cyrilzakka/clinical-trials huggingface dataset:
Secondary PRevention in Cardiovascular Disease by a Nursing Guided Program (SPRING)

DESIGN: Controlled clinical trial with single randomization, unmasked, open and multicentric.

CENTERS: University Hospital of A Coruña and University Hospital of Ferrol CONDITION TO STUDY: Acute Coronary Syndrome (ACS). INTERVENTION:monitored outhospital not inhospital supervised. MAIN OBJECTIVE: To determine the incidence of major adverse events (total mortality, new ACS, coronary revascularization, all-cause hospitalization) during the one-year period after hospitalization for ACS.

The SPRING study aims to learn whether a remote, nurse-guided secondary prevention program reduces adverse events in patients who suffer an infarction during the subsequent one-year period. The SPRING study focuses not only on adverse events but also on the patients' state of life in terms of diet, physical exercise, emotional state, tobacco use, and adherence to medical treatment. Nursing is a profession in charge of preserving the health of patients, which is why the remote secondary cardiovascular prevention program of this study is coordinated by a nurse.

Eligibility Criteria:
Inclusion Criteria:

* All patients who have suffered an ACS in the health area of A Coruña or Ferrol from the beginning of the study inclusion period until reaching the fixed sample size.
* Ages between 18 and 75 years.
* Patients with ability to read and understand the participation sheet in the study.
* Patients signing informed consent to participate in the study.
* Patients living in the health care area of HUAC or HUF.

Exclusion Criteria:

* Patients who are dependent for the Basic Activities of Daily Living (BADL) or who suffer from severe cognitive impairment (which makes reliable anamnesis impossible).
* Patients with a Left Ventricular Ejection Fraction (LVEF) less than or equal to 35%.
* Patients with a NYHA III / IV score and / or the Canadian Cardiovascular Association (CCS) scale of IV.
Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis

Acute pancreatitis (AP) is a common disorder with rising incidence varying between 35 and 80 per 100,000 in Europe and the USA. About 15% of patients develop necrotizing pancreatitis (NP) with a mortality of up to 42% and frequently prolonged hospitalisation in the survivors. Despite a fulminant pathophysiology comparable to that of sepsis, the management of NP is still re-active, symptomatic and mainly based on paradigms with low grade evidence. In sepsis beneficial effects of early goal-directed fluid resuscitation resulting in reduced mortality have been clearly shown. With regard to these data and several studies of NP demonstrating the deleterious effects of fluid loss and haemoconcentration within the first 24h after admission, early goal-directed fluid resuscitation has the potential of improving outcome also in NP. Therefore, it is the aim of this RCT to demonstrate beneficial effects of early goal-directed resuscitation using an algorithm based on modern haemodynamic parameters such as Intra-thoracic Blood Volume Index (ITBI), Extravascular Lung Water Index (ELWI) and Stroke Volume Variation (SVV) which can be easily and safely obtained due to recent progress in haemodynamic monitoring. The algorithm is aimed at maintaining adequate resuscitation (ITBI, SVV) as well as preventing pulmonary over-hydration (ELWI).The use of a similar algorithm in cardiac surgery patients resulted in a significant reduction in catecholamine use, lactate levels, duration of ventilation and ICU stay.

Resuscitation using crystalloids and/or colloids with the following goals:

ITBI: 850 -1000 ml/sqm, if ELWI \<=12\*ml/kg 750 - 850 ml/sqm, if ELWI \>12\*ml/kg and/or PaO2:FiO2 \<200

\*ELWI \<=12ml/kg, if MAP\>65mmHg without catecholamines \<=14ml/kg, if catecholamines required for MAP\>65mmHg SVV \<10% (only in controlled ventilation and sinus rhythm) MAP \>65mmHg (MAP: Mean Arterial Pressure) IAPP \>60mmHg (IAPP: Intra-abdominal Perfusion Pressure)

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of pancreatitis:

   * Typical pain
   * Increase in serum lipase or amylase
2. Onset of abdominal pain within \<=48h before admission
3. APACHE II \>= 8
4. Evidence of \>= 1 predictor of severe pancreatitis:

   * Haematocrit \>44% (male) or \>40% (female), respectively
   * Blood glucose \> 125 mg/dl;
   * CRP \>= 10 mg/dl;
   * Age \> 55 years;
   * Leukocytes \>= 16 G/L
   * GOT \> 250 U/L;
   * LDH \> 350 U/L
   * Calcium \< 2,0 mmol/L
   * CK \> upper normal range
   * Balthazar-score(CT classification) Grade C-E
   * Any organ failure

Exclusion Criteria:

1. Pregnancy
2. NYHA \>II
3. Pre-existing disease with life expectancy \< 3 months
Paracetamol Metabolism After Liver Surgery

This observational study will assess the metabolic pathways of paracetamol that are utilised after liver resection.

Paracetamol is normally metabolised by the glucuronidation and sulfation of paracetamol to non toxic end products. If paracetamol is administered in supra-therapeutic doses this pathway becomes saturated and an alternative pathway is utilised. This results in a toxic metabolite called N-acetyl-p-benzoquinone imine (NAPQI). If NAPQI is not metabolised by glutathione to cysteine and mercapturic acid, then NAPQI bind to hepatic cells resulting in necrosis and hepatotoxicity.

Therefore the investigators plan to measure the levels of the paracetamol metabolites in patient undergoing liver resection.

Patients will undergo liver resection according to their onco-surgical requirements. As part of the normal post operative care they will receive 1g paracetamol every six hours unless stated otherwise by the operating surgeon. Urinary samples will be taken for the first 4 post operative days and used for analysis of the urinary paracetamol metabolite levels.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing liver surgery

Exclusion Criteria:

* Contra-indication to paracetamol
* Inability to give written, informed consent.
* Jaundice (Bilirubin \> 100 μmol/L).
* Liver resection combined with secondary surgical procedure.
* Age \< 18 years.
* Pregnant women.
Metabolic Effects of a Pre-meal Protein Drink With or Without Added Amino Acids at a Subsequent Composite Meal

The purpose of the study was to investigate the efficacy of intake of whey or soy protein isolates, respectively, with or without supplementation of amino acids, on post-meal insulin secretion and glycaemic regulation. Additionally, the effect on plasma amino acids, gut hormones and ghrelin in plasma, as well as subjective satiety was investigated.

Hyperglycaemia in type 2 diabetes (T2D) is associated with an increased risk of cardiovascular diseases, and it has been suggested that reduction of postprandial glycaemia is just as important as lowering fasting blood glucose levels to reach optimal metabolic control and reduce risk of complications in T2D. Observational studies indicate that milk consumption reduces the risk of developing T2D, obesity and cardiovascular disease, and a possible protective mechanism has been ascribed to the protein fraction. It has previously been demonstrated that addition of whey proteins, co-ingested with carbohydrates, stimulates insulin secretion and reduces postprandial glycaemia in both healthy subjects as well as in T2D patients. The effect is mediated through the insulinogenic properties of whey that appears to stem from a generation of a particular amino acid (AA) pattern in postprandial blood after ingestion of whey proteins. In the presently described project it is hypothesized that exchanging part of the whey protein for insulinogenic AA might be useful to optimize an insulinogenic effect. Additionally, soy protein has been suggested to have beneficial effects on insulin resistance and obesity as well on satiety. The possible effect of soy protein on insulin response and glycaemic regulation is therefore also of interest.

A randomized, single blind, within-subject trial was performed. The test meals were provided as breakfasts on 7 different occasions in random order with approximately 1 week between each test. The test subjects were instructed to drink the protein drink immediately prior to eating the standardized sandwich meal. Altogether, the protein drink and the sandwich meal were to be consumed within 12 min.

Eligibility Criteria:
Inclusion Criteria:

* normal fasting blood glucose
* normal BMI

Exclusion Criteria:

* smokers
* vegetarians
* subjects who receives any drug treatment
* lactose malabsorption
Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus

Ubiquitous healthcare service for elderly patients with type 2 diabetes provides real-time glycemic monitoring and glucose control implemented by clinical decision support system (CDSS) using wire and wireless communication and information technology.

To evaluate the clinical efficacy of this system, researchers plan to compare the improvement of glycemic control, self-management, and quality of life among three study groups: control, self glucose monitoring, and U-healthcare group.

Recently, the application of internet-based glucose control system showed better long term glucose control compared to the conventional treatment. This study has become the foundation of web-based methodology in the glucose control. In addition, the combined application of mobile device and web-based monitoring system for chronic diseases showed improvement in various metabolic parameters in obese patients with diabetes and hypertension.

Thus, the application of U-healthcare based on advanced information technology would be helpful in the diabetes management. We plan to provide an individualized U-healthcare service using advanced information technology that enables more effective glucose control.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* age: 60 \~ 85 yrs
* HbA1c: 6.5%-11.0%
* duration of diabetes: less than 30 years
* BMI: 20-35

Exclusion Criteria:

* systemic corticosteroid administered within previous 6 months
* history of myocardial ischemia
* Heart failure, NYHA Class II-IV
* Thyroid disease with abnormal TFT
* Anti-obesity drugs or slimming products within previous 3 months
Novel Organic Kale Products for Prevention of Obesity/Type 2 Diabetes

Investigating the health beneficial effects of freeze-dried Brassica oleracea var. acephala with a high content of fibers, protein, vitamin, minerals, and secondary metabolites on patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes, dietary treatment and/or with oral anti-diabetics
* Diabetes debut \> 30 year
* Plasma fasting blood glucose \> 4mM and \< 12 mM
* HbA1c \> 43 and ≤ 108 mmol/mol
* BMI between 23-40 kg/m2
* Fasting triglyceride \> 1.7 mmol/L and HDL-cholesterol, men: \< 1.03 mmol/L and women: 1.29 mmol/L.

Exclusion Criteria:

* Participating or have been participating in other clinical trials within the last 2 months.
* In treatment with insulin, systemic glucocorticoids, glitazones or GLP-1 analogs.
* Cardiovascular-, physiological-, neurological-, and/or kidney diseases.
* Alcohol- or pill abuse.
* Acute diseases.
* Blood pressure ≥ 160/100
* Pregnant or breastfeeding women.
Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281 as a Combination Therapy in Participants With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma (RCC)

This is an open-label, multi-center, randomized, Phase 1b, adaptive, clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic activity of RO6874281 in combination with atezolizumab with/without bevacizumab in participants with unresectable advanced and/or metastatic RCC. The study will consist of a dose-escalation part and an extension part.


Eligibility Criteria:
Inclusion criteria:

* Unresectable advanced and/or metastatic RCC with component of clear cell histology and/or component of sarcomatoid histology that has not been previously treated with any systemic therapy, including treatment in the adjuvant setting
* During dose escalation only, an additional population with unresectable advanced and/or metastatic 2nd line RCC patients is allowed
* At least one tumor lesion with location accessible to biopsy per clinical judgment of the treating physician
* Consent to provide an archival tumor tissue sample (if available) and to undergo baseline and on treatment tumor biopsies for pharmacodynamic biomarker analysis
* Measurable disease, as defined by RECIST v1.1. At least one lesion accessible for biopsy
* Participants with unilateral pleural effusion are eligible if they fulfill both of the following: (a) New York Heart Association (NYHA) Class 1; (b) Global initiative for obstructive lung disease (GOLD) test level 1 (forced expiratory volume in 1 second \[FEV1\]/ forced vital capacity \[FVC\] less than \[\<\] 0.7 and FEV1 greater than or equal to \[\>=\] 80 percent \[%\] predicted after inhaled bronchodilator)

Adequate hematological function: neutrophil count of ≥1.5 ≥109 cells/L, platelet count of ≥100,000/≥L, Hb ≥9 g/dL (5.6 mmol/L), lymphocytes ≥0.8 ≥109 cells/L.

Exclusion Criteria:

* Symptomatic or untreated central nervous system (CNS) metastases
* Participants with asymptomatic CNS metastases with previous or concomitant brain deficiencies, as defined in the protocol
* Participants with confirmed bilateral pleural effusion
* Episode of significant cardiovascular/cerebrovascular acute disease within 6 months prior to Cycle 1 Day 1
* Active or uncontrolled infections
* Human immunodeficiency virus (HIV) or active Hepatitis A, B, C, D and E virus (HAV, HBV, HCV, HDV and HEV) infection.
* Major surgery or significant traumatic injury \<28 days prior to Cycle 1 Day 1 (excluding fine needle biopsies) or anticipation of the need for major surgery during study treatment
* Serious, non-healing wound; active ulcer; or untreated bone fracture
* Proteinuria as demonstrated by a urine protein to creatinine ratio (UPCR) of \>=1.0 at screening
* History of, active or suspicion of autoimmune disease
* Concurrent use of high dose of systemic steroids. The use of inhaled, topical and ophthalmic steroids is allowed.
CPET in CF Patients With One G551D Mutation Taking VX770

Ivacaftor will restore CFTR function in treated CF patients with the G551D mutation. Improvement in ventilation, salt balance and well-being will contribute to better exercise capacity at all levels of lung function. While potential improvements may be variable across the spectrum of lung function, even small gains at low levels of FEV1 may have significant benefit for some subjects.

The Alfred CF Service is ready to initiate therapy with VX-770 in it's cohort. Investigators therefore have an opportunity to examine correlates between improvements in lung function, exercise capacity, inflammatory markers and indices of wellbeing in CF that may not be repeatable in a single cohort.

Investigators propose a double-blind, placebo-controlled cross-over study of 20 patients currently awaiting initiation of ivacaftor therapy. Patients enrolled in the study will be asked to undergo screening (day -28), and baseline assessments (day 0) and re-assessment studies (day 28) after treatment period 1, followed by baseline assessment at the beginning of treatment period 2 (day 56) and at the conclusion of treatment period 2 (day 84). A further assessment (day 224) will be performed 140 (+/-7) days following commencement on open label Ivacaftor.

After satisfying eligibility criteria, subjects will be randomly assigned to initial active treatment or placebo following a 4 week run-in period. After completion of period 1 and a 4 week washout period, subjects will cross-over to the alternative treatment. After 4 weeks of period 2, subjects will undergo final assessment as shown in the diagram below. However participants choosing not to continue taking ivacaftor in a Named Patient Program or another similar program run by Vertex Pharmaceuticals, Inc., ('Vertex'), at the end of the study period will be required to undergo a Safety Follow-Up visit 28 days after the final dose of study drug. Safety Follow-Up assessments will not include the CPET.

Eligibility Criteria:
Inclusion Criteria:

* All participants will have CF proven based on established criteria (sweat test, genotype and phenotype).
* All participants will have at least one copy of the G551D mutation.
* All will be able to perform an exercise study and complete study questionnaires and assessments.
* Age range will be between 16 and 75 years of age.
* Lung function inclusion will be above 25% predicted FEV1.

Exclusion Criteria:

* Participants will not be included if they are unable to complete study assessments or have had a known adverse reaction to Ivacaftor.
* Female participants will be excluded if found to return a positive pregnancy test at screening.
* Participants will be excluded if using St. John's Wort or rifampicin (strong CYP3A inducers).
* Participants with significant liver dysfunction will be excluded (ALT or ALT above 5 times upper limit of normal).
Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes

The purpose of this study is to compare the treatment day change between immediate postoperative and immediate preoperative intraocular pressure (IOP) between 27-gauge and 23-gauge vitrectomy instruments.

Required follow-up for this study is 3 months post treatment.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent and attend all required study visits;
* Requires vitrectomy in at least one eye;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Previous vitrectomy or glaucoma surgery;
* Planned treatment requires scleral buckling, combined procedures (eg, cataract surgery), silicone oil, and expansive gas other than sterile air;
* Treated with topical IOP lowering medication(s) at any time from baseline assessment to time of surgery;
* Pregnant or planning to become pregnant during the course of the trial;
* Other protocol-defined exclusion criteria may apply.
Change in Airway Responsiveness After Allergen Exposure

Exposure to allergens changes the way the airway responds to some stimuli (methacholine). The investigators will look at whether or not exposure to allergens changes the way the airway responds to a different stimuli (mannitol) and compare that with the known stimuli (methacholine).


Eligibility Criteria:
Inclusion Criteria:

* mild, allergic asthma
* FEV1 greater than 70% predicted
* methacholine PC20 less than or equal to 16mg/ml

Exclusion Criteria:

* known sensitivity to mannitol or other excipient
* diagnosis of any other respiratory or non respiratory disease/disorder that would preclude the individual from participating
* recent thoracic, abdominal or eye surgery
* recent allergen exposure (4 weeks), respiratory infection (6 weeks)
* current immunotherapy
* pregnancy
* history of anaphylaxis
* use of asthma therapies other than short acting beta agonist
Does DNA Sperm Fragmentation Affects Embryo Morphokinetic?

The embryokinetics may be a new prognostic factor for choosing the human embryos with the highest implantation potential. In order to identify the factors that may affect the rate of embryo cleavage, there are many studies about morphokinetics and culture medium, oxygen tension, oocyte quality or type of medication used for ovarian stimulation. However there are no published data with respect to the influence of sperm DNA fragmentation in the embryo kinetic.


Eligibility Criteria:
Inclusion Criteria:

* Patients 36 to 38 years
* Fresh sample semen
* Minimum 6 oocytes
* Semen sample with at least 5 million/ml and at least 30% of progressive motile sperm.

Exclusion Criteria:

* Patients younger than 36 or older than 38 years old
* Frozen semen sample
* Less tan 6 oocytes.
* Semen samples with less than 5 million / ml or less than 30% of motile sperm.
Development of "T-sec" Questionnaire

To design and validate a questionnaire that allows objective assessment of the level of bronchial mucus hypersecretion.

Asthma is a chronic inflammatory disease associated with bronchial mucus hypersecretion (MBH) due to various mechanisms, such as increased mucin secretion, plasma exudation and cytokines. It is currently known that MBH in asthmatic patients is associated with increased mortality and reduced pulmonary function, but there is no tool for its objective assessment.

The aim of the study is to design and validate a questionnaire to objectively assess the level of bronchial mucus hypersecretion in patients with asthma.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 30 and 99 years
* Clinical diagnosis of asthma

Exclusion Criteria:

* Non-Spanish-speaking patients
* Inability to complete the questionnaires
* Failure to sign the informed consent form.
Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia

An Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Ferric Carboxymaltose (FCM) in Infants (0-1 year) with Iron Deficiency Anemia.

A phase II, open-label, multi-center study with 2 Cohorts to evaluate the safety, tolerance, PK, and PD profile of intravenous (IV) FCM in infants 0 to 1 year of age with IDA after receiving either a 5.0 mg/kg or 7.5 mg/kg dose of FCM.

Participants will have a screening evaluation within 14 days of the first dose of study drug. A medically supervised environment is required on Day 1 (day of dosing) and for 4 hours post dosing. Participants are allowed to be enrolled if satisfying the inclusion and exclusion criteria. Participants will return to the study site for additional evaluation and sampling on Days 8 (± 2 days), 15 (± 2 days), 22 (± 2 days), and 36 (± 2 days).

Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants 0 to 1 year of age, medically indicated for iron replacement, with his/her parent or legal guardian willing and able to sign the informed consent form approved by the IRB / Independent Ethics Committee (IEC).
2. Screening Hb ≥7 g/dL to \<10 g/dL.
3. Infants with any of the following conditions:

   * Heart failure with IDA defined as syndromes of excessive preload, excessive afterload, abnormal rhythm, or decreased contractility
   * Gastrointestinal diseases with acquired short bowel syndrome (due to volvulus, necrotizing enterocolitis from surgical resection or spontaneous intestinal perforation)
   * Gastrointestinal intolerance of oral iron or an unsatisfactory response to oral iron
   * Other conditions associated with IDA which in the opinion of the investigator might benefit from administration of FCM

Exclusion Criteria:

1. Known history of hypersensitivity reaction to FCM.
2. Body weight \<2.5 kg.
3. History of acquired iron overload, hemochromatosis, or other iron accumulation disorders.
4. Hemodialysis-dependent chronic kidney disease.
5. History of significant diseases of the liver, hematopoietic system, cardiovascular system, or other conditions which, on the opinion of the investigator, may place a participant at added risk for participation in the study.
6. Active infection.
7. Anemia due to reasons other than iron deficiency (e.g., hemoglobinopathy vitamin B12 deficiency, or folic acid deficiency).
8. Blood transfusion in the 4 weeks prior to consent.
9. Administration of an iron-containing product within 14 days of administration of the study article.
10. Administration and / or use of an investigational product (drug or device) within 30 days of screening.
11. Current participation in another clinical trial.
12. Unable to comply with study procedures and assessments.