cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study of Lyophilized Plasma in Patients on Warfarin

This is a multi center, phase 2 randomized controlled study to determine the effect of lyophilized plasma in patients on warfarin therapy.


Eligibility Criteria:
Inclusion Criteria

1. Patients receiving oral anticoagulation with warfarin derived agents.
2. Patients who have need for urgent surgery, an invasive procedure or identification of a patient with active bleeding where oral or parenteral vitamin K therapy is deemed too slow in its action for reversal of warfarin anticoagulant effects.
3. Patients with an elevated international normalized ratio.

Exclusion Criteria

1. Patients who are clinically unstable.
2. Patients who have congenital or acquired coagulopathies (other than warfarin therapy).
3. Patients who have received medications that could interfere with the results of laboratory testing.
4. Pregnant or nursing women.
5. Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion.
6. Patients previously enrolled in this study.
7. Active illicit drug use.
A Phase 1 Absolute Bioavailability Study For Oral Crizotinib In Healthy Volunteers

This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over single-dose study to test the absolute bioavailability of oral crizotinib formulation to IV formulation in healthy adult volunteers. Fourteen (14) subjects will be enrolled to obtain at least 12 evaluable subjects who complete the study. Each subject will receive two treatments (A and B) with a washout period of at least 14 days between each treatment.

evaluate the absolute bioavailability of oral crizotinib to IV crizotinib.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female of non-childbearing potential subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs)

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).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males within 6 months of screening.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* 12-lead ECG demonstrating QTc \>450 msec at Screening.
* Pregnant or nursing females; females of childbearing potential, including those with tubal ligation.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
* A positive serology for Hepatitis B or Hepatitis C.
* Subjects who are currently smoking.
Erector Spinae Plane Block in Congenital Heart Disease Patients

Pediatric cardiac patients undergoing surgical anesthesia are at an increased risk of poor neurologic outcome (20-50%). Unattenuated anesthetic exposure and pain contributes to physiologic perturbations that may increase neurologic morbidity. Because of the often-large exposure to anesthetic agents in these cardiac children, at such a young age and the potential modifying anesthetic practice that could lead to improved neurodevelopmental outcomes and surgical recovery is paramount. Regional anesthesia such as thoracic epidurals provide effective analgesia and reduced intraoperative anesthetic needed but carry devastating sequelae neurological risks of epidural hematomas after anticoagulation during cardiopulmonary bypass (CPB). Recently, a newly described erector spinae plane block (ESPB) is superficial to neuraxial or vascular structures, providing opportunity to be placed with less risk for surgery requiring CPB. This block has been described as effective regional anesthesia for adult cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Neonates of at least 32 weeks of gestation, infants and children admitted to The Lucile Packard Children's Hospital for treatment of cyanotic or non-cyanotic heart disease requiring surgical intervention.
* Admitting diagnosis of cyanotic or non-cyanotic heart disease

Exclusion Criteria:

* Neonates less than 32 weeks of gestational age
* Any documented central nervous system malformations.
* Any potential subject requiring unexpected postoperative Extracorporeal membrane oxygenation (ECMO) support
Effects of Multimodal Physical Therapy in Patients With Lumbosacral Radiculopathy

Purposes of the study

To investigate the effect of Multimodal Physical Therapy on pain, daiablility H-reflex, and Diffusion Tensor Imaging (DTI) Parameters in Patients With Lumbosacral Radiculopathy.

Participants will receive Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises. Patients will receive the intervention for six weeks. Outcomes will be assessed at baseline and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* chronic (≥ 3 months) unilateral Lumbosacral Radiculopathy (LSR)
* The LSR is due to paracentral L4-L5 or L5-S1 Lumbar disc herniation
* The LSR is confirmed radiologically by MRI
* The LSR is confirmed clinically by history and physical examination
* The LSR is confirmed neurophysiological by soleus H-reflex assessment
* Body mass Index less than 30
* 20-45 years of age

Exclusion Criteria:

* systematic disease
* Bilateral symptoms
* Lumbar spinal stenosis
* previous surgery
* Steroid injection
* Spinal fracture
* Lumbar spinal stenosis
* Spinal deformity
* Spinal fracture
* Radiological evidence of bilateral nerve root encroachmen
* Evidence of H-reflex amplitude or latency affection on asymptomatic side
Comparing the Efficiency of Two Approaches in Patients at Risk of Developing Intraoperative Floppy Iris Syndrome

Intraoperative Floppy Iris Syndrome (IFIS) is a potentially serious cataract surgery complication. IFIS is most commonly associated with the chronic use of tamsulosin and other alpha1-adrenergic receptor antagonists prescribed in low urinary tract symptoms. There are a number of guidelines for operative technique modifications with the aim to prevent the development of IFIS. The study focuses on two options for prophylactic strategies: the application of atropine drops and the instillation of intracameral epinephrine.

Intraoperative Floppy Iris Syndrome (IFIS) is a complication that may develop during cataract surgery. IFIS is most commonly associated with the chronic use of tamsulosin and other alpha1-adrenergic receptor antagonists prescribed in low urinary tract symptoms. It is characterised by an unstable iris whose increased elasticity may lead to a number of complications during cataract extraction with a negative impact on vision outcomes. Basic features of IFIS are a 'floppy' iris that 'ripples' in irrigation, insufficiently inducible mydriasis with progressive intraoperative miosis (despite repeated application of mydriatics) and the tendency of the iris to prolapse into the phacoemulsification probe.

IFIS is a complication that makes surgery more difficult for the eye surgeon. There is a risk of intraoperative conditions such as rupture of the posterior capsule with lens masses luxation into the vitreous body, damage to the iris by surgical instruments, damage to the endothelium with washout of endothelial cells, hyphaema, or prolapse of the vitreous body into the anterior chamber.

There are several surgical approaches to prevent the development of IFIS and facilitate easier management of the entire cataract extraction in unstable iris. The investigators recommend patients apply 1% atropine drops twice a day for one week during the pre-operative period. A more elegant method is the administration of epinephrine into the anterior chamber at the beginning of the cataract surgery. The aim of this study is to evaluate the effectiveness of two mydriatic agents - the administration of atropine drops and the instillation of epinephrine into the anterior chamber and to compare their effectiveness in preventing IFIS.

Eligibility Criteria:
Inclusion Criteria:

* age-related cataract
* age over 18 years
* men with diagnosed benign prostatic hyperplasia
* history of having taken, or currently taking any systemic α1-adrenergic receptor antagonists for low urinary tract symptoms
* performing of pre-operative examination before cataract surgery
* signed informed consent

Exclusion Criteria:

* presence of any pupil deformity due to e.g. post-traumatic condition
* iris defect of any aetiology
* status post anterior uveitis
Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)

The purpose of this study is to determine the clinical efficacy and safety of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.

Philadelphia chromosome (Ph) is a translocation abnormality leading to the formation of the BCR-ABL gene rearrangement. This genetic abnormality occurs in up to 30% of adult acute lymphoblastic leukemia (ALL), and its presence is known to be the most adverse prognostic factor for ALL. Because long-term survival cannot be achieved by conventional chemotherapy alone, there is a clear medical need for alternative treatment approaches. Imatinib is a potent selective inhibitor of the BCR-ABL protein kinase, and it has been reported that single-agent imatinib induced response in a substantial proportion of Ph-positive ALL (Ph+ALL) patients, but that the response was not durable. The Japan Adult Leukemia Study Group (JALSG) has therefore started a phase 2 study designed to evaluate the clinical effect of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated BCR-ABL-positive ALL
* Age between 15 and 64 years
* Performance status between 0 and 3 (ECOG criteria)
* Adequate functioning of the liver (serum bilirubin level \< 2.0 mg/dL), kidneys (serum creatinine level \< 2.0 mg/dL), and heart (left ventricular ejection fraction greater than 50% and no severe abnormalities detected on electrocardiograms and echocardiographs)
* Written informed consent to participate in the trial

Exclusion Criteria:

* Uncontrolled active infection
* Another severe and/or life-threatening disease
* Positive for HIV antibody and/or hepatitis B surface (HBs) antigen tests
* Another primary malignancy which is clinically active and/or requires medical interventions
* Pregnant and/or lactating women
* Past history of renal failure
Multimedia-based Hormonal Therapy Information Program for Patients With Prostate Cancer

This study takes place in the Divisions of Urology. Patients who have only received hormonal therapy will be enrolled. Patients will be randomly sorted into an experimental group and a control group after completing a pretest questionnaire. The experimental group will receive the the multimedia hormone therapy information program once per week for 6 consecutive weeks, while the control group will receive routine care. The follow-up data collections will be completed at 8 and 12 weeks after the pretest. For quantitative measurement, the main variables will be social support, self-efficacy, quality of life, and positive thinking.

This study takes place in the Divisions of Urology at Chang Gung Memorial Hospitals. Patients who have only received hormonal therapy will be enrolled. With reference to past research findings, self-efficacy theory, and experts' advice, a multimedia hormone therapy information program was developed. The multimedia hormone therapy information program covered 6 topics, namely the recognition of hormone therapy and multimedia information programs, mindfulness, exercise, stress relief, positive thinking, and prevention or reduction of fatigue. A pilot study will be conducted to check the feasibility of intervention study design and the effectiveness of the program will be tested. Patients will be randomly sorted into an experimental group (multimedia information group, n = 36 to 40) and a control group (routine care group, n = 36 to 40) after completing a pretest questionnaire. The experimental group will receive the multimedia information intervention once per week for 6 consecutive weeks, while the control group will receive routine care. The follow-up data collections will be completed at 8 and 12 weeks after the pretest. For quantitative measurement, the main variables will be social support, self-efficacy, quality of life, positive thinking, and satisfaction with program. Generalized Estimating Equations (GEEs) will be used to o analyze data.

Eligibility Criteria:
Inclusion Criteria:

1. patients with prostate cancer who were receiving hormonal therapy
2. patients were at least 20 years old
3. patients were ability to communicate in Chinese or Taiwanese
4. the married partner agrees to study together, or the single patient has a cohabitation partner who agrees to study together.
5. patients or family have a smart phone or tablet and can connect to the Internet.

Exclusion Criteria:

1. having a history of other cancers
2. unknown diagnosis of prostate cancer or unknown disease status
3. patients who received chemotherapy, radiotherapy, radical prostatectomy or other treatments for prostate cancer in the past
4. having history of mental disorder, e.g., phobia, obsessive-compulsive disorder, generalized anxiety, , major depression, mania, manic-depressive psychosis, or dementia
5. the score of Eastern Cooperative Oncology Group performance is ≧ 2
Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)

Primary Objective:

To describe the long-term safety of dupilumab in treatment of participants with moderate to severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551).

Duration per participant was until dupilumab approval for use in asthma and market availability to the participant, or a maximum of 144 weeks (i.e., about 3 years) after the start of treatment (Visit 1), whichever came first.

Eligibility Criteria:
Inclusion criteria:

* Participants with asthma who completed the treatment period in the previous dupilumab asthma clinical study LTS12551.
* Signed written informed consent.

Exclusion criteria:

* Participants who experienced any systemic hypersensitivity reactions to the investigational medicinal product in the previous dupilumab asthma study LTS12551, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab might present an unreasonable risk for the participant.
* Clinically significant comorbidity/lung disease other than asthma.
* Participants with active autoimmune disease or participants who, as per Investigator's medical judgment, were suspected of having high risk for developing autoimmune disease.
* History of malignancy within 5 years before enrollment except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Reasons for Non-treatment of Hepatitis C in HCV Mono-infected Patients Versus HCV-HIV Co-infected Patients in a University Setting

The specific aims of this study are to determine the treatment prescription rates for Hepatitis C virus (HCV) infection in a cohort of HCV mono-infected, and human immunodeficiency virus (HIV)-HCV co-infected patients and to identify the reasons for non-treatment of HCV in these two groups.

Despite recent advances in treatment modalities, a large proportion of patients with HCV do not receive treatment. The reasons for non-treatment need to be elucidated to properly address these factors. Appropriate evaluation and treatment of HCV is important in providing the optimal care to these persons. It is also important to document and characterize treatment patterns and prescription rates for policy, resource allocation and funding purposes. This study will determine the rates of treatment for HCV monoinfected and HCV-HIV co-infected patients, and determine the reasons for non-treatment. It will also directly compare the two populations to determine if any differences exist in the reasons for non-treatment. This study has implications for patient care, their health outcomes, policy making, funding and resource allocation.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be recruited from the Pittsburgh AIDS Center for Treatment (PACT) Clinic and Pitt Treatment and Evaluation Unit (PTEU) and the Center for Liver Diseases (CLD) at the University of Pittsburgh. There are approximately 800 patients in the University of Pittsburgh's PACT/PTEU clinic. Consecutive patients with HCV-HIV co-infection who present to the clinic upon initiation of data gathering would be eligible for participation in this study. An estimated 500-800 patients are seen at the CLD clinic per year, and consecutive patients enrolled in the CLD HCV registry would be considered eligible for this study. To maintain uniformity and consistency of data, only patients seen by one of the study investigators would be enrolled. Recruitment would continue till the study has enrolled 100 HCV-HIV coinfected and 200 HCV mono-infected subjects.

Exclusion Criteria:

* There are no exclusion criteria, except if the patient refuses to participate in the study.
Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease

The purpose of this study is to evaluate the safety of APSLXR in participants with Meniere's disease or other Verigo of vestibular origin. Pharmacokinetics will also be evaluated in a small group.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Meniere's Disease or Vertigo of Vestibular Origin;
* Voluntarily consent to participate in the study;

Exclusion Criteria:

* Female patients who are pregnant or breastfeeding;
* Participants presenting uncontroled systolic hipertension (\>140/90 mmHg);
* Participants presenting uncontroled diabetes (blood glucose \>200 mg/dL).
AMD and Validation Rod-Meditated Dark Adaptation With Everyday Task Performance

The goal is to conduct a cross-sectional, single timepoint study on older adults with early and intermediate AMD, and with subretinal drusenoid deposits (SDD), and those in normal health, establishing an association between dark adaptation and reading performance under dim illumination, both which depend on rod photoreceptors.

The investigators propose two sites for the study, Duke University and UAB. Each site will enroll 100 participants as indicated in the table above, per the AREDS 9-step AMD classification system, with 200 participants in the sample. Because the variance of rod-mediated dark adaptation in AMD patients increases with increasing disease severity, the investigators will implement a larger sample size for intermediate AMD and a smaller sample for patients in normal macular health.

The investigators will collect demographic characteristics (age, race/ethnicity, gender), ocular medical history from the electronic health record, and medication use. In addition, the protocol will focus on measuring the following major components:

1. Comprehensive eye exam
2. Rod-mediated dark adaptation
3. Reading performance
4. Mobility
5. Ellipsoid zone loss and attenuation

Statistical associations will be computed using correlational analysis for the overall sample, within each patient group, and also separately for those with SDD. Sample size estimation is challenging because there is no previous literature on the association between rod-mediated dark adaptation and MNREAD reading performance or MOST performance. With a sample size of 200 participants, the investigators will have adequate statistical power (80%) to detect a correlation of at least 0.20 for the total sample and adequate statistical power to detect within-group correlations of at least 0.40.

Eligibility Criteria:
Inclusion Criteria:

* Capable and willing to provide consent
* Has been diagnosed with early, intermediate dry age-related macular degeneration or geographic atrophy or has a healthy macular for controls
* At least 50 years of age

Exclusion Criteria:

* Unable or unwilling to give consent or unable to read consent since the study involves testing which requires reading
* Under 50 years of age
* Presence of dense cataracts in the study eye (s) that can affect visual function tests
* Presence of glaucoma requiring treatment during the study and/or visual field defects
* Previous retinal laser or surgical therapy in the study eye(s)
* Previous retinal laser or surgical therapy in the study eye(s)
* Any other ocular condition requiring long-term therapy or surgery during the study
* The participant has photographically significant corneal or media opacities in either eye that would preclude adequate ophthalmic imaging and functional testing
* Diagnosis of nystagmus that will interfere with testing
* High myopia -8 Diopters or more severe
* The participant has, in the opinion of the Investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations, and outcome assessments.
Effect of a Tablet-administered Educational Video on Patients´ Knowledge on Osteoporosis and Treatment

Osteoporosis is a highly prevalent disease in which non-adherence is a well-recognized problem. Non-adherence may be due to patients´ lack of knowledge, understanding, and involvement. In this study the investigators aimed to determine the effect of an educational video displayed on a tablet-device. The investigators hypothesized that an educational video would increase patients´ knowledge on osteoporosis and treatment at a two week follow up.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for at DXA scan at the osteoporosis clinic
* Currently on once-weekly alendronate treatment
* Informed consent

Exclusion Criteria:

* Patients that do not understand Danish
* Patients having hearing impairments (unable to hear the video)
* Patients having visual impairments (unable to watch the video)
* Patients diagnosed with dementia
* Patients unable to give written informed consent.