cyrilzakka/clinical-trials huggingface dataset:
Effect of Continuous Positive Airway Pressure (CPAP) Therapy on Changes of Blood Pressure Between Day and Night

to test whether using CPAP can restore the normal pattern of drop of blood pressure during sleep.

OBJECTIVE:

To investigate the effect of CPAP therapy on the restoration of the normal diurnal blood pressure pattern. Possible improvement of the circadian dipper pattern after CPAP therapy, with or without a decrease in the mean blood pressure, might constitute an additional potential benefit of CPAP therapy in reducing cardiovascular risk in patients with OSA.

STUDY DESIGN AND METHODS:

Patients diagnosed with OSA at the sleep center will undergo blood pressure monitoring by measuring the blood pressure every half hour during sleep study. Patients with normal circadian BP changes are treated with CPAP as indicated. Patients with non-dipping BP pattern will be approach to join our study. The patients will receive CPAP therapy. The trial period will be 6 weeks. At the end of the trial, the patients from both treatment arms will undergo a second BP monitoring according to our above-mentioned protocol (systolic, diastolic and mean BP) to determine the circadian BP changes. Apnea-Hypopnea index will be calculated to reflect on the compliance with our therapy. Thus, patients could be divided into two study groups according to their objective compliance.

Baseline population characteristics between the placebo group and CPAP group will be noted. These include apnea-hypopnea index (AHI), medications, other co morbidities and other factors that might affect the normal circadian BP dipping pattern including factors affecting the volume status i.e. diabetes, renal failure, uncontrolled diabetes. Any new medications added during the 6 weeks trial period will be noted.

STATISTICAL ANALYSIS:

The difference in daytime and nighttime BP pattern will be noted between the treated (CPAP) and the non-compliant groups. The circadian BP variation will be recorded in both groups. Changes in the circadian BP pattern will be assessed on an intention-to-treat basis. The odds ratio, p value and confidence interval will be calculated. Correlation between the dipping/non-dipping pattern with CPAP compliance, severity of OSA and number of antihypertensive drugs will be studied as well

Eligibility Criteria:
Inclusion Criteria:

1. All patients with OSA who don't meet the above mentioned exclusion criteria

Exclusion Criteria:

1. Patients who have a normal diurnal sleep pattern (i.e. decrease of more than 30% of the systolic BP at night time)
2. Patients who are on three or more antihypertensives whose blood pressure is not controlled.
3. Patients previously treated with CPAP therapy within the past 3 months
Patient Satisfaction With Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension

This study compares patient symptoms and anterior segment safety in patients treated with timolol hemihydrate, generic timolol gel forming solution or timolol maleate.


Eligibility Criteria:
Inclusion Criteria:

* willing to comply with investigator's and protocol's instructions
* patients signature on the informed consent document
* primary open-angle glaucoma, pigment dispersion or exfoliation glaucoma, or ocular hypertension in at least one eye
* at screening intraocular pressure must be considered to be safe, in both eyes
* in non-qualifying eyes the intraocular pressure should be able to be controlled safely on no pharmacologic therapy or on study medicine alone
* currently treated with one glaucoma medication, untreated intraocular pressure of less than or equal to 28 mm Hg at visit 2 in both eyes

Exclusion Criteria:

* any abnormality preventing reliable applanation tonometry in either eye
* any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber in either eye
* any concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye
* any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial
* females of childbearing potential not using reliable means of birth control
* pregnant or lactating females
* any clinically significant, serious, or severe medical or psychiatric condition
* participation (or current participation) in any investigational drug or device trial within 30 days prior to Visit 1
* severe prior visual acuity or field loss from any cause
* inability to understand the trial procedures, and thus inability to give informed consent
* progressive retinal or optic nerve disease apart from glaucoma
* serious systemic or ocular disease
* intraocular laser surgery within the past three months or corneal or intraocular conventional surgery within the past 6 months
* concurrent use of systemic corticosteroids, by IV, oral, dermal or topical ophthalmic route.
* subjects requiring tear replacement drops or allergy medications with sympathomimetics 24 hours prior to a scheduled study visit
* contraindication to beta-blocker usage including: reactive airway disease, uncontrolled heart failure, or second as well as third degree cardiac block, myasthenia gravis
* any subject the investigator believes will be at risk for glaucomatous progression by their participation in this trial
Human Skin and Gut Mycobiome and Bacteriome Comprehensive Registry

Bacterial and fungal microbiota will be different between individual body sites; however, particular microbiome profiles both whole-body and site-specific will be unique to volunteers with a given parameter such as medical diagnosis, diet, medications taken, geographical area; etc.

Specific aims:

1. Identify and characterize whole-body and site-specific microbiome profiles.
2. Identify phenotypic microbiome profiles unique to individual parameters such as demographics, medical diagnoses, diet; etc.
3. Perform bacterial-bacterial, fungal-fungal and bacterial-fungal correlation analysis to identify potential synergistic and antagonistic species within these unique profiles.

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving informed consent.
* Able and willing to complete all required specified study procedures

Exclusion Criteria:

* Antibiotic or antifungal use whether topical or systemic in the past 2 or 4 weeks, respectively.
* Unable and/or unwilling to complete all required study procedures.
Implementing Personal Health Records to Promote Evidence-Based Cancer Screening

Cancer screening can improve the length and quality of life, yet the average American receives only half of recommended services. Patient-centered personal health records with higher levels of functionality, combined with practice redesign to make use of these functions, can help patients obtain recommended cancer screening tests by linking them to their doctor's records, explaining information in lay language, displaying tailored recommendations and educational resources, providing logistical support and tools to stimulate action, and generating reminders. This project will measure whether making these resources available to primary care practices and patients promotes shared decision-making and increases the delivery of cancer screening compared to existing information systems.

We developed a theory-driven interactive Patient Health Record (PHR) that uses higher functionality to more deeply engage patients in health promotion. The model defines five levels of PHR functionality: (1) collecting patient information, (2) integrating with electronic health records (EHRs), (3) translating information into lay language, (4) providing individualized, guideline-based clinical recommendations, and (5) facilitating patient action. We hypothesize that implementing PHRs with these higher levels of functionality will inform and activate patients in ways that simpler PHRs cannot achieve and will increase uptake of preventive services. In Phase 1, we will randomize 46 practices from three practice-based research networks in eight states to implement a PHR with advanced versus simpler functionality. Control practices will use their existing PHR. Intervention practices will upgrade their PHR to feature an interactive preventive health record (IPHR) that we have previously developed and tested. Intervention practices will locally tailor the IPHR content and learn how to integrate new functions into practice. Phase 1 will feature an implementation assessment in intervention practices, based on the RE-AIM model, to measure Reach (creation of IPHR accounts by patients), Adoption (practice decision to use the IPHR), Implementation (consistency, fidelity, barriers, and facilitators of use), and Maintenance (sustained use). The randomized comparison of intervention and control practices will measure the incremental effect of the IPHR on shared decision-making and receipt of cancer screening tests compared to traditional PHRs (Effectiveness). Data sources will include the EHR/PHR/IPHR databases, patient and practice surveys, recruitment field notes, practice learning collaborative transcripts, practice diaries, and patient phone interviews. This study will inform future efforts to use patient-centered information technology to promote cancer prevention and the feasibility of national dissemination.

Eligibility Criteria:
Inclusion Criteria:

1. Practices in a practice based research network participating in our study that have an existing patient health record
2. Patients that attend our study practices

Exclusion Criteria:

Practices without a patient health record
Patient Care Needs and the Decision-Making Experience of Patients With Cancer and Family Caregivers Regarding Immunotherapy: A Qualitative and Quantitative Mixed Methods Study

Immunotherapy is currently a crucial cancer treatment option. Despite the development of new cancer treatment, patients and their family caregivers still experience complex psychological feelings and challenges about the effectiveness of immunotherapy, financial burden, and treatment related side effects which reflect the problems related to decision-making and the supportive care needs.


Eligibility Criteria:
Patient

Inclusion Criteria:

1. 20 years old and above.
2. Patients diagnosed with cancer by a physician.
3. The patient has a known condition and has received immunotherapy.
4. Those who have received at least 1 time immunotherapy, including: receiving a single drug or immunotherapy combined with other treatment.

Exclusion Criteria:

1. Patients with mental illness.
2. Confused and unable to communicate verbally or in writing to complete the research interviews.
3. Those who are reluctant to accept interviews and participate in research surveys.

Family caregivers

Inclusion Criteria:

1. 20 years old and above.
2. Live with the patient and spend the most time caring for the patient.
3. The primary family caregiver is identified by the patient.

Exclusion Criteria:

1. Caregivers with mental illness.
Platelet-rich Fibrin and Grooving for Sagittal Split Osteotomy

Sagittal split osteotomy (SSO) is a common operation done to move the mandible to correct dentofacial deformities and obstructive sleep apnea (OSA). Inferior alveolar nerve (IAN) injury and associated paresthesia is a well-known negative outcome following SSO, causing temporary or sometimes, permanent numbness in the chin and/or lip. There are limited methods to decrease the occurrence and duration of neurosensory dysfunction. Recent research has shown that platelet-rich fibrin (PRF) aids neurosensory recovery after SSO. Another method to minimize nerve injury is proximal segment grooving (PSG) to create space for the nerve to rest. This grooving method has never been formerly reported. The purpose of this study is to answer the following question: Among patients undergoing bilateral sagittal split osteotomy (BSSO) for dentofacial deformity or OSA, do those who receive PRF with or without PSG, compared to those who do not, have shorter times to functional sensory recovery (FSR) of the IAN? The null hypothesis is that there is no difference among 4 treatment groups and neurosensory outcomes. The specific aims of this proposal are to 1) enroll and randomize subjects who will undergo BSSO for correction of dentofacial deformity or OSA into 4 different treatment groups (PSG with PRF, PSG alone, PRF alone, neither PSG or PRF), 2) measure objective and subjective post-operative nerve function at fixed intervals post-operatively for up to 1 year, 3) compare differences in neurosensory outcomes among treatment groups, and 4) identify other variables that might be associated with differences in neurosensory outcomes.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria include patients ages 18 and older, male or female, with a diagnosis of dentofacial deformity and/or OSA who will undergo BSSO.

Exclusion Criteria:

Exclusion criteria include patients with a history of previous mandibular surgery and preoperative neurosensory dysfunction of the trigeminal nerve. Other exclusion criteria are patients without capacity to consent for themselves or unable to read the consent form. Subjects who have conditions which may impair healing (such those on bisphosphonates treatments, blood thinners, corticosteroids, chemotherapy, etc.) will be excluded from participation in the research.
Atorvastatin for the Treatment of Retinal Vein Occlusion

The ATORVO study is designed to determine whether atorvastatin (Lipitor) can improve vision, when compared to placebo

Retinal vein occlusion (RVO), a common cause of visual loss in the Western world, is a disease whose etiology resembles that of classic atherosclerosis. A therapy that lowers the risk of arterial and venous thrombosis would seem to be a reasonable approach to managing this disease, for which there is currently no treatment.

ATORVO is a randomized double-masked clinical trial comparing a daily dose of 80 mg of atorvastatin to matched placebo in persons recently diagnosed with RVO. At 24 weeks after randomization, we will evaluate each participant's visual acuity and the presence of secondary complications related to RVO.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 40 years and older
* Diagnosed with CRVO or BRVO
* Visual acuity of 20/40 or worse in the affected eye
* Onset of current symptoms of loss of vision within the past 60 days
* Ability to understand spoken English

Exclusion Criteria:

* Current use of a statin or fibrate medication
* Known cardiovascular disease or revascularization, including coronary artery disease (myocardial infarction or angina), stroke or peripheral artery occlusion
* Known diabetes mellitus
* Known liver disease
* Serum low-density lipoprotein cholesterol (LDL-C) \> 5.0 mmol/L
* Baseline serum triglycerides \> 6.0 mmol/L
* Serum ALT above 115 U/L (i.e., 2.5 x upper limit of normal)
* Baseline serum creatinine \> 250 µmol/L
* Ocular surgery within the past 90 days
* Planned ocular or cataract surgery within the study period
* Known retinal disease: age-related macular degeneration, retinal detachment or macular hole, or past history of vein occlusion
* Women who are pregnant or who are breastfeeding
* Participation in another clinical trial concurrently or within 30 days prior to screening
* Known allergy to fluorescein dye
* Current use of cyclosporine medication.
* Current use of an HIV protease inhibitor medication.
Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution

To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in healthy male volunteers


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
2. Subjects unable to understand or to comply with study requirements
Indication to Transplant Patients With High Risk B Cells Lymphoma in Metabolic Complete Remission?

The autograft of patients with prognostically unfavourable B-cells lymphoma cells in first remission remains controversial, in particular since the association of Rituximab with chemotherapy. Even though many randomized and non-randomized studies have been conducted, their is still no standard procedure . Recently, the use of early TEP (positron emission topography) answer, after 2 in 3 cures of chemotherapy allowed to select the poor-responder patients who remain candidate to autograft in front-line. Nevertheless, in good-responder patients, the benefits of an intensification therapy ins term of long-lasting disease control remains discussion.

This institutional retrospective study aims at comparing the outcome of early metabolic responder patients who received an intensification treatment to those who received a standard chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with High Risk Big B Cells Lymphoma
* Age \> 18 years

Exclusion Criteria:

* Not applicable
Galactose Supplementation for the Treatment of MOGHE

Mild malformation of cortical development with oligodendroglial hyperplasia in epilepsy (MOGHE) is a new entity frequently associated with refractory epilepsy and neurodevelopmental disorders. Recently, it has been associated to SLC35A2 (Solute Carrier Family 35 Member A2) brain mosaic pathogenic variants. In addition, patients with germline SLC35A2 pathogenic variants improve with galactose supplementation. Therefore, the investigators aim to elucidate whether d-galactose as an add-on treatment might improve epilepsy and developmental outcomes in patients with MOGHE.


Eligibility Criteria:
Inclusion Criteria:

* MOGHE diagnosis at histopathological examination of the epilepsy surgery tissue.
* Epilepsy refractoriness or ongoing epileptiform activity at EEG.

Exclusion Criteria:

* Allergy to galactose or supplement components.
Comparing the Efficacy of Epidural and Quadratus Lumborum Analgesia After Open Nephrectomy Surgery

This study aims to assess if Quadratus Lumborum (QL) blocks are non-inferior to epidural analgesia for pain control and opioid consumption through the third postoperative day in patients having open partial nephrectomy. Patients satisfying all inclusion and exclusion criteria will be randomized in a 1:1 ratio to either epidural catheter or QL catheter.

QL blocks with a single shot and catheters infusions may be an alternative to epidural analgesia. However, the relative efficacy, safety, and cost of the two approaches remain unclear.

Epidural analgesia is frequently used as a component of multimodal analgesia for thoracic and abdominal surgery. QL block has been introduced recently as a component of multimodal analgesia for lower thoracic and abdominal surgery. In general, insertion of QL catheter is easier and safer than insertion of epidural catheters. QL catheter management is also less complicated than epidural analgesia (fewer catheter displacements and less hemodynamic compromise) and decreases the level of complexity in postoperative care. Our hypothesis is that the subcostal QL approach with a continuous catheter is non-inferior to epidural analgesia for pain control and opioid consumption in patients having open partial nephrectomy procedure.

Eligibility Criteria:
Inclusion Criteria:

Adults having for open unilateral partial nephrectomy surgery.

Exclusion Criteria:

1. Pregnancy 2. Intolerance or allergy to opioids 3. Previous radical nephrectomy surgery/midline incision 4. Contraindication to epidural analgesia 5. Contraindications to QL block 6. Chronic pain characterized by: i.Opioids use for more than 30 consecutive days within the 3 preoperative months at the dose equal or greater than equivalent of 15 mg of morphine ii.Abdominal pain for more than 6 months, present most days of the week-
Registry of Acute Stroke Under New Oral Anticoagulants -Pilot (RASUNOA-Pilot)

The registry of acute stroke under new oral anticoagulants (RASUNOA) is a German multicenter, prospective, observational registry performed at about 50 study centers covering about 50.000 acute ischemic strokes and 6000 acute intracranial hemorrhages per year. Study enrollment will be consecutive. The RASUNOA registry study center is the University Medical Center of the Principal Investigator (Heidelberg, Germany). The registry will focus on treatment decisions and concepts in patients being under treatment with a new oral anticoagulant and suffering from acute ischemic or hemorrhagic stroke.

The main purpose of the study is to collect information from a large, prospectively enrolling multicentre stroke database regarding the optimal management of ischemic and hemorrhagic stroke during anticoagulation with nOAC. Specifically, we aim to obtain critical information regarding the epidemiology, natural history, laboratory and neuroradiological aspects, clinical consequences, and the effects of treatment (i.e. thrombolysis/interventional recanalisation in ischemic stroke and hemostatic therapy in ICH, respectively) in stroke during nOAC. The Registry is not limited to a specific new OAC but intends to examine stroke during use of any of the approved nOAC. The study is not designed to perform comparisons among the different nOAC.

Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years
* informed consent
* acute stroke or intracranial bleeding
* therapy with a new oral anticoagulant (Dabigatran®, Rivaroxaban®, Apixaban®, Edoxaban®)

Exclusion Criteria:

* missing informed consent
Anesthetic Optimization in Pediatric LeFort Surgeries

This study will propose and evaluate a standardized LeFort osteotomy anesthetic protocol for pediatric patients at Johns Hopkins Hospital. There are two cohorts to this study: a prospective cohort who will receive the study anesthesia protocol and a historical cohort that received standard of care. The investigators hope this will help to minimize unnecessary postoperative pain management, inpatient stay, and long-term morbidity and mortality in these patients.

This study will propose and evaluate a standardized LeFort osteotomy anesthetic protocol for pediatric patients at Johns Hopkins Hospital. There are two cohorts to this study: a prospective cohort who will receive the study anesthesia protocol and a historical cohort that received standard of care. The investigators hypothesize that implementation of this standardized protocol will show improved surgical outcomes among these patients as compared to current (discretionary) treatment. This study aims to optimize the anesthetic management of these patients in order to minimize postoperative pain management, inpatient stay, and long-term morbidity and mortality in these complex patients.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing Le Fort osteotomy at Johns Hopkins Hospital
* Age \>= 14 years

Exclusion Criteria:

* Contraindications to standardized anesthetic protocol (intervention arm)
Pharmacological Modulation of Cocaine Effects - 1

The purpose of this study is to conduct human laboratory studies of possible cocaine interactions with various potential treatment medications.


Eligibility Criteria:
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