cyrilzakka/clinical-trials huggingface dataset:
The Nordic Aortic Valve Intervention Trial 4 (NOTION-4)

A randomized clinical trial investigating the incidence and temporal dynamics of subclinical leaflet thickening by cardiac CT in transcatheter bioprosthetic aortic valves in patients randomised to different anti-thrombotic strategies. Additionally, this study aims to examine a possible association between HALT and thromboembolic events.

The NOTION-4 trial is an investigator-initiated, randomized, open label, comparative trial conducted at Rigshospitalet in Copenhagen and Skejby Sygehus in Aarhus. All adult patients that have undergone successful TAVI without contraindications for cardiac CT will be invited to participate in this study. Patients with SR and without known other indication for chronic OAC therapy will be randomized 1:1 either to lifelong ASA or to 3 months of DOAC followed by lifelong ASA. Patients with known AF will be randomized 1:1 to lifelong DOAC versus LAAC within 3 months followed by lifelong ASA.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent successful TAVI according to Valve Academic Research Consortium (VARC)-2 criteria
* Residing in Denmark
* Provided written informed consent

Exclusion Criteria:

* Atrial fibrillation or any other indication for lifelong oral anticoagulant therapy
* Patient deemed not suitable for DOAC treatment because of previous life-threatening or major bleeding, e.g. intracranial haemorrhage or major gastrointestinal bleeding
* Patients with severe renal insufficiency (eGFR \<30 mL/min/1.73 m2)
* Patient with absolute indication for anti-thrombotic therapy, e.g. recent PCI
* Iodine contrast allergy or other condition that prohibits CT imaging
* Age \<18 years
* Women of childbearing potential, pregnant or nursing
Effect of Direct-acting Antiviral Drugs on Erectile Function

Effect of direct-acting antiviral drugs on erectile function

Effect of direct-acting antiviral drugs on erectile function in HCV patients

Eligibility Criteria:
Inclusion Criteria:

* HCV infected patients
* Male

Exclusion Criteria:

* HCC
* Age below 18 years
Safety and Efficacy of CC-10004 for Prurigo Nodularis

This trial will include:

* Study period up to 7 months.
* Office visits monthly lasting approximately 1 hour.
* Blood Draws.
* Oral medication that is taken 2 times daily.
* Photographs and biopsies if agreed.


Eligibility Criteria:
Inclusion Criteria:

* Must understand and voluntarily sign an informed consent form
* Must be male or female and aged ≥ 18 years at time of consent
* Must be able to adhere to the study visit schedule and other protocol requirements
* Must have a diagnosis of prurigo nodularis based on clinical and histological findings and have failed four weeks of treatment with topical therapies, including corticosteroids and/or vitamin D derivatives.
* Must meet the following laboratory criteria:

  * Hemoglobin WNL
  * Hematocrit WNL
  * White blood cell (WBC) count WNL
  * Neutrophils ≥ 1500 /dL
  * Platelets ≥ 100,000 /dL
  * Serum creatinine ≤ 1.5 mg/dL
  * Total bilirubin 2.0 mg/dL
  * Aspartate transaminase (AST \[serum glutamic oxaloacetic transaminase, SGOT\]) and alanine transaminase (ALT \[serum glutamate pyruvic transaminase, SGPT\]) 1.5x upper limit of normal (ULN)
* Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit Must have a negative purified protein derivative (PPD) within 28 days of the baseline visit.
* Must have a negative purified protein derivative (PPD) within 28 days of the baseline visit.

Exclusion Criteria:

* History of cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant by the investigator
* Any systemic treatment (including ultraviolet light, corticosteroids, thalidomide, azathioprine, cyclosporine) within 28 days of study drug administration.
* Any topical treatments (including corticosteroids, vitamin D derivatives) within 14 days of study drug initiation.
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
* Pregnant or lactating female.
Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205

Participants that were assigned to the oral etoposide treatment arm in protocol OSI-774-205 and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide were allowed to participate in this study to assess the safety profile of single-agent erlotinib in participants with recurrent or refractory pediatric ependymoma.

The protocol-specified futility criteria were met at the second interim analysis dated 15 Aug 2012 for OSI-774-205. Per the Data Monitoring Committee's recommendation and FDA's agreement, the enrollment of patients in that study and Study OSI-774-206 was permanently closed.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have been enrolled in OSI-774-205, been randomized to oral etoposide and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide
* Performance status: Lansky ≥ 50% for patients ≤ 10 years of age or younger or Karnofsky ≥ 50% for patients greater than 10 years of age
* Patients must have recovered from any acute toxicity to any prior anti-cancer treatment
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, serum glutamic pyruvic transaminase (SGPT) ALT ≤ 3 x ULN
* Serum creatinine based on age OR Creatinine Clearance/Glomerular Filtration Rate (GFR) ≥ 70 mL/min/m2
* Patients must be neurologically stable for at least 7 days before registration
* Patients, both males and females, with reproductive potential must agree to practice effective contraceptive measures for the duration of study drug therapy and for at least 90 days after completion of study drug therapy
* Patients must be able to take erlotinib orally

Exclusion Criteria:

* Taking strong/moderate CYP3A4 or CYP1A2 inhibitors/inducers ≤ 14 days before registration
* Have received any other chemotherapy or immunotherapy to treat ependymoma after discontinuation from OSI-774-205
* Taking proton pump inhibitors ≤ 14 days before registration
* Participating in another investigational drug trial while on study
* Pregnant or breast-feeding
Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia

Primary objective :

* To explore the relation between 3 doses of GRASPA and duration of asparagine depletion (\< 2µmol/l)

Secondary objective :

* Pharmacokinetic / Pharmacodynamic parameters
* toxicity
* Study duration : 2 years
* Study treatment : Red blood cells loaded with L asparaginase versus native L asparaginase
* Associated treatments : COPRALL chemotherapy
* Randomization : centralised randomisation on scratching list


Eligibility Criteria:
Inclusion Criteria:

* Subject between 1 and 55 year old
* Subject with acute lymphoblastic leukaemia or lymphoblastic lymphoma (excluded burkitt lymphoma) who have relapsed after first remission (medullary or SNC relapse)
* Or patient who still refractory to first line chemotherapy for an ALL
* Patient who gave written informed consent (2 parents for children)

Exclusion Criteria:
An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi

A couples-based alcohol-reduction and economic and relationship-strengthening intervention for HIV-affected couples in Malawi.

This project aims to develop and pilot test a combined economic and relationship-strengthening intervention to redirect funds spent on alcohol into financial investments (e.g., education, income-generating business) and to improve couple relationships and adherence to ART. The study hypothesizes that engaging couples to work together on alcohol use and financial goals-equipped with financial, communication, and problem-solving skills-will decrease alcohol use, and improve relationship dynamics and adherence to ART. Specifically, the project aims: (1) to adapt and integrate two proven interventions, Suubi and Uthando Lwethu, using the ADAPT-ITT method, into a combined intervention for HIV-affected couples with a heavy alcohol user (to be called Mlambe); (2) to develop and pilot test the study procedures to evaluate Mlambe; and (3) to assess the feasibility and acceptability of Mlambe through a pilot study. In the formative phase, the study will develop a draft of the intervention manual and conduct five focus group discussions with couples and key stakeholders to obtain input on the intervention. In the pilot phase, 80 HIV-affected couples with a heavy alcohol user will be enrolled and randomized to either Mlambe or the comparison arm (regular HIV care plus brief advice on alcohol use). The study will conduct qualitative interviews with a subset of 20 couples to contextualize feasibility and acceptability data, and then will analyze the mixed- methods feasibility and acceptability data to refine intervention and procedures for a future trial.

Eligibility Criteria:
Inclusion Criteria:

* in a married or cohabitating union
* have at least one partner with a positive AUDIT-C screen in prior 3 months who is also currently on ART for at least 6 months who has disclosed their HIV status to their partner

Exclusion Criteria:

* severe intimate partner violence reported in previous 3 months and/or fear that safety would be at risk by participation in the study (reported at screening)
PREhospital Routage of Acute STroke Patients With Suspected Large Vessel Occlusion: Mothership Versus Drip and Ship

Background: The outcome of ischemic stroke is related to the brain lesion volume and this volume of infarction is directly related to the time to reperfusion, which therefore depends on the time to initiation of therapy. Acute ischemic stroke is treated medically with the administration of intravenous rtPA, but recent randomized controlled trials have shown the efficacy of mechanical thrombectomy and is now the new gold standard in ischemic stroke. This new therapeutic strategy has created two possibilities for pre-hospital decision-making: i/ transport the patient directly to the nearest stroke unit to receive alteplase and then if indicated perform a thrombectomy (drip and ship) or ii/ bypassing thrombolysis centres in favour of endovascular thrombectomy (mothership).

Objective: To compare cost/effectiveness of transfer to the closest local stroke centre or telemedicine hub to direct transfer to the comprehensive stroke cent(CSC) in patients acute stroke with suspected large vessel occlusion.

Medical and economic expected impact: We hypothesize that direct transportation to CSC is associated with better clinical outcome in case of acute ischaemic stroke due to intracranial large vessel occlusion. However, we have to demonstrate that this approach is not associated with time from onset harm in patients not eligible to mechanical thrombectomy.

Design: Multicenter, two-arm, prospective, open, blinded end-point (PROBE), randomized, clinical trial

Primary endpoint: Incremental cost-utility ratio at 12 months. Secondary endpoints: modified Rankin scale and EuroQoL5D scale at 3 months.

Eligibility criteria: A call to the emergency medical assistance service, 18 years and older, severe acute stroke symptoms, transportation time from scene to the CSC longer than time to go to the nearest stroke unit or telemedicine hub, transportation time from scene to the CSC compatible with IV thrombolysis, known time from onset, RACE score (assessed by medical emergency technicians) ≥5.

Experimental arm: direct transportation to the CSC. Control arm: transfer to the closest local stroke centre or telemedicine hub.

Sample size: 800 patients, 400 for each arm.

Eligibility Criteria:
Inclusion Criteria:

* A call to the emergency medical assistance service;
* age\> 18y,
* known time of stroke onset;
* transportation time from scene to the CSC longer than time to go to the nearest stroke unit or telemedicine hub;
* transportation time from scene to the CSC compatible with IV thrombolysis;
* known time from onset, RACE score ≥5.

Exclusion Criteria:

* transportation time from scene to the CSC longer than time to go to the nearest stroke unit or telemedicine hub.
* no ambulance available
* bedridden patient
Analysis of Human to Human Transmission of Middle East Respiratory Syndrom Coronavirus (MER-CoV)

This study aimed to analysis the characteristics of MERS transmission and the effect of our institutional personal protective equipment on the controlling the MERS at a tertiary Korean Hospital.

Between May 2015 and Nov 2015, total 186 cases of MERS-Cov infections were reported in South Korea. In June 2015, a female patient visited our emergency department (ED) for care of femur fracture. She was suspected of having MERS-Cov and isolated after 10 hours from the visit of our hospital because her clinical feature was not concordance with typical MERS-Cov infection and she denied the any contact of MERS-Cov patient. Before the transport to the isolation room, she stayed at ED during 8 hours, and admitted the general ward during 2 hours. Approximately 150 including the healthcare providers, patients and laypersons were exposed to the case-patient directly or indirectly. The investigators monitored all possible contacts in the hospital during that time, and analysed the CCTV data of hospital and interviewed all risk-persons. After the hospital outbreak ended, The investigators analysed the data of all behavior and contact history of MERS patient, epidermic and clinical data of infected patients and data of personal protective equipments (PPE) of all exposed persons.

Descriptive analysis were conducted for basic epidemiology, transmission rout of MERS in hospital, and the effect of hospital infection control system and PPE of each contacts.

Eligibility Criteria:
Inclusion Criteria:

* All aged persons who have risk of MERS transmission from a case-patients

Exclusion Criteria:

* No risk of transmission
Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 2-month-old infants.
* Available for the entire study period.

Exclusion criteria:

* Previous vaccination with any vaccine before the start of the study.
* Known contraindication to vaccination.
Comparison Between CHF5993 pMDI 200/6/12.5 µg HFA-152a VS CHF5993 pMDI 200/6/12.5 µg HFA-134a in Subjects With Asthma (TRECOS).

The CLI-05993AB6-03 Study is an interventional study designed to investigate the safety and efficacy of a new low global warming potential propellant (HFA-152a) compared to the currently approved one (HFA-134a) in the medication (CHF5993) in patients with moderate to severe asthma

Outpatients attending the hospital clinics/study centers will be recruited. Moderate to severe controlled asthma adult subjects will be recruited. A total of 513 subjects will be randomised. The whole study will last approximately 16 weeks for each subject.

Eligibility Criteria:
Inclusion Criteria:

* Subject's written informed consent obtained prior to any study related procedure;
* Male and female adults aged ≥ 18 and ≤ 75;
* Body mass index (BMI) within the range of 18.0 to 35.0 kg/m2 inclusive;
* Non-smokers or ex-smokers who smoked \< 10 pack-years (pack-years = the number of cigarette packs per day x the number of years) and stopped smoking \> 1 year (6 months for e-cigarettes) prior to screening;
* Diagnosis of asthma: physician-diagnosed asthma for at least
* 6 months and with diagnosis before the age of 50 years;
* Stable asthma therapy: a stable treatment with medium/high doses of inhaled corticosteroids (ICS) + long-acting β-agonist (LABA) + long-acting muscarinic antagonist (LAMA) (fixed or free combination) or medium/high doses of ICS+LABA (fixed or free combination) for at least 4 weeks before screening (medium and high-dose ICS defined as BDP non-extrafine \> 500-1000 μg and \> 1000 μg respectively, or estimated clinical comparable dose).
* Subjects must have a cooperative attitude and the ability to be trained to use correctly the pMDI inhalers and e-Diary, to be able to read/write, to be able to perform the required outcomes measurements (e.g., technically acceptable spirometry, e-Diary completion) and the ability to understand the risks involved.

Exclusion Criteria:

* History of near fatal asthma, hospitalisation for asthma in intensive care unit which in the judgement of the Investigator may place the subject at undue risk, emergency room access for asthma in the previous 6 months before enrolment;
* Asthma exacerbation requiring systemic corticosteroids (SCS) or emergency room admission or hospitalisation within 4 weeks prior to study entry and/or during the run-in period (to be checked again prior to randomisation);
* Non-permanent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medecine
Z-plasty and Heineke-Mikulicz Scrotoplasty in the Management of Penoscrotal Web

The goal of this clinical trial is to compare the surgical outcome of Z-scrotoplasty versus Heineke-Mikulicz scrotoplasty in the management of congenital penoscrotal web in pediatric age group.

The main question\[s\] it aims to answer are:

• Question 1: Is there a difference in the surgical outcome between using Z-scrotoplasty and Heinke Miculickz scrotoplasty in the management of congenital penoscrotal web?\] Participants will be divided into two groups; Group A treated by Z-scrotoplasty and Group B treated by Heineke Miculickz scrotoplasty.

Background: The penoscrotal web may be congenital or acquired after excessive removal of ventral skin during circumcision. There are several previously described surgical techniques for the treatment of congenital webbed penis without a clear comparison between their outcomes. Purpose: the objective of our study was to compare the surgical results of Z-scrotoplasty and Heineke-Mikulicz scrotoplasty in the treatment of congenital webbed penis. Patients \& Methods: Our prospective study included 40 uncircumcised patients presented with a webbed penis. They were divided into group A which was treated by Z-scrotoplasty and group B which was treated by Heineke-Mikulicz scrotoplasty.

Eligibility Criteria:
Inclusion Criteria:

* Patients with congenital penoscrotal web in the pediatric age group

Exclusion Criteria:

* Patients with any penile anomalies
Effect of Midazolam Premedication on Opioid-induced Mask Ventilation Difficulty

Mask ventilation has great importance during anesthesia induction because it is the only way to oxygenate patients who have lost consciousness and spontaneous breathing. Opioid-derived drugs used in anesthesia induction may cause difficulty in mask ventilation due to their chest wall rigidity and respiratory depressant effects. Adequate muscle relaxation and depth of anesthesia may assist with mask ventilation. It is known that premedication reduces anxiety and has a relaxing effect on airway muscles. Midazolam is frequently used in premedication because it has a rapid onset of action and does not cause hemodynamic changes. In addition, midazolam may relax the airway by acting directly on the airway smooth muscle and thus facilitate mask ventilation during anesthesia induction. In this study, the investigators will evaluate the effect of midazolam premedication on the mask ventilation after induction with remifentanil.

American Society of Anesthesiologists (ASA) class I and II patients who are admitted to undergoing elective surgery under general anesthesia will be enrolled. Patients in midazolam group (Group M) will be treated with midazolam premedication (3 cc mixture of 0.035 mg/kg midazolam and normal saline; maximum midazolam dose, 3 mg) intravenously in a waiting area 3 minutes before transportation to an operating room, while 3 cc normal saline will be administered to control group (Group S) patients. The difficulty of mask ventilation will be evaluated before the injection of neuromuscular blocking during general anesthetic induction. The anxiety and sedation levels of patients will be estimated before the intervention and before anesthetic induction in an operating room. Remifentanil will be used as an opioid in the induction of the patients. In anesthesia induction, propofol 1.5 mg/kg will be given after remifentanil is infused at a dose of 0.30 µg/kg/min for three minutes. Before the patients were given muscle relaxants, the patients were evaluated with the Warter scale

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) class I and II patients
* Patients who are scheduled for any elective surgery under general anesthesia

Exclusion Criteria:

* age \<18 or \>60 years
* current cervical spine disease or history of cervical spine surgery;
* morbid obesity (body mass index, ≥35 kg/m2);
* sleep apnea;
* craniofacial anomaly;
* allergic reaction to midazolam and remifentanil
* chronic use of opioid, benzodiazepine, antipsychotic medications
* pregnancy
* presence of muscle weakness or dyspnea
Lower Silesian Orbital Atherectomy Registry (LOAR)

The Lower Silesian Orbital Atherectomy Registry (LOAR), is an observational registry collecting all consecutive cases of percutaneous coronary intervention (PCI) performed with the support of the Orbital Atherectomy Device due to the presence of calcified lesion in coronary arteries. Data will be collected in two cooperating cardiac centers (Department of Cardiology, The Copper Health Center, Lubin, Poland, and Department of Cardiology, Provincial Specialized Hospital in Legnica, Poland).

The study population consisted of all consecutive patients with severely calcified coronary lesions undergoing percutaneous coronary intervention (PCI) with the Orbital Atherectomy Device at two cooperating cardiac centers (Department of Cardiology, The Copper Health Center, Lubin, Poland, and Department of Cardiology, Provincial Specialized Hospital in Legnica, Poland). All study patients had a clinical indication for PCI based on current European Society of Cardiology (ESC) revascularization guidelines, with local heart team support where appropriate.

The decision to perform OA-assisted PCI was left to the discretion of the operator, based on clinical and angiographic features with a concomitant assessment of calcification. Only patients with moderate or severe calcification were enrolled. Calcification severity was defined either by angiographic assessment or by intravascular assessment using intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT). All patients were thoroughly informed about all therapeutic options and PCI-related risks before giving written consent.

Eligibility Criteria:
Inclusion Criteria:

* The presence of moderately to severely calcified lesions.

Exclusion Criteria:

* Lack of patient consent
* Target vessel perforation due to previous unsuccessful lesion preparation
* Pregnancy