cyrilzakka/clinical-trials huggingface dataset:
Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy

This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the sample size calculated 80 persons (40 persons for control group and 40 persons for patient group). Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood Sugar more than 126 mg/dL and proteinuria 30-300 mg/dL (microalbuminuria) and Glomerular Filtration Rate more than 90 mL/min will be chosen. Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 12 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.

This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the sample size calculated 80 persons (40 persons for control group and 40 persons for patient group).

Eligibility Criteria:
Inclusion Criteria:

* more than 18 years old
* diabetic nephropathy
* Fasting Blood Sugar more than 126 milligram per deciliter
* Proteinuria 30-300 milligram per deciliter (microalbuminuria)
* Glomerular Filtration Rate more than 90 milliliter per minute
* Not having hyperthyroidism or hypothyroidism
* Not having any feverish urinary tract infection
* Not using any kind of drug including Cigarette
* Not having any liver disease
* Not having any cancer and inflammatory diseases
* Not having more than 4 kilogram weight loss during last 3 months
* Not using any magnesium-rich supplement

Exclusion Criteria:

* changing medicine dose
* Not having adherence (using less than 75 percent of medicines)
* Cardiac Arrhythmias
Treatment of Sleep Apnea to Improve Metabolic Health

Diabetes and prediabetes prevail among obstructive sleep apnea (OSA) patients. OSA and short sleep both detrimentally affect glycemic control regardless of obesity. With 1 in 10 adults having diabetes, 1 in 10 with prediabetes, and an estimated 600,000 affected by OSA in Sweden, attaining glycemic control is crucial. Though continuous positive airway pressure (CPAP) is the most effective treatment for OSA, its application lacks personalization, ignoring factors like comorbidities and sleep duration. Key unanswered questions regarding CPAP's impact on glycemic control include: 1) Does high CPAP adherence optimize glycemic control? 2) Should short sleep be addressed alongside OSA treatment for glycemic control? 3) Does long-term diabetes hinder CPAP's glycemic control efficacy? The purpose of this project is to enable precision health in CPAP treatment and producing a personalized treatment model for achieving glycemic control in patients with OSA, treated with CPAP. Taking advantage of a large unique patient cohort (600 patients followed over 18 months) with extensive and objective measures on CPAP adherence, OSA reduction, sleep duration, as well as information on comorbidities, anthropometric, lifestyle data, and a wide range of biomarkers related to glycemic control. This comprehensive approach and in-depth analysis will address these questions and generate a personalized treatment strategy for glycemic control in CPAP-treated OSA patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with obstructive sleep apnea
* Planned for CPAP treatment
* 18 years and above

Exclusion Criteria:

* Patient not wanting to participate in study
* Non-Swedish speaking
* Judged by physician as non-fit for study participation
The Effect and Mechanism of lncRNA NBR2 Regulating Endothelial Pyroptosis by Targeting GSDMD in Sepsis

Sepsis is a life-threatening disease characterized by multi-organ failure due to dysregulated host response to infection, with high global mortality of 30-50%. One of the most important pathophysiologic hallmarks in sepsis is vascular endothelial injury that contributes to the severity and outcome of the syndrome. Effective treatments for endothelial cell injury in sepsis have been lacking to improve prognosis. Endothelial pyroptosis is a vital mechanism of vascular endothelial injury in sepsis; mitigation or abolishment of endothelial cell pyroptosis alleviate vascular endothelial damage and improve the prognosis of sepsis mice. Gasdermin D (GSDMD) mediated endothelial pyroptosis plays a critical role in modulating vascular endothelial injury in sepsis.

Long non-coding RNA (lncRNA), as a class of non-coding protein RNA longer than 200 kD, contributes to a variety of cell biological processes. The dysregulation of lncRNA results in the occurrence and development of tumors, diabetes, sepsis and other diseases. Therefore, we detected lncRNA and mRNA expression profile in 26 blood samples of septic patients using Arraystar LncRNA Microarray. We found lncRNA NBR2 regulates septic endothelial pyroptosis.

To assess any correlation of pyroptosis levels with relevant endothelial cell injury parameters and determine the prognostic value in septic patients. we measured the levels of pyroptosis in patients admitted to the Department of Critical Care Medicine for sepsis and investigated the correlation with related markers of endothelium injury. Furthermore, we determined the prognostic value of pyroptosis levels for the mortality of patients with sepsis.

We measured the levels of pyroptosis in patients admitted to the Department of Critical Care Medicine for sepsis and investigated the correlation with related markers of endothelium injury. Furthermore, we determined the prognostic value of pyroptosis levels for the mortality of patients with sepsis.

Eligibility Criteria:
Inclusion Criteria:

* Suspected or confirmed infection
* The sequential organ failure score (SOFA score) increases by more than or equal to 2 points on the basis
* Sign the informed consent

Exclusion Criteria:

1. the age \< 18 or \> 80 years of age
2. pregnant
3. tumor
4. viral hepatitis or liver cirrhosis
5. chronic renal tubular nephritis, chronic renal insufficiency
6. ulcerative colitis or crohn's disease
7. active systemic lupus erythematosus (SLE)
8. acute myocardial infarction
9. acute pancreatitis
10. engaged in other clinical subjects
I-ASV in Cardiac Surgery

'POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II) is an investigator-initiated, international, multicenter, parallel, randomized clinical trial in patients after cardiac surgery.

To compare INTELLiVENT-ASV with conventional ventilation with respect to (i.) quality of ventilation; and (ii.) ICU nursing staff workload in an international cohort of participants receiving postoperative ventilation after cardiac surgery. This study will also determine the effects of INTELLiVENT-ASV on clinical outcomes, including (iii.) duration of postoperative ventilation and (iv.) length of stay in ICU.

Eligibility Criteria:
Inclusion Criteria:

* 1. aged \> 18 years of age;
* 2. scheduled for elective cardiac surgery; and
* 3. expected to receive postoperative ventilation in the ICU for \> 2 hours.

Exclusion Criteria:

1. any emergency or semi-elective surgery (precluding informed written consent);
2. any surgery other than CABG, valve replacement or repair, or a combination (i.e., patients planned for surgery for congenital heart disease, or scheduled for heart transplantation are excluded);
3. enrolled in another interventional trail;
4. no written informed consent obtained;
5. history of recent pneumectomy or lobectomy;
6. history of COPD with oxygen at home;
7. body mass index \> 35;
8. preoperative forced expiratory volume in the first second (FeV1)/forced vital capacity (VC) \< 50% (if available);
9. preoperative arterial oxygen partial pressure (PaO2) \< 60 mm Hg (at room air);
10. preoperative arterial carbon dioxide partial pressure (PaCO2) \> 50 mm Hg;
11. preoperative left ventricular ejection fraction \< 30% (if available);
12. preoperative systolic pulmonary artery pressure \> 60 mm Hg (if available);
13. preoperative left ventricular mechanical support, e.g., Impella®; or
14. preoperative use of veno-venous or veno-arterial extracorporeal support

    At the end of surgery, patients are additionally excluded if a patient:
15. cannot be weaned from the extracorporeal support; or
16. unexpectedly needs implementation of an assist device
EVALUATION OF PROFESSIONAL ATTITUDE, JOB SATISFACTION AND BURNOUT LEVELS OF PHYSIOTHERAPISTS

Our study was planned to investigate the professional attitudes and satisfaction levels of physiotherapists.

It has affected each professional group in different ways. The effects on health workers such as doctors and nurses have been studied in various studies.

However, there are no studies on the effects on physiotherapists. After individuals start their profession In time, they develop an attitude towards their profession through cognitive and emotional orientations. Level of interest in the profession, academic education activities related to the profession, working places, the institution where they work, the level of professional satisfaction of physiotherapists determinant factors of the disease. This study is a prospective questionnaire study. A questionnaire created through Google forms The survey will be conducted by reaching physiotherapists. The survey will start after ethics commission permission is obtained. Age, gender of individuals, year of graduation, level of education, marital status, institution, position/task, occupation of the manager of the organisation, most difficult patient group, the professional field he/she feels most deficient in, the number of training-courses he/she has taken related to the profession after graduation, after graduation The number of congresses-seminars-symposiums related to the profession, the status of following current developments will be questioned; attitude towards physiotherapy profession scale, Minnesota job satisfaction scale, motivation feedback questionnaire, Maslach burnout scale will be applied 1 time. The data will be analysed with SPSS 21.0 (SPSS Inc., Chicago, Illinois, USA).


Eligibility Criteria:
Inclusion Criteria:

To have a bachelor's degree in Physiotherapy and Rehabilitation To be actively practicing the profession of physiotherapist in any institution

Exclusion Criteria:

Graduated but not working as a physiotherapist.
Radio Frequency Ablation (RFA STUDY )

The aim of this study is to investigate the safety and feasibility of a radiofrequency (RF) system employing RFITT (CelonProSurge) probes for the ablative treatment of uterine fibroids.

10 consecutive premenopausal women with symptomatic uterine fibroids not responsive to medical therapies (including progestins, oral contraceptives, and anti-inflammatory drugs) will be recruited at our hospital to be submitted to abdominal myomectomy. All patients will be counseled on the potential risks and benefits of the procedure before giving their own written consent.

Procedures will be performed at the hospital and patients will be under general anesthesia.All patients will be submitted to abdominal myomectomy. Target leiomyomas will be intramural, 5-15 cm in diameter. Intra-operative RF ablation will be carried out followed by surgical removal of the treated leiomyoma. After the removing of the fibroid, it will be send to the pathologist. Specimens of fibroid will be fixed immediately in 10% neutral formaline solution for approximately 3h, then embedded in paraffin, cut into 4mm section and stained with along the direction of the RFA electrode. Pathologic confirmation of ablation will be assessed as follows: the specimens of leiomyoma will be examined grossly for the histologic leiomyoma subtype and for pathologic findings representing treatment, including necrosis, hemorrhage, or fibrosis, using hematoxylin and eosin staining. Treated areas will be measured for their largest orthogonal dimensions in the planar cut surface with the third dimension estimated by summing the affected 0.5-cm-thick sagittal planes. RF ablation volumes will be calculated using the prolate ellipsoid formula. The relationship between thermal dose estimates and pathology will be assessed using Bland-Altman analyses and intra-class correlations. The surgical procedure will be concluded as usual with the same steps of standard approach.

Eligibility Criteria:
Inclusion Criteria:

1. premenopausal women, 25 years of age or older;
2. presence of fibroid-related symptoms (menorrhagia, pelvic pain and/or bulk symptoms) not responsive to medical therapy;
3. uteri \<20-week gestational size on pelvic examination;
4. one myoma 5-15 cm in diameter as measured by transvaginal ultrasound;
5. desire for uterine preservation;
6. normal coagulation profile;
7. normal Pap test result in the last year,
8. hemoglobin level of 10.0 g/dL or more at the time of treatment.

Exclusion Criteria:

1. pedunculated subserosal or intracavitary myomas,
2. a history of pelvic malignancy,
3. presence of cervical dysplasia,
4. a prior procedure to treat or remove myomas,
5. contraindications to general anesthesia or abdominal surgery.
Effects of Individualized Exercise Training in Patients With Peripheral Arterial Disease

The study is designed to investigate individualized exercise training effects on arterial function, walking ability and quality of life in subjects with peripheral arterial disease post surgery.


Eligibility Criteria:
Inclusion Criteria:

* Peripheral arterial disease post surgery \> 1 month
* No discharge of surgical incision
* Intermittent claudication post invasive treatment

Exclusion Criteria:

* Necrosis
* Above/below knee amputee
* Other conditions might affect peripheral vascular elasticity
INcidence of PostOperative Delirium Incidence in Surgical Patients: an Observational Cohort Study in New Zealand

As the population of older adults increases, so too with the number of older adult patients that present for anesthesia and surgery. The development of delirium following surgery has some significant potential effects on patient outcomes; however, POD is often under diagnosed. Some studies reported that more than 50% of patients with delirium were undiagnosed by clinical teams. POD is associated with cognitive decline, increased hospital length of stay, discharge to institutional care, mortality and higher healthcare costs. POD contributes significantly to healthcare inefficiency; a diagnosis of POD is estimated by the Australian Commission on Quality and Safety in Healthcare to cost an additional $27,791 AUD. The incidence of POD reported in clinical trials depends on the risk profile of the study population, the frequency and duration of delirium assessments as well as the surgical procedure. Reported incidence may also vary due to the presence of high-risk pathways involving multi-specialty management and intervention. POD may present as either hyperactive or hypoactive subtypes, the latter being more difficult to detect.

There are few reports on the incidence of POD in New Zealand national level datasets, with single centre studies primarily looking at in-hospital delirium and demonstrating an incidence of 11.2 to 29% on mixed and/or medical wards. A review of elderly patients with neck-of-femur fractures found the incidences of POD to be as high as 39%. The current data suggests a significant level of morbidity due to POD in New Zealand hospitals, however there is lack of national level data in the surgical population; which is crucial for establishing demographic and regional need for effective intervention.


Eligibility Criteria:
Eligible patients include those aged 18 years or over undergoing a surgical procedure in any of 71 public or private hospitals
AVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs

The objective of this global non-interventional study is to evaluate the impact of Acute Exacerbation of Chronic Bronchitis(AECB) on the patient and the community as well as the safety and effect of a treatment with Moxifloxacin tablets in daily life clinical practice. This includes data on the course of symptom relief, speed of return to normal daily life activities as well as records on adverse events.

This study will be performed in accordance with international guidelines like EMEA (EMEA, EUDRALEX Volume 9A, Pharmacovigilance for Medicinal Products for Human Use) as well as local laws.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 35 years of age with a diagnosis of Acute Exacerbation of Chronic Bronchitis (AECB) and decision taken by the investigator to treat with Avelox.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information.
LRRK2 and Other Novel Exosome Proteins in Parkinson's Disease

This proposal seeks to 1) determine whether there are biomarkers associated with Parkinson's disease (PD) susceptibility and/or progression in exosome-proteomes derived from PD patients versus controls, and 2) to determine if LRRK2 expression and/or phosphorylation are significantly lowered in the exosomes of individuals treated with the potent LRRK2 kinase inhibitor sunitinib (a multi-kinase inhibitor compound), to establish an assay for on-target effects for future LRRK2 inhibitor clinical trials.


Eligibility Criteria:
Inclusion Criteria:

Parkinson's disease inclusion criteria:

Inclusion criteria will be based on UK Brain Bank criteria for the clinical diagnosis of PD. These require 1) the presence of bradykinesia and either rest tremor or rigidity; 2) asymmetric onset; 3) progressive motor symptoms 4) age at onset 21-99 years.

Control inclusion criteria: ages of between 21-99 years, a lack of PD in first-degree blood relatives, and a lack of positive responses on more than 3 items on the PD Screening Questionnaire.

Exclusion Criteria:

For all subjects:

include atypical features indicative of a Parkinson-Plus disorder (Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA), Corticobasal Degeneration (CBD)) including cerebellar signs, supranuclear gaze palsy, apraxia and other cortical signs, or prominent autonomic failure, neuroleptic treatment at time of onset of parkinsonism, active treatment with a neuroleptic at time of study entry, History of repeated strokes with stepwise progression of parkinsonism, history of repeated head injury, history of definite encephalitis, prominent gait imbalance early in the course (\< 5 years), dementia, known severe anemia (hematocrit \<30), history of kidney disease and/or current or past glomerular filtration rate (GFR) \<60 possibly indicative of kidney disease, or a serious comorbidity that may interfere with participation in the study.
Juntos/Together Program to Build Confidence for Complex Care Tasks Among Latino Family Caregivers

The overall goal of this study is to culturally adapt and test the effectiveness of Learning Skills Together (LST) in improving self-efficacy among Latino family caregivers. To address this overall goal, the study team propose the following aims: i) culturally adapt the LST intervention for Latino caregivers using a community-engaged approach; and ii) examine the effect of the LST intervention on Latino caregiver self-efficacy, depression, and well-being using a randomized wait-list control group.

The study team will use a randomized wait-list control group design with blinded outcomes assessment to examine the effectiveness of LST-LC on caregiver confidence and self-efficacy in performing complex care tasks. This design has the advantage of making enrollment more feasible as participants may find the intervention highly desirable and will eventually receive it. Yet, the design provides a randomized comparison with a non-intervention control group. Participants will be individually randomized 1:1 to an immediate intervention group (IG) and a wait-list (delayed) control group (WLC).

Eligibility Criteria:
Inclusion Criteria:

1. a family member to an individual living with AD/ADRD (Alzheimers Disease/Alzheimers Disease and related dementias) who has received a diagnosis from a physician,
2. aged 18 years or older,
3. providing assistance with at least two instrumental activities of daily living or one activity of daily living,
4. providing care to a person with dementia in mid-stage as defined by a score between 4 and 6 on the Global Deterioration Scale (GDS), and
5. not paid to provide care

Exclusion Criteria:

1. are unable to read and speak English or Spanish,
2. previously participated in LST, and/or
3. have plans to place the care recipient in a skilled nursing facility within the next 6 months (i.e., study duration).
4. Participants must have a Patient Health Questionnaire (PHQ-9) score of less than 15, the threshold for moderately severe depression
5. Participants with severe depression
Low Dose Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts

A new test for breast cancer screening, molecular breast imaging (MBI) may be more sensitive than mammography for detecting breast cancer in women with dense breasts. The purpose of this study is to see if MBI using a low dose of gamma radiation can find cancers not seen on mammography.

Hypotheses: 1. Low-Dose MBI has a significantly higher sensitivity and specificity and equal or higher positive predictive value than SM in women age 40 and older with mammographically dense breasts. 2. Low-dose MBI has comparable sensitivity and specificity to that previously achieved with MBI using a higher dose of radiation. 3. MBI produces a low false positive rate (specificity \>90%) that permits its use as a screening tool in this patient population.

A previous study demonstrated that the addition of MBI using 20 mCi Tc-99m sestamibi to screening mammography (SM) increased diagnostic yield for breast cancer in dense breasts (supplemental yield of 7.5/1000 screened). After implementing radiation dose reduction techniques, the performance of incident SM and prevalent screen MBI in women with dense breasts will be compared.

Methods:

Women presenting for SM with heterogeneously or extremely dense breasts on past prior SM were enrolled and underwent digital SM and MBI. Study information was sent to all eligible patients in advance of their scheduled SM explaining the study and offering them participation. Eligible patients who requested to participate were offered an MBI on the same day as their SM or within 21 days of the SM. Participants may have participated in this screening study up to two times provided at least 24 months had elapsed since the initial MBI scan. This time period was selected as the average time for a tumor to double in size is approximately 20 months. Hence a 24 month time interval between MBI studies was to enable detection of interval cancers or cancers that were too small to be detected in the initial MBI scan.

MBI was performed with 8 mCi Tc-99m sestamibi and dual-head cadmium zinc telluride detectors. SMs were read independently; MBIs were read in comparison with SM. MBIs were assigned an assessment score of 1-5 which parallels BI-RADS; scores of 3-5 on MBI were considered positive.

Eligibility Criteria:
Inclusion Criteria:

* Past prior SM interpreted as negative or benign \[Breast Imaging Reporting and Data System (BI-RADS) Category 1 or 2\]
* Past prior SM interpreted as heterogeneously dense or extremely dense

Exclusion Criteria:

* Subject is unable to understand and sign the consent form
* Subject is pregnant or lactating
* Subject is physically unable to sit upright and still for 40 minutes
* Subject has self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass, etc.)
* Subject has had needle biopsy within 3 months, or breast surgery within 1 year prior to the study
* Subject is currently taking tamoxifen, Evista (raloxifene), Zoladex or an aromatase inhibitor for adjuvant therapy or chemoprevention.