cyrilzakka/clinical-trials huggingface dataset:
BAY1003803 Single and Multiple Dose Escalation, Safety, Tolerability and Pharmacokinetics Study

Systemic safety following single and multiple dermal administration of BAY1003803


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject
* Age: 18 to 64 years (inclusive) at the first screening visit
* Body mass index (BMI): above or equal 18 and below or equal 30 kg / m² at the first screening visit
* Non-smoker at least 3 months prior to study start and during the study
* Healthy skin on which reddening can be easily recognized

Exclusion Criteria:

* A history of relevant diseases, especially incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, excretion and effect of the study drugs will not be normal, dermal diseases, diseases which present a risk for subjects to be treated with glucocorticoid receptor agonists (e.g. gastric ulcers, cornea ulcer, colitis ulcerosa, severe infections, glaucoma, diabetes, myocardial infarction, thromboembolic disease, hypertension, thyroid disease, tuberculosis, myasthenia gravis, osteoporosis, psychiatric diseases)
* Infections and febrile illness within 4 week before the first study drug administration
* Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them
* Inoculations with live vaccine within 8 weeks before the first study drug administration
* Signs of irritation or folliculitis or any other dermatological conditions in the test areas that would interfere with the planned assessments as judged by the Investigators
* Human leukocyte antigen-DR (HLA-DR) \< 15000 AB/monocyte
A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media

To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a total of 5 days, in children between 6 months and 6 years of age, with AOM.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis, documented by medical history and physical examination, is AOM I 1 week.
* Clinical symptoms include \>=1 of the following: Otalgia (earache or pain), this may be expressed as ear pulling or nabbing; Ear fullness; Decreased hearing, this may be based on reports from parents or legally authorized representatives; Discharge from the external auditory canal (following acute perforation of the tympanic membrane).
* At least two (2) of the following signs are present in at least one ear: Full or bulging or perforated tympanic membrane, which may be erythematous (note - since hyperemia may be present in a febrile or crying child, a red tympanic membrane alone is insufficient for the diagnosis of AOM); Loss of tympanic membrane landmarks (opacity of the tympanic membrane); Abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind the tympanic membrane and edema of the tympanic membrane. Have evidence of middle ear fluid demonstrated by acoustic reflect tympanometry (ear check) showing values of 3, 4 or 5.
* Generally in good health based on medical history, vital signs, physical exam, and historical laboratory results.
* Subject must be a suitable candidate for oral antibiotic therapy.

Exclusion Criteria:

* Previous enrollment in this study.
* Enrollment in any other investigational study using unapproved products or unapproved doses; in the previous four weeks prior to study start.
* Hypersensitivity reactions to cefdinir, other cephalosporins, azithromycin, other macrolide and azalide antibiotics, and/or sensitivity to multiple allergens.
* Presence of tympanostorny tubes or otitis externa at Evaluation 1.
* Systemic treatment with any anti-infective agent within 14 days prior to Evaluation 1 or during the study.
* Treatment with a long-acting injectable antimicrobial agent (e.g., penicillin G benzathine) within 4 weeks prior to study drug administration.
* Concomitant infection that requires additional antimicrobial therapy.
* Evidence of chronic, suppurative otitis media.
* Evidence of perforation of the tympanic membrane \> 24 hours.
* Evidence of a physiologic, anatomic, or immunologic defect, which would interfere with resolution of this episode of acute otitis media.
* Immunocompromised subject (e.g., neutropenic subjects).
* Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the subject's therapeutic response.
* Any expectation that treatment with probenecid will be expected during the study drug administration period.
* Known significant renal or hepatic impairment.
Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies

The purpose of this clinical study is to collect safety and performance data to support a demonstration of substantial equivalence of the Catheter Robotics Remote Catheter System to predicate devices when used to perform EP mapping of the right heart (atrium and ventricle).


Eligibility Criteria:
Inclusion Criteria:

1. \> 18years of age.
2. Indicated for a right-sided electrophysiology ablation study (e.g., atrial flutter, AVNRT, right-sided accessory pathway, or ventricular tachycardia).
3. Willingness, ability, and commitment to participate in the procedure visit and a follow-up evaluation including a clinic visit at 7 (-0, +7) days after the study procedure.
4. Completion of Informed Consent.

Exclusion Criteria:

1. Any contraindication to cardiac catheterization, including pregnancy.
2. Enrollment in any other ongoing cardiac device trial.
3. Right-sided cardiac prosthetics including implanted active energy devices with permanent leads in or through the right atrium and/or ventricle.
4. Corrected or uncorrected atrial septal defect (ASD).
5. Poor general health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e., other disease processes, mental capacity, etc.).
6. Medical condition that will require anticoagulation during study or ablation procedure.
7. Presence of atrial fibrillation or atrial flutter at time of study procedure.
8. Other condition observed prior to the procedure where, in the view of the physician, participation in the study could further present a risk to the subject.

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Lorazepam-Induced Toxicity in the Aged

This study will compare the effects of an acute dose of lorazepam to a placebo in elderly patients with generalized anxiety disorder (GAD).

GAD is among the most common anxiety disorders in the elderly population. The drug lorazepam is widely utilized in the treatment of elderly individuals with GAD. However, single doses of lorazepam have been associated with cognitive toxicity that is typically evident between 1 and 2.5 hours after the drug is administered. The toxic effects include decreased memory and increased swaying, which has been associated with greater risk for falls.

Patients have 4 study visits. A psychiatric evaluation and a memory test are given at the first visit. During the second study visit, patients have a physical exam, an electrocardiogram (ECG), a neuropsychological assessment, an optional magnetic resonance imaging (MRI) brain scan, and other laboratory tests. On the third and fourth visits, patients are randomized to receive either their highest daily dose of lorazepam or placebo. Performance effects and postural sway are determined before drug administration and at 1, 2.5, and 5 hours after the drug is given. Blood samples for the determination of drug levels are also obtained.

Eligibility Criteria:
Inclusion Criteria:

* Lorazepam treatment for at least 3 months
* Cognitively intact

Note: Individuals who are unable or unwilling to have an MRI may be included

Exclusion Criteria:

* Major psychiatric disorder other than GAD
* Significant medical illness which may increase the likelihood of adverse reactions to lorazepam
* Severe loss of hearing or vision
* Current or past history of alcohol dependence
* Substance abuse within the past 6 months
* MRI evidence of infection, infarction, or other lesions suggestive of intervening neurological disease
* Clinical symptoms that suggest neurological disease
* Dementia or other mental syndromes or disorders
Taconic Health Information Network and Community (THINC)

The Taconic IPA, a 2,500 physician independent practice association (IPA) located in Fishkill, New York (NY), is involved in an information technology project to improve the quality, safety and efficiency of healthcare in the region. Over the past three years, the organization has worked with area hospitals and laboratories to create a community wide electronic data exchange. Currently, the Taconic IPA is in the midst of implementing a full electronic health record in some practices and e-prescribing in other practices. The purpose is to study the impact of an electronic health record on safety and quality measures.

We propose to measure differences in patient safety and quality measures among three groups: the control group consisting of physicians with paper-based office practices, a group of physicians using the clinical messaging system and electronic prescribing, and a group of physicians using the EMR and electronic prescribing.

We plan to introduce a vendor based electronic prescribing system by July 2005. This system will be offered to all physicians using clinical messaging and will be integrated with the EMR system. The system will have clinical decision support, such as checks for drug-drug interactions.

Our evaluation will measure differences in rates of medication errors and quality measures amongst these three groups. We will use a study design of a pre-post evaluation with a comparison control group. We will detect medical errors by prescription and chart review. We will determine compliance with quality measures through a combination of electronic data and chart review.

Eligibility Criteria:
Inclusion Criteria:

* Physicians' prescriptions and medical records in office practices enrolled in the study

Exclusion Criteria:

* Other physicians not enrolled in the study
MOR and COMT SNP Polymorphism and Pain

Patients with certain polymorphism in the MOR and COMT genes will display differences in their response to analgesics.

After tissue injury, there is great interindividual variability among patients in the amount of pain experienced (pain intensity and duration of pain) and in the degree of pain relief from analgesics. In experimental settings, Single Nucleotide Polymorphisms (SNP) at the MOR and COMT genes have been found to alter the response to opioids in in vitro models and in human.We will collect clinical data on one hundred patients undergoing surgery. We will obtain DNA extracted via PCR techniques from the patients' blood and we will identify SNPs at the mu opioid receptor and catechol-O-methyltransferase genes. We will analyze the data to search for correlation between clinical patterns of postoperative pain and opioid effects and SNPs.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Give informed consent to participate in this study

Exclusion Criteria:

* Neurologic or psychiatric disease sufficient, in the clinical judgment of the investigator, to compromise informed consent or data collection
* ASA classification score 3 or above
* Patients with past or present history of substance abuse.
* Patients with a history of chronic pain requiring daily analgesic use for more then one month.
* Patients with a current diagnosis of anxiety or depression requiring medical treatment
* Patients allergic to morphine
Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease

A medicine that is FDA-approved for bone marrow stimulation (called Leukine) will be tested for its ability to be tolerated by Alzheimer's disease patients and potentially to improve their memory.

Preliminary preclinical results demonstrated that GM-CSF (Granulocyte macrophage colony-stimulating factor, e.g. Leukine®/Sargramostim) rapidly reduced cerebral amyloid deposition and completely reversed memory deficits in transgenic mouse models of Alzheimer's Disease (AD). To assess the efficacy of GM-CSF in humans, the investigators performed a retrospective analysis of a cognition study of human patients undergoing hematopoietic cell transplantation for cancer and who garner cognitive impairments from the chemotherapy or irradiation. In the patients that received a colony-stimulating factor (CSF) to stimulate the bone marrow and recover immune system function, the investigators found that those who received GM-CSF (Leukine®/Sargramostim) plus G-CSF (Filigrastim) significantly improved in cognitive function as compared to those who received G-CSF alone. These findings combined with over two decades of accrued safety data using recombinant human GM-CSF, Leukine®/Sargramostim, in elderly leukopenic patients, suggested that Leukine® should be tested as a treatment to reverse cerebral amyloid pathology and cognitive impairment in AD.

Eligibility Criteria:
Inclusion Criteria:

1. age 55 to 85 years;
2. should have a mild-to-moderate AD diagnosis (MMSE 10-26 inclusive);
3. should have evidence of elevated cortical amyloid by PET using florbetapir F18 (Amyvid) \[i.e. a positive scan\], assessed qualitatively according to the Amyvid product label.
4. if on anti-dementia treatment should be on stable treatment for at least 2 months (i.e. cholinesterase inhibitor and/or Memantine or Axona);
5. stable on all other medications for at least 30 days prior to screen;
6. should be fluent in English;
7. should be physically able to participate by medical history, clinical exam and tests;
8. should have a study partner to accompany them to scheduled visits.

Exclusion Criteria:

1. clinically relevant arrhythmias;
2. a resting pulse less than 50;
3. active cancer other than non-melanoma skin cancers;
4. use of another investigatory drug within 2 months of screening;
5. significant stroke or head trauma by history or MRI;
6. contraindication for having a MRI;
7. diagnostic and Statistical Manual of Mental Disorders-IV criteria for a current major psychiatric disorder;
8. sensitivity to yeast or yeast products;
9. impaired kidney function as measured by a Glomerular Filtration Rate less than 60 milliliters/min;
10. preexisting fluid retention, pulmonary infiltrates, or congestive heart failure;
11. history of moderate-to-severe lung disease;
12. history of moderate-to-severe liver disease;
13. pregnant women, or any women who feel they are likely to become pregnant during the study;
14. prisoners.
Does Pulmonary Rehabilitation Improve Balance in People With Respiratory Disease?

The purpose of this study is to determine whether participation in pulmonary rehabilitation improves balance in people with respiratory disease.

Falls and chronic respiratory are two major health concerns affecting morbidity and mortality in older adults. Several factors that predispose falls, such as reduced balance, have been documented in people with respiratory disease. Pulmonary rehabilitation programs, which involve customized exercise prescription, are recommended to improve quality of life and disease management in people with chronic obstructive pulmonary disease (COPD). There are many documented benefits to participation in such programs; however, the impact on balance and other falls risk factors has not previously been investigated. Therefore, the aim of this study is to investigate the effect of a pulmonary rehabilitation program on balance and falls risk factors in individuals with respiratory disease. This study will enhance the current management of respiratory disease by improving our understanding of the effects of pulmonary rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of lung disease
* Committed to regular attendance at pulmonary rehabilitation program
* A forced expiratory volume in 1 second (FEV1) \< 80% of predicted
* No change in medications for the past 2 months

Exclusion Criteria:

* Unstable cardiac disease
* Neurological conditions
* Musculoskeletal conditions that prevent participation in exercise sessions.
Integrative Health Interventions in Symptom Management of Pediatric Patients

As healthcare demands high-quality cost-effective care and patients seek self-management strategies, integrative medicine has become more of an interest to patients, physicians, and administrators. The NIH has a dedicated center (National Center for Complementary and Integrative Health) for integrative therapies. Additionally, these treatments must meet evidence-based criteria for efficacy to be considered for reimbursement and in order for clinical settings to integrate them into the standard of care.

The care of children at the quaternary children's hospital is focused in traditional Western medicine modalities of diagnosis, surgery, and medical treatment with pharmacologic medications. However, integrative health modalities, such as acupuncture, massage, Reiki, nutritional supplements, or oral complementary therapies (such as cannabinoids) have been increasingly discussed by our patients, especially during Palliative Care Consults. As healthcare demands high-quality cost-effective care and patients seek self-management strategies, integrative medicine has become more of an interest to patients, physicians, and administrators. The NIH has a dedicated center (National Center for Complementary and Integrative Health) for integrative therapies. Additionally, these treatments must meet evidence-based criteria for efficacy to be considered for reimbursement and in order for clinical settings to integrate them into the standard of care. The objective of this project is to examine feasibility, timing, appropriate measures, and provide the basis for future in-depth study of the outcomes of individual integrative symptom management strategies.

Hypotheses:

Children, adolescents, and young adults will be able to complete electronic self-report questionnaires and physical measures before and after integrative interventions, and monthly.

Caregivers will be able to complete electronic proxy questionnaires before and after integrative interventions, and monthly.

Integrative interventions will be associated with changes on the questionnaires and physical measures such as a decrease in frequency, severity, or level of interference with symptoms.

Participants will rate their satisfaction with integrative interventions positively.

Eligibility Criteria:
Inclusion Criteria:

* Any CHCO patient referred for integrative interventions by the Pain Service or the Palliative Care Service

Exclusion Criteria:

* Patients who have non-consenting providers or caregivers
* Any patient the medical team feels is inappropriate for the study
Hemostatic Gelatin Sponge Versus Collagen Matrix in Alveolar Ridge Preservation

Patients in need of extraction of two teeth followed by implant replacement, with \> 50% buccal bone present following tooth extraction and with 1 or 2 neighbouring teeth present, were invited to participate in an intra-subject RCT comparing hemostatic gelatin sponge to collagen matrix as socket seal in alveolar ridge preservation.

The sample size calculation indicated 16 patients to be included per group. To compensate for dropouts, this number was increased to 20 patients per group. Coincidence (coin flip) determined which site is treated with the gelatine sponge and which with the collagen matrix.

Teeth were extracted without flap elevation. When deemed necessary by the clinician, papillary incisions were made for minimal reflection, which enabled to place elevators without damaging soft tissues. Buccal soft tissues were never raised. Following wound debridement and rinsing, the alveolar socket was filled with collagen-enriched deproteinized bovine bone mineral (C-DBBM, Bio-Oss Collagen® 100 mg or 250 mg, Geistlich Pharma AG, Wolhusen, Switzerland) up to the level of the oral bone crest. Subsequently, a collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland) or gelatin spons (Spongostan Dental® 1x1x1 cm, Ethicon, Johnson \& Johnson, New Brunswick, VS) was sutured on top with 4 to 6 single sutures (Seralon 6/0, Serag Weissner, Naila, Germany) to protect the underlying C-DBBM.

Changes in soft tissue height at the buccal and oral aspect is the primary outcome. A small-field low-dose CBCT image was taken at T0 (immediately postop) and T3 (4 months). Those images were superimposed in specialized software (OnDemand3D, Cybermed Inc., Seoul, South-Korea). Changes in soft tissue height were calculated by subtracting soft tissue height at T3 from soft tissue height at T0.

Secondary outcomes included wound healing and closure in the first three weeks, changes in hard and soft tissues and mucosal scarring after 4 months.


Eligibility Criteria:
Inclusion Criteria:

* good oral hygiene (plaque score \< 25%)
* 1 or 2 neighbouring teeth present
* in need for extraction of two teeth, followed by implant placement
* \>50% bone present
* signed informed consent

Exclusion Criteria:

* systematic diseases
* smoking
* history of periodontitis
* untreated caries lesions
* pregnancy
Congenital Lung Anomalies (CLA) Swiss Database

Congenital lung anomalies include different pathologies such as congenital cystic adenomatoid malformation, pulmonary sequestration, bronchial atresia, emphysema, bronchogenic cyst. They concern less than 1/10000 births and their physiopathological origin is still poorly understood. The main goal of this project is to pool the cases from different swiss centers on a prospective cohort study, first to increase knowledge of clinical and radiological evolution and their correlation with histological data, and second to analyse the pathological embryological mechanism underlying these malformations.

1. To register prospectively clinical, biological, radiological and histological datas in a multicentric database (secured internet link, via Secutrial® software). for children with prenatal diagnosis of this kind of malformation. This study is conducted by a multidisciplinary team, involving obstetricians, neonatologists, pneumologists, pediatric surgeons, radiologists and anatomopathologists.
2. To create a tissue biobank

Outcomes:

1. Contribute to the definition of a standardized procedure at the Swiss level for the treatment of patients suffering from these malformations,
2. Improve the assessment of lesion evolution related to CLA, and
3. Possibly validate some biomarkers, which could help to identify individuals at risk. On the long term, these results could also support the development of innovative therapies targeting the factors involved in lung development.

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with congenital lung anomalies

Exclusion Criteria:

* None