cyrilzakka/clinical-trials huggingface dataset:
Lowering Blood Pressure in Primary Care in Vienna

The aim of this prospective, randomised, open-label, multicentre clinical trial is to enhance blood pressure control in primary care by introducing a standardised and simplified titration regime with single pill combinations (SPC), comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide.

Rationale Hypertension is the single largest contributor to mortality worldwide, accounting for 13% of deaths globally. Approximately 30% of the adult population suffer from hypertension and of those diagnosed and treated, only 30-50% have adequately controlled blood pressure. At present, the importance of hypertension as fundamental risk factors is inadequately addressed among many patients and physicians.

Design The aim of this prospective, randomised, open-label, multicentre clinical trial is to enhance blood pressure control in primary care by introducing a standardised and simplified titration regime with single pill combinations (SPC), comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide.

The trial will randomise 42 family doctors or resident specialists for internal medicine (enrolling 840 patients with treated or untreated hypertension) to either experimental care or standard care for hypertension, latter according to the 2013 European Society of Cardiology Guidelines for the Management of Arterial Hypertension.

Practitioners randomised to experimental care will up-titrate antihypertensive therapy with SPCs in 4-week intervals if the target blood pressure of \< 140/90 mmHg is not reached at the respective follow-up (Figure 1).

Study Outcomes The primary efficacy endpoint will be the proportion of patients achieving the target office blood pressure after 6 months of follow-up. The main secondary endpoint will be the improvement of 24h ambulatory blood pressure (ABPM) profile, measured at inclusion and after 6 months of follow-up.

Safety assessments include the evaluation of treatment emergent adverse events, particularly hospitalisation, worsening of renal function, peripheral oedema and hypotension.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* office blood pressure ≥ 140/90 mmHg
* ACE inhibitor intolerance (experimental arm)

Exclusion Criteria:

* Malignant disease with life expectancy \< 6 months
* Women of childbearing potential (ICH definition) or breastfeeding
* Contraindications or allergies against olmesartan, amlodipine or hydrochlorothiazide (experimental arm)
* Chronic kidney disease grade IV or V (eGFR \< 30 ml/min)
* Recent myocardial infarction or stroke within the preceding 3 months
* Participation in another clinical trial
Feasibility of a Standardized Video for Patient Education and as a Decision Aid on Code Status for Patients in the Emergency Department Pending Admission to the Hospital

The researchers hypothesize that patients and their families will be comfortable watching standardized CPR informational videos and that they would recommend that others watch the videos. Furthermore, the researchers hypothesize that patients and their families will find the videos helpful in their own end-of-life planning.

The code status video, produced by experts in palliative medicine and end of life care, has been evaluated in a variety of healthcare settings to allow patients to make more informed decisions based on realistic information about resuscitation status. This video could be used as a supplement for clinical discussions and decision making. It is not meant to replace a careful, individualized discussion by the clinician with patients and their families, but appears to be a helpful tool to help educate patients in order for them to be better informed to make complicated decisions about their code status. The Emergency Department is an ideal setting to evaluate the video because they could improve patient understanding in an environment with inherently limited face-to-face provider time.

Specific Aims

1. To assess the satisfaction of patients and family members who view the video on cardiopulmonary resuscitation. This will be measured through use of a questionnaire asking them to score their comfort with watching the video and how likely they would be to recommend the video to others.
2. To assess if watching the standardized video changes patients' code status. This will be measured as what patients' code status was before and after watching the video.

Eligibility Criteria:
Inclusion Criteria

* Any patient in the Emergency Department whose disposition is listed as a full admission to the hospital
* Provider willingness to have patient watch the video and be available to answer questions after.
* Age \> 65
* Ability to provide consent

Exclusion Criteria

* Does not speak English
* Hearing or visually impaired
* Prisoner or incarcerated
* Inability to provide consent according to attending Physician or Study Coordinator and legal power of attorney is not present
Role of the Radiologist in Management of Pulsatile Tinnitus

The aim of this study is to detect the role of interventional radiology in management of Pulsatile tinnitus and to detect the best imaging modality for Diagnosis.

Tinnitus is a broad and complex subject concerning a symptom rather than a syndrome or a disease (1 ),New studies indicate that prevalence of tinnitus is 14.5% among those less than 40 years old and 17.5 - 35% among age over 40 years Old( 2-3 ). Vascular tinnitus causes are multiple , Arterial causes like Atherosclerosis , Fibromuscular dysplasia or Dissection of the carotid or vertebral artery , Arteriovenous causes like Cerebral head and neck arteriovenous malformation , Dural arteriovenous fistula and Carotid cavernous fistula Venous like Systemic diseases with hyperdynamic circulation . Chronic anemia, pregnancy, thyrotoxicosis , Idiopathic intracranial hypertension and Dural venous sinus stenosis , Tumors also like Paraganglioma which Some authors believe that para-gangliomas are the most common cause of vascular tinnitus and Vascular metastasis And other Miscellaneous Causes like Paget's disease m Otosclerosis or Otomastoiditis , but others see dural arteriovenous fistula (AVF) ,idiopathicvenous tinnitus, or idiopathic intracranial hypertension the most common causes. (4 - 9) , Also One of the Most important Arterial causes is Atherosclerosis , Atherosclerotic plaques ma produce turbulence of carotid flow and occasionally cause pulsatile tinnitus (10 ) , FMD ( Fibromuscular Dysplasia ) seen in 0.5% to0.6% of carotid angiograms and autopsies, is the second most common cause of extracranial carotid narrowing (11) information obtained from both CT and MRI is complementary In some casesThe angiographic findings may include luminal stenosis, abrupt reconstitution of the lumen, dissecting aneurysm, intimal flap, slow flow, occlusion, and distal emboli (12-15)

Eligibility Criteria:
Inclusion Criteria:

* Patients with pulsatile tinnitus of unknown origin referred by a physician to diagnostic radiology to be assessed by imaging will be included in the study.
* Patient's with clinical diagnosed pulsatile tinnitus.
* patient refused surgical intervention.

Exclusion Criteria:

* History of allergy to the contrast media , Contraindication to MRI and Refusal to sign a consent
* Pregnant women
* patients with atherosclerosis cause only or vascular loop more than 50% in internal auditory canal
A Double-blind, Escalating Dose, Randomized, Placebo-controlled Study Assessing PK, Safety, Tolerability in Non-ambulant DMD Subjects

The purpose of this study is investigate the pharmacokinetics, safety and tolerability of single subcutaneous administration of GSK2402968 in non-ambulant boys with Duchenne muscular dystrophy


Eligibility Criteria:
Inclusion Criteria:

* Duchenne muscular dystrophy resulting from a mutation in the DMD gene, confirmed by a sponsor approved DNA diagnostic technique covering all DMD gene exons, including but not limited to MLPA (Multiplex Ligation-dependent Probe Amplification), CGH (Comparative Genomic Hybridisation), SCAIP (Single Condition Amplification/Internal Primer) or H-RMCA (High-Resolution Melting Curve Analysis), and correctable by treatment with GSK2402968.
* Age 9 years old or greater at Screening;
* Male;
* Non-ambulant (at least 1 year in a wheelchair) within the last 4 years;
* Life expectancy at least three years;
* Willingness and ability to comply with all protocol requirements and procedures;
* QTc \<450msec (based on single or average QTc value of triplicate ECGs obtained over a brief recording period). Note: QTc may be either QTcB or QTcF, machine read or manual overread;
* Subjects must be willing to use adequate contraception (condoms or abstinence), from Screening until at least 5 months after the last dose of study drug;
* Informed assent and/or consent in writing signed by the subject and/or parent(s)/legal guardian (according to local regulations).

Exclusion Criteria:

* Any additional mutation (such as an additional missing exon for DMD) that cannot be treated with GSK2402968;
* Current or history of liver or renal disease;
* Acute illness within 4 weeks of anticipated administration of study medication, which may interfere with study assessments;
* Use of anticoagulants, antithrombotics or antiplatelet agents, previous treatment with investigational drugs, idebenone or other forms of Coenzyme Q10, within 6 months of the first administration of study medication;
* Start of glucocorticosteroids within 6 months or non-stable use of glucocorticosteroids within 3 months of the anticipated first administration of study medication;
* Positive hepatitis B surface antigen (HbsAg), hepatitis C antibody test (HCV), or human immunodeficiency virus (HIV) test at Screening;
* Symptomatic cardiomyopathy;
* Use of alcohol from Screening through to the 1 month Follow-up visit ;
* Any Child in Care.
Interest of a Visual Scale for Evaluating Food Portions as a Screening Tool for Nutritional Risk in Pediatrics

In current practice, there are various nutritional risk scores and diagnostic tools which are used in both inpatient and outpatient settings,however, in some cases, these tools cannot be used due to lack of data.

That's why a tool that doesn't require any anthropometric parameters, such as a visual food intake scale, could be useful to for medical and paramedical staff. In this way, a larger proportion of the paediatric population could benefit from nutritional screening.

HAS defines undernutrition as a state of nutritional imbalance, characterized by a negative energy and/or protein balance. This negative balance may be linked to a deficit in isolated intake and/or an increase in energy and/or protein expenditure.

In current practice, there are various nutritional risk scores and diagnostic tools which are used in both inpatient and outpatient settings. Practitioners can use discs to quickly and easily determine BMI, which corresponds to the ratio of Weight (Kg) / Height² (m). However, in some cases, these tools cannot be used due to lack of data.

That's why a tool that doesn't require any anthropometric parameters could be useful to for medical and paramedical staff. In this way, a larger proportion of the paediatric population could benefit from nutritional screening.

In adults, a visual food intake scale exists and has been validated for screening for nutritional risk. The hypothesis of this study is that the visual food intake scale could be a good tool for screening for nutritional risk in paediatrics

Eligibility Criteria:
Inclusion Criteria:

* Child able to be weighed and measured
* Family with Internet access and telephone number
* Child and at least one parent present during day hospitalization,
* Child able to respond to the SEFI® scale and having completed the 3-day food intake at home

Exclusion Criteria:

* Children and/or parents with comprehension and/or communication difficulties
* Children with any pathological condition making interpretation of results difficult from the investigator's point of view
* Children receiving nutritional support: enteral and parenteral nutrition.
* Child with nutritional follow-up
A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence

The purpose of the study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.

A multi-center clinical trial of Botulinum-A Toxin (Botox) for refractory urge incontinence.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects 21-90 years of age
* subjects has urinary incontinence on 3 day bladder diary
* subject has severe incontinence
* urine dipstick or urine culture negative for urinary tract infection
* cystometrogram without stress urinary leakage
* must have failed at least one anti-cholinergic medication
* negative urine pregnancy test on day of administration of study medication

Exclusion Criteria:

* history of carcinoma of the bladder
* presence of foreign body in the bladder, cystitis or other correctable etiology for Urge Urinary Incontinance
* gross fecal incontinence
* known allergy to sulfa or ciprofloxacin or to lidocaine
* any medical condition that may put the subject at increased risk with exposure to Botox
* females who are pregnant, breast-feeding, or planning a pregnancy during the study or who are of child-bearing potential
* known allergy to any of the components in the study medication
* prior documented resistance to Botox
* evidence of recent alcohol or drug abuse
* concurrent participation in another investigational drug or device study within 30 days
Efficacy of a Disease Management Program in Very Old Patients With Heart Failure

The purpose of this study is to assess the efficacy of a disease management programme (DMP) for very old patients with HF and significant co-morbidity.

METHODS: A multicenter randomized trial will be conducted with 700 patients with heart failure, aged over 75 years, admitted to the acute-care units of the Geriatrics Departments in 8 hospitals. Patients will be randomly allocated to a DMP or to conventional usual-care. Randomization will be stratified by hospital and performed with concealment of the allocation list.

The DMP will be conducted by a case manager, and will include three main components:

1. patient education to improve disease' knowledge and self-care
2. monitoring of clinical status
3. therapeutic adherence. Main statistical analyses will be performed according to the intention-to-treat principle, and will use Cox regression models to examine the association of a DMP with hospital readmission, quality-of-life, and mortality over 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Age:75 y or older
2. Co-morbidity or dependency. At least one of the following criteria: Charlson index \>3, dependency in 2 or more basic activities of daily living,treatment with 5 or more drugs, urgent hospitalization in the last 3 months, three or more diseases with active treatment, limitation in daily living because of vision or hearing impairment, cognition deficit, Parkinson disease, diabetes mellitus, chronic obstructive lung disease, severe anemia, constitutional syndrome
3. Hospital admission with a main diagnosis of heart failure (according to the criteria of the European Society of Cardiology or Framingham criteria) in NYHA functional class II-IV.

Exclusion Criteria:

1. Participation refusal
2. Terminal illness
3. Cognitive decline or severe cognitive deficit, which does not permit a minimum knowledge of the disease, or lack of carers which give consent to study participation
4. Clinical instability as assessed with the Kosecof index
5. Being in waiting list for organ transplant or cardiac surgery
6. Inability to be followed-up because of other reasons (change of place of residence,..)
7. Institutionalization
Amphetamine Cocaine Interaction Study - 2

The purpose of this study is to evaluate results of d-amphetamine - cocaine (pharmacology) interaction study.


Eligibility Criteria:
Please contact site for information.
Neoadjuvant Nab-Paclitaxel and S-1 in Resectable Pancreatic Cancer

There were limited data for nab-paclitaxel and S-1 in pancreatic cancer. To explore the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with resectable pancreatic cancer (stage II and partial stage III defined according to the National Comprehensive Cancer Network definitions ), we designed this study. This study was a single-arm single center prospective phase II clinical study. A total of 72 subjects who meet the criteria will receive neoadjuvant chemotherapy of nab-paclitaxel and S-1 prior to pancreatectomy. Response was reported according to the Response Evaluation Criteria in Solid Tumors guidelines (RECIST, version 1.1) .The primary endpoint is objective response rate. The secondary endpoints include R0/R1 resection rate, disease free survival, overall survival and safety.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed-consent form;
2. Treatment-naive PDAC with histological or cytological diagnosis;
3. Resectable pancreatic cancer stage II and partial stage III defined according to the National Comprehensive Cancer Network definitions;
4. Age≥18 years old and ≤70 years old;
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
6. BMI≥18.5 and NRS2002score\<3;
7. Expected survival over 3 months;
8. Spared organ function satisfying the following laboratory data:leucocyte≥3.0x109/L,neutrophils≥1.5x109/L, hemoglobin≥ 9g/dL, platelets ≥100x109/L, total bilirubin ≤ 1.5 ULN; AST and ALT≤ 2.5 ULN; serum creatinine≤1.5ULN; PT and INR≤ 2.5 ULN;

Exclusion Criteria:

1. Severe Impaired organ functions;
2. Patients who had surgeries, chemotherapy or other treatments before inclusion;
3. Pregnant women or lactating women;
4. Ineligible by the discretion of the investigator.
Effect of Arista Powder on Bleeding in Reductive Mammary Surgery

To evaluate whether Arista AH which contains microporous polysaccharides used as a powder applied to the wound area during mammary surgery reduces the amount of bleeding and the duration of surgery. Both mammae are operated on in the same procedure, and one side without Arista serves as control side

During the operation,before the first incision a randomization envelope is opened. Always starts on the same side, with or without Arista according to the envelope. After surgery, vacuum drains are placed and the amount of drained material and hgb content is measured 24 hours later by nursing staff blinded to what side had Arista.Patients scores postoperative pain with VAS score bilaterally.

Three months postoperatively the patients are checked by a physician blinded for what side had Arista

Eligibility Criteria:
Inclusion Criteria:

* All women for mammary hypertrophy day surgery. No exclusions in this group.
Implementation of Real-time ADE Surveillance and Decision Support

The purpose of this study is to determine if an electronic alerting technology improves time to intervention for possible ADEs, identify what factors affect adoption of ADE alerts, and whether there is a cost benefit associated with the alerting technology.

Inpatient adverse drug events (ADEs) continue to be a major source of morbidity and mortality despite advances in computerized drug safety measures. Reports on the ability of computerized ADE alerts to prevent and mitigate ADEs are lacking. The aims of this project are to 1) Assess organizational, social, and cognitive factors that affect adoption of real-time ADE alerting technology; 2) Analyze the effect of the ADE alerting technology on management and rate of ADEs; and 3) Estimate the cost-benefit of the ADE alerting technology. This study will use a patient randomized design of computerized real-time ADE alerts intended for primary and secondary prevention of ADEs. The ADE alerts promise to reduce mortality, morbidity, and costs due to ADEs. This study will quantify the effect of the alerts in the hands of first-year medical residents and pharmacists. The study will explore the associations of organizational and soci-cognitive barriers and facilitators with the adoption of the ADE alert technology. At the cognitive level, it will explore whether ADE Alerts change user bias in diagnosing ADEs or whether the alerts heighten sensitivity to drug problems.

Eligibility Criteria:
Inclusion Criteria:

- All patients admitted to the SLCVAMC at time of study.

Exclusion Criteria:

- There are no exclusions.
Comparative Measurement of Microcirculation and Other Parameters With the Vital USA VitalDetect™ in Patients With Diabetes Mellitus Type 1 and Type 2 Versus Healthy Participants

The purpose of this clinical study is to optimize the measurement algorithm of the Vital USA VitalDetectTM in measuring the microcirculating blood flow. Further optimization and finally the demonstration of the performance of the VitalDetectTM non-invasive monitoring biosensor in monitoring glucose, and heart rate in patients with type 1 and type 2 diabetes and healthy participants, when operated according to the instructions for use.

The study procedures will be the same for all three groups during the single visit. In all groups of participants, the Vital USA VitalDetect™ will be individually introduced and assigned. During the experimental study visit, microcirculating blood flow (MBF), heart rate, and SpO2 will be measured using the Vital USA VitalDetect™ at 2 time points in between approx. 15 min. MBF will be measured in parallel by use of the LEA Medizintechnik O2C also using a finger on the same hand. The YSI glucose measurements will be employed to generate a robust algorithm for glucose measurements using the VitalDetect™. Parallel measurements of the heart rate and the SpO2 using a patient monitor (Edan iM8b) will be compared to the Vital USA VitalDetect™ device readings. Venous blood will be drawn from every subject to determine proinsulin, insulin and HbA1c values.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetic or healthy subject (25 Type 1, 25 Type 2, 50 healthy subjects)
* Subjects who are able to complete informed consent form (by him/herself or by his/her guardian);
* 18 years old and above;
* Anatomically suitable finger in discretion of the investigator

Exclusion Criteria:

* Does not meet inclusion criteria;
* Any conditions that may hamper good visual contact between the finger and sensor, such as raised birthmarks, scars, tattoos;
* Pregnancy;
* Nursing mothers;
* Any skin scratch(es), damage, over dry, long nails on the measured finger;
* Unsuitable finger with the device might be excluded if recognized during the trial;
* Medication containing nitrates
Use of Harmonic in Breast Surgery

To compare harmonic scalpel with electrocautery for outcomes i.e. estimated blood loss (EBL), operating time, drain Volume and drain Days, seroma formation, surgical site infection and postoperative pain in adult females undergoing MRM at a tertiary care hospital. We hypothesized that harmonic yields better outcome than electrocautery dissection.

In this randomized controlled trial, adult females who underwent MRM between April 2010 and July 2011 were randomized to receive either intervention A (harmonic scalpel) or B (electrocautery). The procedure was standardized except elevation of flaps and axillary dissection, that was performed as per randomization. Patients were followed up in clinic for four weeks. The outcomes were estimated blood loss (EBL), operating time, drain Volume and drain Days, complications (seroma, surgical site infection, hematoma and flap necrosis) and postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Adult females with biopsy proven breast cancer underwent MRM

Exclusion Criteria:

* Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)