cyrilzakka/clinical-trials huggingface dataset:
Study of Home-Embedded Palliative Care for Hemodialysis- (and Peritoneal-) Dependent End-Stage Renal Disease

Home palliative care needs are often under-recognized in patients with End-Stage Renal Disease (ESRD). This pilot study is designed to evaluate the effectiveness of referrals to home palliative care services in improving patient outcomes compared with usual care among patients with ESRD admitted to a Penn hospital. Evaluating the effectiveness of home palliative care services is critical to determine whether increasing access to these services would improve patient-centered outcomes for these high-need patients


Eligibility Criteria:
Inclusion Criteria:

* Be an adult (18 years of age or older) hospitalized at a Penn study hospital
* AND digital signature of ESRD (N18.6) within the last 12 months
* AND resides in the five-county area surrounding Philadelphia which is served by Penn Palliative Care Nurse Practitioner program
* AND have one or more of the following markers of potentially unmet needs: (i) existing home care eligibility or referral for home care (but not already receiving PC); (ii) non-ambulatory status determined via nursing assessment; (iii) severe protein-calorie malnutrition; (iv) 2 or more hospitalizations within the prior year

Exclusion Criteria:

* Patients with functional kidney transplants
* Patients discharged to skilled nursing facilities and LTC facilities
TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis

Granulomatosis with polyangiitis (GPA; Wegener's) is a multi-organ autoimmune disease characterized by necrotizing granulomatous inflammation and vasculitis. Upper respiratory involvement occurs in up to 90% of patients with GPA and is often the first manifestation of the disease. Patients with upper respiratory tract disease are more at risk of local and systemic relapse. Microbial organisms may be involved in inducing disease activity in GPA. Previous culture-dependent studies found that patients with GPA were more likely to be chronic nasal carriers of Staphylococcus aureus compared to non-GPA chronic rhinosinusitis and healthy controls; additionally, GPA patients with S. aureus colonization are more likely to experience a future relapse. This led to a randomized placebo-controlled trial of trimethoprim-sulfamethoxazole (TMP-SMX) which showed this antibiotic/antifungal was effective in preventing relapse in GPA. Whether the benefits of TMP-SMX are related to its antimicrobial properties versus anti-inflammatory effects is still unknown. The objective of this study is to prospectively evaluate the changes in the nasal microbiome, mycobiome, and host immunity in patients with GPA before, during, and after receipt of TMP-SMX for 4 weeks. The target enrollment number is 30 participants, and the investigators will include patients seen at the Penn Vasculitis Center with GPA (diagnosed according to the American College of Rheumatology Classification Criteria or based on investigator's judgment). To analyze nasal microbiome and host immunity, participants will be swabbed with nasal swab and cytobrush for DNA sequencing and other studies. An optional research blood draw is also included. The investigators and coordinators will follow each patient longitudinally over a 6-month period.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 year of age or older
* Both male and female gender will be included
* Patients with GPA will be defined according to classification criteria or according to the investigator's judgment
* Patients must have history of sinonasal involvement related to GPA
* Patients must also be in remission for at least 3 months and expect to remain on stable immunosuppressive therapies for the next 24 weeks, with the exception of minor prednisone changes
* Prednisone dose or equivalent less than or equal to 10mg at enrollment

Exclusion Criteria:

* Receipt of oral antibiotics or antifungals within past 6 weeks including antimicrobials for prevention of Pneumocystis jiroveci pneumonia
* Infection involving sinuses or nose in past 4 weeks
* Receipt of topical nasal antibiotics (including mupirocin) within the past 4 weeks
* Contra-indication or prior adverse reaction to TMP-SMX such as sulfa allergy, severe renal insufficiency (CrCl \< 15 ml/min) or severe hepatic failure according to most recent labs in past 6 months
* At risk for drug interactions related to TMP-SMX
* Intra-nasal cocaine use in prior 3 months
* Known history of HIV or primary immunodeficiency syndrome
* Pregnant or planning to become pregnant in the next 6 months
Think Health! A Personal Weight Management Program

Think Health! A Personal Weight Management Program, or "¡Vive Saludable! Un programa personalizado de control de peso" aims to improve the treatment of obesity in adults in the general population, by conducting research with men and women recruited from primary care medical practices. The study has a particular focus on African Americans and Latino. The design is randomized trial of the effectiveness of two versions of a lifestyle weight loss program called delivered by primary care providers (PCP) and ancillary staff at 5 clinical practice sites to their own patients. The two versions of the lifestyle weight loss program are called Basic (minimal counseling provided by PCP every four months) and Basic Plus (same PCP counseling plus additional counseling by specially trained ancillary practice staff acting as Lifestyle Coaches (LC), monthly for the first 12 months and then every other month for up to 2 years).


Eligibility Criteria:
Inclusion Criteria:

1. Women and men
2. Ages 18 to 70 years
3. Body mass index \> 25 kg/m2 but \< 55 kg/m2 or who weigh \<400 pounds.

Exclusion Criteria:

1. Pregnancy or lactation, since contraindicated for weight loss or affecting weight status
2. Weight loss \> 10 pounds in the previous 3 months
3. Current use of weight loss medications
4. Use of medications known to result in significant weight gain (e.g., oral steroids or second generation anti-psychotics)
5. Psychiatric disorders including untreated major depression, psychosis, bulimia nervosa, and substance abuse
6. Active chemo- or radiation therapy
7. Unstable renal, hepatic, or cardiovascular disease, including malignant arrhythmias
8. Recent (past 3 months) history of myocardial infarction, stroke, or congestive heart failure
9. Participants age \< 18 will be excluded because we are only using adult practices and a different type of program would be needed for patients \< 18, and age \> 70 years will be excluded because our experience has been that a specially tailored program would be needed. As a design consideration, we wanted to decrease the heterogeneity of the program.
10. Participants with a BMI \> 55 kg/m2 will be excluded because they are likely to require more extensive medical and behavioral care than can be provided in this study.
11. More than 1 participant residing in the same household will be excluded to avoid contamination across the treatment conditions.
12. Final exclusion criteria will be determined in collaboration with participating primary care providers
Reliability and Validity of The Figure of 8 Walk Test With and Without Dual-Task

For people with stroke, walking on a curved path is more difficult than walking on a straight path and can lead to falls. Most of the outcome scales assessing the gait of people with stroke involve walking in a straight line or with one turn. Assessing a person with stroke walking on a straight path may not be indicative of real-life gait-related performance. The Figure of 8 Walk Test (F8WT) includes a straight and curved gait that may represent the daily gait. To the best of our knowledge, there are no studies evaluating the reliability and validity of the dual-task F8W test in individuals with stroke. Therefore, the aim of this study was to evaluate the validity and reliability of the F8W and dual-task F8W test in individuals with stroke.

For people with stroke, walking on a curved path is more difficult than walking on a straight path and can lead to falls. Most of the outcome scales assessing the gait of people with stroke involve walking in a straight line or with one turn. Assessing a person with stroke walking on a straight path may not be indicative of real-life gait-related performance. The Figure of 8 Walk Test (F8WT) includes a straight and curved gait that may represent the daily gait. To the best of our knowledge, there are no studies evaluating the reliability and validity of the dual-task F8W test in individuals with stroke. Therefore, the aim of this study was to evaluate the validity and reliability of the F8W and dual-task F8W test in individuals with stroke.

This prospectively designed study evaluated the demographic and clinical characteristics of the participants. The main outcome measures included the F8WT, dual-task F8WT, Standardised Mini Mental Test, The National Institutes of Health Stroke Scale, Timed-Up and Go Test, 10-metre walk test, Modified Four Square Step Test and Six-Spot Step Test.

Eligibility Criteria:
Inclusion Criteria:

* 50 years of age or older,
* Having had only one unilateral stroke at least 6 months before the study,
* Being medically stable,
* Being able to walk at least 10 metres with a cane or independently,
* Getting at least 24 points from the Standardised Mini Mental Test,
* Being able to perform the cognitive task (subtraction) given during the assessments.

Exclusion Criteria:

* Presence of additional orthopaedic, neurological or cardiovascular diseases that may affect balance and walking,
* Uncorrectable visual and hearing problems
Impact of a Non-Drug Choice on Cocaine Reinforcement

Cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. The goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. This study will incorporate self-administration procedures and a non-drug alternative reinforcer, which is hypothesized to reduce the reinforcing effects of cocaine.


Eligibility Criteria:
Inclusion Criteria:

* Cocaine dependence, otherwise healthy

Exclusion Criteria:

* Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease
Anticoagulation Medical Home

The primary study goal is to improve the quality of care transitions for patients with new episodes of venous thromboembolism (VTE).

Primary Outcomes: To measure differences in the quality of care transition, as measured by the Care Transition Measure (CTM)-15 in the investigators target population of patients with incident VTE randomized to either a multicomponent, anticoagulation medical home intervention or usual care.

Secondary Major Outcomes: To measure the difference in recurrent VTE, major hemorrhage, all-cause re-admissions, and mortality between the investigators intervention and comparison groups at 30 and 90 days in the investigators target population.

Secondary Other Outcomes: To measure patient knowledge, health-related quality of life, and time in the therapeutic range (TTR) for patients on warfarin in the investigators target population.


Eligibility Criteria:
Inclusion Criteria:

* hospital admission;
* diagnosis of:

  * VTE (first or subsequent episode); or
  * DVT of leg or pelvis or upper extremities or other site confirmed by ultrasound or CT scan; or
  * PE with a positive CT spiral exam, pulmonary arteriogram, CT angiogram, or high probability ventilation perfusion scan.
* for whom it is anticipated the treating medical team will prescribe an oral anticoagulant upon hospital discharge.

Exclusion Criteria:

* Not engaged in Primary Care (has not seen a Primary Care Practitioner within the previous 18 months).
Oral Health in Covid-19 Survivors

Aims are to assess periodontal health and salivary stress/ immunity responses in COVID-19 survivors

There are lack of data concerning oral health in COVID-19 survivors, nevertheless, many middle-aged patients with oral symptoms of Post-acute COVID-19 report xerostomia and taste impairment and suffer from oral hypofunction, thus may be susceptible to periodontitis and oral frailty. Post-acute or long COVID-19 is/would be the health hallmark of post-COVID-19 era, manifested as a multiplicity of clinical problems and requiring conceptual framework aiming at multidisciplinary health preserving activities. There are various factors which may affect oral and periodontal health in post-COVID-19 era, such as disruption of dental professional care due to the fear of infection, virus-induced disturbance of oral homeostasis and, as a common denominator- COVID-19-induced psychological stress. Expected results would not just offer epidemiological data but also, mechanistic background for defining risks and modified measures aiming to preserve oral health in post-COVID-19 era.

Eligibility Criteria:
Inclusion Criteria:

* self-reported good general health, ≥ 14 erupted teeth excluding third molars. For periodontally healthy: Bleeding on probing score ≤10%, without attachment loss and radiographic bone loss and probing depth ≤ 3 mm in every site (Trombelli L et al., 2018). For periodontitis patients: periodontitis in stages II-IV.

Exclusion Criteria:

* history of periodontal treatment in previous six months, acute oral infection, presence of systemic disease(s), pregnancy, lactation, smoking ≥ 10 cigarettes per day
Timely Detection of Treatment Emergent Serious and Non-serious Adverse Events for Saxenda® in Mexican Patients

This trial is conducted in North America. The aim is to investigate timely detection of pancreatitis cases as well as cases of suspicion of serious and non-serious adverse reactions possibly or probably related to Saxenda® in Mexican patients.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* The decision to initiate the treatment with commercially available Saxenda® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
* Obese patients (BMI equal to or above 30 kg/m\^2) or overweight patients (BMI Equal to or above 27 kg/m\^2) with at least one weight related comorbidity according to Saxenda® label text in Mexico
* Age equal or above 18 years at the time of signing informed consent

Exclusion Criteria:

* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Hypersensitivity to Saxenda® or to any of its excipients
* Females of child-bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
* Diagnosis of type 1 diabetes
Clinical Trial of Quantitative Detection Kit for Hsp90α in Colorectal Cancer

Detect plasma Hsp90α concentration of colorectal cancer patients, healthy volunteers, benign colorectal diseases patients.

Detect plasma Hsp90α concentration of colorectal cancer patients, healthy volunteers, benign colorectal diseases patients, validate accuracy, specificity and sensitivity of Hsp90α kit.

Eligibility Criteria:
Inclusion Criteria:

* colorectal cancer patients, healthy volunteers, benign colorectal diseases patients

Exclusion Criteria:

* Patients who previously accepted radiotherapy
Efficacy of Increasing Physical Activity to Reduce Children's Visceral Fat

The purpose of this trial is to examine whether adding greater physical activity to standard family-based behavioral pediatric obesity treatment decreases the amount of visceral fat among treated overweight children.

Adult studies suggest that greater visceral fat confers more health risk than peripheral fat accumulation and that physical activity interventions (as part of general weight control interventions) are efficacious in reducing adults' visceral fat. There are few studies examining the impact of physical activity and/or general weight loss on children's visceral fat accumulation. The present study compares standard family-based behavioral weight control treatment for pediatric obesity (STANDARD) with standard treatment plus added emphasis on participants attaining high levels of physical activity (ADDED). Both conditions receive the same behavioral dietary intervention and therapeutic contact and attention. The ADDED condition receives the recommendation and goal to be active at least 90 minutes per day, with behavioral strategies targeting increasing and sustaining these high levels of physical activity.

Eligibility Criteria:
Inclusion Criteria:

* 7-12 years old
* \>85th percentile BMI
* have at least one parent with a BMI\>25
* able to engage in at least moderate intensity physical activity
* child and parent willing and able to participate in behavioral treatment
* English-speaking

Exclusion Criteria:

* child or parent already enrolled in another weight control program
* child or parent with a medical condition known to affect weight or growth
* child or parent with significant mental illness that would interfere with engaging in treatment
* child or parent with a current or past diagnosed eating disorder
* child or parent currently taking any medication that affects weight or growth
* child who is more than 120% above their median BMI for age and gender
Prospective Study to Compare Results of STN-DBS Between Early Treated and Late-treated PD Patient

The aim of this study is to investigate the impact of DBS not only no motor outcomes, but also on neuropsychological and psychiatric aspects and on quality of life in young patients with a short history of disease.

Bilateral STN DBS is a powerful treatment for advanced Parkinson disease with Levodopa induced motor complications. The beneficial effects of STN stimulation on motor disability and quality of life have been proved. However, the mean delay before neurosurgery is currently 14 years after diagnosis, when medical treatment no longer controls PD symptoms and quality of life is already severely impaired.

Aim of this study is to prospectively assess the effects of bilateral STN stimulation on motor signs, psychological and psychiatric aspects and quality of life in a group of 20 patients with PD who underwent surgery after 5 years from the onset of the disease. These results will be compared with those of a group of 20 patients with a PD history from more than 10 years.

The two groups of patients will be evaluated at baseline and after 3 and 12 months from DBS implant; at each visit neurological and motor examinations were assessed and dedicated neuropsychological and psychiatric tests will be performed.

Neurosurgery may be considered superior to medical treatment alone even in mild to moderate PD of 10 years duration, rather than a last resort in very advanced stages of the disease. Thanks to this study we could compare motor outcomes and cognitive aspects between DBS patients with a short and with long history of disease

Eligibility Criteria:
Inclusion Criteria:

* suffering from PD of \> 10 years and with LTS (long term L-dopa syndrome), or with a duration of PD of 5 years
* age\< 70 years
* normal brain MRI
* absence of dementia (Mini Mental State Examination ≥ 24)
* absence of severe psychiatric diseases
* Signed informed consent form
* Absence of allergy to metal
* Italian native speaker
* Absence of communicative or perceptive deficits

Exclusion Criteria:

* Any form of familiar PD
* Presence of neoplasia
* Presence of HIV
* Presence of severe metabolic diseases
* Severe cardiac/respiratory/renal or hepatic diseases
* Ongoing treatment with immunodepressive/ immunomodulate drugs
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)

Background: Cardiac rehabilitation (CR) services aim to improve heart disease patients' health and quality of life and reduce the risk of further cardiac events. Depression and anxiety are common among CR patients, and current psychological treatments for cardiac patients have minor effects. However, the NIHR-funded PATHWAY trial found that group Metacognitive Therapy (MCT) was associated with improvements in anxiety and depression when added to CR and was more effective than usual CR alone. Group MCT was also associated with preventing anxiety and depression. The next steps will establish beacon sites for delivering MCT and pilot-test additions to the national audit of cardiac rehabilitation (NACR) data capture mechanism to include an MCT data field. Such steps will support a quantitative and qualitative evaluation of implementation.

Methods: The investigators aim to address questions concerning the quality of patient data recorded, level of adoption at sites, the characteristics of patients attending MCT, the impact of adding MCT to CR on mental health outcomes, and patient, healthcare staff and commissioner views of barriers/enablers to implementation. The investigators will deliver training in group MCT to CR staff from CR services across England. The investigators will conduct semi-structured qualitative interviews with CR staff trained in group MCT to assess views on the training programme, including successes and barriers to implementation of training and delivery. The investigators will interview 8-10 CR stakeholders to identify any barriers to implementation and how these might be resolved.

Discussion: The study will support development of an NHS roll-out strategy and systematic data collection that can be used to evaluate wide-scale implementation. The study can benefit service users by improving patients' mental health outcomes and CR practitioners' clinical skills. Results will be disseminated via peer-reviewed journals, national and international conferences and service user/voluntary sector organisations and networks.


Eligibility Criteria:
Qualitative Inclusion Criteria:

All CR staff must meet the following inclusion criteria to be eligible:

1. Be a healthcare professional working with cardiac rehabilitation services being trained to deliver group-MCT
2. Be a healthcare professional working with cardiac rehabilitation or be a professional working at the commissioner level
3. Minimum of 18 years old
4. Competent level of English Language skills (able to read, understand and complete interviews in English).

Exclusion Criteria:

1. Below 18 years of age
2. Not a healthcare professional or professional working at the commissioner level
3. Does not have a competent level of English language skills

Audit inclusion criteria:

All patients attending CR who meet the NICE recommendations for acute coronary syndrome (NG185) and heart failure (NG106) will be offered group MCT as part of routine CR.
Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

Study of eculizumab ability to correct the reperfusion injury of the kidney allograft.

Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion injury, it is hypothesized that C5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. It was further hypothesized that eculizumab, antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent ischemic reperfusion injury in high risk recipients. For testing this hypothesis, this study is a pilot prospective study to test the efficacy of eculizumab in preventing the development of reperfusion injury and contribute graft survival.

Eligibility Criteria:
Inclusion Criteria:

1. age 1-80
2. weight - \>6 kg
3. male or female
4. recipient of first kidney graft either from standard criteria deceased or live donor
5. end stage renal disease or congenital nephrotic syndrome -

Exclusion Criteria:

1. Blood group (ABO) incompatible transplantation
2. presence of donor-specific anti-human leukocyte antigen (HLA) antibodies
3. multiorgan transplantation
4. previous transplant
5. patients infected with HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV)
6. patients with haemolytic-uraemic syndrome (HUS) -