cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Etanercept in Patients With Psoriasis

The purpose of this study is to evaluate safety and efficacy of etanercept in patients with psoriasis who had an unsatisfactory response to traditional DMARDs.


Eligibility Criteria:
Inclusion Criteria:

* has plaque psoriasis and has shown an unsatisfactory response to traditional DMARDs
* 18 to 75 years old
* has PGA of 3 or more at Day 0
* has BSA of 3% or more at Day 0
* has psoriasis severe enough to be eligible to systemic therapy
* willing to use an effective method of contraception for at least 30 days before Day 0 and until at least 1 month after the last drug administration;
* capable of giving informed consent
* with normal or non clinically significant chest X-ray within 6 months prior to Day 0
* with negative Purified Protein Derivative (PPD) or Quantiferon TB Gold test within 90 days prior to Day 0
* female patients of childbearing potential have a negative serum pregnancy test
* patient is able to start etanercept per the approved product monograph

Exclusion Criteria:

* has used topical steroids, topical tar preparations, or other anti-psoriatic preparations within the two weeks prior to Day 0 or during the study period
* has presence of erythrodermic, pustular or guttate psoriasis
* has had significant infections within the 30 days prior to Day 0
* has received investigational drugs within the four weeks prior to screening or during the study period
* has been treated with systemic anti-psoriatic drugs such as steroids, retinoids, cyclosporine, PUVA therapy or methotrexate within the four weeks prior to Day 0 or during the study period
* received systemic antibiotics within the four weeks prior to Day 0
* has been treated with ultraviolet light therapy (UVB, nbUVB) within the two weeks prior to Day 0 or during the study period
* has used infliximab within 14 days of Day 0 or during the study period
* has used other biologic agents for the treatment of psoriasis besides etanercept 8 weeks prior to Day 0 or during the study period
* has had an allergic reaction to infliximab
* has an unstable or serious medical condition as defined by the investigator or presence of any significant medical condition that might cause this study to be detrimental to the patient
* uncontrolled or severe comorbidities such as poorly controlled diabetes mellitus, NYHA class III or IV heart failure, history of myocardial infarction or cerebrovascular accident or transient ischemic attack within three months of screening visit; unstable angina pectoris
* uncontrolled hypertension, oxygen-dependent severe pulmonary disease
* has a known sero-positivity for HIV virus or history of any other immunosuppressive disease
* has active or chronic Hepatitis B or C
* has any mycobacterial disease, patient with a chest X-Ray suggestive of tuberculosis or patient taking anti-tuberculosis medication
* has a known hypersensitivity to etanercept or one of its components
* has received a live attenuated vaccine within the 12 weeks prior to Day 0 or plans to receive one during the study
* current pregnancy or lactation
Application of Electrical Neurostimulation Transcutaneous in Patients With Primary Dysmenorrhea.

The present study aims to verify the analgesic potential of a new methodological proposal for application for transcutaneous electrical nerve stimulation (TENS interactive) using patients with primary dysmenorrhoea and compare it with placebo in a randomized double blind study with convenience sample.

The denouement will be the intensity of pain from visual analogue scale.

Eligibility Criteria:
Inclusion Criteria:

* Primary dysmenorrhoea
* Moderate to severe pain

Exclusion Criteria:

* Secondary dysmenorrhea
* Users of intrauterine device
* Cognitive impairment
* Failure to appear for treatment
* Pacemaker use
* Illicit drug use
* Epilepsy
* Skin problems
* Use of pain medication before the application of TENS
Sex Disparities in Hypoxic Vasodilation and Impact of Obesity

The purpose of this project is to examine key mechanisms contributing to sex-differences in hypoxic vasodilation and the impact of obesity, with particular emphasis on the sympathetic nervous system.

Patients with sleep apnea are at increased risk of developing cardiovascular disease - with women at potentially greater risk than men. Contributing mechanisms are not well understood, but may be related to how women respond to low oxygen and, given over 70% of patients with sleep apnea are obese, the impact of obesity. This project seeks to increase our understanding of mechanisms that may contribute to sex differences in the cardiovascular response to low oxygen with the hope that this knowledge will improve the efficacy of current therapies and support the discovery of novel therapeutics.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>18 kg/m2

Exclusion Criteria:

* Pregnancy, breastfeeding
* Diagnosed sleep apnea or AHI \>10 events/hr
* Current smoking/Nicotine use
* Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy
* Nerve/neurologic disease
* Cardiovascular, hepatic, renal, respiratory disease
* Blood pressure ≥140/90 mmHg
* Diabetes, Polycystic ovarian syndrome
* Communication barriers
* Prescription medications, Sensitivity to lidocaine
Effect of Aromatherapy on Pain, Anxiety and Satisfaction in Cannulation

The most active members of the healthcare professionals responsible for hemodialysis units are nurses, and they have a key role in pain, anxiety and satisfaction management as they are responsible for cannulation. Therefore, complementary and integrated practices need to be implemented based on evidence to strengthen the independent role of nurses in managing pain and anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Those who are over 18 years of age,
* Able to answer questions and communicate,
* No hearing, vision or speech impairments,
* Regularly undergoing hemodialysis three times a week,
* Having arterio-venous fistula for at least 3 months,
* Having pain during needle cannulation and scoring at least two or more points on the Visual Analogue Scale (VAS),
* Having been on hemodialysis for at least three months,
* Agreeing to participate in the study with their own consent,
* Patients who are not allergic to clove oil will be included in the study.

Exclusion Criteria:

* Having neuropathic pain,
* Patients with arterio-venous fistula and loss of sensation of more than 50% in the extremity,
* Patients with infection in the arterio-venous fistula line,
* Patients with aneurysm or pseudoaneurysm in arterio-venous fistula,
* Patients who have used analgesic medication/s in the last 6 hours,
* Patients who have used sedative agent(s) in the last 6 hours,
* Patients who used local anesthetic agents before needle intervention will not be included in the study.
Study of 5-fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer

The purpose of this research is to see if adjusting the dose of 5-fluorouracil based on its concentration in your blood will improve the treatment of your metastatic colon cancer.

5-fluorouracil (5-FU) has been the most widely used agent in the treatment of early stage and advanced colorectal cancer. Traditionally, 5-FU dosing is based on body surface area (BSA). However, BSA-dosing has been associated with a wide range of pharmacokinetic (PK) variability, resulting in marked differences in drug exposure and toxicities in an individual. There is a significant association between the risk of 5-FU-related toxicities and the extent of 5- FU systemic exposure, which can be measured using a well-established pharmacokinetic (PK) assay.

Eligibility Criteria:
Inclusion Criteria:

* Males or females at least 18 years of age.
* Histologically confirmed metastatic colorectal cancer eligible for treatment with 5-FU.
* No prior therapy for metastatic disease. If adjuvant 5-FU or FOLFOX was administered, the last dose must have been at least 6 months prior to the diagnosis of metastatic disease.
* Adequate organ function.
* Eastern Cooperative Oncology Group (ECOG) status less than or equal to 2.
* Life expectancy \> 3 months.

Exclusion Criteria:

* Untreated brain metastasis. Treated brain metastases are allowed as long as symptoms have resolved off of steroids.
* At least 4 weeks from any prior surgery or 2 weeks from radiation treatments.
* Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Development and Feasibility Testing of a Lung Cancer Screening Decision Aid

This study evaluates the feasibility and acceptability of LuCaS Choices, a web-based decision aid designed to facilitate informed decision making about participation in lung cancer screening among individuals at high risk of lung cancer due to heavy cigarette smoking.

The proposed project will develop an innovative web-based decision aid (DA) to improve decision making for lung cancer screening (LCS) among individuals at high risk for lung cancer due to cigarette smoking. Recent National Lung Screening Trial (NLST) data demonstrated a 20% relative reduction in lung cancer mortality for low dose computed tomography screening as compared to chest X-ray among individuals at high lung cancer risk. Given that lung cancer is the leading cause of cancer death in the United States with an estimated 160,340 deaths predicted for 2012, the new data have reinvigorated interest in LCS. However, LCS carries substantial risks including a high false positive rate, over-diagnosis, adverse psychosocial consequences, and increased radiation exposure. Further, it is unknown whether LCS would reduce lung cancer mortality among individuals who smoke but do not meet NLST eligibility criteria. Therefore, there is currently no clear best choice for whether a given individual should be screened or not. Decisions about participating in LCS should be well informed and consistent with individual preferences. However, previous data indicate that individuals who do undergo LCS rarely have a thorough understanding of the risks or benefits.

To address this rapidly emerging public health challenge, this research has developed a web-based decision aid (DA) to facilitate informed decision making regarding LCS in individuals at high risk for lung cancer (i.e., cigarette smokers), and will assess feasibility of DA administration and proposed methods for conducting a future randomized clinical trial (RCT) of DA effectiveness. The content of the DA will be based on the investigators previous studies exploring LCS decision making and other recent research.

The specific aim of the currently proposed research are to conduct a feasibility trial of the DA among individuals at high risk of lung cancer due to heavy cigarette smoking. Investigators will recruit participants to assess feasibility of: 1) delivering the DA intervention in a community setting, and 2) conducting research procedures and assessment tools as planned for a future RCT.

Eligibility Criteria:
Inclusion Criteria:

* be at least 40 years of age
* history of 20 or more pack years of smoking
* ability to read and understand English
* must have a personal phone
* must have Internet access

Exclusion Criteria:

* reporting or demonstrating significant psychological distress
A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH

Part 1: This is a multi-center evaluation of pegozafermin (administered weekly or every other week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in participants with NASH and NAFLD at high risk of NASH, including a pre-defined number of participants with biopsy confirmed NASH and fibrosis stages F1-F3 to be enrolled.

Part 2: This is a multi-center, open label evaluation of pegozafermin at 27 mg administered weekly for 20 weeks in participants with biopsy-proven NASH (NAS ≥4, fibrosis stage F2 or F3).


Eligibility Criteria:
Key Inclusion Criteria:

* Participants must be 21 to 75 years of age inclusive, at the time of signing the informed consent form (ICF).
* Evidence of steatosis by Fibroscan and magnetic resonance imaging based proton density fat fraction (MRI-PDFF)
* NASH or NAFLD at high risk for NASH as reflected by AT LEAST ONE of the following:
* Diagnosis of NASH with fibrosis (stages F1, F2 or F3), without cirrhosis, by percutaneous liver biopsy within 24 months prior to screening
* Central obesity WITH type 2 diabetes mellitus (T2DM)
* Central obesity WITH either increased alanine transaminase (ALT) and/or Fibroscan vibration-controlled transient elastography (VCTE) score ≥7 KPa.
* Part 2 only: Biopsy-proven NASH in a liver biopsy obtained within 24 weeks of baseline with fibrosis stage F2 or F3 and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation. A small number of high risk F1 allowed.

Key Exclusion Criteria:

* Clinically significant disorder or a history of any illness that, in the opinion of the Investigator, might confound the results of the study, or pose additional risk to the participant by participation in the study.
* History of type 1 diabetes.
* Weight loss of more than 5% within 3 months prior to Day -1 or more than 10% within 6 months prior to Day -1 or planning to try to lose weight during conduct of study.
* History of a liver disorder other than NASH or clinical suspicion of a liver disorder other than NASH
* History of cirrhosis or evidence of cirrhosis
Cognitive Function Assessment in Patients With Focal Brain Injury

This research relates to the study of cognitive deficits related to various focal brain lesions and their localizations in the brain.

it involves building a large database of behavioural responses measured during the performance of cognitive tasks in patients with focal brain injury, to allow to better understand function of brain.

The study of patients with focal lesions is at the origin of many key discoveries in the field of neurology and cognitive neuroscience.

There are many mechanisms of injury in the brain. The investigators focus on delineated lesions (as opposed to panencephalic, infectious or traumatic lesions), including stroke, excision of intracranial expansive processes or cortectomies of epileptogenic foci.

At the CHUGA, several hundred patients are hospitalized each year for stroke, several dozen patients are operated on brain tumor and about thirty patients benefit from surgical treatment for their epilepsy.

Post-injury cognitive disorders represent a large heterogeneous class of neurological disorders. They are differentiated by various clinical and neuropsychological profiles involving different higher functions such as attention, language, memory, decision-making or executive functions. This variability observed in these disorders complicates their characterization. Especially, there is no, on a sufficiently large scale, data collection to establish whether cognitive deficits are explained by the relative contribution of the type of test used, the location of the lesion, the nature of the pathology and the post-injury delay. This requires a large cohort of patients.

The objective of this project is precisely to build a structure-function database in patients with focal brain injury (post-stroke or post-cortical resection), with the aim of conducting a transnosographic and longitudinal study of brain functions in these patients. To the knowledge of the investigators, this type of approach has not yet been proposed. Such a project should eventually lead to a better understanding of the nature of the cognitive deficits observed in different types of lesions, and to refine the correlations between structures and functions. This project is in line with the objectives set by the University Hospital Federation NeuroPsyNov, which was labeled in 2015 (Dir P. Kahane, fhu-neuropsynov.chu-grenoble.fr) and aims to encourage transnosographic and translational studies of neurological and psychiatric diseases.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, 18-70 years old
* A single, focal anatomical lesion of a given cerebral territory (post vascular, post surgical resection) documented by MRI
* Intellectual ability and understanding of instructions compatible with the cognitive tasks to be performed

Exclusion Criteria:

* Patient deprived of liberty
* Somatic disorder likely to affect cognitive abilities
* Pregnant or nursing woman
Comparison of Ultrasonographic and Clinical Features of Different Energy Levels Extracorporeal Shock Wave Therapy in Plantar Fasciitis

Plantar fasciitis is the most common cause of heel pain in adults. It received FDA approval in 2000 for ESWT in the treatment of plantar fasciitis in adults whose pain did not resolve with conservative treatment.

ESWT energy levels are categorized as high, medium and low. It is not yet clear which energy level is most effective in the clinical recovery and pain relief of plantar fasciitis after ESWT treatment. Although there are studies in the literature evaluating the effect of different energy densities in the treatment of plantar fasciitis with ESWT, there are very few studies comparing different treatment doses of ESWT.

The aim of this study was to evaluate and compare the therapeutic effects of low, medium and high energy ESWT in patients with plantar fasciitis, and also to examine the correlation between plantar fascia thickness changes ultrasonographically and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

presence of heel pain, tenderness at the insertion site of the plantar fascia on the anteromedial aspect of the calcaneal tubercle elicited by palpation, and unresponsiveness to medical treatment.

Exclusion Criteria:

history of inflammatory rheumatic disease, trauma of the foot or foot surgery, local dermatological lesion or infection, impaired peripheral circulation, a neurological disorder such as radiculopathy and neuropathy, patients with sequelae of lower extremity fracture, a congenital or acquired deformity, malignancy, cardiac pacemaker, metal implant at the application site, pregnancy, anticoagulant use for coagulopathy
Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue

Fatigue is a prevalent adverse event associated with systemic therapy using tyrosine kinase inhibitors (TKIs). Meldonium, a fatty acid oxidation inhibitor, modifies the carnitine pathway, a nutrient critical for fat metabolism. The World Anti-Doping Agency (WADA) classified meldonium as a banned substance due to its documented use by athletes aiming to enhance physical performance. In this study, the safety and preliminary efficacy of meldonium in treatment-related fatigue will be assessed.

Fatigue is a frequent symptom of cancer and the most common adverse event of treatment with tyrosine kinase inhibitors. For example, in phase 2 randomized study 59% of patients with metastatic renal cell carcinoma experienced any grade fatigue during treatment with the combination of lenvatinib and everolimus. Fourteen percent of patients had grade 3 fatigue or asthenia. Fatigue was also most frequently reported treatment-related adverse event in patients with unresectable hepatocellular carcinoma (30%), and advanced thyroid cancer (60%) treated with lenvatinib. Additionally, fatigue is one of the most common adverse events associated with the administration of checkpoint inhibitors. Frequency of fatigue was 55% in patients with endometrial cancer treated with combination of pembrolizumab and lenvatinib.

Meldonium is a fatty acid oxidation inhibitor, and it is now principally used for heart conditions, such as angina, heart attack, heart failure, and others. The compound works by altering pathways for carnitine, a nutrient involved in fat metabolism. Meldonium received the greatest fame in sport. The World Anti-Doping Agency (WADA) added meldonium to their list of banned substances in 2016 because of evidence of its use by athletes with the intention of enhancing performance. Center for Preventive Doping Research and European Monitoring Center for Emerging Doping Agents showed that mildronate demonstrates an increase in endurance performance of athletes, improved rehabilitation after exercise, protection against stress, and enhanced activations of the central nervous system functions. Based on these data, meldonium can be a possible option in cancer patients with fatigue treated with targeted or imminotargeted therapy. Moreover, the compound could decrease the number of vascular adverse events of TKIs.

Eligibility Criteria:
Inclusion Criteria:

* metastatic renal cell carcinoma
* measurable disease based on RECIST 1.1 criteria
* systemic therapy with targeted or immunotargeted therapy
* any grade of fatigue associated with targeted or immunotargeted therapy
* ECOG PS \&lt;2
* signed informed consent

Exclusion Criteria:

* Any treatment for fatigue
* Uncompensated hypothyroidism
* Anemia
* Pregnant or nursing
* Local and/or systemic infections requiring antibiotics or COVID-19 within 28 days prior to study entry
* Other malignancy
* Brain metastases
Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP

The purpose of this research study is to evaluate antiresorptive therapy with denosumab (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal women with idiopathic osteoporosis.

Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial, "A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women" (NCT01440803) may be eligible to participate in the current study, a 36-month open-label pilot study of denosumab (Prolia®, 60mg subcutaneous (SC) every 6 months).

The goals of the study are to estimate the effects of denosumab on central and peripheral, as well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data to inform the design of a future randomized study. This study presents the first opportunity to study the effects of denosumab after TPTD in this unique and severely affected group of young women.

Funding Source: FDA Office of Orphan Products Development (OOPD).

Osteoporosis in premenopausal women with normal menstrual function and no specific cause is termed idiopathic osteoporosis (IOP). IOP is a rare disease with an estimated prevalence of \<200,000 affected premenopausal women in the United States.

Denosumab, a potent inhibitor of osteoclast-mediated bone resorption, leads to continuous gains in both trabecular and cortical bone mineral density (BMD). Moreover, denosumab is not retained in the skeleton, and may thus be preferable for use in young women who may be contemplating future pregnancies. The investigators hypothesize that denosumab, initiated after completion of two years of TPTD, will maintain or improve central and peripheral areal and volumetric BMD, microstructure and stiffness in premenopausal women with IOP.

Eligibility Criteria:
Inclusion Criteria:

* All women completing NCT01440803 who remain without a disease or medication that causes osteoporosis will be offered enrollment into this study.
* (Premenopausal status is no longer be required for entry.)

Exclusion Criteria:

* Renal insufficiency or liver disease: Creatinine, transaminase (AST)/alanine transaminase (ALT) above upper limit of normal
* Vitamin D deficiency: 25-hydroxyvitamin D (25-OHD) \<30 ng/mL
* Pregnancy: urine pregnancy test must be negative