cyrilzakka/clinical-trials huggingface dataset:
Optimization of Management for Sporadic Bilateral Renal Cell Carcinoma

Sporadic bilateral renal cell carcinoma (BRCC) is a rare situation of RCC. The treatment for BRCC is controversial and there is a lack of authoritative guidelines about the management of BRCC. The goal of this cohort study is to identify prognostic factors, construct predictive nomograms, and optimize management for sporadic BRCC patients. The main questions it aims to answer are:

What are the factors influencing the prognosis of BRCC patients? What's the appropriate treatment for BRCC patients?

Researchers will analysis the prognostic factors and compare the prognosis of BRCC patients receiving different treatments.

Sporadic bilateral renal cell carcinoma (BRCC) is a rare situation of RCC. The treatment for BRCC is controversial and there is a lack of authoritative guidelines about the management of BRCC. This cohort study aims to identify prognostic factors, construct predictive nomograms, and optimize surgical treatment for sporadic BRCC patients. The main questions it aims to answer are:

What are the factors influencing the prognosis of BRCC patients? What's the appropriate treatment for BRCC patients? In this retrospective population-based cohort study, patients diagnosed with sporadic BRCC between 2000 and 2020 were identified from the Surveillance, Epidemiology, and End Results (SEER) database. Researchers will analysis the prognostic factors and compare the prognosis of BRCC patients receiving different treatments.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Clinical diagnosis of localized BRCC (M0) from 2000 to 2020.
* Active follow-up.
* Complete clinicopathological information.

Exclusion Criteria:

* Diagnosed by autopsy or death certificate only.
* Tending to suffer from hereditary RCC, including those complicating with pancreatic neuroendocrine tumor (pNET) or hemangioblastoma.
* Unavailable key information.
Cardiovascular Health Study (CHS) Events Follow-up Study

To support follow-up for the Cardiovascular Health Study (CHS) of coronary heart disease and stroke risk factors in adults 65 years or older.

BACKGROUND:

The Cardiovascular Health Study (CHS) is an NHLBI-funded cohort study of risk factors for coronary heart disease (CHD) and stroke in adults 65 years or older. In the early 1990s, 5888 participants underwent examinations that included traditional risk factors and measures of sub-clinical disease. During follow-up, many exam components were repeated, and CVD events were ascertained. The National Heart, Lung, and Blood Institute has extended CHS contract funding (1) to implement a model for a transition from contract-funding to investigator-initiated research and (2) to enhance access to CHS data for future papers and ancillary studies by CHS and non-CHS colleagues. The Events Follow-up Study will provide a foundation for the transition. Current and future papers and ancillary studies using CHS data or stored specimens will have additional power and can be conducted more efficiently if a service events-core continues to collect and adjudicate CVD events and deaths in a standardized fashion.

DESIGN NARRATIVE:

Structurally, the primary aims are: (1) to evaluate the incidence rates of and risk factors for CVD in older adults, including comparisons between blacks and whites, men and women, young old and old; (2) the evaluation of prognosis in inception cohorts of older adults with new-onset conditions such as heart failure (HF) and atrial fibrillation; and (3) the evaluation of associations between risk-factor change and the incidence of subsequent events. Questions of interest include: What are the determinants of the low CHD incidence in women 80 yrs and older? Do older black women also have a low CHD incidence? What are the determinants of CHD, HF, and stroke in adults 80 and older? Are risk factors different between men and women, whites and blacks? Do traditional risk factors and measures of sub-clinical disease continue to be powerful predictors of CHD, HF and stroke in those 80 and older? In this study, the investigators expect to make over 20,000 phone calls to identify 6000 hospitalizations, 1000 deaths, 3000 events for detailed review, and 1500 new events, including 370 CHD, 300 stroke, and 450 HF. These new events represent an increase in the number of CVD events of 29% to 35% in whites and an increase of 40% to 49% in blacks. The data and specimens collected in CHS represent a major national resource for the study of health, aging, and cardiovascular disease in older adults. Additional events follow-up will not only provide the opportunity to address the aims of this study, but also enhance the power of current and future CHS papers and ancillary studies by CHS and non-CHS colleagues.

Eligibility Criteria:
No eligibility criteria
Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk

The present study is a new approach of examining tailored cognitive-behavioral interventions for fibromyalgia patients at risk. For this purpose, fibromyalgia patients are screened with respect to cognitive-behavioral risk factors and these patients are offered tailored cognitive-behavioral treatment options. It is expected that this approach will result in increased magnitude and maintenance of effects.

The fibromyalgia syndrome is a chronic condition with widespread pain that poses a great challenge for patients, rheumatologists and society because of the lack of optimal treatment options. There is extensive evidence that, in comparison with patients with rheumatoid arthritis, fibromyalgia patients report higher levels of functional disability, pain, fatigue, and lower levels of quality of life. Although effectiveness of pharmacological agents and other interventions is generally limited, most promising effects have been found for non-pharmacological treatments, particularly those with a primary focus on cognitive-behavioral treatment components. However, also these treatment outcomes are characterized by large individual variation. Particularly patients with less impairments in daily life seem to benefit less from these treatments. In line with the international literature, previous findings of the research group suggest that effectiveness might be increased when tailored cognitive-behavioural treatments are solely offered to patients at risk.

In the present project the effects of tailored interventions based on cognitive-behavioral factors for patients at risk are studied. In a randomized, controlled trial, fibromyalgia patients are screened for risk profiles. Patients at risk will be assigned to tailored cognitive or behavioral treatment conditions, depending on their risk profile with respect to cognitive-behavioral factors. Half of the patients are subsequently randomly assigned to a waiting list control condition. It is expected that this tailored treatment approach will increase magnitude and maintenance of treatment effects for pain, disability, fatigue and increased quality of life, which means an important step forward for patients, involved professionals and society.

Eligibility Criteria:
Inclusion Criteria:

* fibromyalgia according to the criteria of the American College of Rheumatology (ACR)

Exclusion Criteria:

* physical or psychological comorbidity that interferes with cognitive-behavioral treatment
* participation in other clinical trials
* other psychological treatments
* pregnancy
* illiteracy
* difficulties with understanding Dutch language
Possible Manifestation of Rhinitis After Nasal Fracture

We would like to investigate our hypothesis of a higher prevalence of nasal fracture in the history of idiopathic rhinitis (IR) patients compared to healthy controls. Therefore a retrospective analysis of 310 patients with a nasal fracture in the past would be useful to investigate the incidence of IR in this cohort afterwards (5-10 y later).

The patient population will be recruited by sending patient questionnaires (form in addendum) to patients who suffered a nasal fracture five to ten years ago (time period 2005-2013) with nose reposition afterwards under general anaesthesia in the chirurgical day care centre (CDC) of university hospital (UZ) Leuven.

The control population (HC) will be recruited by sending a slightly adapted questionnaire (form in addendum) to patients who had surgery of the vocal cords under general anaesthesia in the CDC of UZ Leuven in the same period as the patient group. The control group will be age and sex-matched with the patient group.

Eligibility Criteria:
Inclusion Criteria:

* Presence of nasal fracture in 2005-2013 and
* Diagnosis ascertained by a Ear-Nose-Throat (ENT) specialist and
* Followed by nose reposition surgery under general anaesthesia and
* Described in the clinical operation report as "mobile nose bones" OR Available radiography

Inclusion criteria of the control group:

* Presence of problem on vocal cords without previous nasal fracture
* Surgery of the vocal cords under general anaesthesia in 2005-2013
The Effect of a Combined Nature-based and Virtual Mindfulness Intervention on Perceived Stress in Healthcare Workers

Rationale: Healthcare workers that care for patients with COVID-19 are at increased risk for stress-related symptoms. When these symptoms are chronic, they can result in burnout and other mental health conditions that can exacerbate the current national health crisis. Social distancing can limit the accessibility of mental health services. Feasible and effective interventions are needed to reduce stress-related symptoms and promote resilience in this population, while adhering to federal and local guidelines to mitigate the transmission of SARS-CoV-2.

Objectives: To investigate the feasibility and efficacy of a combined nature-based and virtual mindfulness intervention on stress-related symptoms and psychological resilience in healthcare workers that care for patients with COVID-19. Both components are reported to reduce levels of perceived stress and increase psychological resilience; however, the potential additive effect of their combined delivery is unknown.

Methods: Ninety healthcare workers will be randomized into one of three groups: Nature+Mindfulness (n=30), Nature only (n=30), and Control (n=30). All participants will undergo assessments at baseline (week 0), post nature intervention (\~week 1), and post mindfulness intervention (\~week 3). The two intervention groups will have one final assessment at 2-month follow-up (\~week 11). Perceived stress is the primary endpoint and will be assessed with the Perceived Stress Scale. Secondary endpoints include sleep quality, burnout, posttraumatic stress, anxiety, depression, mindfulness, self-efficacy, and psycho-social-spiritual healing.

Anticipated Results: We anticipate that participants in the Nature+Mindfulness group will have greater reductions in stress-related symptoms and greater increases in psychological resilience compared with the Nature only and Control groups.

Potential participants will be recruited through First Descents, a non-profit 501(c)(3) organization located in the United States.

The nature-based intervention is three days long and includes activities such as hiking, mountain-biking, and kayaking. The virtual mindfulness intervention is 10 to 25 minutes daily for 10 days and is offered online. Mindfulness exercises include mindful breathing, body scan, and loving-kindness meditation.

Eligibility Criteria:
Inclusion: In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Is 18 years old or older
2. Is a healthcare worker that cares for patients with COVID-19
3. Has access to technology to access study resources online
4. Is fluent in English
5. Is able to provide their own consent

Exclusion: An individual who meets any of the following criteria will be excluded from participation in this study:

1. Is experiencing an acute psychiatric condition
2. Has a hearing impairment that is not modified with aids or devices
Computertomography-guided Wire Marking of the Liver

The aim of the study is to evaluate if it is possible to mark with a wire colorectal hepatic metastases after complete response to a neoadjuvant chemotherapy.Primary the investigators want to investigate if the wire marking is a possibility to mark respectively to identify these lesions. Further the investigators want to evaluate how many patients with complete radiologic have complete histologic response in their specimen respectively in how many specimens in the definitive histology tumor cells are visible.

Colorectal Cancer is most common in western countries. In 2007 in Austria 4462 new colorectal cancers were diagnosed. The most common place of metastasis is the liver. Approximately 15% of patients have metastasis at time of diagnosis of primary tumor and further 50% will develop metastases in the further course of the disease.However only 10-25% of patients are candidates for liver resection. New chemotherapeutics, new targeted therapies with monoclonal antibodies and better surgical techniques improved response rates, resection rates and overall survival. Owing to improved response rates metastases in the liver partially respectively completely disappeared, so that these lesions are not more visible in apparative diagnostic like CT-scan and MRI.

The question is now what to do with this patients? In the literature there is no evidence how to manage these patients. Conservative management would lead to a reoccurrence of metastases in the liver. On the other side surgical management is difficult, because metastases are preoperatively and intraoperatively not visible and resection is only possible with the removement of greater amounts of healthy tissue.

The computer tomography-guided wire marking of the metastases in the liver is a possibility to overcome these problems. All patients with complete radiologic response of metastases in the liver and metastases ≤ 1 cm are included in the study (RECISTE-Criteria). On day of surgical procedure patients will brought to interventional radiologist and based on computer tomography images before neoadjuvant chemotherapy the lesions will be marked computer tomography-guided with a wire(X-Reidy Breast Lesion Localization Needle, Cook Medical). The wire is placed percutaneously and under antibiotic prophylaxis. After the marking procedure, the patient is brought into the operating room to resect the metastases in the liver.

Eligibility Criteria:
Inclusion Criteria:

* Histologic verified cancer of the colon and rectum with metastases into the liver
* Neoadjuvant chemotherapy with complete radiologic response of metastases in apparative diagnostic respectively metastases with a diameter ≤ 1 cm.
* Technically Resectability
* Age ≥ 18 Years
* Written informed consent

Exclusion Criteria:

* Age \< 18 Years
* Technically Irresectability
* Neoadjuvant chemotherapy and response of metastases, however with a diameter \> 1 cm.
Efficacy of TOCT and (tDCS) for Gait Improvement in Patients With Chronic Stroke

Stroke is one of the major causes of disability in the Western world. Initially gait is the most affected function, 80% of patients lose this ability.

Rehabilitation in stroke patients improves walking abilities in terms of gait and related gait activities, though six months after stroke many patients are significantly disabled.

Recently, a prospective study of 205 stroke patients showed that approximately 21% of patients have a significant decrease of mobility between the first and the third year after stroke. The main finding showed that inactivity was the most important factor for the mobility decline.

Evidence about effects of direct current brain stimulation on motor recovery function of lower limb are still little, some show that quadriceps strength after stimulation of damaged M1 area increased. Another study where tDCS was associated with robotic gait training did not report any effect compared to treatment alone. It is necessary to define if a different dosage of stimulation or the association of tDCS with gait training can improve walking and if further studies are required to investigate their effectiveness.

The aim of this clinical trial is to test the possibility of gait improvement through the association of tDCS with a specific task-oriented circuit training for walking abilities, balance and mobility.

Inclusion criteria:

* Males and females subjects. Age \> 18 years, \<75 years.
* Diagnosis of first ischemic stroke \> 6 months.
* Mini mental State Examination (MMSE) \>24;
* Functional Ambulation Classification (FAC) higher or equal to 4

Eligibility Criteria:
Inclusion criteria:

* Males and females subjects. Age \> 18 years, \<75 years.
* Diagnosis of first ischemic stroke \> 6 months.
* MMSE\>24;
* FAC higher or equal to 4

Exclusion Criteria:

* Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current, presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants).
* Neurological or psychiatric pathology.
* Severe cardio-pulmonary, renal, hepatic diseases.
* Pregnancy.
Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin

This is a study to evaluate the safety, tolerability, and activity of OAP-189 in subjects with type 2 diabetes who are taking metformin for their diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have been diagnosed with type 2 diabetes, with HbA1c level \>=7.0% and \<=11.0% and a fasting glucose level \<=280 mg/dL.
* Men or women of nonchildbearing potential (WONCBP), aged 18 to 65 years inclusive on study day 1.
* Body mass index in the range of 27 to 40kg/m² (inclusive) and body weight \>=50 kg.
* Subjects must be otherwise generally healthy, but may be enrolled with a stable chronic illness, if it is well controlled and does not interfere with the primary objective of the study.
* Subjects must currently be treated for diabetes with metformin alone at a total daily dose of \>=1gm (administered QD or BID) and that dose must have been stable for at least 4 weeks before study day 1.
* Nonsmoker.

Exclusion Criteria:

* Any significant disease with the exception of diabetes mellitus.
* Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product.
* Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
* Any clinically important problems in physical examination results, vitals sign measurements, ECGs, or clinical laboratory test results.
* Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
* Positive findings of urine drug screen
* Use of any investigational or non-permitted prescription drug within 30 days before investigational product administration.
Immediate Parent -Infant Skin-to-Skin Study (IPISTOSS)

The World Health Organization recommend all stable low birth weight neonates to have Skin-to-skin-Contact (SSC) after birth. Intermittent SSC is used in Sweden in neonatal units. Observations indicate that SSC makes neonates feel good. However, there is limited research done on SSC treatment on neonates born prior to week 33.

The aim of this study is to investigate whether Skin-to-skin-Contact (SSC) leads to an improved physiological stabilization, altered epigenetic profile and improved longterm psychomotor outcome in neonates born in gestation age between week 28+0 - 32+6. This is a parallel, two-arm, multicentre, randomized controlled superiority trial. The two arms to be compared are a) immediate SSC with one parent/caregiver continous during the first 6 hours after birth and as much as possible during the first 72 hours, and b) conventional method of care during the same time.


Eligibility Criteria:
Inclusion Criteria:

* Born in gestation week plus days 28+0 - 32+6.
* Born at maternity ward at study center
* Consent from parents/caregivers
* Parent or caregiver or substitute are available to start skin-to-skin Contact during the first hour of life.

Exclusion Criteria:

* Born outside the hospital
* Triplets or more
* Known malformation which will require immediate surgical action
* On-going resuscitation or intensive Medical care (mechanic ventilation or inotropy) after the first lifespan

  \* Known congenital infection
* Parent/care giver can not communicate in Swedish/Norwegian or English
* Not suited for the study for other reasons (according to the principal investigator)
The Effect of Staining Beverage on Color Alteration During In-office Tooth Bleaching

This double-blind randomized controlled clinical trial aimed to investigate the effect of staining beverage on color alteration of in-office tooth bleaching procedures.

Sixty-three eligible participants (25 males and 38 females, mean age 26.5 years) with at least one maxillary tooth demonstrating shade A3 or darker will be recruited and randomly allocated into 3 groups (n = 21), according to the different staining beverage used in this clinical trial: Coffee for group C, Tea for group T, and distilled water for group W. All participants will receive in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval). The participants will be instructed to use only the provided beverage rinses for 30 seconds, four times daily. Colour parameters (CIE L\*, a\*, b\*) will be measured with a spectrophotometer (Vita Easyshade Advance 4.0) at baseline (T1), after the first bleaching session (T2), after the second bleaching session (T3), 1 week after the completion of in-office bleaching (T4), and 3 weeks after the completion of in-office bleaching (T5). The colour differences (ΔE) and whiteness index (W) will also be calculated. The data will be statistically analysed through repeated ANOVA and Tukey's test (α = 0.05).

Eligibility Criteria:
Inclusion Criteria:

* patients between 18 and 30 years of age, with fully erupted upper and lower incisors and canines without dental or periodontal disease or restorations, and with at least one maxillary tooth presenting color score A3 or darker, as measured with the Vita Classical guide (Vita Zahnfabrik, Bad Sa ̈ ckingen, Germany) ordered by brightness

Exclusion Criteria:

* patients with systemic diseases or oral mucosal disorders, previous bleaching treatment, patients undergoing orthodontic treatment, pregnant women, people with known allergy to the product ingredients, smokers, and alcohol abusers.
Multidimensional Assessment and Intervention for Elder Self-Neglect

This study is designed to assess the best method for caring for elders reported to Adult Protective Services (APS) for self-neglect. Specifically, this study will compare APS usual care coupled with interdisciplinary comprehensive geriatric care to APS usual care alone in improving the health and quality of live among elders with substantiated self-neglect.


Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older
* English Speaking
* Resident of Harris County, Houston Texas
* Community-dwelling
* Substantiated Self-Neglect

Exclusion Criteria:

* No other substantiated allegations
* Non-community dweller
* No available for projected follow-up period
* Impaired decision-making with no available proxy
* Already receiving care from TEAM or within the past year
* Terminal Illness