cyrilzakka/clinical-trials huggingface dataset:
VItamin D Metabolism in SEnescent Cardiac Surgery Patients

Advanced age is associated with an increase in postoperative morbidity and mortality in cardiac surgery patients. In detail, compared with younger patients those aged 75 years and older have significantly higher rates of in-hospital mortality, cerebrovascular events, pneumonia, and dialysis. In addition, older cardiac surgery patients have longer mechanical ventilation times. Vitamin D exerts several beneficial effects on the cardiovascular system. Moreover, it has immuno-modulatory and anti-inflammatory properties. The hormonal form of vitamin D, 1,25-dihydroxyvitamin D, is an independent predictor of mid-term mortality in cardiac transplant recipients. 1,25-dihydroxyvitamin D also predicts mid-term and long-term mortality in patients with a high risk for cardiovascular disease. Mild renal impairment, insufficient vitamin D levels, and secondary hyperparathyroidism are common in frail elderly individuals. The present study aimed to investigate whether cardiac surgery exerts age-dependent effects on calciotropic hormones, components of the immune system, and inflammatory processes.It is hypothesized that (i) baseline 1,25-dihydroxyvitamin D levels are lower in patients \<= 75 years of age compared to younger patients, (ii) cardiac surgery results in a transient decrease in circulating 1,25-dihydroxyvitamin D, and (iii) that the decrease in 1,25-dihydroxyvitamin D is probably more pronounced in older than in younger cardiac surgery patients.


Eligibility Criteria:
Inclusion Criteria:

* age: \<= 65 years and \>= 75 years
* first elective cardiac surgery (bypass or combined bypass and heart valve surgery)
* written informed consent

Exclusion Criteria:

* emergency cardiac intervention
* primary hyperparathyreoidism
* primary and secondary hypoparathyreoidism
* daily vitamin D supplementation \> 10 micrograms
[Al18F]PSMA137 PET/CT Imaging for PSMA-Positive Cancer Patients

To investigate the radioactive uptake of \[Al 18 F\]PSMA137 in PCa patients, and evaluate the ability of \[Al 18 F\]PSMA137 to detect PSMA overexpression in PCa patients (especially those with recurrent or advanced PCa).To provide an approach for screening patients high expression of PSMA, efficacy monitoring, drug resistance and early warning of recurrence and metastasis to achieve the individualized antitumor treatment of targeted drugs.

Prostate cancer (PCa) is the most common malignant tumor in the male reproductive system, and its prognosis and treatment mainly depend on the discovery of the primary disease and the early stage of metastasis, while traditional imaging and histological methods are difficult to meet the clinical requirements for the early diagnosis and accurate staging of PCa.Positron emission tomography (PET) has the characteristics of precision and non-invasive, so the development of PCa targeted molecular probe is of great significance for improving the specificity and accuracy of PCa diagnosis.

PSMA is a highly specific prostatic epithelial membrane antigen, which is highly expressed in solid tumors such as Prostate cancer. More than 90% of Prostate cancer cells express PSMA, so PSMA can be used as an important imaging target for Prostate cancer.

The radionuclides used for PET imaging include 18F (T 1/2 =109.8min), which has a suitable half-life and cyclotron preparation to enable the high yield synthesis of 18F labeled tracer, so it can be used in more patients and provided to other departments without on-site tracer production facilities.In addition, coordination labeling method is simple, easy to realize automatic synthesis technology and medicine box preparation.Therefore, 18F-labeled PSMA targeted molecular probe is a hot spot in the diagnosis of prostate cancer.

\[Al18F\]PSMA137 is a novel PSMA targeted tracer labeled with 18F. NOTA is used as a bifunctional chelating agent to facilitate better chelation with Al18F. It has a higher tumor uptake and a faster metabolism in normal organs with a lower background.\[Al18F\]PSMA137, as a novel targeted molecular probe, shows excellent properties in tumor cell uptake.This project provides research on \[Al18F\]PSMA137 PET/CT imaging for patients with suspected PCa, and provides basis for early diagnosis of PCa, formulation of treatment plan and efficacy evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Men over 18 years of age need to undergo \[Al18F\]PSMA137 PET/CT examination for suspected prostate cancer.
* The patients can fully understand and voluntarily participate in this experiment, and sign the informed consent.

Exclusion Criteria:

* Significant hepatic or renal dysfunction;
* Patients with malignant tumors other than prostate cancer within 2 years;
* Ready to pregnant;
* The patient can not tolerate all clinical tests.
A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol

The purpose of this study is to evaluate the efficacy and safety of atorvastatin for the treatment of Taiwanese patients with diabetes and high cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* Adult Taiwanese outpatients with type 2 diabetes mellitus and high cholesterol
* Hemoglobin A1c levels of ≤10%, LDL-C levels of ≥130 mg/dL, and serum triglyceride levels of \<400 mg/dL

Exclusion Criteria:

* Type I diabetes mellitus
* Secondary causes of high cholesterol
* Elevated liver enzymes
Nursing Students' Personality Traits and Competence in Workplace Violence Management

Aim: The aim of this study was to determine the relationship between nursing students' personality traits and competence in workplace violence management.

Background: Violence against nursing students is a growing concern in nursing education, clinical practice, and professional development and needs to be managed.

Design: A cross-sectional study. Methods: This study was conducted with 321 nursing students in the summer of 2022.


Eligibility Criteria:
Inclusion Criteria:

* Being in the nursing students at the research university,
* Being in the \>18 years age,
* Agree to participate in the study

Exclusion Criteria:

* Being in the \<18 years age,
* Disagree to participate in the study
Quality of Life During Treatment of Chronic Hepatitis C (P05278/MK-4031-336)

The primary objective of this study is to evaluate the impact of chronic hepatitis C (CHC), and the treatment thereof with peginterferon alpha-2b (PEG) and ribavirin (RBV) according to standard clinical practice, on the health-related quality of life (HRQL) of a cohort of participants throughout 72 weeks of follow-up. HRQL was assessed using the 36-Item Short-Form Health Survey (SF-36) and the Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV).

As widely shown in previous reports Hepatitis C Virus (HCV) patients commonly experience fatigue, anxiety, and depression. These symptoms negatively affect patients' functional health, ability to work, self-perceived health, HRQL and well-being. Psychosocial issues and reduced HRQL are frequently experienced by HCV patients. HCV patients have more HRQL impairment than the general population. There is some evidence that HCV patients who experience greater fatigue, greater psychiatric symptoms, and poorer HRQL are more likely to discontinue treatment prematurely, with a negative impact on virological response. In addition to well-known side effects of interferon, one important determinant of HRQL during anti-viral therapy for HCV is development of RBV-induced anemia. Treatment of anemia improves HRQL, potentially impacting adherence to antiviral regimen and improving virologic response. These issues emphasize the importance of investigating the physical and psychosocial experiences and HRQL of HCV patients.

The sample size of the study must allow evaluating HRQL of HCV patients based on the SF-36 before PEG treatment and at each of the following study visits.

To be able to detect differences of or over 4.2 points in the vitality dimension between the basal visit and following visits, estimating a standard deviation of 22 points, a statistical power of 80%, and a level of significance of 0.05, 216 patients will be needed. Considering a loss of follow up of 15%, a total of 238 patients are planned for this study.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with chronic hepatitis C (CHC)
* Participants with HCV genotype 1
* Participants who, at the time of the study, are referred to the Hospital Pharmacy Service to begin treatment with PEG and RBV for 48 weeks
* Available to understand and to give Informed Consent

Exclusion Criteria:

- Participants co-infected with Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
Psychological and Pain Factors in Knee Osteoarthritis

This study aims to determine if baseline measures of psychology and pain sensitivity can predict changes in physical function at 1 year in patients with knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of knee OA based on clinical and radiographic ACR criteria
* Pain in or around the knee on most days of the past month
* Aged 40 years or above
* Ambulatory with or without walking aid

Exclusion Criteria:

* Inflammatory arthritis (rheumatoid arthritis, lupus, etc.)
* Recent knee injury or surgery (past 3 months)
* Severe comorbidity likely to prevent study completion (dementia, terminal illness)
* inability to comply with study procedures or follow up
Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma

The primary objective of this study is to compare the efficacy of GEM plus Z-360 versus GEM plus placebo on the overall survival (OS) in subjects with metastatic Pancreatic Adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects with histological or cytological evidence of metastatic Pancreatic Adenocarcinoma, Measurable disease or non-measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version criteria
* 2. Subjects with a life expectancy of at least 12 weeks,
* 3. Subjects with an Eastern cooperative oncology group performance status (ECOG PS) of 0, 1 or 2,
* 4. Subjects with the following adequate organ functions:

  * White blood cell count ≥3,000/μL (or absolute neutrophil count ≥1,500/μL) and ≤ 12,000/μL ,
  * Platelet count ≥100.0 × 10\^9/L,
  * Hemoglobin ≥9.0 g/dL,
  * Serum creatinine ≤1.5 × the upper limit normal (ULN),
  * Total bilirubin ≤2.0 × ULN,
  * Serum aspartate transaminase levels ≤3.0 × ULN (≤5.0 × ULN in presence of liver metastases), and
  * Serum alanine aminotransferase levels ≤3.0 × ULN (≤5.0 × ULN in presence of liver metastases).

Exclusion Criteria:

* Subjects received the following previous therapies for Pancreatic Adenocarcinoma:

  * Surgery within the 4 weeks prior to randomization,
  * Radiation and chemoradiation within the 12 weeks prior to randomization,
  * Radiation for pain relief within the 4 weeks prior to randomization,
  * Gemcitabine used as a neoadjuvant or an adjuvant on surgery within the 24 weeks prior to randomization,
  * Chemotherapy except GEM used as an adjuvant on surgery within the 4 weeks prior to randomization,
  * Gemcitabine ≥600 mg/m\^2 as sensitizer for chemoradiation,
  * Gemcitabine \<600 mg/m\^2 as sensitizer for chemoradiation within the 12 weeks prior to randomization,
  * Gemcitabine used for systemic chemotherapy, or
  * Systemic chemotherapies except GEM within the 4 weeks prior to randomization.
Cryptosporidiosis and Enteropathogens in Bangladesh

The purpose of this study is to explore the role of anti-parasite antibody in protection of children from the parasitic infection cryptosporidiosis. This work has the promise of identifying immune pathways important for protection from parasitic infections of the gut, and will help with designing a vaccine to prevent this infection estimated to cause, from diarrhea and malnutrition, an overall burden of 12 million disability-adjusted life-years in children.


Eligibility Criteria:
Inclusion Criteria:

* Mother willing to sign informed consent form.
* Healthy infant
* No obvious congenital abnormalities or birth defects.
* Stable household with no plans to leave the area for the next one year.

Exclusion Criteria:

* Parents are not willing to have child's blood drawn.
* Parents are planning to enroll child into another interventional clinical study during the time period of this trial that could affect the outcomes of this study.
* Mother not willing to have blood drawn and breast milk extracted.
* Parents not willing to have field research assistant in home two times per week.
* History of seizures or other apparent neurologic disorders.
* Infant has any sibling currently or previously enrolled in this study, including a twin.
Asymmetric Locomotor Training in the Elderly to Restore Physical Function

Innovative advances in rehabilitation technology have created a split-belt treadmill capable of providing a much needed intervention aimed at limiting mobility disability. When desynchronized, the split-belt treadmill imposes demands on each leg such that the central nervous system must adapt to the challenge. Based on preliminary data from our lab utilizing the split-belt treadmill, the investigators hypothesize this intervention can challenge the locomotor processes required for safe, efficient gait while concurrently providing an aerobic stimulus will produce favorable changes in physical function in older adults at risk for mobility disability.

For this pilot study the investigators will enroll 20 sedentary older adults at risk for disability (usual gait speed ≤ 1.0 m/s). Participants will be assigned to one of two 12-week interventions. Therefore the final training pool will consist of 10 split-belt participants and 10 traditional treadmill participants. Aim 1 will test the hypothesis that compared with a traditional treadmill intervention a split-belt treadmill intervention will result in improved mobility, as measure by 400 meter walk time, as well self reported physical function/disability as measured by the Pepper Assessment Tool for Disability. Aim 2 will test the hypothesis that compared with a traditional treadmill intervention a split-belt treadmill intervention will results in improved gait variability. To date, no experimental study has evaluated these propositions in a controlled trial testing the effects of split-belt training in older adults at risk for disability.

Eligibility Criteria:
Inclusion Criteria:

* aged 65 to 89
* walking speed of ≤ 1 m/s
* ≥ 0.033s of stance time variability
* sedentary as defined by spending less than 20 minutes per week in the past month getting regular physical activity

Exclusion Criteria:

* Significant cognitive impairment
* Failure to provide informed consent
* The need of a walker during the 400 meter walk
* Progressive, degenerative neurological disease
* Severe diabetes, requiring use of insulin
Effect of the Posterior Ligamentous Complex on the Adjacent Segments Degeneration After Lumbar Surgery

To investigate whether destroying the adjacent posterior ligamentous complex (PLC) has an effect on adjacent segment degeneration (ASD) after L5/S1 posterior lumbar interbody fusion (PLIF)

Purpose: To investigate whether destroying the adjacent posterior ligamentous complex (PLC) has an effect on adjacent segment degeneration (ASD) after L5/S1 posterior lumbar interbody fusion (PLIF).

Methods: This retrospective study was performed in patients who received L5/S1 PLIF with pedicle screw instrumentation for lumbar spinal stenosis with or without isthmic spondylolisthesis. They were divided into the total laminectomy group, which had destruction of the PLC of the adjacent segment, or partial laminectomy group, which did not. Vertebral slip, osteophytes, disk height, and range of motion were examined by plain radiography, and thickness of the ligamentum flavum (LF) and anteroposterior diameters of the lumbar vertebral body and spinal canal were assessed by magnetic resonance imaging (MRI). Disc degeneration and spinal stenosis on MRI scans were categorized. The incidence of ASD and clinical outcome were compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

* typical clinical symptoms such as disabling low back or leg pain with or without neurological symptoms, intermittent claudication, with refractory to ≥6 months of strict conservative treatment; and L5/S1 single-level PLIF with pedicle screw instrumentation.

Exclusion Criteria:

* previous spine surgery, acute spinal fracture, infection, and tumor.
Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy

It is difficult to determinate prognostic criteria of Multiple Sclerosis with conventional MRI insofar as physiopathology is not well-known: the precise sequences of events leading to plaque formation and axonal injury are still not completely understood.

Some elements involved in plaque formation can be studied thanks to MR techniques (cerebrospinal fluid and periveinular spaces, neuronal injury, microglia, and cerebral microcirculation's dysfunction).

This study aims at giving a better understanding of MS plaques' physiopathology, using data from modern MRI through a longitudinal followed up with weakly MR 3T examination.

The objective of this work are:

* study weakly development of the active MS plaque with multimodal MRI parameters using advanced MRI techniques: Veinography/3D FLAIR, Diffusion (CDA), Perfusion (CBV, CBF, MTT) MR Spectroscopy (NAA, myo-inositol, choline, lactate...) and enhanced 3DT1 sequences.
* define prognostic markers of MS aggressiveness ("black holes")
* Study development of MS plaque around venous structures.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 50 years.
* Health coverage.
* Any form of MS defined by Mc Donald's criteria (2005).
* Patients having shown an enhanced plaque on a less than six month MRI examination.

Exclusion Criteria:

* Patients with an immunomodulating therapy like natalizumab (Tysabri) and intravenous immunosuppressive therapies. Other therapies will not be excluded from this study. For patients treated by systemic corticotherapy, a one-month delay will be necessary before a MRI examination.
* Cerebral microangiopathy (diabetes, arterial hypertension, vascularitis...)
* Patient with classical MRI contraindication like pace-maker, cardiac valvulosis, claustrophobia, allergy to contrast agent ...
* Pregnancy or pregnancy desire.
* Patient with a low creatinine clearance \<60 ml/mn
FSH Treatment for Non-obstructive Azoospermic Patients

Aim of the study is to evaluate the effect of highly purified human follicle-stimulating hormone treatment on the chance of retrieving testicular sperm (sperm retrieval rate) from infertile male patients with non-obstructive azoospermia of unknown origin.

Preliminary reports showed that hormonal treatment may improve the chance of retrieving viable testicular sperm from men with NOA, but no RCT are available in the field. This randomized placebo-controlled clinical trial sought to evaluate whether the testicular sperm retrieval rate could result higher in NOA patients treated with follicle-stimulating hormone compared to placebo-treated NOA subjects.

Eligibility Criteria:
Inclusion Criteria:

* Azoospermia;
* testis longitudinal axis less than 4.5 cm;
* serum follicle-stimulating hormone greater than 7.6 IU/L

Exclusion Criteria:

* History of testicular biopsy,
* malignancy,
* varicocele,
* hyperprolactinemia,
* thyroid disfunction,
* chemotherapy,
* radiotherapy
Symptom Management in African-American Men With Localized Prostate Cancer

RATIONALE: Gathering information about symptom management from patients with localized prostate cancer may help doctors improve patients' quality of life.

PURPOSE: This clinical trial is studying symptom management in African-American men with localized prostate cancer.

OBJECTIVES:

* Develop a symptom management intervention for African-American men treated for localized prostate cancer, with a particular emphasis on low health literacy men.

OUTLINE: Participants are interviewed by the principal investigator over the phone or meet the principal investigator at the Veterans Administration prostate cancer clinic. If the interview is conducted in the clinic, it is held in a private room in the clinic.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Biopsy-proven localized prostate cancer

  * Has received treatment for prostate cancer
* Patient self-identifies as being of African-American descent

PATIENT CHARACTERISTICS:

* Able to speak and read in English
* Has an address in order to receive study materials by mail (a street address or post office box)
* Has either a telephone in order to be interviewed OR is able to meet the principal investigator at the Veterans Administration prostate clinic and be interviewed there

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Medical Checklists in the Emergency Department

This study aims to investigate whether the use of medical checklists in the emergency department can decrease resuscitation time in critically ill patients.

A scenario evaluating tricyclic antidepressant poisoning will be carried out with and without medical checklist access. Emergency physicians from the Netherlands who are willing to take part in the study are randomly allocated to perform the scenario with or without checklists.

Eligibility Criteria:
Inclusion Criteria:

* Emergency Physicians recognised by KNMG (Koninklijke Nederlandsche Maatschappij tot bevordering van de Geneeskunst) working in the Netherlands

Exclusion Criteria:

* Residents (in Dutch: AIOS) Emergency Medicine
* Interns (in Dutch: ANIOS) Emergency Medicine
The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.

This is an exploratory, prospective and multicentric study aiming to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERα status in patients with metastatic breast cancer HER2 + and ERα neg.

For each included patient, 2 FES-PET Imaging will be performed for the study (before cancer treatment initiation and before the cycle 3 of treatment) at the IUCT-O center (Institut Universitaire du Cancer de Toulouse).

Treatment (trastuzumab + pertuzumab + taxane) will be administered according to the current recommendations in each participant center.

Patients will be followed during the 3 cycles of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Patient with metastatic breast cancer HER2 + (IHC+++ and/or HER2 amplification in ISH according to ASCO recommendations), ERα neg (0% in IHC) and Progesterone Receptor neg (0% in IHC).
3. Patient eligible according to the investigator for a treatment with trastuzumab + pertuzumab + taxane in the metastatic first line.
4. Available biopsy of a tumor lesion (archived material) or biopsiable tumor lesion for study (primitive tumor or metastasis other than bone).
5. OMS ≤ 2.
6. For non-menopausal patients, use of an effective contraceptive method at entry into the study and for the duration of the study.
7. Patient affiliated to a Social Health Insurance in France.
8. Patient must provide written informed consent prior to any study specific procedures.

Exclusion Criteria:

1. Any previous treatment for metastatic disease.
2. Prior adjuvant treatment with anti-HER2 antibodies taken within 6 months.
3. Patient with isolated hepatic metastasis.
4. Patient with hemostasis disorders.
5. Unbalanced Diabetes.
6. Patient with usual formal contraindication to PET/TDM Imaging.
7. Patient who has already started trastuzumab + pertuzumab + taxane treatment.
8. Pregnant or breastfeeding women.
9. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure.
10. Patient protected by law.