cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Multimodal IT Enhanced Hand Hygiene Strategy on Healthcare Associated Infections in Nursing Homes

This study aims to evaluate the effectiveness of a multimodal hand hygiene improvement strategy, enhanced with information technology (IT), in reducing healthcare-associated infections (HAIs) in nursing homes. The goal is to improve infection prevention practices and promote a safer environment for older adults living in long-term care facilities.

Hand hygiene is a key strategy for preventing healthcare-associated infections (HAIs), yet compliance among healthcare workers remains suboptimal due to knowledge gaps, limited resources, unfamiliarity with procedures, and poor adherence. This study aims to assess the effectiveness of an IT-enhanced multimodal hand hygiene intervention in reducing HAIs within nursing homes, thereby improving infection control practices and promoting a safer environment for older adults in long-term care settings.

Eligibility Criteria:
Inclusion Criteria:

* Full-time nurses or nursing assistants in the participating nursing homes
* Proficiency in Mandarin or Taiwanese

Exclusion Criteria:

• Confirmed or anticipated resignation
Enablers and Barriers to Hydroxyurea Use for Sickle Cell Disease Jamaica

Sickle cell disease (SCD) is associated with a lifetime of medical and socio-behavioural complications that require coordination of care from multidisciplinary teams. Access to adequate care for SCD is important as inadequate access can contribute to increased acute care utilization, disjointed care delivery, and earlier mortality for many SCD patients. Hydroxyurea (HU) is the first drug approved for the treatment of SCD and improves many adverse outcomes of SCD and yet its use remains sub-optimal. This mixed-methods study aims to identify the barriers and enablers that SCD patients, caregivers of children (under age 18 years), and health care providers (including physicians, nurses and pharmacists) identify for health care access and HU utilization. The findings may guide development and implementation of strategies to improve access to SCD healthcare and HU uptake which may result in significant benefits to patients, families and the healthcare system including possible reduction in healthcare utilization. Participants will be recruited from the Sickle Cell Unit, Kingston and from all four Jamaican regional health authorities. Questionnaires and interview guides for provider and patient/caregiver assessments are adapted, with permission, from the Sickle Cell Disease Implementation Consortium tools. The study will also examine data on HU usage from the National Health Fund of Jamaica since its addition of SCD to its list of chronic illnesses in 2015. All data collected will be de-identified and maintained in a secure database, with access limited to key personnel. There is minimal risk to participants. Participants will be selected only because of the specific problem under investigation, and not because of easy availability, diminished autonomy, or social bias.


Eligibility Criteria:
Inclusion Criteria:

* SCD Patients (ages 18 and over)
* Adult Caregivers of SCD Children/Adolescents under 18 years
* Healthcare Providers: Physicians, Nurses and Pharmacists who treat and interact with sickle cell patients

Exclusion Criteria:

* SCD patients below age 18 years
* SCD patients who are acutely ill
Mil Familias-Santa Barbara's Operational Pilot to Understand Diabetes in the Latino Community

The Mil Familias Program is a 10-year initiative to reduce the burden of cardio-metabolic disease among Latino families in the Central Coast of California. The Mil Familias Program involves enrolling 1000 Latino families with at least one member in the family having type 2 diabetes, measuring the 5 determinants of human health: genetics, biology, behavior, psychology and environment, training Latino community health workers ("Especialistas") , creating a Living Information (bio)Bank and planning culturally-relevant interventions.

The Mil Familias Pilot Study aims to develop, operationalize and refine methods to both recruit and collect data from 100 adult participants pertaining to the 5 determinants of human health: genetics, biology, behavior, psychology and environment. Specially-trained Latino and bilingual community health workers known as "Especialistas" will be used to help gather data and to serve as the participants trustworthy health companion. Over 100 variables of information pertaining to the 5 determinants of human health (as listed above) will be gathered and stored to create a Living Information (bio)Bank particular to Latinos. The ultimate goal of this research is to provide the target population with effective, culturally-relevant interventions that are geared toward population specific needs.

Eligibility Criteria:
Inclusion criteria:

1. Males or females ≥ 18 years of age at Visit 1 (screening and enrollment).
2. Self-reported Hispanic and/or Latino heritage.
3. Currently residing in Santa Barbara County, California.
4. Established diagnosis of Type 2 diabetes for at least one year prior to enrollment date.
5. Signed and dated written informed consent by the date of Visit 1.
6. Based on the research staff's judgment, subject must have a good understanding, ability, and willingness to adhere to the protocol, including performance of self-monitored data collection during the wearable device portion.

Exclusion Criteria:

1. Diagnosed severe cardiovascular disease, within the 6 months prior to enrollment Visit 1, defined as: previous stroke; decompensated heart failure New York Heart Association class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty.
2. Life expectancy \< 2 years.
3. Any active clinically significant disease or disorder, which in the investigator's opinion could interfere with the participation of the trial.
4. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding comprehension of study activities and informed consent.
5. Participation in other trials involving medication or device within 1 month prior to Visit 1.
6. Known or suspected abuse of alcohol, narcotics, or illicit drugs.
A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis

This open-label, randomized, cross-over study evaluated the effect of tocilizumab (TCZ) on the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female patients with active rheumatoid arthritis (RA) and in healthy female volunteers of child bearing age. The RA patients received OC in combination with TCZ, whereas the healthy volunteers received OC only. The RA patients received OC in 3 cycles of 21 days each; TCZ 8 mg/kg was administered once as an intravenous infusion on the first day of Cycle 2. The healthy volunteers received OC for only one 21-day cycle.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with child bearing potential, 18-44 years of age.
* Rheumatoid arthritis (RA) for over 6 months duration.
* On oral contraceptive without interruption for at least 3 months with normal cycle control.
* Treatment with disease-modifying anth-rheumatic drugs (DMARD) for at least 12 weeks prior to study start.
* Body weight \< 150 kg.

Exclusion Criteria:

* Functional class IV rheumatoid arthritis (American College of Rheumatology \[ACR\] classification).
* History of amenorrhea (unrelated to pregnancy).
* History or current inflammatory joint disease other than RA.
* Rheumatic autoimmune disease other than RA.
Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients

With the availability of well-studied once-daily formulations of tacrolimus, the ability to achieve a true once-daily immunosuppressant regimen along with everolimus and steroids may finally be achievable and have the potential to optimize immunosuppression safety and efficacy in kidney transplantation.

A once-daily immunosuppressant regimen comprising of Envarsus-everolimus-prednisone will have 6-month treatment failure rates that are non-inferior to the twice-daily regimen of Envarsus-mycophenolate mofetil-prednisone and will have improved patient-reported adherence.

Eligibility Criteria:
1. Inclusion criteria

1. Male or female adult (≥18 years old) with a history of solitary kidney transplant within 3 months (±2 months) of transplant with self-reported medication adherence issues, as indicated by a MMAS-8 of at least 1.
2. Patients must be capable of understanding the purposes and risks of the study and have the ability to give written informed consent and be willing to participate and comply with the study.
3. Women of childbearing potential must have a negative pregnancy test within the 48 hours prior to receiving study medication.
4. Women of childbearing potential and sexually active males must be willing to use contraception, as indicated in Section 6 of the protocol. Subjects who are not of reproductive potential (status post bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or vasectomy), not sexually active, whose current partner(s) is not of reproductive potential, or whose sexual activity is exclusively homosexual are eligible without requiring the use of contraception.

2. Exclusion criteria

1. Patients will be excluded if they are pregnant or nursing females or males with a pregnant female partner
2. Recipient of multiple organ transplant
3. Recipient of a non-renal organ
4. Proteinuria \> 800 mg/24 hour
5. eGFR \< 30 ml/min
6. WBC ≤ 2k/mm3
7. Plt ≤ 50k/mm3
8. Triglycerides \> 500 mg/dL
9. HIV positive (HIV ab +)
10. Unable to tolerate oral medications
11. Use of another investigational product within thirty days prior to receiving study medication
12. Acute graft rejection within the past month (Banff 1A or higher) or received an ABO incompatible donor organ.
13. A condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject
Omega-3 Supplementation Combined With Endurance Training Improve Running Economy in Recreational Runners.

Recreational male runners participated in 12 weeks training and omega-3 supplementation programme. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed.

40 healthy, recreational male runners participated in 12 weeks training and supplementation programme. The training protocol was built based on undulatory load manipulation 3:1, which was suggested to be effective to prevent overtraining and stress due to oscillations between volume/intensity. Throughout the study all participants took 4 identical-looking capsules per day (2 in the morning and 2 in the evening) containing either omega-3 fatty acids or medium chain triglycerides as placebo in total amount of 4g of fat per day. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed. Additionally, blood was collected to determine the concentrations of selected proteins (including eNOS, irisin, adiponectin) that may be associated with potential changes in participants' oxygen uptake during the treadmill test.

Eligibility Criteria:
Inclusion Criteria:

* non smoking
* no chronic diseases
* no supplements and medicines
* personal best in 10km run between 35 and 59 min at the turn of 2016 and 2020 y

Exclusion Criteria:

-
Efficacy and Safety of DWJ1248 With Remdesivir in Severe COVID-19 Patients

Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients


Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 19 as of the signed date in written consent
* Subjects with COVID-19 according to RT-PCR test(within 10 days)
* Subjects who need to be hospitalized and injected Remdesivir

Exclusion Criteria:

* Subjects who cannot orally administer the investigational products
* Subjects who requiring mechanical ventilation or ECMO
* Acute Respiratory Distress Syndrome(ARDS), shock, multiple organ dysfunction syndrome
* Subjects who need administration of immunosuppressants
* Subjects who are allergic or sensitive to investigational products or its ingredients
* Crcl \< 30 mL/min or eGFR \< 30 mL/min/1.73m\^2
* AST or ALT \>= 5xULN
* Subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators
Registry and Biorepository for IBD in Central Texas

This is a prospective, non-interventional registry and biorepository for patients with IBD. Longitudinal follow-up data is collected from both patients and their treating gastroenterologist during routine clinical encounters. The biorepository will consist of prospective collection of blood samples, tissue samples, and fecal samples for research purposes, while the participants are undergoing a clinically-indicated procedure (i.e. venipuncture for routine tests, IV catheter placement, and/or endoscopy). Participants may choose to provide any or all of the aforementioned information and/or samples.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 years or older
* Willing and able to provide written consent for participation in the registry and biorepository
* Patients with known or suspected inflammatory bowel disease

Exclusion Criteria:

* Patient is unable to comprehend and/or cooperate with study activities
* Patient is too ill to provide consent
* Coagulopathy that precludes safe biopsy of the bowel
* Comorbidity that precludes safe participation in endoscopic procedures
Comparison of Characteristics Between Faller and Non-faller Transtibial Amputees

Researchers aim to compare demographic characteristics, prosthesis type, functional capacity, and quality of life between faller and non-faller transtibial amputees.

Unilateral transtibial level prosthetic users will be included in this study. After getting the fall history of subjects, those who feel at least one time or more in the last year will be accepted as the faller group. Demographic characteristics, functional capacity, health-related quality of life, and prosthetic types used by amputees will be assessed. The main differences between the faller and non-faller transtibial amputees will be analyzed with the data.

Eligibility Criteria:
Inclusion Criteria:

* Having the ability to walk at least 30-meter independently
* Using the transtibial prosthesis for at least one year.

Exclusion Criteria:

* Multiple limb amputees or prosthetic users
* Having prosthetic discomfort or stump ulcer
Efficacy and Safety of Testogel® in Men With Partial Androgen Deficiency of Aging Males (PADAM)

The purpose of this study is to investigate the effect of a testosterone replacement therapy called Testogel in men with PADAM. The effects on body composition (lean, fat and bone) and other symptoms of PADAM and safety will be studied.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic hypogonadism
* Willing to avoid significant change in the pattern of physical exercise and lifestyle for the duration of the study

Exclusion Criteria:

* Patients with any contraindication for testosterone use
Safety Study of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects

The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol administered to opiate dependent subjects


Eligibility Criteria:
Inclusion Criteria:

* Opiate dependent males and females age 21-45 on stable doses of methadone
* Fluent English speaker
* Willing and able to give written consent

Exclusion Criteria:

* Pregnancy or lactation

FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.
Non-interventional Study Evaluating the Management of Pain Using a Technique Developed and Commonly Used by the Center, in Patients Who Underwent Arthroscopic Surgery of the Shoulder in the Outpatient Setting.

Shoulder surgery is performed usually under interscalene block considered as a gold standard. This anesthesia is well suited for hospitalized patients but not for outpatients. The Orthopedic Surgery Department of Clinique Chénieux has been operating patients requiring arthroscopic shoulder surgery with a short interscalene block relayed by a long suprascapular block. The main objective is to evaluate the effectiveness of this method by measuring the average pain over 3 days after the operation.

The surgery of the shoulder is usually performed under interscalene block (ISB), considered as a gold standard. This anesthesia is well suited for hospitalized patients but not for outpatients. Indeed, the ISB entails, in addition to a sensory block, a motor block often useless and important since it extends beyond the shoulder to the entire upper limb. It can also be a source of anxiety and cause the risk of compression in the limb operated because of the extended sensorimotor block. It is also responsible for a painful bounce almost constant with sometimes the very rapid installation of intense pain when the effect of the sensory block disappears. This pain can be difficult to relieve despite frequent use of opioids.

The Orthopedic and Traumatologic Surgery Department of the Clinique Chénieux has been operating patients requiring arthroscopic surgery of the shoulder according to the following technique. It involves the establishment of a short ISB (between 2h and 4h) relayed by a supra-scapular block (SSB) long (72h) through the placement of a perineural catheter thus allowing a continuous diffusion of Naropein® by an elastomeric pump. The same day or the day after the operation, the patients return to their home and are followed by nurses.

The objective of this technique is to better manage postoperative pain, thus allowing the management of patients in outpatient surgery. A prospective non-interventional study will make it possible, in a context of common practice, to obtain data on the management of pain in operated patients and then to consider a generalization of this practice to other centers.

Eligibility Criteria:
Inclusion Criteria:

* Men, women between 18 and 70 years
* Patient in need of acromioplasty or rotator cuff surgery (ruptured cuff or calcification of the cuff) or reinsertion of the glenoid bead (Bankart intervention)
* Patient with an American Society of Anesthesiologists score (ASA) of 1 or 2

Exclusion Criteria:

* Patient needing shoulder surgery for other indications and open surgery
* Patient with cognitive impairment or dementia symptoms
* Patient with a BMI ≥ 35 without systemic morbidity requiring hospitalization
* Contraindication to the drugs used in the study (hypersensitivity to ropivacaine or other amide-bonded local anesthetics)
* Pregnant or lactating patient
* Patient with severe hepatic impairment
* Class III antiarrhythmic patient
Effect of Continuously Coached Practice Using EMS on ERCP Performance of Trainees

Previous studies have demonstrated that coached EMS practice at the beginning of ERCP training could improve the trainees' skill. However, it is not known whether continuously coached practice using EMS can provide additional benefit.


Eligibility Criteria:
Inclusion Criteria:

* consecutive inpatients with naive papilla undergoing ERCP.

Exclusion Criteria:

* history of partial or total gastrectomy (Billroth I/II, Roux-en-Y);
* duodenal stricture (benign or melignant);
* ampullary carcinoma;
* previously failed selective cannulation;
* chronic pancreatitis with PD stone;
* minor papilla cannulation;
* servere diseases of heart, lung, brain and kidney;
* hemodynamical unstablility;
* pregnant women;
* refusal or unable to give written informed consent.
Stimulation Therapy for Apnea: Reporting Thoughts

Upper airway stimulation (UAS) via unilateral implantation of a phasic hypoglossal nerve stimulation device is a safe and effective alternative treatment for patients with moderate to severe obstructive sleep apnea (OSA) who are unwilling or unable to adhere to positive airway pressure (PAP) therapy. Although adherence to UAS is higher than to PAP, there remain patients who are not using UAS consistently. The aim of this project is to explore critical factors in the use of UAS by OSA patients using qualitative research methods (personal interviews). The proposed study will provide crucial information about patients' concerns regarding UAS use and suggestions for how to support new UAS recipients.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* ADHERE registry patient
* Received UAS implant from June 2017 to present

Exclusion Criteria:

* Patients without up to date contact information
C-Reactive Protein (CRP) Gene Variants and Coronary Artery Disease in a Chinese Han Population

The recognition of the association between circulating C-reactive protein (CRP) levels and risk of coronary heart disease (CHD) has led to an increased emphasis on CRP genetic effects on CRP level and CHD. However, the causality of CRP variants remains uncertain.The objective of this study is to evaluate the association of CRP gene variants and CRP levels in CHD in Chinese Han population. We conduct case-control study in CRP-Han study participants. The common single-nucleotide polymorphisms (SNPs) in the CRP gene, haplotypes, and plasma CRP levels are detected. A Mendelian randomization analysis will be used to help test the likelihood of causal association of gene-CRP levels, CRP levels-CHD and gene-CHD. The investigators hypothesize that CRP gene variants influence the protein level and may participate in CHD progress.

CHD patients and non-CHD population are recruited. CRP level and CHD severity by coronary angiograph will be examined. Mendelian randomization analysis are taken to analyze statically.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of coronary artery disease

Exclusion Criteria:

* with major organ disfunction or acute inflammatory disease
Paracetamol for Cancer Pain

Randomised, double-blind placebo controlled cross-over trial

Main goal:

Optimize the medical pain treatment for patients with advanced cancer disease

Study goal:

Measure paracetamol's additional analgesic effect in a situation where the patient is concomitantly treated with oral opioids eqv. morphine \> 100 mg/d.

National multicenter study with an intention to include 50 patients. 6 days treatment, 3d in each arm. Mean pain score last 24 h: NRS =/\> 4 All drug treatment constant during the study period. The participants are allowed to take as much rescue opioids as necessary to have adequate relief.

Paracetamol/ placebo given orally 1000 mg x 4 daily, three days in each arm, direct crossover.

Daily scoring of pain relief, ESAS, overall satisfaction and rescue medication.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\> 18 years) of both sexes
* Diagnosed with advanced cancer disease
* Ongoing medicinal pain relief treatment in stable dosing with oral opiates equivalent to \> 100 mg oral morphine daily
* NRS median pain score last 24 hrs \> 4
* Able to take tablets (paracetamol) orally

Exclusion Criteria:

* Mental or physical deficiency precluding data collection.
* Reduced liver function judged with bilirubin, INR and transaminases
* Anticoagulation with warfarin
* Ongoing use of NSAIDs or 5-HT3 antagonists, or use of such drugs last week
* Ongoing palliative radiation treatment or radiation treatment during the last 4 weeks.