cyrilzakka/clinical-trials huggingface dataset:
Using Affective Differences to Predict Response to Behavioral Treatment for Major Depressive Disorder

This study will determine how people with depression differ from healthy people in brain activity and interpreting emotions, both before and after receiving a psychotherapy treatment.

Major depressive disorder is a serious form of depression that may be treated with psychotherapy. However, up to 40% of adults with depression do not show reduced symptoms when treated with cognitive therapy or behavioral activation (BA), two common forms of psychotherapy. Certain indicators are generally linked with a successful outcome of psychotherapy-demographic and clinical characteristics, comorbidity, and treatment adherence-but no factors reliably predict outcomes of psychotherapy in individuals. This study will test whether two characteristics related to the way people process emotions, affective asymmetry and affective reactivity, can predict whether people with depression will improve with BA therapy.

Both depressed and healthy participants will be recruited for this study. Participation in this study will last 31 weeks. All participants will complete baseline assessments at Weeks 1 and 2. Depressed participants will then begin receiving 16 weekly sessions of BA therapy. All participants will be assessed again after 8, 16, 17, and 28 weeks. Assessments will include the following: a urine toxicology screening; interviews on mental and physical health, family and childhood experiences, and current mood and functioning; computer tasks; recordings of electroencephalography (EEG) activity; recordings of reaction to a startle probe; recordings of electromyography (EMG) activity; recordings of electrodermal activity (EDA); and measurement of blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants should have no lifetime history of psychiatric disorder
* Depressed participants should have a current diagnosis of major depressive disorder, as defined by the DSM-IV

Exclusion Criteria:

* History of bipolar affective disorder
* History of psychosis
* Current non-psychotic Axis I disorder, if it constitutes the predominant aspect of the clinical presentation and immediately requires treatment other than that offered in the study
* History of substance dependence within the past 6 months
* Antisocial, borderline, schizotypal, or schizoid personality disorders
* Evidence of any medical disorder or condition that could cause depression or preclude the use of study treatments
* Current treatment with catecholaminergic antihypertensive medication, such as reserpine, beta-blockers, clonidine, and alphamethyldopa
* Current use of antidepressant medication
* Clear indication of secondary gain
* Current suicide risk sufficient to preclude treatment on an outpatient basis
* Severe, unstable concurrent psychiatric conditions likely to require hospitalization within 6 months of study entry
* Already receiving a targeted psychotherapy aimed at depression
Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior

This study will investigate within-person changes in smoking behavior when current menthol smokers are switched to non-menthol cigarettes and either tobacco or menthol flavored e-cigarettes.

The goals of this project include evaluating within-subject changes in cigarette satisfaction and smoking behavior after switching from menthol cigarettes and investigating whether outcomes differ between subjects based on use of menthol vs. tobacco flavored e-cigarettes. Within-person changes in cigarette satisfaction and smoking behavior will be assessed during the last week of the non-menthol cigarette smoking period compared to the menthol cigarette smoking period. Preference and use of both the cigarette and e-cigarette products during the switching period will be compared and the extent to which menthol flavored (vs. tobacco) e-cigarettes are preferred among menthol smokers will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* Able to read English
* Cigarette smoker

Exclusion Criteria:

* Seeking smoking cessation treatment
* Serious psychiatric or medical condition
* Use of other drugs
* Unable or unwilling to complete study protocol
Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy

This is a randomized trial to compare intermittent compression devices with or without post-operative Arixtra (fondaparinux sodium) in women undergoing major abdominal surgery for known or presumed gynecologic malignancies. This trial seeks to determine if there is a difference in the rate of deep venous thrombosis between these two groups.

To assess the effectiveness of Arixtra (fondaparinux sodium) in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing open laparotomy (non-laparoscopic) gynecologic surgery.
* Patients must be competent to self-administer injections, or must have caregivers or nurses who can perform injections
* Patients must have signed an approved informed consent

Exclusion Criteria:

* Patients with medical history which requires chronic anticoagulation (i.e. previous DVT, pulmonary embolism, atrial fibrillation, heart valve replacement)
* Patients with contraindications to anticoagulation (generalized bleeding disorders, peptic ulcer disease, hemorrhagic stroke, etc)
* Contraindications to placement of ICDs (history of lower extremity venous stasis ulcers)
* Patients receiving low molecular weight heparin or unfractionated heparin for prophylaxis post-operatively
* Patients who are unable to receive injections as an outpatient and/or unable to undergo a doppler ultrasound of the lower extremities
* Renal insufficiency (creatinine clearance \< 30 mL/min)
* Patients who have a body weight \< 50 kg
* Hypersensitivity to low molecular weight heparin
* Patients who are pregnant or have a positive pregnancy test.
* Patients receiving continuous (indwelling) epidural.
Everbeat Ring ECG Clinical Concordance Study

This study is a cross-sectional observational study conducted in patients referred for routine ECG, to compare output from the everbeat finger-worn ECG device to standard of care (SOC) 12-lead electrocardiography. No intervention is involved in this study. Patients visiting the study site during the study period will be assessed for eligibility on a convenience basis, and observational data will be recorded on those eligible.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 to 90 years.
* Under the care of a board-certified physician and referred for a routine electrocardiogram (ECG)
* Resting heart rate between 50 to 120 beats per minute (BPM).

Exclusion Criteria:

* Inability to wear the everbeat ring.
* Prior history of movement disorders including Parkinson's or benign tremors.
* Prior history of allergic skin reactions to metal including stainless steel.
Development of an Online ACT Intervention for Disorders of Gut-Brain Interaction

The goal of this clinical trial is to develop and test the iACTforDGBI intervention in a sample of Swedish individuals with DGBI (Disorders of Gut-Brain Interaction).

The first substudy of this project (Substudy 1) aims to answer the following question: How can the design of iACTforDGBI be tailored to meet the specific needs of individuals with DGBI and clinically meaningful symptoms of anxiety and depression?

Participants (individuals with symptoms compatible with a DGBI and anxiety and/or depression, and healthcare professionals working in DGBI) will be asked to: a) Evaluate a preliminary version of the iACTforDGBI intervention, consisting of self-guided online sessions. b) Participate in online focus-group interviews and provide information on their views of a preliminary version of the iACTforDGBi intervention


Eligibility Criteria:
DGBI participants:

Inclusion Criteria:

1. Age between 18 and 75 years;
2. Exhibiting clinical symptom severity for at least one DGBI diagnosis (assessed with the Rome IV Diagnostic Questionnaire for Functional Gastrointestinal Disorders in Adults (Palsson et al., 2016));
3. Clinically meaningful levels of depressive symptoms or anxiety: score ≥ 13 on the Montgomery Åsberg Depression Rating Scale (MADRS; depressive symptoms), or score ≥ 10 on the Generalized Anxiety Disorder scale-7 (GAD-7; anxiety symptoms; Spitzer et al., 2006);
4. Stable medication for psychiatric symptoms including anxiety, depression, and sleep problems for at least two months prior to intervention;
5. Ability to read and write Swedish;
6. Access to a device (like a computer, tablet, or smartphone) with access to the internet and that can be used to attend video conferences and preview the intervention platform (i.e., have a microphone and speakers or headphones).

Exclusion Criteria:

1. Currently undergoing any form of psychological intervention;
2. Increased risk of suicide (≥4 points on MADRS item 9);
3. Severe depression (≥34 points on MADRS).

Healthcare professionals:

Inclusion Criteria:

a) Being a healthcare professional currently working with DGBI patients.
Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV

The investigator propose to culturally adapt the mindfulness-based stress reduction (MSBR) intervention for Black/African American women living with HIV (WLWH) to reduce stress and enhance HIV self-care behaviors and viral load (VL) suppression, which has the potential to attenuate prominent racial and gender disparities experienced by Black WLWH in the US. Specifically, the investigator aims to 1) culturally adapt the MBSR intervention for Black WLWH using ADAPT-ITT; 2) pre-pilot the adapted intervention via an open non-randomized pilot study to further refine the culturally adapted intervention; and 3) conduct a 2-armed randomized pilot test of the behavioral intervention compared to standard of care to assess the feasibility and acceptability the adapted MBSR intervention for Black WLWH. The investigator hypothesis that the adapted intervention will be feasible and acceptable to member of the target population.


Eligibility Criteria:
Inclusion Criteria:

* Cisgender females
* HIV seropositive
* 18 years of age or older
* English speaking
* An active patient at the local HIV ambulatory clinic in Alabama.

Exclusion Criteria:

* Non-English speaking
* Appear temporarily impaired (e.g., intoxicated)
* Not willing to or legally unable to provide informed consent.
Wearable Activity Tracking to Curb Hospitalizations

This study is being done to collect patient generated health data to predict the risk of patients needing emergency department visits or hospitalization before, during. and after receiving radiation therapy.

PRIMARY OBJECTIVE:

I. Validate a previously developed step-count model for predicting all-cause acute care (pooled across all devices).

SECONDARY OBJECTIVES:

I. Validate a previously developed model for predicting each ED visits or hospitalizations during external beam RT using continuous step counts before, during, and after treatment.

II. Validate the previously developed step-count model for predicting all-cause acute care for each of the two different device platforms.

III. Validate concordance of step counts across each of the device's platforms in the Apple group.

IV. Validate the previously developed SHIELD-RT Electronic health record (EHR)-based model for predicting unplanned acute care (ED visit or hospitalization).

EXPLORATORY OBJECTIVES:

I. Refinement of the pre-existing models(step count and SHIELD-RT). II. Evaluate association between wearables collected parameters, EHR-based variables, and acute care events.

III. Develop and validate a multi-modal predictive model for predicting acute care.

OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.

* GROUP I: Participants receive Fitbit device and undergo non-interventional, standard of care, radiation therapy.
* GROUP II: Participants receive Fitbit device and utilize their own personal Apple HealthKit-based device and undergo non-interventional, standard of care, radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18.
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2.
* Able to understand study procedures and to comply with them for the entire length of the study.
* Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
* Diagnosis of invasive malignancy.
* Able to ambulate independently (without the assistance of a cane or walker).
* Planned treatment with fractionated external beam radiotherapy over at least 5 days (no fractional requirement).
* Not a previous participant on this protocol for subsequent courses.

Exclusion Criteria:

* Participants bound to a wheelchair.
* Participants unable to ambulate independently (needing assistance of cane or walker).
Web-Mediated Risk Assessment for Endoscopic Screening of Gastric Cancer

Gastric cancer is one of the most common malignancies in China. Early detection is critical for gastric cancer management. However, the diagnosis rate of patients with early gastric cancer is still low. Therefore, the investigator design this study to access whether pre-endoscopic screening risk assessment of genetic and environmental risk factors could improve early gastric cancer diagnosis rate.


Eligibility Criteria:
Inclusion Criteria:

* 1.Age 18-60. 2.Signed informed consent

Exclusion Criteria:

* 1.Severe back ground disease including malignancy. 2.State after gastric surgery. 3.COPD, CHF, CRF and any disease with respiratory disturbances. 4.Deviation of the nasal septum, lack of venous access at the dorsum of the hand or any other technical problem prevents gastric acid collection or base excess evaluation.
Dissemination Strategies and Implementation Outcomes of Adolescent Character Strength Interventions.

The present research study will involve investigating the efficacy of large-scale dissemination models of evidence-based character strength interventions in secondary schools in Kenya. This intervention, derived from a previously tested intervention named Shamiri, or thrive in Kiswahili, uses positive psychology and accessible life skills to build individual resilience and wellness. This will be a one-arm trial with participants recruited from 20 secondary schools in Nairobi, Kiambu and Makueni counties. The investigators estimate a sample size of 3000 youth, working on an intention to treat basis. All interested participants will be admitted to the program, with no exclusion criteria applied. The investigators will report on the efficacy of character strength interventions on wellbeing and mental health outcomes. Further, the investigators will also assess the scalability and acceptability of the program post intervention. Additionally, the investigators will examine moderator effects on the participants, baseline attributes of the participants, and potentially the effects of candidate mediators on intervention effects.

This is a dissemination study whose objective is to explore the effectiveness, acceptability, and scalability of the Shamiri intervention when implemented in a large-scale naturalistic dissemination study in Kenyan secondary schools. Specifically, this study has two broad goals: 1) to test the effectiveness of Shamiri on mental health and psychosocial outcomes when delivered naturalistically on a large scale through either a centralized and de-centralized (train the trainers) administration, and 2) to examine and measure outcomes of these large-scale dissemination models.

For goal 1, participants will receive Shamiri directly through the Shamiri team or through an implementation partner. The investigators will measure mental health and psychosocial outcomes to determine if these outcomes compare to those reported in prior RCTs of Shamiri. The investigators hypothesize that participants receiving Shamiri will experience similar improvements in mental health and psychosocial outcomes as reported in previous RCTs. The investigators don't have a priori hypothesis on whether the mode through which the participants receive the intervention will affect intervention outcomes.

To achieve goal 2, investigators measure the following implementation related outcomes: intervention fidelity, cost, sustainment, acceptability, penetration, and cost-effectiveness. The investigators hypothesize that the Shamiri intervention will achieve high ratings in all intervention outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be high school students in one of the selected schools.
* Participants must be between the ages of 12 to 21.

Exclusion Criteria:

* There will be no other exclusion criteria.
Effects of Collagen Protein on the Amino Acid Profile of the Blood

This project aims to investigate the absorption of enzymatically hydrolysed and non-enzymatically hydrolysed collagen on the Amino acid profile of the blood


Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Medicine influencing protein turnover
* Diabetes
* Smoking
Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women

The purpose of this study is to document differences between men and women in changes in metabolic variables associated with cardiovascular risk in response to a 4 weeks isocaloric controlled nutritional intervention based on the Mediterranean diet in which all foods and drinks are provided to subjects. The investigators hypothesize that the decrease in LDL-cholesterol will be more important in men than in women.

Nutritional interventions promoting the adoption of the traditional Mediterranean diet (MedDiet) are known to have significant and beneficial effects on cardiovascular disease (CVD) risk profile. On the other hand, recent evidence suggests that women respond differently to diet than men. No study has yet compared men and women metabolic response to the MedDiet in a controlled metabolic context in which all foods and drinks consumed are provided to the participant prepared by the research team. Therefore, we do not know whether being fed a MedDiet in controlled conditions would have similar health benefits in men and women. The purpose of this study is to document differences between men and women in changes in metabolic variables associated with cardiovascular risk in response to a 4 weeks isocaloric controlled nutritional intervention based on the MedDiet in which all foods and drinks are provided to subjects. We hypothesize that the decrease in LDL-cholesterol will be more important in men than in women. In this parallel controlled trial, both men and women are assigned to the same 4 weeks experimental diet formulated to be concordant with characteristics of the traditional MedDiet. Data will be collected before and after the controlled nutritional intervention based on the MedDiet.

Eligibility Criteria:
Inclusion Criteria:

* Men and premenopausal women from de Quebec City metropolitan area.
* Slightly elevated LDL-cholesterol concentrations (3.4-4.9 mM) or total cholesterol to HDL-C ratio ≥ 5.0
* At least one of the four following factors of the metabolic syndrome: 1) waist circumference \> 94 cm in men and \> 80 cm in women; 2) TG \> 1.7 mmol/L; 3) fasting glycemia between 6.1 and 6.9 mmol/L and 4) blood pressure concentrations ≥ 130 / 85 mm Hg.
* Age: between 25 to 50 years
* Stable body weight (+/- 2.5 kg) for at least 3 months before the beginning of the study
* In women, a regular menstrual cycle for the last 3 months

Exclusion Criteria:

* Subjects with endocrine disorders, cardiovascular events, type 1 or 2 diabetes and those using medication that could affect dependent variables measured (namely lipid-lowering, hypoglycemic, insulin sensitizers and anti hypertensive medication)
* Smokers
* Subjects with history of alcoholism
* Subjects with food allergies or food aversion that could impede compliance to the Mediterranean diet
* Pregnant women and those using systemic hormonal contraceptives
Effect of Weight Loss and Lifestyle Changes on Vascular Inflammatory Markers in Obese Women

Obesity is an independent risk factor for cardiovascular disease, which may be mediated by increased secretion of proinflammatory cytokines by adipose tissue.

To determine the effect of a program of changes in lifestyle designed to obtain a sustained reduction of body weight on markers of systemic vascular inflammation and insulin resistance.

Randomized single-blind trial conducted from February 1999 to February 2002 at a university hospital in Italy.

One hundred twenty premenopausal obese women (body mass index 30) aged 20 to 46 years without diabetes, hypertension, or hyperlipidemia.

The 60 women randomly assigned to the intervention group received detailed advice about how to achieve a reduction of weight of 10% or more through a low-energy Mediterranean-style diet and increased physical activity. The control group (n = 60) was given general information about healthy food choices and exercise.


Eligibility Criteria:
Inclusion Criteria:

* obese premenopausal women,
* aged 20 to 46 years
* sedentary (\<1 h/wk of physical activity)
* with no evidence of participation in diet reduction programs within the last 6 months.

Exclusion Criteria:

* type 2 diabetes mellitus or impaired glucose tolerance (plasma glucose levels of 140-200 mg/dL \[7.8-11.1 mmol/L\] 2 hours after a 75-g oral glucose load)
* hypertension (blood pressure \>140/90 mm Hg)
* cardiovascular disease, psychiatric problems
* history of alcohol abuse (intake of 500 g/wk in the last year)
* current smoking
* any medication use.
Continuous Glucose Monitoring in Inpatients

The purpose of this study is to contribute to current research regarding the feasibility and accuracy of CGM in the hospital setting for both the medical and cardiovascular intensive care (ICU) patient populations.

The use of continuous glucose monitors (CGM) in the outpatient setting has dramatically increased as these devices continue to improve in both ease of use, accessibility, and accuracy. Federal Drug Administration (FDA) clearance of certain devices has now been granted in both pregnancy and automated insulin delivery systems. As the world has embraced the safety and efficacy of continuous glucose monitors in the outpatient setting, health systems have turned attention to the potential of utilizing these devices to improve glycemic control in the hospital setting. With the announcement of the FDA granting enforcement discretion regarding the use of CGM technology in the hospital setting during the COVID-19 pandemic, the result was an abundance of research evaluating the potential of CGM longevity in the hospital setting.

The Standards of Care in Diabetes: 2023 reported that "preliminary data suggests that CGM can significantly improve glycemic management and other hospital outcomes." Additionally, a systematic review of 32 studies evaluated the accuracy of CGM in the intensive care unit, with a consensus of moderate to good accuracy. CGM in the hospital setting could provide a valuable tool in reducing hypoglycemia, hyperglycemia, and increasing time spent in normoglycemia. Other potential benefits of CGM include a broader view of glucose patterns, capture of asymptomatic hypoglycemia, reduced length of stay, and decreased cost. The Diabetes Technology Society organized the Hospital Consensus Guideline Panel in 2020, with the final report including the recommendation for additional research on the accuracy, data management, and patient-centered outcomes of CGM use in the inpatient setting.

Eligibility Criteria:
Inclusion Criteria:

* Admitted patients 18 years of age or older
* Glucose management per Glucommander and/or receiving POC blood glucose testing
* Patients admitted to Medical 6 or elective or urgent open-heart surgery patients admitted to the Cardiovascular Intensive Care Unit (CVICU)

Exclusion Criteria:

* Patients less than 18 years of age
* Pregnant or currently breastfeeding
* Prisoners
* Patients unable to consent in English.
* Patients with a preexisting insulin pump on admission
* Active skin infection at the insertion site(s)