cyrilzakka/clinical-trials huggingface dataset:
Impact of Bedtime Routines on Sleep and Development in Toddlers

Investigators will recruit up to 100 families (children aged 12.0 to 14.9 months and their primary caregivers) at their scheduled 12-month well child care infant visit at Temple Pediatric Care. The purpose of this randomized controlled trial is to examine the impact of implementation of a bedtime routine program, Connect, Calm, \& Comfort: 3 Cs for Bedtime ZZZs, to promote better sleep and improve developmental outcomes in toddlers from primarily low-income families.

A bedtime routine is a key factor in the promotion of not only healthy sleep, but also potentially of broad development and wellbeing in early childhood. A bedtime routine, in and of itself, embodies the characteristics of nurturing care and early child stimulation especially for at-risk children. It is consistent with the Lancet Early Childhood Series Steering Committee emphasizing the need for nurturing care, which includes adequate health, nutrition, security and safety, responsive caregiving, and early learning opportunities, to help young children (ages 0-5 years) reach their full developmental potential, and to build a strong foundation for subsequent development, health, and wellbeing. Common, adaptive components of a bedtime routine can contribute to an array of positive developmental outcomes beyond improved sleep, inclusive of language development, literacy, child emotional and behavioral regulation, parent-child attachment, and family functioning, among other outcomes. Although studies have been conducted on the relationship between bedtime routines and sleep, there have been few studies looking at bedtime routines and other developmental outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Presenting to a well child visit
* Child between 12.0 to 14.9 months of age
* English-speaking
* Caregiver is legal guardian of infant
* Caregiver is primary caregiver of infant

Exclusion Criteria:

* Non-English speaking
* Absence of primary caregiver at both the 12-month and 15-month well-child visit
Prenatal Education About Reducing Labor Stress (PEARLS)

The purpose of this small randomized controlled trial (RCT) is to compare the impact of a brief (16 hour) 3rd trimester mindfulness-based childbirth education program, "Mind in Labor (MIL): Working with Pain in Childbirth," with a standard care/"treatment as usual" (TAU) active control condition of standard hospital- and community-based childbirth education. The MIL group is expected to demonstrate a reduction in fear of labor (less pain catastrophizing and greater childbirth self-efficacy), less perceived pain in labor, less use of pain medication in labor, greater birth satisfaction, and better prenatal and postpartum psychological adjustment compared to the TAU group.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* No prior full-term pregnancy or live birth prior to the current pregnancy
* In 3rd trimester of healthy, singleton pregnancy
* Willingness to be randomized
* Able to read, write, and understand spoken English
* Planned hospital birth in the San Francisco Bay Area

Exclusion Criteria:

* Current or prior formal meditation experience
* Formal yoga practice prior to pregnancy (brief prenatal yoga practice will not lead to exclusion)
* Participation in other mind/body childbirth preparation course (e.g., with hypnosis focus)
* Planned elective Cesarean birth
* Planned homebirth or other non-hospital birth setting
Effect of End-inspiratory Pause on Gas Exchange During Mediastinal Mass Excision With CO2 Insufflation and One-lung Ventilation

" Mediastinal mass excision is typically performed via video-assisted thoracoscopic surgery (VATS). To secure a clear surgical field, the ipsilateral lung must be deflated, achieved through one-lung ventilation (OLV) and intrathoracic CO₂ insufflation. However, OLV increases intrapulmonary shunt due to continued perfusion of the non-ventilated lung, potentially leading to hypoxemia and hypercapnia.

When performed in the supine position, gas exchange becomes more challenging compared to lateral decubitus due to limited gravitational redistribution of blood flow. Although CO₂ insufflation aids surgical exposure through passive lung deflation, it may also increase CVP and PCWP, reduce cardiac output, and raise PaCO₂, contributing to respiratory acidosis.

End-inspiratory pause (EIP), a ventilatory setting that pauses airflow at end-inspiration, prolongs alveolar gas exchange and improves ventilation-perfusion matching. Prior studies show EIP can enhance gas exchange, reduce microatelectasis, and improve CO₂ clearance in patients with acute lung injury. We therefore aimed to assess the effect of EIP application during VATS mediastinal mass excicion.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 20 to 80 years scheduled for video-assisted thoracoscopic mediastinal tumor resection.
* American Society of Anesthesiologists (ASA) physical status classification of II (patients with mild systemic disease) or III (patients with severe systemic disease limiting activity).

Exclusion Criteria:

* Moderate to severe chronic obstructive pulmonary disease (COPD) according to GOLD criteria: defined as FEV₁/FVC \< 0.7 and FEV₁ ≤ 80% of predicted on pulmonary function testing.
* Diffusion capacity of the lung for carbon monoxide (DLCO) \< 80% of predicted.
* History of pneumothorax or presence of bullae or blebs on preoperative imaging.
* Inability to read or understand the subject information sheet and consent form.
Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan

The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are 20 years old or over with overactive bladder
2. Total number of urinary incontinence episodes per week is 5 or over
3. Mean number of micturition per day is 8 or over
4. Mean number of urinary urgency episodes per day is 1 or over
5. Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

1. Patients with genuine stress incontinence
2. Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection
3. Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study
4. Patients suffering from complications for which anticholinergics are contraindicated
5. Other exclusion criteria as specified in the study protocol
Functional Capacity Through HRV in Multimodal Rehabilitation for Adult Surgery

This prospective, observational cohort study investigates heart rate variability (HRV) monitoring using the Analgesia Nociception Index (ANI) monitor in adult patients undergoing major surgery within a multimodal rehabilitation program. The objective is to correlate HRV indices with functional capacity, physiological reserve, and frailty during the prehabilitation phase.

The study evaluates HRV using the ANI monitor to determine adaptation to training load, optimize analgesic and anesthetic dosing, and predict postoperative complications. The HRV indices of Energy (SDNN) and ANI (HFnu) are monitored at two points: the initial pre-anesthesia consultation and one week before surgery. Results will be compared with the 6-minute walk test, MUST nutrition screening scale, and clinical frailty and FRAIL scales.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Scheduled for major adult surgery
* Any ASA classification
* Signed informed consent

Exclusion Criteria:

* Urgent surgery
* Severe cognitive impairment
* Patient refusal to participate
* Pediatric patients
* Cardiac arrhythmia or atrial fibrillation
One Year Clinical Evaluation of IPS Empress CAD Versus Polished Celtra Duo Ceramic Laminate Veneers

When restoring teeth with IPS Empress laminate veneers, fracture of restorations may occur. So, material with higher mechanical properties is required. Celtra Duo is a new material with glass ceramics infiltrated by 10% zirconia particles which increase the fracture resistance of the material.


Eligibility Criteria:
Inclusion Criteria:

All subjects are required to be:

1. From 18-50 years old, be able to read and sign the informed consent document.
2. Have no active periodontal or pulpal diseases, have teeth with good restorations
3. Psychologically and physically able to tolerate conventional dental procedures
4. Patients with teeth problems indicated for laminate veneer:

   1. Discoloration
   2. Fracture not involving more than 50% enamel loss
   3. Mild malposition
   4. Diastema
   5. Enamel fluorosis
   6. Stained or defective restorations
5. Able to return for follow-up examinations and evaluation

Exclusion Criteria:

1. Patient with post and core endodontically treated teeth
2. Patient with fractured teeth of more than 50% enamel loss
3. Patients with poor oral hygiene and motivation
4. Pregnant women's
5. Patients in the growth stage with partially erupted teeth
6. Psychiatric problems or unrealistic expectations
7. Lack of opposing dentition in the area of interest
8. Patients involved in contact sports
9. Teeth with deep discoloration
A Study of the Effect of RG1662 on Metformin in Healthy Volunteers

This single-center, non-randomized, open-label, two treatment, two period, fixed sequence crossover study will investigate the effect of RG1662 treatment on the activity of key renal transporters in healthy male and female participants using metformin. The effect of RG1662 on other renal function parameters will also be explored.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female participants, aged 18 to 60 years, inclusive
* A body mass index between 18 to 32 kg/m2, inclusive
* Informed consent and agreement to comply with study restrictions

Exclusion Criteria:

* A history of epilepsy, convulsions or significant head injury
* Significant history of drug allergy or a known hypersensitivity to any of the ingredients of any of the study treatments
* Pregnant or lactating
* Impaired renal function or clinically relevant hematuria
* A history of lactic acidosis, or risk factors for lactic acidosis
* Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
Remote Ischemic Preconditioning on Brain Injury in Carotid Endarterectomy

This is a randomized controlled trial designed to test an intervention (Remote ischemic preconditioning) in patients undergoing carotid endarterectomy (CEA).Remote ischemic preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.The purpose of this study is to evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury in patients undergoing carotid endarterectomy compared to control intervention.The outcomes of interest include neurocognitive function,clinical outcomes,and biomarkers of brain injury.

Remote ischemic preconditioning (RIPC) protocol will be induced during anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood pressure cuff inflated to a pressure 200mmHg

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing carotid endarterectomy
* Patients aged 55 years to 80 years

Exclusion Criteria:

* Inability to give informed consent
* Known Deep venous thrombosis (DVT) in arm
* Pre-existing lymphedema or axillary node dissection both arms
* Arteriovenous fistula or graft in both arms
* Left ventricular ejection fraction less than 50%
* Diagnosis of dementia, intellectual disability, or mental illness including depression, anxiety, or schizophrenia
Single Nucleotide Polymorphism (SNP) Panels and Risk Assessment in Women Undergoing Mammography

The primary objective is to compare the predicted lifetime risk values produced by SNP panel assessment to the risk values produced by the prediction models that are most commonly used. A second objective is to examine whether the incorporation of risk assessment panels (standard or SNP based) can improve the positive value of breast biopsies in women with BIRADS 4 mammograms.

Calculating the risk that a woman will develop breast cancer in her lifetime can lead to decreased mortality rates as a result of increased screening and prevention methods when a person is known to be at high risk. Though there are several risk assessment models that are commonly used, it is important to continue to improve the process of calculating risk. Several genetic markers have been noted to potentially indicate risk of developing breast cancer. New tests, called SNP panels, can detect some of these genetic markers. This study aims to use both these SNP panels and the commonly used risk models to calculate risk and examine outcomes in women coming in to do screening mammography. This study will enroll women between the ages of 40-65 who are undergoing screening mammography (n=1000), in addition to women with BIRADS category 4 mammogram readings who are about to undergo biopsy (n=600), all with no personal history of breast or ovarian cancer, ductal carcinoma in situ (DCIS), mantle radiation, or known BRCA 1/2/mutation in self or family members. The participants will only be expected rto provide consent, swabs of the inside of the cheek of her mouth, and baseline questionnaire answers that will allow for a risk assessment to be performed.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 40 and 65 years old undergoing screening mammography at the University of Pennsylvania Health System and women undergoing biopsy as the result of a BIRADS category 4 mammogram result.

Exclusion Criteria:

* Women will be excluded if they have a personal history of breast or ovarian cancer, DCIS, or mantle radiation, or known BRCA 1/2 mutation in self or in family members.
* In addition, women younger than 40 or older than 65 will be excluded if they are in the screening mammography population of potential participants.
Bone Health in Facioscapulohumeral Muscular Dystrophy

This is a cross-sectional single visit study to determine bone health in individuals with FSHD.

Bone health will be assessed using 1) a DEXA scan to measure bone mineral density and lean body mass, and 2) blood tests of biomarkers of bone resorption and formation. These procedures will be correlated to measures of muscle strength testing and timed function tests to determine fracture risk in FSHD individuals considering age, gender, muscle strength and FSHD allele size.

Eligibility Criteria:
Inclusion Criteria:

* Genetic diagnosis of FSHD including chromosome 4 deletion and haplotype
* Age \> 18 years
* Ability to provide written informed consent for participation in the study
* Ability to participate in the DEXA scan

Exclusion Criteria:

* Unwillingness or inability to comply with the requirements of this protocol (in the opinion of the PI) including, but not limited to, the presence of any condition (physical, mental or social) that precludes the participant from comfortably and safely obtaining a DEXA scan, phlebotomy, or neurological examination
Lymphadenectomy in NSCLC With and Without Adjuvant Therapy

Adjuvant therapy in patients affected by NSCLC is indicated in surgically treated cases of N2 disease, while the actual guidelines reported the possibility of a case-by-case decision in case of N1 involvement.

On the other hand, the actual categorization of patients based on the hilar or mediastinal involvement (N1 or N2) risks to be too ineffective and straightforward for prognosis prediction and an indication of adjuvant treatments. This issue was underlined in the 8th TNM proposal for the N sub-classification, with a final proposal of different subgroups based on the number of involved stations. However, the IASLC committee noted that this proposal presented some limits due overlapping or not statistical significance among some survival curves, so the proposal was not adopted in the staging system. Moreover, the committee stated that the lack of information regarding some data such as the number of the resected or the metastatic nodes might affect the results and limited other proposals.

The objectives of this study are:

* To evaluate the prognostic role of the kind of lymphadenectomy, the number of the resected and/or metastatic lymph nodes in surgically treated N positive patients in terms of survival.
* To evaluate the indication and the role of adjuvant treatments in these patients.
* To identify patients with increased risk of early recurrence or poor survival based on the lymph node involvement characteristics In particular, data will be collect in a prospective database including clinical and pathological data, kind of lymphadenectomy, number of resected nodes, number of metastatic nodes, kind and schedule of adjuvant therapy and follow-up status


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age \>18 years
* Non-Small Cell Lung Cancer Histology
* Anatomical lung resection (segmentectomy, lobectomy or bilobectomy, pneumonectomy)
* Pre-operative CT and PET evaluation
* Preoperative and postoperative tumour board discussion
* Intraoperative lymph node assessment (minimum 3 mediastinal stations harvested)
* Lymph node metastases

Exclusion Criteria:

* AGE \< 18 years
* Pregnancy
* Psychiatric disease
* Wedge resection
* Distant metastases
Conservative Treatment of Ingrown Toenail

Ingrown toenail has become one of the most prevalent onychopathies and a frequent reason for consultation in podiatry clinics. In the initial stages of the pathology, conservative treatments are the first choice of therapy. The aim was therefore, to analyze and compare the efficacy of the technique of nail re-education with gauze bandage and nail remodelling for the conservative treatment of onychocryptosis in stage I and IIA, A prospective, longitudinal, randomised clinical trial-type analytical study is proposed. A sample of 20 subjects with stage I and IIA onychocryptosis will be selected. Of these, 10 cases were part of the gauze bandage nail re-education group and the remaining 10 cases were part of the nail remodelling group.


Eligibility Criteria:
Inclusion Criteria:

* Ingrown toenail in stage I or IIa (Mozena Classification)

Exclusion Criteria:

* Patients not allowed for clinical follow-up of the evolution of the pathology.
* Patients presented with deforming pathologies
* Pattens had been surgically operated for ingrown toenail
Exogenous Glucose Oxidation Breath Test

The purpose of this study is to determine if oxidation of 13C glucose to 13CO2 is changed in type 2 diabetic patients.

Recruitment

- Non diabetic participants will be recruited from within the National University of Ireland, Galway student and staff community. Diabetic patients will be recruited from University College Hospital, Galway in collaboration with their hospital consultant.

Test- day

- They will undergo two separate, identical and simultaneous Oral Glucose Tolerance test and 13C-glucose breath tests on two separate occasions after an overnight fast of 12 hours starting at 8pm. On arrival their heart rate, blood pressure, height and weight will be recorded. Following a resting period of 10 minutes, samples will be obtained for fasting glucose and breath enrichment values (at t = -20 and -10mins). At t = 0 min, participants will consume a standard glucose solution. This glucose solution will consist of 150mg of 13C-glucose, 74.85g of glucose and 200ml of water and 25ml of orange flavoring. Breath samples will be obtained immediately after consumption of test solution and repeated every 15 min over a 4-h interval. Blood glucose concentrations will be taken every 15 min starting at t = 15 min, over a 2-h interval and every 30 min for another 2-h interval. Participants will remain at rest throughout the study.

Sample size assessment

- Target recruitment is 40 non-diabetics and 40 diabetic participants. This study will use a Student's t-test to determine difference, or otherwise, in glucose oxidation in breath 13CO2, in 2 different groups of individuals. With power arbitrarily set at 0.8, effect size of 1.21 reduction in breath, and Alpha set at 0.01 a final number of 35 participants is required for each group. The n=40 for each group is set to allow a 5 participant drop out in each group Dillon et al (2009).

Eligibility Criteria:
Inclusion Criteria:

* All research participants must be between 18 and 65 years
* Non-diabetic participants must not be taking any medication for diabetes
* Participants must speak English or Irish proficiently
* All participants must be males
* All participants must live within Galway City
* Type 2 diabetic participants must have been diagnosed within the last five years
* Type 2 diabetic participants must be treated by Metformin alone for their diabetes
* All participants must provide written informed consent to comply with every aspect of the study

Exclusion Criteria:

* Females
A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate

The purpose of this trial is to study the clinical safety, tolerability, and efficacy of zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women between 45 and 79 years of age
* Must be osteopenic/osteoporotic

Exclusion Criteria:

* Any women of child-bearing potential

Other protocol-defined inclusion/exclusion criteria may apply.
CardioVascular Disease Progression and Prognosis in COVID-19

The CVP-COVID19 registry is both a retrospective and prospective study design in order to identify predictors of cardiovascular disease progression and mortality for COVID-19. The registry enrolls consecutive patients with positive microbiological tests for SARS-CoV-2 admitted to an academic hospital in northern Italy for worsening of COVID-19 symptoms. The study does not test any new diagnostic or therapeutic approach. Patients are treated according to good clinical practice. Patients characteristics, including medical history (with particular attention to cardiovascular and pneumological risk factors), features of physical examination, results laboratory and radiological tests and treatments (pre- and in-hospital) are related with patient outcome. Logistic analysis (univariate, multivariate and propensity) are performed in order to identify factors associated with disease progression. Primary endpoint: mortality.

Members of the Steering Committee:

Olivia Manfrini (Università di Bologna, Italy) Raffaele Bugiardini (Università di Bologna, Italy) Stefano Nava (Università di Bologna, Italy) Elisabetta Poluzzi (Università di Bologna, Italy) Maria Carla Re (Università di Bologna, Italy) Caterina Vocale (Policlinico Sant'Orsola) Study Coordinator: Edina Cenko (Università di Bologna, Italy)

Eligibility Criteria:
Inclusion Criteria:

hospitalization for COVID-19

Exclusion Criteria:

age \<18 years