cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism

The purpose of this study is to characterize the safety and tolerability of single rising doses of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism.


Eligibility Criteria:
Inclusion Criteria:

* Subjects provides written informed consent.
* Intact parathyroid hormone (iPTH) ≥ 400 pg/mL (≥ 300 and \< 1200 pg/ml for Cohorts 1-3).
* Serum corrected calcium ≥ 9.0 mg/dL
* Receiving hemodialysis three times per week for at least 3 months and had adequate hemodialysis with a delivered Kt/V (dialyzer clearance of urea \* dialysis time/ volume of distribution of urea) ≥ 1.2 or urea reduction ratio (URR)

  ≥ 65%.
* Excepting chronic renal failure, subject is judged to be in stable medical condition based on medical history, physical examination, and routine laboratory tests

Exclusion Criteria:

* History or symptomatic ventricular dysrhythmias
* History of angina pectoris or congestive heart failure
* History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months
* History of or treatment for seizure disorder
* Recent (3 months) parathyroidectomy
Role of Interleukin-1 in Postprandial Fatigue - The Cheesecake Study

The aim of the study is to investigate, if postprandial fatigue symptoms after ingestion of a high-fat, high-carbohydrate meal are regulated by Interleukin (IL)-1 and can be prevented by inhibition of IL-1 using a single dose injection of a specific IL-1 receptor antagonist.


Eligibility Criteria:
Inclusion Criteria:

* male
* non-smoking
* apparently healthy
* BMI \>18 and ≤25 kg/m2
* Age 20-50 years
* Willingness to use contraceptive measures adequate to prevent the subject's partner from becoming pregnant during the study. Adequate contraceptive measures include hormonal methods used for two or more cycles prior to screening (e.g., oral contraceptive pills, contraceptive patch, or contraceptive vaginal ring), double barrier methods (e.g., contraceptive sponge, diaphragm used in conjunction with contraceptive foam or jelly, and condom used in conjunction with contraceptive foam or jelly), intrauterine methods (IUD), sterilization (e.g., tubal ligation or a monogamous relationship with a vasectomized partner), and abstinence.

Exclusion Criteria:

* Clinical signs of infection in the week before inclusion or history of infection during the last 2 months (CRP \>5mg/l)
* Impaired fasting glucose (fasting plasma glucose \>5.5mmol/l)
* Hematologic disease (leukocyte count \< 1.5x109/l, hemoglobin \<11 g/dl, platelets \<100 x 103/ul)
* Kidney disease (creatinine \> 1.5 mg/dL))
* Liver disease (transaminases \>2x upper normal range)
* Heart disease
* Pulmonary disease
* Inflammatory disease
* History of carcinoma
* History of tuberculosis
* Alcohol consumption \>40g/d
* Smoking
* Known allergy towards Anakinra
* Known allergy towards ingredients of the test meal
* Current treatment with any drug in the week before inclusion, including vitamin supplementation (especially vitamin C and E)
* Use of any investigational drug within 30 days prior to enrollment or within 5 half-lives of the investigational drug, whichever is longer
* Subject refusing or unable to give written informed consent
Web-based Management of Female Stress Urinary Incontinence

The purpose of this study is to determine whether treatment of female stress urinary incontinence using a web-based programme is effective.

Female urinary incontinence is very common and affects up to one fourth of grownup women. It may reduce quality of life for those affected and costs for society are high. The most common type of urinary incontinence is stress urinary incontinence (SUI), i.e leakage when coughing, sneezing or jumping. There is no association between SUI and serious medical conditions. Thus investigation can be kept to a minimum, including structured history taking and a bladder diary for correct diagnosis. Treatment with lifestyle intervention and pelvic floor muscle training (PFMT) give improvement or cure in 60-70% of women. A small study indicates that treatment with cognitive behavioural therapy (CBT) may improve incontinence-related quality of life and symptoms of urinary incontinence. Web-based management of SUI has as far as we know never been evaluated in a randomized controlled study. The aim of this study is to determine if web-based management of female SUI, with a treatment using PFMT and elements of CBT is effective compared to treatment supported by a pamphlet. The duration of the treatment programme is three months, follow-up at four months, 1 year and two years.

Eligibility Criteria:
Inclusion Criteria:

* stress urinary incontinence
* leakage once a week or more often
* ability to read and write Swedish
* asset to computer with Internet connection

Exclusion Criteria:

* pregnancy
* former incontinence surgery
* known malignancy in lower abdomen
* difficulties with passing urine
* visual blood in urine
* intermenstrual bleeding
* severe psychiatric diagnosis
* neurological disease with affection on sensibility in legs or lower abdomen
Evolution of Family Alliance in Families With a Designated Adolescent Patient (12-18 Years) During a Family Therapy Process

The proposed study focuses on the relational characteristics of the family and their evolution in the course of family therapy, through the evolution of the family alliance (degree of coordination achieved by its members to perform a task) and co-parenting (support that the mother and father give each other in their roles as parents), assuming that the family therapy allows the improvement of these two aspects. The family alliance is evaluated via a standardized observation situation (Lausanne Family Play LFP adapted from the Lausanne Trilogy Play LTP) whose sessions are filmed. The alliance assessment is carried out by the coding and scales of the FASS (Family Alliance Assessment Scales,) tool during viewing.


Eligibility Criteria:
Inclusion Criteria:

* Families attended in family therapy by the G02 sector teams and the Bondy family therapy team attached to G14 and I05, with a designated adolescent patient (aged 12-18).
* Family whose parents or co-parents live under the same roof. Co-parents designate adults to be responsible for the care and education of one or more children (Talbot \&Mchale, 2004)
* Blended families

Exclusion Criteria:

* Single parent family without co-parents (in-laws, grandparents...) living under the same roof
* Insufficient mastery of French
* Separated parents (lack of daily life is unsuitable for scales chosen)
* patient without social security scheme
* Persons in emergency situations.
* Persons unable to give their personal consent, of whom adults under guardianship
Systematic Post-Implementation Evaluation of Stents

To conduct a quality assurance project to establish the differences in health care processes and cost effectiveness of having the thin-strut Orsiro stent versus the thicker strut Promus stent on the shelf (i.e. as the most accessible stent).

Background:

Individual patient-level randomized trials have suggested that the ultrathin strut Orsiro stent is associated with a lower risk of adverse ischemic events than the thin strut Promus stent. However, there are theoretical advantages of each stent in regards to usability, delivery and radial strength.

Study design:

The SPECS trial is a prospective, open-label, cross-sectional, cluster randomized quality assurance project, in which cardiac catheterization laboratories (hereafter referred to as center) in Västra Götaland Sweden will participate. Each week each center will place either Orsiro or Promus in the shelf in the cath lab as the most accessible stent (their workhorse stent). The specific stent to be placed on the shelf at each center each week will be randomly decided.

All patients will be treated according to local treatment guidelines and at the discretion of the interventional cardiologists, including the choice of stents.

The patients will be identified via the Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) registry. The events at will be identified and extracted from Patient registry (Socialstyrelsen), Population registry (Folkbokföringen), Causes of death registry (Socialstyrelsen). Stent usage will be monitored via SWEDEHEART and local databases (stents for which the package was opened but the stent discarded).

Study population:

Patients undergoing percutaneous coronary intervention (PCI) in Västra Götaland.

Primary objectives:

To investigate the cost-effectivess of placing either thin or thick strut stents on the shelf in the cath lab.

To investigate the weekly costs associated with placing either thin or thick strut stents on the shelf in the cath lab.

All outcomes will be tracked over time to assess whether greater experience with the thin strut stents results in changes in any cost differences over time.

If a sufficient number of patients are treated over the course of the project, retrospective analyses may be conducted using the assigned shelf stent as an instrument for assessing the effect of thin vs. thick stents on outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing PCI at any hospital participating in the study

Exclusion Criteria:

* None
Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution

This open-label, pilot study will evaluate the tolerance and change in the microbiome from the use of APR-TD011 ((RLF-TD011) wound cleansing spray for the treatment of CTCL skin lesions.


Eligibility Criteria:
Inclusion Criteria:

* Adults with early-stage mycosis fungoides (stages IA-IB)
* At least two target lesions that have been present for at least 3 weeks and is at least 10 cm2 , so that at least one lesion may be allocated to each of the treatment regimes
* Target lesion with swab that is culture positive for staphylococcus aureus, but not to an extent that would require systemic antibiotics
* Agree to avoid washing or using a topical application at the target lesion starting the night before each scheduled study visit.
* Agree for the duration of study participation to avoid using dilute bleach or vinegar baths, or other antiseptic use, at the target lesion from screening throughout the study.

Exclusion Criteria:

* Patients currently or recently (within past 4 weeks) on topical or systemic antibiotics adults unable to provide informed consent, (infants, children, teenagers, pregnant women, prisoners and other vulnerable populations.
Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy

The primary objectives of this study are:

In infants of women exposed to SPIKEVAX during pregnancy, to assess:

* If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital malformations (MCMs).
* If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of adverse neonatal and infant outcomes, specifically neonatal encephalopathy, small for gestational age, respiratory distress in the newborn, and incidence of hospitalization due to infections including coronavirus disease 2019 (COVID-19).
* In women exposed to SPIKEVAX during pregnancy, to assess whether exposure to SPIKEVAX is associated with an increased prevalence of hypertensive disorders \[e.g., pre-eclampsia, eclampsia, and gestational hypertension\] gestational diabetes, and post-partum hemorrhage; and
* To assess whether exposure to SPIKEVAX during pregnancy is associated with an increased incidence of stillbirth, preterm birth, and medically attended spontaneous abortion.


Eligibility Criteria:
Inclusion Criteria:

* EOP within study period
* Continuous enrollment in a health plan contributing to the HealthCare Integrated Research Database℠ (HIRD) database for at least 90 days prior to the estimated LMP.

Exclusion Criteria:

* Exposure to any non-Moderna COVID-19 vaccines at any time prior to LMP and from LMP through the exposure ascertainment period for the outcome of interest. However, pregnant women exposed to other non-Moderna vaccines in addition to SPIKEVAX will be included in a sensitivity analysis.
* Instances where the outcome of a pregnancy is not documented (e.g., a prenatal care claim is followed by no further documentation of pregnancy, termination, or delivery where the participant remains enrolled in the health plan) may also be observed. The number of these possibly exposed pregnancies will be tabulated and described; however, they will not be included in the descriptive or comparative analyses.
Prevalence of Sarcopenia and Sarcopenic Obesity in Older Adults

Syndromes such as sarcopenia, sarcopenic obesity and osteosarcopenic obesity are commonly seen in older adults. They result from the impairment of muscle, bone and adipose tissue. Thus, they lead to a decrease in quality of life and increase morbidity and mortality. The aim of this study is to report the prevalence of sarcopenia, sarcopenic obesity and osteosarcopenic obesity in community-dwelling outpatient older adults and to investigate the related factors.


Eligibility Criteria:
Inclusion Criteria:

* Being at the age of 65 or older
* Being able to complete 4-m walk test

Exclusion Criteria:

* \<24 points on Mini-Mental State Examination
* 12 points or higher on Geriatric Depression Scale
The Impact on Linkage-to-care of an Alternative Hepatitis C Screening Method in PWID

Screening, diagnosis and treatment of HCV in PWID, should be part of a harm reduction strategy. Treatment of HCV infected PWID should be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population. More frequent diagnosis, new methods that prevent loss of tracking, and access to antiviral treatment are all strategies that must be implemented jointly if the prevalence of HCV infection in our setting is to be reduced.


Eligibility Criteria:
Inclusion Criteria:

* PWID
* \>18 years of age
* Signed consent form

Exclusion Criteria:
Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119)

The aim of the study is to compare the effect of roflumilast on lung function in patients with COPD. Roflumilast will be administered orally once daily in the morning at one dose level. The study duration consists of a baseline period (4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of roflumilast.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent
* Patients with a history of chronic obstructive pulmonary disease (COPD) as defined by the GOLD criteria (2003)
* FEV1/FVC ratio (post bronchodilator) smaller or equal 70%
* FEV1 (post bronchodilator) 30-80% of predicted
* Fixed airway obstruction
* Current smoker or former smoker (smoking cessation at least one year ago) with a smoking history of at least 10 pack years
* Clinically stable COPD within 4 weeks prior to baseline visit
* Availability of a chest x-ray

Main Exclusion Criteria:

* COPD exacerbation indicated by a treatment with systemic glucocorticosteroids
* Lower respiratory tract infection
* Diagnosis of asthma
* Known alpha-1-antitrypsin deficiency
* Need for long term oxygen therapy defined as longer or equal 16 hours/day
* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
* Known infection with HIV, active hepatitis and/or liver insufficiency (according to the Child Pugh score A or worse)
* Diagnosis or history of cancer
* Clinically significant cardiopulmonary abnormalities
* Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
* Female patients of childbearing potential, not using reliable method of contraception for the entire study duration, post-menopausal \> 1 year or who are not using any other method considered sufficiently reliable by the investigator in individual cases
* Participation in another study (use of investigational product) within 30 days preceding the baseline visit or re-entry of patients already enroled in this trial
* Alcohol or drug abuse
* Inability to follow the study procedures due to e.g., language problems, physiological disorders
* Use of not allowed drugs
* Suspected hypersensitivity to the study medication or rescue medication
The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage

Anastomotic leakage (AL) is considered the commonest major complication after surgery for rectal cancer. Transanal tube drainage role in the prevention of AL is still debatable.

Patients who underwent low or ultralow anterior resection for rectal cancer were enrolled between 01/2015 and 06/2017. A de-Pezzer catheter was placed transanally after the creation of the anastomosis, secured to the buttocks, and connected to a urine bag to allow monitoring the amount and the color of the drainage. The catheter was removed on the 3rd day postoperative if the volume collected was insignificant.

Patients were followed-up on the ward and then in the outpatient's department at two weeks, and one month postoperative. Patients who were suspected to have AL underwent CT with rectal contrast to assess the integrity of the anastomosis. The primary outcome was the incidence of AL. We adopted the definition published by the International Study Group of Rectal Cancer.

Eligibility Criteria:
Inclusion Criteria:

* Low or ultralow anterior resection with primary anastomosis for biopsy-proven primary rectal cancer

Exclusion Criteria:

* No anastomosis
Age-related Conditions in the Context of Multimorbidity and Frailty: Relative Weight of Frailty in Determining the Course and Outcomes of Different Chronic Diseases and Viceversa

Observational study. Participants of the FRASNET study (9th March 2017, Protocol No. 24/INT/2017) who were evaluated in 2016 and 2017 will be contacted to be re-evaluated with multidimensional visits as part of the present study in order to assess trajectories and biomarkers of frailty and sarcopenia. Moreover, are going to evaluate with the same multidimensional visits patients with mild cognitive impairment and dementia followed up at the Neurologic Unit of the San Raffaele Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Having participated in the FRASNET study or being a patient with mild cognitive impairment or dementia followed up at the Neurologic Unit of the San Raffaele Hospital
* Ability to sign written informed consent
* \> 18 years old

Exclusion Criteria:

* Life expectancy \< 6 months
* Unwillingness to participate in the study
* Unstable clinical disease(for ex. serious acute pathologies)
Comparison of Normal Readings and Repeatability Across Skin Colors

Observational comparison study of three commercially available regional oxygen saturation devices on a wide range of skin colors.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* of any race or ethnicity
* greater than eighteen years of age
* weighs greater than or equal to 40 kilograms
* is not currently admitted to the hospital
* is not known to be pregnant
* understands English
* is willing and able to provide informed consent and comply with study procedures

Exclusion Criteria:

* is less than eighteen years of age
* weighs less than 40 kilograms
* if known to be pregnant
* is a current patient in the hospital
* does not understand English
* has known anemia
* is unwilling and able to provide informed consent and comply with study procedures
Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy

The purpose of this research is to determine whether a 16-week virtually supervised aerobic and resistance exercise program is feasible in patients receiving first-line chemotherapy after surgery for ovarian or endometrial cancer and if it will improve lower extremity function (function of the legs), lessen chemotherapy-induced peripheral neuropathy (CIPN; numbness or tingling in the hands or feet), and if there is any effect on inflammatory blood markers (the level of a certain marker in the blood that is associated with inflammation; redness and swelling).

This research study is a randomized controlled trial that will compare an exercise group to a control group on lower extremity function, CIPN, and inflammatory markers in ovarian or endometrial cancer patients undergoing first-line chemotherapy after surgery.

The names of the study interventions involved in this study are/is:

* Aerobic and resistance exercise; virtually supervised 16-week aerobic and resistance exercise performed at home via Zoom
* Attention control for 16 weeks, home-based stretching

The research study procedures include: screening for eligibility and study interventions including evaluations and follow up visits.

It is expected that about 30 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with stages III-IV ovarian or endometrial cancer
* Receiving first-line carboplatin and paclitaxel chemotherapy after surgery
* ≥18 years, children under the age of 18 will be excluded due to rarity of disease
* Physician's clearance to participate in moderate-vigorous intensity exercise
* Able to read, write, and understand English
* Ability to understand and the willingness to sign an informed consent document
* Willing to undergo two venous blood draws for the study

Exclusion Criteria:

* Pre-existing musculoskeletal, neurological, or cardiorespiratory conditions, as determined by the treating oncologist
* Participants with uncontrolled intercurrent illness, as determined by the treating oncologist
* Participants with psychiatric illness/social situations that would limit compliance with study requirements, as determined by the treating oncologist
* Participants who have received prior chemotherapy for cancer treatment (e.g. taxanes for breast cancer)
Refining the Interpretation of the Tinel's Sign for Carpal Tunnel Syndrome

This is an observational study to investigate the electromyographic (EMG) activity and nerve conduction velocity (NCV) of healthy individuals during the Tinel's Sign performed at different wrist positions. The study aims to identify the wrist position that best isolates median nerve activity during the Tinel's Sign.

The study will be conducted in a controlled laboratory setting, equipped with an electromyography (EMG) machine and a nerve conduction velocity (NCV) measurement device. We will recruit 30 healthy adults, aged 18-45 years, with no history of hand or wrist pain, neurological or muscular disorders. Participants will be excluded if they have any contraindications to EMG or NCV measurement. The independent variable will be the wrist position during the Tinel's Sign, and the dependent variables will be the EMG activity of the thenar and hypothenar muscles and the NCV of the median and ulnar nerves. EMG activity will be measured using surface electrodes placed on the thenar and hypothenar muscles. NCV will be measured using a standard NCV measurement device. To minimize bias, the same trained examiner will perform all tests and measurements, and the examiner will be blinded to the EMG and NCV data during the tests. Differences in EMG activity and NCV across different wrist positions will be analyzed using repeated measures ANOVA. Post-hoc pairwise comparisons will be performed using Bonferroni correction. The study protocol will be submitted to the local ethics committee for approval, and all participants will provide informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals aged 18-45 years
* No history of hand or wrist pain, neurological or muscular disorders

Exclusion Criteria:

* Any contraindications to EMG or NCV measurement