cyrilzakka/clinical-trials huggingface dataset:
A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects 18 to 70 years of age
* Chronic HCV infection for at least 6 months prior to Baseline (Day 1)
* Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis
* Monoinfection with HCV genotype 1a or 1b
* HCV treatment-naïve
* Body mass index (BMI) between 18 and 36 kg/m2
* Creatinine clearance \>/= 50 mL/min
* Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
* Screening laboratory values within defined thresholds for ALT, AST, leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH), potassium, magnesium

Exclusion Criteria:

* Autoimmune disease
* Decompensated liver disease or cirrhosis
* Poorly controlled diabetes mellitus
* Severe psychiatric illness
* Severe chronic obstructive pulmonary disease (COPD)
* Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
* Suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers)
* History of hemoglobinopathy
* Known retinal disease
* Subjects who are immunosuppressed
* Subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse
* Subjects who are on or are expected to be on a potent cytochrome P450 (CYP) 3A4 or Pgp inhibitor, or a QT prolonging medication within 2 weeks of Baseline (Day 1) or during the study
* Subjects must have no history of clinically significant cardiac disease, including a family history of Long QT syndrome, and no relevant electrocardiogram (ECG) abnormalities at screening
Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM)

This is a randomized, controlled, open, three-armed, multi-centre study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on anthropometric parameters, metabolic syndrome, infectious, immunological profile, cardiovascular system, bone mass and quality of life in patients affected by primary or secondary adrenal insufficiency.

Hypocortisolism is a disease with more than 80% 1-year mortality before the availability of synthetic glucocorticoids. Current replacement therapy has improved this dramatically, but recent data suggest that outcome is still compromised. Patient receiving conventional glucocorticoids therapy have compromised quality of life, reduced bone mass, increased risk factors for cardiovascular disease, infectious, tumors and premature mortality that is more than twice the mortality rate in the background population. Circulating cortisol levels follow a distinct diurnal pattern with high levels in the early morning and low trough values around midnight. Using available formulations for replacement therapy this circadian rhythm is had to mimic and also during the active time of the day high peaks and low troughs occur.

In this trial a dual-release hydrocortisone preparations that has in healthy volunteers been able to mimic the circadian pattern of circulating cortisol was studied in patients with primary and secondary adrenal insufficiency.

Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed (e.g. more than 6 months ago) primary or secondary adrenal insufficiency with a stable daily glucocorticoid substitution dose for at least 3 months prior to study entry
* Signed informed consent to participate in the study

Exclusion Criteria:

* acute primary or secondary adrenal insufficiency
* clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepatobiliary, pancreatic disease
* clinically significant renal dysfunction
* any medication with agents which could interfere with glucocorticoid kinetics
Lesion Sterilization And Tissue Repair Versus Zinc Oxide And Eugenol For Treatment of Necrotic Primary Molars

The aim of this study is to evaluate the clinical and radiographic success of Lesion Sterilization And Tissue Repair \[ LSTR\] antibiotic paste versus Zinc Oxide and Eugenol pulpectomy in the treatment of non-vital primary molars.

Primary teeth with infected root canals are a common problem, particularly in patients where the infection has reached the peri radicular tissues .

Among the pastes used in the pulp therapy of primary teeth with pulp necrosis, zinc oxide and eugenol paste has been a reference in dentistry since 1930. Endodontic treatment using zinc oxide and eugenol paste has shown satisfactory clinical and radiographic results, requires mechanical chemical preparation before filling root canals.

The main difficulties of endodontic treatment of primary molars are related to the anatomical complexity of the root canals and the long time needed to carry out the treatment. The additional difficulty involved in diagnosing root resorption is a limiting condition for determining the actual working length and instrumentation.

Other pastes have been studied, such as those containing antibiotics in their composition, thus dispensing with root canal instrumentation (such as lesion sterilization and tissue repair using triple antibiotic paste in treatment of non-vital primary molars.

Lesion sterilization and tissue repair using triple antibiotic paste has relevant clinical and radiographic success rates in treatment of non-vital primary molars.

Eligibility Criteria:
Inclusion Criteria:

* Children:

  1. Aged between 5 years and 7 years.
  2. With deep caries involving pulp in primary molars.
* Teeth:

  1. Necrotic teeth with or without periapical or furcal lesions.
  2. Primary molars with minimal root resorption not more than 1/3 of root.

Exclusion Criteria:

* Children:

  1. Children with systemic disease
  2. Previous history of allergy to antibiotics used in the study.
  3. Children that will not attend follow up.
* Teeth:

  1. Caries in primary teeth exhibiting pre-shedding mobility.
  2. Non restorable teeth.
Early Identification of Sepsis in Children

This observational nation-wide study is focused on evaluation of the new possible biomarkers for pediatric sepsis and their specificity/sensitivity in combination with usual diagnostic markers for sepsis in the terms of early identification of sepsis, severe sepsis, and septic shock.

The understanding of sepsis pathophysiology underwent a great progress during the last decades and the therapy of sepsis is in the focus of the research for many years, but sepsis is still one of the main causes of death in the ICUs around the world. Systemic inflammatory response syndrome (SIRS) is closely connected with the sepsis development, but SIRS also represents a high risk of organ dysfunction in non-infectious patients (trauma, stress, cardiopulmonary arrest). Early diagnosis and prevention of the organ dysfunction are the mainstay of the correct and timely therapy, but currently there is no reliable, quick and simple method for the diagnosis of sepsis. And also there is no generally accepted clinical or laboratory parameter, which can be used to differentiate between sepsis and SIRS.

There are some commonly available biomarkers that showed promising results in critically ill adult patients. Those include immature platelet fraction (IPF), immature granulocytes (IG) count and nucleated red blood cells (NRBC) count. The knowledge of their variability in different phases of illness (SIRS/sepsis/severe sepsis/septic shock) in pediatric patients is very limited, as is their connection with other generally used markers of infection (CRP, procalcitonin, presepsin).

This study is strictly non-interventional and focused on usability of above mentioned biomarkers in the early diagnosis of sepsis/SIRS and on the reduction of morbidity/mortality of pediatric intensive care unit (PICU) patients with sepsis/SIRS.

In all patients admitted to PICU in selected study period, the inflammation markers - C-reactive protein (CRP), procalcitonin (PCT), presepsin (soluble cluster of differentiation 14-subtypes) and full blood count parameters -IPF,IG,NRBC will be measured at the time of admission and on 3rd, 5th and 7th day of stay in intensive care. The organ dysfunction score will be evaluated daily.

Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to PICU until the 18th year of age
* expected length of stay \> 48 hours

Exclusion Criteria:

* oncology patients
* immunosuppressive therapy
* immunostimulant therapy
* autoimmune disease
* post-organ transplant patient
* thrombocytopaenia, thrombocytopathy
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose treatment with MK-1029 in adults with mild to moderate persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* If female, must be of non-childbearing potential
* Have a history of mild to moderate asthma for at least 6 months
* Other than asthma, in general good health
* Able to perform reproducible pulmonary function testing
* Is a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 12 months
* Have body mass index (BMI) ≥17 kg/m\^2, but ≤35 kg/m\^2

Exclusion Criteria:

* Demonstrate a decrease in absolute forced expiratory volume in 1 second (FEV1) of \>20% from the Screening Visit to the Baseline Visit
* Experience a decrease in AM or PM peak expiratory flow (PEF) below the Stability Limit on any 2 consecutive days prior to the Baseline Visit
* Require the use of \>8 inhalations per day of short-acting beta2-agonist metered dose inhaler (MDI) or \>2 nebulized treatments per day of 2.5 mg albuterol, on any 2 consecutive days from the Screening Visit up to the Baseline Visit
* Experience an exacerbation defined as a clinical deterioration of asthma, as judged by the clinical investigator, that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded medication (other than short-acting beta agonists \[SABA\]) at any time from the Screening Visit up to the Baseline Visit
* Have been hospitalized for treatment of asthma or required oral corticosteroids for treatment of asthma within the past 6 months, or has ever required ventilator support for respiratory failure secondary to asthma
* Require the chronic use of high-dose inhaled corticosteroids
* Have been diagnosed with chronic obstructive pulmonary disease (COPD) or any other clinically relevant lung disease, other than asthma
* Have a history of any illness that might confound the results of the study or poses additional risk to the participant
* Have had recent (within 4 weeks of first dose) or ongoing upper or lower respiratory tract infection
* Is nursing
* Have a history of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART

This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA \< 50 copies/ml (PCR) and CD4 levels \> 400.


Eligibility Criteria:
1. Adults at least 18 years of age.
2. CD4 cell count of \> 400 cells.
3. Plasma HIV-1 RNA \< 50 copies/ml on two occasions: one within the six weeks prior to starting Baseline and the other during Baseline.
4. History of virologic success with suppression of HIV RNA level \< 50 copies/ml during the last nine months documented a minimum of two times during the last ten months or a minimum of three times during the last fifteen months while patient is receiving a HAART regiment. During the four months prior to starting Baseline, continuing through Baseline and the 64 week study period, the HAART regimen must remain unchanged and contain at least one of the following ten anti-retroviral drugs:

   * Abacavir (Ziagen)
   * Zidovudine (Retrovir) AZT
   * Zalcitabine (Hivid) ddC
   * Didanosine (Videx) ddl
   * Stavudine (Zerit) d4T
   * Efavirenz (Sustiva)
   * Indinavir (Crixivan)
   * Ritonavir (Norvir)
   * Nelfinavir (Viracept)
   * Amprenavir (Agenerase)

   Only one HIV plasma RNA level \> 50, but \< 100 copies/ml is permitted during the four month period immediately prior to starting Baseline.
5. Karnofsky performance status of at least 70.
6. The following laboratory parameters within 21 days prior to treatment:

   * Hemoglobin \> 9.2 g/dL for men and \> 8.9 g/dL for women;
   * Neutrophil count \> 1000;
   * Platelet count \> 75,000;
   * AST/ALT \< 4.0 x upper limit of normal (ULN);
   * Serum creatinine \< 1.5 x ULN or a creatinine clearance \> 50 mL/min.
7. Ability and willingness to give written informed consent.
8. For females with child bearing potential: A negative serum pregnancy test within 14 days prior to randomization. Females of child bearing potential agree to use an effective means of contraception.
9. The patient must have completed any elective routine immunizations (including influenza vaccination) eight or more weeks prior to first dose of study drug.
The Effect of Glucose-Insulin-Potassium Infusion in Patients Undergoing Cardiac Surgery

The purpose of this study is to evaluate the cardioprotective effects of a short term infusion of glucose-insulin-potassium (GIK) during heart surgery.

Cardiac surgery with cardiopulmonary bypass and ischemic cardiac arrest is associated with a wide spectrum of perioperative myocardial ischemic-reperfusion injuries resulting in significant cardiac morbidity, namely contractile dysfunction, myocardial infarction, and low cardiac output syndrome requiring prolonged intensive care and hospital stay. The infusion of glucose-insulin-potassium (GIK) is one of the oldest cardioprotective interventions during cardiac surgery. Although experimental evidence is strong, clinical data remain conflicting. We will investigate the impact of short term GIK on the extent of myocardial injuries as well as on the left-ventricular systolic and diastolic function in 2 high-risk groups of cardiac surgical patients: Patients with cardiac dysfunction undergoing aortocoronary bypass surgery and patients with severe aortic stenosis.

Eligibility Criteria:
Inclusion Criteria:

* Severe aortic stenosis
* Coronary artery disease associated with poor left ventricular function
* Parsonnet score \>7

Exclusion Criteria:

* Dementia or inability to understand the study protocol
* Off-pump and emergent cardiac surgery
* Poorly controlled diabetes mellitus
* Severe renal insufficiency
* Abnormal liver function Child-Plugh - C
* Body Mass Index \< 18 and \> 35
MRI STUDY OF THE LPEC

Cricoid pressure is still considered as a standard of care in order to prevent the gastric regurgitation in full stomach surgery1.

However, this attitude has been challenged in several case reports as oesophageal rupture, difficult intubation, and even failing to occlude the oesophagus. Moreover, in a large prospective randomized study , this maneuver has failed to show a definite benefit2.

The lateral deviation to the left of the oeso deviate to the left side3,4 has led to the description of a new maneuver to compress directly the oesophagus at the low left paratracheal level. This maneuver has been shown to prevent gastric air insuflation during the ventilation.

In the present study, the investigators aim to asses with an magnetic resonance imaging the compressibility of the oesophagus.


Eligibility Criteria:
Inclusion Criteria:

* Adults Volunteers

Exclusion Criteria:

* Pregnancy
* Claustrophob
* Thyroid goiter
Effects of Opioids and NSAIDs on Sympathetic Nervous System and Vascular Function

Evaluation of the effect of different analgesic treatments (Tramadol, Paracetamol, Diclofenac) on sympathetic nerve activity, blood pressure, heart rate, heart rate, and vascular function in osteoarthritis patients and healthy subjects.

Hundreds of millions of patients worldwide require pain-relieving therapy to maintain an acceptable quality of life. Pain relievers, including non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, however, exert unwanted potent adverse systemic off-target effects and their use is associated with a well-documented excess of cerebrovascular and cardiovascular events. This of particular concern for the one fourth of the world's population aged over 35 years suffering from chronic pain, particularly with arthritis of whom half also present with established or at high risk of cardiovascular disease. This uncertainty around the cardiovascular safety of pain relieving drugs leaves practitioners and their patients with difficult management decisions and underscores the need to investigate potential differential cardiovascular effects of NSAIDs and opioids and to better delineate the underlying mechanisms involved. Indeed, currently available NSAIDs invariably disrupt the balance between prostacyclin and thromboxane, but may also exert multiple and opposing cardiovascular effects on endothelial factors, including nitric oxide and reactive oxygen species, the sympathetic nervous system and vascular inflammation. Intriguingly, the net effect of pain relieving drugs on vascular function and sympathetic nerve activity and its resulting deterioration of blood pressure control is increasingly recognized as a major possible determinant in explaining the cardiovascular side effects of NSAIDs. As a result of the ongoing concerns around the cardiovascular safety of NSAIDs and coxibs many patients are being withheld effective pain relieve or switched to opioids and/or paracetamol under the assumption of their yet unproven greater cardiovascular safety. The absence of evidence about the cardiovascular safety of these drugs presents a major dilemma for patients and physicians, who have been warned about the toxicity of NSAIDs.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years of age, male or female, with a diagnosis of osteoarthritis or healthy subjects ≥ 18 years of age;
2. Written informed consent;

Exclusion criteria:

1. History of hypersensitivity or allergy to any of the study drugs
2. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to Visit 1;
3. Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 3 months after Visit 1;
4. Presence of significant endocrine diseases;
5. Presence of active acute infectious diseases;
6. Known narrow-angle glaucoma;
7. Known epilepsy;
8. Cimino-shunt operation on both arms;
9. Pregnancy, intention thereof during study, lack of sufficient contraception, breastfeeding;
10. Drug or alcohol abuse;
Counter-Regulatory Impairment and the Effect of Microvascular Insulin Transfer in Type 1 Diabetes Mellitus

The researchers plan to test the following hypothesis:

A good level of glucose control in Type 1 Diabetes Mellitus (T1DM) is dependent on two levels of feedback from the body:

1. the transport of insulin through small blood vessels: suggesting that hypoglycemia leads to increased insulin sensitivity which then causes recurrent hypoglycemia;
2. the endocrine level, defined as insulin-glucose interaction and hormonal counter-regulation.

The researchers plan to investigate the relationships between hypoglycemia, insulin transport, and counter-regulation. This study will ultimately lead to a better understanding of risk for recurrent hypoglycemia.


Eligibility Criteria:
Inclusion Criteria:

* Participated in and satisfied all of the inclusion criteria of NCT00315939
* 18 years of age or older
* Have Type 1 Diabetes Mellitus defined by American Diabetes Association criteria or judgment of physician
* Since our major goal is the investigation of hypoglycemia, we will preferentially recruit patients with a history of severe hypoglycemia/moderate hypoglycemia anticipating that approximately (\~) half of the recruited subjects will have had two or more severe or moderate hypoglycemia episodes in the past 12 months

Exclusion Criteria:

* Age \< 18
* Pregnancy
* Use of oral steroids
* Hematocrit \< 36% (females); \< 38% (males)
* Symptomatic heart disease (e.g., history of myocardial infarction, history of coronary bypass or stenting procedure, angina, episode of chest pain of cardiac etiology with documented EKG changes, positive stress test or catheterization with coronary blockages \> 50%)
* History of an ischemic cerebrovascular event
* Active substance abuse
* Psychosis
* Mental retardation
* Severe depression
Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients

This is a retrospective observational cohort study, the primary objective is investigate the activity and efficacy of anti PD-1 antibodies in children, adolescents and young adult melanoma patients, with radically resected or metastatic disease

The aim of the study is to evaluate the activity and efficacy of anti PD-1 antibodies in adolescent, childhood and young adult with early and advanced melanomas through a multicenter transnational European retrospective analysis Clinical outcomes will be retrospectively retrieved beginning from the primary diagnosis of melanoma. Clinical outcomes will be retrospectively evaluated starting from the time of start of treatment for up to a the most recent follow-up. Data collected will include demographic information, disease history, baseline conditions, clinical outcomes of interest.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of either sex aged ≥ 12 years;
2. Histologically confirmed melanoma;
3. Anti PD-1 Immunotherapy (Ipilimumab plus Nivolumab);
4. Previous and subsequent treatments will be collected;
5. Clinical and follow-up data available

Exclusion Criteria:

1. No immunotherapy received;
2. No melanoma;
3. Age \> 30 yrs