cyrilzakka/clinical-trials huggingface dataset:
Telemonitoring System for Improving Continuity of Care in Patients With Chronic Coronary Syndrome (TELSINCORC)

In a randomized clinical trial, a comprehensive telerehabilitation system with a prolonged follow-up strategy demonstrated superiority over a control group with centre-based cardiac rehabilitation in terms of physical activity, VO2 max, adherence to a Mediterranean diet, lipid particle profile and cost-effectiveness. The aim of this study is to demonstrate an extension of the benefit to patients with chronic coronary syndrome in primary care.

The patients who have suffered an acute coronary event have a recurrence rate of 2.5% to 15.5% person-years during the first year. Control of cardiovascular risk factors can improve the prognosis of these patients. Following the results of a clinical trial to validate a comprehensive monitoring system called Cardioplan, with a prolonged monitoring strategy, The investigators aim to conduct a study in patients with chronic coronary syndrome in the primary care setting comparing a control group with standard follow-up and a 10-month telemonitored group. Four primary care centres will participate. Two health centres attend mainly a population with a medium-high upper socioeconomic level and the other two mainly a population with a medium-low socioeconomic level. A total of 160 subjects are expected to be included in the follow-up, with 80 subjects in each study group. The primary endpoint is to demonstrate that telemonitored follow-up improves functional exercise capacity compared to usual care, by assessing the distance in meters covered in the 6-minute walk test.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Patients after more than one year of an acute coronary syndrome of both sexes.
* Age equal to or less than 72 years.

Exclusion Criteria:

* Refusal of informed consent
* Advanced biological age.
* Kidney failure (GFR \< 30ml/min/1.73 m2).
* Liver failure (GOT \>2 times normal value).
* Ejection fraction less than 50%.
* Uncontrolled blood pressure (\>140/90 mmHg).
* Uncontrolled heart failure.
* Dissecting aortic aneurysm.
* Uncontrolled ventricular tachycardia or other dangerous ventricular arrhythmias.
* Aortic or mitral valve disease.
* Recent systemic or pulmonary embolism.
* Active or recent thrombophlebitis.
* Acute infectious diseases.
* Uncontrolled supraventricular arrhythmias or tachycardia.
* Repeated or frequent ventricular ectopic activity.
* Moderate pulmonary hypertension.
* Ventricular aneurysm.
* Uncontrolled diabetes, thyrotoxicosis, myxedema,
* Conduction disorders such as: complete atrioventricular block. Left bundle branch block.
* Wolf-Parkinson-White syndrome.
* Fixed rate pacing.
* Severe anaemia.
* Psychoneurotic disorders.
* Neuromuscular, musculoskeletal and arthritic disorders that may limit activity. may limit activity.
Protocol TARC-ABPA

The main objective of this study is to determine if a doubling of serum TARC (compared to baseline) is associated with the occurrence of exacerbations of ABPA.

The secondary objectives of the study are :

1. To investigate if induced sputum eosinophils count (compared to baseline) is associated with the occurrence of exacerbations.
2. To examine if the exhaled NO (compared to a baseline) is associated with the occurrence of exacerbations.
3. To investigate if activation of circulating T cells (compared to a baseline) is associated with the occurrence of exacerbations.
4. To examine if the rate of specific Asp f IgG measured by ELISA (compared to a baseline) is associated with the occurrence of exacerbations.
5. To determine if the variation of one of the markers above, TARC or Asp f specific IgE measured at baseline, may be associated with the radiological stage of the disease (ABPA-S, ABPA-CB, ABPA-ORF).
6. To investigate if there is a link between fungal exposure at home (visually assessed by the contamination level and the proportion of positive samples for Asp. f) and the frequency of exacerbations.
7. To establish if some of the clinical, functional or biological data studied are associated with the frequency of exacerbations.


Eligibility Criteria:
Pre-inclusion criteria :

* Major patients, of indifferent sex,
* Patients insured,
* Patients accepting to give, after information, their signed informed consent form,
* Patients affected by ABPA,
* Patients in remission without treatment, or stable under current treatment for at least 3 months.

Inclusion criteria :

This inclusion will be definitive in V1, if :

* The pre-inclusion criteria are respected,
* The patient has not presented any exacerbation since V0 thereby define a basic state.

If patient could not be included, it will be possible to re-screen him for the study, provided he meets the pre-inclusion and inclusion criteria. In this case, a new V0 will be scheduled at least 3 months after the first V0.

Exclusion criteria :

* Minor patients,
* Adults under guardianship,
* Pregnant or lactating women,
* Patients unable to follow the protocol or to give consent,
* Patients with an infection of the lower respiratory tract in the 4 weeks preceding V0 or between V0 and V1,
* Patients who were hospitalized for respiratory problems in the 4 weeks preceding V0 or between V0 and V1,
* Patients with chronic inflammatory diseases unrelated to ABPA which could influence the results,
* Patients with cancer,
* Patients followed for cystic fibrosis defined by a positive sweat test,
* Patients with known compliance problems identified prior to the study.
Oregon Military Employee Sleep and Health Study

This study is a randomized controlled trial that assesses the effects of (1) the Family-Supportive Supervisor Behavior (FSSB) and Sleep Leadership training and (2) sleep/cognitive effectiveness feedback intervention on health and well-being among full-time employees in the Oregon National Guard, their supervisors, and their families. The interventions involving both health protection and health promotion are expected to contribute to improvements in employees' and their supervisors' sleep, risk behaviors, mental and physical health, and injury, as well as employees' and their spouse/partners' family experiences, health and well-being, and workplace outcomes.

The overall goal of the Military Employee Sleep and Health (MESH) study is to improve safety, health and well-being of service members in the Oregon National Guard and their families. The MESH Study seeks to do this by training supervisors to support Oregon National Guard service members by focusing on a reduction in work-life stress while increasing sleep health.

The Oregon MESH Study proposes that leadership can influence a fundamental change in the recognition of sleep health and service members' overall well-being and the well-being of their family members. With the support of the Oregon National Guard, the MESH Study will provide family-support and sleep leadership training for supervisors while raising awareness of sleep through daily non-invasive sleep measurements.

The investigators of the Oregon MESH Study expect positive results for study participants, including reduced stress and increased social support. Longer term, these effects are expected to create a more supportive work environment, which has positive effects on safety, health, well-being, family, and organizational outcomes. The investigators also expect that providing service members with individual sleep feedback will reduce sleep problems and improve sleep awareness.

Eligibility Criteria:
Inclusion Criteria:

* Full-time employees in the Oregon National Guard, including Military Technicians and Active Guard Reserves.

Exclusion Criteria:

-
Impairment of Reading Ability in Dry Eye Patients

To assess the reading function impairment in patients with dry eye and to assess the effects of reading on the ocular surface.

This study is being done to understand how reading is affected in people with dry eye in comparison with healthy controls and what effect reading has on the ocular surface in patients with dry eye.

Eligibility Criteria:
Inclusion Criteria:

* age of 50 or greater,
* literacy in English language,
* ability to give informed consent

Exclusion Criteria:

* binocular vision below 20/25,
* any ocular surgery within the last 3 months,
* mental issues,
* illiteracy,
* language problems which might possibly interfere with reading ability,
* history of taking or current use of topical prescription anti-inflammatory eye drops (including, cyclosporine and steroids as well as any glaucoma eye drops).
A Cluster-randomized Controlled Knowledge Translation Feasibility Study in Alberta Community Pharmacies

Background: Despite evidence of benefit for pharmacist involvement in chronic disease management, the provision of these services in community pharmacy has been suboptimal. The Promoting Action on Research Implementation in Health Services (PARiHS) framework suggests that for knowledge translation to be effective, there must be evidence of benefit, a context conducive to implementation, and facilitation to support uptake. We hypothesize that while the evidence and context components of this framework are satisfied, that uptake into practice has been insufficient because of a lack of facilitation. This protocol describes the rationale and methods of a feasibility study to test a facilitated pharmacy practice intervention based on the PARiHS framework, to assist community pharmacists in increasing the number of formal and documented medication management services completed for patients with diabetes, dyslipidemia, and hypertension.

Methods: A cluster-randomized before-after design will compare ten pharmacies from within a single organization, with the unit of randomization being the pharmacy. Pharmacies will be randomized to facilitated intervention based on the PARiHS framework or usual practice. The Alberta Context Tool will be used to establish the context of practice in each pharmacy. Pharmacies randomized to the intervention will receive task-focused facilitation from an external facilitator, with the goal of developing alternative team processes to allow the greater provision of medication management services for patients with diabetes, hypertension, and dyslipidemia. The primary outcome will be a process evaluation of the needs of community pharmacies to provide more clinical services, the acceptability and uptake of modifications made, and the willingness of pharmacies to participate. Secondary outcomes will include the change in the number of formal and documented medication management services in the aforementioned chronic conditions provided 6 months before, versus after, the intervention between the two groups, and identification of feasible quantitative outcomes for evaluating the effect of the intervention on patient care outcomes.

Results: To date, the study has identified and enrolled the ten pharmacies required and initiated the intervention process.

Conclusion: This study will be the first to examine the role of facilitation in pharmacy practice, with the goal of scalable and sustainable practice change.

Please see the following publication for a detailed description of the work:

Pilot and Feasibility Studies 01/2015; 1(2). DOI: 10.1186/2055-5784-1-2

Eligibility Criteria:
Inclusion Criteria:

* Pharmacies: Community pharmacy locations of a medium-sized pharmacy chain with an interest in and the ability to provide medication management services, but have not fully integrated these activities
* Patients: Any Alberta residents qualifying for pharmacy clinical services as defined by the Alberta Pharmacy Fee Framework

Exclusion Criteria:

* None
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study

The management of spontaneous large pneumothorax is not consensual. The current management involves the establishment of a Fuhrman catheter and an outpatient monitoring in pneumology consultation. Another alternative is widespread: simple exsufflation. However, no study has looked at the direct prospective comparison of these 2 treatments.


Eligibility Criteria:
Inclusion Criteria:

* Episode of primary spontaneous pneumothorax wide according to the criteria

Exclusion Criteria:

-
Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer

This was a cross-sectional and an observational study, investigator-initiated study in HER2-low breast cancer patients. Approximately 335 subjects will be enrolled in this study to examine the distribution and features of HRD (Homologous recombination deficiency)/HRR (Homologous recombination repair).

In this study, investigators plan to clarify the frequency of HRR/HRD in Chinese patients with her2-low breast cancer.

In addition, it is planned to investigate any association between invasive disease-free survival (IDFS) / overall survival (OS) and HRD/HRR in her2-low Breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. female patients who have pathologically documented breast cancer that: Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay ASCO/CAP guidelines in the metastatic setting
2. Femalepatients must be at least 18 years of age
3. ECOG Performance Status of 0 or 1
4. patients with operable primary breast cancer who underwent radical surgery and No patients received preoperative neoadjuvant therapy.
5. No distant metastasis occurred
6. Patient must have adequate tumor andbloodsample for biomarker assessment

Exclusion Criteria:

1. recurrent or advanced metastatic breast cancer
2. Bilateral breast cancer (including multifocal breast cancer. All histological lesions were HER2 1+ or 2+, not detected by FISH amplification and HR positive according to ASCO guidelines)
3. Other malignant tumors within 5?years
4. Clinical diagnosis and treatment information is incomplete
Treatment of ATFL Tears With PRP

PRP will enhance ATFL tears healing by time and quality.


Eligibility Criteria:
Inclusion Criteria:

* athletes 18-30 years old 1st sprain within 3 days from injury

Exclusion Criteria:
The Colder Fluids - Intravenous Infusion of 10 Degrees Celsius Fluids and Its Effects on Circulation and Hemostasis

The aim of this study is to investigate the effect of respectively 10 and 22 degrees Celsius Ringer's lactate solution on the physiological response in healthy adults. In a single center crossover study the investigators will include and randomize 25 healthy volunteers to receive 1 liter of Ringer's lactate either cold (10°C, 50°F), or at room temperature (22°C, 71,6°F) with 100 ml/min. Fluids will be administered through a peripheral vein. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures.

The main outcomes of this study are:

Primary:

• The increase in Mean Arterial Pressure (MAP) 30 minutes after started infusion

Secondary:

* Time until return of MAP to baseline value after infusion.
* Changes in Visual Analog Scale (VAS) of discomfort during infusion
* Changes in temperature, blood pressure, heart rate, peripheral oxygen saturation cardiac index, cardiac output, total peripheral resistance index and stroke volume
* Changes in the intravascular volume status and the fluid responsiveness
* Changes in biochemical parameters at baseline, 30 and 60 minutes.
* Changes in Rotational thromboelastometry (ROTEM) analysis at baseline, 30 and 60 minutes


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-64

Exclusion Criteria:

* Pre-existing medical problems that are contraindicated for cold crystalloid infusions.
* Pregnancy (validated through a certified urine pregnancy test)
* Body mass index \>35 kg/m2
* Medication use, including over-the-counter anti-pyretics within 48 hours, with exception of allergy medication and contraceptives.
* Any family history or predisposition of coagulopathies.
* Any intake of inhibitors of 11β-Hydroxysteroid dehydrogenase the past 48 hours (products containing liquorice)
A Trial of Two Daclizumab Dosing Strategies vs. No Induction Treatment With Tacrolimus, Mycophenolate Mofetil , & Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients

The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab in simultaneous kidney/pancreas transplant recipients.

The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab as an adjunctive immunosuppressive agent in simultaneous kidney/pancreas transplant recipients receiving tacrolimus, mycophenolate mofetil, and steroids as primary maintenance immunosuppression.

Eligibility Criteria:
Inclusion Criteria:

* Simultaneous kidney/pancreas transplant recipients
* Insulin dependent Type 1 or 2 diabetes pretransplant
* Recipient age 18-65 years
* Donor age 5-65 years
* Women must have negative serum pregnancy test and practice birth control for study duration
* Negative T-cell crossmatch
* Parent (or guardian) is able to understand the consent form and give written informed consent

Exclusion Criteria:

* Prior treatment with daclizumab
* Known sensitivity or contraindication to tacrolimus, MMF, or steroids
* Patient with significant or active infection
* Patients with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum
* Patients whose life expectancy is severely limited by diseases other than renal disease
* Ongoing substance abuse, drug or alcohol
* Major ongoing psychiatric illness or recent history of noncompliance
* Insufficient cardiovascular reserve
* Malignancy within last 5 years, excluding nonmelanoma skin cancers
* Serologic evidence of infection with HIV or Hepatitis B surface antigen positive
* Investigational drug within 30 days prior to transplant surgery
* Anti-T cell therapy within 30 days prior to transplant surgery
A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

The purpose of the study is to demonstrate the clinical efficacy of abatacept (body-weight tiered dose approximating 10 mg/kg) compared with placebo on a background of methotrexate after 6 months (Day 169) of treatment in Korean patients with active rheumatoid arthritis and an inadequate clinical response to methotrexate


Eligibility Criteria:
Key Inclusion Criteria:

* Rheumatoid arthritis (RA) for longer than 1 year from the time of the initial diagnosis of RA
* Patients must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg, and a stable dose for 28 days prior to treatment (Day 1)
* Methotrexate weekly dose as low as 10 mg is permitted for patients who cannot tolerate higher doses

Key Exclusion Criteria:

* Evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential enrollment
The Use of Isatidis Root and Forsythia Oral Liquid for the Treatment of Mild Cases of COVID-19: A Trial Clinical Study

This study has significant implications for research, as it provides a basis for further studies on the antiviral effects of LGLQ Oral Liquid, encouraging more extensive clinical studies in larger populations and diverse age groups to validate these findings. For medical practice, the findings suggest that LGLQ can be considered an alternative treatment option for mild cases of COVID-19, especially in managing symptoms like fatigue, potentially broadening the range of effective treatments available to healthcare practitioners. In terms of policy, the demonstrated efficacy of LGLQ could lead to its inclusion in treatment guidelines for COVID-19 and other viral infections, fostering a more integrated approach combining Western medicine and Traditional Chinese Medicine in the global fight against pandemics. The insights from this study might prompt health policymakers to reassess the potential of herbal formulations in managing and treating infectious diseases and consider them in the development of future healthcare strategies and policies.


Eligibility Criteria:
Inclusion Criteria:

* the diagnosis of SARS-Cov-2 infection confirmed by quantitative polymerase chain reaction (qPCR) test
* aged 18 years or older
* patients received more than 2 doses of SARS-Cov-2 vaccine
* asymptomatic or mild at the time of hospitalization

Exclusion Criteria:

* patients with malignant diseases, autoimmune diseases, liver and kidney diseases, blood diseases, neurological diseases, endocrine diseases and other serious diseases may affect the patient's participation in the trial or affect the results of the study
* pregnant women, lactating mothers; allergic conditions
* allergic to the known components of the drug
* patients vaccinated with vaccines less than 1 shot
* Patient does not agree to participate in this study
Comparison of Two Pharmacist-led Population Management Approaches to Increase Monitoring of Vitamin B12 and Serum Creatinine Levels for Patients on Metformin

The purpose of this project is to compare two pharmacist-led population management strategies designed to increase the rate of appropriate monitoring of vitamin B12 and serum creatinine for patients taking metformin.


Eligibility Criteria:
Inclusion Criteria:

* On Metformin for at least one year
* Activated patient portal for electronic messaging
* Patient of an attending physician at Ohio State General Internal Medicine
* No serum vitamin B12 and/or no serum creatinine measurement in the past year
Effect of Low-dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED)

In patients with chronic hepatitis C, the ultimate treatment goal is the improvement of liver histology and inhibition of progression to liver cirrhosis and hepatocellular carcinoma (HCC). These effects are reported to be correlated with sustained ALT improvement. Therefore, the aim of this study is to determine if a low-dose (0.25, 0.5, or 1.0 mcg/kg SC QW) PegIntron monotherapy administered for 12 weeks will result in ALT normalization in Japanese patients with chronic hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

Patients with chronic hepatitis C patients (CHC) who met all of the following criteria:

* At least 20 years of age and willing to sign an informed consent
* Patients who can practice contraception
* Patients who are classified either as relapsers or non-responders.
* Weight between 45 and 100 kg
* Patients willing to be hospitalized for 3 days after the start of treatment
* Patients with positive HCV-RNA
* Serum ALT level: Over 60 IU/L, equal to or less than 150 IU/L
* Neutrophil count: equal to or more than 1,200 /mm\^3
* Platelet count：equal to or more than 100,000/mm\^3

Exclusion Criteria:

* Patients with conditions which would interfere with the evaluation of therapeutic efficacy of the study drug and patients for whom assurance of safety is a concern were excluded from the study.