cyrilzakka/clinical-trials huggingface dataset:
Cerebral and Peripheral Electrical Stimulation on Isometric Quadriceps Strength

Quadriceps muscle strength is a key goal to be achieved in rehabilitation protocols for a variety of musculoskeletal conditions. Both cerebral and peripheral electrical stimulations can modulate motor brain areas involved in motor functions and has the potential to optimize muscle capacity. However, their effects on quadriceps function are lacking.

This study aims to investigate the effects of transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (PES) on quadriceps strength in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with no complaints of pain, discomfort in the musculoskeletal system.

Exclusion Criteria:

* Musculoskeletal or neurological disorder
* Under medication
Long-Term Study On Home Spirometry After Lung Transplantation

Prospective cohort, mono-center study included electronic data of home spirometry (HS, lung function) of lung transplant recipients

Study period between 1/2/2000 and 31/12/2003 Follow-up until 31/12/2007

Patient will be stratified according to adherence to HS during the first 2 postoperative years Good adherent patient: patient performed ≥ 80% of predicted HS within 24 months Moderate adherent patient: patient performed ≥ 50% of predicted HS within 24 months Non-adherent patient: patient performed \< 50% of predicted HS within 24 months.

Primary outcome measure graft loss at end of follow-up

Secondary outcome measure number of acute rejections during follow-up number of hospitalisation during follow-up Incidence of bronchiolitis obliterans syndrome during follow-up

Eligibility Criteria:
Inclusion Criteria:

* Any type of lung transplant incl single, double, combined and re-do
* \> 18 years of age
* LTx or HLTx ≥ 6mts post Tx
* Stable health condition at study entry (pt stays within home environment)
* Sufficient language skills for AMOS training
* Successful AMOS training
* Follow-up at our center (≥6 mts post LTx)
* Willingness to participate by informed consent

Exclusion Criteria:

* Refused consent
* BOS diagnosis before study inclusion
* Malignancy before study inclusion
* Loss for follow-up (≤ 6 mts after study inclusion
Modernizing Perinatal Syphilis Testing

Treponema pallidum is a bacterium that causes the disease syphilis. The primary objective of the study is to evaluate the testing performance of two diagnostic molecular techniques \[quantitative polymerase chain reaction (qPCR) and transcription-mediated amplification (TMA)\] for the detection of Treponema pallidum in maternal and neonatal specimens from participants with the diagnosis of syphilis using the Centers for Disease Control's (CDC's) Sexually Transmitted Infections (STI) Treatment Guidelines for adult and congenital syphilis.


Eligibility Criteria:
Inclusion Criteria:

* Maternal diagnosis of syphilis by 2021 CDC STI guidelines, irrespective of treatment status; AND viable pregnancy with gestational age ≥ 12 weeks OR postpartum ≤ 96 hours from delivery
* Neonates of pregnancies affected by syphilis ≤ 72 hours of birth

Exclusion Criteria:

* Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive)
* Planning to move outside of study prior to ND testing
Hemostatic Profile in Patients Affected by COVID-19

Coronavirus disease-2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), has been associated with the occurrence of cardiovascular adverse events including acute myocardial injury, acute heart failure, cardiac arrhythmias, and thromboembolic disease. These complications represent an important issue in COVID-19 patients accounting for the increased morbidity and mortality of this syndrome. According to a scoping review, venous thromboembolism and stroke occurred in approximately 20% and 3% of patients, respectively, with higher frequency observed in severely ill patients admitted to intensive care units. Despite the use of pharmacological thromboprophylaxis, the thrombotic risk still remained elevated in severe COVID-19 patients, and the optimal doses and timing of anticoagulation are not yet defined. The pathogenesis of COVID-19 associated thrombosis recognizes a prominent role of endothelial damage induced by both direct viral injury and an excessive and aberrant hyper-inflammatory host immune response associated to an increase in infection-related cytokines and chemokines. The occurrence of a hypercoagulable state in COVID-19 patients associated to a profound endothelial cell activation/dysfunction can result in the pathological phenomenon of immunothrombosis.

In this study, in a prospective cohort of consecutive COVID-19 hospitalized patients, an extensive characterization of the hemostatic alterations were performed, in order to: 1) clarify mechanisms underlying the coagulopathy in these patients; 2) how and to what extent the concomitant infection with SARS-CoV-2 affect this coagulopathy; and 3) identify biomarkers potentially predictive of disease outcome (i.e. any thrombotic recurrence and death).


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* Adult patients admitted with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) positivity (by real time-PCR) from nasal swab or deep respiratory specimen or with clinical signs suggestive of SARS-Cov-2
* Patients who have signed informed consent. If there is no possibility of obtaining informed consent for the clinical picture (eg adult patients sedated and curarized for acute respiratory failure and consequent mechanical ventilation), the patient's consent will be assumed until the contrary will be manifested.

Exclusion Criteria:

-
Efficiency of Rosuvastatin Versus the Fixed Combination of Ezetimibe/Simvastatin in Outpatients

The aim of this study is to evaluate the effectiveness of Rosuvastatin versus Ezetimibe/Simvastatin in dyslipidemic patients treated for at least 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Dislipidemic population treated with rosuvastatin or ezetimibe/simvastatin for at least for 8 weeks
* Who have completed at least 80% of the treatment
* To have determinations at least of CT, TG C-LDL and CHDL before starting treatment and after 8 weeks of taking the medicine

Exclusion Criteria:

* Initiating different therapy lipid lowering to Rosuvastatin or Ezetimibe/Simvastatin
Biomarkers in Pulmonary Hypertension Associated to Interstitial Lung Disease

The presence of an abnormally increased pulmonary blood pressure worsens the prognosis of patients with interstitial pulmonary disease.

The aim of this study is to estimate the frequency of an increased blood pressure in the lungs among patient with interstitial pulmonary disease, and to evaluate the use of different biomarkers in diagnosis of the condition.

The presence of increased pulmonary blood pressure is established by echocardiography and confirmed by right heart catheterization.

The ability of NT-proBNP, vWf, troponin-t, D-dimer and exhaled NO to predict the presence of increased pressure in the pulmonary circulation is evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Interstitial pulmonary disease
Dexamethasone for Post Traumatic Headache

This is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache.


Eligibility Criteria:
Inclusion Criteria:

Meet International Classification of Headache Disorders criteria for acute post-traumatic headache as follows:

* Traumatic injury to the head has occurred
* Headache has developed within 7 days of injury to the head
* Headache is not better accounted for by another diagnosis (e.g., migraine or tension-type headache)
* The headache must be rated as moderate or severe in intensity at the time of initial evaluation

Exclusion Criteria:

* More than ten days have elapsed since the head trauma
* Headache has already been treated with an anti-dopaminergic medication
* Medication allergies
* Contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications
Phase I/IIa Study: RR001 Administered Following Chemotherapy Cycles for Patients with Locally Advanced Pancreatic Carcinoma

RR001, a cell-based gene therapy administered following chemotherapy cycles for the treatment of patients with locally advanced pancreatic cancer. Phase I /IIa clinical trial (open label and non-randomized) to test the effects (safety \& efficacy) of increasing doses of RR001

This study is intended for people diagnosed with locally advanced pancreatic ductal adenocarcinoma.

Currently, surgical resection is the only treatment that offers a chance to cure this type of tumor, but only a few percentage of locally advanced pancreatic adenocarcinoma patients is able to benefit from this approach. Thus, research is aimed at identifying new treatment strategies based on innovative approaches that can increase the number of people who can access surgery as radically as possible.

The SNIPER study aims to evaluate for the first time in humans the applicability and safety of a new drug (called RR001) based on autologous cells, that are, cells taken from the same subject who receives them. These cells are derived from adipose tissue and are genetically modified to deliver a potent anti-cancer death ligand normally produced by the body with the role to kill tumoral cells.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed pancreatic ductal adenocarcinoma classified as locally advanced pancreatic adenocarcinoma (LPAC)
* Patients with no evidence of peritoneal or hematogenous metastasis
* Patients must be eligible for chemotherapy treatment (based on standard of care) treatment
* Patient older than 18 years of age
* Adequate hepatic and kidney function/Safe hematologic profile
* Negative serum pregnancy test for females of childbearing potential
* Willingness and ability to comply with the scheduled visits, treatment plan, imaging procedures, laboratory tests and other study procedures, including lipoaspirate collection (liposuction)

Exclusion Criteria:

* Patient with pancreatic cystic tumor, pancreatic pseudocyst, or tumor different from adenocarcinoma
* Patients with immunosuppression or susceptibility to viral infection
* Patients with HIV, hepatitis B, hepatitis C, HTLV-I/II, Treponema Pallidum infections
* Patients with liver cirrhosis or other documented liver diseases
* Patient contraindication to use chemotherapy treatments
* Previous hematopoietic stem cell or organ transplantation
* Patient with cardiac vascular impairments/ hypertension
* Active autoimmune disease
* Patient has had major open surgery prior to the administration of study treatment
Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer

The purpose of this study is to determine whether prostate cancer growth can be slowed in patients who receive Androgel® 1% at 10 gram dose.

The primary objective of the study is to determine the effect of testosterone replacement on time to disease progression and time to clinical cancer progression.

The secondary objectives are to describe the effect of testosterone replacement on patient-reported quality of life (FACT-P, FACT-fatigue and specific measures from the Expanded Prostate Cancer Index (EPIC): Sexual and Hormonal Assessments), and hand-grip strength; to describe changes in total testosterone, free testosterone, and PSA levels; to explore AR levels in circulating tumor cells as a marker of treatment benefit.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer
* Patient must have received primary definitive local therapy to the prostate (surgery and/or radiotherapy)
* Patient was surgically or pharmacologically castrated at least 6 months prior to starting the study
* Patient must have had a previous trial of anti-androgen therapy
* Patient must have a rising PSA
* No evidence of distant metastatic disease
* ECOG performance status \< 2
* Age \>18 years
* Patients must have normal hepatic function

Exclusion Criteria:

* Patients with a history of any previous cytotoxic therapy or radionuclide therapy (such as rhenium, strontium, or samarium)
* Patients may not be receiving any other investigational agents
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients receiving renal dialysis
* Patients with significant pulmonary disease who have received chronic or pulse steroid therapy within the last 3 months prior to randomization will be excluded
* Patients who have known hypersensitivity to any of the AndroGel ingredients, including testosterone that is chemically synthesized from soy
Antimicrobial Hernia Repair Device

This prospective early feasibility clinical study will collect information regarding the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated and contaminated (i.e., Class II and Class III) surgical fields.


Eligibility Criteria:
Inclusion Criteria:

* Patient with ventral or incisional hernia that is to be surgically corrected in a Class II and Class III surgical field.

Exclusion Criteria:

* Less than 21 years old
* Unwilling or unable to sign and date the informed consent
* Pregnant, breastfeeding, or planning to become pregnant prior to completing the study
* Unable or unwilling to comply with follow-up schedule
* Simultaneously participating in another investigational drug or device study.
* Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint.
Epidemiology of Insulin Growth Factor (IGF) and Cardiovascular Events

To explore the role of insulin growth factor in cardiovascular disease in older men and women.

BACKGROUND:

Insulin-like growth factor-I (IGF-I) is the main mediator of effects of growth hormone (GH) and an important regulator of cell cycle/differentiation and inhibitor of apoptosis. Consistent with laboratory studies showing potentially beneficial effects of IGF-I on the cardiovascular and cerebrovascular systems, GH-deficient individuals have high cardiovascular disease (CVD) mortality and evidence of premature atherosclerotic disease that is reversible with GH replacement. In addition, several epidemiological and clinical studies have shown an association between low serum IGF-I levels and myocardial infarction (MI) and congestive heart failure (CHF) among persons without frank abnormalities of the GH/IGF-I axis.

DESIGN NARRATIVE:

The study is the first prospective investigation to assess whether serum levels of IGF-I and two of its important binding proteins, IGFBP-3, and IGFBP-1, are associated with incidence of confirmed incident cardiovascular disease (CVD) events in older male and female adults. Specimens and data for this study will be obtained from the Cardiovascular Health Study (CHS), a large, multi-center NHLBI-funded prospective cohort study of 5,888 community-dwelling men and women 65 years or older. The study uses an efficient case-cohort study design to select specimens for testing, involving evaluation of 750 incident myocardial infarction (MI)/fatal coronary heart disease (CHD) cases, 500 incident stroke cases, 750 incident congestive heart failure (CHF) cases, and a comparison sub-cohort of 750 individuals selected at random from the study population. The study examines the association between baseline serum IGF-I, IGFBP-1, and IGFBP-3 level and the future occurrence of first incident MI/fatal CHD, ischemic stroke, and CHF. Multivariate regression models are used to control for potential confounding factors including age, sex, race/ethnicity, anthropometry and body composition, fasting and 2-hour post-load glucose and insulin levels, dietary intake, physical activity, hormone replacement therapy and other medications, and other CVD risk markers such as lipids, inflammatory factors, and coagulation/fibrinolysis markers.

Eligibility Criteria:
Medicare-eligible adults as well as other age-eligible individuals residing in the household
A Real Life Evaluation of the Performance of a Large Volume Nebulizer

Continuous albuterol has become the standard of care for patients in status asthmaticus. We have previously performed an in-vitro study comparing 4 different brands of continuous nebulizers. We now want to compare the in-vitro with the in-vivo performance of the brand we use. we hypothesize that there will be no difference between in-vivo and in-vitro results.

There will be no intervention to the patients. Nebulizers will be used as per current policies and procedures. They will only be marked on the outside at the water level every 2 hours for the first 6 hours. Once ready to be discarded will be collected for laboratory testing Once in the laboratory, nebulizers will be weight on a precision scale without liquid, then they will be filled with normal saline to the first mark (6th hour) and re-weight. The nebulizers will be filled to next mark and re-weight until 200 mls. of total volume are achieved. Solution output will be calculated as the weight difference between the 2 hour periods.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients admitted to Pediatric Intensive Care Unit due to status asthmaticus, requiring continuous albuterol nebulization.

Exclusion Criteria:

* Patients requiring invasive or non-invasive ventilation.
Effect of Progressive Muscle Relaxation on Anxiety and Comfort

This study aimed to examine the effect of relaxation exercise applied to patients who will undergo elective coronary angiography (CAG) for the first time, on their vital signs, anxiety and comfort levels.

The main questions it aims to answer are:

1. Does progressive relaxation exercises affect CAG patients' vital signs.
2. Does progressive relaxation exercises affect CAG patients' anxiety levels.
3. Does progressive relaxation exercises affect CAG patients' comfort levels. Researchers will compare the intervention group with the control group to see if relaxation exercise is effective.

Before coronary angiography, patients will undergo a relaxation exercise once. Vital signs, comfort and anxiety level will be evaluated before and after angiography.

Coronary angiography (CAG) is considered the "gold standard" in determining coronary anatomy. And it is used very frequently in the diagnosis and treatment of coronary artery disease. CAG, which is an invasive procedure, causes anxiety in patients undergoing the procedure. Anxiety leads to negative consequences in vital signs such as increased blood pressure, pulse and respiration rate, and pain intensity. Pain, anxiety and many factors that develop due to invasive procedures such as angiography also reduce the comfort level of patients. Reducing anxiety and pain, preventing negativities in vital signs, and increasing comfort contribute to the success of the procedure, the patient's level of well-being, and satisfaction with health care services. This study aimed to determine the effect of progressive relaxation exercise on patients' vital signs, anxiety and comfort levels in patients undergoing angiography.

Eligibility Criteria:
Inclusion Criteria:

* undergo CAG for the first time
* has a chest score of 5 or less on the pain scale
* has no history of mental disorder according to medical records
* is able to communicate

Exclusion Criteria:

* Admission to the intensive care unit after the CAG procedure
* starting analgesic or perlinganit infusion
* wanting to quit the research
Interoception-Based Yoga for Chronic Pain

The purpose of this research is to examine the feasibility and acceptability of an interoception-based yoga program for chronic pain. Interoception involves your ability to feel sensations in your body (such as your heartbeat or muscle tension) as well as how you think about and interpret those sensations. Interoception may be an important component of chronic pain and the research team is studying whether yoga can change how you feel, think about, and interpret sensations in your body.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported chronic pain lasting ≥ 3 months (such as widespread musculoskeletal pain, fibromyalgia, migraine etc.)
* In the past week, has pain interfered with your day-to-day activities? Yes
* Self-reported ambulatory ability without an assistive device
* Self-reported ability to get on and off the floor without assistance.
* No ongoing mind-body practice (\<1x/week over the past 6 months).
* Physical Activity Readiness Questionnaire Screen Pass or Physician Consent
* English-speaking
* Able and willing to provide consent
* No plans to move or travel outside the area in the next 2 months

Exclusion Criteria:

* Ages \<18 or ≥ 65 at time of screening
* Pain lasting \< 3 months
* In the past week, has pain interfered with your day-to-day activities? No
* Use of any assistive device (e.g. cane, walker, wheelchair).
* Inability to get on and off the floor without assistance.
* A consistent ongoing mind-body practice (mindfulness, yoga, meditation, tai chi, qigong), at least 1x/week over the past 6 months
* Physical Activity Readiness Questionnaire Screen Fail or non-consent of physician
* Non-English speaking
* Non-consent
* Plans to move or significant travel outside the area in the next 2 months
* Known pregnancy
* Recent surgery or acute bone, joint or nerve injury (within the past 6 months)
* Severe or progressive neurological conditions such as Parkinson's disease, dementia, multiple sclerosis, or acquired brain injury
* Separate pain-related diagnoses: cancer-related pain, complex regional pain syndrome, postural orthostatic tachycardia syndrome, functional neurological/ movement disorders
* Active or planned worker's compensation or personal injury claim
* Concurrent participation in another interventional study (e.g. physical activity, mind-body or drug trials)