cyrilzakka/clinical-trials huggingface dataset:
Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen

The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.


Eligibility Criteria:
Main Inclusion Criteria:

* Participant is male with hemophilia A or B with inhibitors, with a high titer (≥5 Bethesda unit (BU)) or a historical high anamnestic response.
* Participant is 12 to 65 years old at the time of screening.
* Participant is currently using or has used bypassing agents for treatment of bleeding episodes.
* Participant has an annualized bleed rate of 5 or more bleeding episodes per year on average over the 2 years prior to the Screening visit.
* Participant has a Karnofsky Performance Score ≥60.
* Participant is hepatitis C virus negative (HCV-) either by antibody testing or polymerase chain reaction (PCR); or hepatitis C virus positive (HCV+) with stable hepatic disease.
* Participant is human immunodeficiency virus negative (HIV-) or HIV+ with stable disease, CD4+ count ≥200 cells/mm\^3 at screening.
* Participant is willing and able to comply with the requirements of the protocol.

Main Exclusion Criteria:

* Participant is not willing to go on an on-demand treatment scheme.
* Participant is positive for a FVII inhibitor at screening.
* Participant has clinically symptomatic liver disease.
* Participant has a platelet count \<100,000/µL.
* The use of α-interferon with or without ribavirin is planned for an HCV-infected participant or the use of a protease inhibitor is planned for an HIV-infected participant.

  * Participants currently taking any of these medications for ≥30 days are eligible.
* Participant has a known hypersensitivity to rFVIIa, hamster or murine proteins, or Tween 80.
* Participant has a known history of being non-responsive to rFVIIa treatment of bleeding episodes.
* Participant has a prior history of thromboembolic event or diagnosis of other diseases that may increase the participant's risk of thromboembolic complications.
* Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
* Participant is a family member or employee of the investigator.
* Participant is scheduled for surgery during the study period.
The Effect of Citric Flavonoid on Endothelial Function

This randomized, double-blind, placebo-controlled, parallel study aims to determine the 6-week and acute effects of daily administration of a citrus flavonoid on cardiovascular and intestinal health as assessed by investigation of endothelial function, blood pressure and heart rate, glucose/insulin metabolism, lipid profile and gut barrier function in overweigh subjects.

Futhermore we aim to relate the specific intestinal (microbial) metabolism with final serum levels of specific metabolites of the study product.


Eligibility Criteria:
Inclusion Criteria:

* Overweight men/women (BMI 25-35 kg/m2)
* Healthy individuals
* Age between 18 and 70 years
* Fasting glucose \< 7.0 mmol/L
* Normal HbA1c (4.4 to 6.2%)

Exclusion Criteria:

* Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L)
* Gastroenterological diseases or abdominal surgery
* Cardiovascular diseases, cancer, liver or kidney malfunction, thyroid disorders, disease with a life expectancy shorter than 5 years
* Self-admitted HIV-positive status
* Abuse of products; alcohol (\> 20 alcoholic consumptions per week) and drugs
* Smoking
* Plans to lose weight or following a hypocaloric diet during the study period
* Weight gain or loss \> 3 kg in previous 3 months
* Use of medication interfering with endpoints
* Intake of antihypertensive medication, statins, corticosteroids, NSAIDs, ciclosporin A, rifampicin are strictly forbidden
* Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
* Hormone replacement therapy (women)
* Use of antibiotics in the 90 days prior to the start of study
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study
* Known pregnancy (assessed by a pregnancy test before start of study), lactation
* Blood donation within 3 months before study period
* Failure to comply prohibited intake of hesperidin containing food products during study period and prohibited intake of food products that are able to influence the FMD measurements one day prior to test days.
* History of any side effects towards the intake of flavonoids or citrus fruits
NatiOnal Referral cenTEr Study of Transthyretin Amyloid Cardiomyopathy(ATTR) Patients on Tafamidis

All ATTRwt patients on tafamidis 61 mg treatment will be clinically evaluated before treatment initiation and subsequently every six months for the eligibility to continue tafamidis treatment, according to Italian Medicines Agency regulations. C onsidering the significant risk of developing heart rhythm disturbances due to cardiac amyloidosis, especially in transthyretin form (ATTRwt), in routine clinical practice a stricter heart rhythm monitoring is recommended in ATTRwt patients. Moreover, particular attention is usually paid for those who present atrio-ventricular and/or intraventricular block at the baseline electrocardiogram. Data about rhythm disturbances and diuretic dose need will be collected during the planned physical examination every six months and the Holter ECG monitoring requested by the physician at the end of every planned clinical evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ATTRwt amyloidosis.
* 18 years or older;
* evidence of cardiac involvement at echocardiography or cardiac MRI.
* No known prior history of atrial fibrillation or major bradyarrhythmia (second degree atrioventricular block, third-degree atrioventricular block, high-grade atrioventricular block or alternating right and left branch block)
* female patients who are postmenopausal for at least 1 year before the screening visit
* patients on therapy or candidates for therapy with tafamidis 61 mg
* voluntary written consent must be given before performance of any study-related procedure not part of standard medical care with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.

Exclusion Criteria:

* Non-ATTR amyloidosis;
* NYHA class III and IV;
* Pregnant or nursing women;
* Previous pacemaker implantation;
* any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with a fully comprehension of the written consent form
Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon

Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to kill cancer cells directly. This study is being done to see how colorectal cancer responds to treatment with the combination of bevacizumab and chemotherapy.

Due to greater patient convenience and favorable toxicity profiles, clinical practice has seen an increased use of the combinations of capecitabine with oxaliplatin (CAPOX) and capecitabine with irinotecan (CAPIRI). Given the data documenting the improved efficacy for 5-FU based chemotherapy in combination with bevacizumab, it is important to investigate the potential advantages of adding this agent to regimens containing capecitabine.

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of colon or rectal cancer from either the colon or rectum or a metastatic site (beyond the colon or rectum)
* Evidence of adequate organ function (such as liver, kidneys, etc.)

Exclusion Criteria:

* Diagnosis of anal cancer
* Patients who are candidates for surgery
* Patients who have received previous treatments
* Pregnant or lactating women
* History of chronic disease(s) or other serious medical conditions
Behavioral Activation for Major Depression With and Without Mindfulness

The objective of the study is to compare, in individuals who meet the diagnostic criteria for major depression, the effects of Behavioral Activation (BA) strictly behavioral with a BA protocol that includes mindfulness practices. The secondary objectives are: a) to verify if the changes in the level of depressive symptoms found after the treatment will be kept during the follow-up in both groups; b) evaluate the possible moderating role of baseline depression levels on the effectiveness of interventions; c) evaluate relapse rates after treatment; and d) test a BA protocol as a single treatment. The primary hypothesis is that BA protocol with mindfulness practices is superior to BA without mindfulness practices.

Depression, according to the Word Health Organization, is the leading cause of disability in the world, often leading to a decrease in productivity and the departure from work activities, which generates economic impacts to the own health system. Between 2005 and 2015, an increase of almost 20% was identified in cases of depression worldwide. The impact of the disease on the world economy between 2011 and 2030 is expected at US $ 5,36 billion.

Behavioral Activation (BA) and interventions with mindfulness are recognized as effective for depression. On the other hand, as currently the BA is complemented with strategies of the Third Generation Therapies, including mindfulness, no study has compared a protocol strictly behavioral with any treatment and there is also insufficient data to affirm if the BA has better benefits than interventions that include or are based on mindfulness or vice versa.

The aim of this study is is to compare, in individuals who meet the diagnostic criteria for major depression, the effects of BA strictly behavioral with a BA protocol that includes mindfulness practices. The two intervention are face to face, in group (8 weeks), by a randomized controlled trial (RCT). Our main hypothesis is that la intervencion BA with mindfulness practices will be more efficacious to improve the symptomatology depressive, compared to a group with only BA the end of treatment. 150 participants diagnosed with depression will participate in the RCT.

Eligibility Criteria:
Inclusion Criteria:

* Be older than 18 years of age,
* To meet current DSM-5 criteria for major depression
* Be willing to participate in the study
* Be able to understand and read Spanish.

Exclusion Criteria:

* Not being able to read and write;
* Psychiatric conditions present that may affect study participation: schizophrenia, substance abuse, bipolar disorder, eating disorders, obsessive-compulsive disorder, social phobia, self-injurious behavior without suicidal intent;
* Be in psychotherapy;
* Have participated in three sessions of behavioral therapy and / or cognitive therapy;
* Have regular practice in any type of meditation;
* Disagreement in maintaining the dose of psychotropic medications without changes during the session period, if in use.
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 811 in Subjects With Psoriasis

The purpose of this study is to assess the safety, tolerability, immunogenicity, and clinical effects of AMG 811 following single subcutaneous dose administration in subjects with moderate to severe psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 55 years old inclusive at Screening
* Active but clinically stable, plaque psoriasis
* Psoriasis involving ≥ 10% of the body surface area
* A minimum PASI score of ≥ 10 obtained during the screening period
* Additional inclusion criteria apply

Exclusion Criteria:

* Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
* Evidence of skin conditions other than psoriasis (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis
* Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject
* Additional exclusion criteria apply
Cross-over Study to Evaluate the Rate and the Extent of Iron Absorption of an ODF Iron Supplement vs an Iron Supplement in Capsules

Open, monocentric, comparative, cross-over study to evaluate the rate and the extent of iron absorption after a single oral dose of (A) IBSA Iron orodispersible film vs (B) SiderAL® FORTE capsules in healthy women aged 18 to 55 years.

Open, monocentric, comparative cross-over study to compare the rate and the extent of iron absorption after a single oral dose of (A) IBSA Iron orodispersible film vs (B) SiderAL® FORTE capsules in healthy women aged 18 to 55 years.

IBSA Iron is a food supplement based on ferric pyrophosphate and folic acid in orodispersible film.

SiderAL® FORTE is a preparation based on ferric pyrophosphate and Vit.C in capsules.

Each subject will be observed for two consecutive days (phase I, day -1 and day 0) and after a 7-day washout (phase II) for an additional two consecutive days (day -1 and day 0). Half of the enrolled subjects will take A in phase I and B in phase II; the remaining half of the enrolled subjects will take B in phase I and A in phase II.

In the two days (day -1 and day 0) of both phases, peripheral blood samples will be taken and the defined parameters, indicative of blood iron levels, will be measured.

The primary endpoint is the AUC0-t, Tmax and Cmax of serum iron. The secondary endpoints are the standard parameters indicative of blood iron levels.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed prior to inclusion in the study;
* Women 18-55 years;
* Ability to understand the nature and the purpose of the study, including possible risks and side effects;
* Cability to collaborate with the investigator and meet the requirements of the entire study

Exclusion Criteria:

* Smoke
* Clinically significant abnormalities in the ECG evaluation
* Clinically significant abnormal laboratory values indicative of disease
* Known allergy or presumed hypersensitivity to the food supplement investigated (iron) and / or to the excipients of the two formulations;
* History of anaphylaxis from drugs, dietary supplements or allergic reactions in general, which the investigator believed could influence the outcome of the study
* Significant history of kidney, liver, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the purpose of the study
* Taking herbal remedies and dietary supplements in the 2 weeks prior to the start of the study
* Taking corticosteroids, thyroid hormones, antibiotics, antiepileptics
* Alcohol abuse
* Any clinical condition that in the investigator's judgment is deemed incompatible with study participation
* Women who are pregnant or breastfeeding
Microscopic Peritoneal Metastases After Complete Macroscopic Cytoreductive Surgery for Epithelial Ovarian Cancer

The objective of the cytoreductive surgery carried out for the management of ovarian cancers is to obtain a complete macroscopic cytoreduction. This means that all visible peritoneal metastases must be resected. The peritoneum is the most frequent site of recurrence after initial management. There is no data on the existence, prevalence of microscopic peritoneal metastases. It nevertheless represents a therapeutic target (intraperitoneal chemotherapy). The main objective is the demonstration of microscopic peritoneal metastases in macroscopically healthy peritoneum after complete macroscopic cytoreductive surgery.

Understanding biology and progression mechanisms of peritoneal metastases (PM) of epithelial ovarian cancer (EOC) is a cornerstone in the knowledge and the comprehensive management of the disease, as PM will occur in the majority of patients. Indeed, the goal of cytoreductive surgery (CRS) in these patients is to completely remove all visible peritoneal invasion because the absence of residual disease after surgery is known to improve the prognosis.

Despite clinical remission after the completion of complete surgery and platinum-based chemotherapy, 60% of patient develop peritoneal recurrence. This suggests that microscopic lesions may be present that are not eradicated by surgery, not controlled by systemic chemotherapy and that may be one of the mechanisms leading to peritoneal recurrence. Peritoneal carcinomatosis is responsible for the greatest morbidity and mortality in women with EOC.

There are very few studies in the literature on microscopic peritoneal involvement in EOC, its detection and potential role in the progression of cancer. The peritoneum should be considered an organ in its own right and the surgeon must treat peritoneal metastases with the intent to cure. To follow the recommendations, this microscopic disease must be managed, because complete CRS is now a skill that can be mastered skill and its uses is a validated guideline. Moreover, "complete CRS" should be defined as "without macroscopic residual disease" thus highlighting the presence of microscopic disease.

The goal of this study is to add scientific evidence for the existence of Microscopic Peritoneal Metastases (mPM) and to justify the need for additional diagnostic and therapeutic approaches.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years-old, French nationality
* with epithelial ovarian or tubal cancer
* Complete macroscopic cytoreductive surgery (CC-0) regardless of the sequence compared to chemotherapy.
* Patient giving express consent

Exclusion Criteria:

* Borderline ovarian tumor
* Incomplete cytoreductive surgery
* Pregnant women
* Major under guardianship / trusteeship,
* Not insured
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects

Phase 1, randomized, double-blind, placebo-controlled first-in-human study to investigate the safety, tolerability, PK and PD properties of single ascending intravenous (IV) and subcutaneous (SC) doses of KPL-404 in healthy subjects

This study includes 2 single ascending dose (SAD) parts; (Part A) IV SAD (up to 5 planned dose level cohorts) and Part B SC SAD (up to 3 planned dose level cohorts).

Safety assessments will include adverse events (AEs), concomitant medications, clinical laboratory, vital signs, 12-lead electrocardiogram, and physical examination. Serial blood samples for PK, PD, and anti-drug antibodies will be performed during each part of the study during the Treatment and Safety Evaluation Period.

Eligibility Criteria:
Key Inclusion Criteria:

* Healthy subjects
* Body mass index (BMI) in the range of 18.0 - 32.0 kg/m2

Key Exclusion Criteria:

* Poor peripheral venous access
* Clinically-significant illness within 4 weeks of dose administration
* Active or acute infection requiring systemic antibiotic treatment within 2 weeks prior to Screening
Regadenoson R-T Perfusion Imaging Trial

To exam the feasibility and accuracy of Regadenoson real time perfusion (RTPE) Imaging during vasodilator stress with Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography.

To exam the feasibility and accuracy of RTPE during vasodilator stress with 400micrograms of the adenosine receptor (A2A) agonist Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography. Sensitivity, specificity , and accuracy of perfusion and wall motion analysis to identify a coronary stenosis\> 50% in diameter by quantitive angiography will be analyzed

Eligibility Criteria:
Inclusion Criteria:

* Male or female. Age ≥30 years.
* Resting Left Ventricular Ejection Fraction \> 40% using Simpson's biplane measurement.
* Scheduled for coronary angiography within 30 days of the Regadenoson stress test.
* Negative urine pregnancy test within 2 hours of ultrasound contrast administration required of females of childbearing age unless post-menopausal or with evidence of surgical sterilization.
* Be conscious and coherent, and able to communicate effectively with trial personnel.
* Agreeable to undergo the additional stress test and coronary angiography
* Have at least an intermediate likelihood of coronary disease based on the following clinical profile
* Good apical echo images with at least 50% of each coronary artery territory well visualized.

Exclusion Criteria:

* Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
* Pregnancy or lactation.
* Complicated hemodynamic instability (i.e., New York Heart Association (NYHA) Class IV heart failure, unstable angina at rest despite medical therapy).
* Life expectancy of less than two months or terminally ill.
* Congestive (idiopathic) or hypertrophic cardiomyopathy.
* Known left main disease.
* Heart transplant recipient, hypertrophic cardiomyopathy, acute myo- or pericarditis.
* Resting Left Ventricular Ejection Fraction \< 40%
* Large inducible perfusion defects or wall motion abnormalities during prior stress imaging study associated with left ventricular cavity dilatation.
* Early positive treadmill EKG within the first stage of the test.
* History of \>1st degree heart block, sick sinus syndrome or high grade atrioventricular (AV) block without a pacemaker.
* Dipyridamole use within 30 hours of stress test, or consumption of methylxanthines within 12 hours, or use of sublingual nitroglycerin within two hours.
* Participation In another investigational study within one month of this study.
Reveal LINQ Respiration Clinical Study

The LINQ™ Respiration study will collect and characterize Reveal LINQ™ derived respiration data from patients undergoing a simulated 24-hour time period while being monitored with capnography.

The Reveal LINQ™ Respiration study is a Non-Significant Risk IDE, observational, non-randomized, multi-center, clinical study. The study is expected to be conducted at up to 5 centers in the United States and up to 100 subjects will be enrolled, with no more than 25 subjects enrolled per site. In addition, a minimum of 30% of all enrolled subjects will have a history of heart failure.

All enrolled subjects will either have the investigational LINQ HF or ALLEVIATE-HF RAMware downloaded onto their implanted Reveal LINQ device, Holter monitor and capnography monitor applied and undergo a series of activity and breathing maneuvers. The expected duration of subject participation in the study (from start of study procedures to study exit) is approximately 1.5 hours. The expected total study duration (from time of first enrollment to the exit of last enrolled subject) is approximately 3 months.

All Adverse events will be collected throughout the study duration of a subject's participation in the study, beginning at the time of informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 55 years old
* Patient (or patient's legally authorized representative) is willing and able to provide written informed consent
* Patient is willing and able to comply with the study procedures
* Patient has an active Medtronic Reveal LINQ device that has been implanted for ≥ 60 days and no more than 3 years

Exclusion Criteria:

* Patient has an existing condition that necessitates the use of supplemental oxygen
* Patient has an active acute respiratory infection or a respiratory disorder that may affect ability to perform respiratory maneuvers
* Patient has NYHA Class IV heart failure per most recent assessment
* Any concomitant condition that might endanger the patient through participation in the study or interfere with study procedures, as assessed by the investigator
* Patient is enrolled in another study that could confound the results of this study
* Patient has an existing implantation of Medtronic IPG, ICD, CRT-D or CRT-P device