cyrilzakka/clinical-trials huggingface dataset:
Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure

The purpose of this study is to evaluate the vision and posterior segment of eyes in children and young adults less than 22 years of age with risk, suspicion, or past medical history significant for elevated intracranial pressure (ICP). Patients will have visual acuity and color vision tested. Assessment of the posterior segment will involve using a non-invasive (non-contact) imaging technique (i.e. a portable fundus camera in clinic and hospital settings).

The need for non-invasive evaluation of ICP is an active area of study. The current gold standard is intraventricular or intraparenchymal catheters but these are invasive, expensive, and require sedation; and thus the need for an effective non-invasive screening tool. The utility of funduscopy in identifying processes affecting ICP has long been recognized, i.e. papilledema, ocular venous engorgement, blurring of the optic disk. Studies have demonstrated that funduscopy may have a role in the qualitative assessment of increased ICP as a highly sensitive test. However, conventional bedside funduscopy does not allow for image capture and may necessitate pupillary dilation. Portable fundus cameras address these issues, allowing image capture and storage and the potential for non-mydriatic imaging, i.e. imaging without dilation of eyes. And as demonstrated in a recent study, portable fundus cameras are efficient (median exam time was 3 minutes and 24 seconds in a pediatric Emergency Department).

Additionally, ICP screening in asymptomatic patients remains limited. Patients being treated with medications for acne, specifically tetracyclines (e.g. minocycline and doxycycline), retinol, and isotretinol, are at particular risk for increased ICP but often are not identified until they are symptomatic (i.e. headaches, visual loss, papilledema). Symptom onset has been documented from 2 weeks up to 1 year from drug initiation. The percentage of patients with subclinical asymptomatic disease is unclear. This study would allow us to describe the presence of subclinical disease in our population and the role/utility of routine non-invasive screening methods.

Eligibility Criteria:
Inclusion Criteria:

* Capable and willing to provide consent
* Less than 22 years of age
* History of or suspicion for elevated ICP or starting/currently taking high-risk medications associated with increased risk for elevated ICP

Exclusion Criteria:

* Unable or unwilling to give consent
* Over 21 years of age
Safety and Efficacy Study of Matrilin-3 Pretreated Autologous Adipose Derived Mesenchymal Stem Cells Implantation in Chronic Low Back Pain Patients With Lumbar Intervertebral Disc Degeneration

To investigate the safety and efficacy of autologous adipose-derived mesenchymal stem cell spheroids pretreated with matrillin-3 in chronic low back pain patients with lumbar intervertebral disc degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 19-70 years
* Among the subjects with low back pain, conventional conservative treatment is performed, but the back pain or hip pain persists for more than 3 months, and it is determined that the cause of the back pain is a degenerative disc (MRI checks for a degenerative disc)
* Has Oswestry Disability score(ODI) ≥ 30%
* Has Visual Analogue Scale(VAS) ≥ 4
* Between lumbar 1-sacral 1, Magnetic Resonance Imaging (MRI) grade according to the Pfirrmann classification is 3\~4.
* Has one or two degenerative lumbar discs identified by MRI (Confirmation of low back pain due to disc through various nerve block procedures.)
* Consent was prepared for stem cell administration

Exclusion Criteria:

* Patient requiring surgery due to severe pain in lower extremities due to severe nerve compression due to severe lumbar stenosis or prolapse of lumbar nucleus.
* patient with spinal instability, spondylitis, or vertebral fracture
* type 3 Modic change is in an endplate
* Patient whose disc height has decreased by more than 1/2 due to severe disc degenerative change
* Patient with severe osteoporosis (The average value of the T score in the lumbar spine bone density test is -2.5 or less)
* has undergone surgery, such as disc resection, on the disc to which the cells will be administered
* Patient who received lumbar epidural steroid injection 3 weeks before cell administration
* Pregnant or lactating women
* Among female patients who are likely to become pregnant during the clinical trial, who do not use medically acceptable methods of contraception

  * medically acceptable methods of contraception: condom, Oral contraception lasting for at least 3 months, Has received an infusion pill before 3 months, using an injectable or implantable contraceptive, or installed an intrauterine contraceptive device
* has a history of psychiatry or who are currently undergoing treatment, who judged that it is difficult to proceed with the clinical trial under the judgment of the researcher
* Patient with drug or alcohol addiction who cannot understand the purpose and method of this clinical trial
* Patient who participated in other clinical trials within 3 months prior to participation in the trial
* Patient who may affect this clinical trial due to serious medical conditions (hypertension not controlled by drugs, diabetes not controlled by drugs, cirrhosis, kidney failure, tumors)
* Patient with a history of malignant tumors within the last 5 years
* has a history of administration of cell therapy products
* Other persons who have clinically significant findings deemed inappropriate for this clinical trial due to medical judgment by the person in charge of the clinical trial
Iconographies for Risk Communication and Reduction of Patient's Anxiety in a Colorectal Cancer Screening Program

Background: Participants in the colon and rectal cancer (CRC) screening program that have a positive result in the Fecal Immunological Test (FIT) are visited by the screening nurse who explains the meaning of the positive test and the need to perform a colonoscopy. Having a positive result in the screening test can have a negative psychological impact on patients causing anguish.

Objective: To evaluate whether the use of iconographies to communicate the risks of possible diagnoses to patients with positive FIT improves the understanding of the information and reduces the degree of anguish.

Methods: Quasi-experimental pre-post intervention study with a control group. 240 individuals (men and women between 50-69 years of age, with a positive FIT result attending the nursing visit) will be included in two non-concurrent study groups (120 individuals per group). The control group will receive the nurse visit as usual. For the intervention group, the nurse will use iconographies to communicate the risk of the different possible diagnoses and the risk of complications of the colonoscopy. The degree of distress (Distress Thermometer and a scale of emotion-faces) will be measured before and after the visit and the understanding of the information (visual analog scale) after the visit. The degree of distress between the control group and intervention group will be compared.

If the results are favorable, the systematic use of iconographies can be implemented in the nursing screening visit and be extended to other Screening Units.


Eligibility Criteria:
Inclusion Criteria:

* women and men AND
* between 50 and 69 years of age AND
* who participate in the colorectal cancer screening program and have a positive result in the FIT AND
* who attend the nursing visit.

Exclusion Criteria:

* People who do not understand Catalan or Spanish OR
* with cognitive deterioration that prevents them from answering a questionnaire OR
* who do not know how to read or write.
Clinical Trial ES 900 - 2016

The primary objective of this clinical trial is to assess the clinical performance of the investigational device. To that end, for each measure and the in-vivo repeatability will be quantified, as well as the mean measurement deviation with respect to the current gold standard device. As a secondary objective of the study, raw measurement data will be collected, to allow for improvements of existing algorithms, development of additional measure and and for retrospective analysis.

EYESTAR 900 (the investigational device) is a new device by HAAG-STREIT AG, for measurement of optical biometry and advanced corneal topography by swept-source optical coherence tomography (OCT).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older;
* volunteers with phakic eyes, no cataract surgery indicated and with existing vitreous;
* patients seeking cataract surgery;
* patients with pseudophakic eye;
* patients with oil-filled eye;
* patients with aphakic eye.

Exclusion Criteria:

* underage patients (younger than 18 years);
* vulnerable patients;
* inability to give informed consent;
* inability to maintain stable fixation.
Effects of Neurodynamic Sliding Versus Eccentric Training on Lower Extremity Function, Strength and Proprioception in Athletes with Short Hamstring Syndrome.

Hamstring strains are among the most common injuries in field sports, accounting for 10% of all team sports injuries and often leading to long-term absence from activities. Risk factors include older age, previous injuries, reduced flexibility, and strength deficits. The hamstrings play a critical role in dynamic stability and joint preservation, particularly for the hip and knee. While stretching is crucial for injury prevention, there is debate over optimal techniques.

The neurodynamic sliding technique (NST) and eccentric training (ET) are two methods that can improve flexibility and reduce injury risk. This study uniquely combines ET with NST to address hamstring tightness in athletes, aiming to evaluate their effects individually and in combination on knee muscle strength, range of motion, proprioception, and lower limb function compared to a control group.

The hypotheses examine whether these interventions differ in their impact on eccentric and concentric knee strength, the knee flexor/extensor strength ratio, range of motion, proprioception, and dynamic balance (measured via the Y Balance Test). The null hypothesis (H0) proposes no differences, while the alternative hypothesis (H1) suggests significant differences among the intervention methods.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-30 years old
2. Have a normal body mass index (BMI)
3. Have hamstring tightness as indicated by the results of an SLR examination of less than 75o (39).
4. Have hamstring tightness as indicated Active Knee Extension Test (AKET) was used to evaluate hamstring shortness. Individuals with AKET angles less than 150 degrees were considered as samples (146).
5. Ability to perform exercises.
6. Don't having plates (implants) in the lower limbs.
7. Not having a history of fracture in the lower limb (with or without realignment process).
8. Not having history of surgery to repair joint capsules, ligaments, muscles, and nerves,
9. A history of or experiencing Hernia Nucleus Pulposus (HNP).

Exclusion Criteria:

1. Receiving physical therapy or other conventional therapy in the past 6 months.
2. Absence in one of the pre- or post-test sessions.
3. Absence of more than two sessions in practice sessions.
Crestor RAPID (The Efficacy of RosuvAstatin for Korean Dyslipidemia PatIents With Diabetes)

To evaluate the efficacy of rosuvastatin in Korean dyslipidemia patients with diabetes


Eligibility Criteria:
Inclusion Criteria:

* Hyperlipidemia patients who are prescribed with rosuvastatin 10mg, based on clinical grounds and fulfil the following criteria

  1. Over 18 years of age
  2. Diagnosed with DM based on fasting or post-load glucose data and/or clinical assessment by the clinician

Exclusion Criteria:

1. Patients already taking other hyperlipidemic agents
2. Patients who do not fulfil the indication criteria for statin therapy
3. Patients who do not have baseline and/or follow-up lipid data to verify the efficacy data
Combination Chemotherapy Before Surgery in Treating Women With Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells and shrink tumors so they can be removed during surgery.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy before surgery in treating women who have locally advanced, inflammatory, or large surgically removable breast cancer.

OBJECTIVES: I. Determine the toxicity of neoadjuvant capecitabine, cyclophosphamide, and epirubicin in women with locally advanced or inflammatory or large operable breast cancer. II. Determine the maximum tolerated dose of this regimen in this patient population.

OUTLINE: This is a multicenter dose escalation study of capecitabine. Patients receive neoadjuvant cyclophosphamide IV and epirubicin IV on day 1 and oral capecitabine twice daily on days 1-14. Treatment continues every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A total of 3-33 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed carcinoma of the breast Locally advanced or inflammatory disease (T4, any N or any T, N2 or N3 or T4d) OR Large operable disease (large T2 or T3 for which tumor shrinkage is needed) No distant metastasis on chest x-ray, liver ultrasound, or bone scan except for ipsilateral supraclavicular nodes No abnormal bone scintigrams that cannot be confirmed as benign Hormone Receptor Status Not specified

PATIENT CHARACTERISTICS: Age: 18 to 70 Sex: Female Menopausal status: Not specified Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: LVEF normal by echocardiography or MUGA Other: Not pregnant or nursing Fertile patients must use effective contraception No other serious uncontrolled illnesses No uncontrolled psychiatric or addictive disorders No other concurrent or prior malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
Using the Cholinergic Anti-Inflammatory Pathway to Treat Systemic Lupus Musculoskeletal Pain

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune, inflammatory disease and musculoskeletal pain is one of the most common symptoms. This study will investigate whether transcutaneous stimulation of the vagus nerve will decrease lupus musculoskeletal pain. This study will additionally investigate the biologic effects of vagus nerve stimulation on inflammation. It will be the first clinical study using one of the body's own pathways of modulating the immune system and inflammatory response, the cholinergic anti-inflammatory pathway, in SLE.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years,
2. SLE (defined by the ACR or SLICC criteria),
3. Musculoskeletal pain ≥ 4 on a non-anchored VAS 10 cm scale
4. BILAG C on Musculoskeletal Domain of the BILAG 2004
5. If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 28 days before baseline,
6. If on background immunosuppressive treatment the dose must be stable for at least 28 days before baseline
7. Able and willing to give written informed consent and comply with the requirements of the study protocol.

Exclusion Criteria:

1. Treatment with rituximab within one year of baseline (subjects with previous treatment with rituximab can enter study only with documentation of B cell repletion),
2. Treatment with cyclophosphamide within 2 months of baseline,
3. Expectation to increase steroids and/or immunosuppressive treatment,
4. Anti-phospholipid syndrome,
5. Fibromyalgia (fibromyalgia will be defined as a score \> 13 on the Fibromyalgia Symptom Scale (FSS).
6. Treatment with an anti-cholinergic medication, including over the counter medications,
7. Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
8. Current tobacco or nicotine user,
9. Joint replacement within 60 days prior to study enrollment or planned within the course of the study,
10. Any planned surgical procedure requiring general anesthesia within the course of the study,
11. Intra-articular cortisone injections within 28 days of the start of study,
12. Chronic inflammatory disorders apart from SLE affecting the joints,
13. Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing (Day 0), whichever is the greater length of time,
14. Active infection including hepatitis B or hepatitis C at baseline,
15. Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention,
16. Pregnancy or lactation,
17. Comorbid disease that may require administration of corticosteroid use,
18. Inability to comply with study and follow-up procedures.
Estrogen Exposure and Atherosclerosis in Postmenopausal Women

One hundred Spanish postmenopausal women accepted to be investigated for cardiovascular risk actors including clinical features, serum biochemical parameters, single nucleotide polymorphisms for estrogen receptor, and imaging parameters, carotid intima-media thickness (91 women) and coronary computed tomography (32 women). Multivariable analysis confirmed that both age and glucose level directly affected IMT. Estrogenic exposure, as measured by the allele associated with lower expression of the ER beta gene, was protective at the sinus and the wall. Findings at the coronary arteries, either moderate or high calcium index (CAC) and/or significant lumen stenosis were sporadic and did not allow for establishing association with any of the variables assessed.

One hundred postmenopausal women living in the urban area of Valencia were invited to participate in a cross-sectional study in which a list of clinical and analytical risk factors for cardiovascular disease were assessed. Clinical factors included weight, waist circumference, body mass index and blood pressure. Analytical parameters included lipidogram, serum glucose and insulin, thyroid hormones (TSH and total T4), vitamin D, ultra-sensitive C-reactive protein, estradiol, and osteoprotegerin. Imaging studies were performed to identify the atherosclerotic burden at the carotid artery (intima-media thickness, measured by a high frequency ultrasound probe), and the coronaries (both coronary artery calcium(CAC) score and the degree of lumen stenosis). Genetic susceptibility was measured by studying single nucleotide polymorphisms of the estrogen receptor. The independent effect of each variable was analyzed with multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women free of previous diagnosis of cardiovascular disease, Caucasian ethnicity, urban origin, medium or medium-low socioeconomic extraction.

Exclusion Criteria:

* Previous diagnosis of cardiovascular disease, inability to understand the purpose and conditions of the study..
Empiric Antibiotic Treatment for Septic Patients in the Intensive Care Unit

Sepsis is one of the most common causes of ICU admission. About 5-15% of patients admitted to the hospital with an infection will have sepsis, and about 30-40% of them will have septic shock. About 34% of septic patients and about 53% of patients with septic shock will die within 28 days of admission. Broad-spectrum empiric antibiotic treatment (depending on the source of infection and patient risk factors) is one of the cornerstones of sepsis management. According to the recommendations of the surviving sepsis campaign, empiric antibiotic treatment should be given within one hour of the patient's arrival for patients with sepsis or septic shock. Administration of inappropriate antibiotics in the first 24 hours of admission was found in 34% of septic patients in various studies, and administration of inappropriate antibiotics (or when administered in delay) was found to be associated with increased morbidity and mortality.

In this study, we will assess the proportion of patients who were admitted to the ICU due to sepsis or septic shock and received empiric antibiotic treatment which, in retrospect, according to the growth in the cultures later on, was inappropriate. We will also assess the therapeutic results in these patients - mainly significant morbidity and mortality within 28 days, and compare them to the group of patients who received appropriate antibiotic therapy. We would also like to assess what were the possible reasons for inappropriate empiric antibiotic treatment, in order to draw conclusions to reduce the rate of these cases.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the general ICU due to sepsis or septic shock between 1/1/20 and 31/12/20

Exclusion Criteria: Patients who were admitted due to other non-infectious etiologies

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