cyrilzakka/clinical-trials huggingface dataset:
Promoting Positive Mental Health for Sustainable Eating Behaviors

The main aim of the present study is to assess the effects and the effectiveness of a psychological intervention based on the principles of well-being therapy (WBT) in promoting weight-loss, sustainable and healthy eating behaviors and an optimal psychological functioning in patients with obesity.

The primary objective of this pilot study is to assess the effects and the effectiveness, both post-treatment and at 1- and 3-month follow-ups, of a group intervention inspired by the principles of Well-Being Therapy (WBT), combined with a nutritional education, compared to treatment as usual (TAU), namely a Basic Nutritional Intervention (BNI) in a group setting, in terms of weight loss.

The secondary objective is to evaluate the effects and effectiveness of this intervention, both post-treatment and at 1- and 3-month follow-ups, compared to BNI, in promoting healthy and sustainable eating behaviors and an optimal psychological functioning. This includes the promotion of balanced psychological well-being levels and functional eating styles, and the reduction of both psychological distress and dysfunctional justification cognitive mechanisms use.

After being informed about the study and its potential risks, all patients giving written informed consent will be randomly assigned to either the experimental group or the control group. Both groups will participate in five weekly online group sessions of two hours each.

Eligibility Criteria:
INCLUSION CRITERIA

Patients are included in the study if they:

1. are affiliated with the Clinical Nutrition and Metabolism Unit of Policlinico S. Orsola-Malpighi;
2. have a BMI ≥ 30;
3. are aged ≥ 18 years;
4. voluntarily agree to participate in the study;
5. have access to a computer and can use it independently.

EXCLUSION CRITERIA

Patients are excluded from the study if they:

1. do not sign the informed consent to participate in the study;
2. have limited knowledge of the Italian language;
3. have cognitive deficits;
4. meet the diagnostic criteria for one or more of the following psychiatric diagnoses: drug and/or alcohol abuse, psychotic disorders, neuro-cognitive disorders, suicidal behaviors;
5. participate in another weight loss study or program;
6. take weight loss medications;
7. engage in individual or group psychotherapeutic interventions;
8. have undergone weight loss surgery in the 16 months preceding the study and during the entire study period (approximately five months);
9. (only women) were/are pregnant or were/are planning pregnancy in the 16 months preceding the study and during the entire study period (approximately five months).
Age and Gender Corrected Body Mass Index

Esophagectomy for cancer is often accompanied with severe preoperative weight loss. Body Mass Index (BMI) values are age-independent and the same for both sexes. From the perspective that these two parameters should actually be taken into account too, we developed a model to calculate "age-gender specific BMI-percentiles" (AG-BMI) and tested this model in relation to survival outcome after esophagectomy for cancer.

Age-Gender specific BMI percentiles are more accurate compared to the current BMI classes in predicting Overall Survival (OS) after esophagectomy for cancer. Furthermore we believe in a more devastating impact on OS from underweight and not from overweight.

By preoperatively identifying risk patients for poorer OS, especially the non-tumoral deaths, this can be a tool to tailor postoperative nutritional strategies to counter further weight loss and bringing postoperative weight to normal ranges.

Eligibility Criteria:
Inclusion Criteria:

* any type of esophagectomy

Exclusion Criteria:

* Preoperative organ metastasis (cM+ or yM+)
* esophageal bypass surgery
Duragesic® (Fentanyl Transdermal System) Functionality Trial in Chronic Low Back Pain

The purpose of this study is to assess physical functionality changes over a minimum of 9 weeks in patients with non-malignant chronic low back pain who are taking short-acting opioids (narcotic pain medications) for 4 or more weeks, and who start taking the long-acting opioid fentanyl in the form of a transdermal (skin) patch.

Chronic pain (pain that lasts for more than 3 months) can limit physical functioning and negatively affect a person socially and emotionally. Chronic low back pain (that is not caused by cancer) is a very common condition that affects up to a third of people in the US at any time. The primary objective of the trial is to assess functionality changes over a minimum period of 9 weeks using the Oswestry Disability Index (ODI) - a questionnaire to measure disability - in patients with non-malignant chronic low back pain who are taking short-acting opioids chronically, and who initiate treatment with Duragesic® (transdermal fentanyl). The patch delivers fentanyl in doses of 25, 50, 75, or 100 micrograms per hour. The ODI is comprised of 10 sections; each section consists of 6 response alternatives. The 10 scales assessed by the ODI are Pain Intensity, Personal Care (washing, dressing, etc.), Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, and Traveling. The secondary objective is to assess changes in health-related quality of life (HRQoL) over the treatment period using the Total Pain Experience (TPE) subscale of the Treatment Outcomes in Pain Survey (TOPS), a questionnaire designed to measure HRQoL changes in patients with chronic pain. The TOPS contains 112 items that are scored into 16 scales. These scales include: Pain Symptoms, Lower Body Functional Limitations, Upper Body Functional Limitations, Perceived Family/Social Disability, Objective Family/Social Disability, Objective Work Disability, TPE (a combination of 5 other scales), Life Control, Passive Coping, Solicitous Responses, Work Limitations, Fear Avoidance, Patient Satisfaction with Outcomes, Health Care Satisfaction, Vitality, and Mental Health (the last two from a questionnaire known as the Short Form-36, or SF-36. Fentanyl transdermal system (skin patch) in a dosage prescribed by the clinical investigator according to the usual standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain (not related to cancer) for at least 3 months
* current use of short-acting opioid (narcotic pain medication) for at least 4 weeks
* initiating fentanyl transdermal patch.

Exclusion Criteria:

* Confusion or reduced level of consciousness
* skin disease
* malignancies (cancer)
* currently hospitalized
* treated with a long-acting opioid within the last 2 months
* pregnant or breast-feeding
* abusing drugs or alcohol
Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography

Introduction Patients undergoing invasive coronary angiography experience anxiety due to various factors. This can lead to physiological and psychological complications, compromising patient comfort and overall procedural outcomes. Benzodiazepines are commonly used to reduce periprocedural anxiety, although the effect is modest. VR is an promising nonpharmacological intervention that can be used to reduce anxiety in patients undergoing an invasive coronary angiography.

Methods and analysis A single-center open-label randomized controlled trial was performed to assess the effectiveness of add-on VR therapy on anxiety in 100 patients undergoing invasive coronary angiography and experiencing anxiety in periprocedural setting. The primary outcome is the NRS anxiety score measured just before obtaining arterial access. Secondary outcomes are physiological measures of anxiety and the State-Trait Anxiety Inventory, Perceived Stress Scale, and IGroup presence questionnaire. The NRS anxiety level and physiological measurements will be taken at five scheduled times between pre procedural, peri and post procedural. The State-Trait Anxiety Inventory and Perceived Stress Scale will be performed prior to coronary angiography and the State-Trait Anxiety Inventory (state form) and the IGroup Presence questionnaire will be performed post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥16 years undergoing elective cardiac catheterisation
* Patient is willing and able to comply with the study protocol
* NRS anxiety score ≥ 4

Exclusion Criteria:

* History of dementia
* Severe hearing/visual impairment not corrected
* Depression or anxiety disorder
Community Glaucoma Screening Follow-up

The purpose of this study is to determine if one of three interventions improves follow-up rates for screening exam participants who are instructed to have a definitive eye exam.

To determine if one of three interventions: vouchers, telephone calls, and personal contacts, improves follow-up rates for screening exam participants who are instructed to have a definitive eye exam.

Eligibility Criteria:
Inclusion Criteria:

* All who had an eye screening exam.

Exclusion Criteria:

* None
HemosprayTM for Gastrointestinal Bleeding From Cancer

Title: The efficacy of hemostatic powder TC-325 versus standard endoscopic treatment for gastrointestinal bleeding from malignancy; a multi-center randomized trial

Background: Gastrointestinal (GI) bleeding arising from malignant tumors is increasingly recognized as a result of oncological advances and improved detection methods. However, conventional endoscopic hemostatic methods are not reliable to control bleeding. It has a trend to be an effective hemostasis method for active GI bleeding from tumor, however, in view of the lack of RCTs and large-scale studies, the efficacy of TC-325 is still inconclusive.

Objective: To evaluate the efficacy of TC325 in endoscopic hemostasis treatment for malignant gastrointestinal hemorrhage.The 24-hour, 72-hour, 30-day, 90-day and 180-day rebleeding rate were assessed as the outcomes of treatment as well as 6-month mortality.

Study design: Single-blinded, multi-center, randomized-control trial study The intervention (experimental) arm: TC-325 alone (define failure if continued bleeding despite application of 1 syringes) The control arm: Standard of (traditional) endoscopic treatments

\*\* Crossover is possible. Inclusion criteria: Patients with acute upper or lower GIB from a lesion that is actively bleeding at index endoscopy (spurting or oozing) and is suspected to be malignant or diagnosed as malignancy from previous tissue diagnosis.

Exclusion criteria: Patients less than 18 years old, previously included in the trial, ECOG score 3 or 4, pregnancy/lactation, and/or bleeding from GI sources suspected of not being malignant. If an endoscopist is unsure of the malignant likelihood of the lesion, he/she will not be enrolled.

Sample size: 112 in total

Duration of participation for each volunteer: 180 days


Eligibility Criteria:
Inclusion Criteria:

* Acute upper or lower gastrointestinal bleeding
* Endoscopy shows actively bleeding at index endoscopy (spurting or oozing)
* Bleeding from malignancy

Exclusion Criteria:

* Less than 18 years old
* Previously included in the trial
* Eastern Cooperative Oncology Group (ECOG) score 3 or 4
* Pregnancy/lactation
* Bleeding from GI sources suspected of not being malignant
Investigation of the Effect of Toilet Training Given to Children

In the study, it was aimed to examine the factors affecting the toilet training of children aged 18-36 months who have no problems in social-emotional development and the effect of professional support on the toilet training process.

Toilet training studies in Turkey and analyzes of bladder, bowel control and training completion times in these studies are limited. In this study, training processes were examined separately, and the factors that were not studied frequently until today were investigated. Also the effects of the professional support provided to children who did not have problems in social-emotional development on the process were examined.

Eligibility Criteria:
Inclusion Criteria:

* not having received toilet training
* age of the child between 18-36 months
* normal social-emotional development
* no known chronic disease

Exclusion Criteria:

* having received toilet training
* the child's age is outside the range of 18-36 months
* abnormal social-emotional development
* presence of chronic disease
Comparing Nose & Mouth Breathing During Exercise

The purpose of this study is to compare physiological responses in cardiovascular variables between nose and mouth breathing at rest and during exercise.

Breathing patterns can affect the cardiovascular system. Little is known about how nose versus mouth breathing affects cardiovascular variables (blood pressure, heart rate, etc.) at rest and during exercise. It has been suggested that breathing through the nose can cause calmness and lower blood pressure. However, research is needed to examine the extent to which breathing through the nose affects cardiovascular variables at rest and during exercise. Therefore, we will compare cardiovascular variables between nose-only and mouth-only breathing. The rate of breathing will be fixed (using an audible metronome) for both breathing conditions (nose-only vs mouth-only) based on an individual's free breathing (i.e., no breathing cues) breathing rate.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index: ≤30 kg/m2
* Resting Blood pressure: ≤140/90 mmHg

Exclusion Criteria:

* Overt cardiovascular (e.g., diagnosed hypertension), respiratory, neurological, renal, liver, and/or metabolic health condition
* Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes)
Metabolic Changes in Patients With Chronic Cardiopulmonary Disease

This study aims to evaluate prevalence of sarcopenia and cachexia in patients with chronic cardiopulmonary disease. The investigators will also investigate metabolic disorders like glucose metabolism, presence of metabolic syndrome, body composition and histological changes in skeletal muscle and body fat. Finally, patients will be followed for clinical endpoints.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic disease (Heart failure, COPD, malignancy, CKD) or no diagnosis (controls)

Exclusion Criteria:

* refuse to participate
Risk-based Screen and Prognostic Analysis for Second Primary Malignancies in Kidney Cancer Patients

Second primary malignancy (SPM) significantly impacts the survival and prognosis of patients. This study endeavors to identify risk and prognostic factors associated with SPM after first primary kidney cancer and construct predictive nomograms.

In recent years, with the advancement of cancer treatment techniques and the prolonged survival of patients, the prevalence of Second primary malignancy (SPM) has been escalating, emerging as a significant health issue among cancer survivors. The goal of this study is to identify risk and prognostic factors associated with SPM after first primary kidney cancer and construct nomograms to provide clinical evidence. The main questions this study aims to answer are: (1) What are the risk factors associated with the prevalence of SPM after kidney cancer? (2) What are the prognostic factors associated with the overall survival (OS) of kidney cancer patients with SPM? (3) How to accurately predict the probability of developing SPM after kidney cancer and the OS of kidney cancer patients with SPM? In this retrospective population-based cohort study, Patients diagnosed with first primary kidney cancer between 2000 and 2020 were retrospectively enrolled from the Surveillance, Epidemiology, and End Results (SEER) database. Researchers will concentrate on the risk and prognostic factors of SPM after kidney cancer, and develop nomograms to forecast the development and overall survival (OS) of SPM after kidney cancer.

Eligibility Criteria:
Inclusion Criteria:

* (1) Diagnosed age was between 18 and 80 years old
* (2) Diagnosed histologically confirmed as first primary kidney cancer
* (3) The staging of kidney cancer was early or localized advanced (T1/2/3N0M0)
* (4) Detailed survival data and follow-up information should be provided

Exclusion Criteria:

* (1) Histological conformation for diagnosis was unavailable
* (2) The type of reporting source was "Death certificate only" or "Autopsy only"
* (3) Patients with other malignancies before the diagnosis of primary kidney cancer
* (4) The staging of kidney cancer was not early or localized advanced (T1/2/3N0M0)
* (5) Diagnosis interval between first primary malignancy (FPM) and second primary malignancy (SPM) was less than 6 months
* (6) The information was not complete
Duration of Protection: GSK DTaP Vaccines

The purpose of this study is to assess duration of protection for GSK DTaP vaccines in preventing pertussis.


Eligibility Criteria:
Inclusion Criteria:

* Kaiser Permanente Northern California (KPNC) member who received 5 doses of acellular pertussis vaccines be-tween ages 1 month and 84 months at KPNC.
* The 5th dose was given between the ages of 47 and 84 months.
* All 5 DTaP doses received were manufactured by GSK, depending on study objective (otherwise this criterion will not apply).
* Born in 1999 and later.

Inclusion criteria for cases:

• All individuals meeting above inclusion criteria who tested PCR-positive for pertussis and negative for parapertussis during the study period.

Inclusion criteria for PCR-negative controls:

• All individuals meeting above inclusion criteria who tested PCR-negative for both pertussis and parapertussis during the study period.

Inclusion criteria for KPNC-matched controls:

* All individuals from the general KPNC population meeting above inclusion criteria who match a PCR-positive case on sex, age, race or ethnic group, and medical center.
* KPNC members on the day their matched case under-went the PCR test (anchor date).

Exclusion Criteria:

* Individuals whose PCR test date (or anchor date) is less than 2 weeks after receiving their 5th DTaP dose.
* Individuals who were not KPNC members for greater than 3 months between their 5th DTaP dose and PCR test date (or anchor date).
* Individuals who received reduced antigen content pertussis vaccine (Tdap) or any pertussis-containing vaccine after their 5th DTaP dose but before their PCR test date (or anchor date).

Exclusion criteria for controls:

• Individuals will be excluded from serving as a control once they test positive for pertussis.
HeartLinc, a Study With AMI Patients Undergoing PCI

HeartLinc is a non-interventional patient study to demonstrate medical utility of the lncRNA to predict HF in AMI patients. 300 patients are expected to be recruited.

The recruiting phase of the study includes the recruitment of patients (36 months) and is followed by 12 month of monitoring for each patient. After deciding MI and PCI treatment by physical exam, ECG and other diagnostic methods, blood samples will be collected. After undergoing PCI, samples of the same patients will be collected during hospitalization days after PCI (D0-3) according to the patient study flowchart. After hospitalization, patients will be contacted by phone call or written questionary after 30 days (D30). After 6 and 12 months, patients are reinvited for a routine rehospitalisation to perform clinical exams and ECGs. Blood and urine samples will be collected after 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Myocardial infarction in association with a recent acute coronary syndrome \<24 hrs leading to a coronary angioplasty decision
* Myocardial infarction with ST-elevation (STEMI) or myocardial infarction following acute coronary syndrome without ST-segment shift with a significant elevation of non-ST troponin (NSTEMI)
* Participation in the Hearlink Cohort
* Collecting and signed informed consent for Heartlink study participation and consent to participate in the ancillary Heartlink 2 study

Exclusion Criteria:

* Sudden Cardiac arrest which resulted in resuscitation other than single, non-repeated electric shock,
* cardiogenic shock
* Severe extra-cardiac diseases involving the short-term life expectancy of patients (risk of death at one year
* Programmed major non-cardiac surgery
* Known Altered Left Ventricular function before Acute Coronary Syndrome inclusion
* History of left, right or global heart failure
* Significant heart failure at hospital admittance (KILLIP 2)
* Acute Coronary Syndrome know more than 24 hours
* History of Myocardial infarction
* Participation in any other in progress or stopped study for less than 3 months other than the Heartlink study
Angiotensin II Blockade and Inflammation in Obesity

Overweight and obesity, which afflicts \~65% of the U.S. population and more than 1 billion people worldwide, increases the risk of developing hypertension. Activation of the renin angiotensin system (RAS) is an important mechanism by which obesity leads to hypertension. In addition to its vasoconstricting and sodium retaining actions, angiotensin II also has potent pro-inflammatory actions including macrophage infiltration and expression of proinflammatory cytokines in target tissues. Adipose tissue and skeletal muscle appear to be a key sites for the generation of proinflammatory cytokines. Although angiotensin II receptor blockade reduces inflammation in many tissues, the effects on adipose tissue and skeletal muscle in humans are not clear. Importantly, the chronic low grade inflammatory state that accompanies obesity complicates hypertension by contributing to insulin resistance and accelerating cardiovascular disease. Therefore, the general aim of the present proposal will be to determine the influence of angiotensin II receptor blockade on adipose tissue and skeletal muscle inflammation and its relation to improvements in insulin sensitivity, if observed, in obese hypertensive humans. To address these aims, 44 obese (BMI\>30 kg/m2) hypertensive (BP\>140 systolic and/or 90 diastolic) individuals (age=50-65 years) will be randomized to receive 8 weeks of either the angiotensin II receptor antagonist, olmesartan medoxomil, or no treatment in a crossover manner. Subcutaneous adipose tissue and skeletal muscle biopsies will be obtained and insulin sensitivity (intravenous glucose tolerance tests) will be assessed at baseline and following 8 weeks of each intervention. A two week washout period will separate the interventions.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age
* Weight stable for previous 6 months (+2.0kg)
* Sedentary to recreationally active
* Willing to be randomized to treatment or placebo
* Verbal and written informed consent
* Approved for participation by Medical Director (Jose Rivero, M.D.)

Exclusion Criteria:

* Blood pressure outside stated range
* Diabetes or taking diabetes medications
* Total cholesterol \>6.2 mmol/L; triglycerides \>4.5 mmol/L
* Past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, or hematological-oncological disease
* Evidence of renal insufficiency; GFR\< 60 ml/min\*
* Medications (including but not limited to antihypertensives, statins or other with anti-inflammatory actions) or antioxidant vitamins or supplements
* Known allergy or hypersensitivity to olmesartan or any of its components
* Pregnant or planning to become pregnant