cyrilzakka/clinical-trials huggingface dataset:
Education for Prevention and Treatment of Frailty

Frailty is a condition with a high prevalence in older adults, leading to higher vulnerability and increasing the risk of adverse health outcomes and disabilities. The aging of the population in Spain is accelerating quickly, consequently, it is necessary to advise the population on the appropriate path to healthy aging, free of fragility and their secondary problems.

To evaluate the efficacy and efficiency of a Fragsalud program for the prevention and multifactorial treatment of frailty in people over 65 years of age living in the community compared to the usual treatment. Material and methods: A Single blind randomized, two-arm clinical trial; control group and intervention group, multicenter, with 15 months of follow-up, with evaluations blinded at the beginning, and in the follow-up at 12 and 15 months. A recruitment of 196 people over 65 years of age with criteria of pre-frailty or frailty according to Fried's criteria. The Fragsalud education program will be taught in the intervention group; while control group will follow the usual health care. The evolution of the criteria of frailty, cognitive state, eating pattern, emotional state, quality of sleep, perceived social support, quality of life, functional capacity in daily life, adverse results, assessment of self-efficacy and cost-utility analysis variables will be evaluated. Possible confounding factors such as sociodemographic variables, comorbidity and polymedication will be controlled. Intention-to-treat analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 65 years of age who present frailty or pre-frailty, assessed using the Fried criteria adapted to Spanish population;
* Patients belonging to Clinical Management Units participating in the study and who will remain in it for the 15 months of the study;
* Patients who can come to the Health Center alone or accompanied.

Exclusion Criteria:

* Patients with no full control of their capabilities.
* Patients who do not understand Spanish;
* Patients with allergies to plastic or metal.
* Patients who are instutionalized.
Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin

This study is to evaluate the impact of providing high protein supplementation in the form of a medical food bar containing 20grams of protein eath to hypoalbuminemic dialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with ESRD undergoing center hemodialysis or peritoneal dialysis for more than 90 days.
* 18 years of age or older.
* Must have a reasonable expectation of remaining on treatment for at least 3 months.
* Must have an average serum albumin of \<3.5 g/dL over the three months prior to entry into the study.
* Must be able to understand and sign the informed consent.
* Must be willing and able to participate in nutrition interviews for determination of nutrient intake from conventional foods.

Exclusion Criteria:

* Allergy to protein, milk, nuts or wheat.
* Documented ongoing acute infection or inflammatory process including treatment with antibiotics within a two week time of study entry.
* Severe acidosis defined as pre-dialysis serum bicarbonate levels of \<15 mEq/L.
* Presence of conditions that would affect normal response to repletion of protein and calories, such as gastrointestinal disorders including inflammatory bowel disease.
* Hospitalization for an infectious condition within 4 weeks prior to study entry.
* Planned surgery within the three month study period including planned kidney transplantation.
Vasoactive Hormones During the Night in Patients With Obstructive Sleep Apnea and Healthy Controls.

Obstructive sleep apnea syndrome is complicated by considerable cardiovascular morbidity and mortality, at least partly due to hypertension. Nocturnal hypoxia, hypercapnia and acidosis stimulate chemoreceptors and presumably increased secretion of vasoactive hormones which might be responsible for hypertension in these patients.

The aim of this study is to measure the secretion of vasoactive hormones at night and to analyse the relationship between vasoactive hormones, oxygen saturation and the blood pressure at night.


Eligibility Criteria:
Inclusion Criteria:

Male and female Age 20-65 Obstructive sleep apnea

Exclusion Criteria:

Drug or alcohol abuse Pregnancy or breast feeding Cancer Clinical signs or history of disease in the heart, lungs, kidney or endocrine organs Abnormal laboratory tests Albuminuria or glucosuria Aterial hypertension for healthy subjects
Pre-hospital ECMO or Conventional Resuscitation for Refractory Cardiac Arrest

This pilot study aims to determine feasibility of randomising patients to receive pre-hospital Extracorporeal Cardiopulmonary Resuscitation (ECPR) compared to conventional cardiac arrest care for refractory out of hospital cardiac arrest (OHCA).

The success of this study will be measured by the number of patients recruited into the study successfully treated with the treatment they were randomised to receive in the pre-Hospital setting.

Conventional cardiac arrest care, including high performance cardiopulmonary resuscitation, defibrillation and administration of drugs such as adrenaline is the current treatment for out of hospital cardiac arrest. In cases where this treatment does not see spontaneous circulation restored promptly, the patients cardiac arrest is termed refractory. Refractory Cardiac arrest is coupled with an increased risk of hypoxic injury to vital organs and the prospect of survival with good neurological recovery decreases dramatically.

ECPR is an effective way to restore circulation for patients with refractory OHCA. Hospital based ECPR is the most common process by which refractory OHCA patients are treated with ECPR. Patients are transported to an ECPR capable hospital while receiving mechanical CPR. Transporting patients while receiving mechanical CPR is challenging and may lead to less effective CPR (low flow). It may also delay access to urgent hospital based treatments due to the extra time required to load a patient receiving mechanical CPR.

Pre-Hospital ECPR is where the ECMO team rapidly attends the scene and implements ECMO while CPR is on-going at the scene. Benefits of this approach may include reduced low-flow time due to both earlier ECMO initiation as well as allowing the emergency responders focus on delivering high performance CPR rather than loading the patient for transport.

The results of this study will inform a larger study where researchers will compare these two treatments to determine if ECPR leads to higher survival rates and better recovery for patients with refractory OHCA. Observational data for pre-hospital ECPR in the Australian setting looks promising. However ECPR systems are expensive and resource intensive, making answering this question an imperative.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18-70 years old
* Witnessed cardiac arrest
* Bystander CPR
* Refractory cardiac arrest (\>20 mins, but \<45 mins)
* Initial cardiac rhythm VF, VT or PEA
* Within hours of PACER service operation (e.g. mon-fri 0800-1700)
* Within 25 mins of rapid response ambulance (code 1 lights and sirens)

Exclusion Criteria:

* Initial cardiac rhythm asystole
* ROSC with sustained recovery
* Technically not possible to perform percutaneous cannulation
* Evidence of/suspectedSignificant end stage disease:
* Severe disability impairing activities of daily living
* End-stage organ - cardiac, liver, lung, renal
* Other life-limiting diseases e.g malignancy, terminal illness
* Advance health care directive (not for resuscitation)
Geriatric HIV Cohort in Sub Sahara Africa

The overall goal of the proposal is to improve capacity for detection and management of non-communicable diseases and geriatric syndromes in the aging HIV population in sub-Saharan Africa

The establishment and scale up of solid and sustainable HIV programs in sub-Saharan Africa (SSA) has led to a reduction in mortality and morbidity from HIV related opportunistic infections and some HIV related cancers. This improved survival has resulted in two phenomena: the first is the surfacing of non-communicable diseases (NCDs) in the HIV population, especially in those on long-term ART, and the second is increased longevity leading to increasing numbers of elderly HIV infected individuals

Eligibility Criteria:
Inclusion Criteria:

Age 60 years and above

* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Any clinical (physical and psychiatric) condition which prevents the patients to participate safely in the study procedures according to the judgments of a physician.
* Subjects already enrolled in experimental clinical trial.
Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy

The purpose of this study is to compare the Ankle Dorsiflexion Dynasplint System (DS) to static night splint for the reduction of pain from Plantar Fasciitis (Fasciopathy).


Eligibility Criteria:
Inclusion Criteria:

* All patients will have had a history of at least 3 consecutive months of plantar heel pain well-localized to the plantar fascia.
* All patients will have failed an initial treatment of non-weight bearing plantar and Achilles stretching.
* Diagnosis will be confirmed by physical examination by a single physician (JPF) with a typical point of maximum tenderness over the medial tubercle of the calcaneus

Exclusion Criteria:

* rheumatoid arthritis
* local infection
* pregnancy
* patients with tumors
* unresolved fractures
* severe peripheral vascular disease
* history of prior plantar fascia surgery
* history of plantar fascia rupture
* age \<18 years
* recent ( within 6 weeks) steroid injection
Macro-scale Estimators of Covid-19's Worldwide Cases and Deaths

In this study, investigators try to estimate Covid-19 Cases and Deaths using countrywide annual macro-scale indicators (i.e., estimators) such as non-communicable disease data from WHO (who. int), social and economical indicators from UN (un.org) and Worldbank (worldbank.org), and Covid-19 Cases and Deaths from Worldometer (https://www.worldometers.info).

There are some known risk factors for the emergence and mortality of Covid-19 cases. There are also some regulations and recommendations by healthcare executives and government officers such as wearing masks, social distance, staying at home, lockdowns, and so forth. On the other hand, there could be other social, economic, and health-related factors in the society level that discriminate between countries significantly in terms of having considerable differences regarding both the frequency and mortality of Covid-19. The aim of the present study is to find out these social, economic, and health-related factors that could explain some significant portion of Covid-19 cases and deaths worldwide.

This study involves 171 countries of which required datasets are commonly available in the UN, Worldometer, and WHO. The investigators will obtain macro-scale indicators like non-communicable disease data from WHO (who. int), social and economical indicators from UN (un.org) and Worldbank (worldbank.org), and Covid-19 data from Worldometer (https://www.worldometers.info).

The investigators will conduct statistical data analysis and create predictive models in order to determine indicators. The investigators will also consider that possible different models for explaining Covid-19 Cases and mortality in both common and different estimators could explain the variations in countrywide deaths and cases.

Eligibility Criteria:
Inclusion Criteria:

* All recorded cases by the authority

Exclusion Criteria:

* None
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation

The study is designed to collect data on the acute and long-term (1 year) safety and effectiveness outcome when an ablation procedure is performed in a commercial and standard of care setting with the FARAPULSE™ Pulsed Field Ablation System, whereby the FARAWAVE NAV Ablation catheter is used in conjunction with the OPAL HDx Mapping System. In addition, the study intends to analyse the association between several workflow-related variables, inclusive of intracardiac electro-anatomical mapping and ablation strategy with procedure-related complications (safety parameters), and one-year effectiveness parameters.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are prospectively planned and intended to be treated with the FARAPULSE™ Pulsed Field Ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care
* Subjects who are willing and capable of providing informed consent
* Subjects who are willing and capable of participating to this Registry at an approved clinical investigational center
* Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law
* Subjects are planned to undergo an ablation procedure whereby the FARAWAVE NAV PF Ablation Catheter is used in conjunction with the OPAL HDx Mapping System.

Exclusion Criteria:

* Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study. Exceptions are when the subject is participating in a mandatory governmental registry, or a purely observational registry, that do not interfere with the current study
Omega-3 Fatty Acids Plus Vitamin E Cosupplementation Versus Vitamin E in Fibrocystic Breast Patient

to identify the effect of omega-3 plus vitamin E cosupplementation on mastalgia in patients with FCC and to compare its effect with that of vitamin E only.

120 patients will be enrolled in the study and divided into three groups each group consisted 40 patient then the severity of mastalgia in the three groups before, through and after intervention. Radiological assessment was done before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* all females with mastalgia aged 18 to 55

Exclusion Criteria:

Pregnant and lactating women, patient who had a recent breast abscess or breast drainage, patient used omega-3 and vitamin E supplementation before the trial and postmenopausal women.

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The Impact of Family Financial Support on Health Related Quality of Life

The investigators have partnered with financial coaching organizations to establish what the investigators have termed a "Medical-Financial Partnership (MFP)" that offers financial coaching to improve financial and mental health. The investigators will evaluate the MFP's impact on health related quality of life using the Patient Reported Outcome Measurement Information System (PROMIS) 10 Global Short Form.

Financial coaching is a new tool in the field of community development, but it has already demonstrated significant financial impact in a number of studies, including one randomized trial conducted by the Urban Institute. Financial coaching improves participant financial literacy, budgeting, saving for financial emergencies, and debt level. The investigators' project will help clinicians and the field of community economic development understand health and well-being through a new economic lens and assess the health-related impacts of the emerging field of financial coaching. The investigators have partnered with financial coaching organizations to establish what they have termed a "Medical-Financial Partnership (MFP)" that offers financial coaching to improve financial and mental health. The investigators will evaluate the MFP's impact on health related quality of life using the Patient Reported Outcome Measurement Information System (PROMIS)10 Global Short Form.

Community-based participants will be recruited from South Los Angeles and randomized to receive either monthly financial coaching plus access to referral for social services (intervention) or access to referral for social services alone (control). Inclusion criteria include having dependents under age 18, having some form of income, and having a tax identification number (social security number or Individual Tax Identification Number). Participants will be surveyed quarterly regarding their health related quality of life using the PROMIS-10 Global Short Form.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be caregivers/parents with one or more child dependents, some form of income, and a tax identification number.

Exclusion Criteria:

* Inability to participate in financial coaching due to activity/cognitive limitations or primary language other than English or Spanish.
HKT-500 in Adult Patients With Ankle Sprain

The objective of this study is to demonstrate the multiple-dose efficacy and safety of HKT-500 for the treatment of ankle sprain.

Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or older who have a painful, acute, benign, ankle sprain of the lateral ligament(s) within the previous 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Grade I or Grade II Ankle Sprain.

Exclusion Criteria:

* The subject is a women of childbearing potential who has a positive urine pregnancy test, who is lactating, who is not surgically sterile (by tubal ligation or hysterectomy), or at least 2 years postmenopausal, and has not practice an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months prior to Visit 1.
Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness

An open label study to investigate the safety and efficacy of tradipitant in participants affected by motion sickness during travel

This is an open label study to investigate the efficacy and safety of tradipitant in motion sickness affected male and female participants during events historically known to cause motion sickness.

Eligibility Criteria:
Inclusion Criteria:

* History of Motion Sickness
* Age 18-75

Exclusion Criteria:

* Nausea-inducing disorder other than motion sickness
* BMI \> 40
* History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists
Improving Service Delivery Through Access Points

CBOCs represent one of VA's main managed care strategies for shifting the focus of care from the inpatient to the outpatient setting and for improving the health of our nation's veterans. Hypothesis-driven research is critically needed to test the basic assumptions motivating the expansion of CBOCs throughout the VA health care system.

Background:

CBOCs represent one of VA's main managed care strategies for shifting the focus of care from the inpatient to the outpatient setting and for improving the health of our nation's veterans. Hypothesis-driven research is critically needed to test the basic assumptions motivating the expansion of CBOCs throughout the VA health care system.

Objectives:

The purpose was to determine how increased geographic access to primary care services affects service use and costs. Two specific aims addressed were: 1) to determine how CBOCs impact the service use of all existing users and existing users with the following ambulatory care sensitive conditions (ACSC): alcohol dependence, angina, chronic obstructive pulmonary disease (COPD), depression, diabetes and hypertension; and 2) to describe how CBOCs affect the workload and costs of the VA health care system from the VISN's perspective.

Methods:

A quasi-experimental pre-post study design with intervention and reference groups was employed to compare service use and costs in the 18 months following the establishment of a new CBOC. Fifteen CBOCs from 11 VISNs were included in the analysis. For specific aim 1, the intervention group was defined as existing users in the catchment area of a new CBOC and the reference group was defined as matched existing users outside CBOC catchment areas. Multivariate statistical regression analyses were used to estimate the impact of residing within the CBOC catchment area on use and cost in the post-period, controlling for patient casemix and use/cost in the 18 month pre-period. For specific aim 2, the intervention group was defined as zip codes in the catchment area of a new CBOC and the reference group was defined as matched zip codes outside CBOC catchment areas. Average use and costs for all users, existing users and new users from intervention zip codes and reference zip codes were compared.

Status:

Complete.

Eligibility Criteria:
Inclusion Criteria:

Subjects must live in the catchment area of a specified CBOC and have been diagnosed with a tracer condition.

Exclusion Criteria:
Evaluation of the Effect of Myopic Femtosecond Laser Assisted-LASIK on Anterior Chamber Flare Values and Corneal Endothelial Cells: A Prospective Before-and-After Study

This study aimed to investigate whether femtosecond laser-assisted LASIK (FS-LASIK) surgery causes inflammation in the anterior chamber and to analyze its effect on endothelial cells.

Since FS-LASIK surgery is applied using both an FS laser and an excimer laser, we aimed to determine the direct and indirect effects of these applications on the corneal endothelium, the intensity of the inflammation, and the blood-aqueous barrier in the anterior chamber. To the best of our knowledge, the effects of FS-LASIK on anterior chamber inflammation have not been previously investigated. Therefore, we evaluated these effects using objective measurement methods, such as specular microscopy and laser flare photometry.

Eligibility Criteria:
Inclusion Criteria:

* The patients who performed Femtosecond laser assisted LASIK for myopia or myopic astigmatism.
* Uncomplicated surgery

Exclusion Criteria:

* Complicated surgery,
* Hyperopic or hyperopic astigmatism
* Lack of follow-up measurements
A Single Dose Study of SHR0410 in Healthy Male Participants

This is a randomized, double-blind, placebo-controlled, single ascending-dose study to investigate the effect of a single intravenous (IV) dose of SHR0410 at 6 dose levels (0.5 μg/kg, 1 μg/kg, 2 μg/kg, 5 μg/kg, 10 μg/kg and 20 μg/kg) in healthy participants.

Forty eight eligible participants will be enrolled into the 6 dose cohorts. For each cohort, a sentinel group of 2 subjects (1 receiving SHR0410 and 1 receiving placebo) will be dosed first (1:1 ratio). If no drug related adverse events occur in the sentinel participants, the remaining 6 subjects in a cohort will be dosed on the next day or later in a 5:1 ratio (5 subjects receiving SHR0410 and 1 subject receiving placebo). SHR0410 will be diluted in saline and administered as a 15 min constant dose IV infusion at a rate of 20 ml/hr on Day 1.

Eligibility Criteria:
Inclusion Criteria:

1. Male between the ages of 18 and 45 years, inclusive.
2. Body mass index (BMI) of 18.0 to 30.0 kg/m2 and a total body weight of 50 kg to 125kg, inclusive.
3. Considered generally healthy upon completion of medical history, physical examination, vital signs, SpO2, laboratory parameters, and ECG, as judged by the Investigator.

Exclusion Criteria:

1. Known sensitivity to any of the components of the investigational product formulation, or any other opioids.
2. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
3. Any other medical or psychological condition, which in the opinion of the Investigator, might create undue risk to the participant or interfere with the participant's ability to comply with the protocol requirements, or to complete the study.