cyrilzakka/clinical-trials huggingface dataset:
Early Versus Delayed Timing of Intervention in Patients With Acute Coronary Syndromes

The timing of intervention study is a prospective, randomized, international, multicentre comparison of the relative efficacy, safety, and cost effectiveness of a management strategy of coronary angiography and intervention performed within 24 hours of randomization versus delayed coronary angiography and intervention in patients after 36 hours with acute coronary syndromes (ACS).


Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting or admitted to hospital with symptoms suspected to represent an acute coronary syndrome (unstable angina or MI without persistent ST elevation) i.e., clinical history consistent with new onset, or a worsening pattern, of characteristic ischemic chest pain or ischemic symptoms occurring at rest or with minimal activity (lasting longer than five minutes or requiring sublingual nitroglycerin for relief of the pain)
2. Able to randomise within 24 hours of the onset of the most recent episode of symptoms
3. At least two of the three following additional criteria:

   * Age more than or equal to 60 years
   * Troponin T or I or Creatine Kinase - Myocardial Bands (CK-MB) above the upper limit of normal for the local institution
   * ElectroCardioGram (ECG) changes compatible with ischemia (i.e., ST depression at least 1 mm in two contiguous leads or T wave inversion mroe than 3 mm or any dynamic ST shift or transient ST elevation)
4. Written informed consent dated and signed

Exclusion Criteria:

1. Age less than 21 years
2. Not a suitable candidate for revascularisation
3. Co-morbid condition with life expectancy less than six months
Multicentric Study Comparing Carcinological and Functional Results of Surgery

National multicentric prospective open study, comparing two current surgical methods: laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.

The aim of this study is to show that radical prostatectomy by laparoscopic way could obtain carcinological results not lower than theses with radical retropubic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Male, old patient of less than 70 years,
* having a prostate cancer proven histologically, requiring a radical prostatectomy.
* Clinical stage T1c and rate of PSA (with 20 ng/ml).
* Osseous scintiscanning and abdomen-pelvic scanner negative.
* Patient informed of the study and its participation.
* Patient affiliated to a social security system.

Exclusion Criteria:

* Contra-indication with the surgery or the anaesthesia.
* Antecedent of prostate resection or adenomectomy.
* Antecedent of inguinal hernia treatment.
* Antecedent of deep venous thrombosis of the lower limbs or pulmonary embolism
* Patient privatized of freedom.
Decreasing Medication Errors by Caregivers Using a Health Literacy Intervention

Giving medications to children can be confusing; studies have shown that caregivers make dosing administration errors up to 50% of the time. There are many reasons that there are so many errors, including the fact that dosing for children is based on their weight, liquid medications come in many different forms, and caregivers often give medicines using kitchen teaspoons and tablespoons. Caregivers who have difficulty reading have even more difficulty understanding medication instructions. We are developing and testing a web-based educational module to teach caregivers how to give medications. We are focusing on the pediatric emergency department because we know that this population has low literacy levels, and that many antibiotics are prescribed in this setting. We anticipate that those caregivers that view the interactive module will have increased knowledge on how to give medications once they get home.

Dosing error rates of home administration of medications to children have been reported to be as high as 50%. Contributing to this error rate are the complexity of pediatric weight-based dosing, confusing formulations of liquid medications, and a reliance on non-standardized dosing tools such as kitchen teaspoons and tablespoons to administer medications. Families with low health literacy are at particular risk for medication administration errors. Health literacy promoting interventions to improve medication administration such as dissemination of a pictogram-based medication list have been shown to work for common over-the-counter medications such as acetaminophen, but their effect on administration practices for common medications prescribed in the pediatric emergency department (PED) has not been evaluated. Of the 50,000 patients seen in the PED each year, approximately 85% of patients are discharged with a prescription for medication. This makes the PED an ideal setting to implement a health literacy intervention to reduce medication administration errors at home. The investigators are proposing to conduct a randomized controlled trial of an educational module focused on how to administer antibiotics at home and test whether there is an improvement in care practices.

Eligibility Criteria:
Inclusion Criteria:

Caregivers of:

* Patients aged 2 months to 8 years
* Patients triaged to Emergency Severity Index (ESI) level 4 or 5 in the pediatric emergency department.
* Patients with at least one prescription for a liquid, tablet or ointment antibiotic.

Exclusion Criteria:

Caregivers of:

* Patients in need of immediate care.
* Patients hospitalized.
Pilot Study of Slow Release Oral Milrinone in Patients With Advanced Heart Failure

Advanced heart failure (HF), ineffective pumping of the heart, is a common, life-threatening cardiovascular disorder, characterised by marked symptomatic limitation and frequent hospitalization. It is particularly prevalent in older individuals (up to 10% of the population) and it has become the most common cause for hospitalization in people \>65yrs. As such it is also one of the leading consumers of healthcare spending. Recurrent hospitalization is frequently due in significant part to the lack of viable therapeutic options for severe HF. During hospital admission, medications through a drip to give through a vein (intravenous therapy), is required to improve heart pumping capacity (such as milrinone).They are frequently used and in many cases prolonged treatment periods of intravenous therapy are required. In a growing number of cases, there is a need to continue this treatment at home, however this is particularly costly and often complicated by intravenous line infection. As such there is an expanding need for therapeutic options in patients with advanced HF. Over 20 years ago, studies of the potential utility of a rapid release form of oral milrinone were examined, however these studies demonstrated adverse effects due to its quick release.

This study aims to determine the safety and tolerability of slow release oral milrinone in advanced HF patients with no further clinical option and to evaluate its effects on HF status.


Eligibility Criteria:
Inclusion Criteria:

* Advanced HF (current inpatients) with no further clinical options as defined by treating cardiologist.
* NYHA III-IV
* LVEF\<35%
* Recurrent hospitalization (\>/=3 admissions in the preceding 12 months) for HF
* On optimal tolerated medical/device therapy. Stable therapy for 48hrs.
* Age 18-85 yrs
* Provide written informed consent prior to any study procedure and agree to adhere to all protocol requirements

Exclusion Criteria:

* Hypotension (BPsys\<85)
* Unstable rhythm including frequent non-sustained ventricular tachycardia or poorly controlled atrial fibrillation (ventricular rate \>100).
* Severe renal impairment Cr\>250umol/L or dialysis.
* Other life-threatening eg neoplastic, haematological, hepatic or pulmonary disease.
* Pregnancy or female with childbearing potential and inability to use contraception
Exploring Immunosuppressant Medication Adherence in Kidney Transplant Patients

To describe the beliefs, understanding and experience of immunosuppressant medication adherence in our current transplant patient population through a series of patient focus groups

The investigators want to understand more about why some of our kidney transplant patients find it difficult to take their anti-rejection medicines as intended. It is hoped that if the investigators can improve their understanding of why some patients struggle with their anti-rejection medicines, the investigators will be able to find better ways to help our transplant patients and so fewer patients may develop problems with their transplant. This study will collect qualitative data from a series of focus groups with kidney transplant recipients to explore their beliefs, understanding and experience of anti-rejection medication adherence. The focus groups will also explore the support that participants have received to help them with their medication adherence and what support they feel should be available to them and to others in the future to optimise anti-rejection medication adherence in transplant patients. Five focus groups will be undertaken. Each focus group will include six patients and will last for approximately 1.5 hours. All participants will be kidney transplant recipients transplanted and followed up at Imperial College Renal and Transplant Centre.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients transplanted and under the active follow up of ICRTC.
* Speak and understand English
* 18 years and above

Exclusion Criteria:

* Unable to speak and understand English
* Below 18 years
Comparison of SCS and PMR in Patients With Refractory Angina Pectoris

Randomised trial of Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR) in patients with Refractory Angina Pectoris.

Hypothesis: difference in exercise tolerance at 12 months between SCS and PMR

The purpose of this open, parallel, single-center prospective, randomised controlled trial is to compare two treatments: Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR) and assess their use and longer term effect in patients with Refractory Angina Pectoris.

Eligibility Criteria:
Inclusion Criteria:

* Patient limiting angina (CCS III or IV) despite maximally tolerated medical therapy
* Documented coronary artery disease (within the last 9 months prior baseline), which is unsuitable for conventional revascularisation techniques
* Patient has documented reversible ischemia on nuclear scan (Tc-99 sestamibi)
* Patient is limited in daily activities, primarily exercice capability, by their angina pain
* Age 18 or older
* Patient must understand the therapy and give informed consent
* Patient must be available for appropriate follow-up times for length of Study
* Non pregnant woman

Exclusion criteria:

* Not candidate for surgical implantation of SCS and/or not for PMR and/or unable to use SCS device appropriately for treatment
* Patient who has had one or more major cardiac events within 2 months
* Patient with myocardial wall thickness\< 8 mm in the ischaemic area to be treated as verified by echocardiography
* Patient with extensive peripheral vascular disease that precludes vascular access required for PMR
* Patient on intravenous therapy to control their symptoms
* Patient who is unlikely to survive for more than 12 months due to non cardiac condition e.g.malignancy
* patient who has other diseases that are considered of greater clinical significance than the angina pectoris that would impact the ability of the clinician to adequately assess the incremental effects of the trial treatment
* Patient with ejection fraction of less than 30 % as verified by echocardiography
* Patient with cause of angina other than coronary artery disease (e.g. syndrome "X" patient)
* Patient who are unable to perform treadmill exercice test per protocol
* Patient who was previously enrolled in this study, or is currently in another clinical study, which will interfere with this protocol
* Patient who has has SCS , a TMLR or PMR procedure in the past
* Patient with an implanted pacemaker or defibrillator
* Patient who has medical conditions which may require Magnetic resonance Imaging (MRI)
* Patient with history of dementia or other persisting mental disorders significantly interfering with ability to cooperate or comply with the requirements of the study or comprehend informed consent
* Patient with history of Alcohol og Drug abuse
Study of the Collaborative Life Skills Program

This study tests the effectiveness of a newly developed integrated school-home behavioral intervention for behaviors related to Attention Deficit Hyperactivity Disorder (ADHD). The intervention is implemented by school-based mental health professionals within school settings.


Eligibility Criteria:
Inclusion Criteria:

* Attending a participating school and in 2-5th grade
* Referral by LSP as a child with apparent ADHD-related problems
* ≥ 6 symptoms (item score ≥ 2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Child Symptom Inventory
* ≥ 3 on the Impairment Rating Scale by parent and teacher (cross-situational impairment)
* FSIQ or VIQ ≥ 80 (necessary for cognitive demands of the child skills curriculum)
* Caretaker consents to participate in treatment, child assents to participate

Exclusion Criteria:

* Presence of conditions that are incompatible with this study's treatment.
* severe visual or hearing impairment,
* severe language delay,
* psychosis,
* pervasive developmental disorder
* Parent or child does not read or speak English or does not read or speak Spanish for our Spanish language implementation of CLS (inability to complete assessment measures or participate in group treatments).
* Child is in an all-day special education classroom (children in these classrooms are frequently receiving intensive behavior modification programs such that the intervention would be expected to require modification for use in these settings)
* Children taking psychotropic medication for any reason other than to treat ADHD
* Children planning to change (start or stop) psychotropic medication
* Children who have changed a regimen of psychotropic medication (started or stopped) within 30 days prior to screening
Study of Hormonal Sideeffects in Patients Taking Levetiracetam, Carbamazepine or Lamotrigine for Epilepsy

Some antiepileptic drugs are found to have hormonal side effects. We want to study possible hormonal side effects of the relatively new antiepileptic drug; levetiracetam and compare it to the older drugs; lamotrigine and carbamazepine. The participants are going to fill in a questionnaire and we will collect blood samples from them, to analyse hormones.

We have previously performed long-term studies of rats treated with levetiracetam and compared them with a control group. Here we have found that levetiracetam has a probable effect on the ovaries, since the treated animals had larger ovaries, fewer cysts, more corpora lutea and more secondary follicles than the untreated animals (Taubøll et al 2004). Blood tests on the animals showed that those treated with levetiracetam had higher testosterone levels and lower levels of estrogen and FSH, whilst LH and progesterone levels were unaffected by the treatment (Svalheim et al, 2005a, b). Studies on cell cultures from pig ovaries, as carried out by our group in collaboration with Jagiellonian University, Krakow, Poland, appeared to support these findings (Taubøll et al. 2006, submitted).

Our wish therefore now is to study fertile men and women in order to look for any changes in the balance of sex hormones during use of levetiracetam in order to establish whether the findings in animal trials are clinically relevant to humans.

Eligibility Criteria:
Inclusion Criteria:

* Having epilepsy
* Age 18- 45
* Using levetiracetam/ lamotrigine or carbamazepine in monotherapy for at least 6 months

Exclusion Criteria:

* Hormonal diseases( ie; diabetes, hypo/ hyperthyroid disease)
* Use of hormonal anticonception drugs or other hormonal drugs.
Study Bronchoalveolar Lavage Fluid Driven Pathogenic Diagnosis of Lower Respiratory Tract Infections

Comparison of microbiological yield from Bronchoalveolar Lavage Fluid (BALF) for the two common-used volume bronchoalveolar lavages(60ml and 120ml)in patients with different types of lower respiratory tract infection.

Assessment of the safety of two common-used volume bronchoalveolar lavages(60ml and 120ml), including the incidence of hospital-acquired pneumonia within 14 days after bronchoscopy, and other bronchoalveolar lavage related adverse events.

The morbidity and mortality of lower respiratory tract infection gradually increased in recent years, but the etiological diagnosis rate is still low. Quickly identifying the pathogenic bacteria and the corresponding antimicrobial therapy treatment is particularly important. Fibrotic bronchoscopy combined with bronchoalveolar lavage (BAL) has become a routine diagnostic tool for pulmonary infections in immunocompromised patients.

The correct operation of bronchoalveolar lavage and normalization of bronchoalveolar lavage fluid is a prerequisite for the exact results of the pathogen of BALF.

American Thoracic Society recommended amount of 100-300ml of saline solution was instilled into the distal bronchial tree in the diagnosis of interstitial lung diseases. But there is no standard of lavage fluid volume in the etiological diagnosis of lower respiratory tract infections, ranging from 60ml to 250ml ever reported in literature.

Less lavage volume would be more safer in patients with lower respiratory tract infections. The investigators hypothesize that microbiological yield would be no significant difference in patients with low volume （60ml) compared with large volume (120ml).

The purpose of this study is to explore a more effective and safer way of bronchoalveolar lavage in lower respiratory tract infection patients, and determine the pathogenic distribution among them.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of lower respiratory infection
2. Indication for bronchoalveolar lavage.

Exclusion Criteria:

1. Noninfectious pulmonary infiltration
2. Contraindication of bronchoscopy： Severe heart or pulmonary dysfunction Recent occurrence of myocardial infarction unstable angina pectoris Severe coagulation disorders (DIC), Massive hemoptysis Gastrointestinal bleeding Thrombocytopenia (\<50\*109/L) Severe superior vena cava obstruction syndrome Aortic aneurysm Multiple pulmonary bulla Extreme exhaustion
3. Diagnosed or highly suspected of tuberculosis infection
4. Researchers think that can not be entered into the group.
Citrate Anticoagulation During MARS Treatment

The optimal anticoagulation procedure during MARS treatment has not been defined. In various multi-centre trials, such as MARS-RELIEF, anticoagulation procedures are left to the discretion of the treating physician. On the one hand, given the increased risk of bleeding associated with liver failure, high dosage of anticoagulation therapy should be avoided. On the other hand, contact of blood or blood components with the extracorporeal circuit will likely result in coagulation activation or even loss of coagulation factors.

Citrate anticoagulation has gained popularity, especially in hemodialysis patients. It results in a highly effective anticoagulation, exclusively confined to the extracorporeal circulation. Moreover, dependent on the type of dialyser membrane, citrate anticoagulation resulted in reduced activation of other cellular components.

In contrast to hemodialysis patients, experience with citrate anticoagulation during treatment with artificial liver devices is limited. The liver contributes substantially to the metabolism of exogenous citrate. As a result, cirrhotic patients have decreased endogenous citrate clearances. Importantly, blood purification devices contribute substantially to overall citrate clearance, thereby preventing accumulation of citrate. Several centres, including our own, have gained experience with citrate anticoagulation during fractionated plasma separation and adsorption (FPSA), a related liver dialysis device, in the treatment of liver failure patients.

Citrate anticoagulation during MARS treatment has not been studied so far.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled MARS treatment
* Age over 18 years
* Informed consent
* Admitted to Intensive Care Unit

Exclusion Criteria:

* Blood or plasma transfusion within 48 hours before study
* Hypocalcemia (ionised Ca \< 0.90 mmol/l)
* Acidosis (pH \< 7.25) due to any cause
* Use of citrate containing medications
Implantation Failure and PGD

The aim of this study is to performed a randomized controlled trial to evaluate the usefulness of preimplantation genetic diagnosis (PGD) in patients with repetitive implantation failure. Patients will be prospectively randomized in two groups: standard IVF with blastocyst transfer on day-5 and transfer day-5 after PGD for aneuploidy screening for chromosomes 13, 15, 16, 18, 21, 22, X and Y. The end points of the study are: Cancellation rate; implantation rate and ongoing implantation rate. Inclusion criteria are: patients with ≥2 previous IVF failure without clinical or biochemical pregnancy with transfer of at least 2 good quality embryos per transfer. Exclusion criteria will be uterine abnormalities , abnormal karyotypes, abnormal result in thrombophilia screening and low responder patients (less than 4 expected oocytes).


Eligibility Criteria:
Inclusion Criteria:

* Patients of any age with ≥2 previous cycles, negative TIG or biochemical pregnancy with fresh transfer of at least 2 embryos in each cycle.

Exclusion Criteria:

* Patients with PGD indication (age, repetitive miscarriage, chromosomal anomalies, etc. )
* Patients with ectopic pregnancies in previous cycles.
* Recipient of oocyte donation.
* Patients in which 4 or less oocytes are to be retrieved.
A First-in-human, Proof of Concept Study of CPK850 in Patients With RLBP1 Retinitis Pigmentosa

The purpose of this first-in-human study is to explore the maximum tolerated dose (MTD) of CPK850 as determined by the single ascending dose ranging portion of the study. This study will also evaluate the safety and potential efficacy of CPK850 on improving visual function in patients with decreased visual function from RLBP1 retinitis pigmentosa due to biallelic mutations in the RLBP1 gene.

This study will potentially include 4 cohorts with a minimum of 3 patients per cohort. This trial design used a staggered patient enrollment with continuous data reviews to limit as much unforeseen risk as possible prior to enrolling each patient in each cohort or initiating another cohort. Only one eye (designated as the study or treated eye) will be dosed per patient. Each patient will be followed for 5 years after the subretinal injection of CPK850.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 to 70 years inclusive.
* The visual acuity in the study eye at the screening 1 visit should be no better than 60 ETDRS letters.
* Clinical diagnosis of Bothnia dystrophy, Newfoundland rod-cone dystrophy or other progressive retinitis pigmentosa phenotype with mutations in the RLBP1 gene verified by genetic testing.
* Visible photoreceptor (outer nuclear) and Retinal Pigment Epithelium (RPE) layers on standard OCT scan in the study eye at the screening 1 visit.

Exclusion Criteria:

* History of hypersensitivity to the study drug or to drugs of similar classes or to any of the medications required in the perioperative period.
* Pre-existing eye conditions that would preclude the planned surgery or interfere with the interpretation of study endpoints
* Any contraindication to the planned surgery or anesthesia as determined by the treating physician (surgeon, anesthesiologist, internist, or designee).
* Women who are pregnant, or lactating or women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for two months after treatment