cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain

The purpose of this study is to see if pelvic girdle pain can be more effectively treated with the use of injectable anti-inflammatory medication plus physical therapy compared with physical therapy and a saline injection.

Pelvic girdle pain (PGP) in pregnancy is common with prevalence estimates of 45%.1 It is defined as pain experienced between the posterior iliac crest and the gluteal fold, particularly in the region of the sacroiliac joint.2 Pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the symphysis. In PGP, the endurance capacity for standing, walking and sitting is diminished. The diagnosis of PGP can be reached after exclusion of lumbar causes and must be reproducible by specific clinical tests. While various pain mechanisms including mechanical, hormonal, inflammatory, and neural have been proposed in the development of PGP, the etiology and pathogenesis is poorly understood. It is possible that musculoskeletal changes influenced by hormonal (Relaxin) elevation in pregnancy predispose pregnant women to acute musculoskeletal injury presenting clinically as PGP. An inflammatory response in other acute musculoskeletal injuries has been well described3 and may also occur in pregnancy related PGP particularly given the musculoskeletal vulnerability during this time. Though PGP is common in pregnancy, no study to date has investigated the efficacy of anti-inflammatory treatment in pregnancy related PGP in order to better establish the contribution of inflammation in the etiology of pregnancy related PGP.

Eligibility Criteria:
Inclusion Criteria:

* Women who are not doing other therapies for pain (physical therapy, chiropractic management, pool)
* Women between age 21 and 50 who plan to deliver at Loyola or Gottlieb
* Pain Numeric Rating Scale (NRS) on average of greater than or equal to 5/10 at Visit 1
* Pain must be between the upper level of the iliac crests and the gluteal folds in conjunction with or separately from pain in the pubic symphysis and influenced by position and locomotion
* 2/4 positive physical examination tests on the symptomatic side including the P4 test, the LDL test, pubic symphysis palpation and the acute straight leg rise (ASLR)

Exclusion Criteria:

* Women presenting with PGP in the first or third trimester (\<13 weeks gestation or \>28 weeks gestation)
* Women with pubic symphysis (anterior) pain alone
* Women who do not plan to deliver a baby at Loyola or Gottlieb
* Pain above the upper level of the iliac crest
* History of lumbar or pelvic fracture, neoplasm, inflammatory disease, active urogenital infection or active gastrointestinal illness, current physical therapy or other therapies for PGP, or previous surgery of the lumbar spine, pelvic girdle, hip joint or femur
* History or signs of radiculopathy or other systemic neurologic disease
* Women with diabetes or gestational diabetes
Inhaled Lavender Applied at Hemodialysis Patients and Effect on Pain, Comfort, and Anxiety

The procedure of puncturing during needle insertion and moving needles within the tissues, the insertion angle, diameter of needles, and insertion techniques all lead the patient to experience pain. However, patients tolerate needle insertion more easily when the pain is managed well. Therefore, pharmacological and non-pharmacological methods are needed in pain control in order to improve comfort when undergoing hemodialysis (HD), and to facilitate patient's compliance to treatment over a longer period. Being one of the non-pharmacological practices, aromatherapy is a part of phototherapy, which means "therapy with plants" and also aims to manage symptoms such as pain as well as the treatment itself.

Experience of the arteriovenous fistula puncture-related pain can have unpleasant effects on the patients, it causes that hemodialysis patients experience more disability, depression, irritability, and insomnia than other patients in adapting to stress. Experiencing continued pain can also affect the level of hemodialysis acceptance in patients and ultimately decrease quality of life. Therefore, pain control is an important priority in these patients. In this regard, in various studies, different pharmacological and non-pharmacological approaches have been used to alleviate the pain.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* On maintenance hemodialysis three times per week for four hours per session
* Receiving hemodialysis therapy for a least six moths at the time of the study
* Having the ability to smell
* Able to communicate in Turkish
* Willing to participate to the study

Exclusion Criteria:

* 18 years of age younger
* Absence of psychiatric disorders that cause cognitive dysfunction, such as Alzheimer's disease or chronic psychosis
* Pregnant women, patients with a history of allergies, respiratory diseases, neuropathy and peripheral vascular diseases
* Administered with painkillers in the past 3 hours
* Having infection at the fistula area
* Requiring more than one attempt for fistula puncturing
* Unwilling to to participate to the study
Assessment of Pruritus Improvement With Pimecrolimus Treatment on the Areas Affected by Mild-to-moderate AD, in Patients 2- to 11- Year-old

The purpose of this study is to assess the efficacy and safety of pimecrolimus cream 1% in relation to the improvement of pruritus in pediatric patients (2- to 11- year-old) with mild to moderate atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female.
* Age: between 2 - 12 years.
* Outpatients with diagnosis of atopic dermatitis
* Atopic dermatitis affecting ≥ 5% of Total Body Surface Area at Baseline Investigator's Global Assessment score of 2 (mild) or 3 (moderate).
* Baseline visit pruritus (itching) severity assessment score of 2 (moderate) or 3 (severe).
* Patients or patient's legal guardian who has been informed of the study procedures and has signed the informed consent form approved for the study prior to starting any study related procedures, including washout (in case that it would be necessary).

Exclusion Criteria:

* Patients being breast-fed by women receiving systemic or prohibited medication.
* Children with known hypersensitivity to study medication.
* Children who received phototherapy or systemic therapy (immunosuppressants, cytostatics) known to affect atopic dermatitis within the previous month or topical therapy (tar, topical corticosteroids), systemic corticosteroids, systemic antibiotics or leukotriene antagonists within the previous week.
* Children who received investigational drugs within 8 weeks prior to first application of study medication.
* Children who had concurrent skin disease or active bacterial, viral or fungal infection.
* Immunocompromised children (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or children with a history of malignant disease.

Other protocol-defined inclusion/exclusion criteria may apply.
Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients

Thi is an observational, non interventional, cohort analysis by using administrative databases (drugs treatment, laboratory and diagnostic tests, specialist visits and hospitalizations) of Sicilia region to evaluate treatment patterns of patients after Acute Coronary Syndrome (ACS) event.

HEALTH-DB ACS

Eligibility Criteria:
Inclusion Criteria:

* Subjects discharged alive from hospitalization for ACS

Exclusion Criteria:

* All patients that don't have a continuative presence as beneficiaries of the region between January 1st, 2007 and December 31st 2011 will be excluded from analysis.
Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops

Aim of this prospective study is to assess the pathophysiology of Takotsubo Syndrome by obtaining pressure volume loops with conductance catheters, which allows detailed conclusions regarding systolic and diastolic hemondynamics and subsequently regarding potential underlying mechanisms


Eligibility Criteria:
Inclusion Criteria:

* Confirmed Takotsubo syndrome according to current diagnostic criteria including complete normalization of left ventricular function during follow-up
* Sinus rhythm during invasive measurements
* Age ≥18 years
* Written informed consent

Exclusion Criteria:

* Cardiogenic shock
* Signs of myocarditis or myocardial infarction with spontaneous lysis of thrombus in cardiac magnetic resonance imaging
* Pregnancy
* Participation in another trial
Brief Behavioral Insomnia Treatment Study

The purpose of this study is to determine whether a brief, behavioral treatment for insomnia is effective in addressing social and occupational functioning and overall health among Veterans with insomnia disorder.

This study is a randomized, controlled trial of a telephone-based, brief insomnia treatment in primary care in order to accomplish the goal of improving psychosocial functioning in Veterans who meet criteria for Insomnia Disorder. The primary outcome for the trial will be psychosocial functioning, with insomnia severity serving as the secondary outcome. Additional goals include evaluating durability of treatment gains and obtaining feedback from participants about the utility and feasibility of the proposed insomnia treatment.

Eligibility Criteria:
Inclusion Criteria:

* Veterans between the ages of 18-75 years.
* Meet DSM-5 Criteria for Insomnia Disorder.
* Able attend in-person appointments at the San Francisco VA Medical Center
* The investigators will not exclude individuals who are taking insomnia or antidepressant medications, provided they have been stable on these medications for at least one month and still meet criteria for Insomnia Disorder as described above.

  * Specifically, individuals receiving benzodiazepine or benzodiazepine receptor agonists, anticonvulsants, atypical antipsychotic medication, or non-SSRI antidepressant medications such as trazodone will not be excluded provided they meet the criteria described above.
* The investigators will not exclude Veterans receiving any type of psychotherapy, provided they have received this treatment for at least three months and do not plan to discontinue this treatment during the BBTI trial.

  * However, individual who need to start a new type of psychotherapy during the course of the treatment will be excluded, or they will need to wait three months in order to enroll in the trial.
* The investigators will not exclude individuals with TBI.
* The investigators will not exclude individuals with chronic pain.
* The investigators will not exclude individuals based on any other mental health condition, including posttraumatic stress disorder and depression.

Exclusion Criteria:

* Conditions that may be associated with comorbid insomnia, including a lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, and alcohol or drug dependence within the past year.
* Individuals who meet criteria for alcohol or drug abuse will be asked to reduce alcohol to recommended limits during the course of the study and/or refrain from drug use in order to be included.
* Veterans with suicidal or homicidal ideation.
* Veterans who are pregnant, due to the biological impact of pregnancy on sleep.
* Veterans who work night or rotating shifts.
* Veterans with untreated moderate to severe sleep apnea (those receiving treatment will not be excluded from the study).
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function

The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.


Eligibility Criteria:
Key Inclusion Criteria:

Cohort 1:

* Individuals with mildly impaired and normal hepatic function.
* Individuals with mild hepatic impairment must have a score of 5-6 on the Child-Pugh-Turcotte (CPT) classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Cohort 2:

* Individuals with moderately impaired and normal hepatic function.
* Individuals with moderate hepatic impairment must have a score of 7-9 on the CPT classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Cohort 3:

* Individuals with severely impaired and normal hepatic function.
* Individuals with severe hepatic impairment must have a score of 10-15 on the CPT classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
The Effect of Experimentally Decreasing Sedentary Behaviour on Subjective Well-being

This study will explore the causality between outcomes of subjective well-being and sedentary behavior, through experimentally decreasing the sedentary behavior levels of university students. Half of the eligible participants will receive a behavioral counseling intervention to increase non-sedentary behavior over one week, while the other half will receive no instructions. After one week, all participants will receive no instructions and continue to wear the inclinometer for another week.

The relationship between subjective well-being (SWB) and sedentary behavior (SB) has been briefly explored. However, the causality of the relationship (i.e., do higher levels of SB cause changes in SWB, or vice-versa) has not been fully examined. Experimentally decreasing SB and observing the potential subsequent effect on SWB may help to determine the causation between SB and SWB.

A sedentary sample of full-time university students attending Western University will be recruited. Upon obtaining consent, demographics will be taken. Sedentary behavior will be confirmed objectively through inclinometer wear for 1-week. Upon confirmation of sufficient sedentary time, participants will complete questionnaires assessing past-week: SWB, SB, physical activity, depression, and anxiety questionnaires. Participants will also be randomized to either a behavioral counseling intervention group, or a no-contact control group. Participants will then continue wearing the inclinometer for 1 week. After the intervention week, participants will complete the questionnaires again, after which all participants will be told to continue daily behavior, and wear the inclinometer for another week. Upon completion of this follow-up week, participants will complete questionnaires again.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Full-time student attending Western University
* Able to read and write in English
* Objectively report ≥7 hours of average daily sedentary time, via ActivPAL4 inclinometer

Exclusion Criteria:

* Self-reporting a mental illness
* Currently having a physical disability that would prevent walking
Adherence to CPAP in Patients With OSA. Ten Year Follow up

The management of OSA is aimed to improve symptoms and mitigate reduce other health consequences. Continuous Positive Airway Pressure (CPAP) is the recognized treatment for OSA, able to reverse the pathophysiology of OSA and improving sleep continuity, resulting in improvements in daytime sleepiness and quality of life (QoL). However, low adherence to this treatment reduces the potential to achieve these benefits. The aim of this real life retrospective observational study was to assess the adherence to CPAP at 12 month and 10 years. The investigators evaluated also predicitve factors of adherence.

Methods The protocol was approved (2215 CE, June, 19, 2018) by the Ethical Committee of the Istituti Clinici Scientifici (ICS) Maugeri, Pavia, Italy. All patients at admission to the Scientific Institute of Tradate gave the informed consent to the scientific use of their data.

Study Participants This study was conducted on a database of patients' discharge records, available between August, 2006 and December, 2009.

Adaptation to CPAP: titration of CPAP was performed either by full-night manual titration according to the AASM Guidelines or by automatic titration with Auto-Set systems. Further 4 day-time hours of adaptation were performed along two days. Patients underwent also four face to face sessions with the respiratory therapist, for feed-back of adaptation, optimal comprehension of procedure of CPAP management. The presence of a caregiver (if any) was strongly suggested.

Statistical Analysis An ad hoc electronic form was created to collect all study variables. Qualitative variables were described with absolute and relative (percentages) frequencies, whereas quantitative variables were summarized with means (standard deviations) or medians (interquartile ranges) based on their normal distribution, respectively.

In-between comparison for qualitative and quantitative variables was performed with the chi-squared or Fisher exact test when appropriate, and Student t or Mann-Whitney test in case of parametric or non-parametric distribution, respectively. Comparison of the temporal variation of continuous variables for the same group was assessed with Anova or Friedman's test, depending on their normal distribution.

Uni- and multi-variable logistic regression analysis was performed to assess which covariates could be associated with the adherence to CPAP.

A two-tailed p-value \<0.05 was considered significant. All statistical analyses were carried out using the statistical software STATA version 15 (StatsCorp, Texas).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of OSA
* admitted for adaptation to CPAP

Exclusion Criteria:

* other sleep related diseases
* concomitant lung or thoracic diseases (including chronic respiratory failure requiring long term oxygen therapy)
* major comorbidities (e.g. psychiatric conditions, cancer, end-stage renal failure)
* familiar conditions preventing long-term home CPAP
* patients already treated with CPAP
Impact of Surgical Position on Stone-Free Rates in Retrograde Intrarenal Surgery

The goal of this clinical trial is to determine whether the surgical position during retrograde intrarenal surgery (RIRS) affects stone-free rates in adults with kidney stones. The main questions it aims to answer are:

* Does the modified lithotomy position result in a higher stone-free rate compared to the standard lithotomy position?
* Are there differences in complication rates between the two surgical positions?

Researchers will compare patients undergoing RIRS in the standard lithotomy position to those in the modified lithotomy position (30-degree Trendelenburg with elevated surgical side) to assess its impact on stone clearance and surgical outcomes.

Participants will:

* Be randomly assigned to one of two surgical positions
* Undergo RIRS with standard surgical procedures
* Have follow-up imaging to assess stone clearance after surgery

This study aims to improve surgical techniques and patient outcomes in kidney stone treatment.


Eligibility Criteria:
Inclusion Criteria:

* Presence of single or multiple kidney stones, with the largest stone ≤2 cm
* Age ≥18 years
* Provided written informed consent to participate in the study
* Indicated for retrograde intrarenal surgery (RIRS) as a treatment approach

Exclusion Criteria:

* Severe cardiovascular disease (e.g., heart failure)
* Congenital kidney anomalies (e.g., horseshoe kidney, ectopic kidney)
* Concurrent ureteral stones
* Pregnancy or planning pregnancy
* History of previous kidney surgery on the same side
* Active urinary tract infection (UTI)
* Coagulopathy or use of anticoagulant therapy that cannot be stopped before surgery
Treatment of Elevated Arterial Pulmonary Pressure With Inhaled Iloprost

The purpose of this study is to determine if iloprost is effective in the treatment of elevated arterial pulmonary pressure in children with ventilator treated respiratory distress syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Elevated arterial pulmonary pressure
* GA \> 24 GW
* 24-48 hours of age
* Ventilator treatment

Exclusion Criteria:

* Congenital anomalies
* Severe hypotension
Social Convoy Palliative Care (Convoy-Pal) Mobile Health for Older Adults

The aim of this study is to test the feasibility and usability of the Convoy-Pal mobile intervention among older adults. The study is a pilot waitlist control RCT with 40 patients and their convoys randomized to one of two arms: Convoy-Pal intervention or waitlist control. Feasibility will be assessed by recruitment, attrition, and data collection on measures of quality of life and social support. Usability will be captured by self-report usability scales and actual back end utilization data.


Eligibility Criteria:
Inclusion Criteria:

* ≥65 years of age
* self-report diagnosis of heart failure (HF)
* have multiple chronic conditions (MCC) based on the Disease Burden/Morbidity Assessment by Self-Report (Individuals will be eligible if they self-report the number of diagnosis \> 2 and a disease burden score \>2 indicating the presence of at least two chronic conditions that limit activities of daily of living)
* community dwelling in the United States
* English speaking

Exclusion Criteria:

* Self-reported diagnosis of Alzheimer's disease or dementia
* Self-reported diagnosis of a severe mental health problem (e.g. schizophrenia, bipolar affective disorder or other psychotic illness)
* Participation in community-based palliative care in the last 12 months
Gastrointestinal Tolerability of a Partially Hydrolyzed Ready-to-feed Infant Formula in Healthy Newborns

Gastrointestinal tolerability of a partially hydrolyzed, whey-based, ready-to-feed infant formula in healthy newborns during the birth hospitalization period: a post-market study


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent has been obtained from both parents or a legally acceptable representative (LAR).
* Full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2500 g and ≤ 4500 g.
* Parent(s) must have independently elected, before enrollment, to formula feed.
* Infant age ≤ 24 hours after birth.
* Child's parents / LAR are of legal age of consent, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol.

Exclusion Criteria:

* Infant is exclusively breastfed.
* Evidence of significant cardiac, respiratory, endocrine, hematologic, gastrointestinal, or other systemic diseases, infections, or disorders.
* Infant has other condition that, in the judgement of the investigator, would make the infant inappropriate for entry into the study.
* Conditions that require infant feedings other than those specified in the protocol.
* Infant is currently participating in another interventional clinical trial that impacts study outcomes.