cyrilzakka/clinical-trials huggingface dataset:
Analysis of Factors Determining Increase of Serum Sodium in Hyponatremic Patients

The aim of this study is to further analyse the dataset of the Hyponatremia Registry, a multicenter, prospective, observational study conducted between September 2020 and February 2013 in the United States of America and the European Union. The primary interest was to provide evidence to investigators' hypothesis that baseline sodium levels are a predominant factor determining the rapidity of sodium increase irrespective of the given treatment. Further investigators aimed to identify other independent predictors of the increase of plasma sodium upon treatment.

Hyponatremia is the most common electrolyte disorder in outpatients and hospitalized patients. Overly rapid sodium increase is associated with increased risk for osmotic demyelination. Smaller analyses have suggested that the slope of the sodium increment is higher with lower baseline sodium levels but this has not been confirmed in large datasets. Investigators have recently published the results of analysis on patients from the Otsuka HN-Registry on thiazide-induced hyponatremia (cooperation with Otsuka). In that dataset was founded the same association and there had been hints that this relationship holds true for all kinds of treatment including no treatment at all.

Investigators took the datasets of those patients presenting with Hyponatremia that could be classified into one etiology group by the treating physician for further analysis. Patients with euvolemic, hypervolemic, hypovolemic or thiazide-associated HN were included in investigators' analysis. Furthermore investigators only considered those cases in which the patient record provided at least one documented plasma \[Na+\] within \<25 hours after the first plasma \[Na+\] ≤130mEq/L had been measured.

All variables collected in the HN registry were included in the data base. All available information on ingested or administered solutes was recorded. Linear mixed effects models were applied to conduct multivariable repeated measures analyses.

Following questions are to be answered in this study

1. Is the baseline sodium level a predominant factor determining the rapidity of sodium increase?
2. Ist he rapidity of sodium increase correlated to the given treatment?
3. Can other predominant factors of slope of sodium increase be determined?

Eligibility Criteria:
Inclusion Criteria:

* Patients with hypotonic hyponatremia \<130 mmol/l enrolled in the Hyponatremia Registry and classified as Euvolemic Hyponatremia, Hypervolemic Hyponatremia, Hypovolemic Hyponatremia or Thiazide associated Hyponatremia-Group

Exclusion Criteria:

* Patients, who could not be assigned to one etiology group
An Observational Post-Authorization Safety Specialist Cohort Event Monitoring Study (SCEM) to Monitor the Safety and Utilization of Rivaroxaban (Xarelto®).

This study aims to evaluate the use of rivaroxaban and its short term safety when used by patients for the new indications of prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE. Any adult patient started by their care team on rivaroxaban or an alternative anticoagulant for the specified indications during the study period will be eligible to take part. A questionnaire will be completed by the care team of each patient at the start of treatment and again 12 weeks later. The care team will complete the questionnaires using information from the patient's medical notes, not by asking the patient directly. If a participant has an adverse event during the 12 week period, we may ask the patient's care team to fill out a further follow up questionnaire. No other examinations or tests will be performed. Patients will only be recruited to the study after the clinical decision to prescribe rivaroxaban or an alternative anticoagulant has been made, so that prescribing behaviour is not altered by the study. It is an observational, non-interventional study covering the whole of England and Wales.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or above after study start
* index date on or after study start
* signed, informed consent
* patients treated for DVT or PE
* patients with non-valvular AF (with one or more risk factors) treated for prevention of stroke and systemic embolism

Exclusion Criteria:

* any use of univalent direct thrombin inhibitor or direct factor Xa inhibitors
* use of anticoagulant therapy or other vitamin K antagonists recorded within one year prior to index date
Anti-microbial Role of Non-antibiotic Agents Against Cutibacterium Acnes in Patients With Acne Vulgaris

* To evaluate and compare the anti-biofilm activity of Salicylic acid, Isotretinoin, and N-acetylcysteine against C. acne .
* To assess the possible role of Salicylic acid, Isotretinoin, and N-acetylcysteine in improving the susceptibility of C. acne for Azithromycin and Doxycycline.

The study was carried out on 24 patients with acne vulgaris. They were recruited from the outpatient clinic of the Dermatology and Venereology and Andrology Department, Zagazig University Hospitals, Egypt.

The degree of severity of lesions was determined by the global acne grading system (GAGS)

Microbiological samples were collected from all patients for:

1. Isolation of C. acnes
2. Antibiotic susceptibility testing for C. acnes isolates aganist the most commonly used antibiotics in treatment of acne(Azithromycin and Doxycycline) in the presence and absence of Salicylic acid, Isotretinoin, and N-acetylcysteine
3. Testing biofilm forming ability of C. acnes isolates in the presence and absence of Salicylic acid, Isotretinoin, and N-acetylcysteine

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients.
* Patients of both sexes.
* Patients with acne vulgaris with different grades

Exclusion Criteria:

* Patients received topical or oral treatment within 6 weeks prior to microbiological sampling
Effectiveness of Cognitive Behavioral Intervention in Patients With Symptoms Somatization in Primary Care

The purpose of this study is to evaluate the efectiveness of a behavioral cognitive grupal intervention (BCI) in patients with somatization symptoms which has an effect on the perceived quality of life front conventional intervention.

Aim: to determine whether a cognitive-behavioral group intervention in patients with unexplicated somatic symptoms, that have come to the primary care medical in Madrid, is more effective than normal practice in terms of improving life quality at one year.

Method:

Design:cluster randomized trial. Setting: study in Health Centers Primary Care of Area of Madrid Health Service. unit of randomization are centres.Analysis unit: patients between 18 and 65 years old.

Intervention: The cognitive behavioral grupal Terapy in the internention group and the usual intervention in the control group.

Sample size adjusted for design effect=242 (121 in each arm). Main response variable: preceived quality of life (SF-12).

Data Analysis:comparison of the proportion of patients that improve in 4 or more points in the area of Mental Healthcare from the SF-12 in both groups,at 6 months and 1 year after patient inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Attending patients with 2 or more medically unexplained somatic symptoms during the last 6 months.
* Having came to medical examination on primary care at least 10 times during the last year.
* be able to follow the trial´s demands, not have plans for moving another place and understand the Spanish language.
* Patients who consent to take part.

Exclusion Criteria:

* Diagnostics on serious mental disorder.
* Suicidal intentions at the moment of getting involved in the study.
* Diagnostics on addiction to toxic substances.
* Diagnostics on well-known body illness responsible for the symptoms.
* Previous psychotherapy during the previous year.
Brown Fat Activity and White Fat Accumulation

White and brown adipocytes differ in their expression of hormones, cytokines, and inflammatory factors, and they modulate different biological functions. While white adipose tissue (WAT) serves as the primary site of energy storage, brown adipose tissue (BAT) instead metabolizes fat to produce heat and regulate body temperature. BAT is likely present in all humans, but the low prevalence of BAT depiction in adults and elderly subjects has hindered longitudinal assessments of the relation between BAT activity and WAT. Under typical imaging conditions, BAT is detected more frequently in children and teenagers than in adults with malignancy. Since most children with cancer have significantly shorter treatment courses and greater survival rates compared to adult patients, the investigators have the ability to examine the relation of repeated measures of body composition and BAT by selecting pediatric patients. In this study, the investigators will longitudinally examine whether BAT activity is related to changes in weight and the amounts of SAT, VAT, and abdominal muscle in children successfully treated for pediatric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients had PET/CT scans with evidence of malignant disease
* Patients had no metabolically active BAT at diagnosis on their PET/CT scan
* Patients were disease free within 1 year of diagnosis

Exclusion Criteria:

* Patients had PET/CT scans with no evidence of malignant disease
* Patients with metabolically active BAT at diagnosis on their PET/CT scan
* Patients were not disease free within 1 year of diagnosis
Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients

The rationales of a clinical trial comparing intralesional antimonial therapy versus wound care management in patients with old world cutaneous leishmaniasis (OWCL) are the following:

1. The effectiveness of the current mainstay treatment with intralesional antimonials for CL is subject to discussion, especially in L. major lesions which are predominant in Northern Afghanistan
2. The importance of wound care management in patients with OWCL has been emphasized by Gonzalez et al. (2008) and its efficacy is confirmed in the Kabul trial with L. tropica patients.

Parallel to the clinical efficacy the trial investigates the cost-effectiveness and -utility of the treatment options under study.


Eligibility Criteria:
Inclusion Criteria:

1. Present a suspected Old World Cutaneous Leishmaniasis lesion confirmed by Giemsa stained wound smears with no other skin diseases or infections and who
2. Have never been previously treated with antimonial injections or any other form of anti-leishmanial medication.

Exclusion Criteria:

1. Patients with more than one lesion are excluded.
2. Patients with a lesion age of \> 3 months are also excluded. The experience of the Kabul trial shows that patients presenting themselves for the first time with a lesion, which is older than three months, have either been pre-treated somewhere else and/or show a poor compliance during the trial.
3. Patients below 12 years of age have to be excluded from the trial, because they cannot fill in the EQ-5D and Skindex questionnaire part of the health economic evaluation.
4. Intralesional antimony injections are too painful for lesions located on the nose, lips or eyes. Therefore, patients presenting these lesions are excluded from the trial.
5. For compliance reasons addicted patients and patients not available for follow-up are exclude from the trial.
6. Patients with major uncontrolled diseases as tuberculosis, diabetes or HIV are excluded from the trial, since their management requires additional co-medications, which may affect wound healing.
Executive Function in Early Childhood

Despite the fact that a substantial number of school age children struggle with both reading and math acquisition, the brain mechanisms of the overlapping aspects of reading and math skills, thought in part to be linked via executive functions (EF), have not been unpacked. This project will use a longitudinal design, following children from Kindergarten through 1st grade, to understand how the brain networks associated with reading, math, and EF interact to predict academic outcomes and, in those who struggle academically, intervention response.

This longitudinal study will be conducted with 260 Kindergartners, staggered across multiple cohorts, who are followed through 1st grade. There will be three time points of testing for each cohort: fall of Kindergarten, spring of Kindergarten, and in the fall of 1st grade.

After the third testing time point, in the fall of 1st grade, the bottom 1/3 of readers in the sample will be selected to participate in the intervention arm of the study. These students will be randomly placed in one of two arms: business-as-usual, in which children receive no additional instruction; or the reading intervention condition, in which they receive 20 hours of 1:1 reading intervention over 6 weeks. Children in both sub-sample arms are assessed again after tutoring is complete, in the spring of 1st grade.

Neuroimaging through magnetic resonance imaging (MRI) and functional magnetic resonance imaging (fMRI) will occur as part of study participation in conjunction with testing at fall of Kindergarten, fall of 1st grade, and spring of 1st grade time points.

Eligibility Criteria:
Inclusion Criteria:

1. Children in Kindergarten (approximate ages 4-9 years)
2. Native English speakers

Exclusion Criteria:

1. Children not in Kindergarten at time of enrollment;
2. previous diagnosis of Intellectual Disability;
3. known uncorrectable visual impairment;
4. documented hearing impairment greater than or equal to a 25 decibel (dB) loss;
5. medical contraindication to MRI procedures (e.g., metal devices) - excludes from MRI procedures only;
6. known intelligence quotient (IQ) below 70;
7. a pervasive developmental disorder; and
8. any known neurologic pathology, including epilepsy, spina bifida, cerebral palsy, traumatic brain injury, and brain tumors.
9. Comorbid severe psychiatric disorders will also be excluded, as will those who are taking psychotropic medications, with the exception of stimulant medication for Attention Deficit Hyperactivity Disorder (ADHD). Children who meet criteria for ADHD will be eligible as long as they are not taking psychotropic medications, with the exception of stimulant medication for ADHD.
Preoperative Self-assessment for Cardio-pulmonary Risk Stratification

This prospective study intends to development and validation a patient self-assessment questionnaire. The aim of the self-assessment, by questionnaire, is to estimate the risk of postoperative pulmonary complications (PPC).

PPC are common adverse events operative patients. Existing concepts of pulmonary risk evaluation are based on complex risk scores, preoperative apparatus examinations, laboratory parameters and medical findings. The significance of apparatus diagnostics for the preoperative Pulmonary risk evaluation is highly controversial and guidelines recommend a reluctant use. A large prospective study (PREDICT, unpublished to date, NCT02566343) showed that lung function assessment in patients with COPD symptoms undergoing major non-cardiac surgery did not improve the anamnestic risk assessment. In a large study it could be shown that a subjective self-assessment of physical performance by means of a structured questionnaire (DASI), in contrast to a subjective medical assessment, suitable for predicting perioperative cardiac events. Our unpublished data show that a subjective self-assessment of "limited exercise capacity" in patients with COPD is predictive of PPC is suitable.

Objectives:

* Development of a self-assessment questionnaire as part of a Delphi trial
* Validation of the self-assessment questionnaire

Methodology:

Prospective observational, case control study of 5000 patients undergoing surgery in general anesthesia (estimated enrollment of 5500 patients with a dropout rate of approximately 10%).

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Operations in general anesthesia

Exclusion Criteria:

* \< 18 Years
* Pregnancy
* Lack of cooperation
Isolated Growth Hormone Deficiency and Amennorrhea

This is a case report of a 14-year old female with no menstruation history.

This is a case report of a 14-year-old with a chief complaint of inability to menstruate. Lab tests were done.

Eligibility Criteria:
Inclusion Criteria:

* A single female participant with amenorrhea

Exclusion Criteria:

* The study only included the above subject
Conscious Movement Processing, Postural Stability and Muscle Efficiency in Older Adults

This study aims to address critical knowledge gaps by investigating the effects of trait conscious movement processing propensity on real-time (state) conscious movement processing propensity, postural stability, and muscle efficiency in older adults at risk of falling in Hong Kong with high and low trait conscious movement processing propensities, while standing in a challenging environment with different levels of standing task difficulties. The study results would contribute to our scientific understanding of the mechanisms of conscious movement processing in older adults while maintaining standing balance in a challenging environment. It could inform the follow-up investigations for the development of the most appropriate psychomotor standing balance re-education intervention in rehabilitation so as to mitigate the effect of conscious movement processing and the risk of falling in older adults. The findings from the proposed research could ultimately help improve the outcome of fall rehabilitation programmes and reduce the impact of falls in the older adults in Hong Kong.


Eligibility Criteria:
Inclusion Criteria:

* 65 years old or above;
* able to stand independently without a walking aid.

Exclusion Criteria:

* a history of any major cerebrovascular and/or neurological disorders (e.g., stroke, Parkinson's disease);
* a history of a major fall event within the past year;
* the existence of an unstable medical or mobility condition that could affect safety in this study;
* a score of 23/30 or below in the Chinese version of Mini-Mental State Examination (MMSE-C);
* a static visual acuity poorer than 20/40 vision (examined by the Tumbling-E eye chart).
Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer

Cytokine-induced killer (CIK) cells show cytolytic activity against tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining Radiation therapy with adoptive cellular therapy after surgery may be more effective than uses radiation therapy alone in treating esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* cytologically or histologically confirmed esophageal carcinoma
* Tumor extension beyond muscularis propria and/or nodal involvement without evidence of M1 disease
* Prior en bloc resection, with curative intent, of all known tumor
* No metastatic disease
* Age: \> 18
* Karnofsky performance status ≥ 70
* At least 3 weeks since prior surgery
* Normal functions of heart, lung, liver, kidney and bone marrow
* Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
* All patients must be evaluated by a radiation oncologist prior to enrollment to ensure patient is appropriate for radiotherapy
* Informed consent signed

Exclusion Criteria:

* Patients with metastatic disease.
* Patients who are pregnant or nursing.
* Patients with poor bone marrow, liver and kidney functions, which would make radiation therapy intolerable
* Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
The Study of Nutrition of Children and Adolescents With GERD

This trial is to study the aspects of nutrition in children and adolescents with GERD compared to the sex and age-matched control group

The aim of the study is to assess the differences in nutrition of pediatric patients with GERD compared to the control group. The secondary aim is to study possible associations of the data on nutritional habits revealed with the use of food frequency questionnaire (FFQ) and the data of 24-hours oesophageal pH-impedance examination.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate (written informed consent and consent from parents or legal representative according to the local law);
* Age 6 to 17 years old inclusive,
* Possibility to assess symptoms, data of the medical history and receive answers to the questions about usual diet.

Exclusion Criteria:

* history of abdominal surgery;
* presence of varicose veins of the stomach and/or the oesophagus either in medical history or found during the study;
* inability to tolerate at least one of the invasive procedures or lacking data of the other instrumental examinations required by protocol;
* general condition of the patient making impossible to perform all the examinations or when performing the procedures is not safe and reasonable based on the opinion of the investigator that it may exacerbate the disease flow or put the patient at risk;
* intake of medications which may influence the clinical and instrumental data, including, but not limited to: non-steroid anti-inflammatory agents, glucocorticosteroids (except for skin products, if they were used for 2 weeks or less at the time of inclusion into the study), medications affecting adrenergic, acetylcholine receptors, antidepressants, tranquillizers, sedatives, those with known local irritant effect on the gastrointestinal tract mucosa; the use of proton pump inhibitors and H2 receptors blockers are not allowed during the study, a wash-out period for at least 2 weeks is necessary before the enrolment.
The Effect of Balance Exercises on Cognitive Function

The aim of our study is to examine the effects of balance exercises performed in virtual and real environments on visual-spatial attention and mental rotation in healthy young adult individuals using EEG brain oscillations.


Eligibility Criteria:
Inclusion Criteria:

* There wouldn't be any neurological conditions
* There wouldn't be drug use such as psychiatric drug
* There wouldn't be lower extremity surgery
* There wouldn't be epilepsy
* Be healthy
* Take minimum 68 points of System Usability Scale

Exclusion Criteria:

* Neurologic disorder
* Epilepsy
* Active sport life
* Colour blindness