cyrilzakka/clinical-trials huggingface dataset:
Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication

The purpose of this study is to determine whether the daily nurse review of the indication of the urinary catheter compared to the everyday care of the working staff is effective to reduce the rate of catheter-associated urinary tract infection in adults hospitalized.

Healthcare-associated infection (HAI)in hospitalized patients are very frequent, especially the catheter-associated urinary tract infection, which prolongs the hospital stay and costs, and is about 3 times more likely to die during hospitalization than patients not infected.

The measures of aseptic insertion and closed systems of collection, as well as the rational use of the probe reduce the risk for infection.

A checklist that contains the agreed indications of catheter, related to obstruction, incontinence, skin lesions in sacral region, monitoring or surgical procedures allows the daily review of the indication of the probe. If the patient doesn´t meet at least one of the criteria, should be recommended the withdrawal of the catheter.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient with a permanent urinary catheter (balloon catheter)
* Urinary catheter placed in the hospitalization (previous day) or at admission

Exclusion Criteria:

* Urinary tract infection diagnosis at time of the insertion
* Spinal cord injury or neurogenic bladder at admission
Influence of Periodontitis and Coronary Heart Disease on Galectin-3

The aim of this study was to analyze the association between serum and salivary Galectin-3 levels in patients with periodontitis. Furthermore, the objective was to determine if the periodontitis influenced serum and salivary Galectin-3 levels

Healthy controls (n=38), patients with CHD (n=39), periodontitis (n=40), and a combination of periodontitis + CHD (n=38) were enrolled in the present study. The analyzed sample undergo a demographical, clinical and periodontal evaluation and serological analyses including Endothelin-1 (ET-1) and for serum and salivary Galectin-3 levels.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least 16 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
A Clinical Study of a Zoster Vaccine in Healthy Adults >= 40 Years

Varicella-zoster virus (VZV) is a herpesvirus that causes two distinct clinical syndromes.Primary infection is manifested as varicella (chickenpox), whereas reactivation of latent VZV results in a localized eruption known as herpes zoster. Most people 40 years of age or older had evidence of previous VZV infection. This study plans to have 522 adults above 40 years old involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated zoster vaccine. The investigational vaccine is produced by Shanghai Institute of Biological Products Co., Ltd. The safety and immunogenicity of the zoster vaccine is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged over 40 years (male or female).
* Able to comply with all clinical trial protocol requirements and willing to complete all the visit plan process during the whole clinical trial observation period.
* Able to understand the content of informed consent and willing to sign the informed consent.
* Able to complete the diary card independently.
* Patients with chronic diseases need to be in a stable period.
* Axillary temperature ≤37.0°C.

Exclusion Criteria:

* Prior history of herpes zoster.
* Prior history of vaccination with herpes zoster vaccine or chickenpox vaccine.
* History of allergic disease likely to be exacerbated by any component of the vaccine.
* Taking immunoglobulins and/or any blood products within the last 3 months or will receive these products during the study period.
* Taking certain pharmaceuticals to be like salicylate kind, including aspirin, and difluorosalicylic, or going to take these medicine during the study period.
* Participation in another research study involving receipt of an investigational product in the last 30 days.
* Prior administration of live vaccine in last 30 days.
* Prior administration of subunit vaccine, inactivated vaccine or allergic therapy in last 14 days.
* History of serious disease and the participation in the clinical trial is likely to increase the disease risk and interfere with the observation of clinical trial index.
* Taking immunosuppressive therapy in last 6 months.
* Any autoimmune disease or immunodeficient state, autoimmune disease or immunodeficient disease.
* Active tuberculosis patient.
* Acute or chronic infections at the vaccination day (axillary temperature≥ 38.0°C).
* Coagulation disorders (coagulation factor deficiency, coagulopathy or platelet disorder) diagnosed by doctors, or obvious bruises or blood coagulation noticed.
* Woman who is breast-feeding.
* Previous history of mental and neurological diseases (e.g. depression, epilepsy or convulsion)
* Planned to move before the end of the study or leave the country for a long time during the scheduled study visit.
* Abnormal Blood Routine and Biochemical Indexes before Inoculation (except for minor abnormalities that are not clinically significant as judged by doctors)
* Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.
Chronic Kidney Disease at Northeast Taiwan: Biomarker and Multidisciplinary Care

CKD is a global endemic disease with increased comorbidities and mortality. The prevalence and the incidence of the end-stage renal disease (ESRD) are extremely high in Taiwan. Early diagnosis of disease and proper management remain challenging. The aims of this study are:

1. Explore risk factors associated with CKD
2. Establish multidisciplinary care model for CKD patients
3. Development cost-effective clinical care pathway for CKD
4. Provide bio-specimen repository for future study

CKD is a global endemic disease with increased comorbidities and mortality. The prevalence and the incidence of the end-stage renal disease (ESRD) are extremely high in Taiwan. Early diagnosis of disease and proper management remain challenging. The aims of this study are:

1. Explore risk factors associated with CKD: demographic, social and genetics factors
2. Establish multidisciplinary care model for CKD patients
3. Development cost-effective clinical care pathway for CKD
4. Provide bio-specimen repository for future study: serum, PBMC, urine and stool

Eligibility Criteria:
Inclusion Criteria:

* Subjects visiting outpatient clinics of nephrology of Chang Gung Memorial Hospital

Exclusion Criteria:

* Patient receiving dialysis or transplantation
* Unwilling to participate
Door-to-door Survey of Cardiovascular Health, Stroke and Ischemic Heart Disease in Atahualpa

The aim of the Atahualpa project is to evaluate the cardiovascular (CVH) status of the inhabitants of a rural village of coastal Ecuador as well as to determine the prevalence and retrospective incidence of stroke and ischemic heart disease. The protocol may be used as a pilot for large-scale studies attempting to evaluate the CVH of rural or even urban centers of Latin America, to implement cost-effective strategies directed to reduce the burden of stroke and cardiovascular diseases in the population at large.

This is a 3-phase epidemiological study. During Phase I, two general physicians and a nurse will perform a door-to-door survey of all Atahualpa residents aged ≥ 40 years. These persons will be eligible for being screened with standardized questionnaires to identify those with suspected stroke or ischemic heart disease, and to evaluate their cardiovascular health (CVH). Persons will be directly interviewed unless aphasic or mentally impaired; in such cases, relatives or caregivers will answer the questions. We plan to use the epidemiologic method of capture-recapture to enhance the detection of all possible cases of stroke and ischemic heart disease \[13\]. So, besides the door-to-door survey, we will review the medical records from the only one health center of Atahualpa, as well as the original files of our survey performed in 2003 at the same village \[12\].

In Phase II, certified neurologists and cardiologists will move to Atahualpa to examine all individuals who screened as suspected cases of stroke or ischemic heart disease. In addition, a random sample of 2% of individuals who were considered negative during the screening phase (matched by age and gender to suspected cases) will also undergo a complete neurologic and cardiologic examination to assess possible false negative cases during the survey. In Phase III, all patients with a clinical diagnosis of stroke and ischemic heart disease will be invited to undergo further examination in Guayaquil.

Eligibility Criteria:
Inclusion Criteria:

* Atahualpa residents aged ≥ 40 years

Exclusion Criteria:

* Patients who do not sign the informed consent form
Infant Fecal Insult Study

The rationale for the study is to better understand the dynamics of skin microflora following skin barrier disruption in an adult dermatitis model. The results from this study will provide insights in the complex interaction between skin microbiome and epidermis under normal and disease conditions


Eligibility Criteria:
Inclusion Criteria:

* Healthy Subjects with Fitzpatrick Skin Types I, II or III

Exclusion Criteria:

* Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color
Determinants of Early Functional Outcome After Reconstructive Surgery

This exploratory study will quantify and describe patient-reported and objective measures of sensorimotor, neuromuscular, psychophysiological and genotypical performance capabilities and levels of habitual physical activity prior to and around the time of surgery.

Despite the positive outcomes of total knee arthroplasty (TKA) surgery on symptoms such as pain, perceived function and health-related quality of life (QoL) current research highlights the persistent deleterious effects of retained aberrant neuromuscular alterations on physical function, which may also directly impact falls risk. Importantly, observed increases in neuromuscular deficits that occur prior to surgery track through into the post-operative stage with functional limitations that are sustained and which can persist at least one year after surgery. Clearly, it is crucial to strive to identify modifiable factors that might successfully ameliorate this pathophysiological process prior to surgery, reduce post surgical impairments and which also accelerate recovery.

Among other determinants that might contribute towards understanding of optimal functional recovery following reconstructive knee surgery is the influence of genes. The evaluation of specific genotypes and subsequent protein expression might provide further insight into the extent of genetic influence. For example, it is not yet known whether patients with specific genotypes experience an accelerated recovery. Currently, there is a paucity of research on the influence of gene-environment interactions on an individual's response to physical conditioning.

The proposed research will be an exploratory study, involving four repeated-measures assessments from 10 weeks prior to surgery to 12 weeks after surgery. This study offers a novel evaluation of the overall patterning of changes and will quantify and describe patient-reported and objective measures of sensorimotor, neuromuscular, psychophysiological performance capabilities, genotypes and levels of habitual physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Males and females over the age of 18, diagnosed with severe osteoarthritis and awaiting primary TKA.

Exclusion Criteria:

* Individuals electing primary knee arthroplasty surgery due to a knee joint disease other than osteoarthritis
* Rheumatic disorder
* Other orthopaedic conditions affecting lower body function
* Neurological disorders
Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile

The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.

The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patient is able to understand the nature of study and has provided written informed consent.
* Patient with Acute Coronary Syndrome, with or without elevation of the ST segment at the EKG (the last with elevation of troponins).
* Patient with coronariography at the episode of ACS showing severe lesions treated with stent.
* Patient with risk index for 6-month mortality (GRACE score) of more than 118.
* Patient with risk index for stroke (CHA2DS2-VACS score) of more than 2.

Exclusion Criteria:

* Patient with history of AF.
* Patient with episodes of AF during admission at the current episode.
* Patient with pacemaker or ICD (implantable cardioverter-defibrillator) previously.
* Patient with indication of pacemaker or ICD in current or short-term phase.
* Patient is participating in another interventional clinical investigation.
* Patient is pregnant or breast feeding.
* Patient´s life-expectancy is less than 24 months.
Intensive Care of Elderly: What do They Wish for Themselves?

Do very elderly adults wish intensive care in the event of acute life-threatening illness and are their next of kin able to predict these preferences?

Very elderly patients are a steeply increasing patient population in intensive care units (ICUs), but the overall benefit of intensive care for these patients remains controversial. Will ICU admission improve survival and quality of life, or will it prolong suffering and delay natural death? Little is known about very elderly Norwegians life sustaining treatment (LST) preferences in these situations where treatment benefit is uncertain.

This project aims to improve critically ill very elderly patients' ICU trajectories by bringing forth knowledge about their treatment preferences, their family members' ability to predict these preferences, and by directing attention to the challenges of consent to critical care in cases of medical uncertainty.

A selv administered, mailed survey will be distributed among 400 outpatients aged 80 years or older and their next of kin. Respondents will be recruited at the ophthalmologic, ear-nose-and-throat and orthopaedic outpatient clinics at Haukeland University Hospital Bergen, Norway.

The investigators developed and validated a survey tool for this purpose, containing 3 hypothetical scenarios of acute life-threatening illness. The scenarios are randomly chosen from 20 hypothetical patient histories and are representative for ICU admission diagnoses in Norway and Europe. The participants will be asked for treatment choices, i.e. wishing admission to intensive care or not. A response option 'not wishing to engage in the treatment decision' is also provided.

Furthermore, the questionnaire includes factors that may influence elderlies' treatment preferences and proxies' ability to predict these preferences including: demographics, religion, previous experience with and / or communication about critical illness, comorbidity, frailty, quality of life, and projections (i.e. the proxy's own treatment preferences).

The respondents are requested to explain their choices by free-text comments after each scenario. They are also asked to elaborate how they wish next-of-kin should contribute to decision making in these cases. Additional space for free-text comments is provided in the end of the questionnaire.

The study design is exploratory. Responses will be analysed with both quantitative statistics and qualitative methods.


Eligibility Criteria:
Inclusion Criteria: Outpatients aged 80 years or older who register for appointment at the ophthalmologic, ear-nose-and-throat, and orthopaedic outpatient clinic at Haukeland University Hospital, Bergen, Norway.

Exclusion Criteria:

1. not consenting to participate
2. living in permanent care facility / nursing home
3. not able to complete the questionnaire owing to:

   * severely reduced vision / blindness
   * high degree of frailty (Clinical frailty scale ≥ 7)
   * cognitive impairment
Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Stem Cell Transplantation

This is a prospective study of the safety and efficacy of nivolumab for the treatment of relapsed or residual haematological malignancies after allogeneic stem cell transplantation (alloSCT).

Eligible patients will receive nivolumab at a dose of 3mg/kg intravenously every 2 weeks. The primary objective is to evaluate the incidence, severity and treatment responsiveness of GVHD following nivolumab treatment post-alloSCT.


Eligibility Criteria:
Inclusion Criteria:

* Prior allogeneic stem cell transplant for a haematological malignancy
* Confirmed relapse of haematological malignancy or persistent disease post-alloSCT
* Immunosuppression cessation for minimum of 2 weeks
* Life expectancy \> 2 months
* ECOG performance status 0-2
* Greater than or equal to 30% CD3+ donor chimerism
* Serum creatinine ≤ 1.5 times upper limit of normal OR creatinine clearance ≥ 40mL/min
* AST and ALT ≤ 3 times upper limit of normal
* Total bilirubin ≤ 1.5 times upper limit of normal (except patients with Gilbert Syndrome)
* Signed written informed consent

Exclusion Criteria:

* Current evidence of any grade of GVHD
* Prior history of grade 2 or higher acute GVHD
* Moderate chronic GVHD within the previous 6 months or any prior history of severe chronic GVHD
* Active, known or suspected autoimmune disease (excluding vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger)
* Positive hepatitis B virus surface antigen
* Positive hepatitis C virus antibody
* Known human immunodeficiency virus infection
Acupuncture for Post-Thoracotomy Pain

Pain after surgery for lung cancer (thoracotomy) may persist for years and require long-term analgesic use. Prior studies have shown that acupuncture reduces pain and medication use in the early post-operative period after abdominal surgery, suggesting that acupuncture may have a role in preventing chronic post-thoracotomy pain. This study is being done in order to determine the effects of acupuncture on pain in patients undergoing surgery for lung cancer.

Rationale:

Acupuncture is the insertion of very fine needles into the skin to treat symptoms. In recent years, researchers have come to understand how acupuncture might work in terms of nerve stimulation and the release of chemical messages in the body. Researchers have found evidence that acupuncture is useful in treating a variety of conditions, including headache, nausea, and pain after surgery.

Pain is a common problem after surgery for lung cancer. Many patients experience pain in the first few days after surgery, despite medication. In some patients, this pain can last for many months or years afterwards.

Purpose:

A pilot study of acupuncture in patients undergoing lung cancer surgery was conducted previously and found that this study was feasible to implement and well-received by patients. We now wish to conduct a larger study in order to determine the effects of acupuncture on pain in patients undergoing surgery for lung cancer.

* To determine whether acupuncture versus placebo acupuncture after thoracotomy reduces pain or analgesic use
* To determine whether acupuncture affects the immediate post-operative period and/or 30, 60,90 days and approximately 12 months later.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral thoracotomy at Memorial Sloan-Kettering Cancer Center (MSKCC)
* Age greater than or equal to 18 years old.

Exclusion Criteria:

* Any of the following procedures: hemiclamshell, clamshell, extrapleural approach, chest wall involvement, esophagectomy. These more extensive procedures have a higher risk of complications.
* Acupuncture treatment in the previous six weeks, to discount any persisting effect of acupuncture
* Platelets \< 20,000 or International Normalized Ratio (INR) \> 2.5 or absolute neutrophil count (ANC) \< 0.5; though it would be unusual for any patient to be operated on with such values, it seems wise as a precautionary measure to avoid risk of bleeding from acupuncture.
* Known cardiac conditions constituting a high or moderate risk of endocarditis as defined by the American Heart Association criteria
* Patients unable to remove studs without assistance, who have no home assistance, and who are unable or unwilling to return to the hospital in the event that they decide to remove studs before the post-discharge visit.
A Study to Learn About the Study Medicine Called PF-07905428 in Healthy Participants and Participants With Acne Vulgaris

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07905428) for the potential treatment of acne vulgaris.

This study is seeking participants who:

* Are male or female between the ages of 18 and 40
* Are generally healthy
* Are diagnosed with moderate to severe acne vulgaris (Cohort 4 only)

The study medicine will be applied every day on the participant's face and/or back for 14 days (Cohorts 1 and 2) or for 28 days (Cohort 3 and 4).

The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help the investigators determine if the study medicine is safe and effective.

Participants will take part in this study for approximately 2 months. During this time, they will have 17 study visits (Cohorts 1 and 2) or 31 study visits (Cohorts 3 and 4) at the study clinic. The study team will also call participants once at the end of the study over the phone.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation.
* Only for participants who are enrolling with acne vulgaris: diagnosis of acne vulgaris for 3 months or greater
* For participants enrolling in Cohort 1-3 with acne vulgaris (optional): mild to moderate facial acne vulgaris
* For participants enrolling in Cohort 4 with acne vulgaris: moderate to severe facial acne vulgaris

Exclusion Criteria:

* Participants with very severe acne
* Participants with autoinflammatory syndromes
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C.
* Participants with clinically significant laboratory abnormalities