cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients

This study was a randomized controlled trial to investigate the immune response of influenza vaccines when doses were increased. and a second vaccination together with an increase in the amount of vaccine in patients with chronic kidney disease receiving hemodialysis

1. Patients with chronic kidney disease undergoing dialysis will be examined by an internist.
2. Collect the necessary basic information of patients who agree to participate in the treatment.
3. Patients will be randomized to be divided into 3 groups: those who will receive an standard dose of influenza vaccine, those who will receive double standard dose of influenza vaccine (double-dose) and those who will receive double standard dose of influenza vaccine and Six months after the first dose of vaccination (double-booster-dose), 50 people per group.
4. Non-dialysis volunteers will be invited to participate in the research. to be a control group of 25 people
5. Patients with chronic kidney disease and volunteers will receive basic laboratory blood tests.
6. Patients with chronic kidney disease and volunteers will be vaccinated against influenza. shoulder muscle area according to random groups The details of using Influvac vaccine of that year are produced by Abbott.
7. Patients with chronic kidney disease and volunteers are asked about the potential side effects of vaccination. according to research guidelines both systemic side effects and injection site Each time receiving hemodialysis 3 times a week for 2 weeks after vaccination
8. Patients with chronic kidney disease and volunteers were asked about the onset of symptoms of respiratory infection throughout the 12-month study period after vaccination.
9. Patients will receive a blood test to check their immune response to influenza vaccine. (Hemagglutination inhibition assays and activation and/or exhaustion T cell markers, T cell subpopulation by flow cytometry) at 1, 6, 7 and 12 months after influenza vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Received kidney replacement therapy with dialysis for more than 1 month.
* Hemodialysis at least 3 times a week
* (Kt/v) greater than 1.2
* Never received an organ transplant.
* Life expectancy of more than 1 year
* Research participants or representatives are welcome to join the project by signing.

Exclusion Criteria:

* History of any vaccinations in the 4 weeks prior to the study.
* History of receiving influenza vaccine 6 months before entering this study.
* History of allergy to flu vaccine or allergic to egg white
* Fever or headache, muscle pain (influenza-like illness) 3 days before vaccination
* Thrombocytopenia
* On immunosuppressive drug (Prednisolone 15 mg daily or equivalent for two weeks in a row in the previous 3 months) or immunocompromised patient
* Patient or family history of having had Guillain-Barre disease. (Guillain-Barre syndrome)
* The research participant or his representative refuses or requests to withdraw.
Effect of Intermittent ThetaBurst Stimulation in Treatment-resistant Bipolar Depression

The aim is to evaluate the evaluate the clinical interest and the safety of repetitive transcranial magnetic stimulation (rTMS) delivered as intermittent Theta burst stimulation(iTBS) on severity of depression in patients with treatment-resistant bipolar disorder.

Methods: A double-blind randomized sham-controlled pilot study will be conducted in 40 patients with bipolar treatment-resistant depression receiving either active (n=20) or sham (n=20) iTBS over the left dorsolateral prefrontal cortex.

Depression severity will be assessed by an investigator blinded to iTBS condition before and after 10 to 30 iTBS sessions depending on remission onset. Remission will be defined as Beck Depression Inventory, BDI score\<10.

Objective/Hypothesis: The investigators hypothesized the superiority of active iTBS over sham ITBS

Eligibility Criteria:
Inclusion Criteria:

* Bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, DSM-IV criteria
* Montgomery and Asberg depression scale \> 20

Exclusion Criteria:

* other psychiatric features, rapid cycles
* Benzodiazepines intake
* pregnancy
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo and Active Control in Major Depressive Disorder

This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a documented clinical diagnosis of Major Depressive Disorder.
* Be able to understand and comply with the requirements of the study.
* Able to understand and provide written informed consent

Exclusion Criteria:

* Patients (female) must not be pregnant or lactating
* Current or past diagnosis of stroke or transient ischemic attack (TIA).
CHACO Study: Control of Arterial Hypertension in Colombian Patients

Epidemiological study (cross-sectional study) in order to determine the patients who present an adequate control of the Blood Pressure (BP), in a population of Colombian patients diagnosed with Arterial Hypertension (AH) and who are under pharmacological treatment.

OBJECTIVE: To determine the proportion of patients who present an adequate control of the Blood Pressure (BP), in a population of Colombian patients diagnosed with Arterial Hypertension (AH) and who are under pharmacological treatment.

MATERIALS AND METHODS: Epidemiological study (cross-sectional study), multicentre type, in patients older than 18 years with prior diagnosis of AH in Colombia. The blood pressure control will be evaluated as the main variable (only one single blood pressure check in the doctor's office). Other secondary variables to evaluate are: demographical analysis, type (s) of antihypertensive treatment (s) used in patients, level of BP control, adverse events associated with antihypertensive treatment, comorbidities and risk factors, adherence, perception about the possible benefits of the use of combined therapy in "mono-tablet" versus "multi-tablet". The analysis will be carried out from two perspectives: A first descriptive approach and a second analytical approach, with a level of significance of 5%.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Prior diagnosis of Arterial Hypertension (AH) ≥ 3 months before
* Patients who are under pharmacological treatment of AH ≥ 3 months before

Exclusion Criteria:

* The patient has rejected the participation in the study.
* Patients who, in the judgment of the Investigator, do not understand or are not willing to adequately answer the questions.
* Mental or psychiatric illness that, in the judgment of the investigator, does not allow adequate information to be obtained.
The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer

To confirm the tolerability and safety of combined administration of ONO-7913, ONO-4538 and the standard of care FOLFOX in combination with bevacizumab or cetuximab as first-line treatment in patients with unresectable advanced or recurrent colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

1. Unresectable advanced or recurrent colorectal cancer
2. Life expectancy of at least 3 months
3. Patients with ECOG performance status 0 or 1

Exclusion Criteria:

1. Patients with severe complication
2. Patients with multiple primary cancers
CMR or Angiography for FFR-guided Revascularisation

Around 50% of patients that present with ST Elevation Myocardial Infarction (STEMI) have residual disease in the non-culprit lesions. If the residual disease should be treated, what should guide intervention? Fractional Flow Reserve (FFR) has been proposed as a guide for intervention, however new developments in cardiovascular magnetic resonance (CMR) allows for non-invasive FFR measurements.

If FFR from CMR can predict physiological significant stenosis as good as FFR from invasive angiography, unnecessary invasive producers can be avoided in patients with STEMI.

Early reperfusion of epicardial coronaries is essential for salvage of ischemic myocardium, reducing both morbidity and mortality in patients with ST elevation myocardial infarction (STEMI). Current European Society of Cardiology guidelines recommend percutaneous coronary intervention (PCI) of the infarct related artery (IRA) for patients presenting with STEMI, with residual disease initially being treated conservatively. Large meta-analyses of observational studies have shown that PCI of the IRA only results in a reduced mortality compared to full revascularization in patients with STEMI and simultaneous multivessel disease. However, recent small randomized controlled trials indicate that full revascularization reduces morbidity, but have been underpowered to show any reduction in mortality. Furthermore, physiological guidance of coronary intervention by fractional flow reserve (FFR) reduces mortality compared to angiography guided PCI in both stable angina and non-STEMI (NSTEMI). However, if performing full revascularization guided by FFR in patients with STEMI improves clinical outcome, compared to initial conservative approach is not known.

Assessment of myocardial perfusion in rest and during pharmacological stress is widely used for non-invasive diagnosis of myocardial ischemia, where cardiovascular magnetic resonance (CMR) has a high diagnostic accuracy. Newly developed first pass perfusion imaging with cardiovascular magnetic resonance (CMR) allows for quantification of myocardial perfusion, and CMR derived FFR. However, it is currently not known if FFR from CMR and invasive angiography correlate with each other. If FFR from CMR can predict physiological significant stenosis as good as FFR from invasive angiography, unnecessary invasive producers can be avoided in patients with STEMI.

Eligibility Criteria:
Inclusion Criteria:

* Patients included in the active arm of FULL REVASC, that has not undergone invasive FFR, and give written informed consent.

Exclusion Criteria:

* Asthma/Chronic Obstructive Pulmonary Disease, systolic blood pressure under 90 mmHg, bradycardia (less than 45 beats/min), persistent second or third AtrioVentricular-block, Sick Sinus Syndrome, Long QT Syndrome, atrial fibrillation, severe aortic stenosis, severe heart failure (NHYA class III-IV), metallic implants, kidney failure (less than 30 ml/min/1.73 square meters body surface area), current treatment with the drugs Persantin, theophyllamin or Fevarin.
Impact of Night Shift Work on 24-hour Blood Glucose Levels

This study will determine whether nurses regularly working night shifts have elevated 24-hour glucose levels compared to nurses regularly working day shifts, using continuous glucose monitoring (CGM).


Eligibility Criteria:
Inclusion Criteria:

* • RNs working at least a 0.6 FTE and 12-hour night or day shift (not able to alternate between days and nights) for at least the past two months

  * Free from presence of uncontrolled chronic illness and specifically prediabetes, Type 1 or Type 2 diabetes (but not including history of gestational diabetes) and not currently taking any glucose-lowering or steroid medication
  * Not currently pregnant or breastfeeding
  * English speaking and able to provide informed consent
  * Must own and know how to operate a Smartphone
  * Must be willing and able to wear two small sensors attached by adhesive for the study duration, the Fibion SENS activity monitor and the Dexcom G6 continuous glucose monitor
  * Must regularly consume food during shifts and refrain from actively attempting weight loss during the study duration
  * Must work only one job at the time of study participation
Fluid Therapy During Brain Tumor Resection in Children

Fluid management of children during neurosurgery is not well established. Hypotonic solutions, commonly still used in pediatric patients, may enhance cerebral edema and worse operative conditions. This study compares two different isotonic solutions administered perioperatively regarding acid base and fluid electrolyte disturbances.


Eligibility Criteria:
Inclusion Criteria:

* Children undergoing elective craniotomy for brain tumor resection
* Informed consent form signed and dated by legal guardian and investigator
* Informed assent form signed by the patient if appropriate

Exclusion Criteria:

* Uncontrolled Intracranial hypertension
* Severe heart, kidney, or pulmonary disease
* non-corrected electrolyte imbalance
* allergy to the solution administered
A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)

The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of 'Flowise Cerebral Flow Diverter' for the treatment of unruptured wide-necked cerebral aneurysm in the internal carotid artery.

Flowise is indicated for use in patients with unruptured wide-necked aneurysm in the internal carotid artery. Consecutive subject data should be collected at discharge, 1, 3, and 6 month post Flowise implantation.

Eligibility Criteria:
Inclusion Criteria:

* Functional neurological state ≤2 mRS
* Unruptured wide-neck aneurysm in the internal carotid artery has a size \>8mm, a neck ≥4mm, or dome/neck ratio \<2
* Parent artery with diameter ≥3.25mm and ≤4.5mm
* Patient willing to provide written informed consent and comply with follow-up requirements

Exclusion Criteria:

* Intracranial hemorrhage within 30 days
* Untreated ruptured intracranial aneurysm
* ≥1 intracranial aneurysm except the target one requires treatment within 6 months
* Immunosuppressive disease
* Active infectious disease (e.g. endocarditis, meningitis)
* Platelet count \< 100 x 103 cells/mm3
* Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.
Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17

The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is a male or female aged 6-17 years inclusive at the time of consent.
2. Subject must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
3. Subject must have a Baseline ADHD-RS-IV total score ≥28.
4. Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
5. Subject is able to swallow a capsule.

Exclusion Criteria:

1. Subject has failed to respond to more than one adequate course (dose and duration) of stimulant therapy. One course must have been a long-acting formulation.
2. Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
3. Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently, demonstrating active suicidal ideation.
4. Subject has glaucoma.
5. Subject weighs less than 22.7kg (50lbs).
6. Subject is significantly overweight based on Centre for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at Screening. Significantly overweight is defined as a BMI \>97th percentile for this study.
7. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or methylphenidate.
8. Subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the test or reference products.
9. Subject has a history of seizures (other than infantile febrile seizures), a tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
10. Subject has a known history of symptomatic cardiovascular disease, advance arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
11. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
12. Subject is well controlled on their current ADHD medication with acceptable tolerability.
13. Subject has a pre-existing severe gastrointestinal tract narrowing (pathologic or iatrogenic).
Pediatric Atopic Dermatitis (AD) Internet Survey

The purpose of this study is to evaluate whether participation in an Internet-based intervention helps improve atopic dermatitis treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Any child age 2 to 8 with a diagnosis of atopic dermatitis confirmed by a dermatologist, together with the child's parent/guardian. Written consent must be given by parent/guardian.

Exclusion Criteria:

* Child is less than 2 or greater than 8 years of age.
* Known allergy or sensitivity to topical triamcinolone in the child.
* Inability to complete all study-related visits, or inability to complete the Internet survey due to inadequate Internet access.
* Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study. Subjects who are on systemic anti-inflammatory treatments for atopic dermatitis must be on a stable dose for at least 3 months prior to enrollment.
Impact of Oral Versatile Antioxidants on Glaucoma Progression

Background: The significance of retinal ganglion cell protection in the glaucoma led the view that, glaucomatous optical neuropathy can also be considered as a pathology of central nervous system. It is known that α-tocopherol and Gingko Biloba have specific neuroprotective and vasoregulatory activities, in addition to antioxidant effects. In this study, the investigators compared early neuroprotective effects of α-tocopherol and GB with each other as well as control and a strong antioxidant formulation in patients with glaucoma.

Methods: In this non-randomized control trial, 120 eyes of 60 patients with glaucoma were enrolled into the study and divided into 4 groups, each consisting of 30 eyes. Unlike the controls, patients in the 3 antioxidant groups received α-tocopherol, Gingko Biloba and a strong antioxidant formula for 3 months. Central vision field and MD, PSD and OCT as well as thickness of retinal nerve fiber layer, ganglion cell counts and c/d ratios were recorded. The data were compared statistically.

A significant difference was observed between MD, PSD, s-RNFL and m-RNFL levels of groups (p\<0.05) (Table 3), but when compared with Groups of Vit E and AOF, MD and s-RNFL levels of the Group GB were significantly low and PSD level was significantly high in the same group. m-RNFL level of the Vit E group was significantly higher than m-RNFL levels of GB, AOF and Control groups (p\<0.05, p\<0.01). In the comparison of Vitamin E with GB, MD values were found significantly higher and PSD values were significantly low (p\<0.05). No statistically significant difference was present between I-RNFL levels of groups (p\>0.05). While the difference between c/d levels of groups were highly significant (p\<0.01) (Table 3), c/d levels of Vit E and GB groups were found significantly lower than c/d levels of AOF and Control groups (p\<0.01). c/d level of the Vit E group is significantly lower than c/d levels of AOF and Control groups (p\<0.01). No statistically significant difference was found between c/d levels of other groups (p\>0.05).

No statistically significant difference was present between s-GCC and i-GCC levels of groups (p\>0.05). A high statistically significant difference was found between m-GCC levels of groups (p\<0.01). While highly 201 significant and significant difference were present between m-GCC level of the Vit E Group and m-GCC levels of AOF and Control Groups, respectively, (p\<0.01, p\<0.05), m-GCC level of the Group GB was significantly higher than that of Group AOF (p\<0.05). No statistically significant difference was observed between m-GCC levels of other groups (p\>0.05).

Eligibility Criteria:
Inclusion Criteria:

* Patients who received follow-up in our glaucoma polyclinics

Exclusion Criteria:

* Known ocular or systemic concomitant disorders
* Previous glaucoma surgeries
* Antioxidant usage
The Association Between Plasma Metabolites and the Risk, Efficacy and Prognosis in Early Breast Cancer

This study investigates plasma metabolites to clarify the relationship between these metabolites and breast cancer, aiming to identify valuable biomarkers. Furthermore, by incorporating clinical information-such as cancer stage, type, treatment outcomes, and prognosis-into prospective studies, the research seeks to further examine the correlation between plasma metabolites, treatment efficacy, and prognosis.

Compared to normal tissues, tumor tissues exhibit significant metabolic changes. Consequently, tumor metabolic dysregulation is recognized as a novel marker of cancer. Differential analysis of metabolic phenotypes has the potential to establish new patient stratification criteria and biomarkers that facilitate personalized therapy. Breast cancer is the most prevalent malignant tumor among women. With advancements in metabolomics sequencing technology, an increasing number of researchers are focusing on the role of metabolomics in the diagnosis and treatment of breast cancer. It is important to note that the significance of individual metabolites in relation to breast cancer varies across studies; therefore, a standardized metabolic profile for assessing breast cancer risk has yet to be established.

This project collected data from natural populations and breast cancer patients by analyzing plasma metabolites alongside clinical treatment information. The goals of this study are to explore the correlation between plasma metabolites and breast cancer, as well as to identify biomarkers that characterize therapeutic efficacy and prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Cohort 1 Control Group: women without breast cancer or other malignancies. Case Group: patients with histologically confirmed carcinoma in situ or invasive breast cancer; no prior treatment; no distant metastasis; and not associated with other malignant tumor diseases.
* Cohort 2 Pathologically diagnosed as breast cancer; Treatment niave patients; To receive standard neoadjuvant therapy; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) .
* Cohort 3 Patients who have been discharged after breast cancer treatment.

Exclusion Criteria:

* Histologically undiagnosed breast cancer. Breast cancer with distant metastases. Combined with other malignant tumors. Participants must not have participated in other clinical trials within the past month, unless those trials are observational or non-interventional in nature.