cyrilzakka/clinical-trials huggingface dataset:
An Efficacy and Safety Study of Telaprevir in Patients With Genotype 1 Hepatitis C Infection After Liver Transplantation

The purpose of this study is to evaluate the effectiveness of telaprevir in combination with Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C virus (HCV) genotype 1.

This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination.

Eligibility Criteria:
Inclusion Criteria:

* First time liver transplant recipient whose primary pre-transplant diagnosis was chronic hepatitis C genotype 1
* More than 6 months to 10 years post-liver transplant
* Patient did or did not receive treatment for HCV prior to liver transplantation
* Patient must agree to have a liver graft biopsy during the screening period unless they had a biopsy within three months of the screening period (for patients between 6 months and one year post transplant) or within six months of the screening period (for patients who are more than one year post transplant)
* A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of ribavirin

Exclusion Criteria:

* Patient is currently infected or co-infected with HCV of another genotype than genotype 1
* Patient received treatment for hepatitis C following liver transplantation
* Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
* Patient with human immunodeficiency virus or hepatitis B virus co-infection
* Patient with active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma)
A Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers

A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers.

The study will evaluate minimum of 2 dose levels of AB680 in 8 participants per cohort. Cohorts will be gender-balanced to the extent possible, and will be randomized 3:1, active vs placebo, respectively.

The participants will be closely observed for the first 48 hours following drug administration to monitor the general tolerability of AB680.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged 18 to 55 years, inclusive, at screening
* Body mass index 18 to 32 kilograms/m\^2 inclusive
* Willing and able to sign informed consent
* Negative tests for hepatitis B surface antigen, anti-hepatitis C virus, and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening
* Healthy as determined by pre-study screening

Exclusion Criteria:

* History of clinically significant drug and/or food allergies
* Positive drug and alcohol screen at screening and (each) admission to the clinical research center.
* Participation in a drug study within 60 days prior to (the first) drug administration in the current study. Participation in more than 4 other drug studies in the 12 months prior to (the first) drug administration in the current study
* Participants who have significant infection or known inflammatory process on screening or admission
Minocycline Treatment for Cystoid Macular Edema

Cystoid macular edema (CME) is one of sight-threatening, immune-related ocular diseases. The efficacy of current treatments for CME (anti-VEGF, glucocorticoids and other agents) are limiting. Minocycline, acting as a broad-spectrum antibiotic, is among tetracycline family and recently, its immunomodulatory and anti-apoptosis function has been replied to several immune diseases and degenerative diseases. This study aims to explore the efficacy and safety of minocycline for CME.


Eligibility Criteria:
Inclusion Criteria:

* Participant diagnosed with CME.
* Participant aged from 18-60 years old.
* Participant that signed the informed consent document and is able to complete the following visits.

Exclusion Criteria:

* Participant is allergy to minocycline or tetracyclines.
* Participant has no contraindications of minocycline or tetracyclines.
* Participant has an abnormal function of liver, heart, kidney and thyroid.
* Female that is pregnant, breast-feeding or planning to become pregnant.
* Participant that is currently using other medications.
Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Neurocritical Patients

Neurocritical ill patients are frequently transfused. Red blood cell transfusion (RBCT) in these patients has been associated with deleterious effects, including higher rates of nosocomial infections, multi-organ failure, and mortality. Therefore, it seems crucial to avoid any unnecessary RBCT.

Most critically ill patients tolerate hemoglobin levels near 7 g/dL without an increase in morbidity or mortality rates. In this regard, a recent sub-analysis of TRICC trial has showed that TBI patients may tolerate hemoglobin levels as low as 7 g/dL, but other studies including neurocritical patients suggested that severe anemia may worsen clinical outcome. Therefore, optimal hemoglobin levels in neurocritical care patients remain largely unknown. Some textbooks and guidelines recommend to transfuse these patients to reach hemoglobin levels near to 10 g/dL, despite the lack of a solid scientific background supporting this target.

Even though it has not been demonstrated, hemoglobin-based RBCT prescription could result in over- or under-transfusion in neurocritical patients. Alternatively, it has been suggested that more physiological transfusion triggers, using direct signals coming from the brain, will progressively replace arbitrary hemoglobin-based transfusion triggers in the neurocritical patients \[65\]. At the neurocritical units, patients are often monitored by using non-invasive methods, such as near infrared spectroscopy which indirectly measures regional cerebral oxygen saturation (rSO2). Changes in rSO2 values have been shown to directly correlate with changes in erythrocyte mass, thus increasing with RBCT and decreasing with blood losses. Moreover, rSO2 values also show a good correlation with clinical outcome and other variables which are often monitored in TBI patients.

The purpose of this study is to ascertain as to whether rSO2 levels are more efficacious than conventional hemoglobin levels in guiding RBCT in patients admitted to a neurocritical care unit.


Eligibility Criteria:
Inclusion Criteria:

* Severe traumatic brain injury (Glasgow coma scale \< 9), subarachnoid hemorrhage (Hunt and Hess scale ≥ 3) or intracranial hemorrhage
* Moderate anemia. Hemoglobin levels \> 7 g/dL and \< 10 g/dL
* Hemodynamical stability (mean arterial pressure \> 75 mm Hg)
* Respiratory stability (PaO2 / FiO2 ratio \> 220)
* Expected length of ICU stay \> 3 days

Exclusion Criteria:

* Patient's relatives' refusal to patient's inclusion in the study
* Active bleeding
* Ongoing need for blood products
* Patients necessitating ongoing resuscitation
* End-stage in which death is imminent
* Antecedents of angina or myocardial infarction (poor cardiopulmonary reserve)
* Deficient signal of rSO2 impeding its proper valuation
A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)

This study is to prove that there is no difference in the number of healthy male volunteers that will experience pyrexia (i.e. fever with body temperature of 38°C or higher) within a 24 hour period after administration of a single dose of 6mg/kg of PF-05280014 or trastuzumab sourced from the United States (trastuzumab-US). The study will also compare the safety of both drugs.

Safety evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kg\^m2; and a total body weight \>50 kg (110 lbs).
* Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiogram (ECHO) within 8 weeks prior to randomization.
* Subjects who have previously been exposed to a biologic agent (other than a HER2 inhibitor) may enroll provided that at least 3 months have passed since the last administration of that drug.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Previous exposure to an anti-HER2 antibody.
* History of serious allergic or anaphylactic reaction to a therapeutic drug or benzyl alcohol.
Retinal Metabolic Imaging in a Diverse Population

This research project aims to evaluate use in a clinical context of a novel imaging instrument, the Metabolic Hyperspectral retina Camera (MHRC) from Optina Diagnostics. This camera enables the acquisition of retinal images at multiple colors (up to 100 specific colors) and therefore extract way more information that can be captured with a conventional retinal camera (up to 3 colors). This additional color information available for each pixel of the image could be useful to identify signs of pathologies having manifestations in the retina. The performances of this new prototype camera will be evaluated and the acquisition procedures optimized in a diverse population of subjects.

Hyperspectral retinal imaging results from several consecutive images taken while the filter scans a wide spectral range to obtain one spectrum for each image pixel. The combination of imaging and spectroscopy offered by hyperspectral imaging makes it possible to identify and quantify several specific biomolecules in the retina and the optic nerve, thus paving the way for metabolic imaging of the fundus. Subsequent analysis of the light signal with algorithms and image analysis software tools permits extracting molecular information modulated according to the underlying pathology. This technique thus permits direct, non-invasive and inexpensive diagnosis of pathologies of the retina and systemic pathologies presenting manifestations in the eye.

In this research project, Optina Diagnostics aims to evaluate in a clinical context a novel Metabolic Hyperspectral Retinal Camera (MHRC) based on a mydriatic camera customized for observation of the fundus in combination with a tunable filter, i.e., one permitting selection of a specific wavelength, in order to provide monochromatic light in the visible and near infrared spectrum (energy spectrum between 450 and 900 nm).

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and up with vision in at least one eye.

Exclusion Criteria:

* Inadequate pupil dilation (\< 6mm diameter) or contraindicated
* Deficient visual fixation
* Refractive error outside the -9 to +9 range
* Media opacities or intraocular bleeding preventing retinal imaging
A Study to Evaluate the Efficacy of Investigational OTC Eye Drops

This is a single center, double-blinded study designed to demonstrate the therapeutic equivalence of over-the-counter eye drops in healthy adults with red eyes.

Eligible participants will use assigned eye drop products as directed. Participants will be required to attend 2 consecutive clinic visits. Assessments for eye redness and eye comfort will be completed. Participants will complete brief questionnaires about their eyes.

Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
2. Able and willing to provide a signed and dated Informed Consent document and Authorization for the Release of Health Information for Research
3. Male or female of any race or ethnicity, aged 18 years and older;
4. Females of childbearing potential who have a negative urine pregnancy test at the Screening/Baseline visit (Visit 1);
5. Able to read and understand English;
6. Healthy subjects with redness in both eyes
7. History of topical ocular drugs or desire to use within the last 6 months;
8. Ocular health within normal limits,
9. Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product. Females must have used such birth control for at least 3 months prior to the Screening/Baseline Visit 1.

Exclusion Criteria:

1. Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
2. Known sensitivity, allergy or contraindications to any investigational product ingredient;
3. Females who are pregnant, planning to become pregnant or breastfeeding during the study;
4. Subjects who were previously screened and determined to be ineligible for the study;
5. Use of a therapeutic eye treatment (over-the-counter or prescription) within 2 days of the Screening/Baseline visit (Visit 1) and throughout study participation;
6. Participation in any clinical study investigation within 30 days of Screening/Baseline visit (Visit 1);
7. Relative, partner or staff of any clinical research site personnel;
8. Active infection of any type at the start of the study; particularly, presence of active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection;
9. Any ocular condition that could affect the subject's safety or trial parameter, such as severe ocular allergy;
10. Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period;
11. Has a compromised immune system;
12. Has any acute or chronic, medical or psychiatric conditions
13. Contact lens use within 24 hours prior to clinic Visit 1 and during their participation in the study;
14. Saline eye drop use within 24 hours prior to clinic Visit 1 and during their participation in the study;
15. Use of any new OTC or prescription medications within 24 hours prior to clinic Visit 1 and throughout study participation.
Sucking and Sucrose as Pain Relief for Infants

Sucking and sucrose have been shown to reduce pain during venous puncture in neonates. Our study is designed to see if sucking and sucrose relieve pain during venous puncture in infants age 3-12 months.

100 infants age 3-12 months old without neurologic, developmental or cardio-respiratory impairment, needing venous puncture for IV access, or blood aspiration, will be randomly assigned to one of 2 groups - with or without pacifier. During the puncture, each patient with pacifier will receive either 1 cc of water or 1 cc of sucrose (the solutions prepared and marked blindly) . Each patient without pacifier 2 will receive 1 cc of water without pacifier,will receive either 1 cc of water or 1 cc of sucrose (the solutions prepared and marked blindly). FLACC pain score will be used for apin assessment before, during and after the puncture.Comparison of the four groups will be done after the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* age 3-12 months
* hospitalized in pediatric ward B
* need venous puncture

Exclusion Criteria:

* neurological deficit
* developmental delay
* Cyanotic heart disease
* symptomatic respiratory disease
* known problematic venous access
Dose-Dependent Effect of Early Antiplatelet Therapy in Acute Ischemic Stroke

The aim of this study is to evaluate the low-response prevalence of early antiplatelet therapy and to test the influence of different aspirin dosages in patients with acute ischemic strokes (AIS).

Antiplatelet agents are important therapeutic options in treating patients with acute ischemic strokes to prevent recurrent ischemic events or death. The aim of this study was to evaluate the low-response prevalence of early antiplatelet therapy and the influence of different aspirin dosages in patients with acute ischemic strokes (AIS).

Eligibility Criteria:
Inclusion Criteria:

* suspected acute cerebrovascular ischemic events and patients who were admitted to the stroke unit where antiplatelet therapy was initiated

Exclusion Criteria:

* severe liver disorders, current gastrointestinal disorders, congestive heart failure, life-threatening malignancies and a personal or family history of bleeding disorders
Effectiveness of KOS-862 in the Treatment of Lung Cancer

The purpose of this study is to determine whether a potential drug known as KOS-862 or "Epothilone D" has an effect as a 2nd line treatment in non-small cell lung cancer (NSCLC) for patients having failed one prior platinum-containing chemotherapy regimen.

To determine the antitumor activity, based on the confirmed objective response rate, of KOS-862, administered intravenously weekly for 3 weeks every 4 weeks, in patients with non-small cell lung cancer (NSCLC) whose disease has progressed following initial chemotherapy for advanced or metastatic disease.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Measurable disease
* One previous treatment of a platinum based drug such as cisplatin or carboplatin
* At least 3 weeks since last surgery/radiation/chemotherapy

Exclusion Criteria:

* Brain metastases
* Changes in the rhythm of your heart that are considered significant as determined by an ECG tracing
Relationship Between the Sagittal Lumbopelvic Alignment and Balance Control in Adolescents With Mechanical Low Back Pain

To examine the relationships between lumbopelvic sagittal alignment parameters (lumbar lordosis, sacral slope, pelvic tilt, and pelvic incidence) and balance control in adolescents with mechanical low back pain.

To examine the relationships between lumbopelvic sagittal alignment parameters (lumbar lordosis, sacral slope, pelvic tilt, and pelvic incidence) and balance control in adolescents with mechanical low back pain.Patients will be recruited from the secondary schools in Benha city be general invitations, and the study will be conducted at outpatient clinic of faculty of physical therapy, Benha University

Eligibility Criteria:
Inclusion Criteria:

* age between 15 and 18 years, either sex, and symptoms lasting longer than three months, which imply chronicity

Exclusion Criteria:

* Spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for LBP
Atrial Electromechanical Function in Endurance Athletes With and Without Atrial Fibrillation

This study evaluates cardiac structure and function differences between healthy endurance trained athletes with atrial fibrillation and healthy age matched endurance trained athletes without atrial fibrillation. It is hypothesized that despite having similar structural adaptations of the heart (due to endurance training), athletes with atrial fibrillation display will impaired heart functional measures compared to endurance athletes without atrial fibrillation.

Regular physical activity, including vigorous exercise, lowers cardiovascular risk factors, including the risk of developing Atrial Fibrillation (AF), one of the most commonly diagnosed types of arrhythmias. Paradoxically, despite the cardioprotective effects of exercise, middle aged endurance athletes are at 5 fold risk of developing AF compared to active individuals. Long standing endurance training induces significant changes to the heart- collectively known as the 'athlete's heart.' While these changes may be beneficial for performance, they may be conducive in promoting the risk of AF in this cohort. The aim of this study is to compare cardiac structure and function in endurance athletes diagnosed with AF (n=17) and in healthy aged matched endurance athletes (n=17). Male subjects between ages 45 and 65 years old with a long-standing history of endurance training and competition will be recruited. Heart structure and function will be compared at rest and during submaximal exercise. Participants will also complete fitness assessments and questionnaires that characterize their lifetime involvement in exercise training. This study will address the gap in the literature regarding the interaction of endurance training and AF risk.

Eligibility Criteria:
Inclusion Criteria:

ALL participants:

* endurance athlete (cyclist, runner, triathlete or other) who participate in vigorous year-round training of 4-6 hours per week for a minimum of 20 years
* participation in atleast one major competition per year (marathon/triathlon/endurance competition)
* sinus rhythm during all assessments

Inclusion criteria specific to endurance athletes with AF:

* diagnosed with lone paroxysmal AF in the last 4 years
* able to verify diagnosis (ECG or Holter verification/proof of diagnosis),
* can be on any type of medication.

Inclusion criteria specific to healthy endurance athletes without AF:

* previous participation in Athlete's Heart Study
* has completed resting cardiac magnetic resonance imaging and resting electrocardiogram

Exclusion Criteria:

* females
* no more than \>1 hour per week of resistance training
* treatment or prior diagnosis of cardiovascular disease, valvular disease, hypertension, heart failure, diabetes, thyroid disorder, sleep apnea, current/recent viral disease, chronic inflammatory disease
* previous (within 10 years) or current smoking
* recreational drug use or alcohol consumption in excess of accepted standards
* inability to provide informed consent
* inability to verify AF diagnosis (if AF athlete).
Compassion Meditation and ReliefLink App for Suicidal, Low-Income, African Americans

The purpose of this study is to conduct a pilot randomized controlled trial (RCT) with low-income, suicidal African American women and men that compares the relative effectiveness of compassion meditation (CM) versus a support group (SG) .

The purpose of this study is to conduct a pilot randomized controlled trial (RCT) with low-income, suicidal African American women and men that compares the relative effectiveness of compassion meditation (CM) versus a support group (SG) for (1) reducing psychological distress (suicidal ideation, depressive symptoms, and shame); (2) bolstering interpersonal connectedness; and (3) enhancing self-compassion and mindfulness. It is hypothesized that at post-intervention and follow-up, compared to individuals in the SG, those in the CM intervention will endorse less psychological distress (suicidal ideation, depressive symptoms, and shame), more interpersonal connectedness, and greater levels of self-compassion and mindfulness.

Eligibility Criteria:
Inclusion Criteria:

* self-identify as African American or Black
* speak English
* present to medical and psychiatric emergency rooms at Grady Health System following a suicide attempt
* moderate level of intent associated with the attempt (SSI \>= 8 required)
* Mini Mental State Exam (MMSE) score \> 22

Exclusion Criteria:

* significant cognitive impairments (MMSE \< 22)
* active psychosis (diagnosed based on Psychotic Screen (PS))
* imminently life-threatening medical condition