cyrilzakka/clinical-trials huggingface dataset:
Evaluating a Mobile Self-management Application for Patients With COPD Chronic Obstructive Pulmonary Disease

The objective of the study is to evaluate the effects of a mobile self-management app in clinical practice for recently discharged COPD patients on application use, self-management, anxiety and depression, expectations and experiences, patients' and health care professionals' satisfaction and hospital readmissions.

Usability testing techniques were used to receive feedback on a prototype of the app, before starting the feasibility study. Patients were recruited from a large teaching hospital. The COPD app provided patients with an 8 week self-management program. The application had three views: timeline, information page, and contact page. The start date was each patients' date of discharge. The timeline was classified in 8 weeks, and each week included the lung exacerbation plan, daily and extra medication, information and education and questionnaires. The first week also included a video of a pulmonologist explaining the purpose of the app and additional information about the functionalities of the COPD app. The timeline consisted of the lung exacerbation action plan, medication overview, weekly questionnaires and monitoring, and consultations (video consultation after 4 weeks and face-to-face consultation after 8 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 Years
* Diagnosed with COPD
* Admissions to the hospital for exacerbation
* Having (access to) a tablet or smartphone
* Working internet connection
* Proficiency in using a tablet or smartphone
* Ability to read and understand the Dutch language
* Signed informed consent
* At least one hospitalization for COPD exacerbation in the year preceding the study (outcome was...)

Exclusion Criteria:

* No exacerbation of COPD
* Comorbidities: cancer, severe cognitive or psychiatric comorbidities
* No access to a tablet or smartpone
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection.

This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or 180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks. Group 7 will receive standard of care (SOC) for 48 weeks. There will be a 24 week period of treatment-free follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-65 years of age;
* chronic hepatitis C, genotype 1;
* chronic liver disease consistent with CHC;
* compensated liver disease.

Exclusion Criteria:

* infection with any HCV genotype other than genotype 1;
* previous treatment for CHC;
* medical condition associated with chronic liver disease other than CHC;
* HIV, hepatitis A, hepatitis B infection.
Dose Finding Study in COPD

The primary objective of this study is to determine the optimum dose of BEA 2180 BR inhalation solut ion delivered by the Respimat ? inhaler once daily for four weeks in patients with COPD.


Eligibility Criteria:
1. Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 \>=30% and \<= 60% of predicted normal and FEV1 \<=70% of FVC at the baseline PFTs at Visit 1 (at both timepoints).
2. All patients must have an increase in FEV1 of at least 12% from baseline (th e -10 minute measurement) 45 min after inhalation of 80 ?g Atrovent MDI.
3. Male or female patients 40 years of age or older.
4. Smoker or ex-smoker with a history of more than 10 pack years.

1. Patients with any other significant disease will be excluded. 2. Patients with a history of asthma or allergic rhinitis will be excluded.
Association Between Erythroferron and Perioperative Hemoglobin Levels in Patient Undergoing Heart Valve Surgery

In patients undergoing cardiac surgery, perioperative anemia is an important factor in surgical recovery. In addition to the low preoperative hemoglobin level, the delayed recovery of the postoperative hemoglobin level is an important problem affecting the incidence of postoperative anemia. Erythroferron is the early response to of the red blood cell production in stressful situations such as anemia, bleeding, and hypoxia. Therefore, it is thought that acute blood loss and systemic inflammatory reaction that inevitably occurs after cardiac surgery will synthesize erythroferron, which helps to restore hemoglobin level at postoperative period by promoting hematopoiesis by simultaneously inhibiting hepcidin and activating hematopoiesis.

In this study, the investigators will investigate the association between Erythroferron and perioperative hemoglobin levels in patient undergoing heart valve surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 20 years
* undergoing elective valvular heart surgery

Exclusion Criteria:

* Emergency operation
* Co-operation with other surgeries
* Patients with cardiogenic shock or ventricular-assist device (eg. ECMO, IABP)
* Patients requiring mechanical ventilator care in preoperative period
* Patient with severe chronic kidney disease (GFR(CKD-EPI) \<30ml/min/1.73m2)
* Patients with preoperative infection status (Eg. Sepsis)
* Patients with acute bleeding status
* Hemoglobin concentration below 10g/dL
* Disease directly affecting hematopoiesis (eg. Leukemia, myeloma, aplastic anemia)
* Uncompensated liver cirrhosis, acute hepatitis, alcoholics
* Patients who participated in other clinical studies that could affect prognosis
* Patients who cannot understand the informed consent (eg. Foreigner)
Virtual Reality 3D-Surgery Modeling to Enhance Head and Neck Cancer Surgery Quality

This clinical trial studies the use of virtual reality technology and three dimensional surgery (3D-surgery) modeling to enhance current treatments in head and neck cancer surgery. Virtual reality 3D-surgery modeling may improve quality of surgical planning and interdisciplinary communication between surgeons and pathologists during the treatment of head and neck squamous cell cancer and ultimately increase the accuracy of planning, the quality of communication, and maximize the outcome patients with head and neck cancer experience throughout treatment.

PRIMARY OBJECTIVES:

To assess the potential for preoperative virtual reality and 3D pathological modeling to reduce total number of margin events as defined in the study as the number of positive frozen margins, number of positive final margins and the number of unexpected defect driven margins.

SECONDARY OBJECTIVES:

To assess the impact of preoperative virtual reality and 3D pathologic modeling as treatment for head and neck squamous cell carcinoma on event free survival (EFS) at 18-36 months after resection as defined by recurrence at the primary site.

TERTIARY OBJECTIVE:

I. To evaluate the quality of existing interdisciplinary intraoperative communication using the proposed VR/3D-case enhancement protocols (CEPs) as an evaluating medium.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (VR/3D-CEPs + STANDARD TREATMENT): Prior to surgery (day 0-13), patients undergo virtual reality 3D tumor resection via VR/3D-CEPs. Patients' pre-surgical computed tomography (CT) scans are reviewed per standard of care. Patients then undergo surgical resection on day 14-29 and a 3D model of true tumor is created and imported into the virtual reality environment.

ARM II (STANDARD TREATMENT): Prior to surgery (day 0-13), patients' pre-surgical CT scans are reviewed per standard of care. Patients then undergo surgical resection on day 14-29.

After completion of study intervention, patients are followed for up to 36 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cancer of the head and neck (oral cavity, oropharynx, larynx, hypopharynx, T1-T4)
* Receiving treatment at Thomas Jefferson University - Center City by a fellowship-trained HNC surgeon
* Eligible for definitive resection
* Age \> 18
* Provide signed written informed consent document

Exclusion Criteria:

* Impaired judgement or those unable to provide informed consent
* Any factor that would place the patient at increased risk or preclude the individual's full compliance with or completion of the study
* Nasopharyngeal carcinoma
* Contraindications for surgery
* Enrollment in other clinical trial
Adjusting to Chronic Conditions Using Education Support and Skills

Medically ill patients with Congestive Heart Failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD) are at increased risk for developing symptoms of anxiety and depression and are among the least frequent users of mental health services and treatments. To address the needs of chronically ill patients, we created a time-limited psychosocial intervention to maximize treatment benefits and improve the efficiency and ability of mental health care practitioners to provide services within medical care settings. This study is separated into two randomized study groups. The first group of participants will receive the ACCESS intervention immediately. The second group of participants will be followed for a period of 6 months. After a period of 6 months, those who continue to have symptoms of depression and/or anxiety will be offered the ACCESS intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18+;
2. Confirmation of CHF or COPD diagnosis according to medical chart review;
3. Ongoing symptoms of functional limitations due to CHF (NYHA classification of II , III, or IV as obtained by telephone interview) or COPD (Score of 3 or greater on the Medical Research Council Dyspnoea Scale \[MRC\] as obtained by telephone interview);
4. Eligible patients must have clinically significant symptoms of either anxiety and/or depression as measured using patient self report questionnaires. Clinical cutoff scores for depression will be based on the Beck Depression Inventory - Second Edition (scores of 14 or more) while anxiety cutoffs will be determined using the State-Trait Anxiety Inventory - trait subscale (score of 40 or greater);
5. Eligible patients will be English-speaking, as this intervention has not yet been translated to any other language.

Exclusion Criteria:

1. History of substance abuse, bipolar disorder, psychosis or active suicidal intent (obtained from standardized structured clinical interview);
2. NYHA class I, or MRC levels 1 and 2. Class 1 CHF patients and Level 1 and 2 COPD patients (by definition) will have no significantly limiting CHF or COPD symptoms. This information will be obtained through patient self-report of CHF and COPD symptoms;
3. Mental status examination score in the cognitively impaired range on an established 6-item screen;
4. Inability to provide informed consent or severe physical limitations restricting completion of the study protocol (e.g. vision, hearing, or physical functioning);
5. Non-English speaking patients will be excluded from participation, as this intervention has not yet been translated to any other language.
Tadalafil Effects in Left Ventricle Diastolic Dysfunction in Resistant Hypertensive Patients

Left ventricle diastolic dysfunction (LVDD) is associated with resistant hypertension. In addition, brain natriuretic peptide (BNP) levels are elevated when LVDD is present. It has been shown that phosphodiesterase-5 (PDE5) inhibition improves left ventricle diastolic function in hypertensive rats, despite any difference in blood pressure levels. Also, left ventricle diastolic function enhancement reduces BNP concentration in hypertensive patients. However, it is unknown if these effects exists in humans with resistant hypertension. Therefore, this study was developed to evaluate if the use of a PDE5 inhibitor (tadalafil) for 2 weeks improves LVDD and its effects in BNP levels in resistant hypertensive patients.

Resistant hypertensive patients have a high incidence of left ventricle diastolic dysfunction (LVDD). Lowering blood pressure levels improves diastolic function, however, there is no proved effective treatment specifically for this disease. Studies in hypertensive rats have shown presence of phosphodiesterase-5 in cardiac cells and an improvement in left ventricle diastolic function using a phosphodiesterase-5 (PDE5) inhibitor, the sildenafil. PDE5 has also been demonstrated in human heart cells with cardiac disease. In addition, LVDD is associated with high levels of brain natriuretic peptide (BNP), which reduces with diastolic function improvement. Therefore, it is reasonable to suppose that PDE-5 inhibitor use in humans with LVDD and resistant hypertension could improve diastolic function. Objective: Evaluate the chronic effect of a PDE-5 inhibitor on LVDD and BNP levels in resistant hypertensive patients. Casuistic and methods: 20 resistant hypertensive patients with LVDD types I and II will be evaluated with echocardiography study, ambulatory blood pressure monitoring (ABPM), office blood pressure measurements, endothelial function analysis using the brachial artery flow mediation dilation technique (FMD) and BNP plasma levels. Then, the subjects will receive oral placebo for 2 weeks. After this period, the same exams will be repeated. Two weeks later, the protocol will be performed again to the same 20 patients, using tadalafil (the longest half-life PDE-5 inhibitor) 20mg orally instead of the placebo. Hypothesis: investigators hypothesize that the use of tadalafil will improve left ventricle diastolic function with BNP reduced levels and this effect will be independent of blood pressure decrease or endothelial function improvement.

Eligibility Criteria:
Inclusion Criteria:

* resistant hypertension (according to Resistant Hypertension - American Heart Association Statement - 2008);
* compliance with antihypertensive treatment;
* age \>35 years;
* left ventricle diastolic dysfunction types I and II

Exclusion Criteria:

* valvulopathy
* decompensated heart failure
* important cardiac arrhythmias
* nephropathy
* hepatopathy
* autoimmune disease
* tabagism
* decompensated diabetes
* uncontrolled dislipidemia
Dual-Energy Computed Tomography (DECT) in Acute Neck Infections: Comparison With Magnetic Resonance Imaging (MRI)

The purpose of this prospective study is to compare MRI and DECT in imaging acute neck infection. 50 patients suspected for neck infection will undergo both modalities, which will then be compared in terms of depiction of edema, conspicuity of inflammation, and characterization and number of abscesses. We hypothesize that DECT will have diagnostic performance comparable to that of MRI, and superior to that of traditional single-energy CT. This study will yield important new information about the performance of DECT, a novel and rapid method for emergency imaging.

Deep neck infections present challenges even in modern medicine, due to complex anatomy and potentially lethal complications. True extent of the infection is difficult to assess clinically. Therefore, medical imaging is useful in determining the exact location and extent of disease. In suspected neck infection, computed tomography (CT) has traditionally been the first-line imaging method. However, magnetic resonance imaging (MRI) provides excellent soft-tissue characterization surpassing that of CT in the initial evaluation of neck infections. Previous studies have shown than MRI is superior to CT in terms of lesion conspicuity and number of affected spaces in neck infections. As an alternative to MRI, dual-energy CT (DECT) could offer improved soft tissue sensitivity compared with traditional single-energy CT. DECT refers to CT imaging carried out with two kinds of spectra of x-ray. In this prospective comparative study, we will recruit emergency patients with suspected neck infection. Neck MRI will be completed as part of standard clinical care, and DECT as part of this research study. After study completion, DECT and MRI will be compared by neuroradiologists, both modalities at separate occasions, blinded to the clinical information and diagnosis as well to the result of the other modality. Clinical care will be based on MRI as is usual practise. Surgical findings will be considered gold standard.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Suspicion of acute neck infection as deemed by the referring physician

Exclusion Criteria:

* History of a serious adverse reaction to intravenous iodine- or gadolinium-based contrast agent
* Severe kidney dysfunction (eGFR \< 30 mL/min/1.73m2)
* Foreign metallic objects incompatible with MRI in the body
* Inability to give informed consent, as deemed by study physician
* Inability to follow study instructions
Three Lifestyle Interventions on Endothelial Function and Cardiometabolic Risk in Obese Patients With Metabolic Syndrome

Obese patients with metabolic syndrome without diabetes or ischemic heart disease were randomized to three lifestyle interventions: 1. hypocaloric tailored diet with standard recommendations 2. pragmatic healthy style diet adapted to brazilian habits with portion control and pedometers to perform 10000 steps daily recorded or 3. pragmatic healthy style diet adapted to brazilian habits with portion control plus fitness three times a week under direct supervision. The main outcome was brachial reactivity, a surrogate marker of atherosclerosis, and secondary outcomes were cardiometabolic profile, arterial pressure and anthropometric measures: weight,waist circumference and bioimpedanciometry to access fat proportion and insulin sensitivity.

It's a 12 week single center randomized controlled trial to evaluate three different lifestyle interventions on flow mediated vasodilatation, cardiometabolic profile and anthropometric parameters in non-diabetic persons with metabolic syndrome without coronary heart disease.

After informed consent, they will be randomized to 3 different lifestyle interventions: 1. Hypocaloric tailored AHA type 1 diet plus standard exercise advice; 2. Pragmatic portion controlled healthy diet plus pedometers to perform 10.000 steps daily or 3. pragmatic portion controlled healthy diet plus fitness under direct supervision,using heart rate monitors to adjust workload to achieve the target heart rate (75% of the maximum attainable heart rate - HRpeak, as determined by their individual maximal treadmill exercise test).Main outcome is endothelium vasodilation accessed through brachial ultrasound, a surrogate marker of atherosclerosis. Secondary outcomes are anthropometric data: weight, waist circumference and fat proportion, cardiometabolic profile and insulin sensitivity (HOMA-R).

Eligibility Criteria:
Inclusion Criteria:

* men and women 30-55 years with BMI 30-40 and waist 95 cm or more
* normal OGTT
* normal treadmill stress test
* plus 2 of 4:

  1. low serum levels of HDL cholesterol (\<40 mg⁄dL for men or \< 50 mg ⁄dL for women);
  2. hypertriglyceridemia (triglyceride levels of 150 mg⁄dL or greater);
  3. impaired glucose homeostasis (fasting plasma glucose concentration of 110 mg⁄dL or greater or glucose of 140 mg⁄dL or greater after OGTT or
  4. hypertension (systolic blood pressure ≥ 140 or diastolic blood pressure ≥90 mmHg or treatment with antihypertensive drugs).

Exclusion Criteria:

* diabetes
* ischemic heart disease or any abnormality on treadmill stress test
* inflammatory or chronic disorder
* pregnancy
* lactation
* creatinine level of 1,5 mg/dL or more
* gastrointestinal problems or musculoskeletal disorders that would prevent them to follow the test diets or exercise interventions
* liver dysfunction with a factor of at least 3 above the upper limit of normal in AST and ALT levels
* thyroid dysfunction, with serum TSH out of normal limits
* use of immunosuppressive drugs, corticosteroids or anorexigen
Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries

The PACCOCATH FEM study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis after femoropopliteal angioplasty.

Background: Treatment of patients with peripheral arterial disease (PAD) in the femoropopliteal arteries by percutaneous intervention is still limited by high rates of restenosis. The aim of the present study is to evaluate the efficacy and safety of a novel method of short time local drug delivery based on a paclitaxel-coated balloon in femoropopliteal arteries.

Methods and results: The double-blind and randomized study enrolled n=79 patients with occlusion or stenosis of femoropopliteal arteries. Inclusion criteria were clinical Rutherford stage 1-5, occlusion or hemodynamic relevant stenosis (≥ 70 % diameter) of femoropopliteal arteries and successful guiding wire recanalization. The primary endpoint was the late lumen loss after 6 months follow-up as seen in angiography. Secondary endpoints included the rate of restenosis (a binary variable), change of ankle brachial index (ABI), rutherford class and major adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Rutherford stage 1, 2, 3, 4 oder 5
* Occlusion or Stenosis of Superficial femoral and/or popliteal artery
* Successful guide wire passage of the lesion
* Patient suitable of vascular surgery in case of complication
* Written consent
* Patient is willing to take part in follow up examinations within the study

Exclusion Criteria:

* Acute ischemia
* Distal run off less than one vessel
* Pregnancy
* Hyperthyroidism
* Thrombocytes \<100.000/mm3 or \>700.000/mm3, Leucocytes \<3.000/mm3
* Life expectancy less than two years
* Patients not willing to enter the study
Doppler Evaluation in RA Patients After Adalimumab.

The purpose is to study the relationship between RA disease activity based on Doppler quantification and the subsequent clinical response (EULAR response) to treatment with Adalimumab during 12 months. The purpose is also to compare the Doppler quantification with conventional clinical methods and semiquantitative Doppler assessment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\> 18 years of age), male or female
* Rheumatoid arthritis according to the 1987 ACR or 2010 EULAR/ACR classification criteria
* Moderate to high disease activity
* Ongoing anti-rheumatic treatment with DMARD, with stable dosage during the last 3 months, and being a candidate for anti-TNF add-on therapy OR ongoing treatment with first anti-TNF therapy and being a candidate for switch to another anti-TNF therapy
* Women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study
* Signed Informed Consent \*Signed Informed Consent must be obtained before any study specific procedures take place.

Exclusion Criteria:

* Biologic treatment with Adalimumab before inclusion
* Two or more ongoing biologic treatments before inclusion
* Treatment with other biologic treatment than anti-TNF therapy before inclusion
* Any contraindication for treatment with Adalimumab
* Intraarticular corticosteroid injection during the last 4 weeks before each follow-up visit
* Positive for tuberculosis or hepatitis B.
* Ongoing pregnancy or lactation