cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular risk participants with hypercholesterolemia in South Korea and Taiwan.

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment.
* To evaluate the effect of alirocumab on other lipid parameters: apolipoprotein B (Apo B), non high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein (a) (Lp \[a\]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), and apolipoprotein A-1 (Apo A-1).
* To evaluate the safety and tolerability of alirocumab.
* To evaluate the development of anti-alirocumab antibodies (ADA).

The maximum study duration was approximately 35 weeks per participant, including up to 3 weeks screening period, 24 weeks double-blind treatment period, and 8 weeks follow-up period.

Eligibility Criteria:
Inclusion criteria:

Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin with or without other LMT, both at stable dose for at least 4 weeks prior to screening visit (Week -3).

Exclusion criteria:

* Aged \<18 years or legal age of adulthood, whichever was greater.
* Participants without established CHD or CHD risk equivalent.
* LDL-C \<70 mg/dL (\<1.81 mmol/L) in participants with a history of documented cardiovascular disease.
* LDL-C \<100 mg/dL (\<2.59 mmol/L) in participants without a history of documented cardiovascular disease.
* Not on a stable dose of LMT (including statin) for at least 4 weeks prior to the screening visit (Week -3) or between screening to randomization visits.
* Currently taking a statin other than atorvastatin, rosuvastatin or simvastatin.
* Atorvastatin, rosuvastatin or simvastatin was not taken daily or not taken at a registered dose.
* Daily doses above atorvastatin 80 mg, rosuvastatin 20 mg or simvastatin 40 mg.
* Fasting serum triglycerides \>400 mg/dL (\>4.52 mmol/L) at the screening period.

The above information is not intended to contain all considerations relevant to a participants's potential participation in a clinical trial.
Patient Reported Outcomes, Postoperative Pain and Pain Relief After Day Case Surgery (POPPY)

Around 3 out of 4 operations in the UK are performed as day-case, meaning the patient goes home on the same day of their operation. Hospitals usually do not follow up patients after day-case operations so we do not know very much about their short or long-term recovery. Some patients, even those who have had small operations, can develop persistent pain afterwards that continues for a long time (months to years). These patients may end up taking strong painkillers for a long time and this risks serious side effects and long-term health problems.

The POPPY study aims to find out what recovery from day-case operations is like from the patient's point of view. We will look at the first week after patients' operations and then at 3 months to see if they are in pain, and if so what pain relief they are taking.

All adults over the 5-day study period having day-case operations in the UK, with an anaesthetist, will be eligible if they have access to a smartphone. Patients will be recruited on the day of their operation from over 100 NHS hospitals. Some relevant information about the patient's current health, operation and anaesthetic will be recorded from their notes. Afterwards participants will get a text message at days 1, 3 and 7 and the at 3 months. These will connect to a data secure online questionnaire about pain, recovery, and what medications they are taking. A small number of participants with ongoing pain at 3 months will be invited to take part in a structured interview to understand their experience in more depth.

This study will provide important information that may be used to improve care of patients having day-case operations and plan future research studies aimed to prevent persistent pain and long-term use of strong painkillers.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older on day of surgery
* Day-case surgery as defined by National Day Surgery Delivery Pack (NEED REF)
* An anaesthetist must be present for case.
* The procedure must involve one or more of: sedation, regional anaesthesia, central neuraxial anaesthesia or general anaesthesia

Exclusion Criteria:

* Less than 18 years of age on day of surgery
* No anaesthetist involved with the procedure (such as local anaesthesia provided by a surgeon)
* Overnight stay (admission to hospital)
* Participant lacking capacity for consent
* Diagnostic and/or minimally invasive procedures (e.g., radiology, endoscopy, or cardiology procedures)
* Pregnancy or obstetric related procedures (pregnancy per-se is not an exclusion criterion).
* Currently breast feeding
* Ophthalmic procedures
* No access to Smartphone and email
* Prisoners

Eligibility for qualitative component:

As above, plus reporting PPSP and/or PPOU at day 97 post operative
In Vivo Lung Perfusion for Pulmonary Metastases of Sarcoma

Sarcoma which has spread to the lungs is most often treated with surgery. Even with surgery, most patients will not be cured and will die from their disease, probably because of small cancer cells that are present in the lungs at the time of surgery, but cannot be seen or detected. It is for this reason that we are looking for a better treatment. Giving chemotherapy after surgery is generally not recommended because it has significant side effects and no benefit has been proven.

This study is investigating a new technique for delivering chemotherapy directly into the lungs at the time of surgery. Delivering chemotherapy directly to the lungs could potentially kill any microscopic cancer cells that are present in the lungs at the time of surgery, while sparing other major organs in the body from the side effects of chemotherapy. This technique is called In Vivo Lung Perfusion (IVLP). This is a Phase I, non-randomized, dose escalation study that will act as a pilot study for a larger prospective, multicenter, controlled clinical trial. Patients who have bilateral disease will have one lung undergo IVLP and the other lung will remain untreated with the IVLP (the other lung will be treated as current standard of care - either surgery or radiation) as a control lung. The patients will undergo a posterolateral thoracotomy. Lung metastases will be identified by visualization or palpation. After surgical isolation of the lung by proximal control of pulmonary artery and veins, IVLP will be initiated. After 3 hours of IVLP, the lung metastases will be removed in the usual fashion. Patients will be cared for post-surgery according to institutional standards. The patients will be followed for up to 2 years. The primary endpoint is safety. Secondary endpoints include additional safety endpoints and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Soft Tissue or Osteogenic Sarcoma
* Presence of bilateral pulmonary metastases
* 3 or more lung lesions in total
* Age less than 65 years
* ECOG 0-2
* Absence of extra-pulmonary disease
* Contralateral disease amenable to surgery or radiation
* All lung lesions in the lung to be treated with IVLP can be resected with wedge or segmental resections (non-IVLP treated lung will be treated with radiation or surgery 4-12 weeks prior to IVLP)

Exclusion Criteria:

* Patient has previously received more than 450 mg of doxorubicin
* Left Ventricular Ejection Fraction \<50%
* History of significant pulmonary disease or pneumonitis
* Pregnant or lactating females
* Age 65 years or older, or less than 18 years
* Inability to understand the informed consent process
* Hypersenstivity to doxorubicin
* Current participation in another therapeutic clinical trial
* Previous lung metastatectomy
Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)

Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Giving combination chemotherapy together with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer ('1st-line' treatment) may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with cetuximab is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of cetuximab in combination with a standard and effective chemotherapy (5-Fluorouracil (5FU)/Folinic acid (FA) plus irinotecan) for metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone on patient expressing the epidermal growth factor (EGF) receptor.

Patients expressing this EGF Receptor will be randomly assign in one of the 2 groups to either receive the combination chemotherapy alone or with cetuximab (open-label study) and will then be treated until progression of the disease or unacceptable toxicity occur. Regular efficacy assessments (every 8 weeks) based on imaging will be performed throughout the study together with regular safety assessments (e.g. safety labs). An independent Safety Board of experts will also monitor safety data.

After participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator.

The entire study (from the first patient entering the study to the last collect of follow-up information) is 4-5 years long.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
* Inoperable metastatic disease
* Immunohistochemical evidence of epidermal growth factor receptor expression in tumor tissue
* Presence of at least 1 bi-dimensionally measurable index lesion

Exclusion Criteria:

* Previous irinotecan-based chemotherapy
* Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated more than 6 months before the start of study treatment
* Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of study treatment
* Brain metastasis
APOLLO-B: A Study to Evaluate Patisiran in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

The purpose of this study is to evaluate the efficacy and safety of patisiran in participants with ATTR amyloidosis with cardiomyopathy.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either hereditary ATTR amyloidosis with cardiomyopathy or wild-type ATTR amyloidosis with cardiomyopathy
* Medical history of heart failure with at least 1 prior hospitalization for heart failure, or current clinical evidence (signs and symptoms of heart failure)
* Clinically stable with no cardiovascular related hospitalizations within 6 weeks of study start
* Has never taken tafamidis before (tafamidis naïve) or currently on tafamidis for ≥6 months with evidence of disease progression while on tafamidis treatment
* Able to complete ≥150 m on the 6-minute walk test
* Screening N-terminal pro B-type natriuretic peptide (NT-proBNP), a blood marker of heart failure severity, \>300 ng/L and \<8500 ng/L; in participants with permanent or persistent atrial fibrillation, screening NT-proBNP\> 600 ng/L and \<8500 ng/L

Exclusion Criteria:

* Known primary amyloidosis (AL) or leptomeningeal amyloidosis.
* Received prior TTR lowering treatment
* New York Heart Association heart failure classification of III and at high risk
* New York Heart Association heart failure classification of IV
* Neuropathy requiring cane or stick to walk, or is wheelchair bound
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2
* Abnormal liver function
* Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
* Has non-amyloid disease that significantly affects ability to walk (e.g., severe chronic obstructive pulmonary disease, severe arthritis, or peripheral vascular disease affecting ambulation)
* Prior or planned heart, liver, or other organ transplant
* Other cardiomyopathy not related to ATTR amyloidosis
Mupirocin-Iodophor ICU Decolonization Swap Out Trial

The Swap Out Trial is a cluster randomized controlled trial of HCA hospitals, evaluating the non-inferiority of two decolonization regimens:

Arm 1 Routine Care: ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing; Arm 2 Intervention: ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing Note: that enrolled "subjects" represents 137 individual HCA Hospitals (representing \~235 ICUs) that have been randomized.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria includes all U.S. HCA hospitals with an adult ICU;
* Note: Unit of randomization is the hospital, but the participants are hospital adult ICUs
* All patients within adult ICUs are included, including rare patients \<18 years and \>=12 years.

Exclusion Criteria:

* Exclusion criteria includes ICUs with an average length of stay of less than 2 days;
* HCA hospitals that are not able to transfer or merge data into the centralized data warehouse for the baseline and intervention periods of the study are also excluded.
Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in STEMI and NSTEMI Patients

The purpose of the PINPOINT study is to compare pharmacokinetics (PK) and pharmacodynamics (PD) of ticagrelor in ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) patients designated to invasive strategy. Data regarding comparison of PK and antiplatelet action of ticagrelor in STEMI and NSTEMI are sparse. Recommended dosing regimens of ticagrelor are identical for both STEMI and NSTEMI, although it is not known whether PK and PD features of ticagrelor are uniform in these patients.

The European Society of Cardiology and American Heart Association guidelines recommend use of ticagrelor or prasugrel as a treatment of choice in patients with both STEMI and NSTEMI (class of recommendation I, level of evidence B). Recommended dosing regimens of ticagrelor are identical in STEMI and NSTEMI patients, although epidemiology, clinical approach and early outcomes differ between these two types of myocardial infarction. It is not known whether PK and PD features of ticagrelor are uniform in STEMI and NSTEMI patients. However, the existing body of evidence suggest that PK and PD of ticagrelor may be attenuated in STEMI patients compared to healthy subjects and patients with stable coronary artery disease, which may expose STEMI patients at increased risk of developing thrombotic complications secondary to insufficient platelet inhibition. The PINPOINT study could provide a valuable insight into the knowledge regarding ticagrelor action in STEMI vs. NSTEMI patients.

Since there is no reference study comparing pharmacokinetics of ticagrelor in STEMI and NSTEMI patients, we decided to perform an internal pilot study of approximately 30 patients (15 patients with each type of myocardial infarction) for estimating the final sample size.

Eligibility Criteria:
Inclusion Criteria:

* provision of informed consent prior to any study specific procedures
* diagnosis of acute ST-segment elevation myocardial infarction or acute non-ST-segment elevation myocardial infarction
* male or non-pregnant female, 18 years old and older
* provision of informed consent for angiography and PCI

Exclusion Criteria:

* treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
* hypersensitivity to ticagrelor
* current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
* active bleeding
* history of intracranial hemorrhage
* recent gastrointestinal bleeding (within 30 days)
* history of coagulation disorders
* history of moderate or severe hepatic impairment
* history of major surgery or severe trauma (within 3 months)
* second or third degree atrioventricular block during screening for eligibility
* patient required dialysis
* manifest infection or inflammatory state
* Killip class III or IV during screening for eligibility
* respiratory failure
* current therapy with strong CYP3A inhibitors or strong CYP3A inducers
Clinical Investigation of the WaveLight® EX500 Excimer Laser

The purpose of this study is to collect efficacy and safety data on the WaveLight EX500 excimer laser system for the correction of hyperopia with and without astigmatism by laser in situ keratomileusis (LASIK) treatment.

Qualified subjects will receive LASIK treatment in both eyes and be followed for 1 year. Subjects will be asked to attend a total of 9 visits (Screening, Surgery, Day 1, Week 1, Month 1, Month 3, Month 6, Month 9, and Month 12). Total expected duration of subject participation is approximately 1 year.

Eligibility Criteria:
Key Inclusion Criteria:

* Intended to treat bilaterally;
* Hyperopia with or without astigmatism as specified in the protocol;
* Stable vision as specified in the protocol;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Glaucoma;
* Cataracts;
* Previous eye surgery;
* Intent to have monovision treatment;
* Other protocol-defined exclusion criteria may apply.
The Severe Soft Tissue Bleeding Study

The objective of this study is to evaluate the safety and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe soft tissue bleeding during abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects \>= 18 years of age, requiring elective, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures;
* Presence of an appropriate severe bleeding soft tissue Target Bleeding Site (TBS) as identified intra-operatively by the surgeon;
* Subjects must be willing to participate in the study, and provide written informed consent.

Exclusion Criteria:

* Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
* Bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of the FP to blood flow and pressure during healing and absorption of the product;
* Subject with TBS within an actively infected field;
* Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
* Subjects with known intolerance to blood products or to one of the components of the study product;
* Subjects unwilling to receive blood products;
* Subjects with known immunodeficiency diseases (including known HIV);
* Subjects who are known, current alcohol and / or drug abusers;
* Subjects who have participated in another investigational drug or device research study within 30 days of enrollment;
* Female subjects who are pregnant or nursing.
AME Study of [14C]-YH4808 in Healthy Male Subjects

The purpose of this study is to determine the absorption, metabolism, and excretion (AME) kinetics of YH4808 and to determine and characterize metabolites present in plasma, urine, and feces in man following a single dose of \[14C\] YH4808 200 mg (\~100 µCi ±20 µCi) administered as a single oral dose.

Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to Study Entry (ie, prior to Check-in \[Day -1\]). Subjects will be confined at the Clinical Research Unit (CRU) from Check in (Day -1) until Discharge Criteria have been met (as early as Day 6 and as late as Day 11). In this study design, physical examinations, electrocardiograms (ECGs), vital signs, How do you feel? (HDYF?) Inquiries, and clinical laboratory evaluations will be performed at Screening, at specified times during the study, and/or at Clinic Discharge. All AEs, whether volunteered, elicited, or noted on physical examination, will be recorded throughout the study (ie, from dosing on Day 1 until Clinic Discharge \[Day 11\]).

Eligibility Criteria:
Inclusion Criteria:

* clinical laboratory evaluations within the reference range for the test laboratory
* negative test for selected drugs of abuse, hepatitis panel and HIV antibody screens
* able to comprehend and willing to sign an Informed Consent Form

Exclusion Criteria:

* significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
* participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in
* donation of blood from 30 days prior to Screening through Study Completion, inclusive, or of plasma from 2 weeks prior to Screening through Study Completion, inclusive
Research on the Efficacy of the "T.O.P. Computer Training" Procedure in the Treatment of Alcohol Dependence

The investigators evaluate the efficacy of a computerised program (T.O.P. tool) consisting of an approach avoidance training (AAT) (to retrain action tendencies for alcohol-related stimuli), a visual probe training (VPT) (to retrain attentional bias for alcohol-related stimuli) and the combination of both training procedures versus placebo training, as an add-on to treatment as usual (psycho-education and cognitive behavioral therapy).

The investigators include hospitalized detoxified alcohol-dependent patients, who receive a four week training procedure, existing of a pre-assessment, 6 training sessions and a post-assessment.

Outcome measures consist of behavioral measures (consumption of alcohol - self report over 1 year), questionnaires (AUDIT; craving on 9-point likert scale) and approach avoidance and visual probe measurement tasks.

A six month and 1 year follow-up is included (behavioral measures and AUDIT). Further, the investigators will also assess credibility (9-point likert scale) of the training procedure before the start of the training and immediately after the assessment of the AAT and VPT training.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized alcohol-dependent patients, choosing for abstinence en committed to treatment
* detoxification (with benzodiazepines) is terminated
* Dutch speaking

Exclusion Criteria:

* neurological condition, such as Korsakoff syndrome
* cognitive problems (cut-off \<26/30 on the Montral Cognitive Assessment)
* psychotic disorders
* visual and motor problems at the hands
* non-Dutch speaking
* mental retardation
* patients who are illiterate