization with healthy volunteers, these two steps being essential to making the tool available to clinician-researchers.


Eligibility Criteria:
Inclusion Criteria:

* French-speaking subject aged 18 to 65 years old
* Signed consent to participate
* History of head trauma of moderate to severe intensity, i.e. having presented the high risk criteria of the study by Masters et al. (1987) at the time of the head trauma, and occurred a maximum of 5 years after inclusion in the VANOLIX study

Exclusion Criteria:

* Visual or hearing or motor deficit disrupting the taking of cognitive tests
* Subject with insufficient knowledge of counting (up to 25), the alphabet, reading, or French writing
* Subject with a severe intellectual disability
* Subject with past psychiatric or behavioral disorders requiring a stay \>2 days in a specialized environment or requiring current treatment other than a single anxiolytic
* Current treatment with antidepressant
* Current treatment with antipsychotic or multiple anxiolytics
* Single anxiolytic treatment initiated or increased for less than 1 month or current antiepileptic treatment
* Subject with a neurological condition or a history leading to cerebral dysfunction likely to interfere with the cognitive assessment
TENS in Persons With MS

Persons with multiple sclerosis (pwMS) often have an increased sense of fatigue. Furthermore, they present walking difficulties which negatively affects their mobility and results in an additional increase of fatigue. Previous literature suggests that transcutaneous electrical nerve stimulation (TENS) of leg muscles might increase their walking capacity and decrease perception of fatigue. In the present study we aim to investigate whether TENS of leg muscles reduces walking difficulties and sense of fatigue in pwMS in comparison with a short strength training protocol or no training. A similar aim is addressed after TENS of elbow flexor muscles.

Subjects with relapsing remitting or progressive MS, will undergo transcutaneous electrical nerve stimulation (TENS), strength exercises (SExerc), both TENS and SExerc (COMB) simultaneously, or sham stimulation without training (CON) of both leg and arm muscles. Force and fatigue measurements are performed before, directly after and three weeks after the training sessions and contain walking, fatigue, and strength assessments.

Main study parameters are changes in the scores of i) the six-minute walking test (6-MWT), ii) the perceived walking disability (MSWS-12) and iii) fatigue questionnaires (FSS and MFIS). Additional study parameters are changes in muscle force and muscle fatigability.


Eligibility Criteria:
Inclusion Criteria:

* EDSS score \< 7
* MSWS score \> 30
* FSS score \> 4 or MFIS score \> 38.
* no known cardiovascular disorder or having a positive advice on a sport medical examination

Exclusion Criteria:

* being a participant in an exercise study
* having a psychiatric disorder
* having cognitive or communication problems which reduces the capacity to understand instructions
* planned a change in medication during the training period
* having a neurological disorder other than MS
* having cardiovascular disorders and no positive advice from a sport medical examination
* having a pacemaker or another implantable electronic apparatus.
* being pregnant