cyrilzakka/clinical-trials huggingface dataset:
The Study to Compare the Treatment of Angioplasty and Stents in SFA Occlusions.

The main objective of this study is to assess the patency rate of the nitinol self-expandable stent device in the treatment of superficial femoral artery (SFA) occlusions as compared to angioplasty only.

This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ nitinol self-expanding stent as compared to balloon angioplasty only. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study.

The study population will consist of symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, long de novo or restenotic occlusions (5 - 14.5 cm) on diagnostic imaging with a history of at least 6 months. The occlusions must not extend beyond the proximal popliteal artery. For the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. The distal popliteal artery must be patent with no hemodynamic stenosis as well as two calf vessels. Reference vessel diameter must be \>= 4.0 to \<= 6.0 mm.

Trial participants will be randomized to the SMART™ nitinol self-expanding stent or to balloon angioplasty only.

Patients will be followed for twelve months post-procedure. Study examinations will be done at screening, procedure time, discharge, six, and twelve months post procedure.

This study will be conducted at 8 investigational sites in The Netherlands.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 6 months
2. The patient should be suitable for percutaneous transluminal angioplasty (PTA) and also for stenting.

Exclusion Criteria:

1. Poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft.
2. Patient having total occlusions or severe stenosis of the iliac artery on the same side must be excluded.
3. Gangrene in index limb (Rutherford category 6).
Ambrisentan for Treatment of Portopulmonary Hypertension

Portopulmonary hypertension denotes pulmonary hypertension complicating portal hypertension and is present in approximately 5% of cirrhotic patients. Treatment options include prostanoids, sildenafil, and the endothelin-receptor antagonists, bosentan and ambrisentan.

This study investigates the safety and efficacy of ambrisentan in portopulmonary hypertension.

Patients with clinically significant PoPH (resting mean pulmonary arterial pressure \>25 mm Hg, pulmonary vascular resistance \>400 dynes\*s\*cm-5) will be offered treatment with ambrisentan. Patients will be followed clinically and hemodynamically up to 12 months after start of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with portal hypertension, age \>18 years
* Cirrhosis of any etiology; Child-Pugh class A and B
* Noncirrhotic portal hypertension (e.g. chronic portal vein thrombosis)
* Informed consent

Exclusion Criteria:

* Presence of other causes for pulmonary arterial hypertension
* History of pulmonary embolism or myocardial infarction within 6 months before study start
* Child-Pugh class C
* Presence of hepatocellular carcinoma
* Liver transplantation
* HIV infection
* Severe obstructive or restrictive pulmonary disease (predicted FEV1 or VC \<65%, respectively)
* Severe dilated cardiomyopathy (EF \<50%)
* Latent left-heart insufficiency
* Pregnancy and lactation
* Esophageal variceal hemorrhage within the last 6 months
* Refractory ascites
* Hepatorenal syndrome
* Persistent hepatic encephalopathy \> grade 1
* Bilirubin \>3.0 mg/dl
* AST and/or ALT \>3x ULN
* Creatinine \>2.0 mg/dl
* Known hypersensitivity to ambrisentan
A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation

This study aims to evaluate the efficacy and safety of the docusate sodium and sorbitol rectal solution produced by Ferring Pharmaceutical (China) Ltd. in treating Chinese patients with constipation.


Eligibility Criteria:
Inclusion Criteria:

* Have signed the informed consent form and have been verbally told of the details of the trial and treatment procedures
* Is a citizen of the People's Republic of China
* Males and females aged between 18 and 65 years inclusive
* A history of constipation symptoms for at least 6 months, with occurrence of two or more of the symptoms during the 3 months before screening:

  1. More than 1/4 of stool classifiable as Type I or Type II on the Bristol Stool Scale;
  2. Sensation of incomplete evacuation at least 1/4 of the time;
  3. Straining during defecation at least 1/4 of the time;
  4. Sensation of ano-rectal blockage or obstruction during defecation at least 1/4 of the time;
  5. Manual manoeuvres needed often to facilitate defecations (e.g. digital evacuation) at least 1/4 of the time;
  6. Fewer than 3 bowel movements per week
* No bowel movement within two days prior to randomisation

Exclusion Criteria:

* Patients who are suspected to have colorectal cancer;
* Patients showing signs of bleeding in the digestive tract or inflammatory bowel disease;
* Patients experiencing abdominal discomfort or intestinal blockage for which the cause has yet to be determined;
* Patients allergic to docusate or sorbitol;
* Patients allergic to glycerine;
* Those pregnant, breastfeeding, or with the intention of becoming pregnant, or fertile women who are not on effective birth control（i.e. an IUD (intrauterine device), oral contraceptives or other obstructive measures;
* Severe liver damage (ALT (alanine aminotransferase), AST (aspartate transaminase), TBIL (serum total bilirubin) more than 2 times the upper limit of normal)
* Kidney function impairment (Cr (creatinine clearance rate), BUN (blood urea nitrogen) more than 1.5 times the upper limit of normal)
* Patients who have participated in any other clinical trial during the last 3 months;
* Diabetics who are currently undergoing insulin treatment;
* Patients who are unable to suspend using treatments that affect the kinetics of the digestive system in the 5 days prior randomisation. Such treatments include prokinetic drugs, erythromycin analogues, laxatives, etc;
* Other patient factor(s) (e.g. medical history, concurrent illness(es), laboratory test result(s), etc.) at Screening that in the opinion of the investigator(s) would put the trial patient at excessive risk;
* Patients who are unable to act in a legal capacity, unable to meet or perform study requirements, or are known or suspected as unable to comply with the study protocol.
Lp(a) With CCTA Assessed Parameters and Clinical Outcomes

Lipoprotein(a) \[Lp(a)\] is a risk factor for cardiovascular events, although the underlying mechanism remains unclear. This study evaluated the relationship between Lp(a) and high-risk attributes (HRA) by coronary computed tomography angiography (CCTA) as well as their prognostic value.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Lp(a) meaured within 1 week of CCTA examination.

Exclusion Criteria:

* unstable angina pectoris
* acute myocardial infarction
* New York Heart Association class III-IV heart failure
* with a history of bypass surgery
* active infection
* respiratory failure
* chronic kidney disease (estimated glomerular filtration rate \[eGFR\] \<60 ml/min/1.73 m2)
* liver dysfunction (liver enzyme \>3 upper reference limit \[URL\] or bilirubin \>2 URL)
* malignancy
* systemic connective tissue disease
* poor CCTA imaging quality not suitable for analysis
* other situations not suitable for the study
Minimal Residual Disease: A Trial Using Liquid Biopsies in Solid Malignancies.

The NHS' Genomic Medicine Service offers whole genome sequencing as part of the drive to improve cancer outcomes. It is recognised that actionable mutations (current and emerging), will ultimately improve outcomes across multiple disease sites by identifying which treatments may benefit individual patients the most, and by providing earlier and more accurate diagnoses. However, testing in the cancer setting is currently limited to haematological malignancies and sarcoma. The majority of patients with solid tumours do not yet have access to this platform and the benefits that it may bring. Therefore, expanding genomic testing capacity within a research setting has potential to benefit those patients that would otherwise not be able to access testing. In this study we will be using tissue derived from patients undergoing surgery for cancer to validate an in-house genomic testing platform against Roche's Foundation Medicine genomic profile service, which is an FDA- approved commercial platform.

In addition, two blood samples will be taken in order that we can test whether markers present in the tissue may also be seen in blood. We hope that this will help us monitor minimal residual disease in patients, allowing earlier detection of relapse/recurrence than radiology currently allows.

Patients may also agree to donate optional excess fresh tissue from their surgery. This will be integrated with other laboratory platforms which may offer information on prospective drug response based on genotypic profiles (e.g., patient-derived explants).


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Diagnosed with solid tumour that requires surgical resection, and has a high propensity of relapse.
* Fit for planned surgical procedure.
* Able (in the Investigators opinion) and willing to comply with all study requirements.
* Willing to allow his or her General Practitioner, Consultant, and Clinical Geneticist, if appropriate, to be notified of participation in the study.

Exclusion Criteria:

* Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
* Not fit for surgery.
* Not willing to donate blood and tissue samples.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* Participants who have participated in another research study involving an investigational product in the past 12 weeks.
Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation

Aerosol delivery through a ventilator is influenced by numerous factors from ventilator-related, circuit-related to device-related factors. Aerosolized drug delivery through a ventilator system was studied on bench model with albuterol, yet the results were often overestimated. The objective of this study was to evaluate inhaled bronchodilator and mucolytic agents delivered through a ventilator system.

Aerosolized medication is used widely to patients with respiratory illness and admitted in the intensive care unit, and includes bronchodilators, steroids, mucolytics, and antibiotics. Aerosol delivery through a ventilator is influenced by numerous factors from ventilator-related, circuit-related to device-related factors. Aerosolized drug delivery through a ventilator system was studied on bench model with albuterol, yet the results were often overestimated. Only few clinical trials on aerosol delivery deposition were published in the last decades. In addition, inhaled bronchodilators, mucolytics, antibiotics, and steroids are often administered to ventilated patients in the intensive care units in Taiwan, but they are never studied. Therefore, the aim of this study was to evaluate inhaled bronchodilator and mucolytics (acetylcystine) delivered by a jet nebulizer through a ventilator system to intubated patients.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical ventilated patients with an endotracheal tube intubated
* Receiving aerosol therapy with salbutamol or acetylcystine
* On relatively stable medical condition

Exclusion Criteria:

* Pregnant
* Unstable hemodynamic status (e.g. blood pressure \<100/60 mmHg, under Intra-aortic balloon pump)
* Infected with airborne pathogens (e.g. tuberculosis or Influenza virus)
* Poor oxygenation (fraction of inspiratory oxygen \>0.8, under high frequency oscillatory ventilation, or extracorporeal membrane oxygenation)
A Non- Inferiority Comparative Study Between Seretide® and Salmeterol/Fluticasone Eurofarma in Patients with Asthma

The primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the disease's symptoms.

The primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the disease's symptoms.

Primary endpoint: Forced expiratory volume in 1 second (FEV1) at the final visit.

Secondary endpoints: Expiratory Flow Peak (EFP), symptoms score, FEV1 throughout the study, use of rescue medication, compliance with inhaler use, inhaler acceptance and preference, and frequency of the observed adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Sign the ICF
* ≥ 12 years old
* Have a persistent asthma diagnosis, as per GINA classification,18 with symptoms for at least 6 months and clinically stable for at least 1 month with the ACQ-7 test (please see Appendix C) ≤ 3.0
* Current use of inhaled corticosteroid (up to 1000 µg of beclomethasone dipropionate) whether combined or not with long-term β2-adrenergics and relief medication (salbutamol or equivalent)
* Initial FEV1 of at least 40% of the normal value expected
* Blood cortisol evaluation within the normal limits.

Exclusion Criteria:

* Use of oral or parenteral corticosteroid within the last 3 previous months to the study
* Hospitalization needed due to asthma within the last 3 previous months to the study
* Active smokers, defined as the consumption of cigarettes, pipes, cigars or any other form of smoking in any amount within the last 3 months
* Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological or psychiatric disease or chronic respiratory disease other than asthma
* Recent (\<6 months) or expected participation during this study in other clinical trials involving drugs of any nature or in studies consisting of any - Intolerance or allergy to any component of the drugs evaluated in the study
* Pregnant or lactating women
* Chronic use of routine β-blockers, orally or intravenously, including ophthalmic solutions.
A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis

The purpose of this study is to investigate the effectiveness profile of guselkumab used in a real-life setting in participants with moderate facial and/or genital psoriasis. Effectiveness will be evaluated using the static Physicians Global Assessment (sPGA) for the facial region and the sPGA for the genital region.


Eligibility Criteria:
Inclusion Criteria:

Participants included in the study:

* must have a first or confirmed diagnosis of psoriasis, requiring systemic treatment with significant involvement (defined as a Static Physician's Global Assessment \[sPGA\] score greater than or equal to \[\>=\] 3) involving the facial and/or genital regions
* must have started treatment according to the approved indication as described in the current version of summary of product characteristics (SmPC) of the product approved in Italy. Enrollment may occur at any time after the first injection of guselkumab but before completion of the next visit at week 4 or 12 as scheduled according to common clinical practice
* must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

Exclusion Criteria:

Participants will be excluded from the study if they:

* have any contraindication to the use of guselkumab, as stated in the current SmPC of the product approved in Italy
* received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of guselkumab treatment
* are currently enrolled in another clinical trial or investigational study
* are currently enrolled in an observational study sponsored or managed by a Janssen company
* participant unable to read, to write, to understand and sign the informed consent form (ICF)
Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C]-CORT113176 in Healthy Male Participants

This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of \[14C\]-CORT113176 in healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 18.0 to 30.0 kg/m\^2, inclusive
* Willing and able to participate in the whole study
* Have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)
* Provide written informed consent
* Adhere to the contraception requirements.

Exclusion Criteria:

* Have received any investigational medicine in a clinical research study within 90 days
* Are, or are immediate family members of, a study site or sponsor employee
* Evidence of current severe acute respiratory syndrome (SARS-CoV-2) infection
* History of any drug or alcohol abuse, or regularly consume \>21 units alcohol per week
* Current smoker or user of e-cigarettes and nicotine replacement products within the last 6 months
* Have pregnant or lactating partners
* Radiation exposure, exceeding 5 milliSieverts (mSv) in the last 12 months or 10 mSv in the last 5 years
* Clinically significant abnormal results of clinical chemistry, hematology or urinalysis as judged by the investigator
* Confirmed positive drugs of abuse test result
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
* Active renal and/or hepatic disease
* History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal (GI) disease, neurological or psychiatric disorder
* Any form of cancer within the last 5 years (exceptions apply)
* History and/or symptoms of adrenal insufficiency
* Condition that could be aggravated by glucocorticoid antagonism or activation
* Donation of blood or plasma or loss of greater than 400 mL of blood within the previous 3 months
* Are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) within 14 days. COVID-19 vaccines are accepted concomitant medications. Exceptions may apply on a case by case basis.
* Currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months or 3 months for inhaled products
* Additional criteria apply.
Effect of Atazanavir-ritonavir on the Pharmacokinetics and Toxicity of Lumefantrine

A case control pharmacokinetic study evaluating the effects of atazanavir-ritonavir on the pharmacokinetics and toxicity of lumefantrine in people living with HIV attending APIN clinic of the Lagos University Teaching Hospital

Atazanavir-ritonavir (ATVr) based antiretroviral therapy and artemether-lumefantrine (AL) are commonly used drugs for the treatment of Human Immune Deficiency Virus (HIV) infection and malaria respectively in Nigeria. However, both drugs interact with Cytochrome P 3A4 (CYP 3A4) isoenzymes which may spawn clinically significant pharmacokinetic interactions.

The study was aimed at evaluating the effects of atazanavir-ritonavir on the pharmacokinetics and toxicity of lumefantrine.

In a case control pharmacokinetic study, twenty participants who tested positive for Plasmodium falciparum malaria were recruited and divided into two groups (ATVr-arm, n=10; and Control-arm, n= 10). All the participants were administered with 6 doses of AL 80-480 mg (Coartem). Thereafter, blood samples were collected from them at different time intervals over seven days. The lumefantrine concentration in each sample was determined with high-performance liquid chromatography (HPLC) and entered into WinNonlin® software to determine the pharmacokinetic parameters of lumefantrine which were compared between the test and control groups. Toxicity was evaluated with adverse events monitoring, electrocardiography, haematological and blood chemistry tests at pre and post doses of artemether-lumefantrine.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or non-gravid female ≥18 years of age,
* Informed written consent,
* Malaria parasitaemia
* Axillary temperature ≥37.5°C or history of fever within 24 hours before visiting the clinic and with, at least, any of the following signs and symptoms of uncomplicated malaria: chills, sweats, headaches, muscle aches, nausea, vomiting, diarrhoea, body weakness, poor appetite and pallor.
* Hemoglobin (Hb) ≥8 g/dl
* Body weight ≥35 kg
* HIV positive (ATVr arm), HIV negative (AL/control arm)

Exclusion Criteria:

* Severe anaemia' (Haemoglobin levels \< 8g/dl)
* Smokers/alcoholics and users of substances which inhibit or induce CYP3A4 iso enzymes
* Withdrawal of consent
* Known allergy to any of the study drugs
* Development of complications or severe adverse effects
* Smokers/alcoholics and users of caffeine, drugs which induce or inhibit CYP3A4 and CYP2B6
* Evidence of chronic illnesses such as diabetes, hypertension, psychiatric illnesses
* Subject taking any drugs or having any condition known to prolong QT-intervals
* Signs of severe malaria
* Use of anti-tubercular drugs for at least three months prior to enrolment
* Being on anti-malarial drugs within four weeks prior to enrolment
* Pregnant or nursing mother.