cyrilzakka/clinical-trials huggingface dataset:
Double Sequential External Defibrillation in Patients With Atrial Fibrillation Refractory to DC Cardioversion

Atrial fibrillation (AF) is a common cardiac arrhythmia that leads to increased risk of heart failure, hospitalization, thromboembolic events, and death. Restoration of normal heart rhythm is performed in many patients with AF to improve symptoms. In this study, the investigators will consider patients who fail 2 or more trials of DC cardioversion as having refractory AF.

The aim of this study is to assess whether the use of double sequential defibrillation in patients with refractory AF has a higher success rate in reverting them to a normal heart rhythm than a third cardioversion.

This is a phase III, randomized controlled, single-centered, superiority trial. All patients with AF admitted to the coronary care unit (CCU) for DC cardioversion, and refractory to at least two trials of DC cardioversion will be enrolled. Patients are randomized into two arms: the first will receive a third trial of DC cardioversion (standard of care) and the second will receive double sequential external defibrillation.

The resolution of AF by reverting back to normal sinus rhythm is the primary outcome of the investigators. This will be determined using EKG (electrocardiogram) immediately after DC cardioversion or double sequential defibrillation.

Patients presenting to the CCU with persistent AF for direct current (DC) cardioversion, who meet the inclusion criteria and fail to revert to normal sinus rhythm after two DC cardioversion attempts will be invited for enrollment in the study. No sampling will be carried out for the sake of this study.

Patients meeting the eligibility criteria will receive double sequential external defibrillation (DSED) or a third DC cardioversion (standard of care).

DSED is the process of using two defibrillators near simultaneously at their highest allowed energy setting and aims to treat refractory atrial fibrillation. The first set of pads is placed in the traditional anterolateral position and the second set can be either placed adjacent to the first set (antero-lateral) or in the antero-posterior position. Shocks are then delivered simultaneously or near simultaneously.

Eligibility Criteria:
Inclusion Criteria:

- Atrial Fibrillation patients admitted to the CCU for DC cardioversion, and refractory to at least two trials of DC cardioversion

Exclusion Criteria:

* Patients with Atrial Fibrillation not requiring DC cardioversion
* Patients with Atrial Fibrillation who reverted after a maximum of two trials of DC cardioversion
Effectiveness of WhatsApp (a Messenger Program) Usage in Emergency Department (ED)

Effective communication between consulting physicians and the emergency physicians is critical for patients in the emergency department. The aim of this study was to determinate effectiveness of whatsApp usage for communication between physicians.

Effective communication between consulting physicians and the emergency physicians is critical for patients in the emergency department. Many hospitals still use outdated pager systems as the foundation for clinical communication between physicians and other health care professionals. But, outdated pager systems contain some problems including long waiting-times for the return of a page, high costs, frequent interruptions, and the inability to identify the location or identity of the caller. This outdated communication technologies in healthcare can place patient safety at risk. Therefore they are no longer seen as an effective communication tool given the obvious advantages of Smart phones. WhatsApp Messenger, which is a messaging program for smart phones, is the most commonly used for communication in at present. As of September 2015, WhatsApp incorporated announced more than 900 million users. This is making it the most globally popular messaging application. WhatsApp Messenger have been started to be used for communication in healthcare. So, this study aims to trial the effect of whatsApp usage for communication between physicians.

Study Design and Setting: A prospective, randomized, double-blind, controlled, single-center, clinical trial was conducted in ED of a tertiary care university hospital with an annual census of approximately 200,000 visits.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients who performed consultation in emergency department.
2. Patients who are consulted to a physician using whatsApp on a regular basis and who is chosen by an assistant blinded to the study.

Exclusion Criteria:

1. Patients below 18 years of age
2. Missing emergency service consultations
3. Patients with more than one consultation call
4. Consultations which do not determined the arrival duration to emergency service
A Study to Investigate the Effect of MCE on Glucose and Insulin Responses in Healthy Males

Maize Cob Extract (MCE) is intended to be used as a bulking agent in food. The purpose of this study is to determine the glycaemic and insulinemic response of MCE consumed in isolation compared to glucose; the glycaemic and insulinemic response will also be determined for MCE alone and in combination with glucose. This is a randomised, double-blind, single-centre trial in 10 healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* Be able to give written informed consent;
* Be between 18 and 60 years of age inclusive;
* Have a body mass index \<30 Kg/m2;
* Have a fasting glucose level of ≤6.0 mmol/L
* Be in general good health, as determined by the investigator;
* Be willing to fast for at least 10 hours before the study visit.

Exclusion Criteria:

* The presence of any of the following criteria will exclude the participant from participating in the study:
* Are less than 18 or greater than 60 years of age;
* Recent gastroenteritis or food borne illness such as confirmed food poisoning within the past 4 weeks;
* Have taken a medication or dietary supplement that may influence GI activity within the 2-weeks prior to screening;
* Have a history of abdominal surgery (excluding appendectomy);
* Have taken anaesthesia within the past 4 weeks;
* Have taken antibiotics within the past 12-weeks;
* Have a recent history of drug and/or alcohol abuse at the time of enrolment;
* Are a smoker (defined as \>5 cigarettes/week);
* Have made any major dietary change in the past 3 months;
* Have planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
* Have an active gastrointestinal disorder or previous gastrointestinal surgery;
* Have irritable bowel syndrome, diagnosed or undiagnosed and treated with chronic medications;
* Have a metabolic or endocrine disorder such as diabetes, thyroidism, or other metabolic disorder;
* Have a severe chronic disease i.e. cancer, renal failure, hepatitis, HIV, cirrhosis etc., or with a history of such diseases;
* Have a gastrointestinal disease i.e., chronic diarrhoea, Crohn's disease, ulcerative colitis, diverticulosis, stomach or duodenal ulcers, or with a history of such diseases;
* Are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a systemic steroid for \>30 days, or chemotherapy or radiotherapy within the last year);
* Experiences alarm features such as weight loss, rectal bleeding, recent change in bowel habit (\<3 months) or abdominal pain;
* Participants who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial;
* Participant is currently receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study
Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis

The purpose of this study is to compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on hemodialysis.

The immune response of HEPLISAV compared with Engerix-B and Fendrix and measured by seroprotection rate (SPR) at 4 weeks after the booster injection

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Has loss of renal function and is receiving hemodialysis treatments
* Is not seroprotected against hepatitis B (has anti-HBs \< 10 mIU/mL)
* In the opinion of the investigator, is clinically stable
* Be serum negative for HBsAg, anti-hepatitis B core antigen (HBc), hepatitis C virus (HCV), and HIV
* Is not scheduled to undergo a kidney transplant during the study period
* If female, and of childbearing potential, subject must be: surgically sterile or neither pregnant nor breast-feeding, consistently using a highly effective method of birth control for at least one month prior to study entry, and agrees to use two forms of birth control consistently throughout the study.

Exclusion Criteria:

* If female, is pregnant, breastfeeding, or planning a pregnancy;
* Has a history of or is at high risk for recent exposure to HBV, HCV, or HIV;
* Has known history of autoimmune disease;
* Has history of sensitivity to any component of study vaccines;
* Has a current condition other than renal disease or has substance or alcohol abuse that would interfere with compliance or with interpretation of the study results;
* Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin;
* Has uncontrolled diabetes;
* Has received a kidney transplant previously that is still functioning and requires anti-rejection medication;
* Has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period;
* Has received the following prior to the study injection: 3 days: intravenous iron; 21 days: any inactivated virus or bacterial vaccine; 28 days: any live virus or bacterial vaccine; systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids; granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF); any other investigational medicinal agent;
* At any time: an injection of deoxyribonucleic acid (DNA) plasmids or oligonucleotides; investigational or intradermal hepatitis B vaccine.
Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia

Safety and efficacy of direct thrombin inhibitors versus enoxaparin in patients with staphylococcus aureus bacteraemia.

The study hypothesizes that inhibition of the coagulase-activity of S. aureus by direct thrombin inhibitors is safe and translates into a better outcome of patients with S. aureus bacteremia.

Single center randomized controlled trial of direct thrombin inhibitors versus standard enoxaparin.

* Feasibility: proportion of patients eligible for randomization; clinically attained concentration of DTI and resulting staphylothrombin inhibition
* Safety: bleeding events (major/ clinically relevant non-major)
* Efficacy: thrombotic events during the thromboprophylactic treatment + 3 days
* Secondary outcome measures

  * Coagulation parameters: evolution of D-dimers from day 0-4; other lab parameters of coagulation (PT/APTT/fibrinogen/platelet count)
  * Inflammatory parameters: CRP, white blood cell count, neutrophilia
  * Clinical outcomes: metastatic infections, assessed clinically or by PET/CT; relapse of S. aureus bacteremia; defervescence; persistent positive blood cultures; hospital stay, mortality.

Eligibility Criteria:
Inclusion Criteria:

* Positive blood culture for staphylococcus aureus
* Symptoms or signs of infection
* Indication for thromboprophylaxis

Exclusion Criteria:

* Contraindication for thromboprophylaxis
* Significant active bleeding or risk of excessive bleeding
* Heparin-induced thrombocytopenia
* Severe liver and kidney disease
* Pregnancy and lactation.
Estramustine, Docetaxel and Zoledronate Treatment in Hormone-Refractory Adenocarcinoma of the Prostate

Purpose: The aim of this clinical trail is to evaluate the effectiveness of Zoledronate (Zometa) combined with Estramustine and Docetaxel (Taxotere) in the treatment of patients with hormone-refractory prostate cancer.

Hormone refractory prostate cancer refers to advanced disease in which the patient no longer responds to conventional hormonal treatment. When hormone therapy is no longer successful, chemotherapy is a treatment option. However, current single-agent treatment has shown to have limited benefit. In this clinical trail, investigators are evaluating the effectiveness of Zoledronate(Zometa) combined with Estramustine and Docetaxel (Taxotere) in the treatment of patients with hormone refractory prostate cancer. Zometa is a bisphosphonate, and may reduce or delay skeletal complications caused by bone metastases. Estramustine and Taxotere are chemotherapy drugs that have shown activity in hormone refractory prostate cancer. Eligible patients will be randomized to receive Estramustine and Docetaxel (Taxotere) in combination with Zometa or Zometa given alone.

Eligibility Criteria:
All patients must have a histologic diagnosis of hormone-refractory adenocarcinoma of the prostate, and hormone refractory disease must be demonstrated by the appearance of new lesions on bone or CT scan and/or a rising PSA value. (No evidence of brain metastasis or untreated spinal cord compression.)

Patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen withdrawal and demonstrate a rising PSA 4 weeks after withdrawal from flutamide and 6 weeks after withdrawal from bicalutamide.

Patient must not be undergoing current chemotherapy, biologic therapy, other investigational or alternative anti-cancer directed therapy or radiation therapy.

Prior radiation therapy must have completed more than 4 weeks prior to registration.

Patients may not have received prior taxane-based cytotoxic chemotherapy for hormone refractory disease.
QLB and Radical Cystectomy, Postoperative Pain

There are ca 1000 new cases of bladder cancer in Finland/year. The curative therapy for high risk bladder cancer is radical cystectomy. The golden standard is still an open surgery despite development of laparoscopic techniques. Epidural analgesia is considered as most effective for the treatment of postoperative pain. However, there is a need for other effective options, because epidural analgesia has some contraindications and risks for serious complications. Recently quadratus lumborum block has gained popularity in the treatment of postoperative pain after various surgeries in the area from hip to mamilla. It is more beneficial than other peripheral blocks, since it covers also the visceral nerves. Contrary to the need of epidural catether a single shot QLB has reported to last up to 48 hours.

Inadequately treated acute postoperative pain is considered as one of the main risk factors for persistent postoperative pain.

44 patients aging 18-85 will be recruited based on a power calculation. The primary outcome measure is the acute postoperative need for rescue analgesics. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of life and persistent pain.

44 patients, uindergoing radical cystectomy, aging 18-85 will be recruited based on a power calculation. The 44 patients will be divided in 2 groups, the intervention group receiving a quadratus lumborum block (75mg ropivacaine) and the no intervention group receiving the current standard care of our hospital -an epidural.

The primary outcome measure is the acute postoperative need for rescue analgesics. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of life and persistent pain.

Eligibility Criteria:
Inclusion Criteria:

* patients with bladder cancer coming to the open radical cystectomy.

Exclusion Criteria:

* age under 18y or over 85y,
* diabetes type 1 with complications,
* no co-operation or inadequate finnish language,
* persistent pain for other reason.
Distal Femur Fx: ORIF(Open Reduction and Internal Fixation) vs DFR (Distal Femur Replacement Total Knee Arthroplasty)

Supracondylar femur periprosthetic fractures about a total knee arthroplasty (TKA) are a catastrophic and challenging complication of TKA and unfortunately are increasing in incidence. Fixation of these fractures can be challenging due to altered anatomy for the TKA and the presence of the metallic femoral component and have a relatively high complication rate. As a result, some surgeons elect to treat these fractures with a distal femur replacement total knee arthroplasty (DFR). The purpose of this study is to prospectively evaluate periprosthetic femur fractures treated with ORIF or DFR and compare various outcomes measures (Get up and go times, KOOS Jr score)

Supracondylar femur periprosthetic fractures about a total knee arthroplasty (TKA) are a catastrophic and challenging complication of TKA and unfortunately are increasing in incidence. Fixation of these fractures can be challenging due to altered anatomy for the TKA and the presence of the metallic femoral component and have a relatively high complication rate. As a result, some surgeons elect to treat these fractures with a distal femur replacement total knee arthroplasty (DFR). Several small retrospective studies have compared outcomes with mixed results. To the authors' knowledge there are no prospective studies evaluating the outcomes after treatment of periprosthetic distal femur fractures. The purpose of this study is to prospectively evaluate periprosthetic femur fractures treated with ORIF or DFR and compare various outcomes measures (Get up and go times, KOOS Jr score).

Eligibility Criteria:
Inclusion Criteria:

* English speaking patients
* 55 years or older with Su Type II or Su Type II periprosthetic femur fractures requiring surgical intervention and are medically fit to undergo surgical intervention

Exclusion Criteria:

* Patients with an active total knee prosthetic infection
* Patients unable to undergo surgical intervention
* Patient with an open fracture
* Non-English-speaking patients
* Oncologic/pathologic fracture
* Poly-trauma patient (or other associated major orthopaedic injuries)
Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face

Interventional, monocentric, national, single-arm, uncontrolled, open, prospective phase IV study. Since this study is not powered for confirmative testing, analysis is done by descriptive statistics Eligible AK patients receive Tirbanibulin on sun-damaged areas of the face for five days, according to the SmPC. Diagnosis and monitoring of treatment effects are supported by UV imaging using Canfield VISIA®. Safety and efficacy are assessed at end of treatment visit (EoT, approximately 3 days after the last dose, i.e, day 8 ± 2) and at a follow-up visit (FuV) 57 ± 7 d after the start of the treatment. UV images (Canfield VISIA®) will be taken at baseline, EoT and FuV, accompanied by conventional dermatological assessment according to clinical routine.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Diagnosed with sun-damaged skin on the face and AK in the treatment area
* Willing and able to comply with all study procedures
* Use of medically acceptable contraception in males or females of child-bearing potential
* 51 -100 years of age
* Negative pregnancy test at baseline in females of childbearing potential

Exclusion Criteria:

* Allergy or intolerance towards the active ingredient or any of the constituents of the IMP
* Any contraindication for the IMP, according to the most recent version of the SmPC
* Open lesions of any kind on the face
* Concomitant cutaneous malignancy in treatment area, including but not restricted to squamous skin cancer
* Immune deficiency
* Participation in another clinical trial during the last six months
* Pregnancy or lactation
Evaluation of the Application of PEGylated Recombinant Human Granulocyte Stimulating Factor Injection (PEG-rhG-CSF) in Chemotherapy of Elderly Lymphoma Patients

A multicenter, open, one-arm clinical study evaluated the efficacy and safety of Jinyouli in preventing neutropenia after chemotherapy in elderly lymphoma patients who met the criteria for admission. Chemotherapy regimen: The investigator selected according to the specific condition the corresponding standard chemotherapy regimen, the chemotherapy regimen used, FN risk ≥ 20%, or 10% \< FN risk \< 20% with at least one high risk factor for FN, from the first cycle of chemotherapy, 24-72 after chemotherapy hour subcutaneous injection of Jinyouli.


Eligibility Criteria:
Inclusion Criteria:

* (1) Age ≥ 65 years, gender is not limited;
* (2) Patients with lymphoma diagnosed by histopathology or cytology;
* (3) Patients requiring multi-cycle chemotherapy;
* (4) Planned chemotherapy regimen FN risk ≥ 20 % (see Annex I), or 10% \<FN risk \< 20% (see Annex II) with high risk factors for at least one FN;
* (5) Physical status (KPS) score ≥ 70 points;
* (6) Expected Survival period of more than 3 months;
* (7) normal bone marrow hematopoietic function (ANC ≥1.5×109/L, PLT≥100×109/L, Hb≥80g/L, WBC≥3.0×109/L);
* (8) The testers (or their legal representatives/guardians) must sign an informed consent form.

Exclusion Criteria:

* (1) Lymphoma central involvement;
* (2) Hematopoietic stem cell transplantation or organ transplantation;
* (3) Insufficient local or systemic infection;
* (4) Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
* (5) Liver function tests total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are \>2.5 times the upper limit of normal, if the above indicators are \>5 times due to liver metastasis Upper limit of normal value; renal function test: serum creatinine (Cr) \> 2 times the upper limit of normal;
* (6) allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
* (7) Severe mental illness, affecting informed consent and/or adverse reaction expression or observation;
* (8) The investigator judges patients who are not suitable for participation.