cyrilzakka/clinical-trials huggingface dataset:
Treatment of Refractory Gout With ACTH or Methylprednisolone

To clarify the therapeutic effect and safety evaluation of ACTH in refractory gouty arthritis and special population, and to explore its mechanism of action.

When patients with acute gout have multiple comorbidities and complications , traditional treatment methods are often contraindicated . From the current clinical research evidence , we have seen the non-inferior effect of ACTH on glucocorticoids and non-steroidal anti-inflammatory drugs in the treatment of acute gout , as well as the good safety and extensive anti-inflammatory effect in addition to efficacy . Therefore , we designed this study to update and improve the treatment of acute gout attacks , and to try to clarify the mechanism of action .

Eligibility Criteria:
Inclusion Criteria:

* (123 items and 1 item from 4-7 are met simultaneously) :

  1. Meet the 2015 ACR/EULAR classification diagnostic criteria for gout
  2. Acute gouty arthritis
  3. Age ≥18
  4. Repeated attacks and prolonged pain (more than 1 month);
  5. poor response or intolerance to colchicine or NSAIDs;
  6. Liver and kidney dysfunction;
  7. Old age;

Exclusion Criteria:

* 1) History of gastrointestinal bleeding and active ulcer 2) The application history of glucocorticoids and ACTH in 1 month before screening 3) Pregnancy and lactation 4) Drug and alcohol abuse 5) Malignant tumor (treated or untreated within 5 years) 6) Mental illness inability to communicate or have language barriers and inability to fully understand and cooperate 7) negligent compensatory heart failure, unstable angina pectoris, stroke, transient ischemic attack, myocardial infarction, and severe arrhythmia occurred within 6 months 8) The investigator did not consider it appropriate to participate in the study
Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC

This study is a prospective non-interventional real-world study enrolling patients with advanced breast cancer who are ER+/HER2- and have ESR1- gene mutations, collecting information on patients' complaints, physical examination, laboratory tests, imaging tests and adverse events to observe the safety of elacestrant treatment.


Eligibility Criteria:
Inclusion Criteria:

* 1. must have a histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease unsuitable for excision or radical radiotherapy, or evidence of metastatic disease unsuitable for radical treatment.
* 2. female ≥ 18 years of age
* 3. female subjects must be postmenopausal (meeting any of the following criteria is sufficient) a) Has undergone oophorectomy. b) Age ≥ 60 years. c) 40 years old \< age ≤ 60 years old with 1 year of menopause. d) Age \<60 years and receiving ovarian suppression therapy.
* 4. ER-positive and HER2-negative status and ESR1-mutation positive must be confirmed.
* 5. must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy.
* 6. have normal organ function (as assessed by the investigator).

Exclusion Criteria:

* 1. women who are pregnant or breastfeeding
* 2. known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements
* 3. other conditions that make enrollment in the study unsuitable, at the discretion of the investigator
Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.

Comparative pharmacokinetic study of new oral nicotine replacement therapy products.

This study compares new oral Nicotine Replacement Therapy (NRT) products containing 2 and 4 mg nicotine with NiQuitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of treatment A, B, C, and D are given once in the morning during separate treatment visits scheduled in a crossover setting with randomized treatment sequences, also including a fifth treatment visit with either treatment E or F. The study will include 104 healthy smokers between the ages of 19 and 50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. The study will be performed at two sites with 52 subjects at each site. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With High Cholesterol (P03434)

This study was designed to assess whether co-administration of ezetimibe 10 mg with atorvastatin 10 mg in treatment naïve subjects would be more effective than treatment with atorvastatin 10 mg alone for reducing LDL-concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant female subjects, who demonstrated willingness to participate and comply with procedures by signing informed consent, and who were \>=18 years and \<=75 years of age, were eligible to participate if they had: a baseline LDL-C concentration \>=3.3 mmol/L (130 mg/dL) to \<=4.9 mmol/L (190 mg/dL); a baseline triglyceride concentration of \<3.99 mmol/L (350 mg/dL); a documented history of coronary heart disease (CHD); a stable weight history for 4 weeks prior to baseline; completion of the designated washout periods for all prohibited medications; and did not fulfill any of the exclusion criteria for the study.

Exclusion Criteria:

* Body Mass Index of \>=30 kg/m\^2 at baseline (increased to 35 kg/m\^2 in protocol amendment 1
* Liver transaminase (ALT, AST) \>1.5 times the upper limit of normal and with no active liver disease at baseline
* Evidence of current myopathy (excluding subjects with CK \>1.5 times above the upper limit of normal at baseline
* Clinical lab tests (CBC, blood chemistries, urinalysis) results outside the normal range or unacceptable to the investigator at baseline
* Type II diabetes mellitus that was poorly controlled (HbA1c\>9%), newly diagnosed, or changed their anti-diabetic therapy within 3 months of baseline
* Type I diabetes mellitus and not on a stable insulin regimen for 3 months prior to baseline or who had a recent history of repeated hypoglycaemia or unstable glycaemic control
* Known hypersensitivity to HMG-CoA reductase inhibitors
* Alcohol consumption \>14 units (women)/21 units (men) (unit = 0.5 pint of beer or wine, or single measure of spirits)
* Pregnancy, lactation, or any condition or situation which, in the opinion of the investigator, posed a risk to the subject or interfered with participation in this study.
* Any of the following medical conditions: HIV positive; congestive heart failure defined by NYHA as Class III or IV; uncontrolled cardiac arrhythmia; MI, acute coronary insufficiency, CABG, or angioplasty within 3 months of baseline; unstable or severe peripheral artery disease within 3 months of baseline; newly diagnosed or unstable angina pectoris at baseline; uncontrolled hypertension with systolic blood pressure \>100 mm Hg at baseline; uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins; impaired renal function or nephritic syndrome at baseline; disorders of the hematological, gastrointestinal, or central nervous systems; diseases other than hyperlipidaemia or coronary heart disease that would have interfered with study evaluations; and cancer.
* Drug abuse or emotional or intellectual problems;
* Use of certain drugs, food, or other agents known to alter cholesterol levels or to cause pharmacokinetic interactions with either ezetimibe or atorvastatin
Montage-Enhanced Sternal Closure

Post-operative recovery after cardiac surgery is influenced by early sternal bone stability. Traditional sternal closure of median sternotomy usually entails the use of 6-10 stainless steel wires. Augmenting sternal closure with techniques to enhance early bone stability should accelerate functional recovery from cardiac surgery thereby reducing post-operative pain, decreasing the need for narcotics, improving breathing and chest wall mechanics, stimulating early mobility and expediting hospital discharge.

This study is a randomized, single-centre, double-blind clinical study comparing the effects of Montage bone putty plus conventional wire closure vs conventional wire closure only on the post-operative recovery of cardiac surgery patients with full medial sternotomy.

Patients undergoing cardiac surgery who are participating in the study will be randomized to either conventional wire cerclage or conventional wire closure plus the use of Montage bone putty. Patients will be followed post-operatively Day 3, 5 and at discharge as well as weeks 2, 4, 6 and months 3, 6 and 12.

Each visit will include: Pain assessment, wound assessment, sternal assessment, analgesic/antibiotic use, spirometry testing, quality of life questionaries (EQ-5D/HAQ) and determination of any adverse events. Chest x-rays will done at discharge and 3, 6, and 12 months to look at sternal healing.

This pilot study will include a total of 65 patient (40 conventional + putty / 20 conventional/ 5 initial open label with putty).

Eligibility Criteria:
Inclusion Criteria:

* undergoing non-emergent cardiac surgery ( cabg only or one valve procedure)
* full median sternotomy approach, with or without cardiopulmonary bypass
* English speaking
* geographically accessible
* written consent

Exclusion Criteria:

* Recent CPR
* previous cardiac surgery
* emergency surgery ( within 24 hrs of assessment)
* chronic lung disease
* history of bleeding disorder
* currently taking Vitamin E supplements
* recent antiplatelet therapy
* excessively poor baseline health-related quality of life or physical functioning
* previous radiotherapy to chest, or on immunosuppressive drugs or current immunosuppressive condition
* active significant systemic infection, history of recurrent infections,
* cognitive impairment ( confusion, dementia, Alzheimer's, current substance abuse)
* history of malignancy within the past year
* recent history of significant alcohol or drug abuse
* females who are pregnant, nursing, or child bearing potential who are not practicing a highly reliable birth control method
* postsurgical life expectancy of less than 90 days
* moderate to severe pectus deformity
* participation in another study
Treatment of M.Graves With Radioactive Iodine: Follow-up Study

Hypothesis: What is the natural course after treatment with radioactive iodine in patients with hyperthyroidism?

What are the determinants for the development of acute hypo- or hyperthyroidism after treatment with radioactive iodine without antithyroid drugs?


Eligibility Criteria:
Inclusion Criteria:

* Patients wth hyperthyroidism who are eligible for treatment with radioactive iodine
* Age \> 18 years

Exclusion Criteria:

* Severe ophthalmopathy
* Pregnancy or wish to pregnancy on short term
* Breastfeeding
* Patients already treated with radioactive iodine
* Known cardiovascular diseases or other severe comorbidity
PINPOINT Feasibility Study

This feasibility study is investigating the application of magnetic resonance imaging (MRI) and transperineal ultrasound (TPUS) to visualise potential sites of relapse and surrounding normal tissue in patient having post-operative prostate cancer radiotherapy. Structure visualisation on MRI and TPUS will be compared to current standard computer tomography (CT) and cone-beam computer tomography (CBCT) imaging.

Approximately 47,000 men are diagnosed with prostate cancer yearly in the UK, 15% of which receive surgery (radical prostatectomy) as primary treatment. Of these men one third develop recurrence after prostatectomy and are offered post-operative radiotherapy.

Radiotherapy is targeted at the area where the prostate used to be, this includes potential relapse sites (PRS); vesicourethral anastomosis, bladder neck and retrovesicle space. When planning post-operative radiotherapy, the lack of a visible target means surrounding normal tissue is used to guide clinical target volume (CTV) delineation. The CTV is the area of tissue to be treated to the full radiotherapy prescription and includes PRS. Typically, the CTV is defined on a radiotherapy planning computer tomography (CT) scan.

The CTV lies adjacent to the bladder and rectum and is highly susceptible to positional changes influenced by organ filling. To identify and correct for CTV displacement during daily radiotherapy a cone-beam CT (CBCT) is acquired, this is an image similar to a CT scan but taken immediately prior to treatment delivery.

CT visualisation of PRS has been reported as inadequate, increasing the risk of missing or miss-identifying CTV structures during radiotherapy planning and delivery. To compensate for restricted visualisation on CT and CBCT an additional 1cm circumference around the CTV is treated to the prescription dose, this volume is referred to as the planning target volume (PTV). This margin reduces the risk of missing the target however its inclusion of normal tissue increases the risk of patient toxicity.

We propose that visualisation of PRS and surrounding normal tissue structures is enhanced on magnetic resonance imaging (MRI) compared to CT and on transperineal ultrasound (TPUS) compared to CBCT. This project investigates the reality of this statement by quantifying the confidence and reliability with which anatomical structures can be identified and delineated on all four image types.

Eligibility Criteria:
Inclusion Criteria:

* Patient has undergone radical prostatectomy
* Histologically confirmed prostate cancer
* Patient due to receive post-operative prostate bed +/- pelvic lymph node radiotherapy
* WHO performance status 0-1
* Age ≥ 18 years
* Written informed consent

Exclusion Criteria:

* Recruitment into POPS trial
* Contraindications to MRI such as having a pacemaker or non-MRI compatible implanted device
DNA Methylation Profile of the SOCS-1 Gene Promoter in Smokers Patients With Chronic Periodontitis.

Periodontitis is related to host genetics, constitution of the dental biofilm and environmental factors such as smoking. DNA methylation is a mechanism of genetic expression that can inhibit or silence gene expression. In this way several researchers have been dedicated to study the genetic influence on the susceptibility and / or increased risk to periodontal disease. Studies have reported association between several epigenetic biomarkers with periodontal inflammation. Considering the hypothesis that there is an association between smoking and methylation in genes related to periodontal disease, the objective of this study was to verify the DNA methylation pattern in oral epithelial cells of patients with chronic periodontitis (CP) in the promoter of a specific gene involved in the control of inflammation, as suppressor of cytokine signaling (SOCS) 1 in smokers and nonsmokers patients.

This was an experimental type study with parallel controls, comparing two groups, a group with consumption of 10 minimum cigarettes per day, with a diagnosis of chronic periodontitis. And another control group were non-smokers with chronic periodontitis. For this, genomic DNA was purified from oral epithelial cells obtained by rinsing with 3% sucrose, for a single time of collection, patients received periodontal treatment after collection and data analysis. The DNA was modified by Sodium bisulfite and the methylation patterns of the DNA were analyzed with the MSPCR technique (Polymerase chain reaction). This study was approved by the Institutional Review Board of the School of Dentistry of Ribeirão Preto (CAAE:57171816.2.0000.5419 ), and all patients need to provide written informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Periodontitis carriers - presence of proximal insertion loss ≥5 mm in more than 30% of the teeth present.
* Periodontal pocket ≥ 5mm
* Smokers who have smoked 10 or more cigarettes per day for the past five years.
* No positive history of basic periodontal treatment in the last six months.

Exclusion Criteria:

* Extensive prosthetic involvement.
* Using anti-inflammatories.
* Pregnant or nursing.
* Presence of systemic alterations that compromise host response or require prophylactic medication for treatment.
* History of constant use of oral antiseptics in the last six months.
Drug Burden Index is Associated With Malnutrition in Community-dwelling Dementia Patients

Malnutrition leads to poor clinical outcomes in dementia patients. The investigator aimed to examine the association between drug burden index (DBI) and anticholinergic burden (ACB) scores with nutrition status in community-dwelling older adults with dementia, considering that drugs may contribute malnutrition.

A total of 415 outpatients with dementia, evaluated by Mini Nutrition Assessment test and registered drug information, are included in the study. The investigator calculated the DBI as the sum of all sedatives and anticholinergics taken continuously for at least four weeks prior to admission and evaluated the ACB score.

Practice Impact: Due to accompanying chronic diseases and symptoms, cholinergic and/or sedative-loaded drugs are often prescribed to dementia patients. In this study, İnvestigators emphasized that in addition to the cholinergic loads of the drugs used, their sedative loads and the drug doses they use are also important. Avoiding prescribing these medications to patients with dementia will protect them from malnutrition and its negative consequences.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of any type of demantia
* Must be able to swallow tablets
* Must be recorded data of medications and doses

Exclusion Criteria:

* Psychiatric disorders
* Mild cognitive impairment
* End-stage diseases (renal, liver, cardiac)
* Uncontrolled thyroid functions
The Safety Integration Stakeholders (SAINTS) Program to Integrate Worker and Patient Safety in Oregon Rural Hospitals

The safety integration stakeholders (saints) program to integrate worker and patient safety in Oregon rural hospitals. The rationale is that the saints program will positively impact outcomes by identifying and training peer leaders on strategies to optimize environmental, administrative, and educational components to become a saint and regularly collaborate with safety stakeholders/administrative leaders at each site through continuous improvement cycles (e.g. plan-do-study-act).

SAINTs program will follow a semi-structured, block randomized control design along with a multi-method process evaluation to identify the extent to which the program was delivered as planned and if it led to the adoption of preventative measures. RCT measures will consist of pre/post survey data (at 6 months, 12 months and 24 months) hosted through REDCap and available via link. Additional secondary, de-identified data in aggregate (e.g. # of patient falls, # of worker compensation claims) will supplement survey data. Process evaluation will consist of implementation logs and interviews with key players (safety and quality officers, front-line peer leaders). The semi-structured design allows for customization among different rural healthcare sites that will have unique resources and needs, therefore requiring unique, tailored solutions. The combination of qualitative and quantitative. The SAINTS program will be implemented in four stages. 1) involvement of patient and worker safety stakeholders (e.g., Employee Health and Safety Officer, Quality Director, unit medical directors), 2) use of Social Network Analysis (SNA) to identify peer-recognized safety leaders; 3) training modules to stakeholders on safety leadership, and 4)in implementation of QI cycles to address barriers to safe patient handling and mobility (SPHM).

Eligibility Criteria:
Inclusion Criteria:

* Employed at participating sites (critical-access hospitals in rural Oregon)
* Patient-care workers (e.g. RNs, CNAs)

Exclusion Criteria:

* Non-clinical staff (e.g. clerical, janitorial)
* Non-unit staff (e.g. physical therapy)
Enteric Nervous System in Parkinson's Disease

The "core" of the neuronal lesions in Parkinson's disease (PD) is the progressive degeneration of dopamine neurons in the substantia nigra. A significant loss of dopamine neurons and the presence of Lewy bodies (a pathological hallmark in PD) in enteric neurons have also been reported in that disease. These lesions may explain the frequent gastro-intestinal dysfunction observed in PD patients. Alterations of other neuronal populations within the enteric nervous system (ENS) as well as the mechanisms responsible for these lesions (type of cell death, alteration of neuromediators gene expression) remain to be identified. The aim of the study is to demonstrate that alterations of the human ENS in PD can be evidenced by bowel biopsies and to determine whether they are correlated to the severity of motor disability and to gastrointestinal dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease patients at 3 different stages:

  * Early PD (before L-DOPA-induced complication);
  * Patients with L-DOPA-induced complication;
  * Patients with balance impairment or cognitive decline.
* Controls: patient at risk of colic cancer for whom a coloscopy is required.