cyrilzakka/clinical-trials huggingface dataset:
Improving Care for Nursing Home Pneumonia in NHCUs and Veterans' Homes

Nursing Home Acquired Pneumonia (NHAP) causes excessive morbidity, mortality, hospitalization, and loss of function. At any given time, 1.1-2.5% of veterans who reside at nursing home care units (NHCUs) and State Veterans Homes (SVHs) are ill with pneumonia. Multi-faceted implementation of evidence-based guidelines has been shown to be feasible in the private sector. Retrospective studies demonstrate an association between guideline adherence and improved survival.

Background:

Nursing Home Acquired Pneumonia (NHAP) causes excessive morbidity, mortality, hospitalization, and loss of function. At any given time, 1.1-2.5% of veterans who reside at nursing home care units (NHCUs) and State Veterans Homes (SVHs) are ill with pneumonia. Multi-faceted implementation of evidence-based guidelines has been shown to be feasible in the private sector. Retrospective studies demonstrate an association between guideline adherence and improved survival.

Objectives:

Assess the feasibility of a QUERI-like strategy to translate the guidelines into practice at VA-affiliated nursing homes through focus groups, interviews, and a small intervention trial.

Methods:

Nursing staff focus groups, key informant interviews, and tests of academic detailing (educational outreach) scripts were conducted at five facilities. Based on the information gathered, the QUERI-like intervention was modified and tested at the Florence, Colorado SVH during one influenza season compared to no intervention at a nearby SVH. Forty random SVH nursing staff took an anonymous telephone survey of knowledge and attitudes about NHAP twice prior to the intervention. A second randomly selected group of CNAs and nurses took the survey after the intervention. Research assistants enrolled residents with NHAP, interviewed them and their nurses about their quality of life, assessed their function and reviewed their medical records. The intervention was multifaceted, including (1) a formative phase to tailor implementation and foster staff investment in process and outcomes, (2) institutional level change to facilitate immunization and use of appropriate antibiotics and tests; (3) interactive educational sessions to improve nursing assessment; and (4) academic detailing to physicians to impact diagnostic and prescribing practices. Data were analyzed by Template Analysis Technique for qualitative data; test-retest reliability of the knowledge and attitude survey; exploratory bivariate comparison of intervention delivery and uptake, process of care and outcomes between the intervention and control facilities.

Status:

Project work is ongoing.

Eligibility Criteria:
Inclusion Criteria:

Residents of Florence and Walsenburg, Colorado State Veterans Homes

Exclusion Criteria:

Residents within 48 hours of death or if in facility \< 5 days
Assessing the Quality of Life and Social Support in Age-Related Macular Degeneration Patients

The aim of this study is to evaluate the quality of life of AMD patients related to vision using the short version of the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25), patients' social support, and their relationship with demographic and clinical variables.

Background and study aims. Age-related macular degeneration (AMD) is the most prevalent chronic progressive ocular disease. It has been shown in several studies that AMD affects the quality of life of patients. The aim of this study is to evaluate the quality of life of AMD patients related to vision using the short version of the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25), patients' social support, and their relationship with demographic and clinical variables.

Who can participate? Patients with AMD, who wish to participate, will be recruited. Patients will be recruited from three locations of the Kazakh Scientific - Research Institute of Eye Diseases in Almaty, Nur-Sultan and Shymkent.

What does the study involve? The study involves collecting demographic data of the participants, collecting baseline visual testing data from medical records, filling out of the NEI-VFQ-25, and answering two yes/no questions related to the social support and reliability of social support.

What are possible benefits and risks of participating? Assessment of quality of life and social support of the AMD patients is a first step of developing targeted psycho-social support programs for AMD patients.

Where is the study run from? Patients will be recruited from three locations of the Kazakh Scientific - Research Institute of Eye Diseases in Almaty, Nur-Sultan and Shymkent.

When is the study starting and how long it is expected to run for? Start date 03/02/2020. End date 27/08/2022.

Who is funding the study? No funding for this study. Who is the main contact? Principal investigator: Inara Ismailova; +380 73 200 0688; i.ismayilova@gmail.com

Eligibility Criteria:
Inclusion Criteria:

* age-related macular degeneration; ability to speak and understand Russian and/or Kazakh language; willingness to participate

Exclusion Criteria:

* Presence of glaucoma, cataracts of grade 2 or more according to the Lens Opacities Classification System (LOCS) III, and the presence of corneal opacities or any other retinal diseases
A Study of TQ-B3139 Capsules in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer

This is a single-arm, multi-center clinical trial to evaluate the safety and efficacy of TQ-B3139 capsules in patients with MET gene abnormal advanced non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 2. Life expectancy ≥12 weeks; 3. MET-altered non-small cell lung cancer (NSCLC) ; 4. Has at least one measurable lesion; 5. Previous standard treatment has failed; 6. Adequate organ system function; 7. Left ventricular ejection fraction (LVEF) ≥50%; 8. Understood and signed an informed consent form.

Exclusion Criteria:

* 1. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 2. Has received c-MET inhibitors; 3. Has received other system anti-tumor treatment within 4 weeks before the first administration; 4. Has received major surgical treatment within 4 weeks before the first administration; 5. Has received radiotherapy or any surgery within 2 weeks before the first administration; 6. Acute toxicity that is ≥ Grade 2 caused by previous cancer therapy; 7. Has active infection within 2 weeks before the first administration; 8. Has currently uncontrollable congestive heart failure; 9. Has currently uncontrollable congestive heart failure; 10. Has continuous arrhythmia ≥ Grade 2, uncontrollable atrial fibrillation or QTc interval \> 480ms; 11. Has uncontrollable effusion; 12. Has interstitial lung diseases; 13. Has severely unstable central nervous system metastasis; 14. Has active viral infection; 15. Has multiple factors affecting oral medication; 16. Breastfeeding or pregnant women; Men unwilling to use adequate contraceptive measures during the study; 17. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
A Phase I Study of Cetuximab in Combination With Gefitinib in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

The purpose of this study is to find a safe and effective dose of Erbitux and Iressa for subject with non small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with advanced or metastatic non small cell lung cancer.
* Subjects should have had at least one prior chemotherapy with a platinum based therapy.

Exclusion Criteria:

* Subjects are excluded from this study if they do not have non small cell lung cancer that is advanced or metastatic or have not had at least one prior platinum based chemotherapy.
Drug-Drug Interaction of Cardizem LA (Diltiazem Hydrochloride) on Pitavastatin

This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug interaction study.

Each subject will qualify for entry into the study not more than 30 days prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. During the treatment period, each subject will receive a once-daily dose of pitavastatin 4 mg on Days 1 through 5 and on Days 11 through 15 and a once-daily dose of diltiazem 240 mg on Days 6 through 15. Subjects will fast overnight for at least 8 hours before dosing and will remain fasted until 4 hours after dosing on the morning of Days 5, 10, and 15.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male or female volunteer aged 18 to 45 years, inclusive.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive.
* Subject has normal hematology, serum chemistry, and urinalysis test results.
* Subject is able and willing to abstain from alcohol, grapefruit-containing foods or beverages, caffeine, or caffeine-containing products, St John's wort, and herbal supplements for 4 days before Day 1 and until after completion of this study.
* Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug and until after study completion.

Exclusion Criteria:

* Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption, distribution, metabolism, or excretion.
* Subject has had a previous allergy or intolerance to treatment with pitavastatin, diltiazem, or any drugs in these classes.
* Subject has a history of drug or alcohol abuse.
* Subject has had a clinically significant illness within 4 weeks before the first dose of study drug.
Support for Increased Physical Activity (Stöd Till Aktivare Motion)

The purpose of this study is to improve and analyze the level of physical activity in immigrant women from the Middle East and Latin America living in Sweden. The investigators will also investigate if glucose, insulin, and lipid metabolism; stress-related hormone production; and subclinical inflammatory activity are affected by the intervention. The follow-up period is 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Age 25 through 64 years
* Physical inactivity
* BMI \> 25
* Immigrant to Sweden from either the Middle East or Latin America

Exclusion Criteria:

* Diabetes mellitus type I
* Ischemic heart disease
* Disability that interferes with the ability to participate in lifestyle-related physical activity
Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial

This early phase I trial investigates enhanced, electronic health record (EHR)-facilitated cancer system control. Cancer and its treatment are often associated with severe, disabling symptoms that have been causally linked to diminished survival, increased healthcare utilization, degraded quality of life, unemployment, and non-adherence to recommended cancer treatments. Collaborative case management for control of moderate or worse sleep disturbance, pain, anxiety, depression, fatigue (SPADE symptoms), and physical dysfunction among cancer survivors and patients with cancer may improve quality of life, symptom severity, and adherence to cancer treatment, and may also reduce need for acute care.

PRIMARY OBJECTIVES:

I. Conduct a cluster randomized pragmatic trial with a stepped wedge design to test the hypothesis that a symptom control-focused enhanced, electronic health record (EHR)-facilitated cancer symptom control (E2C2) intervention will significantly reduce sleep disturbance, pain, anxiety, depression, fatigue (SPADE) symptom and physical dysfunction scores, reduce unplanned hospitalizations and emergency department visits, improve adherence to cancer therapies, and improve self-reported quality of life.

II. Evaluate the hypothesis that use of a multifaceted, evidence-based implementation strategy to support adoption and use of the E2C2 system will result in improvements in implementation and clinical outcomes.

III. Conduct a mixed methods evaluation to detect, understand and reduce disparities in the adoption and implementation of the E2C2 intervention among elderly and rural-dwelling patients with cancer.

OUTLINE:

Patients randomized to E2C2 intervention participate in an interview over 30-45 minutes. Providers and stakeholders also participate in an interview over 15-30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Being seen for a solid or liquid cancer at a Midwest Mayo Clinic Midwest Mayo Clinic Health Systems (MCHS) site or for a solid tumor at Mayo Clinic Rochester

Exclusion Criteria:

* No Minors (under age 18) will receive the questionnaires but no further exclusions can be made based on the standard of care for questionnaire assignment
VItamin C in Thermal injuRY: The VICToRY Trial

This study aims to show that giving high dose, intravenous vitamin C in addition to standard care to burned critically ill patients will be associated with less organ dysfunction, improved survival and a quicker rate of recovery. In this study, all patients will receive standard care and of the patients will also receive high dose intravenous vitamin C, while the other half of patients will receive placebo.

In certain disease states, such as those associated with severe burns and other critical illnesses, the relationship between nutrient deficiencies, altered immune status, and acquired infection has been recognized for many years. More than in any other injury, the inflammation and catabolism associated with severe burns can exacerbate nutrient deficiencies, thereby predisposing patients to impaired immune function and increased risk of developing infectious complications, organ dysfunction, and death.

We aim to conduct a large-scale, multi-center randomized trial to evaluate the effect of high-dose (50mg/kg every 6 hours for 96 hours) intravenous vitamin C in addition to standard of care (SOC) on 28-days composite outcome of Persistent Organ Dysfunction (POD) and all-cause mortality compared to add-on placebo and SOC.

Patients will be allocated to 2 groups, active or control: patients in the active group will receive intravenous vitamin C at 50mg/kg every 6 hrs for 96 hrs. Patients in the control group will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C. This study will be the first large international multi-centre trial examining the effects of high dose intravenous vitamin C in burn patients. It represents a unique collaboration of burn units worldwide that is coordinated by the Clinical Evaluation Research Unit, based in Kingston Ontario Canada, a coordinating center that has demonstrated the ability to run multi-center trials and translate findings into practice.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Deep 2nd and/or 3rd degree burns requiring skin grafting
* Minimum burn size of ≥ 20% Total Body Surface Area (TBSA)

Exclusion Criteria:

* \>24 hours from admission to participating hospital to consent.
* Patients admitted to burn unit \>24 from injury or accident.
* Patients who are moribund (not expected to survive the next 72 hours).
* Pregnancy (pregnancy will be ruled out as part of standard of care) or lactating.
* Enrollment in another industry sponsored ICU intervention study.
* Receiving high-dose IV vitamin C already (enteral or oral vitamin C is allowed).
* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
* Recent history of kidney stones (within the last year).
* Concomitant use of hydroxycobalamin (vitamin B12) for suspected cyanide poisoning.
Red Blood Cells (RBC) Transfusion Related to Central Venous O2 Saturation (ScvO2) Measurement

The objective of this study is to estimate red blood cells (RBC) transfusion related to central venous O2 saturation (ScvO2) measurement. This prospective, randomized trial is performed in visceral, vascular and thoracic surgery units in the university hospital of Lille.

One hundred patients need to be included. Inclusion criteria are: age 18 to 99 year old, patient with central venous catheter in place and fulfilling the haemoglobin (Hb) threshold criteria for RBC transfusion according to the XXIIIth French Consensus Conference in critical care medicine recommendations.

After randomisation, patients will be eligible to receive RBC according to their level of Hb in the standard group and according to the Hb and ScvO2 in the optimization group. Patients without any disease are transfused if their Hb level is below 7g/dL; patients older than 60 years or having sepsis are transfused if their Hb level is 8g/dL or lower and cardiac patients are transfused if their Hb level is 9g/dL or lower. In the second group, transfusion is performed if and only if the ScvO2 level is les than 70% when Hb is under the same threshold levels.

The primary aim of the study is to compare the number of RBC units transfused by group (standard group or optimization group) over a period of 5 days counted from the first decision of transfusion taken post-operative. Considering the randomisation and considering the 50 % reduction of the decisions of transfusion in the group optimization, the absolute blood savings is estimated 25 % for the whole population. Secondary end points include the number of side effects associated with transfusion or when avoiding transfusion, length of hospital stay, and hospital mortality as well as major adverse events.

red blood cells central venous O2 saturation surgery transfusion XXIIIth French Consensus Conference adult

Eligibility Criteria:
Inclusion Criteria:

* central venous catheter
* anemia With reference to french consensus about transfusion

Exclusion Criteria:

* intensive care
* emergency transfusion
* shock, hypovolemia
* need to go under surgery into 4 hours
* acute kidney injury or chronic renal disease
* brain injury
* pregnancy
* heart disease : ischemia \<1 mois
An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults

The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).

This is an open-label extension study to evaluate long-term safety and tolerability of intravenous (IV) anifrolumab in adult participants with moderately-to-severely active SLE. Participants must have completed the qualifying Phase 2 study and meet this study criteria in order to be eligible.

Eligibility Criteria:
Inclusion Criteria:

* Must be willing to use 2 methods of effective contraception
* Must have venous access
* Must be willing to forego participation in other clinical trials for SLE.

Exclusion Criteria:

* Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
* Major surgery within 8 weeks before signing informed consent form (ICF)
* Elective major surgery planned during the study period
* Concomitant Medications within the last 12 weeks: Azathioprine \> 200 mg/day, Mycophenolate mofetil/mycophenolic acid \> 2.0 g/day, oral, subcutaneous, or intramuscular methotrexate \> 25 mg/week
* A live or attenuated vaccine within 4 weeks of signing the ICF
* Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of ICF
Safety and Effectiveness of Capsulotomy in Refractory OCD

Obsessive-compulsive disorder (OCD) is a severely disabling psychiatric disorder with a worldwide lifetime prevalence of 2-3% (Islam et al., 2015).Despite the efficacy of pharmacological and behavioural treatment methods for most OCD patients, roughly one third do not demonstrate significant symptom improvement, even after aggressive treatment (Foa et al, 2007). The effectiveness of neurosurgical treatment methods (including ablative surgery) for those with severely disabling treatment resistant OCD is substantiated by clinical research (Greenberg, Rauch \& Haber, 2010). The brain target of this procedure is usually the area between the anterior and middle third of the anterior limb of the internal capsule.


Eligibility Criteria:
Inclusion Criteria:

1. Obsessive compulsive disorder as the primary psychiatric diagnosis (according to DSM IV-criteria).
2. Severity: Score higher than 25 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
3. Course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (refractory).
4. Refractory: a lack of response to drug therapy after adequate administration (defined as more than 12 weeks at the maximum tolerated dose) of at least three serotonin-reuptake inhibitors, and clomipramine. Adequate psychotherapy, defined as continuously treatment for more than six months with a certified therapist .

Exclusion Criteria:

1. Schizophrenic disorder; bipolar disorder; substance abuse or dependence (except for dependence on nicotine), as assessed with the use of the Mini-International Neuropsychiatric Interview (MINI 6.0.0);
2. Cluster A or B personality disorder according to DSM-IV criteria, as assessed with the use of the Structured Clinical Interview II.
3. A current severe major depressive episode, determined according to DSM-IV criteria (as assessed with the use of the MINI 6.0.0) and defined by HAMD-17 score of more than 20 and a risk of suicide.
4. Abnormal cognitive status (measured by MoCA)
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single-dose of UB-921 in healthy male volunteers.

This is an open-label, two-part, dose-escalation and comparative pharmacokinetics study of UB-921 in healthy male volunteers. There will be two parts: dose escalation study (Main Study) and comparative pharmacokinetics study (Sub-study).

Eligibility Criteria:
Inclusion Criteria:

* Total body weight ≧50 kg (110 lbs)
* No clinically relevant abnormalities
* To agree on using birth control barrier (eg. male condom) during the entire study period.
* Signing the written informed consent form

Exclusion Criteria:

* Previous exposure to chimeric, humanized or human monoclonal antibody, whether licensed or investigational
* A history of drug abuse or heavy drinking.
* Blood donation over 250 mL within 90 days prior to the screening
* Not in the condition to participate in this study considered by investigator(s)