cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia

This study is to determine a dose response signal for LCQ908 monotherapy and to assess the efficacy and safety of adding LCQ908 to Lovaza or fenofibrate.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ages \>18 years of age, inclusive.
* History of plasma TG concentration ≥890 mg/dl (10 mmol/L) or history of lactescent plasma in the fasting state.
* Fasting TG ≥ 750 mg/dL (8.5 mmol/L) at day -7 or repeat of day -7 one week later for those failing to qualify initially and thought likely to qualify on repeat examination prior to randomization.

Exclusion Criteria:

* Treatment with Omega-3 fatty acids or niacin or fibrates within 8 weeks of screening.
* Patients with confirmed Familial Chylomicronemia Syndrome (FCS) with hyperlipoproteinemia (HLP) Type-I diagnosis or known to be homozygotes or compound heterozygotes for mutations in HLP Type I-causing genes (such as LPL, apoCII, CPIHBP1, or LMF1) prior to screening.
* Pancreatitis within 3 months prior to screening.
* Uncontrolled type 2 diabetes (T2DM) (as defined by an HbA1c value of ≥8.0% at screening)
* BMI \> 40 or history of bariatric surgery.
* Nephrotic syndrome, Type 1 diabetes, HIV, HCV or HBV positive.
* Estimated Glomerular Filtration Rate (eGFR) \< 60 ml/min/1.73m2

Other protocol defined inclusion/exclusion criteria may apply
Peri-operative rATG-perfusion of Solid Transplants

The increasing demand for organ transplantation and the shortage of available organs limit the success of organ transplantation programs. Consequently, acceptance of expanded criteria donor (ECD) organs with the consequences of higher risk of unfavorable transplantation outcome has become an increasing reality. Among the most prominent characteristics distinguishing ECD from Standard Criteria Donors (SCD) are risk factors including brain death (BD) or prolonged cold ischemia time (CI) amplifying ischemia reperfusion injury (IRI). Currently there are no standard regimens to improve the quality of ECD organs. Therefore, donor organ treatment might be a promising approach to substantially improve organ quality. It will be investigated whether the application of the peri-operative perfusion of kidneys and livers with the polyclonal antibody rabbit antithymocyte globulin (rATG) ameliorates IRI.

This trial is designed as a parallel armed randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* patients receiving a kidney or liver transplant from deceased donors

Exclusion Criteria:

* Hepatitis C Virus/Human Immunodeficiency Virus, undergoing re-transplantation or under a public guardian
Build a Decision Aid Tool to Help Emergency Intensive Care Specialists in the Context of Hypoxic Ischemic Encephalopathy

The project aims at designing a machine learning solution able to recognize characteristics signals patterns of brain damages in full term babies born within a context of Hypoxic Ischemic Encephalopathy (HIE)

Retrospective study based on a digital EEG signal library intending to design, train and test an efficient AI solution for hypothermia protocol start indications.

The output of the Project is to make available to pediatric resuscitation units an adequate tool to guide them in the decision of hypothermia protocol start in a general context of neurophysiologist competence scarcity. EEG signal that would allow the algorithm design will be based on several parameters of the conventional EEG and not only on signal amplitude

Eligibility Criteria:
Inclusion Criteria:

* Full term (\> 36 weeks)
* HIE context
* EEG recording before 6 hours of life

Exclusion Criteria:

-Opposition of parental authority holders of a patient born after 2015
Study to Investigate Relative Bioavailability of up to Five Different Formulations of AZD5069

Study to investigate relative bioavailability of up to five different formulations of AZD5069

An Open-label, Single Centre Relative Bioavailability Study With an Adaptive Design Comparing up to 5 Solid Oral AZD5069 Formulations After Single Dose Administration to Healthy Volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and/or female volunteers aged 18 to 50 years (inclusive).
2. Non-smokers or ex-smokers with no smoking history for the last 3 months prior to screening.
3. Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at screening; minimum (min) weight 50 kg and maximum (max) weight 100 kg.
4. Healthy volunteers with neutrophil counts within the laboratory range at screening.

   -

Exclusion Criteria:

1. A definite or suspected personal history of severe allergy, intolerance or hypersensitivity or ongoing allergy to drugs with a similar chemical structure or class to AZD5069 and/or the excipients, as judged to be clinically relevant by the Investigator.
2. Healthy volunteers who have previously received AZD5069.
3. Volunteers with latent tuberculosis as suggested by their history and judged by the Investigator; confirmatory testing with eg, Quantiferon(R) -TB Gold may be done if required.
4. Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to the first administration of the IP -
A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting

The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if Cysview and blue light is safe and effective when used repeatedly.


Eligibility Criteria:
1. Patients with bladder cancer in follow-up for tumor recurrence (Note: Patients must be included only at the first surveillance cystoscopy after a histologically confirmed tumor. The histologically confirmed tumor could either be from a TURB or from a surveillance cystoscopy where a biopsy was taken and a tumor was confirmed by histology)
2. History of one or more of the following:

   * Multiple tumors
   * Recurrent tumors
   * High grade tumor(s)

Exclusion Criteria:

1. Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in significant amounts of blood in the urine, which may visually limit cystoscopy. Where the haematuria is light, the patient should not be excluded, if in the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will alleviate the haematuria limitations to cystoscopy)
2. Patients who cannot undergo in-office or operating room cystoscopy (Note: Training patients are eligible even if they cannot undergo operating room cystoscopy)
3. Patients who have received Bacillus Calmette-Guérin (BCG) immunotherapy or intravesical chemotherapy within the past 6 weeks prior to the procedure
4. Porphyria
5. Known allergy to hexaminolevulinate hydrochloride or a similar compound
6. Pregnancy or breast-feeding (all women of child-bearing potential must document a negative urine pregnancy test before study inclusion and use adequate contraception during the study
7. Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days
8. Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
9. Patients that the investigator believes are unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the clinical study, uncooperative attitude or unlikelihood of completing the study
Stage III NSCLC RWE in Chinese Patients

The objectives of this study are to assess molecular testing, treatment patterns and associated clinical outcomes in Chinese patients with treatment-naïve stage III non-small cell lung cancer (NSCLC) in real world setting. This study is a prospective, non-interventional study. It is descriptive in nature and does not attempt to test any specific a priori hypotheses.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older.
* Provision of informed consent prior to any study specific procedures.
* Histologically or cytologically confirmed locally advanced, stage III NSCLC (according to version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology; IASLC Staging Manual in Thoracic Oncology).

Exclusion Criteria:

* Enrolment in studies that prohibit any participation in this observational study.

  * Patients may be concurrently enrolled in unblinded clinical trials, but not blinded clinical trials in which the treatment being administered is unknown.
* Prior surgery, radiotherapy or systemic therapy for NSCLC, including chemotherapy, targeted therapy, anti-angiogenesis, etc.
Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger

This study will investigate the efficacy and safety of ravulizumab compared to placebo in adult participants with thrombotic microangiopathy (TMA) associated with a trigger. Participants will be randomized to receive either ravulizumab plus best supportive care or placebo plus best supportive care. The treatment period is 26 weeks followed by a 26-week off-treatment follow-up period.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Body weight ≥ 30 kilograms
3. Female participants of childbearing potential and male participants with female partners of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab
4. TMA associated with a trigger (autoimmune disease, infection, solid organ transplant, drugs, and malignant hypertension)
5. Vaccinated against meningococcal infection (Neisseria meningitidis), within 3 years prior to, or at the time of, randomization. Participants who initiate study drug treatment less than 2 weeks after receiving a meningococcal vaccine must receive appropriate prophylactic antibiotics for at least 2 weeks after the vaccination. If participant cannot receive the meningococcal vaccine, then participant must be willing to receive antibiotic prophylaxis coverage against N. meningitidis during the entire Treatment Period and for 8 months following the final dose of study drug. Additional vaccination (Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae) may be considered based on individual patient condition.

Exclusion Criteria:

1. Any known gene mutation that causes atypical hemolytic uremic syndrome (aHUS)
2. Postpartum aHUS
3. Known chronic kidney disease
4. TMA due to hematopoietic stem cell transplantation ≤ 12 months of Screening
5. Primary and secondary glomerular diseases other than lupus
6. Diagnosis of primary antiphospholipid antibody syndrome
7. Shiga toxin-producing Escherichia coli infections including but not limited to Shiga toxin-related hemolytic uremic syndrome
8. Known familial or acquired 'a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13' (ADAMTS13) deficiency (activity \< 5%)
9. Positive direct Coombs test which in the judgement of the Investigator is indicative of a clinically significant immune-mediated hemolysis not due to TMA
10. Clinical diagnosis of disseminated intravascular coagulation (DIC) in the judgement of the Investigator
11. Presence of sepsis requiring vasopressors within 7 days prior to or during Screening
12. Presence of monoclonal gammopathy including but not limited to multiple myeloma
13. Known bone marrow insufficiency or failure evidenced by cytopenias
14. Unresolved N. meningitidis infection
15. History of malignancy within 5 years of Screening with the exception of nonmelanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence
16. Use of any complement inhibitors within the past 3 years
17. Respiratory failure requiring mechanical ventilation
Supplementation With Vitamin D to Patients With Heart Failure (D-Heart).

In 200 patients with documented systolic heart failure give supplementation with vitamin D in those with a 25-OH- vitamin D \< 50nmol/L - or placebo.

In those with a vitamin D level \<25nmol/L a substitution of 2400IU will be given, and in those with a vitamin D level 25-50nmol/L a substitution of 1600IU will be given.

Intervention time 12 months. Biomarkers of heart function, quality of life, and hospitalisation will be analysed.

In a population with a systolic heart failure with an EF\<40%, the levels of vitamin D will be analysed. In those with a 25-OH-vitamin D level \<50nmol/L the patients that accept participation, will be randomised into active supplementation as described below, or placebo.

* In those with a 25-OH-vitamin D level \<25nmol/L there will be a supplementation of 2400IU daily
* In those with a vitamin D level 25-50nmol/L there will be a supplementation of 1600IU daily,
* or placebo. Thus based on the basal level of vitamin D the screened patients will either be excluded due to high level of vitamin D, or given one ot the two options of vitamin D dosage based on the basal patient level - or placebo.

The intervention time will be 12 months. In the project 200 heart failure patients will be included. Blood samples including heart failure biomarkers, and biomarkers for inflammation and oxidative stress will be drawn at 3,6, 9 and 12 months.

Health related quality of life will be evaluated by use of Euro-QoL-5D Minnesota Living with Heart Failure.Patient Health Questionnaire-9 Multidimensional Fatigue Inventory 20 questionnaire, as also hospitalisation during the project time.

Cardiac function according to echocardiography will be analysed at start, and study end.

Eligibility Criteria:
Inclusion Criteria:

* Patients with documented and stable systolic heart failure and connected to an outpatient clinic at the Dept of Cardiology in Linköping, or Jönköping, Sweden, and with a 25-OH-vitamin D \<50nmol/L

Exclusion Criteria:

* Patients with unstable heart failure
* Patients with significant valvular disease, or ischemic heart disease planned for operation
* Patients with significant renal or /and liver impairment.
* Patients that do not understand that study information, or that are not willing to participate
A Study of Pharmacokinetics (PK) and Pharmacodynamics (PD) in Relation to Prednisolone in Healthy Males

The purpose of this study is to evaluate the safety, PK, PD, of BMS-791826 and to assess its marker specific PD in relation to Prednisolone in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive
* Signed informed consent

Exclusion Criteria:

* Sexually active fertile men not using effective birth control (barrier contraception) if their partners are women of childbearing potential (WOCBP)
* Any significant acute or chronic medical illness
* History of Gilbert's disease

Other protocol inclusion/exclusion criteria may apply
Bridge-Enhanced ACL Repair vs ACL Reconstruction

The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction.

Enrolled patients will be randomized to either the Bridge-Enhanced ACL Repair (BEAR) technique (new treatment) or an ACL reconstruction (current gold standard of treatment).

Eligibility Criteria:
Inclusion Criteria:

* Age: 14 to 35 years of age.
* Sex: Both male and female
* ACL: Complete tear
* Time from injury to surgery: ≤45 days
* MRI: ACL tissue present on pre-operative MRI - at least 50% of the ACL length must still be attached to the tibial plateau

Exclusion Criteria:

* Prior surgery on affected knee
* Prior joint infection on affected knee
* Regular use of tobacco or nicotine
* Use of corticosteroid within last 3 months
* History of chemotherapy treatment
* History of sickle cell disease
* History of anaphylaxis
* Any condition that could affect healing or infection risk (Diabetes, inflammatory arthritis, etc)
* Operative posterolateral corner injury (LCL complete tear, Biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament)
* Grade III medial collateral ligament injury
* Complete patellar dislocation
* Known allergy to bovine, beef or cow products
Evaluation of Emergency Department Visits and Activity : Study

The main objective will be to evaluate the type of care performed and the main reasons for consulting patients for an odontological emergency in order to better adapt to the flow and expectations of patients.


Eligibility Criteria:
Inclusion criteria:

- All adults (\>18years) consulting in the emergency department (Montpellier University Hospital)

Exclusion criteria:

* person under 18 years old
* patients who does not speak French
Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients

Reports of the use of plasma from convalescent patients and purified immunoglobulin preparations in respiratory infections by various viral agents and SARS-CoV-2 in severely ill patients suggest that specific neutralizing antibodies may benefit their clinical course. During the previous SARS-CoV epidemic in 2003, preparations of hyperimmune equine serum were produced and demonstrated in vitro viral neutralization. These preparations were also successful in several animal models. Taking advantage of the important trajectory of our country in the study and use of equine hyperimmune serums with neutralizing antibodies for snake venom, preparations of hyperimmune serums against recombinant proteins of SARS-CoV-2 were produced through repeated immunization of horses, a first group of animals was inoculated with the "S" (Spike) protein of the virus and the second group with a mixture "M" of the S1 (Spike) proteins, the N (Nucleoprotein) protein and a construct with epitopes of the S1, E (Envelope) and M (Membrane) proteins, generating two different pharmaceutical preparations.

Objective: Evaluate the efficacy and safety of two hyperimmune equine serum anti-Sars-CoV-2 ("S" and "M") formulations as an addition to the standard therapeutic approach for hospitalized patients with COVID-19 over 18 years of age with the presence of at least 2 risk factors and a symptom onset period not exceeding 10 days.

A total of 52 patients will be included and randomly divided into two balanced groups. On day 1, all participants from each group will receive an intravenous infusion containing 10ml (one vial) of hyperimmune equine anti-Sars-CoV-2 serum labeled as A or B.

Patients will be evaluated clinically, general laboratory, SARS-CoV-2 serologies, SARS-CoV-2 viral load and cytokines level as well as pulmonary ultrasound. Data will be collected for both groups on Days 0 to 7, 10 and 14 or discharge after completion of treatment. The study will end for each participant on the day of discharge from the hospital.


Eligibility Criteria:
Inclusion Criteria:

* Agreement to participate in the study by signing the prior informed consent.
* Age over 18 years.
* Inpatient with RT-PCR confirmation of SARS-CoV-2.
* Period of onset of symptoms related to COVID-19 not greater than 10 days
* Presence of at least 2 documented risk factors
* Moderate and severe clinical presentation of the disease.

Exclusion Criteria:

* Patients who did not sign the Informed Consent.
* Critical patient.
* Patient previously bitten by a snake that was treated with equine hyperimmune serum.
* Patients with COVID-19 on an outpatient basis.
* Pregnant women.
* Patients in Hemodialysis program.
* Patients who have already received plasma from a convalescent COVID-19 patient.
* Patients who were classified prior to the diagnosis of COVID-19 by the treating physician as having a reserved prognosis with a short lifespan.
Clinical and Laboratory Characteristics of Patients Admitted With Syncope; Diagnosis and Follow up After These Patients

The investigators hypothesis is that a significant number of patients may remain without specific cause and have recurrent syncope with its associated physical and mental morbidity.

1. Patients with diagnosis of syncope who were admitted to the medical ward will be interviewed and their charts reviewed to rule in or out the diagnosis of syncope.
2. Assess physical and mental injury as a result of syncope.
3. The lab workup will be documented including;

   1. - Routine blood tests.

      * troponin level.
   2. - ECG.

      * Echocardiogram
      * Brain CT.
      * EEG.
      * U/S doppler of carotids.
      * Tilt tests.
4. At the time of diagnosis the final diagnosis will be documented including recommendations for patients to prevent syncope after discharge.
5. Follow up after patients by phone verifying recurrence of syncope and resulting physical and or mental injury if any.

Eligibility Criteria:
Inclusion Criteria:

* patients with diagnosis of syncope on admission to the medical ward.

Exclusion Criteria:

* patients with loss of consciousness due to other than low perfusion of the brain
* patients that can't sign a consent form
* patients that we can't get details about the episode of the syncope