cyrilzakka/clinical-trials huggingface dataset:
Swedish Drug-elution Trial in Peripheral Arterial Disease

Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk of amputation, to exercise-induced pain (intermittent claudication), limiting the patients daily activities. Invasive treatments are often indicated to prevent amputations and to alleviate symptoms. More than two thirds of these procedures are presently performed with endovascular techniques (i.e. percutaneous transluminal angioplasty, PTA with or without stent implantation).

In coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents, DES) reduce restenosis and improve clinical results for the majority of patients. Drug eluting balloons (DEB) are a promising alternative, but there is still little evidence that DES or DEB technology improve clinical outcome in PAD. However, promising results utilizing these new technologies in PAD have been reported in a few studies.

In this trial, we test the hypothesis that drug eluting (DE) technology is superior to conventional endovascular treatment (no-DE) in terms of important clinical outcomes, when applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular lesions. The trial consists of 2 separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each defined by the severity of peripheral arterial disease. Patients with critical limb ischemia are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to SWEDEPAD 2.


Eligibility Criteria:
Inclusion Criteria:

* All adults \> 18 years old willing to be randomized
* Symptomatic PAD (critical limb ischemia or intermittent claudication) caused by \>50% stenosis or occlusion of infrainguinal arteries and eligible for endovascular treatment according to established indications

Exclusion Criteria:

* Acute thromboembolic disease in the leg
* Infrainguinal aneurysmal disease
* Previous participation in the study or in other randomised interventional study of infrainguinal lesions
* Patients without a Swedish personal identification number
Increasing Adherence to Lung Cancer Screening

Investigators are conducting a pragmatic randomized trial testing the effectiveness of patient and clinician nudge strategies on adherence to lung cancer screening (LCS) \& diagnostic follow-up across eligible primary care clinicians \& patients. Following the trial, a subsample of patients \& clinicians will be invited to one-time semi-structured interview \& survey to identify individual \& system-level factors that may restrict or enhance the impact of strategies.

Investigators will conduct a pragmatic clinical trial with a 2 x 2 factorial design with clinicians that provide care to screening-eligible patients who are overdue for annual screening or diagnostic evaluation. The specific nudge strategies to be tested are: 1) gain-framed messaging delivered via text messaging to prompt patient adherence to LCS guidelines (patient nudges); and 2) electronic health record (EHR) prompts alerting clinicians when their patients are due for annual screening or diagnostic follow-up (clinician nudges). The rationale for this study is that changing external stimuli to encourage adherence to evidence-based LCS guidelines will increase early detection of lung cancer by removing individual and system-level barriers to identifying and prompting patients who are due for care. The central hypothesis is that the combination of patient and clinician strategies will have the greatest effect on increasing adherence because it will target multilevel determinants of lung cancer screening identified in our prior research including limited screening knowledge and suboptimal EHR design. The proposed strategies are designed to support equitable implementation across diverse settings and populations.

Eligibility Criteria:
Inclusion Criteria:

Clinicians will be eligible if they:

1. are practicing primary care or specialty care physicians at a recruiting site within the University of Pennsylvania Health System;
2. care for patients who completed LCS via LDCT in 2019-2023; and
3. do not opt-out of study participation.

Patients will be eligible if they:

1. are eligible for LCS based on 2021 US Preventive Services Task Force (USPSTF) population guidelines (aged 50-80; smoking history of 20-pack years; smoked within the last 15 years)
2. completed LCS via LDCT in 2019-2023;
3. have not been diagnosed with lung cancer;
4. meet criteria for non-adherence;
5. remain eligible for LCS during the trial enrollment period; and
6. receive LCS care from a clinician that has not opted-out of study participation

Exclusion Criteria:

Patients will be excluded if they:

a) have a highly suspicious baseline LDCT (Lung-RADS 4B/X) given the presence of existing clinical pathways to ensure adherence in this group
Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity

Free flap reconstruction consists in replacing tissular defect from one body part by another tissu harvested in a distant site. Microsurgery has to be performed to restore vascularization.

Free flaps are now the gold standard in complex reconstruction. While reliable with a success rate superior to 95 %, a failure takes a heavy burden on the patient. Many risk factors have been highlitghted in free flap failure for head and neck microvascular reconstruction.

Among them, malnutrition is still debated. This is a retrospective cohort study comparing complications occurrence between two groups. One group with normal nutritionnal status, the other with malnutrition. Between january 2008 and january 2018, 70 patients who underwent oral cavity reconstruction using free flap were included. This is the first study known to date which uses clinical and biological variables to determine the nutritionnal status.

Malnutrition is not associated with a higher risk for free flap failure in the oral cavity.


Eligibility Criteria:
Inclusion Criteria:

* every consenting patients undergoing free flap reconstruction of the oral cavity

Exclusion Criteria:

* unable to give consent
Collecting Information From Patients and Family Members With Hereditary Colorectal Cancer Syndromes or Who Are at High Risk of Developing Colorectal Cancer

RATIONALE: Gathering medical and family history information from patients and family members may help doctors better understand hereditary colorectal cancer and hereditary polyposis syndrome and identify patients at high risk of developing hereditary colorectal cancer.

PURPOSE: This research study is collecting information from patients and family members with hereditary colorectal cancer or polyposis syndrome or who are at high risk of developing hereditary colorectal cancer.

OBJECTIVES:

Primary

* To identify patients and their family members who have either hereditary colorectal cancer or polyposis syndrome or are at high risk for developing hereditary colorectal cancer.

Secondary

* To establish a tissue and data repository that will be used to further research in hereditary colorectal cancer syndromes.

OUTLINE: Data is collected on patients and their families for inclusion in a hereditary colorectal cancer registry. Registry data is entered into a secure database that includes information on patient demographics and medical and family cancer history. The information collected will be used to formulate screening and surveillance recommendations, to further knowledge of hereditary colorectal cancer, and to facilitate cancer research. Registry data will also be used to improve the quality of current standard of care through timely tracking and notification of patients for follow-up care, identification of registry participants at high risk for developing an inherited form of colon cancer, and by serving as a resource for future research.

Registry patients may undergo optional blood, urine, and/or sputum sample collection for inclusion in the tissue repository. Tissue samples from a previous biopsy may also be obtained. Samples will be stored for future research studies.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets any of the following criteria:

  * Patients and family members with a known hereditary colorectal cancer or polyposis syndrome
  * Patients who meet Amsterdam I, II, or Bethesda criteria
  * Patients with a family history suggestive of a hereditary colorectal or polyposis syndrome
  * Patients diagnosed with colorectal cancer at \< 50 years old
* Patients are identified through surgical, oncological, gynecological, and gastrointestinal programs, as well as outside referrals, self referral, and the Vanderbilit Tumor Registry

PATIENT CHARACTERISTICS:

* See Disease Characteristics

PRIOR CONCURRENT THERAPY:

* Not specified
Immunogenicity and Thrombotic Potential of Circulating Protamine-heparin Complexes in Cardiac Surgery Patients

The primary aim of this study was to describe the prevalence and time course of the occurrence of protamine/heparin antibodies in patients undergoing cardiac surgery on cardiopulmonary bypass.

The second aim was to identify triggers of immunization.

The third aim of this study was to evaluate a potential clinical impact of protamine/heparin antibodies and their platelet-activating properties leading to thromboembolism and other adverse outcomes.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* cardiac surgery on cardiopulmonary bypass

Exclusion Criteria:

* cardiac surgery without cardiopulmonary bypass
* age \< 18 years
* no written consent
Spanish (Spain) Validation of a Specific Symptomatic Questionnaire for Patients With Nocturia

The objective of this study is to validate the spanish (from Spain) version of the "Nocturia Quality of Life Questionnaire and assess their psychometric properties, using the spanish translation provided by the copyright holder.

Internal consistency (measured by Alpha cronbach coefficient), Reproductibility (measured by Intraclass Correlation Coefficient), Convergent Validity (assessed using other already validate questionnaires such the International Prostate Symptom Score (IPSS), King's Health and Pittsburgh Sleeps Quality Index questionnaires) and Discriminant Validity will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Older than 60 years old
* One or more voidings overnight

Exclusion Criteria:

* Sleep disturbances
* Psychiatric diseases
* Surgical procedures during the time of study
* Introduction of new pharmacological treatments during the time of study
* Inability to complete the questionnaires
The Efficacy and Safety of Traditional Chinese Medicine (TCM) to the Patient With Dizziness in Emergency Department

The study is aimed in patients with persistent dizziness as the chief complaint that is treated with acupuncture or/and far-infrared heat-patch attachment intervention over the acupoints for the purpose of dizziness symptoms treatment. The research hypothesis is that the treatment over acupoints in traditional Chinese medicine is effective in treating symptoms of dizziness.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with age between 20 to 80-year-old who can cooperate to the whole treatment, testing and questionnaire.
2. The chief complaint is dizziness which diagnosed by the doctor in charge of the emergency department, in together to exclude the patients with severe unstable vital signs, and then consult for help with Chinese medicine.
3. Sign the clinical trial agreement sheet.

Exclusion Criteria:

1. Inacceptable to the research content
2. Unable to complete the study process
3. Unwilling to cooperate with acupuncture and other treatments
4. Abnormal blood clotting profile
5. With wound or allergy over the treated acupoint
6. Unstable vital sign
7. Post major trauma
Quality of Life Study for Adult Patients With Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia (ALL) accounts for about 20% of adult leukemias. Treatment results in adult ALL have lagged behind the improvements achieved in the pediatric population. A modified version of the Dana Farber Cancer Institute pediatric protocol is used to treat adult patients with ALL. The results seem to be superior to those reported with other adult protocols. However, there is limited data on the impact of such intensified approaches and resulting toxicities on the quality of life (QOL) of these survivors. Identifying important factors affecting the QOL may permit attempts at early interventions and may help to further modify the regimen and mitigate these adverse effects on QOL.

This study is evaluating the quality of life of long term survivors of adult ALL. It involves the patients filling out several questionnaires that are well-validated measures assessing various QOL issues of concern to these patients. The following questionnaires are used in this study:

* EORTC QLQ C30 to assess global health and major health domains
* Brief Pain Inventory (BPI)
* Personal Health Questionnaire (PHQ9) to assess psychosocial distress
* Functional Assessment of Cancer Therapy (FACT) Fatigue Questionnaire
* Peripheral Neuropathy Questionnaire

The data obtained from the questionnaires will be analyzed and the various domains of health will be quantified.


Eligibility Criteria:
Inclusion Criteria:

* previously diagnosed with adult ALL or T-lymphoblastic lymphoma
* Age \>/= 18
* Have completed the two-year modified DFCI protocol at least three months earlier and are in continuous complete remission
* Understand English and are able to fill out questionnaires
Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 in Patients Having to be Vaccinated MenBVac® (Extension EFFIVAC)

The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (\>= 4), before the fourth dose of MenBvac and after: 6 weeks and one year after the fourth dose.


Eligibility Criteria:
Inclusion Criteria:

* children born between 06/04/2004 and 17/04/2008, living in Neufchatel en Bray,and Having participated to the first study,
* children who Have to be Vaccinated MenBVac® for the four times,
* parental authority(ies)assent.

Exclusion Criteria:

* no parental authority(ies)assent,
* no blood sample,
* impossibility of fourth vaccination,
* children yet vaccinated or non eligible for vaccination.
Zenith Alpha™ Abdominal Endovascular Graft

The purpose of this study is to evaluate the clinical performance of the Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.


Eligibility Criteria:
Inclusion Criteria:

* A patient is considered eligible for inclusion in the study if the patient has an infrarenal abdominal aortic or aorto-iliac aneurysm and is intended to be treated with the Zenith Alpha™ Abdominal Endovascular Graft

Exclusion Criteria:

* Life expectancy less than (\<) 2 years
* Inability or refusal to give informed consent by the patient or legally authorized representative
* Unwilling or unable to comply with the study follow-up
Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment

The purpose of this multi-centre, randomised, double-blind, parallel-group study is to compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative administration under goserelin acetate treatment for premenopausal breast cancer patients


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided written informed consent

Exclusion Criteria:

* Medical history of chemotherapy or endocrine therapy for breast cancer, or with treatment history of radiotherapy. Unwillingness to stop taking any drug known to affect sex hormone status (including hormone replacement therapy (HRT).
The Utility of FDG-PET for Radiation Treatment in NSCLC

Patients planned for radical radiation for NSCLC will undergo conventional CT stimulation and also PET/CT scans for definition of radiation target volumes


Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lung cancer to receive radical radiation

Exclusion Criteria:

* unable to tolerate PET/CT scan
Blood Flow Restricted Resistance Training in Peripheral Arterial Disease

A randomised controlled trial evaluating the feasibility and acceptability of a 12 week lower body blood flow restricted resistance exercise programme for people with peripheral arterial disease.

The primary aim of this study is to determine the feasibility of 12 weeks of lower body resistance exercise performed with blood flow restriction (BFR) in people with peripheral arterial disease.

Resistance exercise with BFR involves placing inflatable cuffs proximal to the exercise limbs in order to manipulate blood flow and enhance the training response.

Secondary aim of this study is to evaluate changes in ABPI, muscle size, strength and physical function at mid-and post- intervention.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with PAD 6 months post diagnosis.
* Ankle-brachial pressure index \<0.9.
* People physically able to perform leg press and leg extension resistance exercise.

Exclusion Criteria:

* Ankle-brachial pressure index \>0.89.
* People unable to visit the laboratory twice weekly for exercise sessions.
* People unable to do leg press and leg extension exercise.
* People whose walking is limited by a non-PAD condition.
* People with PAD with critical limb ischemia (including symptoms of pain at rest and skin ulcers).
* People with Dementia.
* People who have had major surgery or myocardial infarction within the past 6 months.
* Previous stroke.
* Previous thrombosis.
* People who have major surgery scheduled during the intervention period.
Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Hospitalizations

The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.

The information normally recorded in the Emergency Department medical record will be used, as well as the available clinical and administrative databases. For reasons of feasibility, the investigators will also restrict the analysis to patients coming to the Emergency Department with non-specific manifestations in the pulmonary, cardiovascular and abdominal districts, represented by one or more of the following symptoms: dyspnoea, chest pain, transient loss of consciousness, abdominal pain.

Eligibility Criteria:
Inclusion Criteria:

All patients aged 18 years and over who arrived at participating centres between 1 January 2023 and 31 December 2024.

Exclusion Criteria:

All patients under 18 years of age arriving at participating centers between January 1, 2023 and December 31, 2024 and all patients arriving at participating centers outside the time frame January 1, 2023 - December 31, 2024.
EpiCor Clinical Study on Rapid Immune Modulating Effects

Clinical verification study evaluating the effects of a nutraceutical product. This study involves thirty participants composed of healthy adults, who will be taking either a placebo or nutraceutical supplement at different times. Testing for immune status, cytokine levels, and immune responsiveness will be conducted to determine the acute impact of the nutraceutical on immune function compared to a placebo.

Clinical study comparing the acute immune effect of a nutraceutical product and a placebo. The nutraceutical supplement is a postbiotic whole food fermentate produced using yeast.

30 subjects will participate in a placebo-controlled, double-blind, randomized, cross-over design, wherein they will be taking a placebo, or nutraceutical product, each separated by a 1-week washout period to evaluate effects within 3 hours of consumption.

Blood samples will be taken 1 hour after participants arrive, then the dose is administered. Samples are taken 1 hour, 2 hours, and 3 hours following administration.

A series of immune panels will be used to determine the acute impacts on immune surveillance, immune cell activation status, and cytokine profiles. Ex vivo immune challenges will be used to determine the direct impacts on immune cells.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults of any gender
* BMI between 18 and 30 (inclusive)
* Veins easy to see in one or both arms (to allow for multiple blood draws)
* Willing to comply with a 24-h wash-out period for vitamins and nutritional supplements
* Willing to comply with study procedures including: maintaining a consistent diet and lifestyle routine throughout the study; consistent habit of bland breakfasts on days of clinic visits; abstaining from exercising and nutritional supplements on the morning of the study visit; abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit; abstaining from music, candy, bum, computer/cell phone use, during clinic visits.

Exclusion Criteria:

* Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder)
* Currently in intensive athletic training (such as marathon runners)
* Currently taking antidepressant or tranquilizing medications
* Taking anti-inflammatory medications on a daily basis
* Currently experiencing intense stressful events/life changes that could negatively affect compliance
* Anything that the investigator judges may put the subject at risk or may unduly influence any of the results of the study
* An unusual sleep routine (examples: working nightshift, irregular routine with frequent late nights)
* Unwilling to maintain a constant intake of supplements over the duration of the study
* Anxiety about having blood drawn
* People of childbearing potential: pregnant, nursing, or trying to become pregnant
* Known food allergies related to ingredients in active test product or placebo

Prescription medication will be evaluated on case-by-case basis.
ScanNav Anatomy PNB Data Collection Study

Study to gather additional data for AI-driven medical device, ScanNav Anatomy PNB.

Volunteer study to gather additional ultrasound training and/or validation data for Artificial Intelligence (AI)-algorithms used in the medical device ScanNav Anatomy PNB.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, at least 18 years of age;
2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

1. Aged \<18 years of age;
2. Unwilling or unable to provide informed consent.