cyrilzakka/clinical-trials huggingface dataset:
Using of Biomarkers and Blood Culture in Early Detection of Systemic Infections

This work aims to:

1. Validate the performance of CRP, and PCT in early differentiating IFI from bacterial bloodstream infections.
2. Compare the results of CRP and PCT with the results of β-D- glucan. 3. Find the relationship between biomarkers levels \[CRP, PCT and β-D- glucan\] and the results of blood culture which is the gold standard of diagnosis.

Immunocompromised children with cancer receiving chemotherapy or undergoing hematopoietic stem cell transplant (HSCT) are at high risk of infections. Invasive fungal infection (IFI) is a significant cause of morbidity and mortality. The incidence of IFI from 5.3% to 24% and the mortality rate from 18.6% to 67.6%. Definite diagnosis of fungal infection in immunocompromised patients is particularly challenging. However, the clinical presentation of IFI is not specific, especially in pediatric patients. The culture of blood is the major method to diagnose proven IFI, but the results are mostly negative, and culture is time consuming. New nonculture-based methods, including antigen-based assays, and molecular detection of fungal DNA which may allow early diagnosis and treatment of fungal infection. Molecular techniques, including DNA sequencing and polymerase chain reaction (PCR). These techniques have become more available in many laboratories; however, it lacks methodological standardization, and the results vary widely among laboratories. More attention paid to the biomarkers. 1, 3- β -D- glucan (BDG) is a component of the fungal cell wall and therefore it considered a pan-fungal detection method. Traditional biomarkers as C-reactive protein (CRP) and procalcitonin (PCT) have also been evaluated for their abilities in distinguishing IFI and other infections. In neonates, CRP levels were significantly higher in fungemia than in bacteremia, in adult patients, there was not a significant difference between the candidemia and bacteremia groups. The PCT value was markedly lower in the fungal infection group than in the bacteremia group at the onset of fever.

Eligibility Criteria:
Inclusion Criteria:

* Patients clinically suspected to have invasive fungal infections such as fever, cough or retrosternal pain, oral mucositis or perianal pain.
* Drug history of corticosteroids or chemotherapy.

Exclusion Criteria:

* Patients refuse to be part of the study.
* Patients have no symptoms of systemic infections.
* Drug history for antimicrobial before blood sample collection.
A Novel Patient Decision Aid for Surgical Treatment Options in Early-Stage Breast Cancer

This is a study to assess the feasibility and acceptability of a novel decision aid (DA) in a newly diagnosed, early-stage breast cancer population. Insights gained from patient feedback and the implementation process will be used to improve the information delivered in the decision aid itself and to plan for a larger scale trial to compare the decision aid to standard of care.

This pilot study will utilize several tools and instruments to measure various aspects of of the implementation of the decision aid. 1. BREAST-Q patient-Reported Outcomes, 2. Ottawa Decision Aid Evaluation Measures, 3. Health Literacy Assessments, 4. Distress Screening Tools, 5. Web-Based Surveys, 6. Semi-Structured Interviews.

Eligibility Criteria:
Inclusion Criteria:

* Adult women age 18-100
* English speaking
* Clinical stage 0-III breast cancer
* Eligible for both lumpectomy and mastectomy

Exclusion Criteria:

* Prior surgical consultation regarding treatment options for breast cancer
* Previous history of breast cancer
* Requires neoadjuvant chemotherapy prior to surgical intervention
The Effect of Huperzine A Injection on Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage: a Pilot Study

Under the premise of basic treatment, to explore the improvement effect of huperzine A injection on short-term and long-term neurocognitive dysfunction in patients with aneurysmal subarachnoid hemorrhage after interventional/surgical treatment.

Description: This is a randomized, controlled, single center, exploratory clinical trial. The subjects are divided into surgical treatment group and interventional treatment group. Each group is divided into test group and control group. The test group is given huperzine A injection (0.2mg/dose) every day, intramuscular injection, for a total of 8 days, and basic treatment is given at the same time; The control group was given basic treatment, and did not receive other neurotrophic drugs except basic drugs. This clinical trial is to evaluate the effect of huperzine A injection on the improvement of postoperative cognitive dysfunction in patients with aneurysmal subarachnoid hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70;

  * The patients were proved to be aneurysmal subarachnoid hemorrhage by imaging examination (head CT, CT angiography (CTA), whole brain angiography (DSA));

    * Hunt Hess was graded I-III at admission;

      * The patients were treated with endovascular therapy or craniotomy and clipping surgery;

        * The time from the onset of aSAH symptoms to admission ≤ 72 hours; ⑥ The subject himself or the guardian of the subject knew and voluntarily signed the informed consent form.

Exclusion Criteria:

* Non aneurysmal subarachnoid hemorrhage;

  * Cognitive dysfunction existed before onset;

    * Patients with angina pectoris, bronchial asthma, mechanical intestinal obstruction, liver and kidney insufficiency, and urinary tract obstruction;

      * Complicated with other nervous system diseases, including nervous system degenerative diseases (Alzheimer's disease, Parkinson's disease, Lewy body dementia, frontotemporal dementia, etc.), neuromyelitis optica, epilepsy, central nervous system infection (such as AIDS, syphilis, etc.), brain traumatic dementia, etc;

        * Psychotic patients, according to DSM-IV-TR standards, including schizophrenia or other mental diseases, bipolar disorder, major depression or delirium;

          * Other cholinesterase inhibitor drugs are being used; ⑦ There are uncorrectable visual and auditory disorders, and neuropsychological tests and scales cannot be completed;

            * Have unstable or serious heart, lung, liver, kidney and hematopoietic system diseases;

              * Pregnant or lactating women and women of childbearing age without reliable contraception, and there is no evidence of negative pregnancy; ⑩ Patients who cannot be followed up as required during the study period; ⑪ Those who are allergic to the test drug; ⑫ Those who have participated in other clinical trials in recent 3 months; ⑬ Patients who are not suitable to participate in the clinical trial.
AI-Guided (GenAIS TM) Versus Standard Physician-Guided Dietary Supplementation for Managing Metabolic Syndrome

The study "AI-Guided (GenAIS TM) Versus Standard Physician-Guided Dietary Supplementation for Managing Metabolic Syndrome" aimed to compare the effectiveness of AI-guided dietary supplement (DS) prescriptions versus standard physician-guided prescriptions in managing metabolic syndrome. This 6-month randomized controlled trial included 160 participants diagnosed with metabolic syndrome. Participants were divided into two groups: one received DS based on physician judgment, and the other based on GenAIS AI system analysis. Primary outcomes focused on changes in metabolic parameters, while secondary outcomes included individual components of metabolic syndrome, inflammation levels, body weight, and adherence to the DS regimen. Data collection involved genetic, metabolic, and clinical profiling, with ethical considerations ensuring participant confidentiality and informed consent.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 75 years.
* Diagnosed with metabolic syndrome, defined by the presence of at least three of the following criteria:
* Waist circumference \> 102 cm (men) or \> 88 cm (women).
* Triglycerides ≥ 150 mg/dL.
* HDL cholesterol \< 40 mg/dL (men) or \< 50 mg/dL (women).
* Blood pressure ≥ 130/85 mm Hg.
* Fasting glucose ≥ 100 mg/dL. • Willingness to provide genetic and metabolic data.

Exclusion Criteria:

* Significant renal, hepatic, or cardiovascular diseases.
* Use of dietary supplements that affect metabolic parameters within the last 3 months.
* Pregnancy or breastfeeding.
A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery

This study will compare the safety and efficacy of a new eye drop formulation with REFRESH PLUS® in participants following LASIK surgery.


Eligibility Criteria:
Inclusion Criteria:

-Patients scheduled for LASIK surgery in both eyes.

Exclusion Criteria:

* Any systemic medication use within 3 months of screening (including over the counter, herbal, prescription, or nutritional supplement) which may affect dry eye or vision
* Use of topical eye medication other than prescribed for use in pre- or post-operative care
* Use of RESTASIS® or other topical ophthalmic cyclosporine product within 6 months prior to Screening
* Eye infection, inflammation, or allergy
* Soft contact lenses in the previous 7 days or rigid contact lenses in the previous 30 days prior to LASIK surgery.
A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon

The aim of this study is to determine whether xenon - as compared to sevoflurane - can be applied safely in patients for general anesthesia before and after CABG implantation.

The study will be conducted by two investigator types: The study enrollment and the post-anesthesia follow-up will be performed by Investigator I who is blinded to the study treatment. Investigator II will only perform general anaesthesia for CABG surgery and will therefore necessarily be unblinded to the treatment conditions.

Patients will be randomly assigned to one of the following study groups. Group 1 (Xenon) will receive xenon for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. Group 2 (Sevoflurane) will receive sevoflurane for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. During extracorporal circulation, general anesthesia will be maintained intravenously in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery disease scheduled for elective CABG
* Patients willing and able to complete the requirements of this study
* Ejection Fraction \> 50%
* EuroSCORE ≤ 8
* men and women \>= 50 yrs
* women without childbearing potential
* ASA Score II-IV

Exclusion Criteria:

* Lack of informed consent
* EuroSCORE \< 8
* MMSE \< 24
* Age \< 50 years
* COPD GOLD \> II, increased need of oxygen
* Renal dysfunction
* Liver function disorders
* Acute coronary syndrome during the last 24 hours; hemodynamic instability
* Requirement of inotropic support
* Off-pump-surgery
* Disabling neuropsychiatric disorders
* History of stroke with residuals
* Hypersensitivity to the study anaesthetics
* Increased intracranial pressure
* Pregnancy and lactation period
* Women of childbearing potential
* Presumed uncooperativeness or legal incapacity
* Participation in a concomitant trial
Effect of Combining Central and Peripheral Cutaneous Electrical Stimulation on Lower Limb Motor Function in People with Stroke: a Single-blinded Randomized Controlled Trial

This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) and transcutaneous electrical nerve stimulation (TENS) in augmenting the efficacy of the lower limb task-oriented training in people with stroke. It is hypothesize that lower limb motor function can be best improved by combining anodal tDCS with Bi-TENS, when compared with sham-tDCS with Bi-TENS, anodal tDCS with placebo-TENS, or control training at improving ankle muscle strength, motor control of lower limbs, walking performance, functional mobility and community integration in people with stroke.

The application of transcutaneous electrical nerve stimulation (TENS) over a paretic lower limb could augment the effects of task-oriented exercise therapy on lower limb motor function in people with stroke, possibly through increased excitability of sensorimotor cortex.

In transcranial direct current stimulation (tDCS), a weak electrical current is applied through electrodes placed on the scalp to modulate cortical excitability and neural activity in targeted brain regions. Anodal tDCS, specifically, involves positioning the positively charged electrode over the targeted cortical area, which facilitates neuronal depolarization and increases cortical excitability in the underlying brain tissue. The enhanced neural excitability induced by anodal tDCS could promote neuroplasticity and optimize motor learning processes, potentially through the modulation of NMDA receptor-dependent mechanisms and alterations in GABAergic activity, leading to improved motor function and rehabilitation outcomes in various neurological conditions.

The next question concerns whether anodal tDCS could be combined with TENS and whether their synergetic effects could maximise the motor output of paretic limbs in people with stroke.

Eligibility Criteria:
Inclusion Criteria:

1. are between 50 and 85 years of age;
2. have had a single stroke more than 6 months and less than 15 years;
3. have at least 5 degrees of active ankle dorsiflexion in the antigravity position;
4. are able to walk 10 m independently, with or without a walking aid;
5. are able to score 6 or higher out of 10 on the abbreviated mental test;
6. have no skin allergies (e.g. redness or itchiness after application of the electrical stimulation pads) to electrical stimulation or electrodes;
7. are able to follow instructions and give informed consent.

Exclusion Criteria:

1. have any additional medical, cardiovascular or orthopedic conditions that would hinder their treatment or assessment;
2. have a cardiac pacemaker;
3. have aphasia or cognitive difficulties that may interfere with their comprehension of instructions;
4. have had one or more epileptic seizures within the year prior to the date of inclusion in the study;
5. have an intracerebral metal clip;
6. have a major somatosensory deficit
7. have any contraindication to tDCS;
8. are currently involved in drug studies or other clinical trials.
The Study of Immune Cell (T Cell) Activity in Patients With Paraneoplastic Neurologic Syndromes

The investigators believe that T cells, cells that are a part of the immune system, are what are causing the neurological problems while also attacking tumor cells. This protocol studies the clinical status of patients with paraneoplastic neurological disorder (PND) as well as their blood to understand the relationship between their neurological disease, their cancer, and their immune system.

Patients with paraneoplastic neurological disorders (PNDs) provide a unique model for studying tumor immunity and neuronal autoimmunity. We hypothesize that T lymphocyte autoimmune dysfunction is involved in the pathogenesis of the paraneoplastic neurological syndromes, and that killer T cells are involved in the targeting and successful killing of tumor cells in these cancer patients. Furthermore, we postulate that this activity may provide a model for autoimmune brain disease. We will assess the immune responses in PND patients, correlate these with the clinical data (time course of disease, symptoms and signs, disability), and collect and archive clinical data, serum and cells from PND patients for current and future studies into the basic immune system phenomenon present in PND patients.

Eligibility Criteria:
Inclusion Criteria:

* Neurological disease which is suspected to be paraneoplastic
* No known active additional malignancy other than non-melanoma skin cancer

Exclusion Criteria:

* Known central nervous system (CNS) metastasis
* Known active additional malignancy
* No pulmonary disease which limits daily activities

if leukapheresis: must be 14 or older no known hepatitis B or C, HIV, or syphilis (by history or prior negative tests) no known IV drug users HgB \> 8.5 WBC \> 3,500 platelets \> 100,000 INR \< 2

if large blood draw (1/2 to 1 unit; children 3 ml/kg) in lieu of leukapheresis: no known IV drug users HgB \> 10 WBC \> 3,500 platelets \> 100,000 INR \< 2

if lumbar puncture: platelets \> 120,000 INR \< 1.2 must be 14 or older
Efficacy of Iron Bisglycinate in Treatment of Iron Deficiency Anemia in Pregnant Women

Anemia in pregnancy is defined by the World Health Organization as hemoglobin levels of ≤ 11 g/dl. Globally, a prevalence rate of 38% was estimated by the World Health Organization for pregnant women.Treatment of iron deficiency anemia during pregnancy remains a main public health issue. Oral iron salts have been recommended for treatment of iron deficiency anemia e.g. ferrous fumarate. Increasing the dose of ferrous fumarate will subsequently increase the bioavailability of iron preparation, however it also increases the frequency of gastrointestinal tract side effects e.g. nausea, constipation, diarrhea, flatulence, and black stained stools. Besides, the increased bioavailable ferrous fumarate may decrease by many foods and / or chelating drugs in the gastrointestinal tract which interfere with its absorption leading to variability in the hemoglobin correction during the treatment.

Ferrous bisglycinate is an iron amino acid chelate. It is formed by reaction of ferrous iron with two molecules of the amino acid glycine by a covalent bound in a process called chelation. Ferrous bisglycinate is claimed to have better patient compliance because of fewer gastrointestinal tract side effects. It is also claimed that ferrous bisglycinate improves iron absorption, storage and increase hemoglobin level better than the conventionally used iron salts.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged 20 to 40 years,
* 14-27 gestational weeks calculated from the first day of their last menstrual period and confirmed by ultrasound
* Singleton fetus
* hemoglobin level from 7-9.9 g/dL.

Exclusion Criteria:

* All women with high risk pregnancy e.g. hypertension, diabetes
* multiple pregnancy
* women with severe anemia (Hb \>7 g/dl)
* anemia due to other causes than iron deficiency as chronic blood loss, hemolytic anemia or thalassemia.
* women with hepatic, renal or cardiovascular abnormality; women with peptic ulcer, esophagitis, gastritis or hiatus hernia
* family history of thalassemia, sickle cell anemia, or malabsorption syndrome
* hypersensitivity to iron preparations or current use of iron supplementation.
Exercise to Improve Balance in Older Adults With Hearing Impairment - a Proof-of-concept Study

Hearing impairment is common in older adults, and recent research points to associations between hearing impairment and balance/mobility. The association may be due to more attentional resources being used to compensate for the sensory loss, with less resources available for maintaining balance. The aim of this projects is therefore to investigate whether an exercise program with focus on motor-cognitive tasks is feasible for older adults with hearing impairment. The study is meant as a proof-of-concept study, where trialling will be evaluated, and results will be used to inform the design of a larger and adequately powered study.

Study design:

This is an experimental (exercise) study with follow-ups three and twelve months after exercise completion.

Participants:

Participants will be recruited from two instances:

* "Praksisnett", which is a collaboration between GPs and researchers in Bergen, Norway, where GPs recruit potential participants to research projects.
* The Ear, Nose, Throat department at Haukeland University Hospital (Bergen), who provide service to older adults with hearing impairment. The aim is to include 60 patients into three intervention arms: i) virtual reality exercises, ii) vestibular rehabilitation exercises and usual care

Intervention arms:

* Virtual reality exercises: Participants will exercise in virtual environments twice weekly. The choice of environments/tasks will be individualized, and progress from sitting/standing exercises, to doing exercises while walking on a treadmill. The aim is to perform cognitive and motor tasks simultanously.
* Vestibular rehabilitation exercises: This is an exercise approach that has been used in clinical groups, such as patients with vestibular disorders and traumatic brain injury. The aim is to perform movements/exercises where the participant is exposed gradually to movements that may be provocative for the vestibular system.

The exercises will be done in a movement lab at Western Norway University of Applied Sciences. Participants will be randomised to either of the three intervention arms using a computerized procedure. Neither participants, testers or deliverers of the intervention will be blinded. Testers and intervention deliverers will be physiotherapists, students enrolled in a master program in clinical physiotherapy and bachelor students in physiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Hearing threshold above 30 dB

Exclusion Criteria:

* Inability to give informed consent,
* Inability to speak Scandinavian languages or English
* Diseases with severe motor impairments (such as mb Parkinsons)
Child Health Improvement Through Computer Automation - Child Neurology (CHICA-CN) Evaluation

The study will evaluate a computer decision support system for child neurology, Child Health Improvement through Computer Automation - Child Neurology (CHICA-CN) using patient chart review, family phone surveys, and physician interviews in a before-after study design.

(CHICA-CN) Child Health Improvement through Computer Automation - Child Neurology is software that works with the electronic health record (EHR) to improve the efficiency and quality of care in the outpatient setting. Built in partnership with the Child Neurology Foundation, CHICA's guidance is based on authoritative guidelines from the American Academy of Neurology and others. The plan is to implement CHICA-CN in the Child Neurology Clinics at Wake Forest Baptist Health. To evaluate CHICA-CN the proposal is to look at data derived from three sources:

1. Chart Review to evaluate quality of care based on measures derived from four algorithms developed from American Academy of Neurology quality measures and typically documented in the medical record. This will be a before-after study design in which measurements will be obtained before and after the installation of CHICA-CN.
2. Parent Phone Surveys to Document the parent experience in terms of physician-patient communication, parent engagement, and satisfaction with use of the patient facing tablet interface. These data will be collected from families of patients identified for the chart review after the intervention.
3. Physician user satisfaction measures, including perceived value of the system and ease of use in general and as regards individual clinical issues. Surveys will be administered to physicians and clinic staff who used CHICA-CN.

Eligibility Criteria:
Inclusion Criteria:

* Must be patients in the participating clinical practices meeting inclusion criteria for one of the four cohorts

Exclusion Criteria:

* N/A