cyrilzakka/clinical-trials huggingface dataset:
Analysis of Induced Sputum and Lung Biopsies by SEM: a Tool to Identify Source of Exposure of Workers to Hazardous Dust

Aim : to validate the qualitative analysis by Scanning Electron Microscope (SEM) of lung samples first in induced sputum in correlation to disease second by comparing hazardous particles in induced sputum to the analysis in lung tissue and finally by assessing if the particles present in transplanted patients correlated with occupational history.

Abstract

Background: On the last few years there is a rise in the public awareness of the danger potential that lies in the exposure to hazardous dust in different professions. The examination of induced sputum has been used from the early eighties to research and diagnose inflammatory lung diseases. We assess here patients with lung disease and occupational history, in order to undergo work up to assess hazardous dust exposure.

Aim : to validate the qualitative analysis by Scanning Electron Microscope (SEM) of lung samples first in induced sputum in correlation to disease second by comparing hazardous particles in induced sputum to the analysis in lung tissue and finally by assessing if the particles present in transplanted patients correlated with occupational history.

Methods: 40 patients referred with occupational history were included. For 24 of them SEM analysis was done in induced sputum (IS) together with questionnaires and in 11 among them the SEM analysis was done both from lung tissue (TS) and IS. In addition 11 lung biopsies from patients with occupational history were scanned by SEM and compared to 10 biopsies from patients with no occupational history.

Eligibility Criteria:
Inclusion Criteria:

* Occupational exposed workers
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis

The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite current or previous NSAID, non-biologic DMARD, or biologic anti-TNFα therapy.


Eligibility Criteria:
Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs.

Exclusion criteria: pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI, previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any biological immunomodulating agent excluding TNF antagonists, previous cell depleting therapy.

Other protocol-defined inclusion/exclusion criteria do apply.
The Effect of Palm Olein, Olive Oil and Lard and on Risk Markers of Cardiovascular Disease

The aim of this study is to compare the effects of a diet rich in palm olein, a fraction of palm oil, to a diet rich in olive oil and a diet rich in Danish lard on plasma total-, LDL and HDL cholesterol as well as triacylglycerol (TAG), fasting insulin and glucose, C reactive protein and plasminogen activator inhibitor 1 in healthy men. The investigators hypothesis is that palm olein and olive oil will have the same effect on plasma total cholesterol, LDL- and HDL concentration and maybe also on the secondary outcome parameters that are related to cardiovascular disease risk. This may be caused by the differences in the sn-positioning of palmitic acid in palm olein. This difference may cause the palmitic acid in palm olein to be more prone to soap formations and excretion than palmitic acid from other sources, e.g. lard.

This study is a double blinded, randomized, controlled 3 x 3 week crossover intervention study, without washout periods. The participants receive the three test foods in random order, decided by draw of lots. Blood samples are drawn in duplicate (on two following days) before and after each dietary period.


Eligibility Criteria:
Inclusion Criteria:

1. All participants must give their informed consent in writing, after having received oral and written information about the study
2. Age: 18-65 y
3. BMI: 18.5 - 30 mg/m2
4. Men
5. Healthy (no known diseases, incl. hypertension, hypercholesterolemia, diabetes and psoriasis)
6. No use of dietary supplements or blood donations two month prior to and during the intervention

Exclusion Criteria:

1. Current or previously cardiovascular disease
2. Diabetes Mellitus or other severe chronic disease, including severe allergies and psoriasis
3. Hypertension
4. Known or suspected abuse of alcohol, drugs or medication
5. Own request: all participants have the right to withdraw from the intervention at any given time without explanation
6. Compliance: participants may be excluded from the intervention if they do not follow the study guidelines
7. Side effects (There are no side effects expected in this study since all test fats are commercial available and use in households world wide)
Impact of Evolocumab on the Antiplatelet Effects of Ticagrelor and Aspirin in Patients With Acute Coronary Syndrome

The aim of the present study is to investigate the effects of evolocumab in addition to statin therapy on platelet reactivity in patients with acute coronary syndrome (ACS) while on Ticagrelor and Aspirin treatment.

Ticagrelor is a commercially available antiplatelet adenosine diphosphate (ADP) antagonists. They exert their antiplatelet effects by binding to P2Y12 receptors on the platelet surface. Ticagrelor is used in combination with aspirin to prevent and treat thrombosis in patients with acute coronary syndrome, particularly after stent implantation.

Aspirin has an established role in the treatment of ACS and secondary prevention of ischaemic heart disease. Aspirin inhibits cyclo-oxygenase (COX) enzymes by irreversible acetylation to block platelet aggregation.

Evolocumab is a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). The use of evolocumab significantly reduced the incidence of cardiovascular events compared to statins alone. Whether the reduction in cardiovascular events is due to LDL reduction or other mechanisms is currently unclear.

Eligibility Criteria:
Inclusion Criteria:

1. Patients were diagnosed as acute coronary disease
2. On therapy with Ticagrelor(90mg bid) and Aspirin(100mg qd), for at least 5 days.
3. Fasting LDL-cholesterol ≥70 mg/dL or a non-high-density lipoprotein cholesterol (HDL-C) of ≥100 mg/dL after ≥4 weeks of optimized stable lipid-lowering therapy with maximally tolerated dose of statin.
4. Have not used Evolocumab in 30 days.

Exclusion Criteria:

1. On treatment with any oral anticoagulant.
2. On treatment with any antiplatelet agent other than Aspirin and Ticagrelor in the past 5 days.
3. Creatinine clearance \<30 mL/minute.
4. Known severe hepatic impairment.
5. History of a serious hypersensitivity reaction to evolocumab
6. Hemodynamic instability
7. Pregnant and breastfeeding women.
Change-a Multi-center Chronic Thromboembolic Pulmonary Hypertension （CTEPH） Database in China

The Change Database is a prospective, observational multi-center disease registry, which will collect data on patients with chronic thromboembolic pulmonary hypertension (CTEPH) in China. It aims to illustrate the epidemiology, management and long-term outcomes of CTEPH.

18 CTEPH centers will be enrolled in the study. The epidemiology, diagnosis，treatments (pulmonary endarterectomy (PEA), balloon pulmonary angioplasty (BPA) and targeted medical therapy), and long-term prognosis of CTEPH will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH)
2. Patients must be willing to provide informed consent
3. Patients must meet the following criteria for CTEPH:

a mean pulmonary artery pressures (mPAP) ≥20 mmHg combined with a pulmonary vascular resistance (PVR) ≥ 3 WU and pulmonary arterial wedge pressure (PAWP)≤ 15 mmHg documented at right heart catheterization with radiographic evidence of organized thrombi involving the pulmonary arteries after 3 months of effective anticoagulation.

Exclusion Criteria:

1. Main cause of PH other than CTEPH
2. Participation in a therapeutic clinical trial with an unknown drug;
3. Withdrawal or lack of informed consent.
Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients

The purpose of this study is to evaluate the effectiveness of a multi-component intervention to improve young cancer survivors' engagement in goal-concordant oncofertility care, concurrently with observing and gathering information on how the intervention is implemented. The investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant oncofertility care.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed cancer or cancer relapse
* Primary language English or Spanish
* Receiving oncology care at participating clinical sites
* Ages 0 to 42 years if female
* Ages 0 to 50 years if male

Exclusion Criteria:

* Non-melanoma skin cancer, because primary treatment is excision with no infertility risk
* Metastatic/Stage IV non-thyroid solid tumors, because of poor prognosis
A Stress Reduction Program for Companies

This protocol proposes a well-being program based in stress reduction program for employees of a company.

objectives: To evaluate the effects of a stress reduction program with a specific orientation for workers and taught to them within their companies.

Methods: Participants with stress complaints were recruited and randomized into two groups: group 1 (G1) received the intervention while group 2 (G2) did not. Both groups were evaluated before the intervention (time 1 - T1); again after the eight weeks of the program for G1 (time 2 - T2); and then at the end of a second eight-week period during which G2 received the intervention and G1 was simply instructed to maintain the practice they had learned without further instruction (time 3- T3).

Disorders resulting from chronic stress are some of the main causes of absenteeism and reduced productivity in companies. A number of successful stress management programs are based on the principle of mindfulness and may help individuals to relieve stress symptoms and to improve well-being and pro-social behavior. The objective of this study was to evaluate the feasibility and efficacy of a weekly one-hour stress reduction program adapted for companies and if the possible benefits would be sustained 8 weeks after the end of the program. Participants with stress complaints were recruited in two companies and they were randomized into two groups: in the first period of the study, group 1 (G1) N=23 received the intervention while group 2 (G2) N=18 did not. Both groups were evaluated before the intervention (time 1 - T1); again after the eight weeks of the program for G1 (time 2 - T2); and then at the end of a second eight-week period during which G2 received the intervention and G1 was simply instructed to maintain the practice they had learned without further instruction (time 3- T3).

Eligibility Criteria:
Inclusion Criteria:

* workers with stress complaints aging from 18 to 60 years. They also had to have at least 8 years of education.

Exclusion Criteria:

* participants with a history of psychiatric or neurological disorders or who were under psychological or psychiatric treatment during the period of the study, or with a history of substance abuse, with the exception of tobacco.
Para Aortic Lymphadenectomy : Always ?

Cervical cancer affects more than 3000 new cases per year in France. The treatment of stage IB3 to IVA cervical cancer is based on concomitant radio-chemotherapy. The irradiation volumes are based, according to current recommendations, on imaging examinations and / or on the results of a laparoscopic Para-aortic lymphadenectomy (PAL). There is some risk of false negatif with the PET/CT. For this reason, most of the time, PAL is offered when there is no pathological paraaortic lymph node on PET/CT. The investigators suppose that this staging surgery could be avoid when no pathological pelvic nodes are identified on PET/CT. The investigators use a retrospective study, to analyse histological report of systematic PAL, comparing to results of pre-operative PET/CT.


Eligibility Criteria:
Inclusion criteria:

- Patients with :

* locally advanced cervical cancer,
* who undergone PAL
* with pre operative PET CT, between January 2015 and december 2019

Exclusion criteria:

- patients aged under 18
Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis

This study evaluates prospectively the effects of an anti-angiotensin II regimen on renal outcome in patients with mesangioproliferative glomerulonephritis followed-up for 10 years.

After signing informed consent, enrolled patients started treatment with ACEi. We decided to prescribe to all patients the same drug (ramipril) at the same dosage (5 mg/day). All patients were examined every 2 months during the first year of follow-up and every 6 months thereafter. At each visit, they underwent a complete physical examination. If the target blood pressure of \<140/90 mmHg was not achieved with ramipril monotherapy, addition of other antihypertensive drug(s) was allowed. Patients complaining adverse side effects attributed to ramipril were switched to losartan (50 mg/day). The patients were also prescribed a normal protein (1 gram/kg/day) and moderately salt-restricted (6-8 grams/day) diet throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* proteinuria ≥ 1 g and \< 3 g/24 hours stable during the 3 months of run-in
* microscopic hematuria (with at least 10 red blood cells per high-power field), without other signs or symptoms of systemic diseases stable during the 3 months of run-in
* no-evidence of renal failure or other relevant diseases
* biopsy diagnosis of I-II stage IgA- or pauciimmune-MsPGN

Exclusion Criteria:

* estimated Glomerular Filtration Rate (eGFR) \<80 ml/min/1.73m2
* previous immunosuppressive treatment
* blood pressure (BP) \>150/90 mmHg
The Effect of Perioperative Lidocaine Intravenous Infusion on Postoperative Recovery After Spine Surgery.

The purpose of this study is to evaluate the effectiveness of perioperative Lidocaine intravenous infusion in reducing postoperative pain for spine surgery patients.

Study design: this study used a prospective, randomized, double-blinded, and placebo-controlled clinical trial.

Sixty patients scheduled for a spine surgery will be randomly assigned to two groups. Lidocaine group will receive an intravenous bolus injection of lidocaine 1.5 mg/kg before intubation, followed by 2 mg/kg/h continuous infusion during the operation. Placebo group will receive the same dosage of saline at the same time. Analgesic requirement will be monitored using patient-controlled Analgesia (PCA protocol: demand dose is 2 mg of morphine, lockout 5 min, maximum dose 15 mg per hour). Forty-eight hours after surgery, we will check the morphine consumption in two groups. Quality of recovery after surgery will be assessed using Q0R15 questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* spine surgery with general anesthesia

Exclusion Criteria:

* lidocaine allergy
* hepatic disease
* dementia or cognitive decline
Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery

The objective of this study is to determine whether the Air Barrier System (ABS) reduces airborne colony-forming units (e.g. bacteria) present at surgery sites during posterior spinal procedures

The ABS is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the ABS can reduce the presence of airborne colony-forming units at the surgery site during posterior spinal procedures.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing lumbar and cervical laminectomy with instrumentation.

Exclusion Criteria:

* Active infection
* Prior prosthesis infection
Retrospective Clinical Outcome of Parotid Tumor Surgery

The aim of this study was to determine the histopathological results of parotid tumors and postoperative complications after partial superficial or total parotidectomy with facial nerve dissection and superficial musculoaponeurotic system reconstruction.


Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of parotid tumor
* Patients received the surgery of parotid tumor at NTUH by single surgeon ( Prof. Lou) from 2004/01 to 2012/12

Exclusion criteria:

-Inflammation or infection disease of parotid gland
High Sensitivity Troponin T Levels Following DC Cardioversion for Atrial Fibrillation / Atrial Flutter

The purpose of this study is to determine if there is a rise in serum high sensitivity troponin T (a marker for heart muscle injury) following a direct current cardioversion (shock therapy) used for patients with atrial fibrillation. This will help us determine if direct current cardioversion results in damage to the heart muscles in a sufficient amount to cause a rise in high sensitivity troponin T.

High sensitivity Troponin T is a relatively new biomarker that is highly sensitive and specific for myocardial injury. Its widespread use has helped in the determination and investigation for myocardial ischemia in patients. Previous studies have shown a rise in creatine kinase (CK) and the more specific creatine kinase-MB isoenzyme (CKMB) after DC cardioversion. Studies on the earlier generation troponin T found that the levels don't rise or rise only minimally after DC cardioversion. The high sensitivity troponin T has never been studied in the setting of DC cardioversion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with atrial fibrillation / atrial flutter attending for direct current external cardioversion
* Age 18 or older

Exclusion Criteria:

* Myocardial infarction within the last 6 weeks
* Coronary artery bypass grafting, percutaneous coronary intervention or any other invasive cardiac procedure within the last 6 weeks
Out-of-home Consumer Food Purchase Behaviour in the Presence and Absence of Value Pricing and Price Promotions

It is important to understand the role that price-based incentives in the out-of-home food sector play in food purchasing, and whether they lead to positive savings for the consumer (as they would likely anticipate when making purchases), or whether these incentives lead to increased spending and increased purchasing of unhealthy products. Additionally, it is important to consider whether the impacts of price-based incentives differ according to a range of demographic characteristics. For example, some evidence suggests that effects of removing a price-based incentive are greater in individuals with a higher BMI. Evidence also suggests there may also be differences in impact according to socioeconomic position (SEP) as individuals in lower SEP groups reportedly use price-based incentives more frequently. If lower SEP individuals are more affected by price-based incentives (i.e. they prompt ordering in excess and greater spend), then the banning of such strategies could help to reduce health inequalities, by nudging lower SEP consumers toward healthier dietary choices in the OOH food sector.

To date, it is unclear what effect policies which remove specific types of price-based incentives would be likely to have on consumer behaviour. In particular, individual product price reductions (e.g. £ off this product), bulk buy price reductions (e.g., Save £ when bought together) and volume value pricing (e.g., the price increase from a small to large portion size not being directly proportional to volume increase).

Therefore our primary objectives are:

• To observe the effect of removing price-based incentives (individual product price reductions, bulk buy price reductions, volume value pricing) in the OOH food sector on:

* Energy purchased per household
* Money spent per household

Secondary Objectives:

• To explore whether any effects of removing price-based incentives differ based on participant characteristics (BMI, SEP, food choice motives)

See attached study protocol for detailed information

Eligibility Criteria:
Inclusion Criteria:

* Currently reside in the United Kingdom
* Over the age of 18 years
* Fluent English speaker Frequently use food delivery apps or websites (at least once a month, on average)
* Frequently eat takeaway pizza (i.e. once every 2-3 months)
* Can complete the study on a laptop or desktop

Exclusion Criteria:

* Partaking in a fast or other restrictive eating for religious reasons at time of participation
* Dietary restrictions/intolerances including:

  * Gluten-free
  * Dairy-free
  * Sugar-free
Increasing Oral Medication Adherence for Metastatic Breast Cancer Patients

Aim of this study is to optimize an adherence increasing intervention designed for metastatic Breast Cancer (BC) patients by applying a full factorial design in order to evaluate the optimal combination of three different intervention components.

Today different types of Oral Anticancer Agents (OAA) are commonly prescribed to Breast Cancer (BC) patients. Patients are reported to prefer the oral modality of administration over the intravenous one for its convenience, flexibility, and easier assumption; nonetheless, the phenomenon of medication non-adherence is well-documented.

Although several interventions have been designed and tested in order to foster medication adherence among BC patients, the great majority of them were focused on adherence to endocrine therapy for early-stage BC patients, with only few exceptions involving metastatic BC patients or considering adherence to other types of OAA.

The aim of this work is to optimize an adherence increasing intervention designed for metastatic BC patients. This will be achieved by applying a full factorial design in order to evaluate the optimal combination of three different intervention components (informative documentation, personalized reminders and feedback).

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of metastatic BC
* Patients with a prescription for any OAA (i.e. oral chemotherapy, endocrine therapy, and Cyclin-Dependent Kinase 4/6 Inhibitors)
* Age \>18 years old
* Patients with a personal smart phone with internet access
* Willingness and ability to comply with scheduled visits and other trial procedures
* Understanding and speaking Italian language
* Written informed consent

Exclusion Criteria:

* Psychiatric disorders or conditions that might impair the ability to give informed consent
* Comorbidity that may impact on compliance to study procedures
Alleged Drug Allergies in Military General Medicine: Patients' Experiences and Beliefs

This study focuses on the experience of the military patient reporting a suspected drug allergy, with its own specificities. Suspicions of drug allergies during a mission expose the doctor to difficulties.

This study will improve understanding of the allergy patient's point of view. The end result could be a set of ideas for measures to raise awareness among these patients, and motivate them to undergo an allergological assessment.


Eligibility Criteria:
Inclusion Criteria:

* Military personnel (active or reservist)
* Reporting a drug allergy during a periodic medical check-up or during a consultation in a medical unit
* Not opposed to participating in the study.

Exclusion Criteria:

* Candidate on admission visit
* Opposition to study
* Minor (under 18 years of age)
* Pregnant, parturient or breast-feeding woman
* Person deprived of liberty by a judicial or administrative decision, person under psychiatric care
* Non-French nationals
* Person of full age subject to a legal protection measure
* Person unable to express non-opposition