cyrilzakka/clinical-trials huggingface dataset:
Effects of IV-Administered Ca-DTPA and Zn-DTPA To Treat Patients With Gadolinium Deposition Disease

Purpose: There are two goals we have for this prospective single arm study; to see an increase in the amount of gadolinium in 24 hour urine collection following each infusion treatment with Calcium and Zinc DTPA, and to see a reduction or elimination of gadolinium deposition disease (GDD) symptoms.

Participants: Twenty (20) patients who are suffering from gadolinium deposition disease (GDD)

Procedures: Over a series of three (3) treatment time-points patients will be treated with IV Ca-DTPA on day one, and Zn-DTPA on day two.


Eligibility Criteria:
Inclusion Criteria: Exhibiting 3 or greater of the following symptoms which must be present after having been administered a GBCA:

* Cognitive disturbance
* Extremity pain
* Headache
* Chest wall pain
* Skin induration
* Skin hyperpigmentation
* Skin pain
* Arthralgia

Exclusion Criteria:

* Pregnant or lactating
* Less than 18 years old
* No evidence of gadolinium (has to have shown previous demonstration of Gd by urine analysis or bone biopsy)
* Known connective tissue disease such as Systemic Lupus Erythematosus or Scleroderma
* Severe hemochromatosis or Wilson's disease
* Glomerular Filtration Rate (GFR) ≤ 60
* Have had an investigational drug within last 30 days
* Unable to give written consent
* Multiple Sclerosis
* Chronic heart failure
* Cirrhosis of the liver
Use of Socially Assistive Robots for Long Term Care Older Adults With Cognitive Impairment and Apathy

The objective of this study is to demonstrate the impact of a socially assistive robot system on reducing apathy among cognitively impaired older adults residing in long term care facilities. Earlier phases of this project demonstrated the feasibility and acceptability of the robotic system. First, investigators will improve the social robotic interaction architecture through additional software development, enhance its versatility, and make it easy for non-experts to run. Second, 188 participants will be randomized to either usual activity programs at the long term care facility, or the usual activity programs plus the robotic activities. Researchers will examine the effect on apathy and also plan on examining underlying individual and facility factors that influence the impact of the robotic activities.


Eligibility Criteria:
Inclusion Criteria:

* Residing \>3 months in long term care facility
* Evidence of mild cognitive impairment (SAGE score 15-16), mild dementia (SAGE score \<15, AD8\<2, DSRD\<19), or moderate dementia (SAGE \<15, AD8\>1, DSRD 19-36)
* Symptoms of apathy (Score 30+ on AES-C)

Exclusion Criteria:

* Severe cognitive impairment
* Physically unable to participate
* Unable to provide assent
* Uncorrected vision or hearing
* Never spoke English
* Unable to sit comfortably in chair
* Acutely ill, terminally ill or unresponsive
* Unable to be moved to activity location
* Aggressive or combative
STRONG for Surgery & Strong for Life - Intensive Prehabilitation for Risk Reduction in Ventral Hernia Repair

The five risky lifestyles Smoking, Nutrition (obesity and malnutrition), risky Alcohol intake, and Physical inactivity (SNAP) are common in surgical patients and associated with worse postoperative outcomes. Mono-factor interventions targeting and improving these risky lifestyles have been shown to reduce the risk at surgery, but there is a lack of systematic assessment of all five lifestyles of the patient before surgery and related optimization.

This study aims to evaluate the effect of intensive combined lifestyle interventions (the STRONG programme) compared with treatment as usual in patients undergoing ventral hernia repair on postoperative complications, health, and costs on short and longer term.

The hypothesis is that the STRONG programme will halve the complication rates within 30 days.

This study is a multicentre randomised controlled trial. A total of 400 participants with one or more of the five risky SNAP lifestyles will be randomised to either the STRONG programme (a prehabilitation intervention) or treatment as usual preoperatively (control). The STRONG programme is individually tailored to the needs of the participants. The program contains education, motivational, and pharmaceutical support. All participants will be followed up at the end of the intervention/at surgery, one, three, and six months after surgery. Long-term outcomes are followed up from national registers two years after surgery.

Interim analysis will be employed.

Eligibility Criteria:
Inclusion Criteria:

* Participants ≥18 years scheduled for ventral hernia repair (defect smaller than 8cm)
* Enough time for at least 4 weeks of prehabilitation
* Screened positive for at least 1 risky SNAP factor
* Signed informed consent

Exclusion Criteria:

* Ventral hernia repairs with defect larger than 8 cm
* Pregnancy/breastfeeding
* Allergy/other contradiction to pharmaceutical and/or nutritional support
* Contradiction to exercise
* Previous complicated alcohol withdrawal symptoms (delirium or seizures)
* Not able to participate in intervention due to psychiatric ilness
Cyclosporine a Pretreatment and Kidney Graft Function

Organ donors included in the study are randomized to a control group or an intervention group receiving 2.5 mg/kg of cyclosporine A before organ procurement. Harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. According to the pretreatment of the transplant, delayed graft function during the first week was evaluated as well as kidney function at different timepoints and mortality during the first year after transplantation.

Organ donors included in the study are randomized to a control group receiving a placebo or an intervention group receiving 2.5 mg/kg of cyclosporine A before organ procurement. In the operating theater organs are harvested. Thereafter, harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. The management of transplanted patients is performed as usual. According to the pretreatment of the transplant, delayed graft function during the first week (need of at least one dialysis session) was evaluated as well as kidney function at different timepoints (slow graft function, estimated creatinine clearance on day 3 and 7, acute and chronic graft rejection), length of hospital stay and mortality during the first year after transplantation.

Eligibility Criteria:
Inclusion Criteria:

For organ donors:

* Male and females aged 18 to 80 years
* Brain death

Inclusion criteria for organ recipients:

* Male and females aged 18 to 80 years
* Indication of kidney transplantation
* Informed consent

Exclusion Criteria:

For organ donors:

* Contra-indication for multiorgan procurement (infections, cancer, etc)
* Preexistent chronic renal failure.
* Refusal for organ procurement by the donor (confirmed by the French national register or reported by the next-of-kin).

Exclusion criteria for organ recipients:

* Need for a double kidney transplantation.
* Need for a multiorgan transplantation
Pilot Testing of Food Images in Children

This is a single, un-replicated visit to the Children's Metabolic Kitchen and Eating Behavior Lab designed to gather data on children's responses to images used in MRI studies. Additionally, a demographic questionnaire for parents will be piloted.

The Pilot Test Session will take place in the Children's Metabolic Kitchen and Eating Behavior Lab in Chandlee Laboratory. Up to four hundred subjects (200 children and 200 parents) may be recruited.

Child Procedures: Both Child and parent's current height and weight will be obtained. After being seated at a computer, they will complete the Children's Anxiety Meter-State (CAMS) and a Freddy Fullness pictorial hunger score. Then their ability to discriminate between portion sizes will be assessed. They will be shown several pictures of macaroni and cheese on a standard white plate with a grey tablecloth background and asked to determine which picture had a larger amount of food. Finally, they will view 180 pictures of common foods and non-food objects (office supplies). After each picture, children will be instructed to answer questions about the image (what is this image, how happy does it make you feel and how excited does it make you feel). Children will then score their hunger again with a Freddy Fullness pictorial hunger score and take a Post-Scanning Questionnaire.

Parent Procedures: Parent's current height and weight will be obtained and he/she will complete a demographic questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Child is 6 to 10 years old
* Child is physically healthy and does not have a diagnosed learning disorder

Exclusion Criteria:

* Child is \< 6 or \> 10 years old
* Child is not physically healthy or has a diagnosed learning disorder
Non-Interruptive Alerts for Improving Use of Clinical Decision Rules

This study is an extension of a planned quality improvement project that aims to promote standard of care by increasing the use of evidence-based clinical decision rules amongst emergency medicine providers in the University of Utah Emergency Department. Patient-specific information from the EHR will be used to recommend the use of relevant clinical decision rules to emergency medicine providers at the point-of-care. These recommendations will be in the form of non-interruptive alerts with one-click access to the suggested decision rules through the MDCalc Connect EHR add-on application. Specific aims of the study are to determine if 1) patient-specific non-interruptive alerts increase the use of clinical decision rules amongst emergency medicine providers and 2) an increase in the use of clinical decision rules affects provider ordering habits.


Eligibility Criteria:
Patient Inclusion Criteria:

* 16 years of age or older
* Qualifying chief complaint\*

Patient Exclusion Criteria:

* None

  * A full list of the qualifying chief complaints is provided in Appendix A of the full research protocol.
Comparison Between Losartan and Benazepril in Diabetic Hypertensive Patients Not Controlled by Amlodipine

The purpose of this study is to compare losartan and benazepril in diabetic patients whose high blood pressure is not controlled by amlodipine and its relationship to statin current use.

Hypertension and diabetes mellitus are important risk factors for cardiovascular morbidity and mortality. Endothelial dysfunction and vascular rigidity are two pathophysiological mechanisms that may explain this relationship. Recent publications showed that both ACEi (angiotensin-converting enzyme inhibitor-induced) and ARB (angiotensin receptor blocker) were capable of improving vascular stiffness and endothelial function, and that these effects occurred despite blood pressure reduction.

This study main objective is to assess if ARB (losartan) effects are different from ACEi (benazepril) in endothelial function in patients with diabetes mellitus type 2 and blood pressure not controlled by amlodipine and its relationship to statin current use.

Secondary analysis of vascular stiffness will be measured by pulse wave velocity and augmentation index. Echocardiographic parameters, such as indexes of diastolic function, will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatorial patients with age between 40 and 70 years-old.
* Systemic arterial hypertension previously diagnosed and in use of two or less anti-hypertensive drugs in the preceding 4 weeks.
* Type 2 diabetes mellitus in use of oral medication that were not changed in the preceding 4 weeks. Glycated hemoglobin A1c less than 9.0%.
* Accepted the consent form.

Exclusion Criteria:

* Office systolic blood pressure equal or more than 180 mmHg, with or without treatment
* Office diastolic blood pressure equal or more than 110 mmHg, with or without treatment
* Evidences of a secondary cause for hypertension
* Glycated hemoglobin A1c \> 9.0%
* Insulin therapy
* Chronic kidney disease stage 4 or 5 or in dialysis
* Advanced target organ lesion, obtained by history or additional exams, and defined by: previous myocardial infarction, heart failure with ejection fraction less than 40%, cerebral vascular accident (ischemic or hemorrhagic), peripheral vascular disease (claudication or doppler with obstruction \> 50% of vascular lumen), retinopathy with visual loss, symptomatic neuropathy.
* Cardiac arrhythmias, except for ectopic beats
* Any clinical or disabling condition that, in the opinion of the investigators, may confound or prejudice study results.
* Severe mitral regurgitation.
* Women in fertile age without contraceptive methods in use.
* Breastfeeding women.
Gamma Knife Radiosurgery vs Initial Conservative Treatment for Vestibular Schwannoma Patients With Preserved Hearing, a Prospective Randomized Study

The effect of Gamma knife radiosurgery (GKRS) on hearing loss, in patients with vestibular schwannoma (VS) and preserved hearing is still unclear. Retrospective data indicate that the hearing is preserved in most patient years after the gamma knife treatment. Recent prospective data suggests that radiosurgery could be a hearing preserving treatment for these patients.

The main objective of this study is to evaluate if GKRS can inhibit progression of hearing loss in patients with VS. Patients with preserved hearing will be offered to participate in the study and randomized ether to GKRS or initial conservative treatment for their vestibular schwannoma. They will then be followed with scheduled magnetic resonance image(MRI) and audiometry and evaluated after one, three and five years after treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients newly (\<6 months) diagnosed with Vestibular schwannoma less than 20 mm in diameter.
2. Vestibular schwannoma with or without evidence of growth.
3. Patients between 18 and 80 years of age.
4. Karnofsky performance score \>70
5. Patients with vestibular schwannoma and preserved hearing according to Gardner Robertson class 1-2, and speech discrimination (SD) scores between 50-100% will participate in the hearing preservation part of the study.

   -

Exclusion Criteria:

* 1. Patients with Neurofibromatosis type 2 will be excluded to achieve a homogenous study population.

  2. Patients who had other treatments prior to the GKRS (usually microsurgery (MS), GKRS or external beam radiation) for their tumour will also be excluded for the same reason.

  3. Patients who are not citizens in the country where they will be followed will be excluded, to reassure the same follow up within the study population.

  4. Hearing loss due injury or to active ear disease, such as Meniere´s disease, otosclerosis or chronic otitis media.

  5. Patients with poor comprehension of the the language in the country where they are followed, such that adequate performance on speech tests, are unlikely.

  6. Claustrophobia, making MR follow up impossible without sedation. 7. Alcohol- or narcotic abuses that effect compliance to the follow up. 8. Uncontrolled neoplastic disease.
POPULAR: POst-operative PULmonary Complications After Use of Muscle Relaxants in Europe

International multicenter observational study of a random-sample cohort of patients undergoing any in-hospital surgical procedure under general or regional anaesthesia during a continued 14-day period of recruitment.

Primary hypothesis of this study is that the use of muscle relaxants, their reversal agents, or neuromuscular monitoring increases the incidence of postoperative pulmonary complications. The secondary hypothesis is that the use of muscle relaxants increases in-hospital mortality.

Overall postoperative mortality for patients undergoing non-cardiac surgery in Europe is 4% (EUSOS study). Postoperative pulmonary complications are a major factor, which increase patient morbidity and mortality (PERISCOPE study). This study is designed to evaluate the effects of management of neuromuscular blockade on postoperative pulmonary complications in a general unrestricted anaesthetized population across Europe. The investigation will be a continuation of the European EUSOS and PERISCOPE studies. Based on a well-recognised body of surrogate data, it is hypothesized that incorrect approaches to the use, monitoring, and reversal of muscle relaxants will increase the incidence of in-hospital postoperative pulmonary complications and prolong hospital stay.

The investigators will not modify a participating centre's customary management of patients. Patients with postoperative pulmonary complications will be identified by postoperative assessment and consulting medical records for events that fulfil the definition of postoperative pulmonary complications.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients undergoing any in-hospital surgical procedure under general or regional anaesthesia during the defined continued 14-day period of recruitment.

Exclusion Criteria:

1. Patients less than 18 years of age
2. Patients scheduled for local or regional anaesthesia only
3. Patient's anaesthetic procedure scheduled outside an operating room
4. Ambulatory patients = Patient planned to be discharged within 12 hours post anaesthesia
5. Patient with preoperatively intubated trachea
6. Patient from an intensive care unit (ICU)
7. Patient scheduled for additional surgical / anaesthetic procedure in the next 7 days
8. Patients who had a surgical / anaesthetic procedure within the past 7 days
9. Patient born outside the predetermined 'month(s)' allocated for the specific study centre.
Non-integrated Costs Increase Effectiveness of Incentives

The investigators will test the hypothesis that the control (no incentive) condition will have the lowest vaccination rate, the main task condition will have a significantly higher vaccination rate while the indirect condition will have the highest vaccination rate.

Participants will be randomly assigned to one of the three message conditions and their vaccination records obtained from the university Occupational Health Department.

The investigators will send e-mails to a complete mailing list of faculty and staff at a university. Each recipient will be randomly assigned to one of three conditions: control, main task incentive or indirect incentive. Our main dependent variable will be whether or not participants decide to get vaccinated. The investigators will obtain their actual vaccination records from the university Occupational Health Department.

Within the e-mail message, participants will indicate whether or not they intend to get vaccinated. Intention serves as an indirect dependent outcome. Upon clicking to indicate their intention, participants are redirected to a page which gives further instructions on how to proceed.

Participants who vaccinate will be asked to complete a brief follow-up questionnaire to evaluate their experience with vaccination and (for those offered and incentive) to provide contact information to receive their payment.

Eligibility Criteria:
Inclusion Criteria:

* Must be faculty or staff at Rutgers University.

Exclusion Criteria:

-
Predictors of Disease Progression in Primary Focal Segmental Glomerulosclerosis

Focal segmental glomerulosclerosis (FSGS) is one of the most common primary glomerular diseases leading to end stage renal disease. In this study, our aim is to evaluate the effects of histopathological, clinical, and laboratory features of patients with primary FSGS on the disease progression.

Focal segmental glomerulosclerosis (FSGS) is one of the most common primary glomerular diseases leading to end stage renal disease worldwide. Numerous studies have been conducted in order to identify the etiology of this debilitating disease. Beyond the etiological research, however, few studies managed to demonstrate the possible predictors of disease progression in patients. Therefore, we aim to evaluate the effects of histopathological, clinical, and laboratory features of patients with primary FSGS on the disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy-proven primary focal segmental glomerulosclerosis.
* Patients who have a renal biopsy available for reviewing including 8 or more glomeruli.
* Patients who have been followed-up for at least 6 months or have progressed to primary outcome regardless the duration of follow-up.

Exclusion Criteria:

* Patients who have secondary focal segmental glomerulosclerosis attributable to any other condition (e.g., obesity, HIV, relevant drug exposure).
* Patients who have a genetic mutation or variation creating a tendency for developing focal segmental glomerulosclerosis.
* Patients who are unwilling or unable to consent.
Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma

The purpose of this study is to determine the effects of combination treatment of Nivolumab with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated advanced Melanoma.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Potential subjects must have advanced Melanoma (stage III or IV as confirmed by biopsy) with spread to other sites in the body and unable to be removed by surgery.
* Potential subjects must be newly diagnosed with advanced melanoma and received no treatment for the advanced disease.

NOTE: Prior adjuvant or neoadjuvant melanoma therapy (including anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways, such as anti-CD-137) is permitted if the therapy was used in the adjuvant or neoadjuvant setting but not in the metastatic setting. These drugs must be discontinued 6 months prior to study entry and the side effects related to the prior therapy resolved.

* Potential subjects (with disease spread to brain) who previously received primary treatment are permitted if there was no evidence of disease as confirmed by the MRI (at least 2 weeks after the primary treatment is complete and with in 6 weeks of the first dose of the study drug). Potential subjects must not have received intravenous steroid treatment (\>10 mg/day) intravenously for at least 2 weeks prior to study drug administration.

Exclusion Criteria:

* Leptomenigeal metastases
* Subjects with autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
* All side effects from previous primary treatments other than alopecia, fatigue, or peripheral neuropathy must have resolved to Grade 1 or baseline before administration of study drug.