cyrilzakka/clinical-trials huggingface dataset:
The Neuro-epigenetics Biomarkers of Postoperative Delirium in Elderly Patients Undergoing Hip/Knee Replacement

Introduction: Postoperative delirium (POD), an acute, transient, fluctuating disturbance in attention, cognition, and level of consciousness, is a common (15-53%) postoperative complication, and it is associated with longer hospital stays, worse functional outcomes, higher healthcare costs, and increased mortality. However, at the current time, effective prevention and treatment are not only hampered by lack of knowledge about the neuropathogenesis of POD but also by a lack of biomarkers that could predict individual risk and assess diagnosis and severity of POD.

Recent studies have focused on inflammatory markers (IL-1, IL-6, IL-8, IL-10, CRP), Alzheimer's disease-related factors (Tau, Aβ40/42), and nerve injury factors (S100β, NSE), but failed to establishing causality between these markers and POD. Furthermore, these results were contradictory. Previous study of the investigators found that the dysregulation of preoperative microRNA (miR)-146a and miR-181c in cerebrospinal fluid (CSF) and serum was associated with the development and severity of POD. Therefore, the investigators hypothesized these neurimmiRs and other neuro-epigenetics biomarkers might participate in the neuropathogenesis of POD.

Purpose: Aims to search for neuro-epigenetics biomarkers to predict and diagnose POD.

Method:

1. Study design: This study is a prospective investigation that searches for neuro-epigenetics biomarkers to predict and diagnose POD.
2. Inclusion criteria / Exclusion Criteria

Inclusion criteria: Eligible patients were at least 65 years old and were scheduled to have hip/knee replacement.

Exclusion Criteria:

1. a past medical history of neurological or clinically evident neurovascular disease (e.g., Alzheimer's disease, other forms of dementia, stroke);
2. Patients diagnosed with malignant or benign tumors;
3. Mini-Mental State Examination (MMSE) scores of 26 or less;
4. American Society of Anesthesiologists (ASA) score \[a global score that assesses the physical status of patients before surgery, ranging from 1 (normal health) to 5 (moribund)\] greater than 3;
5. a history of alcohol abuse and drug dependence;
6. inability to read or severe visual or auditory deficits;
7. unwillingness to comply with the protocol or procedures.

Eligibility Criteria:
Inclusion Criteria: Eligible patients were at least 65 years old and were scheduled to have hip/knee replacement.

Exclusion Criteria:

1. a past medical history of neurological or clinically evident neurovascular disease (e.g., Alzheimer's disease, other forms of dementia, stroke);
2. patients diagnosed with malignant or benign tumors;
3. Mini-Mental State Examination (MMSE) scores of 26 or less;
4. American Society of Anesthesiologists (ASA) score greater than 3;
5. a history of alcohol abuse and drug dependence;
6. inability to read or severe visual or auditory deficits;
7. unwillingness to comply with the protocol or procedures.
Comparison of Gait Parameters Between Floor and Sponge Surfaces and Special Shoes

This study compares the gait pattern of individuals with weight bearing difficulties walking on the floor, a soft surface, or with special shoes (Kyboot).


Eligibility Criteria:
Inclusion Criteria:

* 3 days to 1 month following arthroscopic knee surgery(n=10)
* Following fractures in lower limb with pain during weight-bearing (n=10)
* Back pain and asymmetrical gait (n=10)
* Complex Regional Pain Syndrome with pain during weight-bearing (n=10)

Exclusion Criteria:

* Neurological condition that does not permit walking on soft surface (drop foot)
* Wounds on feet
Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo

A randomized split-body pilot study was planned to confirm efficacy of intralesiona triamcinolone injection in patients with vitiligo

Intralesional corticosteroid injections have been a long-standing treatment for refractory vitiligo, with some patients showing significant improvement without surgical intervention.

The investigators will perform a randomized split-body pilot trial to test the exact efficacy of intralesional triamcinolone injections. The paired symmetric vitiliginous lesions will be randomized to either control or injection groups. All lesions will be treated with narrowband UV-B phototerapy or excimer laser weekly and twice daily application of topical tacrolimus ointment for a total of 12-week period. Intralesional injections of 0.4mg/cc triamcinolone once a week are given to the experimental group. The degree of repigmentation will be assessed as % from baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Age : 19 or older
2. A patient who voluntarily agreed to participate in the study by listening to the explanation of the purpose and method of the study
3. A patient who has bilateral two or more vitiligo lesions with similar degree of progression in the face or trunk
4. A patient who has no further response to excimer laser or short wavelength ultraviolet B therapy, which is a conventional treatment for vitiligo

Exclusion Criteria:

1. Patients under the age of 19
2. Patients with enlarged or spreading lesions of vitiligo
3. Patients who do not want to do so or who refuse to write a consent form
4. Patients who are inadequate for triamcinolone acetonide administration (pregnant women, infectious and systemic fungal infections without effective antimicrobial agents, immunosuppression, hypersensitivity reactions to and concomitant use of triamcinolone or its components, spontaneous thrombocytopenia, purpura, herpes simplex, shingles, chicken pox patients)
5. Others those who are deemed unsuitable for the examination at the discretion of the examiner
A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)

This study will examine the effect of ezetimibe on glucose metabolism in participants with Type 2 diabetes and hypercholesterolemia.The primary hypothesis is that change in glycated hemoglobin (HbA1c) from baseline in the ezetimibe treatment group will be non-inferior to the placebo control group.


Eligibility Criteria:
Inclusion Criteria:

* Have hypercholesterolemia (high cholesterol) and have been diagnosed with type 2 diabetes that is being treated with oral anti-diabetic drugs or insulin or both.
* No change in the medication (drugs, dose and administration) for the treatment of diabetes within previous 12 weeks with exception of small changes in insulin dosing
* No change in diet and exercise therapy within previous 4 weeks

Exclusion Criteria:

* Coexisting disease (hemoglobinopathy, hemolytic anemia, etc.) that may affect HbA1c measurement
* Homozygous or heterozygous familial hypercholesterolemia
* Previously received ezetimibe
* Hypercholesterolemia associated with: hypothyroidism, obstructive gall bladder or biliary disease, chronic renal failure or pancreatitis
* Hyperlipidemia caused by medication
Effect of Mask Use on Hemodynamic Responses During Exertion

The use of masks is a necessity due to the current pandemic conditions. The aim of the study is to examine the effects of the use of masks during effort on dyspnea and fatigue with hemodynamic parameters.

The use of masks is a necessity due to the current pandemic conditions.There are studies on many parameters such as the effect of mask use on saturation (sp02), heart rate (HR) and blood pressure (BP). To determine whether there is a change in the performance of individuals in the masked and unmasked exercise test during exertion due to the scarcity of masked and unmasked maximal exercise tests and the insufficient measurement of the degree of fatigue felt, and to determine whether there is a change in the performance of individuals with and without mask, and to determine the hemodynamic responses in the body together with dyspnea and felt fatigue. This study will be conducted in order to examine the effect on

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to work,
* To be healthy,
* 18-25 age range.

Exclusion Criteria:

* Unstabil angina pectoris,
* Atrial arrhythmia,
* Uncontrollable asthma,
* Pa02 \< 50 mmHg,
* PaCO2\> 70mmHg,
* Individuals with valve disease
* Tachycardia, bradycardia,
* Individuals with a resting systolic blood pressure of 200 mmHg
* Smoking,
* Presence of effective clinical conditions such as nasal deviation.
Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric participants with moderate-to-severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of moderate-to-severe plaque-type psoriasis for at least 6 months prior to baseline as determined by the investigator.
* Have Psoriasis Area and Severity Index (PASI) score ≥12 and a Static Physician Global Assessment (sPGA) ≥3 and body surface area involvement ≥10% at screening and baseline.
* Are candidates for phototherapy or systemic treatment or considered by the investigator as not adequately controlled by topical therapies.
* Male subjects agree to use a reliable method of birth control during the study.
* Female subjects: Participants of childbearing age or childbearing potential who are sexually active who test negative for pregnancy must be counselled and agree to use either 1 highly effective method of contraception or 2 acceptable methods of contraception combined for the duration of the study and for at least 12 weeks following the last dose of study drug, or remain abstinent during the study and for at least 12 weeks following the last dose of study drug.
* Both the child or adolescent and a parent or legal guardian are able to understand and fully participate in the activities of the clinical study and sign their assent and consent, respectively.
* All immunizations are up-to-date in agreement with current immunization guidelines as noted by country specific paediatric authorities (e.g., the American Academy of Paediatrics). Note, subjects who are not up to date or have never been immunized are not to be enrolled in the trial.

Exclusion Criteria:

* Have pustular, erythrodermic, and/or guttate forms of psoriasis.
* Have drug-induced psoriasis.
* Have clinical and/or laboratory evidence of untreated latent or active tuberculosis (TB).
* Participants with a documented history of immune deficiency syndrome.
* Have any other active or recent infection, including chronic or localized infections, within 4 weeks of baseline.
* Subjects with a known history of malignancy, lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly unless ruled out by biopsy.
* Have used any therapeutic agent targeted at reducing interleukin-17.
* Have received other therapies within the specified time frames prior to screening (see below):

  * adalimumab and infliximab 60 days, abatacept 90 days, anakinra 7 days, or any other biologic disease-modifying antirheumatic drug 5 half-lives.
  * systemic therapy for psoriasis and psoriatic arthritis (PsA) (other than above, eg, methotrexate, cyclosporine), phototherapy (eg, photochemotherapy \[psoralen plus ultraviolet A\]) in the previous 4 weeks.
Comparison of Different Video Laryngoscopes in < 1 Year Old Undergoing Neurosurgical Operations: a Prospective Randomized Study

İntubation of pediatric patients is a challenging problem. Video laryngoscopes increased the intubation success rate. We want to compare different video laryngoscopes in this field.

Aim:İntubation of pediatric patients is a challenging problem. Video laryngoscopes increased the intubation success rate. We want to compare different video laryngoscopes in this field.

methods: We enroll total 50 patients \< 1 year old undergoing neurosurgery. We compared the intubation times, success rates and minor complications of Airtraq and c-mac video laryngoscopes in these pediatric patients undergoing neurosurgery.

Eligibility Criteria:
Inclusion Criteria:

\< 1 years old

* undergoing neurosurgery ASA 1-2

Exclusion Criteria:

* \> 1 year old
* asa 3-4
* emergency
Implication of Metabolic and Genomic Modifications in Elderly Subjects

An increase of longevity and of the number of men and women older than 60 years old is observed in most industrialized countries. Aging is a complex, multifactorial and continuous process involving physical and biological modifications such as a notably decrease in glucose tolerance and type 2 diabetes risk. Insulin sensitivity follow-up during aging is difficult mainly because of many confounding factors (environment, lifestyle).

In 2006, SUVIMAX 2 study began, based on the monitoring of volunteers who participated in former SUVIMAX study (1994-2003). This study was a randomised trial which was designed to study the link between a low antioxidant intake and risk of cancer or ischemic heart disease. The subjects recently had a health check-up including complete information about their diet, physical and neurosensory status. Based on these data, a score was established to classify subjects according to their quality of aging ("successful aging versus "problematic aging") These volunteers, who undertook a 13-year follow-up (dietary and medical status), constitute the reference population to determine the mechanisms involved in the insulin resistance development in aging.

The purpose of our research work is to determine whether the quality of aging could influence insulin sensitivity, by studying metabolic profile and change in gene expression (genes involved in glucose metabolism and metabolic senescence in muscle tissue) during aging.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers from the cohort aging SUVIMAX 2
* Men and Women
* over 60 years
* BMI between 18 and 35 kg/m2 (including terminals)
* Normal medical check up
* Blood pressure \< 140/90 mmHg
* Normal glycemia, lipid profile
* sedentary or moderate physical activity (maximum 4 hours per week)

Exclusion Criteria:

* Biological results or anormal chek-up
* medical or surgical history not compatible with study
* severe digestive, cardiovascular, renal, liver or tumor disorders history in the 5 last years
* infectious or inflammatory disease within 2 months
* surgical history within 3 months
* bood donation within 2 months
* coagulation disease, anticoagulant or antiplatelet agents (aspirin ...) treatment
* xylocaïn allergy
* claustrophobia
* Drug that could affect insulin sensitivity (beta blockers, lipid lowering, oral antidiabetics, insulin, , steroids)
Subsequent Bevacizumab Treatment in Patients With HHT. Follow up BABH

Bevacizumab is widely prescribed for the treatment of severe bleeding related to epistaxis or gastrointestinal bleeding in HHT.

We studied the efficacy of bevacizumab on severe bleeding in HHT patients in a randomized study recently published (NCT03227263, J Int Med 2023). In this study, 24 patients were included, 12 patients received bevacizumab and 12 patients received placebo. The duration of patient participation was 6 months, including the 2.5-month treatment period and 3.5 month follow-up after treatment.

We describe the evolution of the number of RBC transfused in HHT patients who received bevacizumab during the year after the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Patient included in BABH study

Exclusion Criteria:

* Patients opposition
Measures of Pain Relevant to Knee Osteoarthritis

The aim is to improve understanding of the assessment of pain experience in patients with osteoarthritis (OA) of the knee. The current study will be divided into two parts. In Study 1, the investigators will analyse existing questionnaires relevant to the mechanisms and therapeutic targets of knee OA to establish discrete dimensions that discriminate between the different mechanisms of pain. On the basis of this analysis, the investigators will refine the questionnaires to maximise their sensitivity to knee OA. In Study 2, the investigators will seek to confirm the factor structure identified in the questionnaires in Study 1 and explore potential mediator and moderator variables between pain and quality of life using the refined measures. The investigators will also evaluate Quantitative Sensory Testing as a predictor of OA knee pain.


Eligibility Criteria:
Inclusion Criteria:

* Participants in Study 1 will have OA of the knee defined and scored radiologically and will report knee pain. Participants in Study 2 will also have OA of the knee, but a clinical diagnosis will suffice.

Exclusion Criteria:

* Inability to speak or understand English
* Under the age of 18 years old
* knee joint surgery within three months prior to participation
* Diagnosed Rheumatoid Arthritis, Psoriatic Arthritis, Gout or any other inflammatory arthritis disorder
* The participants in Study 2 will also be excluded if they participated in Study 1
The Self Match Study: A Study of Informed Choice in the Treatment of Addiction

The purpose of this study is to determine whether patient self-matching (as compared with treatment as usual by expert matching) improves quality of life, retention, and outcome for patients being treated for alcohol problems.

There are at least two good reasons for offering patients a choice when the goal is a change in their behavior. The first is that patients are likely to know what treatment works best for them. Secondly, being allowed to choose between options may increase compliance in treatment. As a randomized controlled trial, this study will compare the efficacy of patient self-matching versus treatment-as-usual expert matching.

The Self-Match Study is expected to increase knowledge on the importance of involving the alcohol dependent patient in choosing what treatment method is best for him/her instead of having experts to do that. The investigators expect to discover patient involvement as a way to improve compliance in treatment, hence preventing that patients drop out of treatment to early. If this hypothesis proves to be right, clinicians will have a viable strategy for matching treatment methods to patients, since the strategy does not demand further resources in the treatment system.


Eligibility Criteria:
Inclusion Criteria:

1. Fulfilling DSM-IV criteria for alcohol abuse or dependence.
2. Native Danish speaking.
3. Having no severe psychosis or cognitive impairment.
4. Accepting to participate in the study.

Exclusion Criteria:

-
Intra-individual Comparison of Conventional and Digital PET/CT Scanners

In this study, the investigators will analyze the impact of digital PET/CT on the final diagnostic conclusion of the scan in patients with lung cancer, breast cancer, esophageal cancer and a group of mescellaneous cancers.

There will be a single injection of the PET radiopharmaceutical FDG, followed by a conventional PET/CT scan and a digital PET scan, in this order or vice versa.

Eligibility Criteria:
Inclusion criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* referred to Isala for a clinically indicated FDG-PET/CT scan
* suspected or proven lung cancer, esophageal cancer, breast cancer or miscellaneous cancer, either as a primary diagnosis or follow-up study
* signed informed consent

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* age \< 18 years
* incapacitated adults
* prisoners
* pregnant patients
* unable to undergo two consecutive PET/CT scans
STEPS: Stepped Transition in Education Program for Students With ASD

Young adults who have Autism Spectrum Disorder (ASD) without co-occurring intellectual impairment face a fairly unique set of challenges as they transition out of secondary school. These students are often quite capable of succeeding in higher education and many of them have interest in pursuing advanced degrees, but the nature of their disability and associated deficits (e.g., poor time management and poor self-regulation) may impede success. Individualized, appropriately timed, and developmentally sensitive transition and support services may promote optimal outcomes for these young people. The goal of this project is to develop a comprehensive program to promote successful transition of students with ASD from high school to post-secondary education.

The investigators propose to refine and then evaluate a novel transition support and intervention program for adolescents and young adults with ASD: STEPS \[Stepped Transition in Education Program for Students with ASD\]. By targeting improved self-regulation (SR) and self-determination (SD) in young people with ASD, the investigators assert that this program may have positive outcomes with respective to college adjustment and functional behavior. Although the program will be finalized during the first phase of the proposed project, at present STEPS is comprised of two levels (or steps), which match the student's particular needs in relation to transition planning. In Step 1, students facing transition (i.e., have identified the college they will attend (either 2-year or 4-year institution) but are still in high school) and their caregivers will receive information to assist in transition planning, undergo readiness self-assessments (to identify degree of preparedness for post-secondary school), and participate in interactive sessions online and in person to promote self-knowledge and determination. The goal of Step 1 is to assist families and students with transition planning, specifically ensuring that families and students have the tools needed to make informed choices and take necessary steps (e.g., remediating identified skill deficits) to increase the likelihood of a successful transition out of high school. In Step 2, college students with ASD will receive fairly intensive supports and interventions, including individual counseling, structured support services, social integration activities, and coaching to promote academic and social success. The following specific aims are proposed.

Eligibility Criteria:
Inclusion Criteria:

* Must be 16 to 25 years
* Must have clinical diagnosis of autism spectrum disorder
* Must be preparing for postsecondary education or enrolled in postsecondary education

Exclusion Criteria:

* Intellectual disability
* Psychiatric disturbance that warrants immediate treatment