cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of an ACT-Based Cognitive Intervention on Quality of Life and Cognitive Function in Elderly Residents With MCI

This study investigates the effects of an Acceptance and Commitment Therapy (ACT)-based cognitive intervention on Quality of Life (QOL) and cognitive function among elderly residents with Mild Cognitive Impairment (MCI) in long-term care settings. The study assesses immediate and long-term impacts on cognitive function, psychological flexibility, social engagement, and overall well-being through structured ACT-based training.

This clinical trial explores the impact of an Acceptance and Commitment Therapy (ACT)-based cognitive intervention on Quality of Life (QOL) and cognitive function in elderly residents with Mild Cognitive Impairment (MCI) living in long-term care facilities. The intervention aims to promote psychological flexibility, which is a core process in ACT, and enhance the residents' ability to engage in meaningful activities despite cognitive limitations.

Participants will engage in structured ACT-based training sessions that include mindfulness exercises, values clarification, and commitment strategies designed to improve cognitive engagement, reduce emotional distress, and foster greater social connection. The study measures both the immediate effects following the intervention and the long-term benefits at follow-up periods to evaluate sustained improvements in cognitive performance, psychological resilience, social involvement, and overall well-being.

By focusing on cognitive and emotional strategies, the intervention seeks to empower elderly residents to live more fulfilling and value-driven lives, even in the face of cognitive decline associated with MCI.

Eligibility Criteria:
Inclusion Criteria:

* Residents aged 65 and older diagnosed with MCI, able to provide informed consent, and residing in participating long-term care facilities.

Exclusion Criteria:

* Individuals with severe cognitive impairment, unstable medical conditions, or psychiatric diagnoses that would interfere with participation.
Double-blind Sitagliptin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Ipragliflozin (MK-0431J-842)

This is a study to assess the safety and efficacy of the addition of sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on ipragliflozin, diet, and exercise therapy. The primary hypothesis of the study is that the addition of sitagliptin once daily compared with placebo provides greater reduction in hemoglobin A1C (HbA1c) as assessed by change from baseline (Week 0) to Week 24.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Inadequate glycemic control on diet/exercise therapy and ipragliflozin monotherapy
* HbA1c ≥7.0% and ≤10.0% before study start

Exclusion Criteria:

* History of type 1 diabetes mellitus or a history of ketoacidosis
* History of any of the following medications: thiazolidinediones (TZD) and/or insulin within 12 weeks prior to study participation, sitagliptin within 8 weeks prior to study participation.
* Currently has a urinary tract infection or genital infection with subjective symptom
Supplemental Nursing System Compared to Bottle Supplementation

This is a randomized controlled trial comparing the SNS to bottle feeding. This study will compare exclusive breastfeeding rates and breast milk feeding rates at discharge, day of life 14, and day of life 28 between neonates hospitalized in the NICU for hyperbilirubinemia between those who receive supplementation by the (SNS) or those who receive supplementation by bottle. Additionally, this study will evaluate mothers' experiences while using the SNS. We hypothesize mothers who utilize the SNS will have higher rates of breast milk feeding compared to mothers who supplement by bottle.

Supplemental feedings in the neonatal intensive care unit (NICU) are common due to the separation of mother and neonate and/or complex medical issues that make direct breastfeeding difficult. The Supplemental Nursing System (SNS) is utilized infrequently in the NICU and there is little data available to compare breastfeeding outcomes of mothers who supplement by bottle compared to SNS. The aims of this study are to understand whether supplementation by SNS improves breastfeeding outcomes compared to neonates supplemented by bottle. From December 1, 2018 - November 30, 2019 there were 195 neonates admitted to Children's Hospital Colorado (CHCO) with a primary diagnosis of hyperbilirubinemia who were born at 37 weeks or greater. This makes up approximately 13.7% of all admissions during that time frame. This is a population of mothers at risk for cessation of exclusive breastfeeding due to the necessity of supplementation. These neonates are frequently supplemented because the mother's milk typically is not yet in to support adequate nutritional intake. These neonates are not often medically complex or have any factors that would bias the results of this study.

Eligibility Criteria:
Inclusion Criteria:

* Neonate inclusion criteria: physician diagnosis of hyperbilirubinemia, otherwise healthy term neonates (gestational age 38 weeks +), appropriate size for gestation, and good latch to mother's nipple, with some consistent suckling behavior per standard assessment.

Maternal inclusion criteria: English or Spanish Speaking (with the use of medical interpreter), 18 years of age or greater, desire to exclusively breast milk feed, and must be available at the bedside for all feeding sessions during hospitalization.

Exclusion Criteria:

* Neonate exclusion criteria: Breast milk jaundice, and any condition that prevents the neonate from breastfeeding efficiently including anatomical abnormalities (cleft lip, cleft palate), neurological impairment, symptomatic hypoglycemia, newly diagnosed infections, cardiac anomalies, and intravenous fluid hydration.

Maternal exclusion criteria: Retained placenta, history of breast reduction surgery or breast radiation, physician diagnosed Sheehan's Syndrome, known hypoplastic breast tissue with a low supply after previous deliveries.
Gemcitabine and Cisplatin in Treating Patients With Metastatic or Recurrent Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of gemcitabine and cisplatin in treating patients who have metastatic or recurrent solid tumors.

OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of gemcitabine and cisplatin in patients with metastatic or recurrent nonhematologic malignancies.

OUTLINE: This is a dose escalation study of gemcitabine. Patients receive gemcitabine IV on days 1 and 8, followed immediately by cisplatin IV over 2 hours on day 8. Courses repeat every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-5 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience dose limiting toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for this study within 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or recurrent nonhematologic malignancy that is not amenable to or has failed standard therapy Measurable or evaluable disease No uncontrolled brain metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Pulmonary: No respiratory failure Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection or other concurrent severe medical illness that would interfere with compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered No prior cisplatin or gemcitabine Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified
Integrated Molecular and Clinical Profiling to Optimize Outcome Prediction in Splenic Marginal Zone Lymphoma

The study aims at developing and validating an integrated clinico-molecular model for an accurate survival prognostication in newly diagnosed SMZL.

Already existing and coded tumor biological material and health-related personal data will be retrospectively collected. Mutation analysis will be performed by targeted deep next generation sequencing of tumor genomic DNA. Deletion of 7q will be assessed by FISH on nuclei isolated from tumor tissues. Immunoglobulin gene rearrangement and mutation status will be analyzed on tumor genomic DNA by PCR and Sanger sequencing. The methylation status of target genes will be assessed by methylation specific PCR on tumor genomic DNA.

The adjusted association between exposure variables and OS will be estimated by Cox regression. This approach will provide the covariates independently associated with OS that will be utilized in the development of a hierarchical molecular model to predict OS. The hierarchical order of relevance in predicting OS among covariates will be established by recursive partitioning analysis. An amalgamation algorithm will be used to merge terminal nodes showing homogenous OS. The discrimination capacity of the model will be assessed by calculating the c-index. Relative survival analysis will be used to provide a measure of the excess mortality experienced by patient's subgroups stratified according to the developed hierarchical molecular models, irrespective of whether the excess mortality is directly or indirectly attributable to the disease. The model developed in the training set will be tested in the validation sets and the model performance (c-index) in the validation set will be compared with that in the training set.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults 18 years or older
* Diagnosis of SMZL on spleen histology before Dec 31st 2010 (to provide the cohort with a minimum follow-up of at least 5 years)
* Availability of tumor material (from spleen, peripheral blood or bone marrow) collected before initiation of medical therapy
* Availability of the baseline and follow-up annotations

Exclusion Criteria:

* Having received any medical therapy including anti CD20 monoclonal antibody, chemotherapy or biological agents before splenectomy
The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia

This research is being done to try to improve the experience of mothers and babies during therapeutic hypothermia. Currently, mothers are not able to hold their baby during hypothermia treatment. Mothers have reported that not being able to hold their baby during this time is stressful. Additionally, it is known that holding has many benefits for mothers' and babies' psychological and physical health.

Therapeutic hypothermia is the standard of care. The experimental interventions of this study are to have mothers hold their babies during this treatment, collect saliva samples from mothers and babies, and test the saliva samples for the hormones cortisol and oxytocin. The investigators will test saliva of infants and their mothers before and after holding. The investigators hope to demonstrate decreased cortisol, a marker for stress, and increased oxytocin, a marker for bonding, in infants and mothers while they are held during therapeutic hypothermia.

The inability to hold an infant being treated with therapeutic hypothermia in the neonatal intensive care unit has been subjectively reported by ours and other research groups as a significant source of stress for parents. The investigators aim to assess the impact of holding on endocrinological markers of stress and bonding. Specifically, the investigators plan to collect salivary cortisol and oxytocin levels from infants undergoing therapeutic hypothermia and their mothers prior to and immediately after a 30-minute holding period.

The investigators hypothesize that measurable increases in salivary oxytocin levels, coinciding with the reported qualitative increased levels of bonding, will be observed after the holding period. The investigators anticipate the reported stress reduction after holding to be quantified by measurable decreases in salivary cortisol levels. The investigators hypothesize these hormone changes will be present in both the mother and the infant when compared to samples taken without the holding intervention.

Eligibility Criteria:
Inclusion Criteria:

* gestational age at birth of 35 weeks or greater
* absence of clinical or electrographic seizures during the first 24 hours of therapeutic hypothermia
* designation as "clinically stable" by the attending neonatologist on service
* respiratory status of: room air, nasal cannula, continuous positive airway pressure or intubated on conventional ventilator

Exclusion Criteria:

* designation as "clinically unstable" by the a member of the medical team
* use of inhaled nitric oxide for persistent pulmonary hypertension of the newborn
* high frequency oscillator ventilation
* presence of electrographic seizures
* use of vasopressors or paralytic agents, presence of chest tubes, wound vacuums, or drains
* in utero opiate exposure
Access to Kidney Transplant of Obese Patients Beginning Dialysis

Obesity is in constant increase all over the world and affects 35% of the global population according to the World Health Organisation. It is associated with other cardiovascular risk factors (particularly hypertension and diabetes) and with high morbi-mortality. It is also responsible for an increase of the risk of developing chronic kidney diseases (CKD). In fact, obese patients represent 25% of the dialysis population and Picardy is one of the most affected areas. However, their access to kidney transplant is still restricted and the reasons are not completely understood.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old.
* Patients with BMI≥30 kg/m2 (for study population) and 25≤BMI≤30 kg/m2(for control population) one month after dialysis initiation.
* Patients agree with their data collection.

Exclusion Criteria:

* Patients with bariatric surgery history.
* Patients needed dialysis for graft dysfunction.
* Data loss.
BL Infusion Trial:Beta-lactam Continuous Versus Intermittent Infusion and Associated Bacterial Resistance and Therapy Outcomes in Critically Ill Patients With Severe Pneumonia

The study plans to randomize a total of 240 patients infected with Gram-negative bacterial pneumonia to receive beta-lactam (meropenem, cefepime, or piperacillin/tazobactam) continuous or intermittent infusion and collect baseline and regular follow-up respiratory cultures to assess the development of new resistance. The investigators will measure beta-lactam concentration to assess the impact of drug exposure on the bacterial resistance.


Eligibility Criteria:
Inclusion Criteria:

* Admission to the ICU with severe pneumonia (IDSA/ATS 2016/2019): presence of signs, symptoms and confirmatory chest imaging consistent with pneumonia (e.g. fever, cough and pulmonary infiltrate by chest radiograph)
* Age ≥18 years
* Positive respiratory culture (with or without an initial positive rapid identification test and/or Gram stain) for Gram-negative bacteria including, but not limited to, P. aeruginosa, K. pneumoniae, E. coli, S. marcescens, H. influenzae, Enterobacter spp., M. catarrhalis, A. baumannii, Achromobacter spp., P. mirabilis, and/or B. cepacia
* Received within the last 72 hours or will receive meropenem, cefepime, or piperacillin/tazobactam therapy

Exclusion Criteria:

* Pregnancy
* Prisoners
* Allergy to the beta-lactams to be administered in this study
* On renal replacement therapy at the time of randomization
* Baseline culture resistant to the beta-lactams in the study
* COVID patients enrolled in other trials
Structural Conditions and Health After Release From Prison

People released from prison experience two times higher cardiovascular (CV) mortality than the general population, have a high prevalence of poor CV health and increased risk of CV events within 2 years of release. Access to high quality healthcare following release from prison is key to preventing poor health and CV outcomes. Our study team will investigate facilitators and barriers to health care access experienced by people released from prison.

Upon release from prison, people face numerous challenges including unstable housing, limited employment, stigma, and poor health. Structural conditions in healthcare systems, including policies, practices and attitudes around healthcare access, transition programs, culture, support of social determinants of health, and specialized services for people released from prison, may influence access and health outcomes for people released from prison. We will enroll people released from prison into a prospective cohort study to examine the association between exposure to structural conditions and 12-month primary outcomes of healthcare utilization (clinic visits, emergency visits, hospitalization) and secondary outcomes of CV hospitalization and all-cause mortality. Moderation by participant characteristics such as self-reported race, ethnicity, gender, age and baseline CV health will be tested.

Eligibility Criteria:
Inclusion Criteria:

* Recenlty released from state prison into the Denver/Aurora Colorado metro area
* Age 18 and older
* Ability to understand study procedures in English or Spanish
* No plans to leave the area for six months

Exclusion Criteria:

* On "current inmate" status or still under correctional observation (i.e., under locked confinement part of the day or night)
* Plans to leave area within six months
* Unable to consent
Laparoscopic Incisional Hernia Repair in Liver Transplant Patients

Retrospective analysis of patients undergoing laparoscopic incisional hernia repair.

Study group: Patients with incisional hernia post liver transplantation Control group: Patients with incisional hernia post any other laparotomy in the upper quadrant.

Primary study outcome parameter: Risk of hernia recurrence. Secondary study outcome parameters: - Hernia repair-related infection rate

- Postoperative morbidity Statistical analysis: Comparison of study versus control group, univariate and multivariate analysis, Chi² and Mann-Whitney-U tests. P-values \<0.05 were considered significant.


Eligibility Criteria:
Inclusion Criteria:

* Incisional hernia
* Laparoscopic repair possible

Exclusion Criteria:

* Other types of ventral hernias
* Laparoscopy not possible
A Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects

The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single dose of E6130 in Japanese healthy adult male participants.

This study consists of 8 cohorts, Cohorts 1 to 8. Cohorts 1 to 7 are designed as a single-center, single dose, placebo-controlled, randomized, ascending dose, double-blind study. Cohort 8 is designed as a single-center, single dose, randomized, open-label, two-group, two-period crossover study. Cohort 8 will be initiated after Cohorts 1 to 7 are completed.

Eligibility Criteria:
Inclusion Criteria

1. Japanese healthy adult males aged ≥20 and \<45 years at the time of informed consent who are non-smokers or able to stop smoking from at least 4 weeks before study drug administration until the post-treatment examination.
2. Has voluntarily consented, in writing, to participate in this study.
3. Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with the conditions.

Exclusion Criteria

1. History of surgical treatment that may affect the pharmacokinetics of the study drug at screening.
2. Suspected to have clinically abnormal symptoms or impairment of organ function requiring treatment on the basis of history and complications at screening, and physical findings, vital signs, ECG findings, or laboratory values at screening or baseline.
3. History of drug allergy at screening.
4. Judged by the investigator or sub-investigator to be inappropriate for participation in this study.
A Network Intervention for Reducing Sexual Risk for HIV With African American Men Who Have Sex With Men (AA MSM)

The purpose of the study is to examine the efficacy of a network-oriented "outreach intervention" to reduce HIV and sexually transmitted infection (STI) related risk behaviors among African American men who have sex with men (AA MSM)and their social network. The hypothesis is to determine whether the new intervention is more efficacious at reducing high risk sexual behaviors than the standard normal of care provided to the public (a single session of individual HIV counseling and testing.

The intervention increases participants' personal level of knowledge and skills concerning HIV prevention and inspires participants to diffuse the information to their social network.

Eligibility Criteria:
Inclusion Criteria:

* Identify as a black / African American male
* Report sex with at least 2 people in past 3 months/ 1 being male
* Willingness to take HIV test or provide documentation if HIV+
* Willingness to identify and recruit friend/relative to study

Exclusion Criteria:

* Under age 18
* Identify as female or transgender
* Not identify as Black / African American
Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM)

Tough Talks is a virtual reality based HIV disclosure intervention that allows HIV+ individuals to practice disclosing to romantic partners. Tough Talks allows participants to have the opportunity to practice disclosing using a variety of strategies and experience different outcomes including acceptance, confusion, lack of HIV knowledge, and rejection.

During Phase I of this project, the investigators developed an iPad based virtual reality system that features three avatars, two virtual locations and three disclosure scenarios which represent a variety of common disclosure experiences and contexts experienced by YMSM. In Phase II the investigators will further enhance Tough Talks and develop a full-feature automated version to test via a multi-site, randomized controlled trial (RCT) through the newly created Center for Innovative Technologies (iTech) across the Prevention and Care Continuum, an NIH-funded center to support adolescent HIV research.

Eligibility Criteria:
Inclusion Criteria:

* 16-29 years
* assigned male at birth
* male identified
* HIV infected
* Owns a mobile device or has access to a laptop or desktop computer
* able to understand, read, and speak English
* Reports 1 or more episodes of anal intercourse with a male partner in the last 6 months

Exclusion Criteria:

* HIV negative
* assigned female at birth
* 15 or younger
* 30 or older