cyrilzakka/clinical-trials huggingface dataset:
Education and Management of PAD in Primary Care

Peripheral arterial disease (PAD) occurs when the vessels carrying blood to the legs become narrowed or blocked. It affects 1 in 5 people aged over 60 and are at risk of losing their leg, developing a heart attack or stroke, or die early.

Early symptoms of peripheral arterial disease (PAD) include aching in the legs when walking which may not be recognised by healthcare professional. Our research has shown that knowledge and recognition of PAD is poor in healthcare professionals and trainees. There appears to be little time provided within healthcare professional training for PAD.

To improve PAD recognition/management, the investigators want to identify the current level of training given to healthcare professionals; opinion towards PAD related to their training and how they prefer to receive training.

With the information gained from this research, the development of an educational training package for GPs, practice nurses and their trainees to improve recognition of PAD is anticipated.

Around 20% of people above 60 years are estimated to have PAD. The prevalence of PAD is expected to rise due to a sedentary life-style, poor dietary choices, rising prevalence of diabetes and longer life-expectancy.

The most common presentation of symptomatic PAD is intermittent claudication - pain on activity. In some cases the reduction in blood flow is so severe that it causes pain at rest, ulceration or gangrene (chronic limb threatening ischemia, CLTI). Approximately 5% of individuals between the age of 55 and 74 in the UK have IC or CLTI. Compared to age-matched individuals, these patients are more likely to suffer cardiovascular events - heart attack and strokes and cognitive impairment (10). Of those with IC, 5% will progress to CLTI. In patients with CLTI the one-year risk of limb amputation is 30% and five-year all-cause mortality is 50%, similar to various advanced forms of cancer. Recognition and management are essential to reducing the limb and life loss sequela.

Management of these high-risk individuals is shared between primary care (diagnosis, treatment of cardiovascular risk-factors, rehabilitation) and secondary care (vascular reconstruction, amputation, specialist management of cardiovascular disease).

This mutli-centre prospective cohort study will investigate the explore the educational experience of UK primary care health practitioners for peripheral arterial disease (PAD), including identification of factors that shape their preferred learning style and assess health professionals opinions of PAD recognition and management.

Eligibility Criteria:
Inclusion Criteria:

1. Practising healthcare practitioners within primary care
2. Participants must be aged 18 years or older
3. Participants must be able to access the online questionnaire
4. Participants must have the capacity to consent
5. Participants should speak English

Exclusion Criteria:

1. Healthcare practitioners who are not in practice.
2. Participants who do not consent
3. Participants who are unable to communicate in English
Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

Exparel is an FDA-approved local anesthetic (bupivacaine), in a long-release formulation. In this study the investigators plan to determine the ability of Exparel to control post-operative pain in common first metatarsophalangeal (MTP) joint procedures (bunion surgery, 1st MTP fusion, and cheilectomy).

The investigators propose a prospective, randomized, single-blinded study of patients who are electing to undergo an outpatient first metatarsophalangeal (MTP) joint procedure (bunionectomy, 1st MTP fusion, or cheilectomy). As a standard, patients undergoing these procedures are given regional anesthesia (adductor canal block plus popliteal block). Patients are then given prescriptions for oral opioids to manage post-operative pain. The purpose of this study is to determine whether a single intrapopliteal administration of Exparel, in conjunction with the standard of care regional block, improves pain relief and therefore decreases use of post-operative opioids.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Undergoing distal or midshaft osteotomy for bunion correction, 1st MTP Fusion, or cheilectomy

Exclusion Criteria:

* Age less than 18
* Unable to read/write English
* Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
* Weight \<70 kg
* Allergy to local anesthetics
* History of long-acting opioid use or opioid tolerance (any patient receiving at least 30 mg of oxycodone or equivalent per day (e.g., 6 tabs of Percocet 5/325 mg) regularly for approximately 7 days or more OR who require increased analgesic doses for a period long enough to develop tolerance to the effects of the opioid including analgesia and sedation)
* Any history of opioid misuse, illicit or prescription
* Prior MTP joint correction on the surgical limb
* Midfoot and hindfoot procedures performed concurrently, on the same day
* Pregnant or breastfeeding
The Effect of Breast Cancer Prevention Journey Program

The aim of this quasi-experimental study is to determine the effect of the "Breast Cancer Prevention Journey Program" on health beliefs about breast cancer in women over 40 years of age who have never had a mammogram before. The research aims to answer the following basic questions:

-Do women who participated in the "Breast Cancer Prevention Journey Program" have different health beliefs about breast cancer than women who did not participate in the program? The researchers will compare the program with routine care to see if the "Breast Cancer Prevention Journey Program" works. The study will be conducted in a quasi-experimental design with a pre-test post-test control group.

Participants in the experimental group will first participate in the "The fight against breast cancer" training structured according to the Health Belief Model. One week after the training, the participants in the experimental group will be taken to mammography screening with free shuttles.

Participants in the control group will not receive any additional intervention. This group will only receive routine intervention within the scope of the breast cancer screening program conducted by the Ministry of Health.


Eligibility Criteria:
Inclusion Criteria:

* Being a woman between the ages of 40-69
* Having never had a mammogram before

Exclusion Criteria:

* Being diagnosed with breast cancer
* Having had a breast operation
Prevention of Unexplained Recurrent Abortion by Enoxaparine

Standard investigations fail to reveal any apparent cause in 50% of the cases of recurrent spontaneous abortion. Prothrombotic mechanisms were initially evoked. Factor V Leiden, Prothrombin G20210A mutation and protein S deficiency are implicated in the meta-analysis of Rey (Lancet).However, they do not account for a large number of miscarriages.Gris JC and coworkers (Blood 2004)carried out an open trial, low-molecular-weight heparin versus low-dose aspirin, in women with one fetal loss and with a constitutional thrombophilic disorder. They conclude for a benefit action of Low-molecular-weight heparin. There is actually no trials concerning women with unexplained recurrent abortions and without known thrombophilia. Nevertheless,aspirin or enoxaparin are often prescribed. It is time to assess these practices. We therefore initiate a multisite, double blind randomized study, enoxaparine versus placebo, in women without known thrombophilia, which experienced unexplained recurrent abortions.


Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 45 years
* 2 or more consecutive spontaneous abortions before the 15th week of pregnancy
* Unexplained abortions
* No maternal or paternal characterized chromosomal aberration
* No Anti-phospholipid Syndrome
* No anatomical abnormality possibly responsible for abortion
* No Factor V Leiden
* No Prothrombin G20210A mutation
* No protein S deficiency
* No protein C deficiency
* No Anti thrombin 3 deficiency
* Proved pregnancy

Exclusion Criteria:

* Contraindications of enoxaparine 4000 U per day
* Women with risk of venous thromboembolism during pregnancy
* No regular anticoagulation or antiplatelet treatment
* Blood Hemoglobin level below 10g/dl
* Blood platelet level below 150 000/mm3
* Creatinine clearance below 30ml/mn
* Anomaly of the coagulation tests
* No informed consent
A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)

The purpose of this study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention.

The purpose of this medical research study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention. This medical research study will also help determine if the combination of abciximab and reduced dose reteplase will decrease the risk of death, and reduce complications of a heart attack at 90 days compared to abciximab alone which is a standard treatment.

Patients will receive either abciximab and reteplease or abciximab alone. Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive either abciximab and reteplease or abciximab and placebo into a vein in their arm for up to 12 hours.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have prolonged, continuous (lasting at least 20 minutes) signs and symptoms of A heart attack not eliminated with nitrates and onset within 6 hours of randomization,and confirmation by Electrocardiogram

Exclusion Criteria:

* Low risk clinical presentation
* patients who will not be undergoing a catherization within 4 hours of the qualifying Electrocardiogram
[68Ga]Ga-NOTA-SNA002 (PD-L1 PET Tracer) for PET/CT in Patients With Solid Tumors

The purpose of this study is to evaluate the safety of \[68Ga\]Ga-NOTA-SNA002 and investigate the uptake of \[68Ga\]Ga-NOTA-SNA002 in patients with solid tumors.

After being informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of \[68Ga\]Ga-NOTA-SNA002 (1.0-5.0mCi) in Day1 and will undergo PET/CT scanning to determine uptake of \[68Ga\]Ga-NOTA-SNA002 in tumor lesions and reference tissues.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years (including boundary values);
2. Have behavioral ability, and voluntarily participate in this clinical study, and sign the informed consent form (ICF);
3. Performance status (ECOG) score 0-2 points (see Appendix 1 for details);
4. Basal heart rate 60-100 beats/min (including boundary values);
5. Blood pressure measurement \< hypertension grade 1 level (including a history of hypertension, systolic blood pressure \< 140 and diastolic blood pressure \< 90 mmHg by exercise or drug treatment);
6. Patients with confirmed solid tumors;
7. Patients who must have at least one image-measurable lesion according to the evaluation criteria for solid tumors (RECISTv1.1);
8. Imaging results show that at least one tumor lesion can be needle biopsy or surgical treatment to obtain specimens (enhanced CT, enhanced MRI or 18F-FluroDeoxyGlucose(FDG) PET/CT results are acceptable);
9. Patients obtained with immunohistochemical PD-L1 expression results within the previous month.

Exclusion Criteria:

1. Those who are unable to follow this clinical trial protocol well enough to make visits, or undergo relevant examinations, or treatment;
2. Those who have extremely poor nutritional status and cannot tolerate the trial;
3. Known or suspected evidence of active autoimmune disease;
4. Patients taking high doses of hormones, such as more than 20mg of hydrocortisone or 5mg of prednisone in the morning and more than 10mg of hydrocortisone or 2.5mg of prednisone at night；
5. Those with known severe allergy to SNA002, similar drugs or excipients；
6. Patients with brain metastases；
7. Serum virology tests: positive results for any of hepatitis B virus surface antigen, hepatitis C virus antibodies, syphilis-specific antibodies or those who cannot be determined to be negative for human immunodeficiency virus antibodies；
8. Women who are pregnant or breastfeeding.
9. Those who, in the opinion of the investigator, are not suitable to participate in this clinical study.
Prospective Randomized Clinical Trial Evaluating the Impact of Vinegar on High Density Lipoprotein

This is a double-blinded randomized placebo controlled prospective clinical trial evaluating the impact of apple cider vinegar on serum HDL. 112 participants will be randomized to consume either 2 tablespoons of vinegar daily or a placebo containing a 2% balsamic vinegar solution in water. Baseline, two month and 4 month blood samples will be obtained for fasting lipids. The primary endpoint is met if HDL levels increase in the treatment arm versus baseline after 2 month intervention.


Eligibility Criteria:
Inclusion Criteria:

* Those older than 18 years of age
* Park Nicollet Health Services patient

Exclusion Criteria:

* Because of a potential positive effect of vinegar on improving diabetes mellitus8 and the subsequent change in medication regime for diabetes diabetic patients will be excluded from this study. If this study finds that vinegar does increase HDL levels, a subsequent study of diabetic patients will be conducted.
* History of allergy to apple cider vinegar
* Those with a terminal illness
* Diagnosis of Inflammatory bowel disease
* Those with Immunosuppression diseases
* Patients on dialysis
* Severe psychiatric illness who are unable to consent or reliably participate
* No evidence of end stage renal disease
* Those who use alcohol greater than or equal to 2 drinks per day
* Those who take in \>3 tsp vinegar/day supplement
* Plans to increase exercise or begin diet during the protocol period
* Any use of niacin or niacin-like compounds
* Initiation of niacin, fibrates (eg gemfibrozil); statin or ezetimibe medication within the last 6 weeks or during the trial
* Inability to read English
* Age less than 18 years given clinical events would be unlikely in this population
* LDL greater than 160mg/dL and requires adjustment or addition of statin therapy (which could reduce HDL)
* History of liver failure in medical history review
* Current smoking (as this can reduce HDL levels and it would be unethical to require people to continue smoking during the study)
Effects of Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Cytokines

This study aims to compare the effects of local wound infiltration with ketamine versus dexmedetomidine when added to bupivacaine on inflammatory cytokine response after total abdominal hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients
* age range (18-60) years,
* weight (50- 90) kg

Exclusion Criteria:

* allergy to study drugs
* significant cardiac disease
* respiratory disease
* renal disease
* hepatic disease
Reproductive Outcomes Following Uterine Septum Resection

Nowadays, there is little data to validate the performance of surgical hysteroscopies in the case of septate uterus, particularly in the case of incidental discoveries. Clinical practice and the experience of teams leads to propose this procedure, but strong evidence for this recommendation is lacking and there is an urgent need for solid data.

A recent randomized trial contradicts this recommendation, but the methodology is questionable on several points.

Investigators wished to associate 2 reference centers with current practice and expertise on this procedure in order to have a cohort of many patients and to have more powerful results.) Investigators purpose a retrospective observational data-based study. The aim is to describe the profile of patients with a partitioned uterus in terms of obstetrical history and to study the consequences of uterine partition resection in terms of obstetrical prognosis (live births, at term, number of miscarriages or premature births).

The aim of this study is to take into account the evaluation of the surgical hysteroscopy gesture by postoperative imaging with in particular the indication of a resection in several stages in case of residual postoperative septum.


Eligibility Criteria:
Inclusion criteria:

Major female (≥18 years old) To be an operating patient at the strabourg university hospital or Bicetre Hospital between January 2009 and December 2019.

Exclusion criteria:

Particular clinical forms of the disease, (associated enlargement metroplasties, other uterine maformations) Minor patients, patients under guardianship
An Intervention to Promote Healthy Behaviors in Homeless Youth

Investigators will use a Solomon 4-group design to test the effectiveness of a brief intervention to promote health behaviors for homeless youth who are 18-23 years of age. We will recruit 300 youths from Austin, TX and 300 from Columbus, OH. We will gather quantitative data on health behaviors and life satisfaction 3 and 6 months following the intervention, which will be delivered on an individual basis. Data will be analyzed using structural equation modeling and ANCOVA statistics.

The specific aims of this proposal are to:

1. determine the effectiveness of a self-reflective preventive intervention to promote responsible substance use and safe sex behaviors (prevent HIV/AIDS) in homeless youths, ages18-23 years;
2. determine whether psychological capital factors mediate the relationship between background risk factors (sexual orientation, duration of homelessness, sex abuse history, history of substance use, past sexual risk behaviors, and service utilization) and improved proximal outcomes (self-efficacy and intentions) and distal outcomes (responsible substance use, safer sex, life satisfaction);
3. determine the effect of pre-testing on intervention proximal outcomes (immediately following intervention) and distal outcomes (at an interval of 3 and 6 months following intervention); and an exploratory aim
4. to explore general and specific differences in proximal and distal outcomes of the intervention between participants in two geographically different sites (Austin, TX and Columbus, OH). We will recruit a total of 600 homeless youths from 2 drop-in centers in 2 geographic areas of the central US: Austin, TX and Columbus, OH. Using a Solomon four-group design with repeated measures, we will conduct a randomized controlled trial of a brief possible selves intervention (PSI) consisting of 6 brief individualized sessions that focus on generating images of one's possible self as feared or as best. Intervention participants will also receive weekly electronic messages to encourage them to move toward a goal of becoming their best possible self. Quantitative data will be collected before, immediately after the intervention, and at intervals of 3 and 6 months following intervention to test hypotheses about the effectiveness of the intervention on health behaviors and life satisfaction as well as the effects of pre-testing on these outcomes using structural equation modeling and ANCOVA statistics. The findings are expected to have a public health impact on further development of individualized services to promote healthy behaviors, healthy lifestyles and life satisfaction for vulnerable youths.

Eligibility Criteria:
Inclusion Criteria:

* does not have current secure place of residence,
* receives services from a homeless street outreach center, and
* is able to read and write English

Exclusion Criteria:

* Currently enrolled in Alcoholics Anonymous or other substance treatment program
Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates

Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.

The death rate is over 50%.There are no special treatments for acute respiratory distress syndrome.

Acute respiratory distress syndrome (ARDS) is one of the serious complications in critically ill neonates. It can result in severe hypoxemia refractory to mechanical ventilation. There are few options for mechanical ventilation for such situations such as high frequency oscillation ventilation and extracorporeal membrane oxygenation. The aim of the present study is to determine whether transfusion of red blood cells can decrease the mortality in neonate with ARDS.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with neonatal ARDS.
* informed parental consent has been obtained

Exclusion Criteria:

* major congenital malformations or complex congenital heart disease
* transferred out of the neonatal intensive care unit without treatment
Elements Vital to Treat Obesity Study

The overall objective of this study is to evaluate the first rigorously optimized, remotely delivered treatment for obesity against the current gold standard treatment in a head-to-head randomized controlled trial. The investigators will be comparing the previously developed and optimized behavioral weight loss intervention (APP) to the Diabetes Prevention Program (DPP), to evaluate program weight-loss success and cost-effectiveness.

The proposed study seeks to determine if the APP program is an effective, resource-sensitive strategy to manage weight for obesity, as compared to the DPP program. During the 24-week active intervention phase, participants will be randomized to one of two treatments: 1) APP, wherein participants receive calorie, fat, and physical activity goals via a Smartphone application for self-monitoring, online educational readings, and biweekly sessions with a Health Promotionist; or 2) DPP, wherein participants are guided to self-monitor their physical activity, food intake, and weight via a participant log, and are guided through 16 sessions by a Health Promotionist. Assessments to track progress will occur remotely at the 3-month, 6-month, and 12-month time points of the program.

Eligibility Criteria:
Inclusion Criteria:

* BMI 30-45
* Weight stable
* Own a Smartphone and be willing to install our Smartphone app
* Willing to conduct video conference calls with study staff

Exclusion Criteria:

* Enrolled in any formal weight loss program
* Taking anti-obesity medications
* Not taking medications that may cause weight gain
* Unstable medical conditions
* Diabetes requiring insulin supplementation
* Crohn's Disease
* Diagnosis of obstructive sleep apnea requiring intervention (i.e., CPAP)
* Assistive devices for mobility
* Hospitalizations for a psychiatric disorder within the past 5 years
* Cardiovascular disease symptoms while performing moderate intensity exercise
* Pregnancy, trying to get pregnant, or lactating.
* Bulimia or binge eating disorder
* Reports of active suicidal ideation
* Current substance abuse or dependence besides nicotine dependence
Trial Comparing Tisseel as an Adjunct to Traditional Hemostasis After Redo Cardiac Surgery

Bleeding after redo cardiac surgery is a common, unresolved and consequences-heavy event as per present day. Tisseel (Baxter inc) sprayed on the already hemostased mediastinum jut before closing seems a promising technique to radically diminish bleeding.

This study aims to verify this efficacy volume in chest drains) and possibly the consensual blood transfusion lessening.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing any kind of redo cardiac surgery with ati least one previous sternotomy

Exclusion Criteria:

* None